The Kentucky Pharmacist May/June 2019

Vol. 14 No. 3 May/June 2019

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

INSIDE:  

Welcome New KPhA Board of Directors Register Online KPhA Annual Meeting & Convention—June 20—23 Marriott Griffin Gate Resort & Spa Lexington

Reg is

ter T oday !

TABLE OF CONTENTS FEATURES KPhA Sip & Mingle Networking Event |4| KPhA Member Spotlight |4| Kentucky Opioid Summit Recap |8| KPhA Annual Meeting & Event Agenda Overview |9| KPhA Board of Directors |11|

Mission Statement: The mission of KPhA is to advocate for and advance the profession through an engaged membership.

On the Cover 

Photos featuring the 2018 KPhA Annual Meeting & Event

Editorial Office: ©Copyright 2019 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |6| Advocacy Matters |12| New KPhA Members |13| Continuing Pharmacy Education |14| Continuing Pharmacy Education Quiz—May |18| Answer Sheet—May |19| Continuing Pharmacy Education |22| Continuing Pharmacy Education Quiz—June |26| Answer Sheet—June |27| Pharmacy Law Brief |28| Campus Corner |29| Pharmacy Policy Issues |30|

Publisher: Mark Glasper Managing Editor: Sarah Franklin Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601.

Phone: 502.227.2303 Fax: 502.227.2258.

Email: info@kphanet.org.

Website: www.kphanet.org.

ADVERTISERS

|2| Kentucky Pharmacists Association | May/June 2019

APSC|5| EPIC |13| PTCB |21| Pharmacists Mutual |32| Cardinal |33| APMS |Back cover|

PRESIDENT’S PERSPECTIVE It is hard to believe, but this is my final message to you as President of our KPhA. My term moved swiftly and once I thrust myself into the role, it seemingly passed very quickly. I suppose the norm would be to reflect and sum up my thoughts and our KPhA’s accomplishments throughout my term as President. I will do a little of that but, as most of you know, I usually do not comply with the norm. So, while I will share some perspective as mentioned above, I will also try one last time as your President to inspire forward thinking and try to challenge us as stewards of the profession on how we proceed going forward. Our KPhA has accomplished many wonderful things over the last 10 months or so. Here are a few of the highlights.

“I witnessed extreme dedication by the chairs of several committees throughout the year and would like to thank all of them and their committee members for the hard work and countless hours of volunteer service to our KPhA.” KPhA has started a new networking event series titled KPhA Sip & Mingle. They are FREE events put together to provide KPhA members the ability to receive live education (non-CE), but more importantly, the ability to network. It encourages the members responsible for hiring pharmacists or technicians to sit in the same room as the very pharmacists or technicians searching for the perfect practice setting. KPhA members are encouraged to bring non-member guests as well in an effort to broaden our membership base. The first event was in Louisville and was a success. The second is in the planning stages as I write this article and will be in Lexington in June.

are all negatively impacted by unfair PBM practices. We may not have passed SB139 this past general session, but we have made great headway on educating legislators which provides us an advantage as we work toward the 2020 general legislative session to fight for simple fair business practices.

Chris Palutis President, KPhA

We have reenergized our relationship with KSHP as our Executive Teams have met on approximately a quarterly basis to ensure we unite together for the betterment of our profession.

KPhA now has a solid seat at the table and is working closely with the KY Medicaid Commissioner on pharmacy related issues.

After five years or so, we have finally put the Drug Abuse Awareness Grant to use by holding the first Kentucky Opioid Summit. This was done by working closely with the other groups also participating in the grant from the KY Board of Pharmacy. These groups were our KPhA, KSHP, KY Board of Pharmacy, UK College of Pharmacy and Sullivan College of Pharmacy and Health Sciences. It was wonderful to be part of the process whereby all of these organizations came together to host the very successful summit.

We will be announcing the newly created Center of Excellence at our annual meeting in June. I will not divulge any specifics here as you will have to attend the annual meeting to hear the details.

I am very proud of the work that so many members of our KPhA have done to support the efforts listed above.

I witnessed extreme dedication by the chairs of several We have done a great job putting the PBMs on notice committees throughout the year and would like to thank that we in fact plan to stand up and fight to level the all of them and their committee members for the hard playing field by demanding fair business practices. As I work and countless hours of volunteer service to our have said many times, we are not searching for a way to KPhA. get any advantage, we just want to be treated fairly and be given the chance to compete. Whether it is an inde- Looking forward, I am excited to transition from Presipendent pharmacy, a local or regional chain, an outpa- dent of our KPhA to Chairman of the Board of Directient hospital pharmacy or a grocery store pharmacy, we tors. While in this new role, I plan to steer the board Continued on pg. 4 |3| www.KPHANET.org

meetings to align with our strategic plan and continue to President is that there is an endless demand for leaderbuild upon the impressive momentum we have been ship and a call to step forward. My final request is to able to achieve over the years. ask each of you to consider being one of the people willing to lead. Step forward to ensure our great profession Now, I would like all of you to think about how each maintains the support needed to evolve and remain releand every one of you can help our profession. Paying vant for decades to come. membership dues, contributing to the Government Affairs Fund or Political Action Committee, or attending In closing, I want to thank all of you for allowing me the our annual meetings are all important aspects of how we privilege to lead our KPhA as President. It has been an continue to support the profession. But I am referring to extremely rewarding experience. something larger. When was the last time you mentored someone with potential but they just needed a nudge to allow them to mature into an even better pharmacist?

Have you volunteered to be on a committee that can benefit from your knowledge and expertise? When was the last time you attended a KY Board of Pharmacy THE location for pharmacy job meeting? Have you visited the new KPhA office or attended a KPhA Board meeting? One of my learnings as

jobs.kphanet.org

seekers + employers for

Member Spotlight

targeted positions.

Rebekah is a PGY1 resident at the Cincinnati VA Medical Center. She joined KPhA so she could create meaningful opportunities and relationships to impact and advance the pharmacy practice. Rebekah loves the fact that pharmacy is so versatile, regardless of the practice setting, and pharmacists are able to work with a wide range of patients with different diagnoses and illnesses. After working as a technician and seeing firsthand the responsibility and service pharmacists provide, Rebekah decided to pursue the career of pharmacy. The biggest lesson Rebekah has learned from pharmacy is to always expect the unexpected. Rebekah’s advice to future pharmacists is to be ready to use your critical thinking skills and to always strive to learn more. Pharmacists are problem solvers and must be ready for any problems that might arise.

Rebekah Wahking

Thursday, June 20, 2019 | 7:30 - 10:00 PM | Tony’s| 401 W Main St, Lexington, KY 40507 Sponsored by Novo Nordisk Free Networking Event Schedule •

7:30-8:00 p.m.

Registration Open

•

8:00-8:30 p.m.

Educational Presentation by Novo Nordisk (non-CEU)

•

8:30-10:00 p.m. Networking Event

Heavy hors d’oeuvres and wine/beer will be available (self-pay for liquor drinks). You do not have to be registered for the KPhA Annual Meeting & Convention to attend. KPhA members are encouraged to bring a potential member as a guest. Please note that guests need to be a pharmacist or pharmacy technician. Any KPhA member who's guest joins KPhA will receive $50 off their next KPhA membership dues invoice. |4| Kentucky Pharmacists Association | May/June 2019

|5| www.KPHANET.org

MY KPhA Rx Pharmacists Shine in Nation’s Capital

By Mark Glasper KPhA Executive Director/CEO I was honored to lead a Kentucky delegation of pharmacists and Sullivan University pharmacy students to the National Community Pharmacists Association Congressional Fly-in April 10-11, 2019 in Washington, D.C. We joined more than 300 community pharmacists from 37 states who participated in the event, marking NCPA’s 50th Annual Congressional Pharmacy Summit.

Special thanks go to KPhA Past President Leon Claywell, Alyson & JT Roby and Ben Mudd for their advocacy efforts in the nation’s capital. I also appreciated the strong show of support by the 11 SUCOPHS students who attended the event, including Hayley Beeler, Thomas Boone-Abraham, Matthew Boyd, Hayley Craven, Timothy Davis, Andrew Dones, Shawna Harmon, Mohammed "Ace" Hasnain, Long Phan, Madison Poteet and Rachel Prater.

Members of the KPhA delegation pause at the steps of the Capitol during the NCPA Congressional Fly-In in Washington D.C.

Congressional Visits Steal the Show You never know whether or not you’ll actually get to meet with your members of Congress when these visits are scheduled a month or two in advance. Their schedulers will tell you that you’re on their calendars but anything can happen to upend those hard earned visits.

Therefore, it’s always a charge when you get to sit down face to face and discuss issues with our elected officials.

The delegation was successful in meeting with Senator Rand Paul (R) and Representatives James Comer (R1st), Brett Guthrie (R-2nd) and John Yarmuth (D-3rd).

We also met with the staffs of Senator Mitch McConnell (R) and Representative Thomas Massie (R-4th). Information packets were left with the staffs of Representatives Andy Barr (R-6th) and Hal Rogers (R-5th). As a Kentucky delegation members explain the harmful tactics bonus, we met with Indiana Representative Trey Holof PBMs and the effects of DIR fees on pharmacies to Sen. lingsworth (R-9th) who had two of the SUCOPHS stuRand Paul. dents as constituents. |6| Kentucky Pharmacists Association | May/June 2019

join the Kentucky delegation in April 2020. You’ll be inspired!

