The Kentucky Pharamcist - September/October 2019 Issue

Vol. 14 No. 5 September/October 2019

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

Join us for the KPhA Legislative Conference on November 1-2, 2019 in Lexington! Register Today!

INSIDE: Legislative Conference October is American Pharmacists Month

TABLE OF CONTENTS FEATURES

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

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

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

Phone: 502.227.2303 Fax: 502.227.2258.

Email: info@kphanet.org.

Website: www.kphanet.org.

Legislative Conference |6| KPhA at the Kentucky State Fair |10| Financial Forum |27| Managing Debt Pressure for Pharmacy Students |29| New Law Clarifies Agency Dispensing of Naloxone |31| Rx and the Law |33| Shoulder to Shoulder in Santo Domingo, Ecuador |38|

On the Cover 

Pictured left to right:: Senator Max Wise, Representative Chad McCoy, KPhA Board of Directors Member, Matt Carrico hosting mock legislator visits at the 2018 Legislative Conference.

IN EVERY ISSUE President’s Perspective |4| My KPhA Rx |7| September CE Article |11| September Quiz |18| September CE Answer Sheet |19| October CE Article |21| October Quiz |25| October Answer Sheet |26| Campus Corner |28| New KPhA Members | 30| Academy of Pharmacy Technicians |32| Pharmacy Policy Issues |34| Pharmacy Law Brief |40|

ADVERTISERS APSC|3| APMS |6| PTCB |20| EPIC |30| Pharmacists Mutual |36| Cardinal |37|

|2| Kentucky Pharmacists Association | September/October 2019

|3| www.KPHANET.org

PRESIDENT’S PERSPECTIVE Congratulations to All Pharmacists; Celebrate Phar- every day for our patients, such as Board Approved Promacists Month in October tocols. Our Government AfHave I told you, the members, and staff how honored I fairs Committee is working am to represent the pharmacists of Kentucky as your very hard on PBM reform as association President? And, there isn’t a better time for well. Many states have passed YOU to be proud of your profession than in October – legislation trying to reign in American Pharmacists Month. You can discover a PBM activities that are taknumber of ways to celebrate by visiting the American ing money from our pharPharmacists Month website. macies in addition to makDon Kupper I am sharing a picture of me in 2004 when I had a simi- ing our patients pay exorbiPresident, KPhA lar honor and served as President of the Kentucky Socie- tant co-pays. KPhA has a ty of Health-System Pharmacists. I was proud to repre- plan and we have partnered sent pharmacists in hospital settings, and appeared on with the Kentucky Independent Pharmacist Alliance the cover of The Kentucky Pharmacist journal in front of (KIPA) to fight for legislation against the ruthless practhe University of Louisville Hospital (picture was photo tices of PBMs. shopped). At that time, The Kentucky Pharmacist was the The 2020 legislative session is very important for all official publication of KPhA and KSHP and it still pharmacists regardless of your practice setting or where stands as the voice for all pharmacy. you practice in Kentucky. We need to stand as one profession. The election season is in full swing and under “KPhA has a plan and we have partnered with the direction of KPhA Executive Director Mark Glasper the Kentucky Independent Pharmacist Alliance and Kentucky Pharmacists Political Advocacy Council Chair Matt Carrico, we have attended several fundrais(KIPA) to fight for legislation against the ruth-

less practices of PBMs.” I am looking forward to a joint meeting between the KPhA and KSHP Executive Committees in October to discuss how we can work together to accomplish great

Don Kupper, KPhA President pictured with his aunt, Ann Kupper.

ing events so far this year for both political parties in Kentucky. We need your help, your consideration of a donation to KPPAC or our Government Affairs Fund would be greatly appreciated. Don’t wait to be asked, things for our profession. I have asked the KPhA Gov- take a step forward for our profession. You can make ernment Affairs Committee that we convene a group to that donation on the KPhA website. put together a bill that Represenative Danny Bentley can Switching gears, I have also shared a picture of my aunt, put before the legislature in 2020 to grant us the ability Ann Kupper, and myself taken this past summer at her to receive compensation for the clinical activities we do |4| Kentucky Pharmacists Association | September/October 2019

home. I was visiting with her to talk about “generational” pharmacists practicing in Kentucky. I am a third-generation pharmacist, and my mother’s dad and my dad were pharmacists. Ann’s husband, Irvin, his two sons and four soon-to-be-five grandchildren are or will be pharmacists in Kentucky. Out of that bunch they have only one third-generation pharmacist. I am very proud of my cousins “once removed” for carrying on the profession. How many generations of pharmacists do we have in Kentucky? KPhA would love to know. Send us a note and a picture if you have one handy to info@kphanet.org. Kentucky Renaissance Pharmacy Museum Curator Gloria Doughty, Museum Board member Lynn Harrelson and I shared some ideas regarding this topic and how it would be great to have this information within the museum and perhaps featured in the pages of The Kentucky Pharmacist.

Lastly, I want to recognize our KPhA pharmacist staff, Jody Jaggers, Jessica Johnson and Michele Pinkston, for the outstanding job they did at the Kentucky State Fair.

I understand they dispensed more than 300 naloxone kits and provided education to “fair goers.” Outstanding Job! (See story on p. 10)

Give Back with AmazonSmile!

Did you know that Amazon donates 0.5% of the price of your eligible AmazonSmile purchases to the Kentucky Pharmacy Education and Research Foundation Inc.?

This contribution supports our educational initiatives.

All you need to do is: Step One: Go to Smile.Amazon.com (https:// smile.amazon.com/ch/31-1012133) Step Two: Choose the Kentucky Pharmacy Education and Research Foundation Inc. as your charity.

Step Three: Whenever you are shopping, start at Smile.Amazon.com Take advantage of this easy way to shop and help the KPERF!

My List for YOU! 1. Maintain your membership; “We NEED YOU! 2. Invite your state representative or senator to your practice setting and talk to him or her about our legislative agenda. Contact KPhA at info@oao.org for details.

3. DONATE to KPPAC and the KPhA Government Affairs Fund.

4. Register for Legislative Conference November 1-2, 2019 at the Marriott Griffin Gate Resort & Spa, Lexington.

5. Join us in 2020 for Pharmacists Day at the Capitol, stay tuned for the date, and I will not let you forget.

Remember, we are ONE Profession! Let’s stand together and have one VOICE.

jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions.

Reminder: Safe Disposal of Controlled Substances went into 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 sells 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

|5| www.KPHANET.org

Legislative Conference November 1-2 | Griffin Gate Marriott | Lexington This conference targets topics such as grassroots legislative advocacy, prescription drug abuse, and the future of healthcare in Kentucky.

Register Online

Agenda Highlights 

Interactive Roundtable Discussions with Legislators

www.kphanet.org



House of Delegates—shaping KPhA’s TelePharmacy position statement

Benefits of Attending:

Check out the website for the full agenda!

|6| Kentucky Pharmacists Association | September/October 2019



Advocacy 101



Networking with Colleagues



Shape KPhA’s Legislative Agenda



Interactive Roundtables



Continuing Education



Rub Elbows with Legislators

MY KPhA Rx Kentucky Pharmacists: Unite!

By Mark Glasper KPhA Executive Director/CEO

tuckians to find access to care.

On behalf of independent pharmacists across Kentucky, KPhA is compelled to act. We are discussing legislation with many groups to address all of the concerns that continue to beat down independents, including low re-

The 2020 legislative session is almost upon us, and Your KPhA Board of Directors, Government Affairs Committee and Comprehensive PBM Reform ad hoc Committee are working actively to help struggling pharmacists across the Commonwealth of Kentucky.

To be successful, we need Your help. It’s imperative

Gubernatorial candidate Andy Beshear meets with (left to right) Board Member Misty Stutz, Executive Director Mark Glasper, President Don Kupper, Board Member and Governmental Affairs Committee Co-Chair Richard Slone, and Board Member Chris Harlow.

KPhA and KIPA representatives meet with Governor Matt Bevin and running mate Senator Ralph Alvarado, MD, to discuss pharmacy issues.

imbursements, all fees after point of sale, and mail-order pharmacies that direct business away from independents and eliminate patient choice. The list is endless.

that you join our grassroots effort no matter the practice PBMs are bad actors. Despite past legislative efforts to setting in which you work. KPhA stands for all pharmarein in PBM actions, they continue to thwart the will of cists and it’s important for all of us to unite because the General Assembly. They play the game of “whack a we’re stronger together! mole,” always finding a way around legislation only to Comprehensive PBM Reform Drives KPhA gouge independent pharmacies and pad their pockets We all recognize the problems PBMs are heaping upon with ill-gotten gains. the shoulders of independent pharmacies. But let me KPhA is actively meeting with legislators, including our also acknowledge there are pharmacists working for House “Pharmacy Caucus” Reps. Danny Bentley, RobPBMs and the MCOs that employ them. They’re good ert Goforth, Steve Sheldon, Derek Lewis and Adam people and good pharmacists. However, we cannot igBowling. We are reaching out to legislators on both nore their companies are driving independent pharmasides of the aisle to drive home the message that PBMs cies out of business while reaping huge profits, driving are having a negative impact on their constituents and up healthcare costs and making it more difficult for Ken|7| www.KPHANET.org

on Kentucky.

Discussing pharmacy issues at the Republican House Caucus event include (left to right) Board Member and KPPAC Chair Matt Carrico, Speaker of the House David Osborne, Majority Whip Chad McCoy, President Don Kupper and Executive Director Mark Glasper.

Senate Majority Floor Leader Damon Thayer meets with (left to right) Chair Chris Palutis, Zena Slone, Board member and KPPAC Chair Matt Carrico, Board Member and Government Affairs Committee Co-Chair Richard Slone, President Don Kupper and Executive Director Mark Glasper at a Lexington area fundraiser hosted by KIPA founders Rosemary and Luther Smith.

Remind your legislators that pharmacists are part of the solution, working with other members of the healthcare system to improve and promote health outcomes and access to care. Pharmacists are the last point of contact with a patient before they receive their medication. Allowing PBMs to erase you from the equation cannot be an option if we truly want our healthcare system to put

The time has come to shine a light on the role PBMs continue to play, increasing healthcare costs for Kentucky taxpayers and driving out-of-pocket costs for all Kentuckians while having a devastating impact on Kentucky’s provider and patient communities. KPhA’s legislation will be the solution for finally reining in PBM actions and improving access to healthcare in the Commonwealth.

A Call to Action: What You Can Do KPhA is laying the groundwork for the 2020 legislative session and you can help us by inviting your legislator to work – at your pharmacy or in whatever practice setting you have.

Plan to provide a brief tour and give your legislator time to meet staff and converse with your patients. Be sure to save time for a conversation with your legislator about the issues affecting pharmacy in Kentucky. Your voice matters locally and statewide, so use it!

(Left to right) Board Member and KPPAC Chair Matt Carrico, House Democratic Floor Leader Rocky Adkins, House Democratic Whip Joni Jenkins and Executive Director Mark Glasper find time to discuss comprehensive PBM reform at a Kentucky House Democratic Caucus fundraiser.

|8| Kentucky Pharmacists Association | September/October 2019

patients first.

If you don’t know your legislator, just go to the Kentucky General Assembly website and click on the “Go” button in the bottom right portion of the homepage.

Enter your address and you’ll immediately find your state legislators. From there you can either call or email them to schedule a meeting.

pharmacists is a must if we are to be effective in our efforts to influence positive outcomes of legislation and regulations affecting the business and practice of pharmacy. The need is real and immediate for more pharmacists to make a financial commitment to the Kentucky Pharmacists Political Advocacy Council (KPPAC) and/or the KPhA Government Affairs Fund.

Your donations will help KPhA and KPPAC be effective in the upcoming election season as well as the 2020 legislative session.

Donations to the KPPAC are vital to KPhA’s advocacy efforts by helping us strengthen relationships with key Kentucky legislators. Your commitment to advocacy makes sure pharmacy’s voice is heard loud and clear by Kentucky’s legislators.

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. Please – consider making a donation today by contacting KPhA at info@kphanet.org or 502-227-2303. And, while you’re at it, think about making it a monthly investment in the future of pharmacy in Kentucky!

Support KPPAC, KPhA Member and Board of Pharmacy Member Ron Poole meets with his legislator, Rep. Melinda Gibbons Prunty.

KPhA Government Affairs Fund Today!

Or, just send me an e-mail at mglasper@kphanet.org or call me at 502-227-2303 and let me know if you’d like to host a legislator. We’ll help you have a positive discussion with your legislator, positioning you as an information resource on health care issues.

Donations to the KPPAC are vital to KPhA’s advocacy efforts by helping us strengthen relationships with key Kentucky legislators. Your commitment to advocacy makes sure pharmacy’s voice is heard loud and clear by Kentucky’s legislators.

Grassroots advocacy has never been more important than it is today. Help KPhA pave the way to a successful 2020 legislative session. Schedule a visit with your legislator TODAY!

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.

Support KPPAC, KPhA Government Affairs Fund Now, more than ever, increased political involvement of

|9| www.KPHANET.org

Feature Article KPhA Pharmacists Educate Hundreds, Dispense Naloxone at Kentucky State Fair What comes to mind when you hear the words Kentucky State Fair? Perhaps it’s blue ribbons, livestock, concerts and people watching. Maybe it’s the food.

For most people, learning how to save lives probably isn’t in the top 10 or even 100 things they might think about at the State Fair.

medication that can immediately and directly save someone’s life. We provided education and resources to hundreds of people from 29 counties.

All the pharmacists on staff at KPhA believed this was one of the most rewarding experiences they have had as patient care professionals.

Each one had people share their stories with them. They worked with parents and grandparents from all zip codes who were worried about family members. They educated and dispensed to teachers, restaurant owners, and Uber drivers who wanted to protect their students, patrons, and riders. They talked with law enforcement officers, pastors, nursing students, doctors and even other pharmacists and were able to dispel some of the myths those individuals had heard about how to respond in an overdose emergency.

