The Kentucky Pharmacist - January/February 2020

Vol. 15 No. 1 January/February 2020

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

INSIDE: Pharmacists Day at the Capitol February 27, 2020

The Voice of Pharmacy in Kentucky

TABLE OF CONTENTS FEATURES Healthcare Providers and Tobacco Cessation Efforts |5| Financial Forum |22| Rx And the Law |23|

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

Editorial Office: ©Copyright 2020 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.

On the Cover 

Pharmacists at the 2019 Pharmacists Day at the Capitol

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |8| January CE Article |10| January Quiz |14| January CE Answer Sheet |15| February CE Article |17| February Quiz |20| February Answer Sheet |21| Pharmacy Policy Issues |24| Campus Corner |25| New KPhA Members |27| Pharmacy Law Brief |28|

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

Phone: 502.227.2303 Fax: 502.227.2258.

Email: info@kphanet.org.

Website: www.kphanet.org.

ADVERTISERS APSC|6| APMS |17| EPIC |27| Pharmacists Mutual |30| Cardinal |31| PTCB |Back Cover|

|2| Kentucky Pharmacists Association | January/February 2020

PRESIDENT’S PERSPECTIVE Your KPhA Board of Directors and Staff have been busy planning in the new year, including our Legislative Agenda for 2020. We have been meeting with Members and their Legislators in district and at the Capitol, including House and Senate Leadership. Our Partners at The Kentucky Retail Federation have assisted us with scheduling many of these high quality meetings as well as updating us on all issues relating to pharmacy concerns. I want to take this opportunity to congratulate KRF Senior Vice President, Government Affairs, Gay Dwyer on her retirement at the end of 2019. Gay has worked with KPhA for many years and we appreciate all of her insight and professionalism that has served us so well. We wish her the best in retirement!

“We also continue to ask you to invite your legislators (representative and/or senator) to your work and highlight the benefits you provide to your patients and the community you serve.”

watch your local print media, radio and television. If you have suggestions for media coverage, even if it focuses on you, please contact Executive Director Mark Glasper or Director of Communications & CE Sarah Franklin and let them know.

We also continue to ask you to invite your legislators Don Kupper (representative and/or senator) to your work and highlight President, KPhA the benefits you provide to your patients and the community you serve. KPhA has talking points to share with you to make your conversations be productive. Be sure to take plenty of pictures and send to Mark and Sarah for our Journal and KPhA social media.

Kappa Psi 100th

Switching gears, my wife Vicki and I had the pleasure recently to celebrate the 100th Anniversary of the Kentucky Graduate Chapter for Kappa Psi Pharmaceutical Fraternity. It is hard to believe both the Upsilon Collegiate Chapter and the Kentucky Graduate Chapter have celebrated this milestone. I had the distinct pleasure to be a part of both celebrations. Please click this link to view the accompanying article. It is fascinating to This past year we have worked with the leaders of the Kenread the story around the beginning of the life of the Graduate tucky Independent Pharmacist Alliance (KIPA), Kentucky Chapter. As a side note, and a personal one at that, I had been Society of Health-System Pharmacists (KSHP), Kentucky close to Dr. Richard Doughty (Gloria’s husband) who was in Hospital Association (KHA) and the Kentucky Primary Care charge of pharmacy admissions at the University of Kentucky Association (KPCA) to develop legislation supporting a and a decorated Kappa Psi National Officer. Before his passCarve-Out for Medicaid prescriptions which will eliminate the ing, he had given me what I believed to be his Kappa Psi pin, ruthless practices of Pharmacy Benefit Managers. KPhA has but in fact it originally belonged to G.L. Curry, (Gordon L. employed communications firm, RunSwitch PR, to assist us Curry). Dr. Curry was an instructor at the Louisville College in promoting this endeavor to legislators, media and the pubof Pharmacy and mentioned in the article as an original memlic. ber of the Ky Graduate Chapter of Kappa Psi. The pin was Additionally, Board Member Cassy Hobbs and her Profesworn by me at my installation as President of The Kentucky sional Compensation Reform Workgroup have crafted lanPharmacists Association. guage for a bill that Representative Danny Bentley will introAs you can see, I take great pride in my pharmacy backduce during the 2020 legislative session. The bill will address ground. This is a great profession and let’s keep it that way. professional compensation for pharmacists in our state whose Please be engaged during this 2020 legislative session and, practice includes Disease Management and Board Approved together, we can win the battle against the forces that threaten Protocols. I wish to thank Cassy’s workgroup for putting a our livelihood! great bill together.

New Kentucky Governor Andy Beshear and his appointments for top-level cabinet positions will present much change for us in Frankfort. However, be assured that KPhA Officers, Staff and our Members will be just as engaged to see our legislative efforts are successful.

In this issue, please find “Your Voice Matters!” Share this page with your patients – make copies, send by e-mail or text – whatever it takes. As pharmacists we must spread the word, and protect our local pharmacists and access to care for all Kentuckians. We are ramping up our efforts for 2020 and KPhA has begun to get the word out on the negative effect PBMs have on our profession and for our patients. Please 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. |3| www.KPHANET.org

Pharmacists Day atHolidays the Capitol Happy Our voices need to be heard in Frankfort. The legislators need to hear from you now more than ever. We have legislation that affects pharmacy in Kentucky. Join us for Pharmacists Day at the capitol to advocate for our profession!

Thursday, February 27, 2020 Kentucky State Capitol Free Event RSVP at kphanet.org

Save the Date!

KPhA Annual Meeting & Convention Louisville Marriott Downtown June 11—14, 2020

|4| Kentucky Pharmacists Association | January/February 2020

Feature Article Healthcare Providers and Tobacco Cessation Efforts Authors: Melinda Ickes, associate professor of health promotion in the UK College of Education, Jim Pauly, faculty at the UK College of Pharmacy, Beth Magner, PharmD and UK College of Pharmacy community resident We are hard pressed to open a newspaper or turn on the news making and logical thinking. Regardless of the delivery methand not hear the latest statistics on vaping. od, nicotine exposure can harm the respiratory system, learning, memory, and attention, as well as other behaviors.

According to the CDC, there have been 2,409 cases of ecigarette, or vaping, product use–associated lung injury Parents and caregivers need to watch for signs of teen e(EVALI) from 50 states, the District of Columbia and two cigarette use. Know how to identify the various names for eU.S. territories (Puerto Rico and U.S. Virgin Islands). Of cigarettes, which include e-cigs, vape pens, pods, e-hookahs, these cases, 52 resulted in death. tank systems, mods and electronic nicotine delivery systems (ENDS). E-cigarettes can also be found in a variety of forms, While product use for these cases includes both nicotinesome of which look like traditional cigarettes or cigars, while containing products (64%) and THC-containing products the newer generations look like pens or USB drives. One of (86%), the CDC notes there has not been one single comthe most popular brands of e-cigarettes is JUUL, which is a pound found to be the main cause of these outbreaks. Vitapod-based system. min E acetate, used most commonly as a thickening agent in THC-containing vaping products, has been linked to some of Pod-based e-cigarette systems are made up of two compothese cases. This risk is supported by previous research that nents: a power source, which contains the battery than can be suggests when Vitamin E acetate is inhaled, it may interfere charged through a USB port, and a pod or cartridge. A carwith normal lung functioning. Even though much of the focus tridge can provide at least 200 puffs and comes in a variety of has been on THC containing products, the risk for those using different flavored e-juices, all with an alarming amount of e-cigarettes with nicotine cannot be overlooked. nicotine. Each JUUL pod is packed with 59 milligrams per milliliter of nicotine, which is equal to the amount of nicotine Many users are unaware that e-cigarettes are considered a found in a pack of cigarettes. Other pods may contain even tobacco product, although they are regulated as such by the more nicotine.

FDA. Vaping is the use of an electronic cigarette (or ecigarette) product that works by heating e-liquids to form an Fruit, candy, and mint flavors are concerning because they aerosol, which is then inhaled. It is not water vapor, but aero- attract young people. That attraction is often fueled by catchy solized particles, which can also exacerbate respiratory symp- advertising which aims to reinforce the social appeal of these toms among non-users who are exposed to secondhand aero- products. Advertising has often been used to recruit sol, similar to secondhand smoke. E-cigarettes can contain “replacement” smokers over the years, targeting teenagers various substances including flavorings, toxic chemicals, and specifically, so we have seen this before. typically nicotine.