Register Now for KPhA Annual Meeting Speaking of making plans, please do just that and register today for the 141st KPhA Annual Meeting & Convention June 20-23, 2019 at the Marriott Griffin Gate Resort in Lexington, Ky. We have a full slate of outstanding CE and great networking opportunities for you to enjoy.

KPhA Past President Leon Claywell, Alyson Roby and JT Roby meet with Rep. Brett Guthrie in between hearings at the Capitol.

We will have a grand opening of the KPhA Hall of Exhibits on Friday, June 21, 2019, from 5:30-7:30 p.m. with a cash bar and hor d’oeuvres. We also have a dedicated exhibitor session on Saturday, June 22, 2019, from 10-11:30 a.m. Please plan to spend time with our exhibitors to discover the latest in the profession.

You also won’t want to miss the KPERF Golf Scramble Thursday, June 20, or our Sip & Mingle Networking Event that evening to kick off the meeting. Look for details on page 9!

KPhA Board member Ben Mudd (l) and SUCOPHS students meet with Rep. James Comer during the NCPA Fly-In. Along with the other fly-in attendees, we charged Capitol Hill to advocate for NCPA’s three priority issues: an end to retroactive pharmacy DIR fees, transparency in generic reimbursement rates in federal programs, and to open Medicare preferred pharmacy networks to all pharmacies willing to accept contractual terms and conditions. We also pressed Congress to grant pharmacists provider status under Medicare Part B and offered recommendations for stemming the opioid epidemic.

SUCOPHS students join me with Rep. John Yarmuth for a photo after meeting to discuss pharmacy issues.

If you’ve never gone to the NCPA Congressional Pharmacy Fly-in, then you need to experience the passion that pharmacists have about the topics that matter most to pharmacy on a national scale. Make plans now to |7| www.KPHANET.org

The inaugural Kentucky Opioid Summit was hosted on March 30, 2019 with over 100 attendees made up of pharmacists, nurses and physicians.

The educational topics included were on the current climate of the crisis, non-opioid treatments, MAT and policy changes. The event was funded by the Kentucky Board of Pharmacy Drug Abuse Awareness grant in partnership with the Kentucky Pharmacists Association, Kentucky Society of HealthSystem Pharmacists, University of Kentucky College of Pharmacy, and Sullivan University College of Pharmacy and Health Sciences.

We would like to thank all of the committee members who assisted in developing the programming for the event, Chris Harlow, chair, Suzi Francis, Trish Freeman, Dan F. McCune, Doug Oyer, Leslie Kenney, Emma Palmer, Larry Hadley, and Jill

Rep. Danny Bentley presents Policy Solutions to the Opioid Crisis to the attendees. |8| Kentucky Pharmacists Association | May/June 2019

Attendees at the Kentucky Opioid Summit.

UK student, Eric Marr addresses the attendees.

LEX 18 and WKYT covered the event.

Jody Jaggers presenting naloxone training to the attendees.

Trish Freeman facilitated the community response panel.

An attendee meets with an exhibitor during a break.

Annual Meeting & Convention Agenda Overview Thursday, June 20, 2019 12:00 PM

KPERF Golf Scramble

Widow’s Watch Course at the Golf Club of the Bluegrass | Nicholasville 7:30 PM

Networking Sip & Mingle Open to all - Annual Meeting Registration not required, but please RSVP online

Friday, June 21, 2019 7:00 AM

Registration Open

7:30 AM

Opening Breakfast

8:00 AM

Continuing Education Session Topic: Weeding Through the Facts (Therapeutic Uses of CBD) Presenter: Shelley Roberts, PharmD

8:50 AM

BREAK

9:00 AM

Concurrent Continuing Education Sessions Topic: Drug Conviction Data in KASPER: What have we learned?

Presenters: Trish Freeman, PhD & Dana Quesinberry, JD, DrPh |9| www.KPHANET.org

Annual Meeting & Convention Agenda Overview Topic: Safety Nets and Trampolines Improv ing Patient Safety in your Pharmacy Presenter: Tara Modisett (APMS) 9:50 AM

BREAK

10:00 AM

Concurrent Continuing Education Sessions Topic: Malpractice Presenter: Kristen Jones

Topic: Kentucky & Legislative Law Update Presenter: Ralph E. Bouvette, RPh, PhD, JD 9:30 AM

Hall of Exhibits Open

11:00 AM

Concurrent Continuing Education Sessions Preceptor Development (Pharmacists only) Presenter: Andrew Ritzel Topic: Pharmacy Technician Presenters: Sara Lisenby, Sarah Lawrence

Topic: CPESN Boot Camp Presenter: Paula Miller 10:50 AM

BREAK

11:00 AM

House of Delegates

12:30 PM

Luncheon

1:30 PM

BREAK

1:40 PM

Concurrent Continuing Education Sessions Topic: Emergency Preparedness Presenter: Michele Pinkston

12:00 PM

Colleges of Pharmacy Update & Preceptor Luncheon

1:00 PM

BREAK

1:10 PM

Transitions of Care Panel

2:00 PM

BREAK

2:10 PM

Continuing Education Session

3:00 PM Topic: CV/T2D Presenter: Kim Birtcher, M.S, Pharm.D, 3:10 PM AACC, FNLA, BCPS-AQ Cardiology, CDE Clinical Professor 6:00 PM

BREAK

2:30 PM

BREAK

7:00 PM

Ray Wirth Awards Banquet

2:40 PM

Concurrent Continuing Education Sessions

9:00 PM

Day Concludes

Topic: Kentucky Board of Pharmacy Update Presenter: Larry Hadley

Sunday, June 23, 2019

Topic: Anaphylaxis – Overview 3:30 PM

BREAK

3:40 PM

Concurrent Continuing Education Sessions Topic: NASPA/NMA Student Pharmacist Self Care Championship Facilitator: Jody Jaggers Topic: MAT Presenter: Jessica Johnson

5:30 PM

Hall of Exhibits Opening Reception

7:30 PM

KPPAC Reception

House of Delegates (Officer Installation) President’s Reception

8:30 AM

Breakfast

9 – 11:00 AM

KPhA Board of Directors New Member Orientation (invitation only)

9:30 AM

Continuing Education Session Topic: New Drug Update Presenter: Daniel R. Malcom, PharmD, BCPS, BCCCP

10:20 AM

BREAK

10:30 AM

Continuing Education Session Topic: New Guidelines Presenters: Jessica Johnson & Tyler Stevens

11:30 AM

Day Concludes

Saturday, June 22, 2019 6:30 AM

Registration Open

7:00 AM

Breakfast

8:00 AM

Reference Committee Meeting

8:00 AM

Continuing Education Session

|10| Kentucky Pharmacists Association | May/June 2019

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Welcome KPhA Board of Directors 2019-20 Chris Palutis Chair Don Kupper President Joel Thornbury President-Elect Brooke Hudspeth Secretary Chris Killmeier Treasurer

Scotty Reams Student Representative UKCOP *Student Representative SUCOPHS *Past President Representative *Vice Speaker of the House *Director *Will be filled at the KPhA Annual Meeting & Convention Thank you to the following Board of Director members for their service: Duane Parsons Treasurer

Matt Carrico Director

Tyler Stevens Speaker of the House

Chad Corum Director

Blake Wiseman Director

Jessika Chilton-Chinn Director Cathy Hanna Director

Dharti Patel Student Representative UKCOP Stephen Drog Student Representative SUCOPHS

Cassy Hobbs Director Ben Mudd Speaker of the House of Delegates Jeff Mills Director Richard Slone Director Angela R. Brunemann Director

Current and post KPhA Board of Directors members.

|11| www.KPHANET.org

Advocacy Matters Ways you can support KPhA’s Advocacy efforts today! 

Participate in grassroots advocacy efforts



Get to know your legislators—they should know your name



Donate to the Political Advocacy Council and the Government Affairs Fund

Donate online to the KPhA Government Affairs Fund Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC. Go to www.kphanet.org. |12| Kentucky Pharmacists Association | May/June 2019

Welcome to KPhA! We’re so happy to have you!

The list reflects new memberships received from March 1, 2019 — April 30, 2019 Corey Brown Pharmacist

James Morgan Technician

Tammy Schlensker Pharmacist

Andraya Clark Associate Member

Laura Murphy Technician

Kimberly Strano Pharmacist

Jack Cluxton Pharmacist

Victor Nwosu Pharmacist

MEMBERSHIP MATTERS:

Brad Deegan Pharmacist

Jenna Parrett Pharmacist

Raymond Float Pharmacist

Sanjeev Patwardhan Pharmacist

To YOU, To YOUR Patients To YOUR Profession!

|13| www.KPHANET.org

May CPE Article Precision Medicine and Pharmacogenomics: An Overview By: Sarah Warren, PharmD, Sr. Clinical Content Specialist - Pharmacogenomics, Wolters Kluwer, Clinical Effectiveness

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-19-005-H01-P &T 1.0 Contact Hours (0.10 CEU) Expires 5/15/22 Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1.

Identify the key aspects of the Precision Medicine Initiative

2.

