The Kentucky Pharmacist November/December 2018

Vol. 13 No. 6 November/December 2018

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

INSIDE:  

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Legislative Conference Recap Complete CE requirement with 2018 Continuing Education Articles Happy Holidays from KPhA

TABLE OF CONTENTS FEATURES Legislative Conference Wrap Up |6| Thank you to our Legislative Conference Sponsors | 7 |

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

Editorial Office: ©Copyright 2018 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

Publisher: Mark Glasper 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.

On the Cover 

Pictured Top to Bottom Rep. Joni L. Jenkins, Rep. Mary Lou Marzian and Rep. Robert Goforth, PharmD address the Legislative Conference attendees.

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Sen. Max Wise, Rep. Chad McCoy and KPhA Board of Directors Member Matt Carrico participate in the Mock Advocacy session at the Legislative Conference.

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |8| Advocacy Matters |11| Continuing Pharmacy Education |12| Campus Corner |25| New KPhA Members | 29| Pharmacy Policy Issues | 30 | Pharmacy Law Brief | 31|

ADVERTISERS APSC|5| EPIC |4 & 29| PTCB |19| Pharmacists Mutual |32| Cardinal |33|

|2| Kentucky Pharmacists Association | November/December 2018

PRESIDENT’S PERSPECTIVE As we enter the fall season, I can’t resist the topic of immunizations. This year seems to have an even larger twist than what we have grown accustomed to each year. Yes, once again we have seen a delay in the release of flu vaccine by several manufacturers, but Hepatitis A has emerged as the headliner this year. Well, at least for us here in the great Commonwealth of Kentucky.

away from the Hep A offering after learning of the need for the second shot.

Hopefully, we do not let this deter our efforts to protect our patients. As with most obstacles, there is a way around this roadChris Palutis block. I was trying to figPresident, KPhA “One thing I enjoy about our profession is that as ure out a work around for pharmacists, in addition to being medication exa group I was going to immunize. I thought I perts, we are looked upon as problem solvers.” would offer a come-back day to administer the booster at a time to be determined six months down As pharmacists, we have the ability to play an imthe road. Just as I thought to pat myself on the portant role in disease prevention by advocating back for arriving at a solution, an even better idea and administering immunizations. Such activities occurred to me. We will give the flu and Hep A are consistent with the preventive aspects of pharmaceutical care and, in my opinion, should be part immunizations on the same day this year, and then of what every pharmacy offers to the patients they simply give the Hep A booster next year when we serve. However, if offering these services does not return to administer the next round of flu vaccinations. I just need to be sure it is less than 365 days fit into your practice setting, you can still contribas recommended by GlaxoSmithKline. This is the ute. You can still be a resource for your patients perfect solution in my opinion. It is within the dosthat you, better than anyone, know so well. In ing guidelines and does not require any additional many instances you know where they live, work, trips for the patient to the pharmacy or us to the pavacation, etc. Taking the opportunity to educate your patients on the purpose of immunizations can tient. go a long way to help protect them and the surOne thing I enjoy about our profession is that as rounding community. Even if you cannot provide pharmacists, in addition to being medication experts, we are looked upon as problem solvers. The the immunization, you can provide information above example may illustrate a simple solution to a needed for them to make an informed decision as well as direct them to a facility nearby to obtain the simple problem. But my bigger point is I could have simply allowed the group to go without the immunization.

Hep A vaccination but, instead, a solution was proSpecifically as it relates to Hepatitis A, what seems vided and in the end more people will be protected. to be the fly in the ointment is the need for the This is an example of why pharmacists are one of booster shot. According to GlaxoSmithKline, after the most trusted professionals. We are trusted and the initial dose, series completion of Havrix is rec- looked to for solutions because over the past several ommended to be administered from six to 12 decades it has become widely known that we go out months. I have heard several groups express the of our way to make sure our patients are safe and as desire to provide vaccination days for their employ- healthy as possible. Simply put, we don’t take the ees for the flu as well as Hep A. But then they back easy road, we take the RIGHT road. |3| www.KPHANET.org

|4| Kentucky Pharmacists Association | November/December 2018

|5| www.KPHANET.org

Legislative Conference Wrap Up The Legislative Conference was held November 2 at the Marriott Louisville Downtown. KPhA offered 6 CE hours, including a Legislative Update by KBOP Executive Director Larry Hadley followed by a USP 800 Update by PCCA Pharmacy Consultant Matt Martin and a presentation on KASPER Utilization for Pharmacists by KPhA Past President Trish Freeman. Interactive roundtable discussions with students and a mock advocacy session were held in the afternoon. The 2019 Legislative Agenda presented by Government Affairs Committee Vice Chair Matt Carrico was passed unanimously and without questions. The updated KPhA Medical Marijuana position statement also was passed unanimously. KPhA presented Friends of Pharmacy Awards to Sen. Stephen Meredith and Sen. Max Wise. The following legislators were also selected as recipients of the award, but were unable to attend and they will be presented the award at a later date Rep. Jim DuPlessis, Rep. Addia Wuchner, Sen. Ralph Alvarado. Special thank you to Magna Pharmaceuticals for sponsoring breakfast and APCI for the sponsoring the afternoon break.

e s on th photo e r o ! m Page View cebook a F A KPh

KPhA President Chris Palutis present Senator Max Wise with a Friend of Pharmacy award along with Mark Glasper, KPhA Executive Director.

KPhA members Matt Carrico and J Leon Claywell network during a break at the Legislative Conference.

KPhA President Chris Palutis present Senator Stephen Meredith with a Friend of Pharmacy award along with Mark Glasper, KPhA Executive Director.

Attendees complete the Networking Bingo.

The continuing education speakers included (L:R) Larry Hadley, Kentucky Board of Pharmacy Executive Director, Matt Martin, PCCA Pharmacy Consultant and former KPhA Past President, Trish Freeman.

|6| Kentucky Pharmacists Association | November/December 2018

|7| www.KPHANET.org

MY KPhA Rx You Spoke, We Listened and Acted, Repeat…

By Mark Glasper KPhA Executive Director/CEO We appreciate the feedback by KPhA members and nonmembers that we received one year ago in our initial Annual Survey of the profession. That input was forwarded to KPhA Board Members and Committees for follow up. I’m happy now to report on progress made and offer a glimpse of the future with the results just in from our second Annual Survey completed in October.

