The Kentucky Pharmacist September/October 2018

Vol. 13 No. 5 September/October 2018

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

Legislative Conference November 2, 2018 Louisville, KY

October is American Pharmacists Month

INSIDE: Emergency Preparedness Month American Pharmacists Month 2018 Legislative Conference

TABLE OF CONTENTS FEATURES Emergency Preparedness Month |10| Financial Forum | 28 | Hepatitis A Information |32|

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

On the Cover 

Editorial Office: ©Copyright 2018 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.

Publisher: Mark Glasper

Marriott Downtown Louisville Site of the 2018 Legislative Conference

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |8| Advocacy Matters |13| Continuing Pharmacy Education |14| Campus Corner |27 | Pharmacy Law Brief | 30 | New KPhA Members | 33 | Pharmacy Policy Issues | 34|

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 APSC|5| EPIC |4 & 33| PTCB |21| Pharmacists Mutual |36| Cardinal |37|

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PRESIDENT’S PERSPECTIVE I was recently given the opportunity to address the incoming PY1 students at the University of Kentucky White Coat Ceremony. Aside from it being an honor to represent our KPhA in welcoming those fine young students into our profession, it allowed me to reflect. The request from the university was for me to focus my speech on the DEVELOP portion of the Pledge of Professionalism. To be honest, I realized I had not given much thought to this pledge in recent years. And after giving my speech, I repeatedly thought about the pledge.

vide will be well received.

Assess the specific needs of your individual communities you serve, and then think outside the box to offer assistance where needed. Remember, with your wealth of medical knowledge, for many, you Chris Palutis are the primary health care President, KPhA provider and so you are looked upon to provide leadership in your community.

“Aside from applying the education we have obtained, I encourage all of us to lead by example.”

Hopefully you take the time to read through the pledge and are willing to see how your own professional development stands up to it. I for one believe we should forever be students of pharmacy. I also believe that once I Over the course of any given year, we may recite the say to myself, “I have no more to learn, develop or reOath of a Pharmacist a few times at different events fine”, it will mean my career in our great profession of which, still to this day, makes the hair on my arms stand pharmacy has come to an end, a day which I hope and up. Which is a good thing, as it means I still have the will strive to never let come. Can you all say the same? passion for our great profession. What I am wondering As a refresher, I have included the pledge in its entirety is, how many of us take the time to reflect on the Pledge here for your reading and reflecting pleasure. of Professionalism? After all, the pledge doesn’t mention it is ok to stop abiding by it once we have our degree in hand and are off to start our exciting new careers.

In fact, it suggests just the opposite. It states that we, as students of pharmacy, should believe there is a need to build and reinforce a professional identity founded on integrity, ethical behavior and honor.

As I read through and contemplated the pledge, I realized that I incorporate many of the pledge’s objectives into my everyday practice. I accomplish this in part by providing different services to my patients in the pharmacy with unwavering empathy and compassion as well as through my work for our KPhA. Aside from applying the education we have obtained, I encourage all of us to lead by example. If we are going to encourage our patients to take an active role in the management of their health, we ought to be mindful of how we live our own lives. Be open-minded and non-judgmental as people of all walks of life need and deserve the same level of compassionate care; truly integrate ourselves into our communities. I promise, any contribution you wish to pro-

Students of the UK College of Pharmacy participate in the White Coat Ceremony and recite the Pledge of Professionalism.

Pledge of Professionalism As a student of pharmacy, I believe there is a need to build and reinforce a professional identity founded on integrity, ethical behavior, and honor. This development, a vital process in my Continued on pg. 6

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PRESIDENT’S PERSPECTIVE CONT. education, will help ensure that I am true to the professional relationship I establish between myself and society as I become a member of the pharmacy community. Integrity must be an essential part of my everyday life and I must practice pharmacy with honesty and commitment to service.

To accomplish this goal of professional development, I, as a student of pharmacy should: • DEVELOP a sense of loyalty and duty to the profession of pharmacy by being a builder of community, one able and willing to contribute to the well-being of others and one who enthusiastically accepts the responsibility and accountability for membership in the profession.

• FOSTER professional competency through life-long learning.

I must strive for high ideals, teamwork and unity within the profession in order to provide optimal patient care.

KPhA President Chris Palutis addresses the students at the University of Kentucky College of Pharmacy White Coat Ceremony.

• SUPPORT my colleagues by actively encouraging personal commitment to the Oath of Maimonides and a Code of Ethics as set forth by the profession.

• INCORPORATE into my life and practice, dedication to excellence. This will require an ongoing reassessment of personal and professional values.

• MAINTAIN the highest ideals and professional attributes to ensure and facilitate the covenantal relationship required of the pharmaceutical care giver.

The profession of pharmacy is one that demands adherence to a set of rigid ethical standards. These high ideals are necessary to ensure the quality of care extended to the patients I serve. As a student of pharmacy, I believe this does not start with graduation; rather, it begins with my membership in this professional college community. Therefore, I must strive to uphold these standards as I advance toward full membership in the profession of pharmacy.

Developed by the American Pharmaceutical Association Academy of Students of Pharmacy/American Association of Colleges of Pharmacy Council of Deans (APhA-ASP/AACP-COD) Task Force on Professionalism; June 26, 1994.

Safe Disposal of Controlled Substances in Effect on July 14, 2018

SB 6 which requires the pharmacy to inform patients about safe disposal of controlled substances, took effect on July 14, 2018. The pharmacy can inform patients by posting a sign or by written or verbal communication.

KPhA is selling signage (13" x 25") for $10.60 (members) and $15.90 (non -members) with shipping/taxes included.

Purchase from KPhA online: www.kphanet.org/store

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Legislative Conference November 2 | Marriott Downtown | Louisville This conference targets topics such as grassroots legislative advocacy, prescription drug abuse, and the future of healthcare in Kentucky.

Register Online

Benefits of Attending: 

Advocacy 101

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Networking with Colleagues



Shape KPhA’s Legislative Agenda

www.kphanet.org 



Interactive Roundtable Discussions And more!

Agenda Highlights 

Morning educational sessions

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House of Delegates Meeting over lunch

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Afternoon interactive roundtables with legislators Full agenda coming soon!

The Campaign for Kentucky’s Pharmacy Future

SAVE THE DATE: 141st KPhA Annual Meeting and Convention June 20-23, 2019 Lexington |7| www.KPHANET.org

MY KPhA Rx Celebrate National Preparedness & American Pharmacists Months

By Mark Glasper KPhA Executive Director/CEO KPhA wants you to commemorate National Preparedness Month in September and American Pharmacists Month in October by doing what you do best – being a pharmacist and reaching out to patients, both current and prospective.

National Preparedness Month – September You may think National Preparedness Month is about natural disasters, including hurricanes, tornadoes and earthquakes and you would be correct. But it’s also about so much more.

Yes, it’s important for you to be prepared. To have a plan in the case of emergencies at home, at work or wherever you are, but it’s also just as important to be prepared to help and that’s what pharmacists do.

And, if you are naloxone certified, contact KPhA Pharmacy Emergency Preparedness Director Jody Jaggers to volunteer with the KPhA/Department of Health mobile pharmacy when it comes to your community. Jody also can link you up with a local residential treatment facility to work with patients being discharged about the use of naloxone. Contact Jody at 502-227-2303 or jjaggers@kphanet.org.

Please turn to page 10 in this issue to learn more about how you can observe National Preparedness Month.

Sponsor your American Pharmacists Month sign today! Contact KPhA at 502-227-2303.

American Pharmacists Month – October The month-long observance of American Pharmacists Month celebrates the accomplishments of pharmacists When was the last time you received CPR training? as well as recognizes the impact pharmacists have on Never you say? Then please consider learning this life saving procedure. How about becoming a naloxone cer- their patients. What better way to show your support of tified pharmacist? You can not only save lives by admin- the profession than by sponsoring a sign outside KPhA istering naloxone but also help educate patients to save headquarters for all to see? Recognize a fellow pharmacist, a professor or a past mentor and we’ll put your sign their lives and the lives of others.

KPhA President-Elect Don Kupper volunteers in the mobile pharmacy.

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on display during the celebratory month. Contact KPhA at 502-227-2303 or info@kphanet.org to order your sign today.

Now that you’ve honored a pharmacist who has special meaning to you, consider the multitude of activities that you can do to celebrate American Pharmacists Month.

For starters, schedule health events, visit schools or host your senator or representative. You can even hold an open house and decorate your pharmacy.

The list goes on and on. Where can you find such a list?

Just visit the American Pharmacists Association website, http://pharmacistsprovidecare.com/americanpharmacists-month, for ideas and tips to celebrate Enjoyed discussion with KPhA President Chris Palutis throughout the month. and Dean Kip Guy after UKCOP white coat ceremony.

And, don’t forget to send us photos of how you celebrate American Pharmacists Month! We’ll share them on line and in The Kentucky Pharmacist.

Where’s Mark?

No matter how or where you celebrate National Preparedness Month and/or American Pharmacists Month, I’d like to help you celebrate. Perhaps you’ve seen my “Where’s Mark?” photos on the KPhA Facebook page, https://www.facebook.com/KyPharmAssoc/.