As tobacco cessation efforts move forward, healthcare providWhat is extremely concerning is that e-cigarettes are now the ers must consider more detailed inquiries about tobacco use most commonly used tobacco product among adolescents, in their patients – patients of all ages. Providers should be with over 5 million U.S. middle and high school students re- knowledgeable on the variety of names and presentations of porting use of e-cigarettes in 2018. The growth of e-cigarette e-cigarettes to understand what patients might be using. use among Kentucky middle and high school students has Healthcare providers also need to be vigilant in asking young also skyrocketed, with 14% of our 8th graders and 27% of our people about their use, especially if they are experiencing any high school seniors reporting current, past 30-day e-cigarette of the following symptoms: use. The teen brain is still developing and is very sensitive to  Respiratory symptoms, including cough, shortness of nicotine. breath, or chest pain A teen’s exposure to psychoactive substances can easily cause dependency, mood disorders, and reduced impulse control. In  Gastrointestinal symptoms, including nausea, vomiting, addition, use of e-cigarettes has been associated with future stomach pain, or diarrhea use of other tobacco products. According to the Surgeon General, current youth e-cigarette users are four times more likely Nonspecific constitutional symptoms, like fever, chills, or weight loss to use combustible cigarettes. This increased risk of dual use is very problematic considering the potential for increased risk Healthcare providers should also be equipped with resources for morbidity and mortality. to help young people quit vaping and using all tobacco prodIt is important to note that nicotine affects many parts of the ucts. More information on available resources can be found through the brain including the areas responsible for impulsive decisionContinued on p. 7 |5| www.KPHANET.org

|6| Kentucky Pharmacists Association | January/February 2020

Feature Article Continued from p. 5 KY State Tobacco & Prevention Program. Kentucky has also invested in My Life, My Quit that will connect young people to a “quit coach� who will provide free, confidential, realtime support. Each teen can get five sessions of personalized =0=support through live texting, phone, or online chat.

As research continues to emerge exploring e-cigarettes as a substitute for adults who already smoke tobacco products, there is no benefit for anyone to start using vape products if they do not currently use tobacco products. It is important to note that vaping is not FDA approved as a smoking cessation or tobacco treatment aid. One major concern with e-cigarettes is that they are unregulated and there is not enough information about what chemicals, toxins, and other dangerous substances are contained within the aerosol.

The risks posed with e-cigarettes are unnecessary and avoidable, and it is time to do our part in stopping this epidemic. We have a chance to speak up for our young people and advocate for strong flavor bans, comprehensive smoke-free community policies that include e-cigarettes and funding for prevention and treatment.

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

|7| www.KPHANET.org

MY KPhA Rx A Legislative Call to Action

By Mark Glasper KPhA Executive Director/CEO

white coats to demonstrate to legislators just how important these issues are to us and how engaged we are in the legislative process. We’ll have a great program with lunch provided and set you up to visit your legislators.

The 2020 legislative session is underway in Kentucky and Your KPhA is advocating actively on behalf of two very important issues: Medicaid Carve Out of Pharmacy Services and Reimbursement for Services within Scope of Practice. It’s also the “long” session for the Kentucky legislature, so the calendar is on our side for getting things done by the end of session on April 15, 2020.

Sen. Ralph Alvarado pictured with KPhA President, Don Kupper, KPhA member Zena Slone and KPhA Board of Directors member, Richard Slone.

As a bonus, pharmacy students from the University of Kentucky and Sullivan University will hold a health fair in an adjacent room at the Capitol for your legislators to stop in for a quick health screening.

We’re all in for Medicaid Carve Out To say KPhA is engaged on this issue is quite the understatement. We have been busy since the 2019 legislative session, meeting and discussing elements of a Medicaid carve out – what will work and what won’t. Your KPhA Board of Directors members Matt Carrico, Treasurer Chris Board of Directors, led by Chair Chris Palutis and PresiKillmeier, Chris Harlow and Cassy Hobbs discuss pharmacy issues with Rep. Joni Jenkins. dent Don Kupper, assembled an ad hoc committee of dedicated KPhA members to work on the issue and help You also have an important role during session – Phar- develop language suitable to all groups engaged on this macy Advocate. KPhA and the entire pharmacy profes- topic. sion in this Commonwealth needs for you to be enIt’s important to note we have worked closely with our gaged, advocating for these issues which will transform friends at the Kentucky Independent Pharmacist Allithe practice of pharmacy and the payment for pharmacy ance (KIPA) to present a united front to legislators. I services in Kentucky. want to thank Rosemary and Luther Smith for their endMake plans now to attend our Pharmacists Day at the Capitol February 27, 2020. We want a huge turnout of

less support of a Medicaid carve out. Together, we also have met with representatives of the Kentucky Society

|8| Kentucky Pharmacists Association | January/February 2020

of Health-System Pharmacists (KSHP), Kentucky Hos- equation. pital Association (KHA), Kentucky Primary Care AssoThat’s why we changed our Provider Status Work ciation (KPCA) and federally qualified health centers Group to Professional Compensation Reform Work (FQHC) to work on a solution for 340B interests.

Group. Led by Co-Chairs Cassy Hobbs and Suzi FranI also want to thank UKCOP Dean Kip Guy and Asso- cis, the group has been busy developing language to be ciate Dean Craig Martin for linking us up with repreintroduced during the 2020 legislative session. At this sentatives of the college and UK HealthCare to discuss writing, KPhA member Rep. Danny Bentley plans to our legislative goals for the 2020 session. They were introduce this landmark legislation in Kentucky. proactive as we have been seeking out the opinions of all We Need Your Help interested groups to ensure a mutually satisfying soluAs you can see, the 2020 legislative session is incredibly important to pharmacy in Kentucky. We have been actively meeting with legislators to tell them how important these issues are to us and to our patients. The KPhA Facebook page has been chronicling our activities as we’ve met with leadership from both sides of the aisle in the House and Senate. We also met with both candidates for Governor, and we now look forward to working with Governor Andy Beshear’s team to advance pharmacy in the Commonwealth.

Rep. Kim Moser and KPhA Board of Directors members Treasurer Chris Killmeier, Matt Carrico and President Don Kupper.

tion to a Medicaid carve out.

An important thank you also goes to Government Affairs Committee Co-Chair Richard Slone and KPPAC Chair Matt Carrico for raising important funds for their respective advocacy efforts. Our voice in Frankfort is amplified many times over due to their exhaustive work on behalf of pharmacy in Kentucky.

Honest Pay for Honest Work Getting you reimbursed for the services you already provide, and that are part of a pharmacist’s scope of practice, just makes sense. Momentum is building across the country for states to give pharmacists “provider status,” so we believe the timing is right to do so in Kentucky.

However, we don’t want to upset the medical community by waiving the “provider status” banner. We just want pharmacists to get paid for the services they provide that are already being reimbursed in the health care

We’ve enlisted the services of RunSwitch PR, the leading communications firm in Kentucky, to help us craft our messaging to get the word out to legislators, the media, the public and, most importantly, to YOU. We need YOU to write your legislators.

We need YOU to call your legislators.

We need YOU to invite your legislators to work or go visit them in Frankfort.

But above all else, we need YOU to be engaged. Tell us when and where you’re meeting with your legislators.

We’ll be there. Use our VoterVoice software to reach out and educate your legislators. They’ll listen. And, talk passionately about your profession and your patients. Pharmacy is stronger with YOU!

jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions. |9| www.KPHANET.org

January CPE Article Pharmacologic Review of Invasive Candidiasis and Current Public Health Concerns Authors: Nina Carrillo University of Kentucky PharmD Candidate 2020; Craig Martin PharmD, MBA, BCPS The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-20-001-H01-P &T 1.0 Contact Hours (0.1 CEU) Expires 2/13/23

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 patients at increased risk of developing invasive fungal infections

2.

Select an appropriate treatment regimen based on patient and pathogen specific factors

3.

Evaluate trends in pathogen resistance to help guide treatment decisions

4.

Understand current public health concerns on the emergence of Candida auris

going immune suppression for chronic diseases are at risk for invasive candidiasis. Table 1 below lists the most common Invasive candidiasis is an opportunistic infection caused by global risks for development of candidiasis. It is important to the yeast genus Candida and typically affects the bloodstream specifically address the addition of intravenous drug use (Candidemia), brain, eyes and bones. Other more common (IVDU) as a risk for invasive candidiasis to this list, as it is sources of Candida infections occur in the mucosa and innot currently included in global sources, but is a growing facclude the oropharynx, esophagus and vagina; however, these tor in the United States. Practitioners in Kentucky are all too are not considered invasive disease and will not be discussed familiar with the rampant effects of the opioid epidemic, but in this article. may be unaware that infectious sequelae from IVDU, particuLargely a health-care associated disease process, invasive can- larly that caused by Candida, have been on the rise. Complicadidiasis typically occurs in immunocompromised patients. It tions ranging from localized abscess at injection site to endois widely recognized as a major cause of morbidity and mor- carditis and chronic infections such as HIV and hepatitis C tality in these patients.1 While there are at least 15 species of should be considered in patients that present with symptoms Candida known to cause human disease, the majority (>90%) of infection and history of IVDU. 6 are caused by the following pathogens: C. albicans (42.1%), C. Treatment Selection glabrata (26.7%), C. parapsilosis (15.9%), C. tropicalis (8.7%), 3 and C. krusei (3.4%). Additionally, the emergence of a sixth The Infectious Disease Society of America (IDSA) separates treatment recommendations for candidiasis into two classes pathogen, Candida auris, has been of global health concern of patients, nonneutropenic and neutropenic. Neutropenia is and will be covered in detail in this article. defined as an absolute neutrophil count (ANC) <1500/mm3.