Accomplishments Speak Volumes You told us in both surveys that reimbursements for independents is your number one issue followed closely by DIR fees or PBM clawbacks. We responded by supporting SB 5, sponsored by Sen. Max Wise, which passed last session and will provide greater PBM transparency and accountability in Medicaid managed care. KPhA also supported HB 200 (Budget bill) which included $12 million in increased dispensing fees for 2018-2019 for Medicaid managed care. Our success in Kentucky has been noted nationally and serves as a model for future legislation in other states.

cists from across the Commonwealth to join students from the University of Kentucky College of Pharmacy and the Sullivan University College of Pharmacy as we celebrate pharmacy and advocate for the profession with our elected officials in Frankfort. Please watch for announcements on this special day.

I might add that your recognition of our advocacy efforts remains strong as results from both surveys registered in the 80% range. We will continue to deliver strong membership value as the voice of the profession in Kentucky legislative and regulatory affairs.

More Networking, More Jobs, More Benefits Please

On the national front, we have worked with the National Community Pharmacists Association on their fight against DIR fees/PBM clawbacks and with the American Pharmacists Association on their mission to achieve provider status for pharmacists everywhere. We have accompanied Kentucky pharmacists and students to Washington, D.C. to lobby legislators on these incredibly important isBoth last year and this year, you’ve requested addisues that affect pharmacists now and in the future. tional networking opportunities more than any othYou also can look forward to our first Pharmacy er product, service or benefit. President Chris PaDay at the Capitol in February. We want pharma- lutis addressed this need in his acceptance speech at |8| Kentucky Pharmacists Association | November/December 2018

the 2018 Annual Meeting and now KPhA will offer free networking events across Kentucky in 2019.

Be on the lookout for one of our free events coming to your area soon!

Strong Marks Demonstrate Satisfaction Overall, KPhA received favorable comments with 82% of respondents either very or somewhat satisfied with their membership and 85% indicated they You’ve indicated learning about new job opportuni- would recommend KPhA to a friend or colleague.

Even more impressive, 94% of respondents said ties is critical for your careers. Let me assure you nothing is more important to me than ensuring jobs KPhA added value to their professional development and a remarkable 98% read KPhA e-blasts are available for pharmacists and for our students graduating from college. That’s why we’re launch- and e-newsletters. ing a brand, new job board on the KPhA website.

KPhA staff take great pride in serving our memYou’ll want to check this new feature often to find bers. We’re so appreciative of your responses on the latest job opportunities available. the Annual Survey. But we won’t stop our mission Speaking of jobs, I’m delighted to announce KPhA of continuous improvement in order to serve you better. Please know you can always reach out to us has landed two, new contracts with the Kentucky Department of Health which will create two more with a question or for assistance. That’s why Your pharmacist positions at KPhA. Both positions will KPhA is Our KPhA, too. involve travel around Kentucky and will address the opioid crisis with educational programs and additional distribution of naloxone (Narcan). Hiring is expected to be completed by the end of 2018, so contact KPhA as soon as possible if these positions are of interest to you.

More than half of survey respondents also highlighted the need for health insurance coverage for themselves as well as their employees. KPhA is currently looking at companies which could offer group health care benefits. We’re also open to hearing from you about companies with which you currently have such plans, so we can talk with them about doing likewise for additional pharmacies.

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

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

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

Purchase from KPhA online: www.kphanet.org/store |9| www.KPHANET.org

At the holiday season our thoughts turn gratefully to those who have made our progress possible. It is in this spirit that we say...Thank you and best wishes for the holidays and Happy New Year!

In observance of the holidays KPhA headquarters will be closed on November 22, 23, December 24, 25, 31 and January 1. The offices will resume regular business hours on January 2.

Time to start holiday shopping with AmazonSmile!

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

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

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

|10| Kentucky Pharmacists Association | November/December 2018

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

Participate in grassroots advocacy efforts

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Get to know your legislators—they should know your name

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Donate to the Political Advocacy Council and the Government Affairs Fund

Donate online to the KPhA Government Affairs Fund Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC. Go to www.kphanet.org. |11| www.KPHANET.org

November CPE Article SLE and RPhs: Pharmacologic Review of Systemic Lupus Erythematosus By: Bhavyata Parag, PharmD, Emily Frederick, PharmD The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-18-020-H01-P &T 1.0 Contact Hours (0.10 CEU) Expires 11/14/21

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.

Discuss epidemiology and general characteristics of systemic lupus erythematous (SLE).

2.

Summarize the role and complications of corticosteroids and non-steroidal anti-inflammatory agents (NSAIDs) in SLE.

3.

Review considerations related to immunosuppressive agents in SLE.

4.

State pharmacologic considerations related to pregnancy and breastfeeding.

Systemic lupus erythematous (SLE) is an autoimmune disorder which affects over one million Americans. It most commonly afflicts young African American, Caucasian, and Hispanic females. Disease presentation and course varies widely, patients with SLE may have manifestations in the kidneys, brain, heart, skin, and vascular system. The most common complication of SLE is lupus nephritis. Up to 60% of SLE patients are affected by lupus nephritis (LN), most commonly within the first ten years of disease onset 1,2. As it is an autoimmune condition, SLE patients commonly experience fluctuating states of flares and remission. Flares can result in high physical stress, eventually resulting in organ damage. Patients with SLE are therefore prone to complications with LN, infections, or cardiovascular disease. With the advent of the current therapies SLE-associated morbidity and mortality has decreased, in recent years. Survival at ten years, after diagnosis, is approximately 92%3. Disease flares are responsible for a large degree of the disease burden in these patients. Goals of therapy in SLE are, therefore, principally aimed at remission of flares and prevention of relapse. Treatment of SLE and LN is complex and has multiple drug specific treatment considerations. This review will focus on the pharmacologic considerations, with a brief inclusion of intravenous immunoglobulin G (IVIG) and plasmapheresis, related to general management of SLE and LN. Pharmacologic considerations in pregnancy and breastfeeding as well as anticoagulant considerations related to disease-associated antiphospholipid antibody syndrome will be also briefly be reviewed [Figure 1].

symptomatic treatment of acute flares. Concern with longterm steroid use is primarily relate to adverse effects (ADE) such as osteoporosis, weight gain, aggressive behavior, anxiety, cataracts, hyperglycemia, and many others. About 90% of patients using CS for greater than 60 days will experience at least one corticosteroid related ADE, even at doses of or equivalent to less than 7.5 mg/day prednisone.4. As patients with SLE often require chronic CS use, they are susceptible to the ADE of CS 3.