I’d like to see where you work in pharmacy or maybe visit with you and your state legislator either in Frankfort or in district. Or, perhaps you’re volunteering with the KPhA/KDPH mobile pharmacy or making presentations to various community groups or students. Just give me a call at 502-227-2303 or e-mail me at mglasper@kphanet.org and I’ll put it on my schedule to attend.

I look forward to hearing from you!

Where’s Mark? Photos Wow! Had a fantastic tour today of Cardinal Health's nuclear pharmacy in Louisville.

Thanks to Mike Wyant and his crew for a very educational tour.

KPhA Board Member Chris Killmeier (r) and I attended a fundraiser for Senator Ralph Alvarado, M.D. in Louisville. A true friend of and advocate for pharmacy, Sen. Alvarado is running for re-election in November.

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September is National Preparedness Month (NPM) in the United States. Preparedness is something we rarely think about until it is too late, and a disaster or emergency is upon us. As pharmacists, we often wield a significant amount of influence with our patients and in our communities. Of course, preparedness starts at home. Every year during NPM, each week is the focus of a different preparedness topic. This year the themes are:

suscitation Program) and First Air or Bloodborne Pathogen certification.

As a pharmacist, you may have already received CPR training as part of your employment. If you have never been trained in CPR consider getting the training. CPR certification is typically only good for a year or two depending on what program you use. If it’s been a while since you were last trained, you should consider being retrained as it’s possible that there have been changes in the procedure since you last took a course. There are other certifications you can pursue as well: ACLS (Advanced Cardiac Life Support), PALS (Pediatric Advanced Life Support), NRP (Neonatal Re-

due to a power outage in the winter? Is damage from an Earthquake covered? Kentucky sits on the New Madrid fault which is overdue a major event. You should review your policy and ask your agent if these things are covered.

Recently there has been a national awareness campaign to encourage bystanders to become trained and equipped to help in a bleeding emergency before professional help arrives. This would also be an excellent skill for pharmacists to have.

With the opioid crisis in Kentucky, another life-saving skill you can put to good professional use is becoming Week 1: Sept 1-8 Make and Practice Your Plan Naloxone Certified. As a naloxone certified pharmacist, Week 2: Sept 9-15 Learn Life Saving Skills you can dispense naloxone pursuant to a physician proWeek 3: Sept 16-22 Check Your Insurance tocol. This is a great way to enhance patient care by edCoverage ucating your overdose risk patients and providing them Week 4: Sept 23-29 Save For an Emergency with naloxone to keep on hand should they need it. AlHaving a plan is the first step to being prepared. In addi- so, if you carry naloxone yourself, you can be a hero and save a life if you encounter someone that has overtion to having a plan, you need to practice your plan!

With your family, at church, at work and wherever you dosed on an opioid. play, practice emergency plans. Know your exits. Make When was the last time you checked your home, auto sure devices that use batteries are periodically checked. or liability insurance coverage for gaps? Are you covMake sure everyone knows where to meet should they ered if your house or property is damaged in a flood? become separated.

What if the “flood” is from pipes freezing and bursting

Lastly, it’s always a good idea to have an emergency fund set aside. Try to have $1,000 set aside for the unexpected things that happen in life. Pharmacists may not be “first” responders, but we can be well prepared to handle any emergency or disaster. For more information check out https://www.ready.gov/

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Become a KPhA Ambassador Today!

Do you have a passion for building and growing relationships?

Do you possess a knowledge of KPhA and an appreciation for the Pharmacy profession?

Are you well connected in your region?

If so, then the KPhA Ambassador Program is for you.

Visit www.kphanet.org/ambassador-program to learn more!

Volunteer Today Pharmacist, pharmacy technician and student pharmacist recruitment is still underway for the Kentucky Pharmacists Association emergency preparedness program! Pharmacy professionals play a critical part in responding to emergency events such as a natural disaster or infectious disease outbreak.

For more information on how you can be involved in the KPhA Pharmacy Emergency Preparedness Initiative, contact KPhA 502-227-2303 or by email at jjaggers@kphanet.org.

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6. See It All KPhA is the only statewide pharmacy organization that represents all pharmacists in all practice settings—you can learn about all the opportunities available within pharmacy and gain insights from pharmacists representing a variety of practice settings.

7. Develop Your Leadership Skills Participate as an active leader in a variety of committees and volunteer leadership positions that will develop your skills as you give back to your profession.

1. Strengthen Your Career KPhA members enjoy educational opportunities designed to increase knowledge and keep up with the latest information.

2. Advance Patient Care

8. Make a Positive Impact By joining KPhA, you are taking a step to ensure the future of the profession in Kentucky. We can’t do this important work without YOU.

The more you learn about drug and treatment updates through our publication, The Kentucky Pharmacist, as well as through attending OUR KPhA meetings, the better equipped you are to help your patients.

9. Make the Connection

3. Network with Others in Your Field

KPhA partners with many industry partners that offer discounts or important expertise that can positively impact your pharmacy.

KPhA members are invited to join their colleagues at the KPhA Annual Meeting & Convention and the Legislative Conference.

4. Advocate for Your Profession By joining KPhA, you are supporting the only organization representing the unified voice of all pharmacists.

During the past year, KPhA’s work on health care legislation and regulation increased policy makers’ awareness of the pharmacist’s role in health care. KPhA continues to

10. Gain the Competitive Edge KPhA gives you exclusive access to unique experiences, career information, and resources designed to meet your needs and provide support as you advance in your career.

5. Proclaim Your Professionalism Adding your name to the ranks of your colleagues who are members declares your pride in the profession. Support KPhA’s advocacy efforts as we work with policy makers to implement health care reform legislation and as we continue to advocate for regulations that positively impact the profession. |12| Kentucky Pharmacists Association | September/October 2018

JOIN TODAY WWW.KPHANET.ORG

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

Participate in grassroots advocacy efforts

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Get to know your legislators—they should know your name

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Donate to the Political Advocacy Council and the Government Affairs Fund

Photo by: Matt Turner

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 form. |13| www.KPHANET.org

September CPE Article Medicinal Cannabis Legislation and Future Implications for Pharmacists By: Jessin Joseph, PharmD, MBA, Pharmaceutical Outcomes and Public Policy Department of Pharmacy Practice and Science, University of Kentucky The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-18-013-H03-P &T 1.5 Contact Hours (0.15 CEU) Expires 09/05/18

KPERF offers all CE articles to members online at www.kphanet.org

Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1.

Comprehend the current status of medicinal cannabis legislation in the United States and specifically in Kentucky

2.

Understand the pharmacology of the endocannabinoid system

3.

Recognize current therapeutic benefits and how they differ

4.

Identify clinical concerns of cannabis

5.

Describe pharmacists’ role in regards to medicinal cannabis

Cannabis use has been on the rise since 2007 in the United States.1 In 2013, there were 19.5 million users of cannabis.1 In recent years, state legislations increased access to cannabis both medicinally and recreationally. The federal government places cannabis as a Schedule I controlled substance, an illegal narcotic.2 As more patients begin medicinal cannabis treatment, it is essential for pharmacists to understand how this drug works in order to address their concerns. At the same time, staying up to date with current policy is vital to be able to practice within the limits of the law.

dronabinol (Marinol), was given a Schedule III classification.

Approved for anorexia in patients with AIDS and chemotherapy induced nausea and vomiting, dronabinol has a moderate to low potential for physical and psychological dependence and less abuse potential than Schedule I and II substances, but more than Schedule IV.2,4 The most recent synthetic cannabinoid to be approved was Syndros, a dronabinol oral solution. In 2017, the FDA approved the formulation with a Schedule II classification.5

With the federal government banning the use of Schedule I substances, it is the role of the Drug Enforcement Administration (DEA) to enforce the controlled substances laws and Medicinal cannabis has been a controversial topic in today’s regulations at the federal level.2 At the same time, the federal healthcare and political climates, with the medicinal value of government expects state and local governments to enforce cannabis still in early stages of research. State and federal these same laws since many states adopt federal law. This laws differ on the legality of the substance. In the early 1900s, discrepancy is what has helped lead to renewed discussions of cannabis and its derivatives (hemp fiber, seeds, and oils) were the legality of cannabis on both the state and federal levels. legal substances. By the 1930s, some states had banned the State Level Legislation substance while the federal government stalled passing any regulations since therapeutic uses for the substance were still In 1996, California became the first state to pass legislation being discovered. The Marijuana Tax Act of 1937 was the for medicinal cannabis. Residents of the state could apply to first legislation proposed by the United States Congress to use herbal whole plant cannabis to alleviate suffering from criminalize unregistered and untaxed production and use of various illnesses. In 2005, the number of states legalizing mecannabis.3 dicinal cannabis increased to 10; by 2015, 23 states had meIn 1970, the passage of the Controlled Substances Act (CSA) dicinal cannabis legislation passed. As of January 2018, 29 placed cannabis as a Schedule I federal substance. Current states and the District of Columbia have legalized cannabis Schedule I substances include heroin, lysergic acid diethylafor medicinal use. Only eight states have legalized the recreamide (LSD), and 3,4-methylenedioxymethamphetamine tional use of cannabis, though not all states allow sales. (ecstasy).2 According to the CSA, Schedule I substances have Among states that have legalized cannabis, 21 states and the no currently accepted medical use and a carry a high potenDistrict of Columbia have decriminalized the possession of tial for abuse.2 In 1985, the only synthetic cannabinoid apsmall amounts of cannabis, meaning that personal possession proved by the Food and Drug Administration (FDA), of a small amount of cannabis is a civil or local infraction that Federal Level Legislation

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Figure 1.

does not include jail time, rather an offense similar to a minor traffic violation.6

holic Beverage and Cannabis Control would regulate cannabis and the bill would give clear indications regarding cultivation and possession, as well as defining which organizations could While some scientific evidence is available, the indications for assist in providing the substance for those in need. The bill medicinal cannabis use varies by state and are not the same. eventually died in committee.8 S.B.243, also introduced in For example, cannabis is legal to treat glaucoma for patients 2017, would allow individuals access to cannabis in end of life in Alaska; however, glaucoma patients in Delaware cannot or palliative care situations. It provided physicians the right to use cannabis because it is not a qualifying indication accordrecommend, transfer, dispense, or administer certain types of ing to Delaware state law. This inconsistency is problematic cannabidiol or CBD to patients in need. The bill failed to for patients, creating limited access to treatment based on their leave the Senate and died in committee as well.9 location.