For the past three years, KPhA has partnered with the Kentucky Department for Public KPhA Director of Pharmacy Public Health Programs, Jody Health (KDPH) and, more recently, the Cabinet for Jaggers provides education at Health and Family Services the Kentucky State Fair.

(CHFS) to train the public on The response was overwhelmingly positive from nearly opioid overdose prevention, recognition and response, everyone engaged. People put aside their personal objecand dispensing naloxone to those we train. tions and instead saw a chance to contribute to keeping New CDC grant opportunities this year allowed KPhA their fellow citizens safe. to create two positions in January focused on addressing the opioid crisis. Jessica Johnson filled one of those roles People who use drugs deserve care. Harm reduction empirically works - both to save lives and engage people in providing academic detailing to prescribers and Jody Jaggers filled the other continuing harm reduction train- long-term recovery. Progress can be incremental, but the Kentucky Pharmacists Association is engaged throughing and naloxone distribution. A Mobile Harm Reducout the Commonwealth to be a piece of that process. tion unit was commissioned in March to be the new home for the naloxone education project as well as other If you are interested in volunteering at one of our ongoon-the-road harm reduction activities in communities ing community naloxone training events, please contact around the Commonwealth.

Jody Jaggers at jjaggers@kphanet.org.

The state requested that the Harm Reduction Unit be on See you next year at the fair! display at the Kentucky State Fair, however KPhA staff was uncertain if the event was going to be the right venue to provide training and dispense naloxone. Would the fair really provide an opportunity to engage with people who need naloxone? Would this opportunity be better than focusing on local events? Would more than 50 boxes of Narcan be dispensed? Would anyone agree to sit through ten minutes of training on both recognizing and responding to overdose emergencies?

The answer to all those questions was a resounding YES! KPhA staff pharmacists Jessica Johnson, Michele Pinkston, and Jody Jaggers, in partnership with CHFS and KDPH, dispensed 316 boxes of Narcan over a five-day period at the Kentucky State Fair. That’s 632 doses of a

KPhA Director of Emergency Preparedness, Michele Pinkston and KPhA Director of Pharmacy Education, Jessica Johnson provide education at the Kentucky State Fair. |10| Kentucky Pharmacists Association | September/October 2019

September CPE Article Preventing and Improving Cardiovascular Outcomes in Diabetes: A Therapeutic Update By: Andrew Rich, PharmD Candidate, Kayla Kreft, PharmD, Tracy E. Macaulay, PharmD The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-19-009-H04-P &T 1.5 Contact Hours (0.15 CEU) Expires 10/14/22

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.

Describe the link between diabetes and cardiovascular disease.

2.

Discuss American Diabetes Association (ADA) recommendations regarding cardiovascular risk management.

3.

Describe the effect that new evidence regarding aspirin for primary prevention had on the ADA recommendations.

4.

Identify patient specific factors that should be considered when determining individual hemoglobin A1C targets.

5.

Explain the impact cardiovascular data for antidiabetic agents have on making individualized treatment plans for patients.

Introduction Diabetes is increasingly prevalent, now affecting over 30 million people in the United States.1 This number is expected to grow, as there were about 1.5 million new diagnoses in the year 2015.1 Diabetes is a complex disease state that requires proper management as uncontrolled diabetes can lead to several long-term complications, including neuropathy, chronic kidney disease (CKD), and retinopathy. Additionally, patients with diabetes are at an increased risk for cardiovascular disease (CVD), with a 1.7-fold higher rate of death from cardiovascular (CV) causes than those without diabetes.2 Evidenced-based, guideline-directed therapies are used to delay the onset of CVD or reduce the risk of further complications in those with established CVD. Given that diabetic patients are typically on lifelong pharmacotherapy, community pharmacists are in a convenient position to frequently assess patient’s CV risk factors and ensure they are utilizing appropriate risk-reducing medications. This article will discuss factors that increase a patient’s risk for CVD and recommend ways in which those risk factors can be minimized. This article will also review hemoglobin (Hgb) A1C goals in patients with diabetes, the CV risk associated with specific medications, and the American Diabetes Association’s (ADA) standards of care for patients with diabetes.

Managing Cardiovascular Disease Risk Factors As pharmacists, it is important to recognize factors that increase a patient’s risk of developing CVD while also making recommendations that help minimize those risks. The most common risk factors identified in patients with diabetes include obesity, hypertension, and dyslipidemia. Additional risk factors include smoking and physical inactivity.2 The more risk factors that a patient has, the greater their chance of developing CVD. Several of these risk factors are reflected in the American Heart Association’s (AHA) and the American College of Cardiology’s (ACC) Risk Estimator Plus, which uses a patient’s risk factors to generate a probability that they

will develop atherosclerotic CVD (ASCVD) within 10-years.

This calculator takes into account the person’s age, sex, race, blood pressure (BP), lipid panel, smoking history, history of diabetes, and whether or not the patient is on hypertension treatment. Therefore, it is best to take a holistic approach when treating these patients, attempting to control all risk factors through the use of both lifestyle modifications and appropriate pharmacologic management. The following recommendations are outlined in Table 1.

Lifestyle Modifications Both the ADA and AHA recommend lifestyle interventions as a first-line method in helping decrease a patient’s CV risk.

Regardless of how long-standing a patient’s diabetes, implementing a healthy diet and exercise regimen has been shown to be both safe and effective at reducing obesity, hypertension, and dyslipidemia. Important diet consideration for patients with diabetes include reducing sodium intake to <2,300 mg/day, getting 8-10 servings of fruits and vegetables per day, consuming 2-3 servings of low-fat dairy each day, and reducing alcohol intake to no more than 2 drinks per day in men and 1 drink per day in women.3 Additionally, the ADA recommends 150 minutes of moderate-intensity activity per week with no more than 2 days of inactivity in a row. Finally, patients with diabetes should perform 2-3 resistance training sessions per week on non-consecutive days.3 In addition to diet and exercise, smoking cessation is one of the most important components of reducing CVD and should be strongly encouraged.

Blood Pressure Management When diet and exercise alone are not sufficient to manage a patient’s blood pressure, anti-hypertensives should be started.

Specific blood pressure targets for patients with diabetes remains unclear however. The Effects of Intensive BloodPressure Control in Type 2 Diabetes Mellitus (ACCORD BP) trial compared intensive (<120 mm Hg) systolic BP control vs |11| www.KPHANET.org

Table 1: ADA Recommendations to Decrease Cardiovascular Risk

Recommendations Limit sodium intake to <2,300 mg/day 8-10 servings of fruits and vegetables per day Diet

2-3 servings of low-fat dairy each day Reduce alcohol intake: Men: ≤2 drinks per day Women: ≤1 drink per day 150 minutes of moderate-intensity activity per week

Exercise

Avoid 2 days of inactivity in a row 2-3 resistance training sessions per week on non-consecutive days

Blood Pressure

Established ASCVD or ASCVD risk >15%: Target <130/80 mm Hg ASCVD risk <15%: <140/90 mm Hg T2DM patients ages 40-75 years à moderate-intensity statin

Lipid Management

T2DM patients ages 20-39 years à consider statin therapy ASCVD or 10-year ASCVD >20% à high-intensity statin Primary prevention:

Aspirin Therapy

Risk-benefit analysis for patients ages 40-75 years at higher risk for ASCVD Secondary Prevention: Aspirin (75-162 mg daily)

standard (<140 mm Hg) systolic BP control. This study showed no significant difference in a composite of nonfatal myocardial infarction (MI), nonfatal stroke, and death from CV causes.4 The Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation – Blood Pressure (ADVANCE-BP) study performed a post-trial assessment of diabetic patients treated with a fixed-dose regimen of perindopril and indapamide vs. placebo. After a median follow-up of 4.4 years, the patients in the treatment arm had a mean BP of 136/73 mm Hg while the placebo arm had a mean BP 141.6/75.2 mm Hg. The treatment arm had significantly fewer deaths from CV causes and a significant decrease in a composite of microvascular and macrovascular outcomes.5 Given the conflicting studies, the ADA recommends individualizing a patient’s blood pressure target based on the patient’s history and ASCVD risk. For patients with established ASCVD or an ASCVD risk >15%, a BP target of <130/80 should be used if it can be reached safely. Those with an ASCVD risk of <15% should target a BP of <140/90 mm Hg.6 The ADA recommends selecting an agent that has been shown to reduce CV events in patients with diabetes, which include angiotensin-converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB), thiazide-like diuretics, or dihydropyridine calcium channel blockers. If the patient has albuminuria, then an ACEi or an ARB should be firstline.6 Lipid Management

Properly managing lipids, specifically low-density lipoprotein (LDL) cholesterol, has been shown in multiple studies to help decrease the risk of CV death, MI, and stroke.7,8 Therefore, the ADA guidelines recommend that all patients ages 40 and older with diabetes be treated with a moderate-intensity statin.6 If the patient has multiple CV risk factors, or similarly if their ASCVD risk score is >20%, then it is reasonable to use a high-intensity statin. If a diabetic patient with ASCVD is on maximally tolerated statin dose, but still has LDL cholesterol levels ≥70 mg/dL, then the addition of ezetimibe or a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor should be considered. If the patient is less than 40 years of age and diagnosed with diabetes, the ADA recommends considering the use of a moderate-intensity statin, especially if multiple cardiovascular risk factors are present.6 The AHA and ACC have similar recommendations, stating that all diabetic patients 40-75 years of age should receive a moderate-intensity statin, regardless of ASCVD risk score.9 The AHA/ACC also state to consider statin therapy in patients ages 20-39, while adding that any diabetic patient age 20-75 should receive a high-intensity statin if they have an LDL cholesterol level ≥190 mg/dL.9 Given this information, it is important to perform an individual risk-benefit analysis for each patient in order to determine what type of lipid lowering therapy they should receive.

Aspirin Therapy The use of aspirin for primary and secondary prevention has been extensively studied, although conflicting evidence has

|12| Kentucky Pharmacists Association | September/October 2019

Table 2: Overview of Cardiovascular Outcomes Trials

LEADER

Inclusion Criteria

SUSTAIN-6

EMPA-REG OUTCOME

CANVAS

DECLARE

SAVOR-TIMI 53

T2DM

T2DM

T2DM

T2DM

T2DM

T2DM

Hgb A1C ≥7.0%

Hgb A1C ≥7.0%

Hgb A1C 6.512.0%

Age ≥50 with ASCVD, CKD, or HF

Hgb A1C ≥7.0% to ≤10.5%

Hgb A1C

Age ≥50 with ASCVD, CKD, or HF

Age ≥30 with CVD

Age ≥60 with multiple risk factors for ASCVD

Age ≥60 with ≥1 risk factor for ASCVD

Hgb A1C 710% (7-9% if no glucose lowering therapy in prior 12 weeks)

Age ≥55 years (men) or ≥60 years (women) with multiple risk factors for ASCVD

Age ≥18 years CVD BMI ≤45 kg/ m2

Dose

Liraglutide 1.8 mg daily

Semaglutide 0.5 mg and 1 mg daily

eGFR ≥30 mL/ min/1.73 m2 Empagliflozin 10 mg and 25 mg daily

MACE Outcome

↓

↓

CV Death

↓

Hospitalizations for HF

No difference

Age ≥50 with ≥2 risk factors for CVD eGFR ≥30 mL/ min/1.73 m2

≥6.5% to <12.0%

CrCl ≥60 mL/ min

Age ≥40 years

with ASCVD Age ≥55 years (men) or ≥60 years (women) with multiple risk factors for ASCVD SCr <6 mg/dL

Canagliflozin 100 mg and 300 mg daily

Dapagliflozin 10 mg daily

Saxagliptin 5 mg daily

↓

↓

No difference

No difference

No difference

↓

No difference

No difference

No difference

No difference

↓

↓

↓

↑

created confusion regarding when and for how long patients should use aspirin. Given the large volume of data supporting the benefit of aspirin in secondary prevention, both the ADA and the ACC/AHA guidelines recommend aspirin (75-162 mg) for patients with established ASCVD.6,10 However, recent studies have raised questions regarding the use of aspirin for primary prevention.

Several studies in non-diabetic patients provide conflicting evidence regarding the use of aspirin for primary prevention of CVD. A recently published meta-analysis looked at 13 trials that randomized 164,225 patients with no history of CVD to receive either aspirin or placebo. The median age of participants was 62 years with an average baseline ASCVD risk score of 10.2%. 19% of these patients had been diagnosed with diabetes. This analysis found that aspirin significantly One primary prevention study specifically looked at the bene- reduced a composite of CV mortality, nonfatal MI, and nonfit of aspirin in patients with diabetes. The A Study of Cardio- fatal stroke, with an absolute risk reduction of 0.41%. Howevvascular Events in Diabetes (ASCEND) trial randomized er, aspirin use also significantly increased the incidence of 15,480 patients, all of whom had no known CVD, in a 1:1 major bleeding with an absolute risk increase of 0.47%.12 fashion to receive either aspirin 100 mg or placebo. After an average follow-up of 7.4 years, there was a 1.1% absolute reDue to the risk-benefit profile in these studies, the AHA/ACC duction in serious CV events, including nonfatal MI, nonfatal does not recommend the routine use of aspirin for primary stroke, and transient ischemic attacks (TIA) in the patients prevention, although they state it can be considered in pataking aspirin than those on placebo (NNT=91; p=0.01). tients ages 40-70 who are at higher risk for ASCVD.10 The However, there was also a 0.9% absolute increase in major ADA states that aspirin can be considered for primary prevenbleeding (gastrointestinal bleeding, intracranial hemorrhage, tion in those at increased cardiovascular risk, but only after a or sight-threatening bleeding; NNH=112; p=0.003). Of note, thorough analysis of the risks and benefits for each patient.6 all patients were age 40 and older, the majority were already Lastly, both the ADA and AHA/ACC recommend avoiding on statin therapy, and only 12% of patients had an Hgb A1C aspirin use in anyone at increased risk of bleeding, such as >8%.11 |13| www.KPHANET.org

Table 3: Overview of Anti-hyperglycemic Agent Classes

GLP-1 Receptor Agonists

SGLT2 Inhibitors

DPP-4 Inhibitors

liraglutide semaglutide

canagliflozin dapagliflozin empagliflozin

alogliptin sitagliptin saxagliptin

Mechanism of Action

Increases glucose-dependent insulin secretion and decreases glucagon secretion

Reduces reabsorption of glucose in the proximal tubule of the kidney

Increases insulin synthesis and release and decreases glucagon secretion

Dosing Requirements

May require dose titration

May require renal dose adjustment

May require renal dose adjustment

Drugs

Warnings/Precautions

Common Adverse Drug Reactions

Black Box Warning: liraglutide is contraindicated in patients with personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 Increased heart rate Headache Nausea/diarrhea

Black Box Warning: Canagliflozin was associated with an approximately 2fold increase risk of lower limb amputations Risk of Ketoacidosis Increased potassium levels Genitourinary fungal infections Renal insufficiency

Potential for severe arthralgias Acute pancreatitis Development of bullous pemphigoid Hypoglycemia Nasopharyngitis

those >70 years of age, those with a history of bleeding, and those with renal disease.