In general, patients with SLE often take CS in doses ranging from less than 7.5mg prednisolone daily to 0.5 mg/kg/day prednisolone depending on severity of SLE flares. Caution should be exercised when increasing CS doses. Increasing prednisolone by even 1 mg/day can result in up to 2.8% increase in organ damage.5 Considerations for treatment with chronic CS include mitigating ADEs and appropriately discontinuing therapy. As mentioned, one of the ADEs associated with chronic steroid use is osteopenia and osteoporosis.

Osteoporosis results from decreased absorption and increased excretion of calcium leading to prevention of vitamin D absorption as well6. Use of calcium and vitamin D with CS doses greater than 5 mg/day may help decrease the risk of bone complications. If patients develop hyperglycemia, another notable side effect, current recommendations are to treat similarly to type 2 diabetes mellitus patients with the goal of maintaining a hemoglobin A1c of less than 7.0%. Additionally, using doses of less than 7.5 mg/day of prednisolone may decrease the risk of osteoporosis and cataracts.3

Anti-inflammatory Agents

Patients may discontinue CS once flare remission is sustained for long periods or if they are unable to tolerate CS. Despite the significant ADEs, caution must still be used when disconThe mainstay of therapy for SLE is glucocorticoids or cortico- tinuing CS. As CS suppress the hypothalamic pituitary adrensteroids (CS). CS have anti-inflammatory and immunosupal axis (HPA), rapid discontinuation of CS can result in a pressive properties which provide benefit in prevention and secondary adrenal insufficiency, deprivation syndrome, and Corticosteroids:

|12| Kentucky Pharmacists Association | November/December 2018

Figure 1. Medication Therapy in SLE

relapse of underlying disease. Common symptoms of CS withdrawal are nausea, fever, generalized weakness, and anorexia.7 In patients receiving CS treatment for less than 14 days, risk of withdrawal is limited; Practitioners can consider discontinuing therapy without a taper. Patients with LN and SLE, however, are typically receiving CS for longer than 14 days and therefore a taper is warranted to avoid withdrawal symptoms and allow recovery of the HPA axis. One of the most commonly recommended regimens for decreasing CS doses is to taper doses to 5 mg/day of prednisone as that is considered the physiologic dose of CS. After decreasing to prednisone 5 mg/day, patients may either have doses tapered over two to four weeks or continue prednisone 5 mg/day for 4 weeks. Slowly decreasing CS doses over weeks may best allow re-establishment of the HPA axis.8,4 Non-steroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs are primarily used for symptomatic management of myalgias, chest pain, and fevers3. Both Cyclooxygenase (COX)-1 and COX-2 inhibitors have been used in the setting

of SLE. NSAIDs such as diclofenac, nabumetone, naproxen and ibuprofen, inhibit COX-1 and COX-2. These nonselective COX inhibitors may increase risk of renal and gastrointestinal (GI) ADE of NSAIDs and are therefore not recommended for long-term use. In addition, patients with SLE have been shown to have an increased risk of aseptic meningitis with exposure to NSAIDs. It has most often reported with the use of ibuprofen. In patients who experience aseptic meningitis, there does not appear to be cross-reactivity with other NSAIDs. However, these patients are at risk for experiencing relapse in aseptic meningitis if re-exposed to the same NSAID which triggered the initial meningitis episode.9 For patients who are able to tolerate and experience symptom relief from NSAIDs, use of a selective COX-2 inhibitor, celecoxib, may be preferred to avoid long-term GI toxicity.

Caution may need to be used in patients with sulfonamide allergies as celecoxib contains a sulfa moiety.10An observational study and literature review of the use of celecoxib in SLE patients, however, did not find an increased risk of aller|13| www.KPHANET.org

gic reactions in SLE patients.11 While COX-2 inhibitors decrease risk of GI bleed, they may increase the risk of cardiovascular events. Risks and benefits of therapy must be weighed in each individual patient. While they decrease GI ADEs, and potentially increase cardiovascular ADEs, the risk for renal toxicity with COX-2 inhibitors is similar to nonselective COX inhibitors. Renal toxicity of NSAIDs manifests by way of causing a relative vasoconstriction of the afferent arteriole. In the setting of lupus nephritis, NSAIDs have been shown to increase risk of acute kidney injury (AKI). In contrast, SLE patients with nephrotic syndrome may benefit still from NSAID use as there is a decrease in glomerular hypertension resulting in long-term renal protection.10,11 NSAID use in this setting should therefore be done cautiously.

MTX or 1 mg daily decreased hematologic ADEs and reduced GI intolerance of MTX. 13,15 Immune Suppressive Therapies Azathioprine:

Azathioprine (AZA) and mycophenolate mofetil (MMF) are both anti-metabolite agents used in the management of moderate SLE. Both agents are initiated with CS and allow patients to be treated with lower total daily doses of CS. CSsparing effects are generally appreciated within six months of therapy.16 Additionally, both MMF and AZA have been shown to decrease flares of renal and extra-renal lupus. AZA is typically used in doses of 2-2.5 mg/kg/day. Doses of 34mg/kg/day may be used in patients requiring higher doses Overall, use of NSAIDs in the setting of SLE or LN is patient for flare prevention. Higher doses were not associated with specific and requires consideration of all patient issues, inhigher infection rates but are also not needed in every patient. cluding medication allergies.