Discuss the progress of the Precision Medicine Initiative thus far

3.

Identify resources for pharmacogenomic information

4.

Discuss some of the barriers and unanswered questions regarding adoption of pharmacogenomics into clinical practice

The Precision Medicine Initiative The Precision Medicine Initiative (PMI) was launched by the Obama administration with an investment of $215 million of the President’s 2016 Budget. The goal of the initiative is to transform health care’s current “one-size-fits-all” model into more accurate methods of prevention and treatment of disease by supporting research, development, and innovation in precision medicine. Precision medicine personalizes treatment for individuals based on their genetics, environment, and lifestyle. It offers providers more clinical tools to help them understand the complex mechanisms underlying disease and to better predict what treatments would be most effective.1 While the transformation of our current health care approach is the goal, precision medicine is more than just a health care initiative. For precision medicine to revolutionize the standard of care, advancements in many industries will need to be achieved.

such as that from commercial laboratories, to be accessed and used by patients, by providers at point-of-care, and by clinical researchers.4

$10 million of the PMI funding was allocated to the Food and Drug Administration (FDA) to aid in the development of high quality databases and regulatory standards that advance precision medicine while protecting public health.1 Next generation sequencing (NGS) is a laboratory technique that can quickly and efficiently sequence an individual’s DNA and identify genomic variations that may help in the diagnosis, treatment, and general understanding of human diseases. In April 2018, the FDA issued final guidance on the design, development, and analytical validation of NGS. In April 2018, the FDA also issued final guidance on the use of FDArecognized public genetic variant databases to support clinical validity for genomic tests. These guidance documents are intended to act as a flexible system of NGS testing oversite, Of the $215 million PMI investment, $5 million was allocated with a goal of fostering innovation among testing developers while ensuring that NGS tests provide accurate and useful to the Office of the National Coordinator for Health Information Technology (ONC) to advance the exchange of health results.5,6 care data across various systems and to aid in the develop$70 million of the PMI funding was given to the National ment of standards for such exchanges.1 To achieve these goals, ONC has launched Sync for Science (S4S), a collabora- Cancer Institute (NCI) to advance the field of precision ontive effort among several electronic health record (EHR) ven- cology.1,7 There are already many genetically targeted cancer treatments currently available, and NCI had begun several dors, the National Institutes of Health (NIH), and the Harvard Medical School Department of Biomedical Informatics. precision medicine clinical trials prior to the launch of PMI. With the PMI funding, NCI is focusing on overcoming drug The S4S technology program allows patients to access their resistance often associated with targeted therapies, developing own health information and share it with researchers study2,3 ing human health and disease. ONC has also launched Sync new laboratory models for research, and establishing a nafor Genes, an initiative whose goal is to enable genomic data, tional database for cancer-related genomic data as well as |14| Kentucky Pharmacists Association | May/June 2019

clinical response and outcomes data. In addition, NCI has expanded its precision medicine cancer treatment clinical trial known as Molecular Analysis for Therapy Choice (NCIMATCH). In this trial, a patient’s tumor is genetically sequenced, and treatment utilized is based on the genetic changes of the tumor, regardless of what type of cancer the patient has. The expansion of NCI-MATCH includes increased patient participation and more detailed sequencing analyses of treated patients.7

cant interactions identified in these individuals, 34% were drug-gene or drug-drug gene interactions. There is also limited evidence that pharmacogenetic testing in the elderly may reduce hospitalization rates.20

One resource for discovering if a drug has any pharmacogenomic links is the FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling, found on the FDA website.21 This table, which is updated periodically, contains a list of all drugs whose FDA-approved labels contain pharmacogenetic The majority of PMI funding, a total of $130 million, was information. It is important to note that pharmacogenetic inallocated to the NIH to develop a national, large-scale reformation can appear in different sections of different drug search cohort.1 With this funding, NIH launched All of Us, a labels, and not all drug labels found in the table include specifresearch program in which any adult in the U.S. can volunteer ic actions to be taken based on a patient’s genomics. A comtheir health data to be used by researchers to advance precimon group of biomarkers found in the table are the genes ension medicine. All of Us, the first research program to adopt coding the cytochrome-P450 (CYP) enzymes. These enzymes, use of ONC’s S4S technology program, is aiming to gather such as CYP2D6 and CYP2C19, are responsible for the hepatdata from one million or more volunteers who adequately ic metabolism of many drugs. Certain alterations in CYP enrepresent the diversity of the U.S. population.8,9 Volunteer zyme genetic makeup have been associated with altered pharparticipants have access to their health information and will macokinetics and, sometimes, indications for dose adjustbe asked to engage in the program in a variety of ways. Paments or the avoidance of particular drugs. In addition, many tient volunteering engagements may include contributing ad- of the drugs listed in the table are targeted cancer therapies, ditional information about one’s medical history and lifestyle, and their pharmacogenomic biomarkers are often tumor muhaving physical measurements taken by a health care provid- tations that serve as indication for a drug’s use (such as er, or providing a blood or urine sample.9 Thus far, over BRAF, EGFR, and HER2). Overall, the FDA Table of Phar110,000 people have registered for All of Us, and the program macogenomic Biomarkers includes more than 260 drugs that was recently awarded $28.6 billion to establish three genome are used in various specialties, such as cardiology, hematolocenters, with a goal of sequencing one million genomes.10 In- gy, infectious disease, neurology, psychiatry, and more.21 dividuals interested in becoming a volunteer participant for Another resource for accessing pharmacogenetic information All of Us can sign up through the program’s website contained in drug labeling is The Pharmacogenomics (https://allofus.nih.gov/).

Knowledgebase (PharmGKB). PharmGKB is an NIH-funded knowledge resource that provides a variety of information on Pharmacogenomics in Precision Medicine how genetic variations can affect drug response. In addition to With the progressive development and advancement of NGS, information about drug-gene associations and genotypethere has been a recent focus on genomics, the study of genes phenotype relationships, PharmGKB contains published cliniand their functions, in precision medicine. Identifying differcal pharmacogenetic guidelines, summaries about important ences in the genes of individuals can help personalize the diag- pharmacogenetic genes, and drug pathways detailing the ponosis and treatment of diseases. Pharmacogenomics combines tential mechanisms of gene influences on drug therapies. pharmacology (the science of drugs) with genomics to study Aside from collecting and curating clinical pharmacogenomic how an individual’s genes may affect the way they respond to information for open and free public access, PharmGKB also specific drugs.11 Variations in genetic makeup are believed to collaborates with other groups to contribute to clinical implehelp explain why a standard dose of a given medication can mentation of pharmacogenomics and to explore important have no therapeutic effect in some patients and cause adverse questions related to pharmacogenomics.12 effects in others. The term “pharmacogenetics” refers to how The Clinical Pharmacogenetics Implementation Consortium specific genes affect specific drugs, while “pharmacogenomics” refers more broadly to the study of how (CPIC) is an international consortium that was established in 2009 as a joint effort between PharmGKB and the Pharthe genome influences response to drugs. However, the two macogenomics Research Network (PGRN). CPIC addresses terms are often used interchangeably.12 what has been one of the major barriers to clinical implemenThe preliminary data behind pharmacogenetics is one reason tation of pharmacogenetic testing: the lack of freely available, the concept has drawn attention in recent years. More than peer-reviewed, updatable, and detailed gene/drug clinical 90% of individuals genotyped possessed at least one actionapractice guidelines.22 CPIC publishes guidelines regarding ble pharmacogenetic variant in several studies assessing the drug choice, dosage, monitoring, etc., based on an individuprevalence of genetic variation. 13-16. It is estimated that 18% of al’s genetic makeup for established gene-drug interactions. prescriptions written in the US have actionable pharmacoCPIC guidelines are endorsed by both the American Society genetic recommendations, and as many as 65% of individuals of Health-System Pharmacists (ASHP) and the American Soreceiving primary care will be exposed to a medication with ciety for Clinical Pharmacology and Therapeutics an established pharmacogenetic association over a five-year (ASCPT).22 The co-chairs of CPIC have recently been awardtime period. 17-18 One study of 1143 individuals found that 501 ed a $5 million grant to continue their work over the next 5 had drug-drug, drug-gene, or drug-drug-gene interactions that years.23 CPIC is continually updating their existing recomhad potential to be clinically significant.19 Of the 1053 signifi- mendations and developing new guidelines as more research |15| www.KPHANET.org

data becomes available.12 The Dutch Pharmacogenetics Working Group (DPWG) was established in 2005 by the Royal Dutch Pharmacist's Association with a similar mission of developing pharmacogenetics-based therapeutic recommendations. Both CPIC and DPWG guidelines are published on the PharmGKB website, which currently contains more than 100 published pharmacogenetic guidelines.12 With an abundance of laboratories offering pharmacogenetic testing and actionable genotype-based drug therapy recommendations beginning to be identified, pharmacogenetics is starting to be adopted into clinical practices. However, there are many important barriers to be overcome prior to the full implementation of pharmacogenetics into clinical practice.