Candidemia specifically, is one of the most common health- Listed in Table 2 are some potential drug related causes of care associated bloodstream infections in the United States. neutropenia pertinent to pharmacists. For the purposes of this This nosocomial infection affects both pediatric and adult article, only the treatment guidelines for uncomplicated canmedicine, and is commonly associated with intensive care didiasis will be discussed. For recommendations on specific units (ICU). A recent multicenter point-prevalence survey disease states, such as native and prosthetic valve endocardiidentified Candida species as one of the most commonly isotis, please refer to the 2016 IDSA Clinical Practice Guideline lated healthcare-associated bloodstream pathogens, ranked at for the Management of Candidiasis at third or fourth in the US.4 Candidemia and invasive candidia- www.idsociety.org/practice-guideline/candidiasis/. 1 sis are associated with up to 47% mortality closely linked to the timing of antifungal therapy and source control.1 Because The IDSA highlights four antifungal drug classes for the management of invasive candidiasis: echinocandins (micafungin, of the high risk of mortality, the necessity for correct and swift therapeutic initiation is an important role for the clinical caspofungin, andulafungin) triazoles (fluconazole, voriconazole, itraconazole posaconazole, and the newest agent pharmacist. isavuconazole), polyenes (amphotericin B [AmB] deoxychoAt-risk Populations late, liposomal AmB, AmB lipid complex [ABLC]), and flucytosine. Due to poor tolerability and limited clinical applicaPatients with immune compromising conditions such as HIV/AIDS and organ transplantation, as well as those under- tions, flucytosine is primarily used as salvage therapy in CNS Introduction

|10| Kentucky Pharmacists Association | January/February 2020

Table 1. Risk factors for invasive candidiasis for adults and children 1,2,5,6 *United States Specific Host-related factors Hematological or solid malignancies

Nonneutropenic patients

I. An echinocandin is recommended as initial therapy a.

Caspofungin: 70 mg LD, then 50 mg daily

Neutropenia

b.

Micafungin: 100 mg daily;

Renal failure

c. Anidulafungin: 200 mg LD, then 100 mg daily)

Hemodialysis Severe acute pancreatitis

II. Fluconazole is an acceptable alternative in certain patient populations

Organ transplant

a.

Not critically ill and low risk for resistant Candida species

Illicit Intravenous Drug Use* Health-care associated factors Long hospitalization in the ICU

b.

Fluconazole IV or PO: 800-mg (12 mg/kg) LD, then 400 mg (6 mg/kg) daily

c.

Voriconazole is effective for candidemia, but offers little advantage over fluconazole as initial therapy.

Use of broad spectrum antibiotics Use of antifungal agents Use of immunosuppressive agents

III. Step-down therapy from an echinocandin to fluconazole

Central venous catheter

A. Recommended when:

Surgical intervention - particularly abdominal

i)

Total parenteral nutrition

ii) Susceptible isolates to fluconazole and

Mechanical ventilation For neonates and children, in addition to adult Prematurity

iii) Negative repeat blood cultures B.

If infection due to C. glabrata and susceptible to triazoles:

Low birth weight

i)

Transition to higher-dose fluconazole 800 mg (12 mg/kg) daily or voriconazole 200–300 (3–4 mg/kg) twice daily

Low American Pediatric Gross Assessment (APGAR) score Congenital malformations 7,8

Table 2. Drug causes of neutropenia * Veterinary drug in the US that may be Chemotherapy and/or radiation therapy Thyroid disorders: Methimazole, propylthiouracil Antibiotics: vancomycin, linezolid, penicillin G and oxacillin Antivirals: ganciclovir and valganciclovir

Patients are clinically stable

C. Voriconazole is recommended as step-down oral therapy C. krusei

for

IV. Testing for azole susceptibility is recommended for all candidemia/candidiasis infections A. Testing for echinocandin susceptibility should be considered if prior treatment with an echinocandin and those with C. glabrata or C. parapsilosis

V. Lipid formulation AmB is a reasonable alternative in intolerance, limited availability, or resistance to other antifungals. In suspected resistance to echinocandin and triazoles, lipid AmB is strongly recommended.

Anti-inflammatories: sulfasalazine

A. AmB dosing: (3–5 mg/kg daily)

Anti-psychotics: clozapine, chlorpromazine

B. If isolates susceptible to triazoles, recommend transition to fluconazole after 5–7 days if clinically stable and repeat cultures negative

Anti-arrhythmics: quinidine and procainamide Levamisole*

VI. All nonneutropenic patients with candidemia should have a dilated ophthalmological examination within the first week after diagnosis

infections and endocarditis and will not be discussed in detail.1 The current IDSA antifungal treatment recommendations for invasive candidiasis in both neutropenic and nonneu- VII. Follow-up blood cultures should be performed tropenic patients are detailed below, however clinical judgeevery 24-48 hours to guide therapy ment should supersede these recommendations.

A. Recommended duration of therapy is 2 weeks after documented clearance of Candida from the bloodstream and resolution of symptoms |11| www.KPHANET.org

Without obvious metastatic complications Neutropenic patients

I. An echinocandin is recommended as initial therapy Caspofungin: 70 mg LD, then 50 mg daily Micafungin: 100 mg daily; Anidulafungin: 200 mg LD, then 100 mg daily)

II. Lipid formulation AmB is an effective but less attractive alternative because of the potential for toxicity AmB dosing: 3–5 mg/kg daily

III. Fluconazole is an alternative for patients who are not critically ill and have had no prior azole exposure 800-mg (12 mg/kg) loading dose, then 400 mg (6 mg/kg) daily

Considerations for therapeutic selection Echinocandins Because there are limited head-to-head comparison trials of ant fungal agents, selection is primarily based on safety and resistance patterns.1 Echinocandins not only have limited adverse effects and drug interactions, but also have a wide spectrum of coverage with less resistance compared to triazoles from C. albicans, C. glabrata and C. krusei. On the other hand, Candida parapsilosis demonstrates potentially innate resistance to echinocandins and use should be based on susceptibility results.1,5 None of the echinocandins require dosage adjustment for renal insufficiency or dialysis. Both caspofungin and micafungin undergo mild hepatic metabolism, however, only caspofungin requires dose adjustment in moderate to severe hepatic dysfunction. Additionally, it is important to recognize that echinocandins have poor penetrability of the CNS, urinary and ocular tracts and should be avoided in sus-

pected candidiasis of these organs.1 Triazoles

IV. Step-down therapy from an echinocandin or AmB to fluconazole/voriconazole if:

As a class, the azoles are responsible for significant drug-drug interactions due to their inhibition of cytochrome P450 enzymes. Additionally, they have high resistance rates to C. glaPatients are clinically stable brata and C. parapsilosis and are only recommended treatments Susceptible isolates to fluconazole and if the pathogen is susceptible.1 Fluconazole specifically has innate resistance by C. krusei and should not be used for this Negative repeat blood cultures species.1 One should also be aware of regional C. albicans reStep-down can occur regardless of neutropenic status* sistance rates to fluconazole as well as patient specific factors for resistance when determining treatment.1,2,5 Fluconazole is V. Voriconazole can be used in situations in which available in both IV and PO options and is readily absorbed additional mold coverage is desired with excellent oral bioavailability. Among the triazoles, fluDosing 400 mg (6 mg/kg) twice daily for 2 doses, then 200– conazole has the greatest penetration into the CNS, urinary and ocular tracts and is often used in the treatment of these 300 mg (3–4 mg/kg) twice daily infections.1 Fluconazole elimination is almost entirely renal VI. For infections due to C. krusei, an echinocandin, and requires dose adjustment with creatinine clearance <50 lipid formulation AmB, or voriconazole is rec- mL/minute.

ommended

VII. Follow-up blood cultures should be performed every 24-48 hours to guide therapy Recommended minimum duration of therapy of 2 weeks after documented clearance of Candida from the bloodstream and resolution of symptoms Without obvious metastatic complications

VIII. Ophthalmological examinations should be performed within the first week after recovery from neutropenia.

IX. In the neutropenic patient, sources of candidiasis other than a CVC (eg, gastrointestinal tract) predominate. Catheter removal should be considered on an individual basis X. Granulocyte colony-stimulating factor (G-CSF)– transfusions can be considered in cases of persistent candidemia with anticipated protracted neutropenia

Table 3. Overview of resistance trends 1,2,5 Echinocandin C. auris C. glabrata C. krusei C. parapsilosis C. tropicalis C. auris*

Ñ X Ñ

Fluconazole

Voriconazole

Ñ X X X X X

X X

Am b

X

Voriconazole is primarily used for step-down to oral therapy in patients with infection due to C. krusei and fluconazoleresistant C. glabrata.1 Unlike fluconazole, voriconazole does not accumulate in the urine and thus should not be used for urinary candidiasis.1 While voriconazole does penetrate the CSF, it does so at a lower concentration than fluconazole and is only preferred in fluconazole resistance. The oral bioavailability of voriconazole is excellent but dependent on stomach contents. Patients should be cautioned not to take this medication with food.1 IV voriconazole is formulated with a cyclodextrin molecule and is not currently recommended for

|12| Kentucky Pharmacists Association | January/February 2020

patients with a creatinine clearance <50 mL/minute due to concern for significant nephrotoxicity.1 Oral voriconazole does not require renal dosing, but is the only triazole needing dose reduction in mild to moderate hepatic dysfunction.