AZA is metabolized to mercaptopurine by thiopurine Smethyltransferase (TMPT) which is then degraded by xanDisease Modifying Agents (DMARDs): thine oxidase.3 Caution must be used when adding allopurinol Hydroxychloroquine: to patient regimens in the setting of azathioprine use, as allopurinol’s action on xanthine oxidase subsequently inhibits the Hydroxychloroquine (HCQ) is the mainstay of therapy for breakdown of mercaptopurine. With the addition of allopurimild SLE flares and in patients with LN. The role of HCQ in nol, AZA doses should be decreased by 60-75% of the original SLE is to decrease flare rates, resolve cutaneous rashes, and dose.17 Patients with low TPMT levels may also have elevated decrease total daily doses of CS. In LN the primary benefit of AZA levels. In both instances, patients have increased risk of HCQ is decreased accumulation of renal damage. In states of leukopenia and overall bone marrow suppression1.7,3 AZA is flare, HCQ is typically given with CS as these agents take used more commonly in SLE and can also be used as maintethree to six months for onset of efficacy. Additionally, the CS- nance treatment of LN.18 sparing effect is delayed by about six months. Chronic use of HCQ can result in tachyphylaxis around two years; however, Mycophenolate Mofetil: most patients continue to be treated with it for an average of six to seven years3. Higher doses are associated with worsen- MMF is used less often than AZA for the treatment of SLE. The role for MMF over AZA is most prevalent in the inducing retinopathy. Consequently, dose reduction of HCQ may 3 2 resolve or decrease ocular issues. If HCQ is poorly tolerated, tion of LN. MMF at doses of 2-3 g/day is sufficient for SLE. chloroquine can be substituted in place of HCQ for treatment Use of MMF at 3 g/day for six months is recommended for induction of LN. Doses may be lower during the maintenance of SLE; however, chloroquine is also associated with ADEs .18 such as seizures, renal toxicity, and retinopathy therefore use period The most commonly reported ADE with MMF is 3 related to the GI tract, especially diarrhea. If problematic, should be carefully considered. patients may be switched to mycophenolic acid which has an Methotrexate: enteric coated formulation. Conversion of MMF to mycophenolic acid is 360mg of MMF to 500 mg mycophenolic acid.3 Methotrexate (MTX) can be used with, or in place of, CS or Alternatively, AZA and MMF can also be interchanged if HCQ for the treatment of mild or moderate SLE. The recom- patients have difficulty tolerating or experience treatment failmended dose in the setting of SLE is less than 25 mg/week.3 ure on either agent.16 Occasionally patients are treated with HCQ and MTX in an effort to maximize CS-sparing effects. Patients with renal im- Tacrolimus and Cyclosporine: pairment should be cautiously prescribed MTX as it accumulates in this setting. In addition, with concomitant use of peni- Tacrolimus (5-FK) and cyclosporine (CSA) are similarly used in moderate SLE to decrease lupus flares. Recommended doscillins, including amoxicillin, MTX excretion is decreased.12 In both the setting of renal impairment or combined use with es of cyclosporine are less than 2.5 mg/kg/day as doses greater than that result in higher rates of hypertension, nausea, penicillin, risk of ADEs with methotrexate increases. diarrhea, and renal impairment.3 In the setting of SLE, moniToxicities associated with MTX are commonly hematologic, toring of tacrolimus levels has not been beneficial in order to hepatic, and GI. MTX is a dihydrofolate reductase inhibitor avoid ADEs. Tacrolimus is used less commonly than most leading to decreased folic acid stores.12 While there is no rec- other agents in SLE patients. In the small case reports pubommendation for folic acid supplementation with MTX in the lished, tacrolimus was discontinued by ~29% of SLE patients setting of SLE or LN, many experts recommend folic acid due to ADEs.19 supplementation for patients with rheumatoid arthritis (RA) and psoriasis to decrease MTX ADEs.13,14,15 Patients with RA Immune Modulation (IVIG and plasmapheresis) and psoriasis typically receive weekly MTX treatment similar IVIG and plasmapheresis have limited evidence for use in to patients with SLE. The use of 5 mg folic acid weekly after SLE. These therapies are used for the treatment of antiphos|14| Kentucky Pharmacists Association | November/December 2018

Table 1. SLE Pharmacologic Considerations in Pregnancy and Breastfeeding

Pregnancy

Breastfeeding

Duration of recommendation

Teratogenic risk

Corticosteroids

Unknown

Unknown

N/A

Variable – cleft lip or palate26

Hydroxychloroquine

Category B

Safe

---

---

Contraindicated

Avoid methotrexate for 3 months before pregnancy (males and females)27

Physical malformations, pulmonary defects, congenital heart defects (septal defects)3,28

Methotrexate

Category X

NSAIDs

Category C

Safe

Avoid especially during 3rd trimester of pregnancy

Azathioprine

Category D

Avoid (recommend discontinuing breastfeeding)

During pregnancy

Mycophenolate mofetil

Category D

Cyclosporine

Category C

Tacrolimus

Category C (use at lowest dose possible)

Avoid (recommend discontinuing breastfeeding)

Avoid (recommend discontinuing breastfeeding) Avoid (recommend discontinuing breastfeeding)

pholipid syndrome and refractory cytopenias. Regimens for IVIG vary but range from 400-500 mg/kg/day in schedules of five consecutive days or monthly.3 IVIG use has been found to decrease required dosing of CS and NSAIDs. While IVIG has low risk of ADE and limited drug interactions, vaccine interactions must be considered. Efficacy of measles, mumps, and rubella (MMR) and varicella, may be decreased by IVIG treatment. These vaccines should only be administered more than two weeks before or eight months after treatment with IVIG.20 If either MMR or varicella are given within one to two weeks prior to IVIG treatment, patients should be re-vaccinated eight months after IVIG treatment. Other active vaccines, such as zoster and influenza, may be given at any time as they are not affected by blood product transfusions.21

During pregnancy, use contraceptive for 4 weeks before and 6 weeks after mycophenolate therapy

Constriction of ductus arteriosus, renal injury, cryptorchism, oligohydramnios29 Skeletal and visceral malformations17

Facial malformations, cleft lip or palate, malformations of limbs, heart, kidney, esophagus30

N/A

N/A

N/A

N/A

exchange as well. Medications most easily removed by plasmapheresis have low volume of distribution (< 0.2 L/kg) and high plasma protein binding (>80%). Of the medications used to treat SLE, methotrexate and steroids have evidence of removal from plasma-exchange. These agents should be dosed after plasmapheresis is completed to avoid removal by plasma-exchange. 22 Anticoagulation

Patients with SLE can develop antiphospholipid syndrome (APS). It is a thrombophilic process that places patients at higher risk for thrombotic events. In the setting of arterial thrombi, treatment options are decided based on origin of thrombosis, cerebral (stroke) or non-cerebral. For patients with cardioembolic strokes, warfarin is recommended. TreatPlasmapheresis, too, is used for the treatment of refractory cytopenias. There is limited evidence for use of plasmaphere- ment with warfarin to an INR goal of 2.0-3.0 is recommended in the setting of unprovoked thromboembolism. On the other sis in SLE and has most often been studied in pregnant SLE 3 patients. As plasmapheresis is a method of removing antibod- hand, treatment with aspirin and clopidogrel may be considies and plasma, medications may be removed through plasma|15| www.KPHANET.org

ered in the case of non-cerebral arterial thrombus with cardiac origin.23 While warfarin has traditionally been the treatment of choice for APS with cardioembolic thrombi, multiple trials are underway to evaluate the role of target specific oral anticoagulants (TSOACs) in APS. Case reports have found variability in treatment success with rivaroxaban, apixaban, and dabigatran for APS. The majority of patients being treated with these agents did not experience recurrent thrombosis; however, a small percentage of patients did experience either thrombosis or bleeding events.24 Until further evidence is published, warfarin remains the treatment of choice for APS. 23

6.