(goal Hgb A1C 7.0-7.9).14 They included patients 40-79 years of age with T2DM who had established ASCVD or patients 55-79 years of age who had 2 or more risk factors for ASCVD. Determining Appropriate Hgb A1C Targets After 3.5 years, the trial was stopped early since there was a 1.41% rate of mortality in the intensive treatment group comIn an effort to determine appropriate A1C targets, several pared to a 1.14% rate of mortality in the standard treatment large studies have analyzed intensive vs. standard glucose control and its effects on both microvascular and macrovascu- group (p=0.04). The primary outcome, which was an annual lar outcomes. Most notable are the UK Prospective Diabetes rate of nonfatal MI, nonfatal stroke, or CV death, showed a rate of 2.11% vs. 2.29% in the intensive vs. standard therapy Study (UKPDS), the Action to Control Cardiovascular Risk in Diabetes (ACCORD), and the Action in Diabetes and Vas- groups, respectively (p=0.16). cular Disease: Preterax and Diamicron MR Controlled Evalu- The primary endpoint in the ADVANCE trial was a compoation (ADVANCE) trials. site of macrovascular events, a composite of microvascular events, and the two former endpoints considered together.15 The UKPDS trial analyzed overweight individuals between the ages of 25-65 who were newly diagnosed with type 2 dia- This study included 11,140 patients 55 years of age and older who had been diagnosed with T2DM anytime from age 30 betes mellitus (T2DM).13 Their primary goal was to determine the effect of intensive glucose control on the incidence of onward. With a median age of 66 and average baseline Hgb A1C of 7.5%, all patients in the study had to have a history of CV complications. 3,867 patients were enrolled in the study, CVD or at least one other risk factor for CVD. Similar to AC70.6% of whom were randomized to intensive control while CORD, ADVANCE randomized patients to intensive therapy the other 29.4% were randomized to conventional therapy, which consisted of controlling diet alone. The intensive group (goal Hgb A1C â&#x2030;¤6.5%) or standard therapy (Hgb A1C goals was further divided into intensive therapy with sulfonylureas based on current ADA guidelines). The study found a combined incidence of macrovascular and microvascular events to (40%) with a fasting glucose goal of <108 mg/dL and intensive therapy with insulin (30%) with a fasting glucose goal of be 18.1% vs. 20.0% in the intensive and standard therapy 72-126 mg/dL. After a median follow-up of 10 years, the inci- groups, respectively (p=0.01). The majority of this difference dence of microvascular complications, including retinopathy, was from a reduction in microvascular events in the intensive treatment group, driven primary by a 1.5% relative reduction vitreous hemorrhage, and renal failure, was 8.6 events per in nephropathy. It is important to note that there was no sig1000 patient-years in the intensive treatment group vs. 11.4 events per 1000 patient-years (p=0.0099). However, there was nificant difference in macrovascular events, with an incidence no statistical difference between the two groups with regard to of 10.0% vs. 10.6% in the intensive vs. standard therapy several individual macrovascular outcomes, including nonfa- groups, respectively (p=0.32). tal MI, nonfatal stroke, congestive heart failure (CHF), and sudden death. Additionally, a follow-up analysis found that controlling blood glucose sooner after diagnosis had retained benefits several years in the future.

The ACCORD trial randomized 10,251 patients to either intensive therapy (goal Hgb A1C <6%) vs standard therapy

These studies reveal a few important points to note when setting glycemic targets for diabetic patients. First, ACCORD shows that older patients, especially those with established ASCVD or at high-risk for ASCVD, with long-standing diabetes may have worse outcomes with more intensive Hgb A1C targets. However, the UKPDS trial has shown that those with

|14| Kentucky Pharmacists Association | September/October 2019

newly diagnosed diabetes may have significant long term benefit with more intensive therapy. These studies have formed the basis for the ADA guidelines, which stress the importance of individualizing a patient’s Hgb A1C goal. For example, patients who have several comorbidities, a history of hypoglycemic events, or a short life expectancy may benefit from less intensive therapy (goal Hgb A1C <8%). On the other hand, patients who are newly diagnosed diabetics or are otherwise healthy may benefit from more intensive therapy (goal Hgb A1C <7%) with significant long-term gain. Therefore, it is important that pharmacists look at the patient’s entire history, along with his or her preferences and available resources, when determining Hgb A1C targets. In addition, the differences in the therapies used between the UKPDS, ACCORD, and ADVANCE trials furthers the hypothesis that certain medications may each carry individual cardiovascular risk.

Therefore, the specific medications chosen to achieve glycemic control is paramount.

Heart Association (NYHA) class II-III symptoms. After 3.8 years of follow up, patients in the liraglutide arm had a 13.0% rate of first occurrence nonfatal MI, nonfatal stroke, or death from CV causes compared to 14.9% in the placebo group (p=0.01). This result was mostly driven by a significant reduction in death from CV causes, with a rate of 4.7% in the liraglutide group compared to 6.0% in the placebo group (p=0.007).

When starting medication in patients with T2DM, metformin is recommended as the initial agent of choice.19 Metformin has been shown to be both safe and effective long term in diabetic patients. However, when metformin alone is not enough in helping patients reach their A1C goals, the ADA now recommends choosing the next agent based on whether or not the patient has established ASCVD, CKD, or HF.19 This recommendation is based on the results of recent trials that have evaluated the safety and efficacy of antidiabetic medications in preventing and reducing poor cardiovascular outcomes. An overview of the following trials can be found in Table 2 and an overview of the medication classes can be found in Table 3.

Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors

The Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6) trial tested another GLP1 receptor agonist, semaglutide 0.5 mg and 1 mg, for noninferiority to placebo in 3,297 T2DM patients with an Hgb A1C ≥7.0%.21 Similar to the LEADER trial, patients ≥50 years of age had to have either established CVD, NYHA class II or III HF, or CKD of stage 3 or greater. Patients ≥60 years of age had to have either persistent microalbuminuria or proteinuria, left ventricle hypertrophy, left ventricle dysfunction, or ankle/brachial pressure index <0.9. After determining that semaglutide was non-inferior to placebo, a post-hoc analysis Selecting Antihyperglycemic Medications showed that semaglutide was superior to placebo in reducing In addition to an increased risk of CVD, diabetic patients also the rate of CV mortality, nonfatal MI, and nonfatal stroke have an increased risk for HF due to altered inflammatory (6.6% vs. 8.9% respectively; p=0.02). This result was driven processes that impair both systolic and diastolic heart funcprimarily by a 1.6% rate of nonfatal stroke in the semaglutide tion.2 Therefore, in an effort to mitigate the risk of CVD and group compared to 2.7% in the placebo group (p=0.04). AddiHF in diabetic patients, different trials have looked at various tionally, patients taking semaglutide had significantly fewer antidiabetic medications and the impact they have on cardio- cases of nephropathy than those taking placebo, but had a vascular outcomes. Some of these trials have shown signifisignificantly higher rate of new or worsening retinopathy. cant increases in the rate of MI, stroke, TIA, and CHF in the patients taking the antidiabetic agent than the patients taking LEADER and SUSTAIN-6 show that both liraglutide and placebo.16,17 Given these poor outcomes, the U.S. Food and semaglutide may decrease the risk of some cardiovascular Drug Administration (FDA) has mandated that all new anti- outcomes, such as nonfatal stroke or even death from CV diabetic medications be tested for their cardiovascular safety, causes. Therefore, the ADA recommends either GLP-1 recepespecially in diabetic patients at higher risk for cardiovascular tor agonist as add-on to metformin, especially in patients with established ASCVD.19 However, the ADA recommends a disease and those with some level of renal compromise.18 slight preference towards liraglutide given the more robust Therefore, it is important to take these studies into account data seen in the LEADER trial. when selecting medications for patients with T2DM.

SGLT2 inhibitors are a relatively new class of medications that block the reabsorption of glucose in the proximal tubule.

Several trials have looked at this class of medication as potentially having cardiovascular benefits in patients with CVD or at risk for CVD. The Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial studied 7,020 patients ages 18 years and older with a body-mass index (BMI) of ≤45 kg/m2, an eGFR ≥30 mL/min/1.73 m2, and established CVD by comparing empagliflozin 10 mg and 25 mg against placebo.22 After a median follow-up of 2.6 years, this study found that 10.5% of patients taking empagliflozin and 12.1% of patients taking placebo had either CV mortality, nonfatal MI, or nonfatal stroke Glucagon-like-peptide-1 (GLP-1) Receptor Agonists (p=0.04). Additionally, the patients in the empagliflozin GLP-1 receptor agonists exert their mechanism by increasing group had significantly fewer hospitalizations for heart failure glucose-dependent insulin secretion while also decreasing glu- than placebo (p=0.002) with similar rates of DKA and renal cagon absorption. The Liraglutide and Cardiovascular Outfailure between the two groups. This study resulted in an comes in Type 2 Diabetes (LEADER) trial randomized 9,340 FDA special alert that empagliflozin helps reduce the risk of T2DM patients with a Hgb A1C ≥7.0% to receive either lirag- CV death in diabetic patients with established ASCVD. lutide 1.8 mg or placebo.20 Patients ≥60 years of age had to In the Canagliflozin and Cardiovascular and Renal Events in have multiple risk factors for CVD, while patients ≥50 years Type 2 Diabetes (CANVAS) trial, the investigators enrolled of age had to have either CVD, cerebrovascular disease, peripheral vascular disease (PVD), CKD, or HF with New York T2DM patients who were either age ≥30 years with CVD or |15| www.KPHANET.org

age ≥50 years with ≥2 risk factors for CVD. Patients also had to have a Hgb A1C ≥7.0% to ≤10.5% and an eGFR >30 mL/min/1.73 m2. These patients were randomized to either canagliflozin 100 mg, 300 mg, or placebo.23 Similar to EMPA-REG OUTCOME, the CANVAS trial showed a significantly lower rate of the composite outcome of death from CV causes, nonfatal MI, and nonfatal stroke in the canagliflozin group (p=0.02). This group also saw a reduction in the number of hospitalizations due to heart failure (95% CI, 0.520.87). Of note, patients in the canagliflozin group had a statistically higher rate of lower limb amputations than placebo (95% CI, 1.41-2.75), leading the FDA to issue a black box warning regarding this risk.

an appropriate agent from either of those two class over a DPP-4 inhibitor in patients with established ASCVD, HF, or CKD.19 Conclusion

As pharmacists, it is important to perform a cardiovascular risk assessment on all diabetic patients. Using this risk assessment, a holistic, individualized approach should be used for each patient in order to determine what actions can be taken to reduce a patient’s risk of CVD without providing further harm. The same is true for those that already have established ASCVD, as they must be counseled on their heightened risk for further cardiovascular events. After obtaining the patient’s cardiovascular history, it is important to assess the need for The most recent SGLT2 inhibitor study, the Dapagliflozin any lifestyle changes, the addition of aspirin or lipid lowering Effect on Cardiovascular Events (DECLARE) trial, enrolled therapy, and blood pressure control. Pharmacists can then type 2 diabetics of at least 40 years of age with a Hgb A1C ensure that patients are taking appropriate antihyperglycemic ≥6.5% but <12.0%.24 Patients also had to have a CrCl ≥60 mL/min and either established ASCVD or ≥1 risk factors for agents that do not exacerbate their cardiovascular risk and can recommend agents that decrease cardiovascular risk as alterASCVD. Patients were randomized in a 1:1 ratio to either natives. As with all recommendations, it is imperative to condapagliflozin 10 mg daily or matching placebo. This study found that dapagliflozin was noninferior to placebo in regards sider a patient’s personal preferences and ability to afford the to the rate of CV death, MI, and ischemic stroke, but did not medication. The ADA Standards of Care are updated every show superiority. Dapagliflozin did show a significant reduc- year and are a great way for pharmacists to stay up-to-date on diabetes and cardiovascular disease. tion in hospitalizations due to heart failure (95% CI, 0.610.88), while at the same time resulting in significantly more References instances of DKA and genital infections.

Given the data from the EMPA-REG OUTCOME, CANVAS, and DECLARE trials, the ADA recommends either empagliflozin, canagliflozin, or dapagliflozin as add-on therapy to metformin in patients with HF or CKD. In patients with established ASCVD, the ADA recommends either empagliflozin or canagliflozin, with a slight preference towards empagliflozin, as add-on therapy given the CV benefits seen in this patient population.19 Dipeptidyl Peptidase 4 (DPP-4) Inhibitors DPP-4 inhibitors are a class of antidiabetic medications that work by increasing insulin secretion and decreasing glucagon secretion from pancreatic cells. Two of the DPP-4 inhibitors, alogliptin and sitagliptin, were compared against placebo in order to determine their CV safety. Both were shown to be non-inferior to placebo with regard to their rates of CV death, nonfatal MI, and nonfatal stroke, but neither were proven to be superior to placebo. A third DPP-4 inhibitor, saxagliptin, was studied in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction (SAVOR-TIMI 53) trial. The trial compared saxagliptin 5 mg daily against placebo in 16,492 T2DM patients with an Hgb A1C of 6.5-12.0% and either a history of CVD or multiple risk factors for CVD. The rate of CV death, nonfatal MI, and nonfatal stroke was found to be 7.3% vs. 7.2% in the saxagliptin and placebo groups, respectively (p=0.99). However, 3.5% of patients in the saxagliptin group were hospitalized for heart failure, compared to 2.8% in the placebo group (p=0.007).