Translation between different software systems (such as results from a commercial laboratory being transferred to an EHR, or information being exchanged between EHRs) is one issue, which is what ONC was allocated their PMI budget to begin addressing. The privacy and security of electronic health information, including patient genotypes, throughout this process is also important. Simplification of genetic results and education of both patients and providers are additional hurdles that will need to be overcome. Critically, health insurance reimbursement for pharmacogenetic testing will also be necessary before pharmacogenomics can be a mainstay of precision medicine in clinical practice. Identification of more drug-gene interactions where there is clinical outcome data supporting the cost-effectiveness of pharmacogenetic testing may increase the likelihood of this occurring, however, this is also a monumental challenge.24, 25 In addition to the barriers that must be overcome, there are many questions related to pharmacogenomic testing that have yet to be answered. One question being debated is whether pharmacogenetic testing should be done preemptively (i.e., before a medication is prescribed) or reactively (after a drug trial has failed by lack of efficacy or experience of adverse reactions). A similar question is whether only the genes relevant to a particular drug therapy should be genotyped when a patient’s DNA is being assessed, or if it is more beneficial to genotype an entire array of genes for future or potential alternative drug therapy considerations. As pharmacogenomic results are integrated into EHRs, additional discussions center around where in the EHR they would be stored, and whether they should be actively delivered with notifications to providers or passively delivered, requiring a health care provider to search for them in order to utilize them. As with most genetic testing, the ethics of genotyping patients for pharmacogenomic purposes is also a current discussion.26 Precision medicine is on the path to becoming the new standard of health care, but it does currently have limitations and room to grow. There are several critical players in precision medicine, including federal regulatory groups, NCI, and NIH. In addition, precision medicine is multifaceted. While genomics appears to be a key aspect to precision medicine, health care data storage and security, laboratory standards, and researcher access to more patient data are also vital to moving it forward. As innovation in technology, research, and knowledge continues, precision medicine will be increasingly realized in the health care system.

|16| Kentucky Pharmacists Association | May/June 2019

References 1. Office of the Press Secretary. FACT SHEET: President Obama’s Precision Medicine Initiative. The White House website. https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/factsheet-president-obama-s-precision-medicine-initiative. January 30, 2015.

Accessed September 13, 2018.

2. White J, Briggs J, Mandel J. NIH and ONC Launch the Sync for Science (S4S) Pilot: Enabling Individual Health Data Access and Donation. Health IT website. https://www.healthit.gov/buzz-blog/health-innovation/nihand-onc-launch-the-sync-for-science-pilot. March 21, 2016. Accessed October 19, 2018.

3. Caban TZ, Chaney K. The Precision Medicine Era is Dawning. Health IT website. https://www.healthit.gov/buzz-blog/precisionmedicine/precision-medicine-era-dawning. April 11, 2017. Accessed October 19, 2018.

4. Sync4Genes About. Sync for Genes website. http://www.sync4genes.org/.

Accessed October 19, 2018.

5. FDA News Release. FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests. U.S. Food and Drug Administration website. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm509 814.htm. Last updated July 7, 2016. Accessed October 19, 2018.

6. Precision Medicine. U.S. Food and Drug Administration website. https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitr odiagnostics/precisionmedicine-medicaldevices/default.htm. Last updated September 27, 2018. Accessed October 19, 2018.

7. NCI and the Precision Medicine Initiative®. National Cancer Institute website. https://www.cancer.gov/research/areas/treatment/pmi-oncology.

Last updated July 24, 2017. Accessed October 19, 2018.

8. Sync for Science: Empowering individuals to participate in health research. Verlily website. https://blog.verily.com/2018/03/sync-for-scienceempowering-individuals.html. March 2, 2018. Accessed October 26, 2018.

9. All of Us Research Program. National Institutes of Health website. https://allofus.nih.gov/. Accessed October 26, 2018.

10. NIH-funded genome centers to accelerate precision medicine discoveries.

National Institutes of Health website. https://allofus.nih.gov/news-eventsand-media/announcements/nih-funded-genome-centers-accelerate-precisionmedicine-discoveries. September 25, 2018. Accessed October 26, 2018.

11. Genetics Home Reference. What is pharmacogenomics? U.S. National Library of Medicine website. https://ghr.nlm.nih.gov/primer/genomicresearch/pharmacogenomics. Last updated December 18, 2018. Accessed December 18, 2018.

12. The Pharmacogenomics Knowledgebase. PharmGKB website. https://www.pharmgkb.org/. Accessed November 1, 2019.

13. Bush WS, Crosslin DR, Owusu-Obeng A, et al. Genetic variation among 82 pharmacogenes: The PGRNseq data from the eMERGE network. Clin Pharmacol Ther. 2016;100(2):160-169.

14. Dawes M, Aloise MN, Ang JS, et al. Introducing pharmacogenetic testing with clinical decision support into primary care: a feasibility study.

CMAJ Open. 2016;4(3):E528-E534.

15. Ji Y, Skierka JM, Blommel JH, et al. Preemptive Pharmacogenomic Testing for Precision Medicine: A Comprehensive Analysis of Five Actionable Pharmacogenomic Genes Using Next-Generation DNA Sequencing and a Customized CYP2D6 Genotyping Cascade. J Mol Diagn. 2016;18(3):438445.

16. Van Driest SL, Shi Y, Bowton EA, et al. Clinically actionable genotypes among 10,000 patients with preemptive pharmacogenomic testing. Clin Pharmacol Ther. 2014;95(4):423-31.

17. Relling MV, Evans WE. Pharmacogenomics in the clinic. Nature.

2015;526(7573):343-350.

18. Schildcrout JS, Denny JC, Bowton E, et al. Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. Clin Pharmacol Ther. 2012;92(2):235-242.

19. Vergbeurgt P, Mamiya T, Oesterheld J. How common are drug and gene interactions? Prevalence in a sample of 1143 patients with CYP2C9, CYP2C19 and CYP2D6 genotyping. Pharmacogenomics. 2014;15(5):655665.

Pharmacists in the Community We encourage members to submit photos that show the great work that pharmacists are doing around the Commonwealth. Please submit via email to info@kphanet.org.

20. Brixner D, Biltaji E, Bress A, et al. The effect of pharmacogenetic profiling with a clinical decision support tool on healthcare resource utilization and estimated costs in the elderly exposed to polypharmacy. J Med Econ.

2016;19(3):213-228.

21. Table of Pharmacogenomic Biomarkers in Drug Labeling. U.S. Food and Drug Administration website. https://www.fda.gov/drugs/scienceresearch/ucm572698.htm. Last updated August 3, 2018. Accessed December 17, 2018.

22. The Clinical Pharmacogenetics Implementation Consortium (CPIC).

CPIC website. https://cpicpgx.org/. Accessed December 17, 2018.

23. St. Jude researchers awarded grant to lead pharmacogenetics implementation efforts. St. Jude Children’s Research Hospital website. https://www.stjude.org/media-resources/news-releases/2018-medicinescience-news/st-jude-researchers-awarded-grant-to-lead-pharmacogeneticsimplementation-efforts.html. Accessed October 30, 2018.

24. McKinnon RA, Ward MB, Sorich MJ. A critical analysis of barriers to the clinical implementation of pharmacogenomics. Ther Clin Risk Manag.

2007;3(5): 751–759.

25. Rule D. Implementing a Pharmacogenomics Program. Clinical Lab Products website. http://www.clpmag.com/2017/05/implementingpharmacogenomics-program/. May 22, 2017. Accessed December 17, 2018.

26. Borden BA, O’Donnell PH. Implementing Preemptive Pharmacogenomics in Clinical Practice. American Association for Clinical Chemistry website. https://www.aacc.org/publications/cln/articles/2018/april/implementingpreemptive-pharmacogenomics-in-clinical-practice. April 1, 2018. Accessed December 17, 2018.

KPhA Board of Directors member, Matt Carrico consults with a child at his independent pharmacy.

KPERF Launches New Continuing Education Online Platform We have transitioned to a new Continuing Education platform. In the past year we have integrated online CPE, but it was not a comprehensive online solution. Now, when you complete your CPE article activities online the credits will be automatically sent to CPE Monitor. You can also begin an activity, pause, and come back to complete the credits. You will also receive an email once your activity is complete, so that you can keep track of the activities you complete. We will continue to allow for mailed quiz submissions, but highly recommend that you try out the new platform!

Please contact Sarah Franklin (sarah@kphanet.org or 502.227.2303) with any questions. We are happy to assist you in obtaining your FREE CPE credits through The Kentucky Pharmacist!

2019 Articles: www.kphanet.org/the-kentucky-pharmacist-cpe-articles-2019 2018 Articles: https://www.kphanet.org/2018-continuing-education-articles |17| www.KPHANET.org

May 2019 — Precision Medicine and Pharmacogenomics: An Overview

1. What was the total budget allocated to the Precision Medicine Initiative at its launch?

6. All of the following are barriers to implementation of pharmacogenetics in clinical practice except:

A. $10 million

A. Establishment of resources for pharmacogenomic information

B. $70 million C. $130 million D. $215 million 2. The Food and Drug Administration (FDA) has released two guidance documents related to what facet of precision medicine?

B. Reimbursement by insurance companies C. Education of patients and providers D. Translation of data between software systems 7. Which of the following are current questions related to clinical use of pharmacogenomics?