Gupta P, Vijayalakshmi B. Corticosteroid physiology and principles of therapy.

Symposium of steroid therapy. Indian J Pediatr. 2008;75: 1039-44.

7.

Margolin L, Cope DK, Bakst-Sisser R, Greenspan J. The steroids withdrawal syndrome: a review of the implications, etiology, and treatments. J Pain Symptom Manage. 2007;33(2): 224-8.

8.

Alves C, Robazzi TCV, Mendonca M. Withdrawal from glucocorticosteroid therapy: clinical practice recommendations. J Pediatri (Rio J). 2008;84(3):192-202.

9.

Otensen M, Villiger PM. Nonsteroidal anti-inflammatory drugs in systemic lupus erythematosus. Lupus. 2000;9(8):566-572.

10.

Sweet R, Mahdavian S, Singh A, Ghazvini P, McKinnon T, Jones D. An update on the management of systemic lupus erythematosus. Journal of hematologic malignancies 2013;3(2):16-23.

11.

Lander SA, Wallace DJ, Weisman MH. Celecoxib for systemic lupus erythematosus: case series and literature review of the use of NSAIDs in SLE. Lupus.

2002(11):340-47.

12.

Bagatini F, Blatt CR, Maliska G, et al. Potential drug interactions in patients with rheumatoid arthritis. Rev Bras Reumatol. 2011;51(1):20-39.

13.

Whittle SL, Hughes RA. Folate supplementation and methotrexate treatment in rheumatoid arthritis: a review. Rheumatology. 2004; 43(3):267-271.

14.

Al-dabagh A, Davis SA, Kinney MA, Huang K, Feldman SR. The effect of folate supplementation on methotrexate efficacy and toxicity in psoriasis patients and folic acid use by dermatologists in the USA. Am J clin Dermatol. 2013; 14(3): 155161.

15.

Strober B, Menon K. Folate supplementation during methotrexate therapy for patients with psoriasis. J Am Acad Dermatol. 2005; 53(4):652-659.

16.

Maimouni HA, Gladman DD, Ibanez D, Urowitz MB. Switching treatment between mycophenolate mofetil and azathioprine in lupus patients: indications and outcomes. Arthritis Care Res. 2014;66(12):1905-09.

17.

Azathioprine [package insert]. Hunt Valley, MD: Prometheus laboratories Inc; 2011.

18.

Hahn BH, McMahon MA, Wilkinson A, et al. American college of rheumatology guidelines for screening, treatment, and management for lupus nephritis. Arthritis Care Res. 2012;64(6):797-808.

19.

Suzuki K, Saito K, Tsujimura S, et al. Tacrolimus, a calcineurin inhibitor, overcomes treatment unresponsiveness mediated by P-glycoprotein on lymphocytes in refractory rheumatoid arthritis. J Rheumatol. 2010:37(3):512-20.

20.

Centers for disease control and prevention (CDC). General recommendations for vaccination and immunoprophylaxis. CDC. Updated June 13, 2017. Retrieved from: https://wwwnc.cdc.gov/travel/yellowbook/2018/the-pre-travelconsultation/general-recommendations-for-vaccination-immunoprophylaxis

21.

Arvas A. Vaccinations in patients with immunosuppression. Turk Pediatri Ars. 2014:49(3):181-185.

22.

Ibrahim RB, Liu C, Cronin SM, et al. Drug removal by plasmapheresis: an evidence-based review. Pharmacotherapy. 2007;27(11):1529-49.

23.

Giannakopoulos B, Krillis SA. How to treat the antiphospholipid syndrome.

Blood. 2009;114(10):2020-30.

24.

White C, Thomason AR, Boyd K, et al. Role of novel oral anticoagulants in the treatment of antiphospholipid syndrome. Hosp Pharm. 2016;51(9):759-67.

25.

Lateel A, Michelle P. Managing lupus during pregnancy. Best Prac Res Clin Rheumatol. 2013 Jun;27(3): 1-20.

Pregnancy Considerations As SLE often effects females and is diagnosed most commonly between age 20-30, pregnancy recommendations of agents should be considered. Table 1 summarizes pharmacologic and therapy considerations for SLE during pregnancy. In general, pregnant patients should limit use of CS in order to avoid gestational complications such as diabetes and hypertension.

NSAIDs, too, should have limited used in pregnancy as there is risk of fetal renal impairment as early as 20 weeks of gestation (2nd trimester).25 AZA and HCQ are the preferred agents for treatment during pregnancy. AZA should be limited to 2 mg/kg/day as doses over 2 mg/kg/day have been shown to increase fetal hematologic issues and increase fetal immune suppression. HCQ may be continued at conventional doses. Continuation of HCQ during pregnancy resulted in decreased flares while discontinuation of HCQ may actually result in increased risk of SLE flare.25 Conclusions: SLE is an autoimmune disease which primarily effects young females. As it is an autoimmune disease, treatment typically is aimed at decreasing flares. Flares may be decreased with the use of anti-inflammatory agents such as corticosteroids. Due to high risk of complications with CS, other pharmacologic treatments have been evaluated for steroid-sparing properties.

These agents are primarily immunosuppressive agents such as HCQ, MTX, MMF, AZA, cyclosporine, and tacrolimus.

These agents have unique drug interactions, ADEs, and administration considerations, which pharmacists should consider when providing care for patients with SLE. References: 1.

Gladman DD, Urowitz MB, Esdaile JM, et al. Guidelines for referral and manage- 26. ment of systemic lupus erythematosus in adults. Arthritis Rheum. 1999;42(9):178596.

2.

Wilhelmus S, Bajema IM, Bertsias GK, et al. Lupus nephritis management guidelines compared. Nephrol Dial Trans. 2016;31:904-13.

3.

4.

5.

27.

Methotrexate [package insert]. Huntsville, AL: DAVA Pharmaceuticals, Inc; 2016.

28.

Dawson AL, Colarusso TR, Reefhuis J, Arena JF. Maternal exposure to methotrexate and birth defects: a population-based study. Am J Med Genet A. 2015;0(9):2212-16.