1.

National Diabetes Statistics Report, 2017. Atlanta, GA: Center for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017.

2.

Leon BM, Maddox TM. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment recommendations and future research. World journal of diabetes. 2015;6(13):1246-1258.

3.

Lifestyle Management: Standards of Medical Care in Diabetes— 2019. Diabetes Care. 2019;42(Supplement 1):S46-S60.

4.

Cushman WC, Evans GW, Byington RP, et al. Effects of Intensive Blood-Pressure Control in Type 2 Diabetes Mellitus. N Eng J Med. 2010;362(17):1575-1585.

5.

Patel A. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. The Lancet. 2007;370(9590):829-840.

6.

Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019;42(Supplement 1):S103S123.

7.

Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Eng J Med. 2015;372(25):2387-2397.

8.

Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Eng J Med. 2017;376(18):1713-1722.

9.

Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/ NLA/PCNA Guideline on the Management of Blood Cholesterol. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. 2018:25709.

10.

Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol. 2019:26029.

Studies indicate that the DPP-4 inhibitors may be a safe option for patients with established ASCVD. However, given the Bowman L, Mafham M, Wallendszus K, et al. Effects of Aspirin potential CV benefits seen in some of the GLP-1 receptor ago- 11. for Primary Prevention in Persons with Diabetes Mellitus. N Eng J Med. nists and SLGT2 inhibitors, the ADA recommends choosing 2018;379(16):1529-1539.

12.

Zheng SL, Roddick AJ. Association of Aspirin Use for Primary Prevention With Cardiovascular Events and Bleeding Events: A Systematic Review and Meta-analysisAssociation of Aspirin Use for Primary Prevention of CVD With Cardiovascular Events and BleedingAssociation of Aspirin Use for Primary Prevention of CVD With Cardiovascular Events and Bleeding.

JAMA. 2019;321(3):277-287.

20.

Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Eng J Med. 2016;375(4):311-322.

21.

Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Eng J Med. 2016;375(19):1834-1844.

13.

King P, Peacock I, Donnelly R. The UK prospective diabetes study Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovas(UKPDS): clinical and therapeutic implications for type 2 diabetes. Br J Clin 22. cular Outcomes, and Mortality in Type 2 Diabetes. N Eng J Med. Pharmacol. 1999;48(5):643-648.

2015;373(22):2117-2128.

14.

Gerstein HC, Miller ME, Byington RP, et al. Effects of Intensive 23.

Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and CardiGlucose Lowering in Type 2 Diabetes. N Eng J Med. 2008;358(24):2545ovascular and Renal Events in Type 2 Diabetes. N Eng J Med. 2559.

2017;377(7):644-657.

15.

Patel A, MacMahon S, Chalmers J, et al. Intensive Blood Glucose 24.

Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and CardioControl and Vascular Outcomes in Patients with Type 2 Diabetes. N Eng J vascular Outcomes in Type 2 Diabetes. N Eng J Med. 2019;380(4):347-357.

Med. 2008;358(24):2560-2572.

16.

Nissen SE, Wolski K, Topol EJ. Effect of Muraglitazar on Death and Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes Mellitus. JAMA. 2005;294(20):2581-2586.

17.

Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet (London, England). 2009;373(9681):2125-2135.

18.

Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. US Department of Health and Human Services. 2008;FDA. 19.

Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetesâ&#x20AC;&#x201D;2019. Diabetes Care. 2019;42(Supplement 1):S90S102.

Save the Date!

KPhA Annual Meeting & Convention Louisville Marriott Downtown June 11â&#x20AC;&#x201D;14, 2020

September 2019â&#x20AC;&#x201D; Preventing and Improving Cardiovascular Outcomes in Diabetes: A Therapeutic Update 1.

What is the main tool used within the ADA Standards of Care to determine the cardiovascular risk of a patient?

A. Framingham Risk Score B. ASCVD Risk Estimator Plus C. Heart Disease Risk Assessment D. SCORE Risk Chart 2.

SCORE Risk ChartAccording to the 2019 ADA Standards of Care, and based on an individuals pooled-cohort estimated 10-year risk of atherosclerotic cardiovascular events (ASCVD risk), what is an appropriate blood pressure goal for a patient?

A. If the patient has an ASCVD risk >10%, the goal should be <140/90 B. If the patient has an ASCVD risk >10%, the goal should be <130/80 C. If the patient has an ASCVD risk >15%, the goal should be <140/90 D. If the patient has an ASCVD risk >15%, the goal should be <130/80 3.

7.

A 64-year-old female patient is coming to see you for diabetes management. Her medical history includes hypertension, diabetes for 12 years, hyperlipidemia, and obesity. Her current HbgA1C is 9.1%. She is currently being treat with metformin and insulin and she is very fearful of hypoglycemia.

According to the ADA, what should be her goal HgbA1C? A. <6.5% B. <7% C. <8% D. <8.5% 8.

When an additional agent needs to be added to metformin, what patient risk factors should be taken into consideration?

A. History of ASCVD B. History of heart failure C. History of chronic kidney disease D. Cost to the patient E. All of the above 9.

Which GLP-1 receptor agonist has the strongest evidence to support its use to reduce major cardiovascular events?

A. Liraglutide B. Semaglutide C. Exenatide D. Dulaglutide

What is first-line for lipid management for a patient with diabetes and atherosclerotic disease according to the ADA? A. High-intensity statin B. Moderate-intensity statin C. High-intensity statin in combination with lifestyle interventions D. Low-intensity statin 10. Which of the following SGLT2 inhibitors decreased major cardiovascular events in addition to reducing hospital admis4. According to the ADA lipid recommendations, which of the sion for heart failure? following diabetic patients should receive a non-statin thera- A. Empagliflozin py, such as a PCSK9 inhibitor or ezetimibe, in addition to a B. Canagliflozin C. Dapagliflozin high-intensity statin?

D. A and B only A. A patient with LDL-C of 132 E. All of the above B. A patient with established atherosclerotic disease and an LDLC of 91 C. A patient LDL-C of 79 Friendly reminder to CPE Monitor to D. A patient with established atherosclerotic disease and an LDLensure all of your credits are listed for C of 59

2019!

5.

Which of the following is true regarding recent data on use of aspirin for primary prevention in diabetic patients without establish ASCVD? A. That the risks of aspirin greatly outweigh the benefits B. That the benefits greatly outweigh the risks C. That the risks and benefits are about the same

https://nabp.pharmacy/cpe-monitor-service/

6.

Aspirin should be given to all patients 50 and older with diabetes plus one additional risk factor for primary prevention of cardiovascular events.

A. True B. False

|18| Kentucky Pharmacists Association | September/October 2019

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

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

Expiration Date: 10/14/2022 Successful Completion: Score of 80% will result in 1.5 contact hour or .15 CEUs. TECHNICIANS ANSWER SHEET September 2019â&#x20AC;&#x201D; Preventing and Improving Cardiovascular Outcomes in Diabetes: A Therapeutic Update (1.5 contact hours) Universal Activity # 0143-0000-19-009-H04-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 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B 8. A B C D E 10. A B C D E 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___________________________

PHARMACISTS ANSWER SHEET September 2019â&#x20AC;&#x201D; Preventing and Improving Cardiovascular Outcomes in Diabetes: A Therapeutic Update (1.5 contact hours) Universal Activity #0143-0000-19-009-H04-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 2. A B C D 4. A B C D 6. A B

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

9. A B C D 10. A B C D E

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

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

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

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

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

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.

|20| Kentucky Pharmacists Association | September/October 2019

October CPE Article Pharmacists as Partners in Public Health: Increasing Access to Hormonal Contraceptives Can Prevent Unintended Pregnancy By: Catherine Serratore, PharmD, MS Candidate The author declares that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-19-010-H01-P &T 1.0 Contact Hour (0.10 CEU) Expires 10/14/22

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.

Recognize the existing barriers to access contraception.

2.

Describe organizational support of pharmacist prescribed hormonal contraception.

3.

Review state legislation authorizing pharmacist-prescribed hormonal contraception.

4.

Summarize pharmacists’ comfort level in prescribing various forms of hormonal contraception.

are in need of affordable services because they have income below the federal poverty level, because they are younger than 20 years old, Unintended pregnancy persists as a major public health problem in or both.4 Even women with insurance, high out of pocket costs, the United States. It occurs when a woman wants to become pregdeductibles, and co-payments still exist and may limit access. It has nant in the future, but not at the time the pregnancy occurs (“wanted been found that women pay 60% of the cost out of pocket for contralater”) or it occurs when a woman never wants to become pregnant ception compared to 33% of the cost out of pocket for non(“unwanted”).1 According to the Centers for Disease Control and contraceptive drugs.4 Not only has high cost created a barrier for Prevention and the Guttmacher Institute, nearly half or 49% of pregwomen to utilize hormonal contraception, but legislation around the nancies were unintended in 2011.1,2 Of all the unintended pregnanU.S. has also created access barriers. cies, teens younger than 15 years old account for 98% of them. OthBarriers in legislation have created another challenge for women to er women at high risk for unintended pregnancy include those who gain access to hormonal contraception. Restrictive and unfavorable are unmarried, less educated, have a low income, or are of African American race.2 Unintended pregnancy forces women to make the legislation impedes access to consistent and affordable hormonal contraception which is the most effective way to prevent unintended challenging ethical decision to carry the baby to term and keep it, pregnancy. In the United States’ Supreme Court case Burwell vergive away the baby through adoption, or undergo abortion. Goals published by Healthy People 2020 prioritize increased contraceptive sus Hobby Lobby, the owner’s religious beliefs inhibited employees’ services, preconception health services, patient education, and coun- access to hormonal contraception through the company’s health seling in an effort to reduce the high rate of unintended pregnancy.3 insurance plan. Similarly, in 2012, Arizona created legislation that allowed employers to exclude coverage of hormonal contraception Multiple barriers prevent women from obtaining effective methods from employee health insurance plans. Also, minors, who account of hormonal contraception. According to the American College of for the highest percentage of unintended pregnancy, are restricted Obstetricians and Gynecologists (ACOG), the most common barrifrom the ability to consent to contraceptive services in approximateers to obtaining hormonal contraception include cost and access.4 ly 20 states.4 All of these legal barriers restrict women’s ability to Women without coverage from health insurance, can pay over properly access contraception to prevent unintended pregnancy. $800.00 for implant contraception or the intrauterine device. Oral Solutions to Barriers contraception costs anywhere from $20.00 to $50.00 monthly and therefore up to a total yearly cost of $600.00. Injectable contracepVarious pharmacy organizations have published statements with tion costs about $60.00 every three months, for a total yearly cost of possible solutions to the barriers that women face when trying to $240.00 and the contraceptive ring can cost up to approximately access hormonal contraception. ACOG states that access to contra$1000.00 per year. These costs do not include the cost of an apception needs to be improved for women to live healthier and more pointment with a health care provider for hormonal contraception satisfying lives. They further state that decades of research and use counseling or the time away from work to be able to go to the aphave shown safety and efficacy of hormonal contraception for the pointment.5 More than half of the women who need contraception majority of women. Due to its proven safety and efficacy, ACOG Background

|21| www.KPHANET.org

supports over the counter access to oral contraception for women.6

On April 1, 2016, pharmacists in California became eligible to prescribe oral, injectable, ring, and patch hormonal contraception for Another organization, the American College of Clinical Pharmacy women of all ages. Following completion of a health questionnaire Women’s Health and Practice Research Network (ACCP), supports and blood pressure reading, pharmacists are able to determine the pharmacists prescribed contraception along with appropriate patient best method of hormonal contraception for each patient. Similarly, health screenings. The organization states that in an effort to support to Oregon, pharmacists in California are not yet able to be reimthe goals of Healthy People 2020, utilizing pharmacists to screen bursed by insurance companies for their services, so many charge patients, initiate prescriptions for contraception, and dispense contrapatients administrative fees.11,16 ception directly to patients is a method to increase access to contraception and decrease unintended pregnancy. They further comment Following California’s lead in 2016, Colorado passed SB 16 – 135 that pharmacists are trained specifically on the dosing and adverse and HB 18 – 1313, allowing pharmacists to provide services in horeffects of hormonal contraception, although it is only small portion monal contraception and smoking cessation. The Boards of Pharmaof the overall pharmacy curriculum. The convenience of pharmacy cy, Medicine, and Nursing along with the Colorado Department of locations may also better meet the needs of women seeking contraPublic Health and Environment approved a statewide hormonal ception outside of a provider’s office.7 contraception protocol that became effective in March 2017. Pharmacists interested in utilizing the protocol in their practice setting Similarly, to ACCP, the American Society of Health System Pharmust complete an Accreditation Council for Pharmacy Education macists (ASHP), also supports expanded access to contraceptive (ACPE)-accredited education program. They may prescribe oral and products through a pharmacist or other health care professional to patch hormonal contraception to those at least 18 years old following reduce unintended pregnancy.8 Differing from ACOG, ASHP utilization of a risk assessment questionnaire and the Colorado states that there are differences in safety and efficacy between the standard procedures algorithm.12,16 varying types of contraception, and that patients need to be provided specific guidance on product selection. Due to this, the organization In 2017, New Mexico approved a statewide hormonal contraception thinks that contraceptive products should be placed in an intermedi- protocol with the goal of expanding access in rural communities and ate category of drug products, that still facilitates patient assessment decreasing barriers like transportation and cost. The protocol allows and professional consultation. The health professional, like the phar- pharmacists with appropriate training and certification to prescribe macist, would still be able to assist in identifying contraindications oral, patch, ring, and injectable hormonal contraception following a and patient specific factors leading to the best type of contraception health screening questionnaire and blood pressure reading. This for the individual patient. Further, ASHP advocates that this proservice is provided to all patients capable of becoming pregnant or posed reclassification should not result in increased costs to women. who wish to use hormonal contraception. If the pharmacist encounIn addition, ASHP realizes that this may result in increased workters a patient with complex health issues, they must be referred to a load and liability for pharmacists, so they should be compensated for provider for further counseling.13,16 their services.8 Based on the support statements published by these The Hawaii Legislature passed SB – 513 in July 2017 authorizing organizations, several states have enacted legislation to allow pharpharmacists to prescribe and dispense hormonal contraception with macists to prescribe hormonal contraception to increase patient acthe goal of increasing access due to the short supply of providers. cess and decrease unintended pregnancy.