A. The exchange of health care data across platforms

A. Preemptive vs reactive testing

B. Next generation sequencing

B. Where genomic data should be stored in the HER

C. Security of personal health data

C. If CYP enzymes are relevant to pharmacogenomics

D. Creation of a national research cohort

D. A and B

3. The National Cancer Institute (NCI) had already begun precision medicine clinical trials before the launch of the Precision Medicine Initiative.

E. A and C

A. True B. False

8. Which of the following is a resource for finding pharmacogenomic guidelines?

A. All of Us B. NCI-MATCH

4. All of the following are true regarding the All of Us program, except:

C. Sync for Genes

A. The goal is to gather data from 100,000 volunteers

D. PharmGKB

B. Individuals can volunteer their health care data to be used 9. The FDA Table of Pharmacogenomic Biomarkers in Drug Labeling contains drugs from which specialty? by researchers C. Individuals may be asked to actively participate in the program

A. Oncology B. Psychiatry

D. It is the first research program to adopt use of the Office C. Cardiology of the National Coordinator for Health Information Technology’s Sync for Science program D. All of the above 5. Which of the following are pharmacogenomics-based therapy guideline developers?

10. What is the overall goal of the Precision Medicine Initiative?

A. Clinical Pharmacogenetics Implementation Consortium (CPIC)

A. To transform health care’s current “one-size-fits-all” model

B. Dutch Pharmacogenetics Working Group (DPWG)

B. To create technology that ensures the privacy and security of health data

C. National Pharmacogenetics Guideline Association (NPGA) D. A and B

C. To include as much pharmacogenomic information as possible in drug labels D. To regulate next generation sequencing laboratories

|18| Kentucky Pharmacists Association | May/June 2019

This activity is a FREE service to members of the Kentucky Pharmacists Association.

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 5/15/2022 Successful Completion: Score of 80% will result in 1.0 contact hour or .10 CEUs. TECHNICIANS ANSWER SHEET May 2019 — Precision Medicine and Pharmacogenomics: An Overview(1.0 contact hour) Universal Activity # 0143-0000-19-005-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B 5. A B C D 7. A B C D E 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #__________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET May 2019 — Precision Medicine and Pharmacogenomics: An Overview (1.0 contact hour) Universal Activity # 0143-0000-19-005-H01-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B 5. A B C D 7. A B C D E 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted. |19| www.KPHANET.org

|20| Kentucky Pharmacists Association | May/June 2019

Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to  completing a continuing education article for publication in The Kentucky Pharmacist.  



Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).



Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not  pertinent to technicians, that needs to be stated clearly at the beginning of the article.



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

Include 3 to 5 objectives using SMART and measurable verbs.

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When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.

Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles.

Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.

|21| www.KPHANET.org

June CPE Article A Primer on Cannabis for Pharmacists By: Amber Cann, PharmD, MBA The author declares that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity #0143-0000-19-006-H01-P &T 1.0 Contact Hour (0.10 CEU) Expires 5/15/2022 Learning Objectives: At the conclusion of this knowledge-based article, the reader should be able to:

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

1.

Compare the two main cannabinoid receptors in the human endocannabinoid system.

2.

List the various routes patients may utilize to administer cannabis.

3.

Compare the two main active components of the cannabis plant and describe how the interact with the human endocannabinoid receptors.

4.

Explain the mechanism by which cannabis may have a role to treat discussed neurological disorders.

5.

Illustrate how cannabis affects pain and how it might play a role in reducing opioid burden

STATUS OF CANNABIS LEGISLATION

THE ENDOCANNABINOID SYSTEM

To date, twenty-nine states have legalized use of cannabis for medicinal purposes. An additional nine states and the District of Columbia have authorized “adult” use (otherwise referred to as “recreational use”). Kentucky has approved some medical legislation, and more bills are being filed to clarify and expand the current regulations. The Controlled Substances Act of 1970 defines marijuana and cannabis products as Schedule I substances. 1 So, how existing and future state laws will be enforced when they are at odds with federal drug laws is yet to be determined.

As cannabis laws evolve, pharmacists, too, must adapt. The established medication expert is remiss if he does not acknowledge that cannabis is now and will be a part of patients’ full healthcare picture. Like any drug, when we understand the mechanism of action in the body, we can reasonably predict how that drug will behave alone and in combination with other substances.

There are two main receptors in the human body’s endogenous cannabinoid system. This system is critical for maintaining system-wide homeostasis. The CB1 receptor (CB1r) is the In January 2019, House Bill 136 was filed which would make most prolific receptor in the brain. It primarily moderates medical marijuana available to patients with “debilitating” control of synaptic function on neurons. The CB2 receptor conditions including chronic pain. The bill puts regulation of (CB2r) is not located on neurons, but on other cells that sigmedical marijuana under the Department of Public Protecnal neurons. The CB2r is primarily located on inflammatory tion Office of Alcoholic Beverage Control. It proposes a state- cells. It influences microglia in the brain as well as how perun system to issue licenses for all members of the supply ripheral immune cells cross the blood-brain barrier. The enchain (growers, dispensaries, practitioners, and patients). dogenous ligands that bind to endocannabinoid receptors are Governor Bevin has stated he would sign a medical marijua- anandamide and 2-arachidonoylglycerol (2-AG). Ananna bill. 2 Another bill, HB 265 aims to clarify what is damide is a lipid present in the brain at low levels; it has a “personal use” quantity of marijuana and to change the pen- high affinity for CB1r and CB2r. 4 Conversely, 2-AG exists alty for possession to a non-criminal fine. The Kentucky Sen- in relatively high levels in the central nervous system and acts ate is also considering cannabis legislation. SB 80 seeks to as a full agonist of CB1r. 5, 6 legalize and regulate recreational use of cannabis and to creAbout 120 individual compounds have been identified in the ate a Department of Cannabis Control. Several other bills have been introduced concerning various aspects of cannabis cannabis plant, to date. Some engage the endocannabinoid and its role in Kentucky. 3 With the depth and breadth of dis- system, while others do not. The two main compounds of cussion circulating in the General Assembly about cannabis, interest to pharmacists are tetrahydrocannabinol (THC) and it is clear the citizens of the Commonwealth and their elected cannabidiol (CBD). THC is the compound traditionally valofficials are interested in advancing the plant’s role in indus- ued by recreational users of cannabis; it produces psychoactive effects when it binds to CB1 receptors. THC has a high try and in healthcare. affinity for both CB1r and CB2r. CBD is the second most abundant phytocannabinoid in the cannabis plant, however, |22| Kentucky Pharmacists Association | May/June 2019

we still do not fully understand how CBD engages the endocannabinoid system. CBD does not bind strongly to CB1r and CB2r. 7

DRUG INTERACTIONS WITH CANNABIS

As research progresses on the many compounds within the cannabis plant, we are discovering increasing potential of drug Plant-based agonists of the human endocannabinoid system interactions with legend and over-the-counter medications. come in the form of carboxylic acids. It is the process of heat- This is where the pharmacist is a crucial member in the team ing the acid that these phytocannabinoids are made chemical- caring for a cannabis-using patient. Many of the cannabis ly active. Traditionally, this heating comes in the form of plant components inhibit or induce cytochrome P450 liver smoking, cooking, or vaporizing parts of the plant. While the enzymes, which metabolizes up to sixty-percent of marketed phytocannabinoid component is chemically the same in the medications. 10 CBD seems to be the most potent player of various varieties of the cannabis plant, it is the interplay bethese in the CYP450 system. 9 As CBD is metabolized by liver tween these components and another family of chemicals in enzymes, it behaves as a “competitive inhibitor” of the same the plant—terpenes—that creates the differences in antienzymes. 10 In so doing, CBD prevents P450 enzymes from .8 inflammatory and psychoactive activity Terpenes make up metabolizing other compounds. Patients who require medicathe cannabis essential oil. 9 These specific compounds are retions with a narrow therapeutic window—like oncologic sponsible for giving cannabis its signature scent. The list of agents, organ transplant anti-rejection medications, and antiterpenes in the cannabis plant is long, but one of note is beta- epileptic drugs—are at even greater risk for adverse effects caryophyllene. This chemical is a constituent of many essenwhen cannabinoids are added to therapy. As such, this effect tial oils, including basil, clove, lavender, hops, and rosemary. can have profound impact on patients’ health outcomes.

It is beta-caryophyllene that drug-sniffing dogs are trained to POSSIBLE USES FOR CANNABINOIDS IN DISEASEdetect as part of law-enforcement drug searches.

MANAGEMENT Growers have long selected for plants that produce higher Even with its interference with major metabolic pathways, THC content, since its psychoactive properties were the desired effect. But, with a growing body of literature suggesting cannabis, and specifically cannabinoids that interact with the CB2r, seem to have a growing role in disease management.