Voriconazole is associated with several adverse drug effects including hepatic injury, visual side effects, photosensitivity, periostitis, and CNS side effects. For these reasons, its use is only recommended in cases of known resistance to fluconazole.1 Itraconazole and posaconazole have not been studied extensively in candidiasis and currently do not have indications for this disease state. Isavuconazole is a recently approved expanded-spectrum triazole with excellent activity against Candida. However, preliminary analysis comparing this drug to an echinocandin for invasive candidiasis did not meet criteria for noninferiority.1 Figure 2. US Map: Clinical cases of Candida auris reported as

Emerging pathogens: Candida auris is an emerging fungal pathogen that presents a serious global health threat. This species of Candida is highly resistant with reported 90% resistance to fluconazole and 30% resistance to AmB.2,3,9 The CDC has estimated approximately 3% of these isolates are also resistant to Echinocandins, making them multidrug resistant with no current treatment options. 2 C. auris causes severe illness in hospitalized patients and has been linked to healthcare outbreaks worldwide due to its high transmissibility, ability to colonize skin and persistence on surfaces.2,9 In April, 2019 The New York Times, in conjunction with Mount Sinai Medical Center in Brooklyn, NY, reported that after one patient with confirmed C. auris candidemia died, the hospital required special cleaning equipment and had to remove ceiling and floor tiles to eradicate this extremely invasive pathogen.13 Complicating matters is the difficulty to even identify C. auris isolates using traditional biochemical methods. Most often this pathogen is misidentified as Candida haemulonii and requires MALDI-TOF or DNA sequencing to properly detect this pathogen, potentially delaying proper treatment and isolation protocols.9 Most C. auris isolates are susceptible to echinocandins in the United States, making this drug class the recommended initial therapy.2,9 However, patients should be monitored closely for resolution of infection given that this organism is highly prone to developing resistance and cases of resistance have been documented in serial isolates after the patient was exposed to the drug.2,9 Switching to or adding liposomal AmB could be considered if the patient is clinically unresponsive to echinocandin treatment or has fungemia for >5 days.2,9

Amphotericin B (AmB) AmB is available in the conventional deoxycholate preparation as well as two lipid formulations (ABLC and liposomal AmB) in the United States. All of these agents possess the same spectrum of activity, but the lipid formulations have significantly fewer adverse drug effects compared to AmB. It is important to note, however, that the lipid formulations have different pharmacological properties and are not interchangeable.1 Conventional AmB is associated with severe nephrotoxicity, resulting in acute kidney injury in up to 50% of patients.

This, in addition to significant electrolyte wasting, and infusion related reactions, limits its use clinically. As a group amphotericin B is less commonly used due to better safety profiles with echinocandins and triazoles, however, when used, the lipid formulations are preferred, with the exception of urinary tract infections.1 Table 3 provides a general overview of current resistance trends for our major pathogens and drug classes in the United States.

X = known and/or reported clinical resistance or decreased efficacy to agent, results of susceptibilities should guide treatment Ñ = concern over rising resistance trends of these isolates

The rise of “superbugs” such as Candida auris expands the already indispensable role for pharmacists in infectious disease medicine. Control of multi-drug resistant pathogens begins with proper antimicrobial and antifungal stewardship.

Ensuring that the patient is on a susceptible drug regimen for the appropriate amount of time and de-escalating therapy where appropriate to reduce unnecessary broad-spectrum activity can curb the rise in antifungal resistance.2 References: 1.

Pappas, P. G., Kauffman, C. A., Andes, D. R., Clancy, C. J., Marr, K. A., Ostrosky-Zeichner, L., … Sobel, J. D. (2015). Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases, civ933. doi: 10.1093/cid/civ933

2.

Centers for Disease Control and Prevention. (2020, January 15). Candida auris: Fungal Disease. Retrieved from https://www.cdc.gov/fungal/candida-auris/index.html

3.

Centers for Disease Control and Prevention. (2020, January 15). Tracking Candida auris: Candida auris: Fungal Disease. Retrieved from https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html

4.

Pfaller M , Neofytos D, Diekema Det al. Epidemiology and outcomes of candidemia in 3648 patients: data from the Prospective Antifungal Therapy (PATH Alliance(R)) registry, 2004–2008. Diagn Microbiol Infect Dis2012; 74:323–31.

5.

Magill, S. S., Edwards, J. R., Bamberg, W., Beldavs, Z. G., Dumyati, G., Kainer, M. A., … Fridkin, S. K. (2014). Multistate Point-Prevalence Survey of Health Care–Associated Infections. New England Journal of Medicine, 370(13), 1198–1208. doi: 10.1056/nejmoa1306801

Continued on p. 16

|13| www.KPHANET.org

January 2020 â&#x20AC;&#x201D; Pharmacologic Review of Invasive Candidiasis and Current Public Health Concerns 1.) Which of the following patients would not be con-

sidered at an increased risk for developing invasive candidiasis?

A. 45 YO male with recent cholecystectomy B. 22 YO female with uncomplicated appendicitis responsive to medical management C. 75 YO male on hemodialysis for 2 years D. 29 week GA infant in the NICU 2.) Which of the following risk factors for candidiasis has recently been added back on in the United States?

A. Abdominal surgeries

6.) Which of the following agents has the best oral bioavailability and tissue penetration?

A. Fluconazole B. Liposomal AmB. C. Voriconazole D. Micafungin 7.) True or False: Step-down therapy from micafungin to PO fluconazole is appropriate in neutropenic patients only if neutropenia is resolved, they are clinically stable with negative blood cultures and have susceptible isolates?

A. True B. False

B. Hematologic cancers C. Use of central venous catheter D. Illicit intravenous drug use 3.) Which of the following patients could be considered at-risk for neutropenia?

8.) Which of the following is not an appropriate therapy in a patient with confirmed C. krusei candidiasis?

A. Voriconazole B. Liposomal AmB

A. 38 YO man on taking clozapine for schizophrenia

C. Fluconazole

B. 24 YO male with recovering from influenza on oseltamivir

D. Echinocandin

C. 2 YO female seen after moderate fall and abrasion to arm

9.) When should addition of voriconazole be considered in neutropenic patients?

D. 61 YO female with hyperthyroidism on levothyroxine

A. When they are improving on micafungin and susceptible to both echinocandins and azoles B. When there is a suspected mold co-infection

4.) Which of the following antifungals requires hepatic dose adjustment in mild-moderate hepatic dysfunction?

C. When step-down therapy is indicated for C. krusei

B. Caspofungin

10. True or False: fluconazole should still be considered an appropriate empiric antifungal for suspected C. auris infections?

C. Voriconazole

A. True

D. Fluconazole

B. False

A. Micafungin

5.) Assuming no prior history of antifungal use, which of the following would be the most appropriate empiric treatment for a patient with confirmed candidemia (C. albicans) with suspected urinary source?

A. Micafungin B. Amphotericin B deoxycholate C. Fluconazole D. Caspofungin

|14| Kentucky Pharmacists Association | January/February 2020

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: 2/13/2023 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEUs. TECHNICIANS ANSWER SHEET January 2020— Pharmacologic Review of Invasive Candidiasis and Current Public Health Concerns Universal Activity # 0143-0000-20-001-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B 9. A B C 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B 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 January 2020— Pharmacologic Review of Invasive Candidiasis and Current Public Health Concerns Universal Activity #0143-0000-20-001-H01-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D

7. A B 8. A B C D

9. A B C 10. A B

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. |15| 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.

References Cont. From p. 13 6. Yapar, N. (2014). Epidemiology and risk factors for invasive candidiasis. Therapeutics and Clinical Risk Management, 95. doi: 10.2147/tcrm.s40160



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.

54, Issue 8, 15 April 2012, Pages 1110– 1122, https://doi.org/10.1093/cid/cis02

13. 1Richtel, M., & Jacobs , A. (2019, April 6). Deadly Germs, Lost Cures: A Mysterious Infection, Spanning the Globe in a Climate of 7. Poowanawittayakom, N., Dutta, A., Stock, S., Touray, S., Ellison, Secrecy. The New York Times. Retrieved from R. T., & Levitz, S. M. (2018). Reemergence of Intravenous Drug Use https://www.nytimes.com/2019/04/06/health/drug-resistantas Risk Factor for Candidemia, Massachusetts, USA. Emerging Incandida-auris.html fectious Diseases, 24(4). doi: 10.3201/eid2404.171807 8. Neutropenia and risk for infection. Centers for Disease Control and Prevention. https://www.cdc.gov/cancer/preventinfections/neutropenia.htm.

Accessed Dec. 4, 2018.