In the 2018 session, State representatives Sims Jr. and Gentry Currently, the Commonwealth of Kentucky has only legalized proposed House Bill 166. The bill laid out a comprehensive the use of cannabidiol oil.7 Senate Bill 124 (S.B. 124) allows plan to provide access to cannabis products to patients. The cannabis products for use in FDA approved studies or comcreation of the Cannabis Enforcement Program by the Departpassionate care programs as well as cannabidiol oil specifical- ment of Alcoholic Beverage Control would provide oversite of ly for the use of “persons participating in a clinical trial or in the proper regulations of the bill. The plan included specific an expanded access program.�7 Since State senators have indebilitating conditions permitted for use in the state as well troduced legislation in the past, including as recently as the and established requirements for cultivators and businesses to 2018 session. The Cannabis Compassion Act or S.B.57 intro- operate in the industry. After reaching committee, legislators duced in 2017 would establish a comprehensive system for medical cannabis within Kentucky. The Department of Alco|15| www.KPHANET.org

filed a discharge petition requiring signatures before it may be (Figure 1). There is moderate evidence cannabis provides appropriated to committee once more.10 short-term sleep outcomes in patients with obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and MS. FinalEndocannabinoid System ly, the report determined there is insufficient evidence of canMore states have proposed legislation for medicinal cannabis nabidiol to be considered effective in patients with a variety of access due to the availability of increasing literature. With this diseases states ranging from cancer and epilepsy to schizophrenia and glaucoma. change in healthcare policy, it is important to remember the role of pharmacists. Pharmacists must be prepared to counsel, educate, and address the concerns of the public regarding the drug. Pharmacists play an important role in their patient’s drug treatment; therefore, it is essential to learn how cannabis affects the human body. This requires understanding the pharmacotherapy of cannabis, as well as the endocannabinoid system’s function in humans.

Cannabis, like many drugs, has an adverse effect profile. In most instances, the adverse effects of a product can be better understood by knowing the levels of specific cannabidiols in the product. Current evidence has shown short term adverse drug reactions including impaired short term memory, impaired motor coordination, altered judgement, and, at high doses, paranoia and psychosis. Long-term adverse effects have not been as extensively studied, though the report from The endocannabinoid system, an inherent system in all hu11 mans, has two main receptors: CB1 and CB2. CB1 receptors the National Academies of Sciences highlights that smoking are located in areas of the brain that coincide with one’s appe- cannabis does not increase the risk of certain cancers. Smoking cannabis, however, has shown to lead to chronic cough tite, memory, and motor responses.11 CB1 receptors can also 11 be found in the gastrointestinal tract and muscle tissue. CB2 and phlegm. There is modest evidence of an association with cannabis use and subtype of testicular cancer. The evidence of receptors found in the brain lack the psychoactive properties an association between cannabis and heart attacks, stroke, found in CB1 receptors; instead, they are more common in and diabetes is currently unclear.

11 immune cells. The two endogenous ligands, 2archidonoylglycerol (2-AG) and anandamide regulate the Pharmacist Concerns and Role endocannabinoid system.11 Both ligands have shown an affinity towards the CB1 receptor working to regulate parts of the As pharmacists, there are many clinical concerns to be aware central nervous system.11 of when discussing cannabis. As a naturally derived product, there can be multiple strains of a cannabis product, and the Cannabinoids are chemical compounds found in natural can- high variability can lead to different clinical effects. Undernabis products that mimic the role of the endogenous ligands. standing the THC and CBD contents in cannabis products as More than 104 cannabinoids have been discovered in recent are strong indicators of the clinical effects. When dosing canyears, but the properties of two specific cannabinoids receive nabis, both CBD and THC contents play a role. While comthe most attention: Δ9-tetrahydrocannabinol (THC) and can- monly measured in milligrams, guidelines are unavailable for nabidiol (CBD). THC is known for its ability to produce the indication specific doses. Unfortunately, routes of administrapsychoactive properties of cannabis or the intoxicated state tion, drug interactions, and an extensive review of adverse most commonly seen in recreational cannabis users. THC reactions is still lacking. These are clinical concerns pharmabinds to CB1 receptors in the brain to activate its psychoactive cists should be able to address with any medication. For pharproperties. CBD can bind to CB1 receptors as a noncompeti- macists working in hospitals, the unknown clinical undertive CB receptor antagonist.12 CBD can also bind to CB2 restanding of cannabis poses a problem in a complex medical ceptors, but with less affinity.11 CBD also binds to G protein- setting. With uncertainty of how the substance works in the coupled receptors in the brain and acts as a 5-HT1A receptor body and potential legal implications of using a federally illepartial agonist.11 CBD’s pharmacological mechanisms show it gal substance, issues with disclosure of use may be common may possess antidepressant, anxiolytic, and neuroprotective with caregivers in all settings. properties.

While medicinal cannabis has been available since 1996, outThe FDA approved cannabis products have a half-life elimicomes studies regarding cannabis use have examined a variety nation that ranges from 4-36 hours.4,5 The chemical comof public health concerns. According to the National Acadepounds found in cannabis are excreted through the urine and mies of Science Engineering and Medicine, studies have are metabolized by the liver. The main metabolite is 11shown a statistical association between cannabis use and inhydroxy-THC in products containing THC.4,5 Evidence has creased risk of motor vehicle accidents as well as statistical shown this metabolite may be responsible for added psychoassociation between cannabis use and an increased risk of active effects when metabolized.11 pediatric overdose injuries, such as respiratory distress, in states where the substance is legal. Perinatal exposure via In 2017, a report entitled The Health Effects of Cannabis and smoking during pregnancy is statistically associated with lowCannabinoids was released by the National Academies of er birth weights. These results pose a cautionary tale for those 11 Science, Engineering, and Medicine. The report evaluated taking medicinal cannabis, especially in the pediatric setting. current literature to determine the health effects of cannabis products. Specific therapeutic indications were evaluated and The National Academies of Science, Engineering, and Mediplaced in categories denoting the weight of evidence. The cine also evaluated the relationship between cannabis and report determined there was strong evidence of cannabinoids mental health. Recent cannabis use and impairments in cognibeing effective for chemotherapy induced nausea & vomiting, tive learning, memory, and attention are associated. Use durchronic pain, and multiple sclerosis (MS) related spasticity ing adolescence has been associated with impairment in aca|16| Kentucky Pharmacists Association | September/October 2018

demic achievement and education, employment, income, social relationships, and social roles. There is substantial evidence cannabis use is associated with increased risk of developing schizophrenia and other psychoses diagnoses and the highest risk among frequent users. There is moderate evidence for an association between cannabis use and better cognitive performance in patients with a history of psychotic disorders, increased symptoms of mania and hypomania in bipolar patients, increased incidence of suicidal ideation and attempts, especially among high frequency users, and an increased risk of social anxiety disorder among regular cannabis users.

The bill died in the House of Representatives without any advancement.

Future Concerns

Support from large national and state level organizations has the impact to change policy. Pharmacists play a unique role in the lives of their patients and it is important to know what may be coming down the pipeline so that we may be prepared to address the concerns of those we care for.