Similarly, to other states, pharmacists utilize a screening questionnaire and treatment algorithm to guide their treatment selection for Review of States with Pharmacist Prescribed Contraception each patient. The pharmacist must refer each patient to their primaThere are currently 6 states in the U.S. with statutes or regulations ry care provider, advanced practice registered nurse, or another prothat allow pharmacists to prescribe hormonal contraception: Oregon, vider of the patient’s choice after dispensing hormonal contraception, California, Colorado, New Mexico, Hawaii, and Maryland. Other which is not required by other states.14,16 states considering legislation to make hormonal contraception availaMaryland is the most recent state that gained approval of a pharmable through pharmacists include Illinois, Minnesota, Missouri, and cist prescribed hormonal contraception protocol in January 2019.

New Hampshire.9 Pharmacists must complete a Board of Pharmacy approved training On January 1, 2016, pharmacists in Oregon became eligible to preprogram consisting of an overview of contraceptive medications, a scribe oral and patch hormonal contraception to women 18 years self-screening risk assessment questionnaire, a standard procedure and older through House Bill 2879. Pharmacists interested in providcontraceptive algorithm, and the U.S. Medical Eligibility Criteria for ing the service complete a five-hour online training course consisting Contraceptive Use. Further, each pharmacist utilizing the protocol of general information on contraception, how to screen to rule out must earn one hour of continuing education related to contraception pregnancy, how to identify medical contraindications, and the referevery time they renew their pharmacist license.15,16 All of these states ral process. Currently, pharmacists are able to bill insurance for the have approved legislation for pharmacist prescribed hormonal concost of the hormonal contraception, so it is still covered for each patraception, which represents a step toward improved access. tient. They are unable, however, to bill insurance for their services but are working towards building billing platforms. In the meantime, Participation by Pharmacists many pharmacists are utilizing the fee for service model. As of April Although several states have approved legislation allowing pharma2016, 350 pharmacists had completed the Oregon training for precists to prescribe hormonal contraception, pharmacists still have to scribing hormonal contraception and over 200 prescriptions have be interested in providing the service. In survey of pharmacists from been filled.10,16

|22| Kentucky Pharmacists Association | September/October 2019

the Mid-Atlantic Division of Kroger, comfort levels with and knowledge about prescribing hormonal contraception before and after a training session were evaluated.17 The survey also identified pharmacists’ perceived barriers and resources needed to prescribe hormonal contraception. A convenience sample of 350 pharmacists from 118 pharmacies was utilized. A pre-training survey was sent via email two weeks prior to a live training session to gather baseline data. Following the pre-training survey, the live training session was held consisting of a one-hour accredited continuing education program delivered at Kroger’s six district meetings by a PGY -1 Pharmacy Resident. Post-training surveys were sent by email three days following the live training session. Of the 350 pharmacists, only 76 pharmacists (22.3%) completed both the pre and post-training surveys, and subsequently included in the analysis.17

cies, 67.9% charged an administrative fee to their patients ranging from $40.00 to $45.00 dollars for their services. The most frequently prescribed type of hormonal contraception by the pharmacies were the pill (77.7%), followed by the ring (40.2%), patch (38.4%), and the injection (8.9%).11 In another survey of California pharmacies, implementation of pharmacist prescribed hormonal contraception was evaluated. A random sample of retail pharmacies participated in a cross – sectional telephone survey. A study staff member or secret shopper called the selected pharmacies and spoke to the staff to determine how services were being implemented. The secret shopper specifically asked about availability of the different types of contraception, the process upon arrival at the pharmacy, if she could obtain hormonal contraception from a pharmacist as a minor, and where else to go if the service was not available at that pharmacy. A total of 480 pharmacies were included in the sample. Of those pharmacies, 376 (78.3%) had information regarding hormonal contraception services.

Among those who had information regarding contraception services only 22 (5.0%) reported actually providing the service.8 More information is needed from other states that have approved legislation to evaluate that impact such legislation is having on reducing barriers to hormonal contraception.

At baseline the majority of pharmacists were comfortable with their knowledge about adverse effects (72.7%), and about half were comfortable with their knowledge about dosing (49.4%). Following the training, their comfort level on adverse effects remained unchanged (p<0.067), while their comfort level significantly increased from baseline on hormonal contraception dosing (p<0.001). The comfort level of pharmacists prescribing hormonal contraception with the use of a protocol or a collaborative practice agreement remained unchanged between the pre- and post-training sessions. (p<0.074 Conclusion and p <0.82, respectively), while the comfort level of prescribing hormonal by knowing when to refer to a provider increased after the Several states are utilizing pharmacists to provide contraception services, as a way to decrease rates of unintended pregnancy. training (p < 0.012).17 Through accredited training programs, pharmacists are gaining The key barriers recognized by pharmacists in this survey were liamore knowledge outside of their pharmacy curriculum about dosing bility, workflow disturbances, gaps in hormonal contraception and adverse effects related to varying types of hormonal contracepknowledge, and the idea of women not seeking out other aspects of tion. Legislation allows pharmacists to not only counsel patients on their healthcare. Other barriers included lack of time, lack of access their contraception, but also prescribe it. Unfortunately, few pharto patient medical records, and lack of reimbursement for the pharmacies have implemented these protocols due to lack of reimburse17 macist’s services. ment from insurance companies. Additional legislation is needed In another study, a sample of 509 pharmacists were surveyed in regarding reimbursement for pharmacist services in order to sustain Oregon regarding their interest and attitudes towards providing acthe services authorized under these protocols. Achieving provider cess to hormonal contraception.18 The majority of pharmacists status and creating a platform with which to bill insurance compa(85%) expressed interest in prescribing hormonal contraception. nies for pharmacist contraception-related services will be key to serPharmacists identified the need of additional training in screening vice expansion and, ultimately, pharmacists’ ability to assist in the and counseling women on contraception use. Less than half deprevention of unintended pregnancy. scribed themselves as “knowledgeable” or “highly knowledgeable” References: regarding use of the contraceptive pill (46%), patch (41.7%), ring (42.1%), progestin only pill (46.8%), progestin injectable (30.7%), 1. The Guttmacher Institute. January 2019 fact sheet unintended implant (18.6%), and the intrauterine device (21.3%). They identipregnancy in the united states. Guttmacher Institute. https:// fied the lack of a payment mechanism as a key barrier to pharmawww.guttmacher.org/fact-sheet/unintended-pregnancy-unitedcists providing contraception services. Due to this barrier, only states. Published: 2019 Jan; accessed 2019 Feb. 39.1% of pharmacists surveyed planned to provide contraceptive 2. Centers for Disease Control and Prevention. Unintended pregservices, but 60.5% thought it would help increase access to contranancy prevention. Centers for Disease Control and Prevention. ception and 65.8% thought it would reduce unintended pregnancy.18 Published: unknown; updated: 2016 Dec 20; accessed: 2019 Implementation and Impact Feb. Although several states of approved legislation and pharmacists feel comfortable in prescribing hormonal contraception following additional training, little is known about the impact it has made on states, expect California. A random sample of 1008 pharmacies in California were surveyed on the hormonal contraception services they provide. Only 11.1% of the sample had initiated contraception services in the year following the legislation. Among those pharma-

3.

Healthy People 2020. Family planning. Health People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/ family-planning. Published: unknown; updated: unknown; accessed: 2019 Feb.

4.

Committee on Health Care for Underserved Women. Committee opinion number 615. The American College of Obstetricians and Gynecologists. https://www.acog.org/Clinical-

|23| www.KPHANET.org

Guidance-and-Publications/Committee-Opinions/Committeeon-Health-Care-for-Underserved-Women/Access-toContraception. Published: 2015 Jan; accessed 2019 Feb. 5.

Kosova, E. How much do different kinds of birth control cost without insurance? National Women’s Health Network. https://nwhn.org/much-different-kinds-birth-control-costwithout-insurance/, Published: 2017 Nov 17; updated: unknown; accessed: 2019 March.

6.

DeFrancesco M. ACOG Statement on Pharmacist Prescribing Law. The American College of Obstetricians and Gynecologists. https://www.acog.org/About-ACOG/News-Room/ Statements/2016/ACOG-Statement-on-Pharmacist-Prescribing -Laws?IsMobileSet=false. Published: 2016 Jan 4; accessed 2019 Mar.

7.

Gomez A. Availability of pharmacist-prescribed contraception in California, 2017. JAMA. 2017; 318(22):2253-2254.

8.

The American Society of Health System Pharmacists. ASHP Policy Positions 1982 – 2018. https://www.ashp.org/-/media/ assets/policy-guidelines/docs/browse-by-document-type-policy -positions-1982-2017-with-rationales-pdf.ashx. Published: 2018; accessed: 2019 Apr.

9.

Yang Y, Kozhimannil K, Snowden J. Pharmacist-prescribed birth control in Oregon and other states. JAMA. 2016; 315(15): 1567 – 1577.

lished: 26 Feb 2018; accessed 2019 Mar. 17. Lio I, Remines J, Pramit A, et al. Pharmacists’ comfort level and knowledge about prescribing hormonal contraception in a supermarket chain pharmacy. J Am Pharm Assoc. 2018; 58: S89 – S93.

18. Rodriquez M, McConneell J, Swartz J, et al. Pharmacists prescription of hormonal contraception in Oregon: baseline knowledge and interest in provision. J Am Pharm Assoc. 2016; 56(5): 521-526.

10. Rodriguez M, Anderson L, Edelman A. Pharmacists begin prescribing hormonal contraception in Oregon: implementation of house bill 2879. Obstet Gynecol. 2016 July; 128(1): 168 – 172.

11. Batra P, Rafie D, Zhang Z, et al. An evaluation of the implementation of pharmacists – prescribed hormonal contraceptives in California. Obstet Gynecol. 2018; 131 (5): 850 – 855.

12. Statewide Protocols (SWPs). Colorado Pharmacists Society. https://www.copharm.org/statewide-protocols. Published: unknown; accessed 2019 Apr. 13. Protocol for Pharmacist Prescription of Hormonal Contraception. New Mexico Board of Pharmacy. http:// www.rld.state.nm.us/uploads/files/ OCConfirmedFinalJune2016.pdf. Published: unknown; accessed 2019 Apr. 14. S.B. NO. 513 A Bill for an Act. The Senate Twenty Ninth Legislature, 2017 State of Hawaii. https:// www.capitol.hawaii.gov/session2017/bills/SB513_.HTM. Published: 2017; accessed 2019 Apr. 15. Neal R. Title 10 Maryland Department of Health Subtitle 34 Board of Pharmacy. 10.34.40 Pharmacists prescribing contraceptives. Maryland Department of Health. https:// health.maryland.gov/regs/Pages/10-34-40-.aspx. Published: 2018 Feb; accessed 2019 Apr. 16. Pharmacist prescribing for hormonal contraceptive medications. National Alliance of State Pharmacy Associations. https://naspa.us/resource/rph-access-contraceptives/. Pub-

|24| Kentucky Pharmacists Association | September/October 2019

October 2019 â&#x20AC;&#x201D; Pharmacists as Partners in Public Health: Increasing Access to Hormonal Contraceptives Can Prevent Unintended Pregnancy 1.What are the most commons barriers to obtaining hormo- C. Hawaii nal contraception?

D. New Hampshire A. Cultural or Religious beliefs B. Low Health Literacy C. Cost and Access

6.Which of the following is NOT a key barrier recognized by pharmacists in prescribing hormonal contraception?

D. Side effects or adverse effects from the medication

A. Gaps in knowledge B. Number of patients

2.Which of the following statements is supported by the American College of Obstetrics and Gynecology?

C. Lack of reimbursement D. Workflow disturbances

A. Over the counter access to contraception B. Pharmacist prescribed contraception with appropriate screenings C. Provider only prescribed contraception

7.In the survey of Oregon pharmacists, what proportion of respondents expressed comfort in prescribing hormonal contraception?

D. Pharmacist or provider prescribed contraception

A. Less than 50% B. Less than 25%

3.Which of the following statements is supported by the American College of Clinical Pharmacy?

C. More than 50% D. More than 75%

A. Over the counter access to contraception B. Pharmacist prescribed contraception with appropriate screenings C. Provider only prescribed contraception D. Pharmacist or provider prescribed contraception

8.What form of hormonal contraception has been the most frequently prescribed by pharmacists in California?

A. Pill B. Ring

C. Patch 4.Which state approved a statewide hormonal contracepD. Injection tion protocol with the goal of expanding access to rural areas?

A. Oregon B. Minnesota C. Colorado D. New Mexico

9.In California, in what fraction of pharmacies are hormonal contraception services actually available to patients?

A. 5% B. 10% C. 20%

5.Which state implemented a statewide hormonal contraception protocol that requires pharmacist utilizing the protocol to gain one hour of continuing education in that subject area annually?