9. AskMayoExpert. Neutropenia. Rochester, Minn.: Mayo Foundation for Medical Education and Research; 2017.

10. Sharon Tsay, Alexander Kallen, Brendan R Jackson, Tom M Chiller, Snigdha Vallabhaneni, Approach to the Investigation and Management of Patients With Candida auris, an Emerging Multidrug-Resistant Yeast, Clinical Infectious Diseases, Volume 66, Issue 2, 15 January 2018, Pages 306– 311, https://doi.org/10.1093/cid/cix744 11. Webb, B. J., Ferraro, J. P., Rea, S., Kaufusi, S., Goodman, B. E., & Spalding, J. (2018). Epidemiology and Clinical Features of Invasive Fungal Infection in a US Health Care Network. Open Forum Infectious Diseases, 5(8). doi: 10.1093/ofid/ofy187 12. David R. Andes, Nasia Safdar, John W. Baddley, Geoffrey Playford, Annette C. Reboli, John H. Rex, Jack D. Sobel, Peter G. Pappas, Bart Jan Kullberg, for the Mycoses Study Group, Impact of Treatment Strategy on Outcomes in Patients with Candidemia and Other Forms of Invasive Candidiasis: A Patient-Level Quantitative Review of Randomized Trials, Clinical Infectious Diseases, Volume

|16| Kentucky Pharmacists Association | January/February 2020

February CPE Article Damage Control: What to Do When a Possible Dispensing Error Comes Back Author: Joseph L. Fink III is Professor of Pharmacy Law and Policy as well as Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington, KY. The author declares that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-20-002-H04-P &T 1.0 Contact Hour (0.10 CEU) Expires 02/13/23

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 results of a theoretical model for examining dispensing errors;

2.

List three goals when dealing with a patient over a prescription error; and

3.

Describe several elements of the PEEER Model for patient communication.

Introduction Humans make errors. This painful truth was emphasized when the National Institute of Medicine published the seminal book entitled To Err Is Human twenty years ago.1 This publication focused the attention of both the lay public and health professionals on the incidence of adverse events occurring during delivery of health care services in the United States. This resulted in a number of health services programs re-examining their processes to attempt to uncover activities associated with unintended damage to patients. All in all, this was a positive development for both patients, the recipients of our services, and the health professionals delivering those services, the vast majority of whom went into health care to improve the health of patients, not to harm them.

Data to Frame the Issue Dr. T. Donald Rucker, a health economist at the College of Pharmacy of The Ohio State University, took a numerical perspective, indeed a very conservative quantifiable point of view by looking at some moderate pharmacy-related data.2 Be patient and follow this calculation.As a point of departure, we will focus on a pharmacist’s output as dispenser of medication or as supervisor of the dispensing process. We will assume a 40-hour work week, which is low in light of what the typical community pharmacist’s work week is these days. Further, we’ll use an extremely conservative assumption that this pharmacist is responsible for the dispensing of six prescriptions per hour (Wow! How long ago was

that!?) That gives us this very modest estimate of the pharmacist’s output per week.

40 hours/week (avg.) x 6 Rx/hour (avg.) = 240 Rx/week Assuming the pharmacist gets two weeks off for vacation per year, we see that our pharmacist’s yearly output is as follows: 50 weeks/year x 240 Rx/week = 12,000 Rx/year The final step is to project that our mythical pharmacist’s career will span forty years, also likely a modestestimate once again, meaning that over the span of professional career this pharmacist will have responsibility for nearly half a million prescriptions: 40 years professional practice x 12,000 Rx/year = 480,000 Rx/career Next Dr. Rucker turned to a focus on the proficiency of the pharmacist – how accurately did the pharmacist fulfill those responsibilities? He performed calculations using a variety of rates of accuracy and applied those to the pharmacist’s career productivity.

|17| www.KPHANET.org

Accuracy Rate

Error rate

Total Errors

an admission of responsibility or liability. However, this can be challenging when dealing with a long-term pa95.0% 5.0% 24,0 tient with whom the pharmacist has had a long-standing relationship or the surviving family members or caregiv97.0% 3.0% 14,400 ers of that patient. One wants to be compassionate and 99.0% 1.0% 4,800 understanding in such trying circumstances. At the same 99.5% 0.5% 2,400 time, one does not want to make a statement that could come back to haunt him or her during a legal proceed99.9% 0.1% 960 ing. Change may be coming because four states have His final calculation might have the greatest significance adopted legislation allowing professionals to admit er– how many patients would perish if those dispensing rors without worrying about the implications of their errors proved to be fatal? He used two separate mortality remarks for later legal proceedings.4 rates – 1/4 of 1% (0.250%) or 1/8 of 1% (0.125%).

During the 1990’s the Food Marketing Institute (FMI), Portion Leading to Patient’s Demise with support from Miles Laboratories, created an educational videotape to educate pharmacists about how to Total Errors 1/4 of 1% 1/8 of 1% conduct such delicate conversations. FMI describes its 24,000 60 30 goal as working “with and on behalf of the entire industry to advance a safer, healthier and more efficient con14,400 36 18 sumer food supply.”5 Many of its member grocery 4,800 12 6 chains include pharmacies. That educational video offering included these goals or considerations for the con2,400 6 3 versation with the patient about a possible prescription 960 2+ 1+ dispensing error: Yes, this calculation is not representative of the current 1. Responding to the patient’s feelings workload for those practicing community pharmacy; the numbers used in the calculations are extremely modest 2. Nonverbal communication but, hopefully, the error rate is low and the estimated 3. Investigating the facts portion of errors leading to death of a patient is high.

4. Offering an appropriate apology and offering a remBut we all know that despite the education, training, edy knowledge and experience of pharmacy practitioners, errors do occur and, unfortunately, they sometimes are 5. Establishing or re-establishing trust fatal for patients. See, for example, the discussion of a Additional recommendations regarding how to handle recent dispensing error case that led to litigation.3 It is not farfetched to think that over the course of a career in such difficult and delicate communications with pathe profession a pharmacist may well be the cause of the tients, family or other caregivers has been prepared by demise of a patient or two given the increasing potency faculty at the University of Kentucky. During 2012 faculty from the UK Colleges of Communications, Health and sophistication of the medications being dispensed.

Sciences, Medicine, Nursing and Pharmacy collaborated This extremely undesirable outcome can occur even if to develop the PEEER© Model for interprofessional the pharmacist does not know that this has occurred, was never informed of this taking place, and has no ink- communication.6 This model for communication was ling that such an untoward result may have happened. It designed to facilitate effective interchange, both among may well may be that the modest figures used in the cal- the members of an interprofessional team caring for the culation above underestimate to some extent the proba- patient as well as with the patient. For the purposes here the focus will be on using those principles to enhance bility of such negative outcomes. communication with a patient or caregiver when an erSuggestions for Communicating about an Error ror has occurred. The principal elements of that apHow should the pharmacist react when a patient or pa- proach to communication could provide useful guidance tient’s representative approaches the pharmacy counter for the approached used to communicate about an error and asks to speak to the pharmacist, leading to a conver- that has occurred. The five elements of that approach sation about a perceived prescription error? Anyone who are: has been in practice for even a relatively short period of time will have had the challenge of dealing with these difficult conversations.

Plain Language

The traditional recommendation from one’s legal advisor is not to say anything that can be construed as

Empathy

Engagement

|18| Kentucky Pharmacists Association | January/February 2020

Empowerment

Conclusion

Errors appear to be inevitable. Despite our best intentions and our efforts to refine systems used in preparing Let’s examine each element in turn with emphasis on medications to go to patients for consumption, errors what each can contribute to challenging conversations. persist. Pharmacists should always be alert for better The key notion of this approach I that these elements ways to conduct their professional activities, looking for should be useful both when communicating with papotential sources of errors, misunderstandings or comtients as well as when doing so with professional colmunication shortcomings. It is important to remember leagues. that the very first provision in the APhA Code of Ethics Plain Language – This element of the model emphasiz- for Pharmacists says this: es that the terminology being used in the communicaI. A pharmacist respects the covenantal relationship tion must be appropriate for the educational and underbetween the patient and pharmacist. Considering standing level of the patient. Scientific or clinical jargon the patient-pharmacist relationship as a covenant should be avoided. Speech should be slow, clear and at means that a pharmacist has moral obligations in a moderate pace. Repeating key points and asking that response to the gift of trust received from society. In the recipient repeat back what is understood can conreturn for this gift, a pharmacist promises to help tribute greatly to successful communication. Offering individuals achieve optimum benefit from their written supplements to be taken home will also facilitate medications, to be committed to their welfare, and understanding. Meet the recipient of the information at to maintain their trust.7 his or her level.

References: Engagement – Engaging the patient emphasizes presenting choices to the recipient of the information. Ex- 1. Institute of Medicine Committee on Quality of Health Care in America. To Err is Human: Building plain treatment or other alternatives clearly and offer a Safer Health System. Washington: National Acadchoices. Provide copies of relevant documents such as emies Press (2000). medication histories.