The Compassionate Access, Research Expansion, and Respect States (CARERS) Act was also introduced in 2015, pushing for the rescheduling of cannabis from Schedule I to Schedule II. 16 The goal of this legislation was to increase access to cannabis in order for more research to be conducted on the substance. Another problem the CARERS Act hoped to solve was in regards to small businesses selling cannabis, which struggle to deposit their money in banks because banks are federally insured institutions. This transaction would put In many settings, cannabis has been termed a “gateway drug.” banks at risk of prosecution if the federal government were to One way to measure the impact of cannabis in this capacity is contest the money deposited in them as sales from illegal to evaluate opioid overdoses and substance abuse disorders in transactions. The CARERS Act prohibited banks from limitstates where medicinal cannabis is legal. From current reing financial services to businesses that provided cannabissearch, there is limited evidence in this linkage. While canna- related services. The bill died in committee, but an updated bis use may be more common in medicinal cannabis states, version of the bill, known as the CARERS Act of 2017, is curthe association does not imply causation. As healthcare prorently in committee in the House of Representatives.17 fessionals, it is important to be conscious of this relationship The American Medical Association (AMA) urges Congress to when making claims with limited evidence. The direct enreview cannabis’s current schedule by stating “marijuana’s gagement pharmacists share with patients can help educate status as a federal Schedule I controlled substance be reviewed the public of its known benefits and risks. with the goal of facilitating the conduct of clinical research Lastly, of the 29 states where cannabis is legal, only three reand development of cannabinoid-based medicines, and alterquire pharmacist involvement in the dispensing of the prodnate delivery methods.”18 The American Pharmacists Associauct. New York, Minnesota, and Connecticut legally necessition (APhA) released a similar policy report stating, “APhA tate pharmacist dispensing of cannabis.13 All three states have supports regulatory changes to facilitate clinical research relatdiffering indications for cannabis and specific licensures are ed to the clinical efficacy and safety associated with the use of necessary before working in dispensaries. The majority of cannabis and its various components.”19 These positions do states with medicinal cannabis legislation do not require phar- not advocate for the rescheduling of cannabis to a specific macist involvement. More information around cannabis may schedule, rather, they advocate for a new assessment of the lead to more states involving pharmacists to dispense the drug so it be can studied properly. The Kentucky Pharmacist’s drug. Ensuring future pharmacists are educated on the clinical Association has adopted a similar policy position to APhA, uses, adverse reactions, drug interactions, and proper admin- neither endorsing nor opposing legislation, rather advocating istration of a legal medicine is necessary. for more research on cannabis.20

In recent years, federal legislation regarding cannabis has gained traction as more and more states passed legislation to legalize medicinal cannabis. The Rohrbacher-Farr amendment, an amendment attached to the Omnibus Budget Act of 2014 under then President Obama’s administration, stated federal dollars would not be used to prosecute individuals in states where medicinal cannabis laws had been passed. While this was upheld during President Obama’s tenure, a different approach has been taken with the President Trump administration. In January of 2018, Attorney General Jeff Sessions lifted the Obama era policy allowing states to legalize cannabis despite federal law prohibiting such actions.14 Federal prosecutors can now enforce federal law in states where this was previously not the case, leading to confusion among medicinal cannabis patients in states where the substance is legal.

References: 1.

National Institute of Drug Abuse. Drug Facts Nationwide Trends. drugabuse.gov. https://www.drugabuse.gov/publications/drugfacts/nationwide-trends.

Published June 2015. Accessed April 27, 2018.

2.

United States Drug Enforcement Administration. Drug Scheduling.

Drug Enforcement Administration website. https://www.dea.gov/druginfo/ds.shtml. Accessed December 20, 2017.

3.

Department of Homeland Security. Did You Know…Marijuana Was Once a Legal Cross-Border Import?. U.S Customs and Border Protection website. https://www.cbp.gov/about/history/did-youknow/marijuana. Updated October 6, 2015. Accessed December 20, 2017.

Prior to Attorney General Session’s decisions, the United States House of Representatives had tried a different approach 4. to cannabis. H.R.1013, introduced in 2015, sought to regulate 15 the cannabis industry like alcohol. The bill would remove 5. cannabis from a Schedule I substance in the Controlled Substances Act and transfer the enforcement of federal laws from the DEA to the Bureau of Alcohol, Tobacco, and Firearms.

6.

Marinol (dronabinol) [package insert]. North Chicago, IL: AbbVie Inc.; 2017.

Syndros (dronabinol) [package insert]. Chandler, AZ: Insys Therapeutics.; 2017.

The National Organization for the Reform of Marijuana Laws. States that have Decriminalized.

|17| www.KPHANET.org

http://norml.org/aboutmarijuana/item/states-that-havedecriminalized. Accessed December 20, 2017.

7.

Kentucky Senate. SB124. http://www.lrc.ky.gov/record/17RS/SB57.htm. Published April 10, 2014. Accessed April 27, 2018.

8.

Kentucky Senate. SB57. http://www.lrc.ky.gov/record/17RS/SB57.htm. Published January 3, 2017. Accessed December 20, 2017.

9.

Kentucky Senate. SB243. http://www.lrc.ky.gov/record/17RS/SB243.htm. Published February 16, 2017. Accessed December 20, 2017.

KPhA Welcomes new Member Services Coordinator/Office Assistant

10. Kentucky House of Representatives. HB166. http://www.lrc.ky.gov/record/18RS/HB166.htm. Published January 10, 2018. Accessed January 12, 2018.

11. The Health Effects of Cannabis and Cannabinoids: the Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press; 2017.

12. Laprairie RB, Bagher AM, Kelly ME, Denovan-wright EM. Cannabidiol is a negative allosteric modulator of the cannabinoid CB1 receptor. Br J Pharmacol. 2015;172(20):4790-805.

13. Bonner L. Pharmacists Take on Medical Cannabis Dispensing Role in Three States. American Pharmacists Association pharmacist.com. http://www.pharmacist.com/article/pharmacists-take-medicalcannabis-dispensing-role-three-states. Published January 13, 2016. Accessed April 12, 2018.

14. Savage C, Healy J. Trump Administration Takes Step That Could Threaten Marijuana Legalization Movement. New York Times. January 4, 2018. https://www.nytimes.com/2018/01/04/us/politics/marijuanalegalization-justice-department-prosecutions.html. Accessed January 12, 2018.

15. United States House of Representatives. Regulate Marijuana Like Alcohol Act. H.R.1013. https://www.congress.gov/bill/114thcongress/house-bill/1013. Published February 20, 2015. Accessed December 20, 2017.

16. United States Senate. Compassionate Access, Research Expansion, and Respect States Act of 2015. S.683 https://www.congress.gov/bill/114th-congress/senate-bill/683. Published March 10, 2015. Accessed December 20, 2017.

17. United States House of Representatives. CARERS Act of 2017.

H.R.2920. https://www.congress.gov/bill/115th-congress/housebill/2920. Published June 15, 2017. Accessed December 20, 2017.

18. American Medical Association. AMA Policy: Medical Marijuana.procon.org. https://medicalmarijuana.procon.org/sourcefiles/AMA09policy.pdf.

Published 2017. Accessed April 12, 2018.

19. American Pharmacists Association. 2014-2015 APhA Policy Committee Report Role of the Pharmacist in the Care of Patients Using Cannabis. pharmacist.com. https://www.pharmacist.com/sites/default/files/files/Role%20of%20t he%20Pharmacist%20in%20the%20Care%20of%20Patients%20Using% 20Cannabis%20.pdf. Published August 2014. Accessed April 12, 2018.

20. Kentucky Pharmacists Association. KPhA Policy Position on Medical Marijuana. kphanet.org. http://www.kphanet.org/policy-positions.

Published February 7, 2016. Accessed April 12, 2018.

Figure 1 Source: The Health Effects of Cannabis and Cannabinoids: the Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press; 2017.

|18| Kentucky Pharmacists Association | September/October 2018

Please join us in welcoming our new staff member, Sydney Hull.

She can be reached by email at shull@kphanet.org.

September 2018 — Medicinal Cannabis Legislation and Future Implications for Pharmacists

1. Which federal regulation placed cannabis as a schedule I substance?

7. From the National Academies of Science, cannabis use in pregnancy been linked to which outcome?

A. Marijuana Tax Act of 1937

A. Low birth weight

B. Controlled Substances Act

B. Preterm labor

C. Rohrbacher-Farr amendment

C. Immature lungs

D. CARERS Act

D. Neonatal abstinence syndrome

2. For which disease is medicinal cannabis shown to have insufficient evidence for treatment?

8. What schedule does the AMA and APhA support for cannabis rescheduling?

A. Chemotherapy induced nausea & vomiting B. Chronic pain C. Epilepsy D. Multiple sclerosis related spasticity

A. Schedule II B. Schedule III C. Schedule IV D. Do not oppose or endorse for a specific schedule

9. Cannabis use in adolescents is related which outcome?

3. Which endogenous ligand is associated with the endocanA. Impaired academic achievement nabinoid system?

A. THC

B. Increased social relationships

B. CBD

C. Increased motor function

C. Anandamide

D. All of the above

D. 11-hydroxy-THC

10. There is moderate evidence in cannabis use and which therapeutic indication?

4. Which of these is a clinical concern for practicing pharmacists in regards to medicinal cannabis?

A. Symptoms of dementia

A. Route of administration

B. Tourette syndrome

B. Dosage

C. Irritable bowel syndrome

C. Strain

D. Short term sleep outcomes in patients with obstructive sleep apnea

D. All of the above 5. Pharmacists dispense cannabis in which of the following states?

A. California, Illinois, Minnesota

CPE Quiz Online www.surveymonkey.com/r/CEQuizSept18

B. Connecticut, Minnesota, New York C. California, Oregon, Washington D. Nevada, Colorado, New Jersey 6. Which proposed legislation would increase access and provide research expansion for medicinal cannabis in the United States?