C Gordon, Amissah-Arthur MB, Gyed M, et al.The British society for rheumatology guideline for the management of systemic lupus erythematosus in adults. Rheumatology. 2018;57:e1-e45.

29.

Ericson-Neilsen W, Kaye AD. Steroids: Pharmacology, Complications, and practice delivery issues. Ochsner J. 2014;14(2):203-207.

Al Sawah S, Zhang X, Zhu B, et al. Effects of corticosteroid use by dose on the risk of developing organ damage over time in systemic lupus erythematosus â&#x20AC;&#x201C; the Hopkins Lupus Cohort. Lupus Sci Med. 2015;2(1)1-9.

Kemp MW, Newnham JP, Challis JG, Jobe AH, Stock SJ. The clinical use of corticosteroids in pregnancy. Hum Reprod Update. 2016;22(2):240-59.

30.

Bloor M, Paech M. Nonsteroidial anti-inflammatory drugs during pregnancy and the initiation of lactation. Anesthe Analg. 2013;116(5)1063-75.

Mycophenolate mofetil [package insert]. Nutley, NJ: Roche Laboratories, Inc; 1998.

|16| Kentucky Pharmacists Association | November/December 2018

November 2018 — SLE and RPhs: Pharmacologic Review of Systemic Lupus Erythematosus

1. The most common complication for SLE affects which organ system?

C. Renal

6. Methotrexate is a folate reductase inhibitor which may cause hematologic adverse effects at high levels in states of renal dysfunction. In addition to renal dysfunction, other medications may decrease excretion of methotrexate.

Which of the following medications would also increase levels of methotrexate?

D. Central Nervous

A. Penicillin

A. Pulmonary B. Cardiovascular

2. Corticosteroids are essential in decreasing inflammation B. Febuxostat in patients with SLE and are known to increase risk of osteC. Allopurinol oporosis. Patients taking prednisone doses at or above_______ should consider taking calcium and vitamin D. Azathioprine D to support bone health.

7. Mycophenolic acid has less GI side effects due to what difference in tablet formulation from mycophenolate moA. 2.5mg PO daily fetil?

B. 5mg PO daily A. Extended – release C. 7.5mg PO dail B. Sustained – release D. 10mg PO daily C. Chewable 3. Long term corticosteroid use, beyond 14 days, has the D. Enteric – coated potential to suppress which endocrine function?

8. IVIG has rare drug interactions however it may affect the efficacy of certain liver vaccinations. Which of the followA. Hypothalamic Pituitary Adrenal Axis ing live vaccines has decreased efficacy when given within B. Parathyroid pituitary Axis eight months of IVIG therapy?

C. Pituitary Adrenal Axis

A. Zoster vaccine

D. Adrenal Pituitary Axis

B. Varicella vaccine

4. NSAIDs are primarily used for symptom management in the treatment of SLE. Which of the following NSAIDs is a known COX-2 inhibitor and may have lower GI side effects?

C. Influenza vaccine

A. Nabumetone B. Naproxen

D. Hepatitis B vaccine 9. In SLE patients who have experienced an arterial thrombus, what is the INR goal with warfarin therapy?

A. 2.0 – 3.0 B. 2.0 - 2.5

C. Celecoxib

C. 2.0 – 3.5

D. Ibuprofen

D. 3.0 – 3.5

5. The corticosteroid sparing effect of hydroxychloroquine is usually seen within _____________ of initiation of therapy.

B. 4 months

10. Many SLE patients are younger females and therefore require SLE treatment throughout pregnancy and breastfeeding to avoid SLE flares or harm to the fetus. Which of the following medications may be cautiously continued during pregnancy but discontinued during breastfeeding?

C. 2 years

A. Tacrolimus and hydroxychloroquine

D. 6 months

B. Mycophenolate mofetil and cyclosporine

A. 1 year

CPE Quiz Online

C. Mycophenolate mofetil and azathioprine D. Tacrolimus and cyclosporine

www.surveymonkey.com/r/CEQuizNov18 |17| www.KPHANET.org

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

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

Expiration Date: 11/14/2021 Successful Completion: Score of 80% will result in 1.0 contact hour or .10 CEUs. TECHNICIANS ANSWER SHEET November 2018 — SLE and RPhs: Pharmacologic Review of Systemic Lupus Erythematosus (1.0 contact hour) Universal Activity # 0143-0000-18-020-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 C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

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

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

PHARMACISTS ANSWER SHEET November 2018 — SLE and RPhs: Pharmacologic Review of Systemic Lupus Erythematosus (1.0 contact hour) Universal Activity # 0143-0000-18-020-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 C D 8. A B C D

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

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

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

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

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

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

|18| Kentucky Pharmacists Association | November/December 2018

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



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



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



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



Include 3 to 5 objectives using SMART and measurable verbs.



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



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

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

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

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

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

|19| www.KPHANET.org

December CPE Article Intellectual Property Issues Affecting Patient Care By: Joseph L. Fink III, B.S.Pharm., J.D., D.Sc. (Hon.), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.

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

Universal Activity #0143-0000-18-021-H03-P &T 1.0 Contact Hour (0.10 CEU) Expires 11/14/2021

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

Goal: To educate pharmacists and pharmacy technicians about the laws related to intellectual property and their interplay with pharmacy practice, thereby enhancing the readers’ understanding of the legal environment of professional practice.

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

Understand the four types or forms of intellectual property recognized by law in the U.S.;

2.

Describe some changes that have occurred related to patent coverage in recent years;

3.

Describe some changes that have occurred in copyright coverage in recent years;

4.

Describe how a trade secret provision in an employment contract could affect pharmacy personnel.

Introduction Four forms of intellectual property (IP) are recognized under the law of the United States and each has the potential to impact the practice of pharmacy and the resultant care of patients. Following a discussion or overview of each type in turn, potential impacts on professional practice will be identified. The expectation is that by being knowledgeable in this area the pharmacist will be able to address IP-related issues as they arise in practice so the impact on patient care is minimized or eliminated. This will also assist the pharmacy staff member to have a more complete understanding of the legal environment for professional practice.

more generally known than the fourth, although a controversy in Kentucky a few years ago cast the spotlight on trade secrets in a commercial context. Each version will be addressed in turn.

Patent 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. Patents were authorized by the U.S. Constitution from its earliest days to provide an incentive for creativity.