Respect

2. Rucker TD. Simplified model for considering the Empathy – The authors of this approach describe this problem of dispensing errors: A systems perspective. element as ”action of understanding, being aware of, J. Pharmacy Teaching 1990;1:63. sensitive to, and vicariously experiencing the feelings, thoughts, and experiences of another.” The emphasis is 3. Fink III JL. Dispensing wrong medication leads to on understanding the patient’s perspective and compatient’s death. Pharm Times. 2019(Sept); 85:64. municating that understanding. That can be done by words or by non-verbal steps such as eye contact or pos- 4. Ogburn JM, Fink III JL. CANDOR creates a safer health care system. Pharm Times 2020(Jan);86:48itive nods. Try to put yourself “in the shoes” of the per49. son to whom you are speaking.

Empowerment – This element means extending to the other person the opportunity to have a choice, some control and responsibility for decision-making. Sharing information with the other person helps to achieve this.

Understand and acknowledge values or beliefs of the person to whom you are speaking. Work to establish short- and long-term goals to be pursued.

Respect – Conduct yourself in a way that honors the dignity of the individual to whom you are speaking.

Present an attitude that that is non-judgmental and that acknowledges and respects patient autonomy. Take into account that the knowledge and experiences of the patient and caregivers are important and can provide valuable insights. Consider religious and cultural practices as well as family routines. Applying these various recommendations about how to communicate respectfully and effectively with others can go a long way to defusing a potentially problematic, even troublesome, confrontation.

5. FMI – The Food Industry Association. www.fmi.org.

6. UK Center for Interprofessional Health Education.

Introduction to the PEEER© Model for Effective Healthcare Team-Patient Communication (undated slide set).

7. APhA Code of Ethics for Pharmacists. Adopted by the APhA membership on October 27, 1994. Available at https://www.pharmacist.com/codeethics?is_sso_called=1.

|19| www.KPHANET.org

February 2020 — Damage Control: What to Do When a Possible Dispensing Error Comes Back 1. The book To Err Is Human that focused on patient safety was published:

C.

Not to admit responsibility or liability

D.

To blame someone else

A.

3 years ago

B.

5 years ago

C.

10 years ago

6. Which of these was not a recommendation from the MI about how to handle such delicate conversations?

D.

20 years ago

A.

Responding to patients’ feelings

B.

Re-establishing trust

C.

Do not offer an apology

D.

Focus on non-verbal communication

2. Publication of To Err Is Human caused professionals and health systems to review: A.

“defensive medicine” initiatives

B.

processes that might cause unintended damages

C. how to communicate among staff when an error has occurred D. how to communicate with a patient when an error has occurred

3. Dr. T. Donald Rucker’ assumptions and calculations resulted in a calculated output for a pharmacist of ___ prescriptions per year.

A}

250,000

B.

500,000

C.

1,000,000

D.

2,000,000

7. The PEEER© Model for communication: A. Is only directed at communication between health professionals B. Is only directed at communication by health professionals with patients C. above

Is directed at both types of communication appearing

8. The “Plain Language” element of he PEEER© Model emphasizes: A.

Use of a language interpreter if appropriate

B.

Minimizing scientific or technical jargon

C.

Addresses only oral communication, not written

D.

Includes speaking not so rapidly

4. Even assuming the pharmacist is 99.9% accurate with dispensing activities, that still could result, using Dr. Rucker’s very conservative approach to calculations, of a career total of how many errors?

9.“Respect” in the PEEER© Model includes all but: A.

Being non-judgmental in approach

A.

1

B.

Respecting patient autonomy and decision-making

B.

10

C.

Considering religious and cultural components

C.

Nearly 100

D.

Being overly polite and solicitous in conversation

D.

Nearly 1,000

5. The traditional recommendation for handling conversations about a possible dispensing error with the patient or caregiver has been: A.

To readily admit culpability

B.

To pledge to do better next time

10. The APhA Code of Ethics for Pharmacists contains a specific admonition for pharmacists to work to maintain patients’ trust.

A.

True

B.

False

|20| Kentucky Pharmacists Association | January/February 2020

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: 2/13/23 Successful Completion: Score of 80% will result in 1.0 contact hours TECHNICIANS ANSWER SHEET. February 2020 — Damage Control: What to Do When a Possible Dispensing Error Comes Back (1.0 contact hours) Universal Activity # 0143-0000-20-002-H04-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 8. A B C D

9. A B C D 10. A B

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 February 2020 — Damage Control: What to Do When a Possible Dispensing Error Comes Back (1.0 contact hours) Universal Activity # 0143-0000-20-002-H04-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 8. A B C D

9. A B C D 10. A B

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. |21| www.KPHANET.org

Financial Forum Why Do You Need A Will?

It may not sound enticing, but creating a will puts power in your hands According to the global analytics firm Gallup, only about 44% of Americans have created a will. This finding may not surprise you. After all, no one wants to be reminded of their mortality or dwell on what might happen upon their death, so writing a last will and testament is seldom prioritized on the to-do list of a Millennial or Gen Xer. What may surprise you, though, is the statistic cited by personal finance website The Balance: around 35% of Americans aged 65 and older lack wills.1,2

rest of your estate in equal shares among your heirs, or you can split it into percentages. For example, you may decide to give 45% each to two children and the remaining 10% to your sibling.

*Executors: Most wills begin by naming an executor.

Executors are responsible for carrying out the wishes outlined in a will. This involves assessing the value of the estate, gathering the assets, paying inheritance tax and other debts (if necessary), and distributing assets among beneficiaries. It is recommended that you name an alternate executor in case your first choice is unable to fulfill the obligation. Some families name multiple children as co-executors, with the intention of thwarting sibling discord, but this can introduce a logistical headache, as all the executors must act unanimously.2,3

1 - https://news.gallup.com/poll/191651/majoritynot.aspx [4/24/18]

A do-it-yourself will may be acceptable, but it may not be advisable. The law does not require a will to be drawn up by a professional, so you could create your own will, with or without using a template. If you make a mistake, however, you will not be around to correct it.

When you draft a will, consider enlisting the help of a A will is an instrument of power. By creating one, you legal, tax, or financial professional who could offer you gain control over the distribution of your assets. If you additional insight, especially if you have a large estate die without one, the state decides what becomes of your or a complex family situation. property, with no regard to your priorities. A will is a Remember, a will puts power in your hands. You have legal document by which an individual or a couple worked hard to create a legacy for your loved ones. You (known as â&#x20AC;&#x153;testatorâ&#x20AC;?) identifies their wishes regarding deserve to decide how that legacy is sustained. the distribution of their assets after death. A will can typically be broken down into four parts: Citations.

*Guardians: A will allows you to designate a guardian for your minor children. The designated guardian you appoint must be able to assume the responsibility. For many people, this is the most important part of a will. If you die without naming a guardian, the courts will decide who takes care of your children. *Gifts: This section enables you to identify people or organizations to whom you wish to give gifts of money or specific possessions, such as jewelry or a car. You can also specify conditional gifts, such as a sum of money to a young daughter, but only when she reaches a certain age. *Estate: Your estate encompasses everything you own, including real property, financial investments, cash, and personal possessions. Once you have identified specific gifts you would like to distribute, you can apportion the

2 - https://www.thebalance.com/wills-4073967 [4/24/18] 3 - https://www.nolo.com/legal-encyclopedia/namingmore-one-executor.html [12/3/18] Pat Reding and Bo Schnurr may be reached at 800-2886669 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

|22| Kentucky Pharmacists Association | January/February 2020

Rx And the Law CONTROLLED SUBSTANCES This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

The opioid crisis has brought a lot of attention to the prescribing and dispensing of opioids. This attention has also extended to the prescribing and dispensing of all controlled substances. I recently attended a seminar which contained a number of sessions on opioids and controlled substances. One of these sessions suggested that every pharmacist should read the DEA's Pharmacist's Manual. That suggestion caused me to ask myself when was the last time I had read it. One human trait is that we tend to forget details over time and our memory becomes a little less sharp. There have been a number of times when I was sure what a contract provision said, only to go back, read the document, and find that what it stated was slightly different from my memory. This same phenomenon applies to the Pharmacist's Manual. The manual is about 80 pages, but it is much more readable than the actual statute and regulations.

pharmacies are using a perpetual inventory system today, that does not replace the required biennial inventories. Physical inventories are required for a new registrant (either opening a new pharmacy or taking over an existing one) and for products that are newly added to a schedule.

The Pharmacist's Manual contains information on a number of topics. Besides a basic introduction to the Schedules, there is a lot of practical information in the manual. There is a section on the transfer and disposal of controlled substances.

This covers transfer to another pharmacy, the original manufacturer, or a reverse distributor. There are numerous reminders to use the triplicate DEA Form 222 to transfer Schedule II substances. Another reason to refresh our memories periodically is that requirements change and if we rely only on our memories, we may not be current. The DEA recently announced the phase out of the triplicate form over the next two years.