A. HR Bill 1013 B. CARERS Act C. Rohrbacher-Farr Amendment D. Omnibus Budget Bill |19| www.KPHANET.org

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: 09/05/2021 Successful Completion: Score of 80% will result in 1.5 contact hour or .15 CEUs. TECHNICIANS ANSWER SHEET September 2018 — Medicinal Cannabis Legislation and Future Implications for Pharmacists (1.5 contact hour) Universal Activity # 0143-0000-18-013-H03-T 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 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 September 2018 — Medicinal Cannabis Legislation and Future Implications for Pharmacists (1.0 contact hour) Universal Activity # 0143-0000-18-013-H03-P 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

9. 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.

|20| Kentucky Pharmacists Association | September/October 2018

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.



Article should begin with the goal or goals of the overall program – usually a few sentences.



Include 3 to 5 objectives using SMART and measurable verbs.



Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.



Include a quiz over the material. Usually between 10 to 12 multiple choice questions.

Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.

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

October CPE Article Federal Expectations of Pharmacists When Dispensing Controlled Substances By: Rachel B. Hardin is a fourth professional year PharmD student at the UK College of Pharmacy. A native of Louisa, she completed her pre-professional education at the University of Kentucky. Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is professor of pharmacy law and policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.

The authors declares there are no financial relationships that could be perceived as real or apparent conflicts of interest. He does report that he chaired the group that created the latest version of the APhA Code of Ethics for Pharmacists.

Universal Activity #0143-0000-18-014-H03-P &T 1.0 Contact Hour (0.10 CEU) Expires 9/5/21

KPERF offers all CE articles to members online at www.kphanet.org

Goal: To discuss pharmacists’ corresponding responsibility and identify common red flags that may arise when evaluating the validity of a controlled substance prescription.

Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1. Describe corresponding responsibility and its implication on pharmacists 2. List the major requirements of a valid controlled substance prescription 3. Identify red flags that a pharmacist should consider when assessing a controlled substance prescription Throughout their time in pharmacy school, pharmacists are inculcated with the notion that one of their most important roles is to protect the patient from the prescriber. The practice of medicine, or other professions entrusted by society with prescribing authority, is engaged in by human beings; that means that errors will materialize. Hopefully, this will not occur very frequently. The pharmacist is interposed between the prescriber and the patient as a double check to filter out errors in prescribing before they are translated into true problems for the patient. A pharmacist who has been in practice for a period of time can recall a situation where a prescriber was treating a child but requested an adult dosage. Alternatively, it may have been that the prescriber requested an antibiotic despite a clear notation in the patient’s chart, and fortunately in the records at the pharmacy as well, that there was an allergy to a medication in that class.

macist’s professional antennae go abuzz and a condition of heightened alert is activated to bring extra scrutiny to the transaction. All that is a reflection of sound preparation of the practitioner and the professionalism of the individual.

Yet one category of medications has a heightened level of awareness that is an expectation emanating from federal law.

This is not a classification based on therapeutic class but rather a categorization derived from the potential of the medication for abuse. Moreover, for this list of medications the heightened awareness expected of the pharmacist is not to focus exclusively on the decisions or actions of the prescriber; for this category the behavior of the patient is also a factor to be weighed.

The U.S. Drug Enforcement Administration is charged with interpreting and enforcing the expectations enacted by Congress in the Comprehensive Drug Abuse Treatment and ConPharmacists learn while in their professional education that trol Act of 1970. The second portion of that statute, known as there are certain medications more prone to problems than Title II or the Federal Controlled Substances Act, gives the others. Some have a narrow therapeutic index, some have sound-alike names that can be mis-heard when the request for DEA authority to propose and adopt regulations pertaining to the production and distribution of a special subcategory of dispensing a prescription medication is coming in over the medications, both over-the-counter and prescription-only, phone, or when the writing is unclear because the prescripdesignated controlled substances. tion has been hurriedly scribbled by the issuer. Others are susceptible to drug-drug or drug-food interactions. In some Unlike the review the pharmacist is to conduct of a prescripcases, these cautions are specific to a certain medication tion to uncover therapeutic incompatibilities or threats to the while with others the alert relates to an entire therapeutic cat- health of the patient due to lax behavior and decision-making egory of medications. Upon receiving a prescription request- of the prescriber, the scrutiny expected to be applied to a coning dispensing of such a pharmaceutical the seasoned phartrolled substance prescription has been elevated to a designa|22| Kentucky Pharmacists Association | September/October 2018

tion of shared or mutual accountability – “corresponding responsibility” being the term settled on by DEA. Corresponding Responsibility According to federal regulations, in order for a controlled substance (CS) prescription to be valid, it must be “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”1 The prescribing practitioner has a responsibility to ensure those conditions are met. Pharmacists have an analogous responsibility, termed a corresponding responsibility, to ensure CS prescriptions are prescribed and dispensed appropriately.2 This corresponding responsibility means that pharmacists are legally responsible for proper prescribing/dispensing and are therefore required to exercise sound professional and independent judgment when evaluating the legitimacy of CS prescriptions.

The DEA has worded the text of the relevant federal regulation this way:

flags for which a pharmacist can look. The following are some of the parameters to assess to reach a conclusion whether the request for dispensing should be honored: 

Is there a standing pharmacist-prescriber relationship?



Is there a standing pharmacist-patient relationship?



What is the address of the patient? What are the distances between the patient, prescriber, and pharmacy?



Are many patients receiving the exact same prescriptions?



Does the prescriber take cash only?



Does the patient want to pay cash for the prescription instead of billing insurance?



Is the prescription written for an unusually large quantity?



Are the directions for use irregular?

The responsibility for the proper prescribing and dispensing of  controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills (sic) the prescription.3 CS Prescription Requirements In order to be valid under federal law, CS prescriptions must be dated and signed on the day of issuance. In addition, they must include the following: 

Full name and address of patient



Drug name, strength, dosage form, quantity prescribed



Directions for use



Refills permitted (if applicable)



Name, address, registration number of practitioner



Practitioner signature (when a verbal order is not permitted)

In addition to expectations under federal law, Kentucky also has some requirements. Prescriptions for Schedule II medications must be written, facsimile, or electronic.4 They are valid for up to 60 days after issuance and may not be refilled. Prescriptions for Schedules III, IV, and V may be written, facsimile, electronic, or oral and are valid for up to six months after issuance and may be refilled up to five times if so authorized.



Does the prescription appear to be photocopied?

Is the prescription written in different color inks or written in different handwritings?

It is important to keep in mind that many various sources list different red flags. No one list, including the one above, is entirely inclusive of everything that should be considered and should not take the place of a pharmacist’s professional judgment. It is the totality of the circumstances that should be the focus – taking everything into account, does all appear proper and acceptable?

The majority of this list of red flags appears in a document published by DEA in what is known as the “Trinity Pharmacy II” case.6 A quite lengthy discussion of what transpired with that pharmacy based in Clearwater, Florida, is available in the Federal Register, the daily publication of the federal government wherein official notice is given of action by governmental agencies. In this case the DEA was taking steps to revoke the pharmacy’s DEA registration. The Federal Register item, which runs over thirty pages, provides great detail regarding the transgressions of the staff at the pharmacy that led DEA to take the revocation action. That notice provides great insight into where the agency will focus its attention when reviewing the activities of staff members at a DEA registered location.

Other Considerations DEA registration numbers can serve as a tool for recognizing forged prescriptions by specifically knowing how they are constructed. Numbers for practitioners (physicians, dentists, veterinarians, etc.) start with the letter A, B, or F; mid-level practitioners (nurse practitioners, optometrists, etc.) have numbers that start with M. That letter is followed by the first letter of the registrant’s last name and then a computer-generated sequence of seven numbers.

Written CS prescriptions must be issued using ink or indelible pencil, computer-generated, or stamped. Pre-printed blanks are not permitted.5 CS prescriptions may only be e-prescribed as long as both the prescriber and pharmacy software meet the Practitioners may also use the DEA number of the hospital or DEA requirements for electronic prescribing. institution by which they are employed; such situations are Red Flags usually encountered with medical residents in training at the institution. The hospital assigns an internal code that consists When evaluating the validity of a prescription, especially a of the institution’s DEA registration number (two letters + prescription for a controlled substance, there are certain red seven numbers) followed by another code to identify the spe-

|23| www.KPHANET.org

cific individual operating under the aegis of the “master” institutional registration, such as AB1234567-012.

medications as requiring the authorization of a state-licensed practitioner in certain fields before the medication can be provided to a patient. An additional level of distribution reDifferent types of practitioners may prescribe differing strictions applies if the pharmaceutical is subject to the reamounts of controlled substances and knowing who can pre- quirements of the Federal Controlled Substances Act as adscribe what can come in handy when evaluating CS prescrip- ministered by the U.S. Drug Enforcement Administration. By tions. In Kentucky, physicians, dentists, veterinarians, and virtue of having been entrusted with these responsibilities, podiatrists could previously prescribe any controlled submembers of the profession of pharmacy have a high standard stance (within their scope of practice) without quantity limits. of expectations applicable to their activities. Professional deHowever, in 2017, the Kentucky General Assembly enacted a cision making must be applied, and the practitioner must be new law that limits prescribing of Schedule II medications to vigilant in daily practice to discharge the responsibilities in a a three-day supply.7 There are exceptions to this limit (based fashion consistent with what the federal government expects. on indication, the professional opinion of the practitioner, etc.), but a pharmacist may assume that a prescription written References for a longer period of time has met one or more of those ex1. 21 C.F.R. §1306 ceptions and is therefore valid.