CBD’s role in inflammation modulation, plants with higher There is a long history of cannabis use in patients undergoing CBD content are being cultivated. Researchers have established the interplay of CBD and THC, and perhaps other can- cancer treatment. Patients discovered that use by inhalation eased chemotherapy-related nausea, stimulated appetite, mitinabis components contribute to an “entourage effect.” 7 Plants with higher CBD content seem to produce lower levels gated anxiety, and even reduced neuropathic pain sometimes THC-related adverse effects like anxiety, paranoia, and forget- caused by caustic treatments. This effect on neuropathic pain, where nerves transmit pain to the brain without an obvious fulness compared to low-CBD strains. This synergy among components may also modulate other pathways we don’t yet physical injury, is of growing interest to researchers. Inflammation may play a part in this nerve injury or stimulation, and know exist. cannabinoids bind with the immune-modulating CB2 recepHOW CANNABIS IS USED BY PATIENTS tors in many tissues. 7 While opioids are the gold standard for acute nociceptive pain (where there is an obvious tissue inSmoked or vaporized, inhaled THC can reach peak serum sult), it has been proposed that sequential or concomitant use concentrations in 6-7 minutes. Cannabis can also be adminis- with opioids for all types of pain conveys a synergistic effect. tered via buccal, mucosal, or sublingual routes. However, This effect, in turn, could help the clinician reduce initial dose these are not as efficient as the inhalation method; it may take and duration of opioid therapy. up to four hours to reach peak levels after administration. Ingested cannabis (in the form of “edibles”) are the least predict- In 2006 a synthetic CB1r inverse agonist named rimonabant able in terms of absorption. Much of the active components was approved in Europe as an anti-obesity drug. The drug was are destroyed by the low pH environment of the stomach. The approved in Brazil the following year. The mechanism of hepatic first-pass effect removed a good portion of active com- action of this drug included a reduction in food intake and ponents from the bloodstream as well. It could take as many increased energy expenditure, as well as fat mass reduction as seven hours to reach peak levels with edible cannabinoids. and improved insulin sensitivity. 11 The drug seemed to have Once broken down by the liver, active metabolites of THC promise, and at the time it was the first drug approved in its can stay in the blood stream for twice as long as the original class. Rimonabant was never approved in the U.S. due to form. Perhaps the least studied method of administration of evidence that it was linked to suicidal ideation and psychotic cannabis is the topical route. Even with a lipophilic base, acepisodes. Just two years after its approval, it was withdrawn tive components seem to be inconsistently absorbed. 9 from the market worldwide, as more evidence of its serious side effects became evident. 12 The risks of rimonabant were Once cannabinoids reach the bloodstream, they are proteindeemed far to outweigh the benefits. Trials on a similar drug bound in plasma. Compounds can be deposited in highlyin development at the time—taranabant—was pulled from vascularized tissues like liver, heart, and adipose. As such, a phase III trials due to the same adverse effect profile. The failsmall percentage of active drug – as little as one percent – ure of CB1r-specific drugs seems to point to the importance of crosses into the brain. Active metabolites are eliminated in the aforementioned entourage effect. CB1 receptors are on the urine and feces about 50 hours after administration. Non- tissues throughout the body, and it appears targeting them for active metabolites can persist in tissues for weeks. a specific effect has unanticipated negative consequences.

More specifically, targeting the CB1r without a balancing ac|23| www.KPHANET.org

tion on the CB2r, or without blocking action in the central nervous system, may negate any benefit to be gained.

The inflammation modulatory effects of cannabis has led researchers to investigate its role in neurological disorders like Alzheimer’s disease, Parkinson’s disease, and epilepsy. Indeed, the FDA approved in June 2018 cannabidiol for rare pediatric epileptic syndromes Lennox-Gastaut and Dravet, under the trade name Epidiolex. When first approved, the product was still a Schedule I substance, but it was granted special orphan drug designation for its two indications.

Shortly after approving cannabidiol, the FDA re-scheduled products containing no more than 0.1% THC. Epidiolex was then granted C-V status. 13 In Alzheimer’s disease, endocannabinoid concentrations are increased in areas of brain damage. 6 THC inhibits acetylcholinesterase through the CB1r, which is the same mechanism targeted by current approved AD medications. Moreover, CB2 receptors are more prevalent in Alzheimer’s patients’ brains, specifically around amyloid-beta plaques, and activation of these receptors facilitates plaque removal. Two small studies performed to evaluate effects of cannabis in patients with AD both reported decreases in delusions and agitation, as well as improved sleep. 14, 15 Parkinson’s disease is another neurological disorder in which cannabis has been proposed as a treatment. This is especially welcome as the number of currently approved medications for Parkinson’s is limited. Here, though, successful animal studies have not translated into striking results in human subjects. A small Israeli study published in 2014 reported that sleep and pain scores in Parkinson’s patients improved, while no significant adverse effects were noted. 16 A year later, South Korean researchers published the mechanism by which cannabinoid receptors interact with the basal ganglion. In this article, the authors posit the anti-inflammatory effects of cannabis provides neuroprotection in the brain by decreasing oxidative stress and increase density of CB2 receptors. 17 They go on to say that cannabinoids can reduce bradykinesia, a primary symptom of Parkinson’s disease by action on the endocannabinoid system.

The list of diseases that have a potential therapeutic place for cannabis therapy is growing. Neurological disorders are an area of interest, given cannabis’ action on human neuronal function. Small studies have been done on patients diagnosed with Parkinson’s disease, Alzheimer’s disease, and epilepsy. Moreover, cannabis research is growing in other areas like multiple sclerosis, amyotrophic lateral sclerosis (ALS), and even non-neurological diseases.

POTENTIAL ROLE IN THE OPIOID CRISIS A study published in the International Journal on Drug Policy in 2014 surveyed authorized medical cannabis patients. 18 The study found that a high percentage of those surveyed— over sixty percent—chose cannabis as a substitute for prescription medications. Thirty percent of patients in the study reported they preferred cannabis to prescription opioids. Patients also reported using cannabis in lieu of antidepressants, alcohol, and illicit drugs. This study supported previous studies’ findings that patients with pain or other chronic condi|24| Kentucky Pharmacists Association | May/June 2019

tions find relief with medical cannabis use and may use fewer opioids and seek illicit drugs less often. Indeed, a new study published in The Journal of Pain reported eighty percent of patients with chronic pain reported substituting cannabis for traditional pain medications. 19 These patients cited fewer adverse effects and better pain control as their reasons for selecting cannabis over other therapies.

The implications on stemming the tide of the national opioid crisis should interest any healthcare professional. Whether or not cannabis can curb opioid use remains to be seen; only through real and rigorous clinical trials will we discover its true potential.

References 1.The controlled substances act. United States Drug Enforcement Administration. Available at: https://www.dea.gov/controlled-substances-act.

Accessed Feb 25, 2019.

2.Hendrick C. Medical marijuana bill heading to Kentucky House. WSAZ. March 7, 2019. Available at: https://www.wsaz.com/content/news/Medical-marijuana-bill-heading-toKentucky-House-506819961.html. Accessed Mar 8, 2019.

3.Legislative record. Kentucky General Assembly. Available at: https://legislature.ky.gov/Legislation/Pages/default.aspx. Accessed Feb 27, 2019.

4.National Center for Biotechnology Information. Anandamide (CID=5281969). PubChem Compound Database. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/5281969. Accessed Feb 27, 2019.

5.Savinainen JR, Jarvinen T, Laine K, Laitinen JT. Despite substantial degradation, 2-arachidonoylglycerol is a potent full efficacy agonist mediating CB1 receptor-dependent G-protein activation in rat cerebellar membranes. British Journal of Pharmacology. 2001;134(3):664-672.

6.Fernandez-Ruiz J, Moro MA, Martinez-Orgado J. Cannabinoids in nurodegenerative dsorders and sroke/bain trauma: from preclinical models to clinical applications. Neurotherapeutics. Oct 2015;12(4):793-806.

7.Medicinal Cannabis: Endocannabinoid System [Video]. Jefferson University Sidney Kimmel Medical College, 2018.

8.Russo EB. Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. British Journal of Pharmacology. Aug 2011;163(7):1344-1364.

9.Backes M. Cannabis Pharmacy. New York: Black Dog & Leventhal; 2017.

10.Project CBD. Drug interactions with cytochrome P450. Project CBD. http://www.projectcbd.org/article/cbd-drug-interactions-role-cytochromep450. Accessed Feb 25, 2019.

11.Fong TM, Heymsfield SB. Cannabinoid-1 receptor inverse agonists: current understanding of mechanism of action and unanswered questions. International Journal of Obesity. Sep 2009;33(9):947-955.

12.BBC News. Anti-obesity drug use suspended. BBC News. Oct 23, 2008.

Available at: http://news.bbc.co.uk/2/hi/health/7687311.stm. Accessed Mar 22, 2019.

13.FDA-approved drug Epidiolex placed in schedule V of controlled substance act. Drug Enforcement Administration. Sep 27, 2018. Available at: https://www.dea.gov/press-releases/2018/09/27/fda-approved-drugepidiolex-placed-schedule-v-controlled-substance-act. Accessed Mar 22, 2019.

14.Safety and efficacy of medical cannabis oil for behavioral and psychological symptoms of dementia: an-open lAlabel, add-on, pilot study. Journal of Alzheimer's Disease. 2016;51(1):15-19.

15.Woodward MR HDSAFBEJ. Dronabinol for the treatment of agitation and aggressive behavior in acutely hospitalized severely demented patients with noncognitive behavioral symptoms. Am J Geriatr Psychiatry. Apr 2014;22(4):415-419.

16.Lotan I TTRYDR. Cannabis (medical marijuana) treatment for motor and non-motor symptoms of Parkinson disease: an open-label observational study. Clin Neuropharmacol. Mar-Apr 2014;37(2):41-44.