The periodic review of the DEA's Pharmacist's Manual is a good risk management tool. During my years of practice, none of my employers recommended or required that I review it. My working knowledge of the DEA regulations was what I drew from my pharmacy law class and any updates that I may have read and retained. Given the scrutiny that is currently being given to the dispensing of controlled substances, an annual review of the Pharmacist's Manual is an excellent risk management tool to help the pharmacist and pharmacy avoid a potential problem brought on by foggy memory of the requirements. In addition, a review of your state statutes and regulations should also be done because your state may have more restrictive standards which you are required to follow.

The manual also contains helpful information for the review and dispensing of controlled substance prescriptions. It provides what information is required to be on the prescription itself and the information required to be on the prescription label. Partial fill situations are addressed as is the dispensing of controlled substances without a prescription. The record of over the counter sales of controlled substances is required to be kept in a bound record book. These types of sales must be made by a pharmacists and cannot be delegated to a nonpharmacist. While the manual contains a lot of practical information, there are some uncommon provisions also. SomeThe speaker at the seminar explained that many pharmacists times these less common situations are problem-prone befeel their duty is to make sure that a controlled substance pre- cause we aren't as familiar with the situation. Suppose one of scription isn't forged or altered. While that is true, the duty is your patients has a valid prescription for a C-IV medication much broader. For a controlled substance prescription to be and requests that you send a refill to their vacation home in valid, it must be issued for a legitimate medical purpose in the Bermuda. Can you send that refill to a foreign country? Not usual course of the prescriber's professional practice. The law unless you are registered with the DEA as an exporter and does not require a pharmacist to dispense a questionable pre- have obtained the necessary permits or submitted the necesscription. The DEA has provided some red flags that may sary declarations for export. The pharmacist might assume it indicate diversion. Those are discussed in 2018 decision and is permissible to send the refill because there is a valid preorder. Corresponding Responsibility is a topic that requires its scription on file. This is an example where a seemingly reaown forum so I won't delve more deeply into it now. sonable conclusion is incorrect.

The DEA Form 222 is also mentioned in the section of the manual on ordering of controlled substances. Topics here include how to order the Form 222, who is authorized to sign the forms, and what to do if the forms are lost or stolen. The manual also contains useful information on what to do when controlled substances are stolen or lost. The DEA must be notified, in writing, within one business day of the discovery of the theft or loss. Completion of the DEA Form 106 in this situation can be made easier by using the biennial inventory and prescription records because you can use these records to determine how much product was stolen or lost. There is also an entire section of recordkeeping requirements. While many

https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2 /pharm_manual.pdf https://www.deadiversion.usdoj.gov/fed_regs/actions/2018/ fr0220_4.pdf#search=red%20flag%20diversion Š Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company.

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly.

|23| www.KPHANET.org

Pharmacy Policy Issues Being Conscious of Conscience Clauses Author: Rachel B. Hardin, Pharm.D., is a 2019 graduate of the UK College of Pharmacy. She is currently completing a PGY1 community pharmacy practice residency through the University of Kentucky College of Pharmacy and Kroger Louisville. A native of Louisa, she completed her pre-professional education at the University of Kentucky.

Issue: After the landmark Roe v. Wade decision in 1973, conscience clauses were enacted by many states and even at the federal level. These clauses, also called “refusal clauses,” are clauses in laws that allow physicians and other healthcare providers to refuse to provide abortions, abortifacient medications, etc., on the basis of religious, personal, or ethical beliefs.1 What implications do conscience clauses have on pharmacy, and how does it impact individual pharmacists?

Discussion: Most states have conscience clauses detailing the right of physicians to refuse certain services based on personal beliefs.2 However, current pharmacy-specific clauses are less frequent and vary greatly between states. Unsurprisingly, most of the pharmacy-related discussion of conscience clauses focuses on emergency contraception (EC) and contraception prescriptions. Whereas some states have laws that allow a pharmacist to refuse to dispense EC medications, others have broad refusal clauses that imply, but do not specifically mention, pharmacists. Additionally, some states require a referral or transfer of the prescription to a willing pharmacist or pharmacy to accompany the refusal. California allows the refusal of prescriptions only if the pharmacist’s employer approves the refusal and it does not prevent patient access to the medication in a timely manner.

On the other hand, some states have tried to mandate EC dispensing by pharmacists. In 2005, the Governor of Illinois issued an administrative rule mandating that pharmacies must dispense contraceptives without delay, as they would with any other type of prescription. After a lengthy challenge through the court system, the Appellate Court of Illinois determined that the new rule violated Illinois law. In 2007, the Washington State Board of Pharmacy mandated that pharmacies stock and sell EC medications.4 After an even lengthier challenge through the court system, the US Court of Appeals for the Ninth Circuit overturned a previous decision declaring the law unconstitutional; the petition for a writ of certiorari was denied, thus allowing the law to stand.

prescription for misoprostol, which had been prescribed to her in order to induce an abortion for her unviable pregnancy.5 Arizona is one of the states that has a pharmacy-specific conscience clause; a stipulation of their law is that medical professionals must state their objection in writing. The incident, which gained notoriety after the woman’s Facebook post received much attention, inspired the Arizona State Board of Pharmacy to announce plans to investigate the incident in order to determine if the law needed to be clarified.

Moreover, the Arizona event highlights the fact that conscience clauses are not only included in legislation but are often included in company policies. For instance, Walgreens’ policy “allows pharmacists to step away from filling a prescription for which they have a moral objection,” as long as they refer the prescription to another pharmacist on duty.6 Similar anecdotes have arisen highlighting comparable policies at other pharmacy chains.

In Kentucky, the conscience clause has not led to any groundbreaking court cases, notorious social media controversies, or anything major in between. In 2001, KY Senate Bill 160 was proposed to prohibit discriminatory practices against pharmacists who refused to participate in abortions on moral, religious, or professional grounds.7 After a few amendments, the bill passed in the Senate but did not go on to become a law.

Many see conscience clauses as something to support or oppose. Proponents say that pharmacists should be able to practice their profession in accordance with their moral, ethical, and religious views. Opponents say that in denying certain medications, pharmacists are stripping patients of their autonomy and potentially endangering their wellbeing. No matter on which side of the fence you sit, it is important to evaluate your own personal beliefs, applicable state laws, and pertinent company policies when providing patient care. Only then can you call yourself a conscientious pharmacist.

Disputes and controversies regarding conscience clauses also arise outside of the courts via news articles, social media posts, etc. A recent example arose in June 2018 when a Walgreens pharmacist in Arizona refused to fill a woman’s |24| Kentucky Pharmacists Association | January/February 2020

Continued on p. 25

Campus Corner UKCOP is First School of Pharmacy to Require Course in Diagnosis as Part of PharmD Program Author: Kristie Colon, UK College of Pharmacy When we launched our new core curriculum in the fall of 2016, we did so with the commitment to continue advancing the pharmacy profession. As the pharmacy practice model has moved from hometown apothecaries to pharmacists being a central point of care for many in the United States, we wanted to make sure our students were more than equipped to practice at the top of their license. As a result, we introduced Differential Diagnosis as a required 2-credit hour stand-alone course for our third-year professional students.

terprofessional communication, mutual understanding in terms of clinical decision-making abilities, and mutual respect regarding roles, responsibilities, and scopes of practice among health professions.

Our students tell us that differential diagnosis training in pharmacy school improved their critical thinking skills, developed their clinical judgment, and built their confidence in communicating with patients and medical professionals regarding patient care. With this type of advanced training, our student We are continuing to develop collaborative patient care proto- pharmacists can be better advocates for their patients and betcols with our medical colleagues and work toward building ter collaborators and communicators with other healthcare more sustainable models of pharmacy practice in the everprofessionals. Our hope is to see this translate into confident changing landscape of healthcare. To that end, we believe it is important to utilize a common language and be explicit about pharmacists and change-agents for advancing the profession what students are learning in terms of pharmacists’ clinical of pharmacy. decision-making abilities using diagnostic reasoning.

When pharmacists provide patient-centered care, they engage in the differential diagnosis process, whether they realize it or not. Differential diagnosis is the process of developing a list of potential causes of a patient’s presenting symptoms, prioritizing and risk stratifying the possibilities in terms of severity, probability, and ability to treat. Actively engaging in the differential thought process enables students to see and discuss how differential diagnosis is applied in pharmacy practice and how it differs from its application in medical practice, which is an important distinction. For example, pharmacists utilize differential diagnosis when patients present to the pharmacy counter with a symptomatic complaint and ask for a recommendation when evaluating whether a patient’s symptoms are due to a potential drug therapy problem, or when evaluating the appropriateness, safety, and efficacy of drug therapy for an established diagnosis.

Pharmacy Policy Issues Continued from p. 24 References 1.

“Pharmacist Conscience Clauses: Laws and Information.”

NCSL.org. National Conference of State Legislatures, May 2012.

2.

Berlinger, Nancy. “Conscience Clauses, Health Care Providers, and Parents,” in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 35-40.

3.

Morr-Fitz, Inc. v. Quinn, 976 N.E.2d 1160 (2012).

4.

Stormans, Inc. v. Wiesman, 136 S. Ct. 2433 (2016).

5.