For many years the duration of a patent was seventeen years from the date of invention. But that duration was extended three years by the General Agreement on Tariffs and Trade of At the outset, it is noteworthy that on October 2, 2018, the 1995. It is also noteworthy that the starting time for exclusiviFDA Commissioner, Scott Gottlieb, issued a news release about some steps the agency would be taking “to further deter ty was changed by that international treaty from the date of ‘gaming’ of the generic drug approval process.” He described invention to the application filing date. this as a commitment to “increase competition in the market for prescription drugs and to help facilitate the entry of lower- During an earlier period, pharmaceutical manufacturers had cost alternatives to improve patient access to affordable medi- been expressing concern about the patent exclusivity period for their innovative medications being eroded by the time it cations.” One area of focus was to shut down practice by brand name pharmaceutical manufacturers that delay approv- took FDA to conduct its pre-marketing approval review. This led to enactment of the Drug Price Competition and Patent al of generics once the initial patent Term Restoration Act during 1984. That statute, known colhas expired. loquially as the Hatch-Waxman Act, has had a tremendous The four forms of intellectual property are patent, copyright, impact for pharmacists and patients by facilitating approval of generic versions of medications. That change to ease markettrademark and trade secret. It is likely that the first three are |20| Kentucky Pharmacists Association | November/December 2018

ing of generic versions of medications was a trade-off during Congress’ consideration of the legislation in exchange for a lengthened patent life term for innovator medications.

the bundle of rights associated with copyright ownership automatically come into existence when the item is created, i.e. put into fixed form.

There are three requirements an innovation must exhibit to have a patent granted: novelty, utility, and nonobviousness.

Novelty means it must be newly developed and utility means it must be useful. The last criterion means that a person who works in that field or specialty would not expect the discovery, i.e., is it distinguishable from prior inventions.

At one time if an item was first published without including the copyright symbol (©) the author lost forever the ability to assert exclusivity. That indication is no longer required in order to assert copyright ownership. Nonetheless, use of the symbol is still recommended in order to communicate to others that copyright is being asserted. Consequently, one will still encounter that symbol when opening the cover of a book or turning on a commercial computer software program.

The potential impact of patents on patient care are numerous.

For example, under the former approach which started the “patent clock” at date of invention there was a rush to the U.S. Patent and Trademark Office to make a filing based on entries in lab notebooks, etc. Under the contemporary approach of using the application filing date to “start the clock”, manufacturers who have, say, a non-sustained release version of a pharmaceutical with X years remaining on that patent will delay filing a patent application for the extended release version to gain the advantage of an exclusivity period that runs farther out into the future.

Although there is no requirement to file the written product with the Copyright Office to secure registration in order for the copyright to be enforceable there are a number of good reasons to do so. Registration of the item creates a legal public record of the creation and is a necessary prerequisite to filing suit in federal court against an alleged infringer.

Impact on patient care with copyrights usually relates to duplication and distribution of patient educational materials. Voluntary health organizations like the American Diabetes AssoAnother impact of patents is derived from the incentive it cre- ciation, American Heart Association and the Kidney Foundaates for invention of new medicaments. If a firm is successful tion allocate a generous portion of their resources to creating in bringing a new product to market it can enjoy the exclusivi- educational materials for patients. These organizations will ty for quite a few years, thereby reaping a financial return on usually gladly provide supplies to pharmacists for distribution its research and development investment. to patients. Those pamphlets and brochures are usually copyrighted by the organization and they put great effort into them having a good appearance to create a positive impression for Copyright the organization. Hence, if a pharmacist were to duplicate a, say, fifth generation photocopy of the brochure the sponsoring Copyrights may be familiar because of their ubiquitousness.

Printed matter, be it a magazine or journal, a book or comput- organization may not be too pleased with that. er software can be protected this way. Copyright is defined as Trademark the exclusive ownership right granted by statute to authors and originators of certain literary or artistic works whereby they are vested for a period of seventy years with the sole and Products bearing notation of a trademark being asserted are exclusive right to multiply copies of the work to publish or encountered very frequently. A trademark is a word, name, sell. symbol or device, or combination of these, used by a manufacturer or seller of goods to distinguish his products from The law of copyright is rooted in the U.S. Constitution which those of other manufacturers or sellers. Thus, the role of a authorizes Congress to “promote the progress of science and trademark is to indicate the source of a product, not the produseful arts, by securing for limited times to authors…the exuct itself. clusive right to their…writings.” [U.S. Constitution, art. 1, §8, cl.8] Over the history of our country the period of exclusivity Unlike copyrights and patents, trademarks do not exist by has been increased from 14 years to the current standard of 70 virtue of a specific provision in the U.S. Constitution. Authoryears. What if the product has coauthors? In that case the ex- ity for federal legislative action related to trademarks derives clusivity expires on the passing of the last surviving coauthor. from the Commerce Clause of the Constitution. [art. 1, §8, cl.

3] The federal statute that governs this area is known as the What can be protected by copyright? Original works of auLanham Act [15 U.S.C. §§1051-1127] and there are also statthorship fixed in a tangible medium of expression, e.g., writutes addressing trademark issues at the state level. ings, software programs and illustrations. In the case of written products, copyright protects the words used and the order A trademark can be: in which they are assembled. It provides no protection to the Words Coca-Cola idea or concept being communicated; it protects the expresColors Pink housing insulation sion of ideas rather than the ideas themselves.

Sounds Harley-Davidson exhaust resonation Slogans “Have you driven a Ford lately?”

At one time a copyright was secured by filing the material with the U.S. Copyright Office. That is no longer the apTrademark rights are created by use of the trademark. There is proach; rather, the U.S. follows what is known as no requirement that it be submitted to or registered with a “presumptive copyright.” Under that contemporary approach government agency. Unlike a copyright or patent, a trademark |21| www.KPHANET.org

has no pre-established finite duration. The trademark has indefinite duration so long as it is used in commerce, is adequately policed and protected, and, if registered, is subject to renewal on a timely basis. Think of the critical decision of the pharmacist John Pemberton, inventor of Coca-Cola, to use trademark to protect the name of his product and indicate its source. Over 150 years later those two words are recognized world-wide and have infinite duration so long as protected.

The same is true of the soft drink Dr Pepper invented by pharmacist Charles Alderton in Waco, Texas, during the 1880’s.

(b) Is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.”

The last type of intellectual property is the least well known.

A trade secret is a plan or process, mechanism or compound known only to its owner and those of his or her employees to whom it is necessary to confide it. It is generally derived from a contractual relationship, not from the U.S. Constitution or from a federal statute. There is the Uniform Trade Secrets Act that was approved by the National Conference of Commissioners on Uniform State Laws in 1979 and amended in 1985. This has been adopted in 46 jurisdictions.