D. 50%

A. California B. Maryland |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: 10/14/22 Successful Completion: Score of 80% will result in 1.0 contact hours or .10 CEUs. TECHNICIANS ANSWER SHEET. October 2019 â&#x20AC;&#x201D; Pharmacists as Partners in Public Health: Increasing Access to Hormonal Contraceptives Can Prevent Unintended Pregnancy 1.0 contact hours) Universal Activity # 0143-0000-19-010-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

3. A B C D 4. A B C D

5. 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)

PHARMACISTS ANSWER SHEET October 2019 â&#x20AC;&#x201D; Pharmacists as Partners in Public Health: Increasing Access to Hormonal Contraceptives Can Prevent Unintended Pregnancy (1.0 contact hours) Universal Activity #0143-0000-19-010-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

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

3. A B C D 4. A B C D

5. 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 Education as a provider of continuing Pharmacy education. |26| Kentucky Pharmacists Association | September/October 2019

Financial Forum Making a Charitable Gift from Your IRA Follow the rules, and you might get a big federal tax break. your tax preparer must identify the distribution as a QCD on your federal tax return. This is crucial and must not be overlooked, because the custodian of your IRA will probably report your QCD as a normal IRA distribution.2 If you itemize your deductions, you should know that a charitable IRA gift does not count as a deductible charitable contribution. (That would If you gift traditional IRA assets to charity, you could amount to a double tax break.) Of course, fewer taxpaysee some big tax savings. The Internal Revenue Service ers have incentive to itemize now, since the standard calls this a Qualified Charitable Distribution (QCD), deduction is so large, thanks to the Tax Cuts & Jobs and you may want to explore its potential. Some criteria Act.1,2 must be met: you need to be at least 70½ years old in If you want to make a charitable IRA gift, start the the year of the donation, the donation must take the form of a direct transfer of assets from the IRA custodi- process before the year ends. If you try to make the gift an to the charity, and the charity must be “qualified” in in late December, your IRA custodian might not be able the eyes of the I.R.S. Any 501(c)(3) non-profit organiza- to move fast enough for you, and the asset transfer may tion meets the I.R.S. qualification, as do houses of wor- occur later than you would like (i.e., after December ship.1 The amount you gift can be applied toward your 31). Talk with a tax or financial professional before the year ends, so that you can plan a charitable IRA donaRequired Minimum Distribution (RMD) for the year, tion with some time to spare. and you may exclude it from your taxable income. If you are retired and well-to-do, a charitable IRA gift Citations: could be a highly tax-efficient move.1,2 Is your annual IRA withdrawal a bother? If you are an affluent retiree, that might be the case. The income is always nice, but the taxes that come with it? Not so much. If only you could satisfy your yearly IRA withdrawal requirement minus the attached taxes. Guess what: there might be a way.

Just how much could you save? That depends on two factors: how much you gift, and your federal income tax bracket. As an example, say you are in the 35% federal income tax bracket, and you donate $40,000 from your traditional IRA to a 501(c)(3) non-profit organization.

That $40,000 will be gone from your taxable income, and the donation will cut your federal tax bill for the year by $14,000 (as 35% of $40,000 is $14,000). Yes, the savings could be significant.2 You can donate as much as $100,000 to a qualified charity this way in a single year. That limit is per IRA owner; if you are married, and you and your spouse both have traditional IRAs, you can each donate up to $100,000.1,2 What about the fine print? There is plenty of that, and it is all worth reading. You may be curious if you can make a QCD from a SIMPLE or SEP-IRA; the answer is no. You can make a QCD from a Roth IRA, but there is little point in it: Roth IRA withdrawals are commonly tax-free.1 Regarding the asset transfer, the critical detail is that you cannot touch the money. The distribution must be payable directly to the non-profit organization or charity, not to you. (Income tax does not need to be withheld from the distribution since the amount withdrawn will not count as taxable income.) In addition,

1 - thebalance.com/qualified-charitable-distributions-3192883 [1/15/18] 2 - marketwatch.com/story/how-retirees-can-save-on-charitabledonations-under-the-new-tax-bill-2018-03-02 [3/2/18] Pat Reding and Bo Schnurr may be reached at 800-288-6669 or pbh@berthelrep.com.

Registered Representative of and securities and investment advisory services offered through Berthel Fisher & Company Financial Services, Inc. Member FINRA/SIPC. PRISM Wealth Advisors LLC is independent of Berthel Fisher & Company Financial Services Inc. This material was prepared by MarketingLibrary.Net Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. All information is believed to be from reliable sources; however we make no representation as to its completeness or accuracy. Please note - investing involves risk, and past performance is no guarantee of future results. The publisher is not engaged in rendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information 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.

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.

|27| www.KPHANET.org

Campus Corner An End to Opioid Deaths. This is What’s Possible.

Author: Kristie Colón, Communications Director, University of Kentucky College of Pharmacy The opioid epidemic has taken hundreds of thousands of lives and devastated millions more. This problem has engaged the passion, knowledge, and persistence of our researchers and pharmacists who work on a daily basis to help people with opioid use disorder.

looked at the opioid epidemic, we saw our community pharmacists as an untapped resource. It’s estimated that 90% of the population lives within five miles of a pharmacy. We know we’re accessible; and we can utilize this accessibility to improve patient care.”

Alumnus Trish Freeman, PhD and Jeff Talbert, PhD professors in the UK College of Pharmacy, are part of the multidisciplinary team that played a crucial role in securing the $87 million HEAL grant to address the opioid use disorder epidemic in Kentucky. Led by Dr. Sharon Walsh director of UK’s Center on Drug and Alcohol Research, the team will collaborate with state and community partners to implement evidence-based Trish Freeman, PhD interventions to save lives and help people achieve recovery, reduce harm, and inform our nation on what evidence-based strategies will help us heal from the opioid crisis. Our goal: decrease the number of opioid deaths by 40% in four years in 16 Kentucky counties.

The College of Pharmacy’s Institute for Pharmaceutical Outcomes and Policy (IPOP), directed by Jeff Talbert, analyzes naloxone dispensing data to understand the impact of this and other policy interventions aimed at mitigating the opioid overdose crisis.

Talbert will serve as co-director of the Data, Informatics and Biostatistics Core, coordinating data integration and data harmonization for the HEAL grant. Freeman will lead interventions designed to reduce the supply of excess opioids through increased disposal of unused medications; identify and reduce risky prescribing and dispensing behaviors among prescribers and pharmacists; and promote increased use of the opioid overdose reversal agent naloxone.

When asked about the impact of the grant, Kip Guy, dean of the College of Pharmacy noted, “The HEAL grant puts the resources needed to develop effective population interventions for the opioid epidemic into the hands of those with a demonWell before the pursuit of the grant, strated track record of addressing the problem. Successes in Freeman and other Kentucky pharmaKentucky demonstrate the necessity of including pharmacists cists already played a key role in the in interprofessional public health interventions. We are the response to the opioid crisis. The UK major point of contact for many of the people in Kentucky.

College of Pharmacy’s Center for the Our front-line researchers are committed to solving not only Advancement of Pharmacy Practice Kentucky’s pressing healthcare problems but doing so in ways (CAPP), in collaboration with key that can be utilized across the globe. At the College of Pharpharmacy stakeholder organizations macy, we encourage innovative discovery and collaborative in Kentucky, led the state’s efforts in research, knowing that we all have a role in improving patient pharmacist-initiated naloxone dispensoutcomes.” ing.

By 2025, it is estimated that Kentucky will experience close to a 30% shortfall in primary care provider adequacy as reported Jeff Talbert, PhD in the Health Resources and Service Administration’s Naloxone is a life-saving drug used to treat overdose and is available at Kentucky pharmacies with- Healthcare Workforce Analysis. This means our community out a prescription. Kentucky was one of the first states to see pharmacists will continue to play a key role working with the rampant abuse of oxycodone and our pharmacists realized other practitioners to address health needs in the Commonwealth, including helping prevent deaths from opioid use. they could be part of a solution.

Many UK College of Pharmacy faculty, including Freeman, helped construct the law that now allows naloxone dispensing by pharmacists. To date, Freeman and others from the College have trained over 2,600 pharmacists and student pharmacists on the proper administration and dispensing of naloxone.

“Pharmacists are highly educated, and grossly underutilized in majority of practice settings,” said Freeman. “When we |28| Kentucky Pharmacists Association | September/October 2019

Feature Article Understanding and Managing Debt Pressure for Pharmacy Students Authors: Long Phan, PharmD Candidate Class of 2020, Sullivan University College of Pharmacy and Health Sciences and Kimberly Elder, PharmD, BCPS, Sullivan University College of Pharmacy and Health Sciences

There are many career paths in the pharmacy profession that students can pursue. While some students know of their career decision as early as starting their pharmacy education, others make up their mind during their final year experiential rotations. Factors that are involved in this life-changing decision can be subjective and are dependent on each student's circumstances. However, one major factor that might have a big impact on their career choice is their anticipated student loan debt after graduation.

The cost of pharmacy school is on the rise over the last decade. Data collected in 2004 -2014 from the National Pharmacist Workforce Study1 and the United States Bureau Labor Statistics 2,3 showed: • An increase (approximately 154%) in average student loan debt from $42,600 to $108,407 among pharmacists who graduated within the previous 5 years and worked at least 30 hours weekly.1 • An increase in mean annual wage (approximately 48%) for pharmacists from $80,300 in 2004 to $118,470 in 2014. 2,3 Why is the student pharmacist debt so high?

There are many issues affecting the debt:4 • A reduction in state support for higher education due to a recent economic recession.

• Regulation issues on loan eligibility and repayment structure. For example, a federal regulation does not let pharmacists place their debt into forbearance during pharmacy residency and fellowship, but it does for dental and medical students.

• A lack of awareness and knowledge about finance management.

load influenced their decision to pursue postgraduate training.

5 This study found that student loan debt was not a significant predictor for choosing to pursue postgraduate training. However, it also showed that there was a 23% decrease of intending to pursue postgraduate training with every one-point increase of debt influence and pressure (odds ratio (OR) =0.77; 95% CI = 0.65-0.91). It also found that students were 36% less likely to choose hospital instead of community pharmacy with each one-point increase of debt influence and pressure (odds ratio(OR) =0.64; 95% CI = 0.5-0.81). The findings were statistically significant.5 It is important that pharmacy students choose their career paths based on personal interests and professional goals without being burdened by any external inputs such as debt influence and pressure. With that, students should be equipped with interventions that help them to manage pressure created from the debts.

What recommended interventions can assist students to understand and better manage debt pressure? 4 • Add a financial course into the pharmacy school curriculum.

• Have a financial expert provide advice and feedback on how to manage student debt and saving throughout pharmacy school.

• Inform students of the Federal Student Loan Forgiveness Program (Pharmacists are forgiven with the remaining balance on their loan under special circumstances such as making 120 qualifying monthly payments and work for qualifying employers under a qualifying repayment plan). For more details: https://studentaid.ed.gov/sa/repay-loans/forgivenesscancellation/public-service • Encourage national pharmacy organization to provide financial management programing at national or regional meetings.

• Increased personnel for administrative and technical tasks in • Encourage school administrators to assess tuition and other colleges of pharmacy leads to higher tuition. costs on a regular basis.

• Extracurricular obligations take time away from students References: being able to work after school.

Influence of debt on career choice A 2019 study by Hagemeier and colleagues studied 763 students from three different colleges of pharmacy with an average predicted student debt of $162,747 and a predicted mean average of 7.4 years to pay off debts. The authors quantified student perceptions related to debt influence and pressure by collecting student’s responses to statements about their concern toward debt, feeling of pressure to become debt-free after graduating from pharmacy school, opinion of whether their debt load factored into their career plan, and whether debt

1. Midwest Pharmacy Workforce Research Consortium. Final report of the 2014 national sample survey of the pharmacist workforce to determine contemporary demographic practice characteristics and quality of work-life.

Minneapolis, MN; 2015.

2. Bureau of Labor Statistics USDoL. Occupational Employment Statistics: May 2004. http://www.bls.gov/oes/special.requests/oesm04in4.zip.

3. Bureau of Labor Statistics USDoL. Occupational Employment Statistics: 2009. http://www.bls.gov/oes/special.requests

oesm09in4.zip.

4. Cain J, Campbell T, Congdon HB, et al. Complex issues affecting student Continued pg. 33 pharmacist debt. Am J Pharm

|29| www.KPHANET.org

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

The list reflects new memberships received from July 1, 2019— August 31, 2019 Stephanie Dalton, Louisville Pharmacist

Derrick Greenwell, Cox’s Creek Pharmacist

Amar Shah, Palatine Pharmacist

Erica Downton, Owenton Technician

Steve Hart, Frankfort Pharmacist

Margaret, Sidebottom, Louisville Pharmacist

James Evans, Vanceburg Pharmacist

Marie Haynes, Louisville Technician

Michaela Stephens, Tompkinsville Pharmacist

Lauren Ford, Benton Pharmacist

Ellyn Schill, Louisville Pharmacist

Erika Waldsmith, Lexington Student

Tyler Frederick, Louisville Pharmacist

Lisa Scott, Frankfort Technician

Michael Willian, Alvaton Pharmacist

Michael Garcia, Lexington Pharmacist

|30| Kentucky Pharmacists Association | September/October 2019

Feature Article New Law Clarifies Agency Dispensing of Naloxone Author: Payton Noble, PharmD Candidate 2020, University of Kentucky College of Pharmacy Across the nation, the opioid epidemic has continued to worsen and is far from over. In an attempt to decrease the number of nationwide opioid overdose deaths, states have used naloxone access laws to increase the availability of naloxone in communities. Naloxone is a fast-acting opioid antagonist that works to reverse Payton Noble, PharmD opioid overdose by counteracting the opioid-induced respiratory depression and can be administered to an opioid overdose victim by nasal spray or injection. Kentucky is in the top ten of states leading the nation in opioid overdose deaths. The total number of opioid-involved deaths in Kentucky reached 1,160 in 2017. In March of 2015, the Kentucky legislature passed Senate Bill 192 (SB 192) which authorizes pharmacists to dispense naloxone under a physician-approved protocol to prevent opioid overdose. Certification for naloxone dispensing for pharmacists is issued by the Kentucky Board of Pharmacy. To become certified, pharmacists must complete a training course and submit proof of completion, along with their application for the naloxone certification license, to the Board of Pharmacy. Currently, only 2,551 of the approximately 5,200 practicing pharmacists in Kentucky are certified to dispense this lifesaving medication. Knowledge concerning the law and regulations could be one of the major barriers keeping pharmacists from becoming certified to dispense naloxone.