Chow, Kat. “Walgreens Pharmacist Refuses to Provide Drug for Ariz. Woman with Unviable Pregnancy.” NPR.org. NPR, 25 June 2018.

Our instructors for the class work as an interprofessional team, which consists of physicians, physician assistants, and pharmacists. Each section of the class meets weekly for 110 minutes to review patient cases with the instructors and think through and discuss possible diagnoses.

6.

Walgreens. (2018, June 25). Statement on incident in Peoria, Ariz. [Press release].

7.

SB 160. Kentucky Legislature (2001). Retrieved from http:// www.lrc.ky.gov/recarch/01rs/SB160.htm

The course emphasizes the application of clinical reasoning through the process of differential diagnosis, a formalized and tangible process that enables instructors to add varying degrees of complexity and depth to the education students already receive, with the ultimate goal of preparing them to fully utilize the Pharmacists’ Patient Care Process.

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.

Being clear about the fact that our students are learning differential diagnosis allows the use of a common language across professions and fosters a necessary skill to address healthcare gaps in primary care. Using common language enhances in|25| www.KPHANET.org

|26| Kentucky Pharmacists Association | January/February 2020

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

The list reflects new memberships received from November 1, 2019— December 31, 2019 Emily Caporal, Louisville Leah Davis, Louisville Jonathan Dilard, Goodlettsville Chad Downing, Crestwood Gregory Gregoriades, Louisville Mark Meador, Scottsville H. Rice, Grand Rivers Darrell Sammons, South Shore Emma Sapp, Alexandria Laura Stinson, Lexington Jackie Sturgeon, Louisville

|27| www.KPHANET.org

Pharmacy Law Brief Intellectual Property

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

Question: As more and more attention is paid to medication prices we’ve been seeing much more emphasis on the availability of generics. At the same time, one need only sit in front of a television in the evening to be bombarded with advertisements for new “breakthrough” pharmaceuticals, some with a list of side effects as long as your arm. I know that patents play a major role in both stimulating research due to the exclusivity they provide for a period of time but they also have a finite duration, meaning that generic versions can follow on at some point. Can you provide some context for intellectual property such as patents plus any other forms with similar protection?

Response: There are four types or forms of intellectual property with patents being the most prominent or most frequently discussed. A patent is a grant made by the federal government to inventors conveying and securing to them the exclusive right to make, use and sell an invention for a period of twenty years from the application filing date. They are authorized by the U.S. Constitution, acknowledgement that the Founding Fathers recognized their importance in stimulating invention and other creative activity. Each country has its own patent system so such protection must be pursued and enforced on a country-by-country basis.

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

The second form of intellectual property is copyright.

This is defined as the exclusive ownership right granted by federal statute to authors and originators of certain literary or artistic works whereby they are vested for a period of the life of the author plus seventy years with the sole and exclusive privilege of multiplying copies of the work to publish and sell. Pharmacists typically encounter this form when dealing with patient educational materials. Perhaps you distribute literature from the American Diabetes Association or the Kidney Foundation. Although those are nonprofit organizations they do protect their written products (paper or web-based) with copyright.

It used to be that if the author did not put a copyright statement on the very first written product distributed he or she would lose the protection. That law has now changed to what is known as “presumption copyright” – you wrote it, you own in. Nonetheless, it is still a good idea to put others on notice by including a copyright statement such as “© by William Shakespeare, 2018.” You’ll probably see such a notification from the software manufacturer/author at the bottom of the first screen when you turn on your computer.

A unique pharmacy-related angle is that for many years the term of a patent was 17 years. However, pharmaceutical manufacturers lobbied Congress to extend that because it was taking 12-13 years to compile and submit all the data necessary for FDA to approve a product for marketing. This occurred at the same time the U.S. was bringing its patent term into conformity with that of Next is a trademark, defined as a word, name, symbol other countries. or device, or combination of these, used by a manufacThere are two types of patents – utility patents and de- turer or seller of goods to distinguish his products from sign patents. The first is the most popular and covers those of other manufacturers or sellers. Two symbols how the product functions or operates. Design patents may be encountered here: a superscript™ or protect the appearance of the product. Utility patents ®indicating that the trademark has been registered with take longer to process through the U.S. Patent and the government. Registration makes enforcing the Trademark Office and cost more. trademark much easier because it Continued on p. 29 |28| Kentucky Pharmacists Association | January/February 2020

Your Voice Matters!

Support KPPAC, KPhAvernment Affairs Fund Today!

Now, more than ever, increased political involvement of 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.

Please – consider making a donation today and, while you’re at it, think about making it a monthly investment in the future of f in Kentucky!

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. DONATE: www.kphanet.org or call 502.227.2303

nasally administered form of butorphanol. The product for nasal administration to treat migraine headaches creates certain legal presumptions. A trademark will be was developed by UK pharmacy professor Dr. Anwar viable and enforceable as long as the owner takes steps Hussein. Pursuant to university regulations, patent proto protect it from infringement. tection was secured by the University of Kentucky ReThe last form is the one less known than all the others -- search Foundation and the product was licensed to a trade secret. This is a plan or process, mechanism or major pharmaceutical manufacturer that successfully compound known only to its owner and those of his or brought it to market. her employees to whom it is necessary to confide it. Its legal basis is a contract or confidentiality agreement between the parties. A pharmacist has given us the very best example of this. John Pemberton, R.Ph., of Atlanta, GA, invented Coca-Cola® and rather than patenting the formula, which would have required disclosing it to the entire world, he chose to protect it by trade secret. A trade secret has no pre-determined lifespan; it is effective as long as the contact is in place and enforced. As a result, the Coca-Cola Company has enjoyed long-term success because it has been able to protect the formula for its main product.

Pharmacy Law Brief Continued from p. 28

A final historical note of local interest -- Stadol® is a |29| www.KPHANET.org

|30| Kentucky Pharmacists Association | January/February 2020

|31| www.KPHANET.org

KPhA BOARD OF DIRECTORS Chris Palutis, Lexington chris@candcrx.com

Chair

Don Kupper, Louisville donku.ulh@gmail.com

President

Joel Thornbury, Pikeville jthorn6@gmail.com

President-Elect

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Chris Harlow, Louisville cpharlow@gmail.com

Past President Representative

Directors

University of Kentucky Student Representative

Martika Martin, Somerset Vice Speaker of the House 12marmar@gmail.com Misty Stutz, Crestwood mstutz@sullivan.edu

Secretary

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Don Kupper, Louisville donku.ulh@gmail.com

President, KPhA

Kimberly Croley, Corbin kscroley@yahoo.com

KPhA Staff

Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org

Cassy Hobbs, Louisville cbeyerle01@gmail.com

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

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Mark Glasper Executive Director mglasper@kphanet.org

Chad Corum, Manchester pharmdky21@gmail.com Cathy Hanna, Lexington channa@apscnet.com

Richard Slone, Hindman richardkslone@msn.com

Chair

Sarah Lawrence, Louisville slawrence@sullivan.edu

Jessika Chilton, Beaver Dam jessikachilton@ymail.com

Jeff Mills, Louisville jeff.mills@nortonhealthcare.org

Bob Oakley, Louisville rsoakley21@gmail.com

Paul Easley, Louisville rpeasley@bellsouth.net

Matt Carrico, Louisville matt@boonevilledrugs.com

Anthony Seo, Louisville jseo0516@my.sullivan.edu

KPERF BOARD OF DIRECTORS

Kevin Lamping, Lexington kevin.lamping@twc.com

Angela Brunemann, Union Angbrunie@gmail.com

Scotty Reams, London scotty.reams@uky.edu

*At-Large Member to Executive Committee

Sullivan University Student Representative

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

|32| Kentucky Pharmacists Association | January/February 2020

â&#x20AC;&#x153;The professional associations have pluralistic functions. Many of these functions are obvious while some are in the process of development. Traditionally, the chief function of the pharmaceutical association has been to set rigorous standards for the quality of professional recruits, pharmaceutical education, and standards or professional practice.

- From The Kentucky Pharmacist, February 1970 Volume XXXIII, Number 2

Frequently Called and Contacted Kentucky Board of Pharmacy

Kentucky Regional Poison Center

State Office Building Annex, Ste. 300

(800) 222-1222

125 Holmes Street

American Pharmacists Association (APhA)

Frankfort, KY 40601

2215 Constitution Avenue NW

(502) 564-7910

Washington, DC 20037-2985

www.pharmacy.ky.gov

(800) 237-2742

Pharmacy Technician Certification Board (PTCB)

www.aphanet.org

2215 Constitution Avenue

National Community Pharmacists Association (NCPA)

Washington, DC 20037-2985

100 Daingerfield Road

(800) 363-8012

Alexandria, VA 22314

www.ptcb.org

(703) 683-8200 www.ncpanet.org

Kentucky Society of Health-System Pharmacists

National Association of Chain Drug Stores (NACDS) 1776 Wilson Blvd., Suite 200 Arlington, VA 22209 www.nacds.org 703-549-3001

info@ncpanet.org

P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 www.kshp.org info@kshp.org

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

|33| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601