Additionally, certified optometrists may prescribe a 72-hour supply of Schedule III, IV, and V medications and hydrocodone combination products. Nurse practitioners have more complicated prescribing practices but can generally prescribe a three-day supply of Schedule II medications (with a couple of exceptions) and a 30-day supply of Schedule III medications. Physician assistants may not prescribe any controlled substance in Kentucky.

2.

Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act, 2010 ed. DEA, Office of Diversion Control. Available at http://www.deadiversion.usdoj.gov/pubs/manuals/pha rm2/.

3.

21 C.F.R. §1306.04(a).

4.

KRS 218A.180

When in Doubt…

5.

“Controlled Substance Questions.” Kentucky Board of Pharmacy. Kentucky.gov. Available at https://pharmacy.ky.gov/Pages/Controlled-SubstancesQuestions.aspx.

When there is any reason to believe it was not issued for a legitimate medical purpose in the practitioner’s usual course of practice, steps can be taken to determine a prescription’s legitimacy. The pharmacist can contact the prescriber for veri- 6. fication. Another option is to require proper identification from the patient. All those steps should be documented in the pharmacy records. If it is believed a prescription is forged, altered, or otherwise invalid, the pharmacist should call the 7. local police. If is believed that there is a pattern of CS prescription abuse, the pharmacist should contact the Kentucky Office of Drug Control and Professional Practices (https://chfs.ky.gov/agencies/os/oig/dai/deppb/Pages/def ault.aspx) or local DEA Diversion Field Office. (Addresses and phone numbers of DEA Field Offices can be found at https://www.deadiversion.usdoj.gov/.)

DEA. Trinity Pharmacy II; Decision and Order, 83 Federal Register 7304-7336 (February 20, 2018). Available at https://www.federalregister.gov/documents/2018/02/2 0/2018-03294/trinity-pharmacy-ii-decision-and-order HB 333. Kentucky Legislature (2017). Available at http://www.lrc.ky.gov/record/17rs/HB333.htm

A pharmacist can refuse to dispense any CS prescription that does not appear to be valid; the law does not require the dispensing of a questionable, suspicious, or otherwise dubious prescription. As previously mentioned, the pharmacist is legally responsible for proper CS prescribing and dispensing.

Pharmacists may be prosecuted along with the prescriber for deliberately ignoring a questionable prescription. Knowingly and intentionally distributing controlled substances in such a manner is a felony offense and can result in the loss of professional license. It is, therefore, crucial for pharmacists to keep their corresponding responsibility in mind when dispensing CS prescriptions.

Over-arching Responsibility Pharmacists are the professional entrusted by society to have custody of and responsibility for distribution of medications that cannot be safely used without professional supervision.

The U.S. Food and Drug Administration designates some |24| Kentucky Pharmacists Association | September/October 2018

CPE Quiz Online www.surveymonkey.com/r/CEQuizOct18

October 2018 — Federal Expectations of Pharmacists When Dispensing Controlled Substances 1. Pharmacists have a “corresponding” responsibility to ensure CS prescription appropriateness. To whom does the responsibility correspond?

A. Patient B. Prescriber C. Pharmacist D. Pharmacy owner 2. Which of these are not generally required on a controlled substance prescription?

A. Address of patient B. Practitioner registration number C. Indication for use D. Directions for use

9. If you receive a prescription bearing a DEA number like this – SA1234567-012 – you should: A. Refuse the prescription outright B. Call the police C. Call the hospital to double check and verify D. Assume this is from a mid-level practitioner 10. E-prescribing is permitted under federal law if: A. The prescriber’s software meets DEA expectations.

B. The pharmacy’s software meets DEA expectations C. A + B but the expectations come from FDA, not DEA D. A + B

3. Red flag checklists do not take the place of professional judgment.

A. True B. False 4. When evaluating a patient’s CS prescription, which of these situations would be least likely to raise suspicion?

A. A new customer with an out-of-town address is requesting to pay cash B. It is the third customer to come in today with a prescription from this prescriber for this drug, strength, and quantity C. A regular patient comes in with a new prescription from the primary care provider that is on file D. The prescription is written in blue ink except for the quantity and strength, which are in black ink 5. Prescriptions for Schedule II medications may not include refills.

A. True B. False 6. How many letters are in a standard DEA registration number?

A. 1 B. 2 C. 3 D. 4 7. Pharmacists are required to dispense any prescription for any patient.

A. True B. False 8. The name of DEA is: A. Drug Enforcement Agency B. Drug Enforcement Administration C. Drug Enactment Activity D. Druggist Enforcement Agency

|25| www.KPHANET.org

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: 9/5/21 Successful Completion: Score of 80% will result in 1.0 contact hours or .10 CEUs. TECHNICIANS ANSWER SHEET. October 2018 — Federal Expectations of Pharmacists When Dispensing Controlled Substances (1.0 contact hours) Universal Activity # 0143-0000-18-014-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B 2. A B C D 4. A B C D

5. A B 6. A B C D

7. A B 8. A B C D

9. 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 October 2018 — Federal Expectations of Pharmacists When Dispensing Controlled Substances (1.0 contact hours) Universal Activity # 0143-0000-18-014-H03-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

3. A B 4. A B C D

5. A B 6. A B C D

7. A B 8. A B C D

9. 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

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.

|26| Kentucky Pharmacists Association | September/October 2018

Campus Corner Preceptor Highlight: Alan Webb Alan Webb, PharmD is the Pharmacy Area Transition Lead for Walgreens Co. Area 156. He is also the recipient of our 2018 Louisville CEC Preceptor of the Year Award and an alumnus of our program!

We were excited to learn a Pictured above: Chris Miller and Alan Webb bit more about Dr. Webb’s practice and hear how he’s partnered with the College since graduating.

How long have you been a preceptor?

I graduated from the University of Kentucky in 2012, and precepted my first UK APPE student in 2013. I immediately became a preceptor upon becoming eligible. I lived in Ohio for two years, and I didn’t have any UK students during that stretch. However, I became a preceptor for the University of Ohio, Ohio Northern University, and Cedarville University. I moved back to Kentucky in 2016 and began taking UK APPE students the following year.

What types of rotations/courses do you precept for?

Currently I have an elective upper management rotation.

What do you like most about precepting?

The most rewarding aspect for me is seeing the growth in students over the six weeks they are on my rotation.

Being on an upper management rotation often pushes students out of their comfort zones as they are required to have conversations regarding store metrics, staffing issues, action planning, etc. It gives students a sense of what it takes to not only be a successful pharmacist, but also how much is involved in running a successful pharmacy.

teaching, being in operations allows me to influence how we care for patients on a larger scale.

What would you tell someone who is thinking about doing a rotation at your location? What should they expect?

The true goal of my rotation is to create leadership behaviors. I want students to understand that a good business model is not solely about the numbers. Positive metrics are merely a symptom of running a successful business. I want students to leave my rotation with the confidence and tools needed to inspire and care for the team they are a part of, whether that be in community or hospital pharmacy.

How would you explain the role of the pharmacist in improving patient care?

The focus is shifting in community pharmacy to truly be more than a medication dispensary. With immunizations, diabetic coaching, medication therapy management, and countless other initiatives that are coming, pharmacists are now positioned to be able to have a holistic impact on patient health.

What role do you see pharmacists playing in addressing some of Kentucky’s public health challenges?

One of the biggest barriers to the well-being of Kentuckians is socioeconomic status and low health literacy. Patients in Kentucky require extra time that medical doctors often cannot provide. Pharmacists are in a unique position of having the expertise paired with availability to truly have a positive impact on not only patient’s health, but their overall well-being.

Why did you choose to partner with the University of Kentucky College of Pharmacy?

As an alumnus of the UK College of Pharmacy (UKCOP), I strongly believe in the culture and education provided there. I view it as an honor to be part of What inspired you to pick your specific area of patient the team that creates such amazing pharmacists. While care? admittedly biased, I believe the best students are found I have always had an affinity for community pharmacy, at the UKCOP! Continued on pg. 31 specifically the operations side of things. Much like |27| www.KPHANET.org

Financial Forum Are Too Many Baby Boomers Too Indebted?

This series, Financial Forum, is presented by PRISM Wealth Advisors, LLC and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

Imagine retiring with $50,000 of debt. Some new retirees owe more than that. Outstanding home loans, education debt, small business loans, and lingering credit card balances threaten to compromise their retirement plans.

How serious is the problem? A study from the University of Michigan’s Retirement Research Center illustrates how bad it has become. Back in 1998, 37% of Americans aged 56-61 shouldered recurring debt; the average such household owed $3,634 each month (in 2012 dollars). Today, 42% of such households do – and the mean debt load is now $17,623.1

er home, driving a cheaper car, or living in a cheaper state; any linked short-term financial expenses might pale in comparison to the potential savings. Whether you pay off your smallest debts first or your highest-interest ones, you are subtracting burdens from your financial life. The fewer financial burdens you have in retirement, the better.