17.More SV CD. Promsing cannabinoid-based therapies for Parkinson's disease: motor symptoms to neuroprotection. Molecular Neurodegeneration.

2015;10(17).

18.Lucas P, Walsh Z. Medical cannabis access, use, and substitution for prescription opioids and other substances: a survey of authorized medical cannabis patients. International Journal on Drug Policy. Apr 2017;42:30-35.

19.Boehnke KF, Scott JR, Litinas E, Sisley S, Williams DA, Clauw DJ. Pills to pot: observational analysis of cannabis substitution among medical cannabis users with chronic pain. The Journal of Pain: Official Journal of the American Pain Society. Jan 2019;18(30735-1):S1526-5900.

20.National Center for Biotechnology Information. 2-Arachidonoylglycerol (CID=5282280). PubChem Compound Database. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/5282280. Accessed Feb 27, 2019.

|25| www.KPHANET.org

June 2019 — A Primer on Cannabis for Pharmacists 1. Which endocannabinoid receptor primarily modulates control of synaptic function on neurons?

A. 2-Arachidonoylglycerol B. Anandamide C. CB1 D. CB2 2. Which endocannabinoid receptor is primarily located on inflammatory cells and influences how peripheral immune cells cross the blood-brain barrier?

A. 2-Arachidonoylglycerol B. Anandamide C. CB1 D. CB2 3. What compound in cannabis is valued by recreational users of cannabis, since it produces psychoactive effects when it binds to CB1 receptors?

A. Tetrahydrocannabinol B. Cannabidiol C. Anandamide D. Sesquiterpene 4. What form of cannabis consumption is the least predictable in how long it will take to reach peak levels?

A. Inhalation B. Oral-mucosal C. Ingestion D. Topical 5. Of these medications, which is most likely to cause unintended adverse outcomes when combined with CBD? A. Diphenhydramine B. Phenytoin C. Cephalexin D. Vitamin D supplements 6. Of these medications, which is most likely to cause unintended adverse outcomes when combined with CBD? A. Diphenhydramine B. Phenytoin C. Cephalexin D. Vitamin D supplements 7. By what mechanism does medical cannabis emulate current Alzheimer’s disease medications?

A. Inhibition of dopamine action on receptors in the amygdala B. Activation of macrophages in the brain’s frontal cortex C. Activation of CB2 receptors in peripheral tissues D. Inhibition of acetylcholinesterase via action on CB1 receptors

|26| Kentucky Pharmacists Association | May/June 2019

8. CBD, THC, and other chemical components of cannabis seem to complement the action of each other. What is this effect called?

A. Entourage effect B. Synergistic effect C. Dual action effect D. Dynamic mechanism effect

This activity is a FREE service to members of the Kentucky Pharmacists Association.

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 5/15/2022 Successful Completion: Score of 80% will result in 1.0 contact hour or .10 CEUs. TECHNICIANS ANSWER SHEET June 2019 — A Primer on Cannabis for Pharmacists (1.0 contact hour) Universal Activity #0143-0000-19-006-H01-P Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #__________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET June 2019 — A Primer on Cannabis for Pharmacists (1.0 contact hour) Universal Activity #0143-0000-19-006-H01-T Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D

7. A B C D 8. A B C D

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted. |27| www.KPHANET.org

Pharmacy Law Brief Administrative Agencies and Pharmacy Author: Joseph L. Fink III, BSPharm., JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy.

Disclaimer: The information in this column is intended for educational Question: Our profession of pharmacy is heavily impacted by the decisions and actions of a wide variety of administrative agencies at both the federal and state levels. Can you provide some insight about the legal framework for their functioning?

Response: Federal agencies – FDA, DEA, CPSC, etc. – and state agencies – Board of Pharmacy, CHFS Drug Enforcement and Professional Practices Branch, etc. – do indeed have an extensive impact on the daily activities of pharmacists. These entities fall under the Executive Branch of government and have no inherent authority of their own; all authority to act is conferred by the legislature through enactment of statutes. For example, the Kentucky General Assembly enacted legislation to confer authority on the Kentucky Board of Pharmacy to issue licenses to pharmacists and permits to pharmacy operators. So, when one sees a proposed regulation issued by an administrative agency that notice will always incorporate a statement about what statute conferred authority on the agency to do what it is doing.

use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

The legislation that confers authority on an agency to act on a given topic or issue must have both a statement of policy and standards. The statement of policy is usually found at the outset of the legislative proposal and is often labeled “Findings”. For a Kentucky-related example, see the Pharmacy Practice Act at K.R.S. 315.002, the very first section in the legislation. For an example of standards see K.R.S. 315.050 where the legislature has laid out a broad framework for the qualifications one needs to become licensed as a pharmacist. The Board of Pharmacy has followed up on that by adding specifics about the number of internship hours required, etc. – see 201 K.A.R. 2:040(3)(1).

that they somewhat mirror government as a whole in what they do, engaging in activities that parallel what the three branches of government do overall: Making Rules Legislative Branch

when an agency is proposing a new regulation that proposal must follow the steps outlined in the Administrative Procedures Act [5 U.S.C. §500 et seq. for federal matters and K.R.S. 13A and 13B for state-level matters]. Typically, the flow of such proposals is that they are first published for public comment. It is worth noting that busy professionals like pharmacists rarely have time to monitor federal and state government publications for proposals that have the potential to impact what they do in their practices and then sit down to formulate comments for submission. They rely on the professional organizations to do that, supporting such initiIf an agency were to attempt to do something that exceeds its authority one might hear the phrase “ultra vir- atives with their dues so the associations can be their es action” used to describe the proposed activity. That representatives. phrase means the proposed activity falls outside the ac- Some scholars who study such matters have looked at tivities authorized for the agency to undertake. the actions of administrative agencies and concluded

It is important to note that in the vast majority of cases |28| Kentucky Pharmacists Association | May/June 2019

Enforcing Rules Executive Branch Interpreting Rules Judicial Branch What if an administrative agency has taken an action that adversely affects what one does, say by suspending or revoking a license or permit? How can one seek review of that decision? An overview of that process involves two separate stages. The first is focused on what one must do to get across the courtroom threshold – will the court even take up the matter?

Cont. pg. 31

Campus Corner Preceptor Highlight: Kami Redecker, PharmD, BCPS, BCOP Kami Redecker, PharmD, BCPS, BCOP

What inspires you about the College of Pharmacy now that you've been a preceptor for a while?

Clinical Pharmacist Specialist - Oncolo- Each student that I have precepted from the University of Kentucky has been outstanding. They are always professional gy Norton Cancer Institute and passionate about pharmacy. They are a pleasure to preWhat motivated you to become a pharmacept and have as a part of our team. cist? Was it an interest you've had since What would you tell someone who is thinking about doing a rotation childhood or did it develop later? at your location? What should they expect?

As a child I knew I wanted to help others initially wanting to be a pediatrician. In high school I fell During my ambulatory care oncology rotation, students educate patients on their oncology regimens per evidence based in love with biology and chemistry. During college I had an incredible professor tat Morehead State University that stirred medicine. They are able to follow up with each patient and my love for biology and pathophysiology even more. I then provide supportive care. Students establish relationships with patients and providers to ensure optimal patient care. Even if began my path to becoming a pharmacist. a student is not interested in oncology, this rotation is a great Tell me about the area of pharmacy you've focused on in your career. opportunity to hone patient education skills and communicaWhat inspired you to pick this specific area of patient care? tion skills with other providers.

During my rotations as a pharmacy student, I spent time on Biography: an elective oncology rotation and fell in love with it. HowevKami Redecker grew up in South Shore, Kentucky. She reer, it was very emotionally taxing so I opted to become an ceived a Bachelor of Science degree in Biology from Moreinpatient hospital pharmacist in order to continue to have head State University in Morehead, Kentucky in 2001 and her some exposure to oncology patients. In 2008, my father was Doctorate of Pharmacy from the Bernard J Dunn School of diagnosed with colon cancer. During his journey, I realized Pharmacy at Shenandoah University in Winchester, Virginia the impact I could have as a pharmacist in the oncology world. I was able to guide him and ease his mind through his in 2005. Following graduation, Dr. Redecker started her cacancer journey as a daughter and a pharmacist. At that point reer as a clinical pharmacist at Winchester Medical Center in Winchester, Virginia. In 2007, she moved to Louisville KenI knew oncology pharmacy was where I belonged. tucky and worked as a clinical staff pharmacist for Norton What have been the most fulfilling moments for you related to your Healthcare where she precepted residents and students. Dr. work?

Redecker earned her Board Certification in Pharmacotherapy Having patients say thank you is incredible. I have always in 2010. In 2012, Dr. Redecker transitioned to Norton Canwanted to help people and being acknowledged for that is an cer Institute, and earned her second Board Certification in honor.

Oncology. She currently serves as a clinical pharmacist specialist in oncology at Norton Cancer Institute - Brownsboro, Our oncology patients are so grateful for all that we do and where she has been instrumental in helping to expand oncolothey show their appreciation consistently. Knowing that I am gy pharmacy services for many solid malignancies. She has able to make their lives less stressful during a very difficult been precepting Norton residents as well as students from the time is very fulfilling.