Although SB 192 authorized pharmacists to initiate the dispensing of naloxone to a â&#x20AC;&#x153;person or agency,â&#x20AC;? pharmacists across the state had expressed concern with the legalities of dispensing naloxone to persons other than the end user.

Thus, pharmacists were reluctant to dispense naloxone to agencies who might further distribute it as part of a harmreduction program. To address this concern, the 2019 Kentucky general assembly passed House Bill 470, which went into effect on June 27, 2019. This bill amended KRS 217.186 to explicitly allow pharmacists to dispense naloxone to a person or agency who provides training and further distributes naloxone to an end user as a part of a harm reduction program.

271.186 is amended to read with the following addition: Notwithstanding any provision of law to the contrary, a pharmacist may utilize the protocol established by this section to dispense naloxone to any person or agency who provides training on the mechanism and circumstances for the administration of naloxone to the public as part of a harm reduction program, regardless of whom the ultimate user of the naloxone may be. The documentation of the dispensing of naloxone to any person or agency operating a harm reduction program shall satisfy any general documentation or recording requirements found in administrative regulations regarding legend drugs promulgated pursuant to this chapter.

Essentially, this new provision allows pharmacists to dispense naloxone to an agency as part of a harm reduction program without knowing the name of the person who will ultimately receive the naloxone. This clarification provides pharmacists the opportunity to assist harm reduction groups in obtaining and further distributing naloxone. A pharmacist can now have confidence in their legal standing when dispensing to an agency, even if that agency is going to use the naloxone received to distribute to others. As long as the pharmacist completes the protocol dispensing requirements to the agency, they are not responsible for what the agency ultimately does with the naloxone it received.

A helpful resource to identify where naloxone is available in pharmacies under protocol is the website https:// odcp.ky.gov/stop-overdoses/. This resourceful link can be provided to your patients and/or posted in your pharmacy to help find locations that dispense naloxone as well as those that offer syringe service programs. This website also provides summaries of Caseyâ&#x20AC;&#x2122;s Law and the Good Samaritan Law, locations of treatment centers, information on naloxone, testimonials, and many other helpful resources.

Pharmacists are the most readily accessible healthcare professionals and are well positioned to serve as partners in public health by providing preventative healthcare services, including the prevention of death due to an opioid overdose.

The bill was sponsored by Representative Chad McCoy (R) and Representative David Osborne (R). Section 1. KRS |31| www.KPHANET.org

Academy of Pharmacy Technicians Study Shows Certified Pharmacy Technicians are More Committed to a Pharmacy Career Than Noncertified More likely to seek expanded responsibilities WASHINGTON, DC -- New research shows nationally certified pharmacy technicians are more committed to a pharmacy career and have a greater desire to take on new and expanded responsibilities than noncertified.

The study*, “Assessing Pharmacy Technician Certification,” published in the June 2019 Journal of the American Pharmacists Association (JAPhA), compared the viewpoints of certified and noncertified technicians, and explored the perceived value of certification in the areas of medication safety, skills and abilities, experience, career engagement and satisfaction, and productivity.

Based on the findings, certified technicians have a stronger organizational commitment and view themselves as making fewer medication errors. They are more likely than noncertified to complete a pharmacy technician training program at a community college or vocational school, work 40 hours or more per week, and have an expectation for higher wages, according to the study.

more likely to have a desire for such duties and roles,” said Schimmel. “We use data like this to help inform our programs and demonstrate their value to the pharmacy community and the public.”

In March, PTCB announced it is expanding its credentialing programs, adding five assessment-based certificate programs for advanced roles, and an Advanced Certified Pharmacy Technician (CPhT-Adv) credential, during the next 2 years. The five certificate programs will include: Technician Product Verification (TPV); Medication History; Billing and Reimbursement; Controlled Substance Diversion Prevention; and Hazardous Drug Management. The TPV and Medication History programs will be the first to be offered later this year.

A 2016 PTCB-sponsored public perception survey revealed that 85% of the public believes it is very important for pharmacy technicians to be certified: 94% say their trust in pharmacy technicians’ work would increase with standardized certification and training; 76% The majority of respondents, both certified and noncerti- say they would seek out a different pharmacy if their fied, said they have confidence in performing the final current pharmacy’s technicians were not certified. Recheck on another technician’s preparation of a new or spondents said certification’s major benefit is its impact refilled medication, a process known as Technician on accuracy and professional knowledge.

Product Verification (TPV) or tech-check-tech. Most in Of the 45 states that regulate pharmacy technicians, 19 both categories reported a sense of pride in their work. require national certification in their regulations. There The Pharmacy Technician Certification Board (PTCB) are more than 288,000 active PTCB-Certified pharmacy funded the research through a grant, and played no role technicians (CPhTs) in the US. in the analysis, interpretation, or publishing of the reMETHODOLOGY sults. “PTCB places the safety of patients above all, so we study technician credentialing and our own programs The research method was a cross-sectional survey of pharmato ensure they advance medication safety by certifying cy technicians from six states representing four US regions.

Technician mailing lists were purchased from Boards of Pharqualified technicians,” said PTCB Executive Director macy, and randomly selected technicians were sent survey and CEO William Schimmel. “This research provides invitations. Six hundred seventy-six technicians (547 certified, new data that identifies specific attributes of certified 103 noncertified, and 26 previously certified) responded, reptechnicians, including higher career engagement and resenting a range of pharmacy practice settings. more desire for job advancement.

“As the role of the pharmacist continues to transform to more patient-focused direct care, there is an increasing call for technicians to fill advanced roles and responsibilities. This study tells us that certified technicians are

*Assessing Pharmacy Technician Certification: A National Survey Comparing Certified And Noncertified Pharmacy Technicians”: James S. Wheeler, Chelsea P. Renfro, Junling Wang, Yanru Qiao, Kenneth C. Hohmeier; JAPhA, June 2019.

|32| Kentucky Pharmacists Association | September/October 2019

Rx and the Law A Pharmacist's Duty to an Unknown Third Party A recent court decision in Michigan re-examined an issue first discussed in this column about ten years ago. In the Sanchez case from Nevada in 2009, the patient, driving while under the influence of prescription medications, hit two men, killing one. The survivor and the decedent's family sued a number of parties, including eight pharmacies, for the injuries and wrongful death.

The Nevada court cited Common Law principles that a person has no duty to control another's dangerous conduct, or to warn others of that dangerous conduct absent a special relationship and foreseeable harm. The court decided that there was no special relationship because the plaintiffs in that case were unidentifiable prior to the accident.

Court also concluded that the pharmacy had no duty to monitor the patient's use of fentanyl.

In a somewhat unusual circumstance, one judge filed a concurring opinion in which he agreed with the conclusion, but urged the Michigan Supreme Court to take up the case because he believed that Michigan case law was based on an incorrect interpretation of the law. He reviewed legislation and regulations from which he concluded that a pharmacist does have a duty to warn of possible adverse events and to monitor the patient's use of medications. The first of these was the Federal regulation under the Controlled Substances Act that created a pharmacist's corresponding responsibility to consider the validity of an order for a controlled substance. The conclusion was that the Michigan case law stating that a pharmacist has no legal duty to monitor the prescribing of controlled substances was at odds with Federal law.

The judge also cited Michigan laws and regulations supporting the conclusion that pharmacists have a broader duty than the current case law outlines.

The Michigan decision dealt with a very similar situation. In this case, a patient's car crossed the centerline and collided with another car, killing two women and injuring another. The patient had received a number of prescriptions for controlled substances, including fentanyl patches, over the previous two years. On the day of the accident, the patient received a prescription for fentaThe judge urged the Michigan Supreme Court to take up nyl patches. Upon leaving the pharmacy, he put a patch in his mouth and chewed it presumably in an attempt to the case because the Court of Appeals did not have the authority to overturn Michigan case law. However, in bypass the time-release mechanism.

April 2019, the Supreme Court declined to hear the apThe decedents' families and the survivor filed suit peal and the Court of Appeals ruling stands. against both the prescriber and the pharmacy alleging While some states' case law still follows the concept of that a special relationship existed between the patient the Learned Intermediary (i.e., the pharmacist has no and the pharmacy and that it was foreseeable that the duty to warn the patient because of the involvement of patient would drive while intoxicated. The pharmacy the prescriber who is the Learned Intermediary). The filed a motion for Summary Judgment stating that no concurring opinion in this case gives us a glimpse of such relationship existed and that it was not foreseeable that the patient would misuse the patch. The trial court where the law is likely to go. As pharmacists continue disagreed with the pharmacyâ&#x20AC;&#x2122;s position and denied their to expand the array of services that they can provide to patients and technological advances place more informotion. mation into their hands, it seems unlikely that pharmaThe pharmacy appealed the ruling to the Michigan cists will be able to continue to rely on the defense of Court of Appeals. The Court of Appeals reviewed a line filling a facially valid prescription. While this may not of pharmacy cases in Michigan dating back to 1980. extend to a duty to unknown third parties, pharmacists The existing rule in Michigan is that a pharmacist does should be prepared for future courts to impose a duty to not have a duty to warn a patient of possible adverse warn patients of possible adverse events and to monitor events when dispensing a drug pursuant to a facially val- their medication usage. id prescription. Based on these cases, the Court conThis series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance cluded, ". . . it would be illogical to impose such a duty Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy on the pharmacist with respect to a third party." The community.

|33| www.KPHANET.org

Pharmacy Policy Issues Can Partial Filling Schedule II Medications be a Solution to the Opioid Crisis?

Author: Mayce N. Vinson, Pharm.D., 2019 graduate of the University of Kentucky College of Pharmacy. A native of Lexington, KY, she completed her pre-professional education at the University of Kentucky with a major in Agricultural Biotechnology.

Issue: As pharmacists, we are well aware of the many and varied issues related to the opioid crisis in our state and nation. In a discussion with a colleague the point came up that giving pharmacists some flexibility to dispense partial quantities of Schedule II medications in appropriate situations may well be intended to address the issue of extra meds being around the house for diversion by those other than the patient. Can you shed some light on this?

ule II medications (for individual doses) is permitted for patients in long term care facilities and those who have a terminal illness, which must be documented on the prescription.3,4

The Comprehensive Addiction and Recovery Act, abbreviated CARA, was enacted during July of 2016 to target prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal.5 Areas of focus included increasing educational efforts, broaden areas for medication disposal to keep them Discussion: It is no secret that the opioid epidemic is from being stolen, enhance drug monitoring programs wreaking havoc in our home state of Kentucky. It is to find those diverting and abusing drugs and to also stated that more than 64,000 people in the United States died from drug overdoses during 2016, with over find those who are at risk, and to allow prescriptions for Schedule II medications to be partially filled as long as 1,400 of those in Kentucky.1,2 With law enforcement certain criteria are met, as seen in Section 702.5 This and legislators working tirelessly to combat this issue, there has been one proposed mechanism that may help section revises the Controlled Substances Act to allow put an end to this crisis: partial filling prescriptions for partial fills on Schedule II medications if â&#x20AC;&#x153;not prohibited by state law, the prescription is filled and written folSchedule II medications. lowing state law, the partial fill is requested by the paThere are many factors that contribute to there being an tient or practitioner, and the total amount dispensed in excess of Schedule II medications being prescribed and all partial fillings doesnâ&#x20AC;&#x2122;t exceed the total amount preavailable. Some actions that have been suggested that scribed.â&#x20AC;?6 The amount remaining after partial filling correlate to the problem are doctors not being adequatecan be filled up to 30 days after the date it was written ly educated on pain management and over-prescribing, or 72 hours in emergency situations.6 patients not knowing how, where, or when to throw out their medication if there is any left over, and that there Senators Elizabeth Warren, Shelley Capito, and several are no guidelines available for prescribing such medica- other backers presented the idea to the Drug Enforcetions. From that myriad of causes, partial filling Sched- ment Administration to be incorporated into CARA. ule II medications has been presented as a possible solu- Each requested the DEA update and clarify their policies on partial filling Schedule II medications and allow tion to the opioid crisis. for the implementation of partial filling to decrease the Current federal and state legislation states a pharmacist amount of medication in circulation.5 They have stated is only allowed to partial fill a prescription for a Schedmany providers are not only hesitant to implement parule II medication if there is not enough in stock.3,4 The tial filling but are confused on the guidelines provided pharmacist must have the full quantity to fill the entire by the DEA providing another barrier to resolving the prescription within 72 hours or a new prescription will issue. need to be obtained.3,4 However, partial filling Sched|34| Kentucky Pharmacists Association | September/October 2019

www.deadiversion.usdoj.gov/21cfr/ While an overall cure for the opioid epidemic may not cfr/1306/1306_13.htm. materialize in the near future, creating and executing new ways to fight it will only get us closer. A main con- 4. “Controlled Substances Questions.” Kentucky Board of tributing factor to this epidemic is excess medication Pharmacy. Available at www.pharmacy.ky.gov/Pages/ Controlled-Substances-Questions.aspx. being left over so that friends and family members can obtain it. Partial filling Schedule II medications to limit 5. “CADCA.” Comprehensive Addiction and Recovery Act the quantity in circulation is a novel way to approach (CARA) | CADCA, 15 July 2018. Available at cadthe crisis. Every effort to reduce the number of overdosca.org/comprehensive-addiction-and-recovery-act-cara. es and deaths is necessary to combat the epidemic plagu6. “Comprehensive Addiction and Recovery Act of 2016.” ing our state and country.