Citations 1 - forbes.com/sites/nextavenue/2017/09/20/how-debt-isthreatening-retirement-dreams/ [9/20/17]

2 - cbsnews.com/news/mortgage-tips-for-retirees-and-nearAre increased mortgage costs to blame? Partly, but not fulretirees/ [10/20/17] ly. Quite a few homeowners do trade up or refinance after 3 - tinyurl.com/ybgvt7po [9/29/17] age 50. The Consumer Financial Protection Bureau notes that between 2001-2011, the percentage of homeowners 65 and older carrying a mortgage went from 22% to 30%. The data for homeowners 75 and older was more alarming.

While 8.4% of this demographic had outstanding home loans in 2001, 21.2% did by 2011.2 Education debt is weighing on boomer households. According to the Motley Fool, the average recent college gradu- Pat Reding and Bo Schnurr may be reached toll-free at 800ate has $30,000-$35,000 in outstanding student loans. It 288-6669 or pbh@berthelrep.com. would take monthly payments of $300-$400 over a decade to Registered Representative of and securities and investment eradicate that kind of debt.3 advisory services offered through Berthel Fisher & Company As good debts have risen, bad debts have also grown. Mag- Financial Services, Inc. Member FINRA/SIPC. PRISM nifyMoney, a financial analytics website, pored over the Wealth Advisors LLC is independent of Berthel Fisher & Compamost recent round of UMRRC data and determined that 32% ny Financial Services Inc. of older consumers now contend with revolving debt each month. The average recurring non-mortgage debt for these seniors: $12,490, of which $4,786 is attributed to credit cards. This material was prepared by MarketingPro, Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. This information has been deA staggering 22% of older Americans have more than rived from sources believed to be accurate. Please note - investing involves risk, and $10,000 in revolving credit card debt – pretty painful when past performance is no guarantee of future results. The publisher is not engaged in you consider that the average credit card carries 14% interrendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information est.1 One school of thought says that retiring with a mortgage is okay. Interest rates on home loans are rising, but they are still not far from historic lows, and homeowners who have bought or refinanced recently could be carrying loans at less than 4% interest. While carrying mortgage debt into retirement may be bearable, owning a home free and clear is better.

should not be construed as investment, tax or legal advice and may not be relied on for the purpose of avoiding any Federal tax penalty. This is neither a solicitation nor recommendation to purchase or sell any investment or insurance product or service, and should not be relied upon as such. All indices are unmanaged and are not illustrative of any particular investment.

How about you? Can you retire debt-free? It may seem improbable, but if small steps are taken, that goal may come within reach. Every year you delay retirement is another year you have full financial power to attack debt. Working longer may not be ideal, but it can give you the potential to start retirement owing less. Cutting off financial support for young adult children can also free up money to pay down debt. They have many more years to pay off what they owe than you do. You could also think about moving to a cheap|28| Kentucky Pharmacists Association | September/October 2018

Campus Corner Sullivan Preceptor Highlight great rotation to experience an interprofessional Featured Site(s): Mission Frankfort Clinic (MFC) and clinic in Honduras Frankfort Regional Medical Center (FRMC)  FRMC – one of the options for a required acute care Area(s): Volunteer opportunity at the Mission Frankfort APPE rotation. The site offers a great team atmosClinic (MFC), Elective Global Health APPE (including phere opportunity with lots of learning activities. a trip to Honduras) and Acute Care APPE at Frankfort Regional Medical Center (FRMC) What unique opportunities are available for a student on this rotation/site?

Preceptor: Dr. Amy Rogers, PharmD MFC – one-on-one learning with interprofessional collaboration How long have you been a preceptor? 3 years Honduras – getting to experience and learn about pharmacy in a third world country Where did you go to phar- FRMC – working in a team-orientated pharmacy with macy school? Sullivan Uni- multiple provider interactions versity College of Pharmacy; PGY1 Pharmacy Prac- What do you love about being a preceptor?

Precepting is a full-circle experience for me. When I was tice FRMC hired as a pharmacy technician for Walmart, I never Any certifications/ imagined that I would pursue a pharmacy career. Not specialty areas? BCPS until my APPEs, did my desire to pursue a residency become evident. During my residency, I was responsible for the students that came through the hospital pharmacy. It was a great experience. I loved being able to help the students critically think through various situaPharmacy set-up in Honduras.

How long has the experience been available as a rota- tions. It was during that time that I knew I wanted to be a preceptor. Precepting is very rewarding. I enjoy meettion/site? ing all the different students and trying to get them to  MFC – a brand new opportunity for pharmacy stuthe next level during their rotation. dents to obtain co-curricular hours The addition of the Global Health APPE elective with  Global Health Elective APPE with Honduras iman immersion to Honduras was very exciting. I have a mersion – 1 year love for the Honduran people and to be able to expand  FRMC Acute Care APPE– 2 years the experience to someone at SUCOP is outstanding!

Preparing for the trip can be exhausting, but once in the Highlights of the rotation/site (s)  MFC – This volunteer opportunity has a lot to offer country and seeing the people’s faces that we are able to help makes all the prep work worth the time and effort. in a short amount of time. Over the course of a month (4 visits), students will get to experience one- The week in Honduras is a fast-pace, non-stop experience that will change the way you think about pharmaon-one interactions with physicians, a glimpse at how to juggle a small formulary pharmacy, and in- cy in third world countries.

Finally, the Mission Frankfort clinic has a piece of my teractive patient experiences from the beginning to heart. I am so excited that we have developed a way for end of the visit.  Global Health – this elective requires a few responsi- both SUCOP and UKCOP students to volunteer. I am the Pharmacist-In-Charge (PIC) of the clinic and I am bilities of participation from August through January with the trip scheduled in late January. This is a fully responsible for the formulary and purchasing. This opportunity allows students to get the full experience in a small-scale setting.

|29| www.KPHANET.org

Pharmacy Law Brief Law Related to Epinephrine Auto-Injectors in Kentucky 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 Question: Epinephrine auto-injectors have been in the lay and professional news quite a bit in recent years. Pricing issues, FDA approval of a generic version of the brand name that’s been around for quite some time, states changing laws to make them more available – those have all been the focus of news reports. That caused me to wonder, are there any specific laws in Kentucky addressing availability of these important products?

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 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.

Response: The General Assembly enacted K.R.S. 311.646 as the Emergency Allergy Treatment Act during 2015 to address the lawful use of these products.

Interesting wording was used:

An individual who has a certificate issued under this section may:

A health-care practitioner may prescribe epinephrine auto-injectors in the name of an authorized entity or to a certified individual for use in accordance with this section.

(b) Possess prescribed epinephrine auto-injectors; and

(a) Receive a prescription for epinephrine auto-injectors from a health-care practitioner;

(c) In an emergency situation when a physician is not immediately available and the certified individual in A pharmacist may dispense epinephrine auto-injectors good faith believes a person is experiencing a severe pursuant to a prescription issued in the name of an au- allergic reaction regardless of whether the person has a thorized entity or to a certified individual. prescription for an epinephrine auto-injector or has preBut who is a “certified individual”? The statute address- viously been diagnosed with an allergy: es that as well: 1. Administer an epinephrine auto-injector to the perThe Department for Public Health, the Kentucky Board of Medical Licensure, the Kentucky Board of Nursing, the American Red Cross, or other training programs approved by the Department of Public Health may conduct in-person or on-line training for administering lifesaving treatment to persons believed in good faith to be experiencing severe allergic reactions and issue a certificate of training to persons completing the training. The training shall include instructions for recognizing the symptoms of anaphylaxis and administering an epinephrine auto-injector.

son; and 2. Provide an epinephrine auto-injector to the person for immediate self-administration.

How about the authorized entity; how is that defined?

"Authorized entity" means an entity that may at any time have allergens present that are capable of causing a severe allergic reaction and has an individual who holds a certificate issued under KRS 311.646 on the premises or officially associated with the entity. The term includes but is not limited to licensed child-care centers Moreover, what is it that an individual so certified may and certified family child-care homes, restaurants, recreation camps, youth sports leagues, theme parks and do? resorts, and sports arenas. |30| Kentucky Pharmacists Association | September/October 2018

What is it authorized to do?

injury under subsection (1) of this section includes:

An authorized entity that acquires and stocks a supply of epinephrine auto-injectors with a valid prescription shall:

(a) A health-care practitioner who prescribes or authorizes the emergency use of the epinephrine auto-injector; (b) A pharmacist who fills a prescription for the epinephrine auto-injector;

(a) Store the epinephrine auto-injectors in accordance with manufacturer's instructions and with any additional (c) A certified individual who provides or administers requirements established by the department; and the epinephrine auto-injector; (b) Designate an employee or agent who holds a certifi(d) An authorized entity who stores or provides the epicate issued under this section to be responsible for the nephrine auto-injector to a certified individual or authorstorage, maintenance, and general oversight of epinephized noncertified individual; and rine auto-injectors acquired by the authorized entity. (e) An individual trainer or training entity providing the Under this wording, the injector could be dispensed to a certified individual. school nurse who is not the patient or to someone runThese products can truly be life-saving when approprining a summer camp for use if needed for campers or ately available and properly used. By understanding the staff members. legal framework for their availability in the CommonThere is an expectation that follow-up occur if the autowealth pharmacists can assist their patients and commuinjector is used. nities to safely pursue activity from which they might “Any individual or entity who administers or provides otherwise shy away. an epinephrine auto-injector to a person who is experiCampus Corner Continued... encing a severe allergic reaction shall contact the local emergency medical services system as soon as possible. SAVE THE DATE! A further expectation is: Any individual or entity who acquires and stocks a supply of epinephrine auto-injectors in accordance with this section shall notify an agent of the local emergency medical services system and the local emergency communications or vehicle dispatch center of the existence, location, and type of the epinephrine auto-injectors acquired if a severe allergic reaction has occurred.