University of Kentucky in this capacity since 2015. Dr. ReYou're not only a pharmacist, but also a preceptor. What motivated decker is an active member of the Hematology Oncology you to become a preceptor?

Pharmacists Association and American College of Clinical Pharmacy. Dr. Redecker has been blessed with dedicated I am blessed with wonderful mentors and was blessed with mentors and preceptors throughout her career. It is an honor amazing preceptors during my training. I will never forget for her to serve in that manner to the next generation of pharthose people and the impact they had on me personally and macists. “A mentor is someone who sees more talent and on my career. As a pharmacist, I want to be that mentor for ability within you, than you see in yourself, and helps bring it others. I enjoy being a part of each student’s journey. The out of you.” — Bob Proctor ability to be a positive influence for them and to watch their growth is very rewarding. |29| www.KPHANET.org

Pharmacy Policy Issues Pharmacy Policy Issues: Should Kentucky Amend Exemptions from Mandatory Vaccination for Religious Submit Questions: jfink@uky.edu Reasons?

Author: Eric M. Marr is a 2019 PharmD Candidate at the UK College of Pharmacy and an MBA Candidate in the Gatton College of Business and Economics at the University of Kentucky. A native of Glasgow, KY, he completed his pre-professional education at Western Kentucky University with a major in Chemistry.

Issue: Immunizations are important but so are the preferences of individuals within a free society. What is the status and current thinking about exemptions from mandatory immunizations for children in Kentucky?

Discussion: Government regulation of mandated vaccination for public school children has been a contentious topic for some time. As far back as the early 1900s, citizens have been fighting states’ police power to mandate a person become vaccinated.1 Given the recent hepatitis A outbreak in Eastern and Central Kentucky, the topic of vaccine preventable illnesses has come back into the limelight. Currently, only three states do not allow religious exemptions for vaccination before a child can attend public school.4 Should Kentucky become the fourth?

Whether a child should be vaccinated before entering the public school system is a decision that is made at the state level. Some states have begun to allow an objection for philosophical reasons and all but three (California, Mississippi, West Virginia) allow exemptions for religious reasons.4 The level of evidence required to show one’s proof of religious reasoning varies from state to state. For example, some states require a signed letter from the leader of the objector’s congregation while others simply require a signature from the child’s parent. In Kentucky, the latter standard is sufficient to satisfy and support the exemption. A parent must fill out an exemption request form, have the form notarized, and then submit the form to the local public health nurse.2 The concern health professionals have is that too many children are not being vaccinated, thus posing a greater risk to those who would benefit from herd immunity.

Non-medical (philosophical and religious) exemptions |30| Kentucky Pharmacists Association | May/June 2019

were created by many states to serve a small subset of the population. With the number of objectors to vaccination increasing over the past decade, however, such exemptions may pose a threat to the health and wellness of the Commonwealth.

The dilemma becomes an issue of infringement on Kentuckians’ First Amendment rights versus promotion of public health and wellness. A study done by Rota et al., published in the American Journal of Public Health in 2000, found that of the 34 states that had religious exemptions from vaccination but not personal/ philosophical exemptions, 19 had never denied a claim.3 This questions the validity of a “religious” exemption in those states as they are, de facto, allowing philosophical exemptions as well. There are easily accessible resources to those who are against vaccination of children which outline how to obtain an exemption in his/her respective state. It could be argued that ambiguous regulations on childhood vaccination are being exploited by such resources.

There is no absence of difficulty in Kentucky amending regulations to make a religious exemption more strenuous to obtain and prevent this exploitation, however.

Some argue that adding complexity to an exemption form may lead people down the path to advocating for philosophical objections while others say it would decrease the number of claims for exemptions. Regardless, the benefits of improving the Commonwealth’s public health outlook should be weighed against the cost of maintaining public trust in the health professions.

In closing, it would be virtuous to remind ourselves that a pharmacist is a medical resource open to the members of the area being served. Our neighbors, our friends,

and our community look to us for answers to their medical questions. If we encounter one of these people who have concerns about the necessity of vaccination, it is our duty to uncover the root cause of that concern before trying to leverage overwhelming medical evidence against it. There is a plethora of misinformation available to anyone who has Internet connection and we, as professionals, cannot fault one for falling victim to it.

Improving a regulation through government intervention in an effort to promote public health could prove to be very effective, but having a conversation with those you serve can be quite impactful.

Gangarosa EJ. Process for obtaining nonmedical exemptions to state immunization laws. Am J Public Health. 2000 (April);91:645-8. http://www.ncsl.org/research/health/school-immunizationexemption-state-laws.aspx

References: Jacobson v. Massachusetts, 197 U.S. 11 (1905) http://chfs.ky.gov/NR/rdonlyres/F2B0AAEC-DB07-46B4AA21-EBF3C686C38D/0/ CommonwealthofKentuckyParentorGuardiansDeclinationonReligiousGroundstoRequiredImmunizat.pdf Rota JS, Salmon DA, Rodewald LE, Chen RT, Hibbs BF, Pharmacy Law Brief Cont. pg. 28 The case must have three elements present. First, the person bringing the case to challenge the decision of the agency must have “standing”, meaning that some interest of his or hers has been adversely affected by the agency’s decision. Second, the case must be “ripe”, meaning that the facts are fully developed with no essential information missing. Third, there must be “exhaustion”, meaning that the individual challenging the agency’s decision must have exhausted all remedies at the level of the administrative agency. An example of that would be if there is an opportunity for a rehearing has that been requested? Note that all three elements must be present to get into court.

One final point is deserving of mention. Is it difficult to mount a challenge to an administrative agency’s action and prevail? As a general notion the answer is yes. The agency comes to court cloaked in its expertise and that of its members, thereby frequently receiving deference by the judge to its ruling on the matter. It can be an uphill battle to challenge the decision of an administrative agency in court but we all know that the agencies do not prevail all the time.

Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of Once one gets into court there are three arguments that professional practice. It is always the best advice for a pharmacan be advanced, any one of which will carry the day.

First is “mistake of law.” Did the agency apply an incor- cist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render rect statutory provision to the activities being scrutinized? A second basis would be “abuse of discretion” – advice in accordance with the full information. for example, did the agency permits some evidence to be introduced at the hearing that was inflammatory or prejudicial? The third basis is “arbitrary or capricious action”, meaning that the agency based its determination on a whim or on some facts not at all relevant to the matter. |31| www.KPHANET.org

|32| Kentucky Pharmacists Association | May/June 2019

|33| www.KPHANET.org

2018—2019 KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES Tyler Stephens, Lexington Speaker of the House stevens.tyler@uky.edu

Chris Harlow, Louisville cpharlow@gmail.com

Chair

Chris Palutis, Lexington chris@candcrx.com

President

Don Kupper, Louisville donku.ulh@gmail.com

President-Elect

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Bob Oakley, Louisville rsoakley21@gmail.com

Chair

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Joel Thornbury, Pikeville jthorn6@gmail.com

Past President Representative

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Chris Palutis, Lexington chris@candcrx.com

President, KPhA

Directors Angela Brunemann, Union Angbrunie@gmail.com

KPERF BOARD OF DIRECTORS

Kimberly Croley, Corbin kscroley@yahoo.com

Matt Carrico, Louisville* matt@boonevilledrugs.com

Kevin Lamping, Lexington klamping@riteaid.com

Jessika Chilton—Chinn, Beaver Dam jessikachilton@ymail.com Dharti Patel, Lexington dharti.patel2@uky.edu

Ben Mudd, Lebanon Vice Speaker of the House bpmu222@gmail.com

University of Kentucky Student Representative

Paul Easley, Louisville rpeasley@bellsouth.net Sarah Lawrence, Louisville slawrence@sullivan.edu

Chad Corum, Manchester pharmdky21@gmail.com

KPERF ADVISORY COUNCIL

Cassy Hobbs, Louisville cbeyerle01@gmail.com Stephen Drog, Louisville sdrog5833@my.sullivan.edu

Sullivan University Student Representative

Chris Killmeier, Louisville cdkillmeier@hotmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com James "Blake" Wiseman, Benton blake.wiseman@gmail.com *At-Large Member to Executive Committee

|34| Kentucky Pharmacists Association | May/June 2019

Matt Carrico, Louisville matt@boonevilledrugs.com Kim Croley, Corbin kscroley@yahoo.com Kimberly Daugherty, Louisville kdaugherty@sullivan.edu Mary Thacker, Louisville mary.thacker@att.net

KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd., Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) info@kphanet.org www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc

“The $3.66 average prescription charge for 1968 was an increase of 2 cents, 12 cents, 14 cents, 17 cents and 35 cents over the 1967, 1966, 1965, 1964 and 1963 Kentucky surveys respectively.”

- From The Kentucky Pharmacist, May1969, Volume XXXII, Number 5

Frequently Called and Contacted Kentucky Pharmacists Association 96 C Michael Davenport Blvd.

Frankfort, KY 40601 (502) 227-2303 info@kphanet.org www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org

National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center SUCOPHS 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

KPhA Staff Mark Glasper Executive Director mglasper@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org

Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness Michele@kphanet.org Sydney Hull Office Assistant/Member Services Coordinator shull@kphanet.org

Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org Jessica Johnson, PharmD Director of Pharmacy Education Jessica@kphanet.org |35| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601