National Association of State Alcohol and Drug Abuse

References: 1.

National Institute on Drug Abuse. “Overdose Death Rates.” NIDA, 15 Sept. 2017. Available at: www.drugabuse.gov/related-topics/trends-statistics/ overdose-death-rates.

2.

Tilley, John, and Van Ingram. “Justice & Public Safety Cabinet.” 2016 Overdose Fatality Report. Available at https://odcp.ky.gov/Documents/2016%20ODCP% 20Overdose%20Fatality%20Report%20Final.pdf.

3.

“Title 21 Code of Federal Regulations.” DEA Diversion Control Division. Available at:

Directors, Inc., July 2016, pp. 11–11. Available at: http://nasadad.org/wp-content/uploads/2016/07/ CARA-Section-by-Section-July-2016.pdf.

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.

Feature Article Continued from p. 27 Educ. 2014; 78 (7): Article 131.

5. Hagemeier NE, Gentry CK, Byrd DC, et al. Student pharmacists’ personal finance perceptions, projected indebtedness upon graduation, and career decision-making. Am J Pharm Educ. 2019; 83(4): Article 6722.

Kentucky Professionals Recovery Network (KYPRN) is a free-standing organization that provides confidential monitoring of licensed professionals struggling with the disease of addiction.

www.kyprn.com KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates and other important announcements, send your email address to info@kphanet.org to get on the list. |35| www.KPHANET.org

|36| Kentucky Pharmacists Association | September/October 2019

|37| www.KPHANET.org

Feature Article Shoulder to Shoulder in Santo Domingo, Ecuador Author: JoAnne Taheri, Pharm.D. So many experiences, so many friends made, and so many opportunities to help so many. Transforming lives, mostly our lives, but in the midst, helping others so needy and so grateful.

large portion of the fee that we all pay on the brigade goes to run this clinic and provide health care to some of the most indigent people there.

We stayed at a former Catholic convent called Santa These are the wonderful memories I had of our Univer- Rosa, a beautiful place, and it was a nice place to come sity of Kentucky health brigade this past March spring home to every evening, where a delicious dinner was break to Ecuador. Craig Borie and Pablo Boada were prepared by a wonderful staff there. Everything green our ambassadors. Craig is the Shoulder to Shoulder and lush there, with a beautiful courtyard to hang out Global Program Manager at UK and Pablo was our and enjoy each other’s company. health brigade leader in Ecuador who guides our stuWe went to six different places in Santo Domingo, with dents, interns, and health care providers in order to proone day spent in the UK Shoulder to Shoulder Clinic. vide additional health care in a country that doesn’t We treated many children, pregnant women, women, have adequate health care for its citizens. men, and elderly people there. The people were so We arrived after a 12+ hour flight from the US in Qui- sweet and appreciative of our care. They had advertised to, Ecuador around 12 midnight. An hourlong cab ride our brigade prior to the week, and all the people had and we arrived at our hostel for the night. We were bought tickets to be able to be seen by our group. dentists, medical students, nurses and nursing students, nurse practitioners, physical therapists/students, physicians, physician assistants, and pharmacists and pharmacy students. Our brigade also included physicians, psychologists, nurses, and medical, psychology and nursing students from the Universidad de la Americas in Quito (UDLA). This group of health care professionals made for a beautiful team approach - collaboration and comradery evident the entire time.

Early Sunday morning, two buses picked us up and we began our two-hour ride to Santo Domingo along a beautiful, mountainous road with curves and a beautiful stream below. Everything was so green, just like Kentucky.

But it was different of course, especially the signs of more poverty and need evident in small towns passed on the way. Santo Domingo is a town that has grown by leaps and bounds- it’s on the road heading to the coast from Quito, and infrastructure hasn’t kept up with demand of their growing population.

This is where we come in. The University of Kentucky runs a small clinic in Santo Domingo year-round, and a

Alejandro Aguavil, one of the heads of the Tsachilla community, in traditional dress.

|38| Kentucky Pharmacists Association | September/October 2019

We had all our medicines in suitcases, and they included antiparasitic meds for the children, antibiotics, antiinflammatories, vitamins, proton pump inhibitors, antacids, eye drops, antibiotic and antifungal creams, rehydration salts, and many others. It was very interesting to set up our pharmacy in churches, clinics, community centers, and on one day, in a tribal area outside of Santo Domingo.

difference in her life!

After the brigade was finished, we packed up our pharmacy suitcases, and headed to Mindo, a beautiful place in the mountains, sort of a “Smokey Mountains” of South America. There were many activities and a wonderful hotel there that was situated by a beautiful swift running stream. Some nice shopping and good restaurants as well. My son and I went to a frog concert, with a tour of the different type frogs in Ecuador at night that was super neat. You can also attend a chocolate tour, go on a zipline, hike to a waterfall, and rappel down a waterfall as well. Lots to do or relax as you see fit.

Then, back to Quito to a pizza restaurant, the local arts and crafts market, and to enjoy one more day before leaving Ecuador. On the way we saw a community that was living on top of a volcano, a very interesting and unique place.

Students from the UK College of Pharmacy pictured with JoAnne Taheri, Pharm.D.

Global health- I encourage all pharmacy students as well as all pharmacists in Kentucky to experience this wonderful health brigade. You won’t be sorry you did.

Contact Craig Borie at craig.borie@uky.edu for more information. There are three health brigades per yearThe Tsa’chillas are an indigenous group that have seven March, May, and August and they always need pharmavillages outside of Santo Domingo. They speak a differ- cists to mentor our wonderful Kentucky pharmacy stuent language, Tsafiki, of the Barbacoan language family. dents.

They also know Spanish but are trying to hold on to Another excellent contact is Melody Ryan, Pharm.D., their own language as well. The Spaniards called them the director of international professional student educaColorado (meaning colored red) as they covered their tion for University of Kentucky College of Pharmacy. bodies with red juices from the achiote seeds to prevent She has made many trips to Ecuador as a pharmacist smallpox. They welcomed us to their community, dancand was on my health brigade this past March. Her ing and holding demonstrations after our health brigade email is melody.ryan@uky.edu. finished seeing their members. We also danced with them, and I consider this as one of the most touching parts of our experience.

One personal story was there was a pregnant woman who seemed to be having pain by a terrific frown on her face. She was there in our pharmacy waiting for her child to get an antiparasitic pill (no clean water in Santo Domingo), and we asked her if she had gotten a number to be seen. She said no, so we directed her to registration, where Emily, one of our nurse practitioners, immediately saw her and determined that she had a urinary JoAnne Taheri, Pharm.D., and students from the UK Coltract infection. This can be serious, especially in preglege of Pharmacy set up the clinic. nancy, and I felt this may have been life saving for her and her future child. How wonderful to have made a |39| www.KPHANET.org

Pharmacy Law Brief “It’s the Law” Author: Joseph L. Fink III, BSPharm., JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Disclaimer: The information in this column is intended for educational 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.

Question: We’ve all heard people say, “Oh, that’s against the law.” or “Well, the law requires this or that.” But my experience reading the news and listening to conversations over the years has led me to conclude that there may be several forms or types of law. Can you shed some light on this?

Response: You are indeed correct; the “law” can be sliced and diced into many categories or classifications.

In fact “the law” is such a broad term that it has numerous varied definitions, all of which can be viewed as correct. Two definitions that work well are:

Regulation – Administrative enactments of executive branch agencies. These often supply details to “make a statute come alive in application.”

“Law is that body of principles that governs conduct and the observance of which can be

Note that each item listed above is subservient to those listed above it; it is a hierarchical listing.

enforced by the government.”

Another way to classify ‘The Law” is by its source or origin. Common Law is a body of principles brought to our country from England to form the basis for our legal system. Many of those rules came from British courts handing down decisions. Remember that those who initially launched what was to evolve to be the United States did not come here to start a separate country; their intention was to start on overseas subdivision of England. An example of Common Law applicable to pharmacy would be the notion that an injured party can bring a lawsuit against a person whose negligence caused damages. This is a well-established principle that evolved during the Middle Ages in England and was brought across the ocean.

“Law is that which must be obeyed and followed by citizens or they will be subject to legal sanctions or consequences.”

One point where pharmacy students sometimes encounter difficulty is differentiating law from policy. For example, it may be a policy of a private health insurance firm that certain things will be covered or not covered. But note that this rule does not include the possibility of governmental sanctions as would be the case if, say, the Federal Controlled Substances Act were violated.

A point of departure for this discussion is the hierarchy of laws. A list can be compiled reflecting the “power” of A somewhat related type of law is Judicial or Case various types of law, as follows: Law. This includes legal principles derived from judiConstitution – A broad statement of the powers of gov- cial decisions on cases brought before them by litigants. ernment and its branches. This is the highest form of A critical distinction between this and Common Law is law and if in conflict with another version the Constitu- one of timing and origin. The latter came along many tion will prevail. centuries before Judicial or Case Law and it originated in England, not in the U.S. as with Judicial or Case Treaty – An agreement among or between nations.

Law. A very important legal doctrine related to Judicial This second in impact only to the Constitution. or Case Law is that of stare decisis, meaning “the deciStatute – A law enacted by the legislature. This is what sion stands.” This is also commonly known as the rule people are usually referring to when they say “The of precedent: if a case presently before the court has law….” identical issues to one decided earlier and it is in the |40| Kentucky Pharmacists Association | September/October 2019

same court system, then the present decision must be consistent with the prior one.

A final distinction of importance is that between criminal law and civil law. Criminal Law defines the parameters of the relationship of the individual to society taken as a whole. For example, when someone robs a bank he or she wrongs not only the owners of the bank but society at large by violating a basic rule, Thou Shall Not Steal. That’s why the title or caption of a criminal case is “Commonwealth versus ___” or “U.S. versus ____” Contrast that with Civil Law that has as its focus the legal relationships between individuals within society.

Two major subdivisions of Civil Law are the law of contracts and rules applicable to torts. That distinction is based on the fact that the law of contracts deals with relationships the parties created themselves by reaching an agreement whereas the law of torts deals with relationships and obligations created by the law itself, e.g., when counseling a patient about medication the pharmacist or pharmacist intern must provide appropriate and relevant information to enhance the patient’s use of the product.

Register Today!

KPhA Legislative Conference Griffin Gate Marriott Resort Lexington, KY November 1-2, 2019

Understanding the various forms of “law” can facilitate a true appreciation of all these rules that govern our activities.

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.

Donate online to the Kentucky Pharmacists Political Advocacy Council Go to www.kphanet.org and click on the Advocacy tab for more information about KPPAC and the donation form. |41| www.KPHANET.org

2019â&#x20AC;&#x201D;2020 KPhA BOARD OF DIRECTORS

Misty Stutz, Crestwood mstutz@sullivan.edu

Chris Palutis, Lexington chris@candcrx.com

Chair

*At-Large Member to Executive Committee

Don Kupper, Louisville donku.ulh@gmail.com

President

KPERF BOARD OF DIRECTORS

President-Elect

Bob Oakley, Louisville rsoakley21@gmail.com

Chair

Joel Thornbury, Pikeville jthorn6@gmail.com

Secretary

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Treasurer

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Past President Representative

Don Kupper, Louisville donku.ulh@gmail.com

President, KPhA

Chris Harlow, Louisville cpharlow@gmail.com Directors

Kimberly Croley, Corbin kscroley@yahoo.com

Angela Brunemann, Union Angbrunie@gmail.com

Kevin Lamping, Lexington klamping@riteaid.com

Matt Carrico, Louisville matt@boonevilledrugs.com

Paul Easley, Louisville rpeasley@bellsouth.net

Jessika Chilton, Beaver Dam jessikachilton@ymail.com

Sarah Lawrence, Louisville slawrence@sullivan.edu

Scotty Reams, London scotty.reams@uky.edu

University of Kentucky Student Representative

Chad Corum, Manchester pharmdky21@gmail.com

KPERF ADVISORY COUNCIL Matt Carrico, Louisville matt@boonevilledrugs.com

Cathy Hanna, Lexington channa@apscnet.com

Kim Croley, Corbin kscroley@yahoo.com

Cassy Hobbs, Louisville cbeyerle01@gmail.com

Kimberly Daugherty, Louisville kdaugherty@sullivan.edu

Anthony Seo, Louisville jseo0516@my.sullivan.edu Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Ben Mudd, Lebanon* Speaker of the House bpmu222@gmail.com Martika Martin, Somerset Vice Speaker of the House 12marmar@gmail.com

Sullivan University Student Representative

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

|42| Kentucky Pharmacists Association | September/October 2019

â&#x20AC;&#x153;He pointed out the importance of professional guidance and assistance, and the need for joint and coordinated efforts by all segments of the profession to counter the damaging effects of the economic trend toward giant consolidations and of inadequately informed crusaders in the new consumerism.â&#x20AC;?

- From The Kentucky Pharmacist, September 1969, Volume XXXII, Number 9

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

Frankfort, KY 40601

Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue

Kentucky Regional Poison Center (800) 222-1222

Washington, DC 20037-2985

American Pharmacists Association (APhA)

(800) 363-8012

2215 Constitution Avenue NW

www.ptcb.org

Washington, DC 20037-2985

Kentucky Board of Pharmacy

Kentucky Society of Health-System Pharmacists

(800) 237-2742

State Office Building Annex, Ste. 300

P.O. Box 4961

(502) 227-2303 info@kphanet.org www.kphanet.org

125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov

www.aphanet.org

Louisville, KY 40204

National Community Pharmacists Association (NCPA)

(502) 456-1851 x2

100 Daingerfield Road

(502) 456-1821 (fax) www.kshp.org info@kshp.org

Alexandria, VA 22314 (703) 683-8200 www.ncpanet.org

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

Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness Michele@kphanet.org Lisa Atha Office Assistant/Member Services Coordinator latha@kphanet.org

Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org Jessica Johnson, PharmD Director of Pharmacy Education Jessica@kphanet.org |43| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601