The legislature also included KRS 311.647 which provides immunity from civil liability for those rendering aid with an auto-injector.

UK Hospital Residency 50th Anniversary Weekend October 12 – October 14 | Lexington, Kentucky Join us as we come together with UK Healthcare to celebrate the legacy of the hospital residency program and welcome back many of our alumni. Contact Amber Bowling for more information and to register for the weekend’s events: amber.bowling@uky.edu Foster Lectureship October 12 | UK College of Pharmacy

University of North Carolina Provost, Dr. Bob Blouin will be this year’s speaker. To join us for the afternoon (1) Any individual or entity who, in good faith and with- lecture, please contact Melissa Barger to reserve your out compensation, renders emergency care or treatment spot: melissa.barger@uky.edu by the use of an epinephrine auto-injector shall be imHomecoming Tailgate Bash & Class of 2018 Zero mune from civil liability for any personal injury as a reYear Reunion sult of the care or treatment, or as a result of any act or October 20 | Lexington, Kentucky failure to act in providing or arranging further medical We’re looking forward to welcoming back our alumni, treatment, if the person acts as an ordinary, reasonable prudent person would have acted under the same or sim- including our most recent grads! We’ll have food, fun, and a cash bar for the College of Pharmacy family and ilar circumstances. friends. Keep an eye out for additional information as (2) The immunity from civil liability for any personal we get closer to football season. |31| www.KPHANET.org

|32| Kentucky Pharmacists Association | September/October 2018

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

The list reflects new memberships received from July1, 2018— August 31, 2018 Alexander Bessler

Samson Lam

James Stark

David Blandford

Carolyn Lamm

Daniel Thies

Kimberly Caudill

Katie Leslie

Chad Wrinn

Manuel Francia

Chelsey Llayton

James Frazier

Trena Llayton

Gary Harris

Laura Riley

Abigail Krabacher

Lindsey Smith

MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession!

If you see one of these new members, please welcome them to the KPhA family!

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Pharmacy Policy Issues Pharmacy Policy Issues: The WHO Model List of Submit Questions: jfink@uky.edu Essential Medicines Author: Taylor R. Elliott is a PY2 student in the Pharm.D. degree program at the UK College of Pharmacy. She is enrolled concurrently in the M.P.H. degree program at the UK College of Public Health. A native of Owensboro, KY, she completed her pre-professional education at Kentucky Wesleyan College with a major in Chemistry.

Issue: From time to time when reading about pharma- personnel. cy and health issues in other countries I encounter a Figure 1 reference to the List of Essential Medicines compiled by the World Health Organization. I’ve never learned much about that. What types of medications are on that list? Is it the same for, say, tropical countries as for those in cooler climes? Who puts items on that list? I assume it is reviewed periodically to see whether something new needs added or some product that has been eclipsed should be replaced. Any background information would be appreciated.

Discussion: What is the WHO Model List of Essential Medicines, and what are some of its benefits and limitations?

According to the World Health Organization (WHO), essential medicines are defined as those that satisfy the priority health care needs of the population. The selection process takes into account an array of factors: disease prevalence and public health relevance, evidence of clinical efficacy and safety, and comparative costs and cost-effectiveness. In 1977, the WHO Expert Committee on Selection and Use of Essential Medicines created the original Model List, which was comprised of 208 medicines. The Model List has been updated with additions and deletions every two years thereafter, with the current version including 433 essential medicines.

Medicines are organized into therapeutic categories (i.e., antibacterial, antiviral, immunosuppressive, cardiovascular, etc.) and are subdivided into core or complementary lists. Medicines belonging to the core list are the most efficacious, safe and cost-effective and should collectively meet the minimum needs for a basic health care system. In contrast, the complementary list represents medicines that pose cost or cost-effectiveness issues and/or require specialized diagnostic techniques or

The WHO’s Model List serves as a guide for individual nations and institutions, in both a conceptual and a practical sense. Conceptually speaking, the term “essential medicines” gives rise to the idea that they are basic human rights. Similar to food, water, and shelter, they are intended to be available to all members of society at an affordable cost, regardless of nationality, race, gender, or socioeconomic status. In addition, the dynamic nature of the Model List indicates the constant need for growth. Every two years, additions and deletions are made for already existing diseases, emerging diseases, and combating resistance. Practically speaking, the WHO’s Model List functions as a template for nations and institutions to reference. Because it is a suggestion and not a mandate, it can be tailored to unique needs in regard to disease prevalence and budgetary

|34| Kentucky Pharmacists Association | September/October 2018

allocation. According to most recent data, four out of five countries have adopted this principle and created their own national lists of essential medicines (NEMLs).

Some regionally diverse countries have produced subdivisions of their national list according to territory, state, or province, respectively. Furthermore, numerous other institutions and organizations utilize the Model List as a basis for their drug supply. Examples include the United Nations High Commissioner for Refugees (UNHCR), the United Nations Children’s Fund (UNICEF), and the United Nations Population Fund (UNFPA). Creation of these lists at all levels (WHO, national, organizational, etc.) should ideally limit irrational drug use and subsequently lead to superior care at less cost. The benefits of the Model List, albeit somewhat ideological, are undeniable.

Figure 2

ent barriers to availability are the density of health care workers and the lack of infrastructure in developing and transitional economies. Over 45% of WHO Member States report to have less than one physician per 1,000 population. Moreover, inadequate modes of transportation and lack of roadways in rural areas provide yet another barrier to an already limited access to care. With these staggering statistics, it is clear how the ideological concept of essential medicines quickly turns into an impractical goal.

The next WHO Expert Committee on Selection and Use of Essential Medicines will meet in 2019. Selections made will be interesting considering the extreme variation of disease prevalence and public health relevance among developing, transitional, and developed economies. As an example, Figures 1 and 2 depict the leading causes of death in 2015 in low-income economies versus high-income economies, respectively.

Although the current global health problems surrounding access to care seem daunting with no clear resolution, the progress made by the WHO Model List of Essential Medicines since its origination in 1977 is invaluable. In future years, it will continue to serve as a guide for individual nations and organizations, and perhaps, with a global effort, the availability and affordability of the essential medicines will improve.

Have an Idea?: This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions regarding topics for consideration are welcome. Please send them to jfink@uky.edu.

References:

However, current global health problems make the implementation of the Model List unfortunately all too unrealistic. In 2015, over 10 million deaths per year could have been avoided, the majority of which depended on medications belonging to the Model List. Perhaps the most evident barrier to the availability of essential medicines is the substantial cost of pharmaceuticals. The WHO estimates that the portion of spending on pharmaceuticals in relation to total health spending is between 25 and 66% in developing countries and between 15 and 30% in transitional economies. Some of the less appar-

For General Information about the World Health Organization. http:// www.who.int/en/ World Health Organization. Essential Medicines. Available at http:// www.who.int/medicines/services/essmedicines_def/en/.

World Health Organization. 10 Facts on Essential Medicines. Available at http://www.who.int/features/factfiles/essential_medicines/en/.

World Health Organization. WHO List of Essential Medicines (20th List), March, 2017, updated August, 2017. Available at http://www.who.int/ medicines/publications/ essentialmedicines/20th_EML2017_FINAL_amendedAug2017.pdf?ua=1.

Figure Source: World Health Organization. The Top 10 Causes of Death.

Available at http://www.who.int/mediacentre/factsheets/fs310/en/ index1.html.

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|36| Kentucky Pharmacists Association | September/October 2018

|37| 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

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

|38| Kentucky Pharmacists Association | September/October 2018

“The facet of pharmacy that seems to worry everyone is the community pharmacist. Well I’m not worried. I, for one, think we’ll be around for a good many years. There is a distinct need for us and as long as we stay abreast of the times, modernize now and then, and take care of the people, we’ll stay.” - Ralph J. Schwartz - From The Kentucky Pharmacist, September 1968, Volume XXXI, Number 9

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 SUCOP 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 Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Pharmacy Emergency Preparedness jjaggers@kphanet.org Sydney Hull Office Assisant/Member Services Coordinator shull@kphanet.org

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to info@kphanet.org.

Deceased members for each year will be honored permanently at the KPhA office.

|39| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601

Legislative Conference Friday, November 2 Louisville, KY

Register Online www.kphanet.org