Having its authority rooted in the law of contracts means that one should closely review the wording of employment contracts to ascertain whether the employer is seeking agreement to some terms in the contract related to trade secrets of the company.

A trade secret is defined as “information, including a formula, pattern, compilation, program, data, device, method, technique, or process that:

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

The U.S. Supreme Court has stated that “the encouragement of invention” is the policy that undergirds the concept of trade secret law.

A prominent example provides further documentation that pharmacist Pemberton received extremely good legal advice.

Not only did he trademark the words Coca-Cola, but he protected the formula for that hugely successful product as a Trademark assertion by the producer of the product is indicat- trade secret, disclosing it only to employees who agreed to ed by using superscript™ to indicate a trademark or, if the keep it secret. trademark has been registered with a government agency, the producer would use ®.

When hired, the employee may make a contractual commitment not to disclose information with which he or she is enA good trademark can be an extremely valuable asset. It can trusted. This could be a product formula or other valuable create in the mind of the purchaser a positive impression of assets of the firm. In pharmacy practice this has been applied quality, service or consistency. Moreover, it can represent an to customer lists stored in the pharmacy’s database. A numinvestment of many millions of dollars in advertising and oth- ber of court rulings have stated that a departing employee er initiatives by the owner to create a positive impression with may not take along a “customer list”. Contrast that ruling consumers. dealing with physical customer lists with one from 1925 in Kentucky that focused on knowledge of prior customers reBenefits to consumers from trademarks include their role in tained in the memory of a departing employee: encouraging the production of quality products and the possibility of reduced time and cost when making purchasing deci- A person who leaves the employment of another has the right to take with him all the skill he has acquired, all the knowledge that he has sions. obtained, and all the information that he has received, so long as nothing is taken that is the property of the employer. Trade secrets Trademarks are widely used with pharmaceutical products, are the property of the employer, and cannot be taken or used by the be they OTC or prescription. Brand name pharmaceuticals have the brand name as a trademark. This was a major issue employee for his own benefit. [Progress Laundry Co. v. Hamilton, 270 S.W. 834 (Ky. 1925).] as states were enacting drug product selection laws in the 1970’s and 80’s. Pharmacists who desired to minimize patient confusion would place on the prescription container label the A Kentucky case in 2001 brought the law of trade secrets to the fore. A couple in Shelbyville claimed to have found the name of the brand name product the patient had been using secret recipe for Kentucky Fried Chicken (“eleven herbs and but that did not reflect the actual generically equivalent conspices”) on a handwritten note in the basement of their home tents. A number of manufacturers pursued legal actions that was formerly owned by Col. Harland Sanders. The reciagainst pharmacists in such circumstances, resulting in a pe was reviewed by knowledgeable staff members at the firm change in labeling practices. Labeling should always accuwho concluded that it was not the Holy Grail of poultry recirately reflect the contents of the container. pes. Kentucky-based YUM! Brands treats that recipe as a trade secret, reportedly storing it in a vault at headquarters.

Trade Secret

(a) Derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use; and

By understanding some aspects of the law of intellectual property the pharmacy staff member can work within the law to optimize patient care while minimizing legal entanglements.

|22| Kentucky Pharmacists Association | November/December 2018

December 2018 — Intellectual Property Issues Affecting Patient Care 1. Which form of intellectual property has the longest preestablished term or duration?

A. Patent B. Copyright C. Trademark D. Trade Secret 2. Which form of intellectual property has an indefinite term or duration?

A. Trademark B. Trade Secret C. Trademark and Trade Secret D. None of the above 3. Which form of intellectual property is based on provisions in a contract of employment?

A. Patent B. Copyright C. Trademark D. Trade Secret 4. Which form of intellectual property was involved in issues of labeling prescription containers when drug product selection/generic interchange occurred?

A. Patent B. Copyright C. Trademark D. Trade Secret 5. What intellectual property related message are you likely to encounter when you arrive at the pharmacy for the day and turn on your computer?

A. Patent B. Copyright C. Trademark D. Trade Secret 6. In recent years the length of protection for exclusivity for a patent has been: A. Lengthened B. Shortened C. Unchanged 7. Over the history of copyright law in the U.S. the length of protection for copyrighted materials has: A. Increased B. Decreased C. Remained unchanged 8. If your contract of employment bears a trade secret provision, one asset of your employer to which this might apply is: A. Reordering or restocking policies and patterns B. Patient or customer lists C. Employment interview questions

9. Which form of intellectual property has come under scrutiny for manufacturers’ practices of delaying filing for protection of a new extended release dosage form until the exclusivity of a prior, standard dosage form bearing the medication has expired?

A. Patent B. Copyright C. Trademark D. Trade Secret 10. To which form of intellectual property would this mark -- ® -- apply: A. Patent B. Copyright C. Trademark D. Trade Secret

CPE Reminder: A pharmacist shall complete a minimum of one and five tenths (1.5) continuing education units (15 contact hours) annually between January 1 through December 31, pursuant to 201 KAR 2:015, Section 5(1). A pharmacist first licensed by the Board within 12 months immediately preceding the annual renewal date shall be exempt from the continuing pharmacy education provisions.

Still need hours? KPERF CPE articles are available to members online at www.kphanet.org under the Education tab.

CPE Quiz Online www.surveymonkey.com/r/CEQuizDec18

|23| www.KPHANET.org

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

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

Expiration Date: 11/14/2021 Successful Completion: Score of 80% will result in 1.0 contact hours or .10 CEUs. TECHNICIANS ANSWER SHEET. December 2018 â&#x20AC;&#x201D; Intellectual Property Issues Affecting Patient Care (1.0 contact hours) Universal Activity # 0143-0000-18-021-H03-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

7. A B C 8. A B C

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

Information presented in the activity:

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

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

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

PHARMACISTS ANSWER SHEET December 2018 â&#x20AC;&#x201D; Intellectual Property Issues Affecting Patient Care (1.0 contact hours) Universal Activity # 0143-0000-18-021-H03-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

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

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

5. A B C D 6. A B C

7. A B C 8. A B C

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

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

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

Signature ____________________________________________Completion Date___________________________

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

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

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

|24| Kentucky Pharmacists Association | November/December 2018

Campus Corner Pharmacy Alumna Goes Beyond the Script Dressed in a Kentucky blue ensemble, with bright red hair and a smile for everyone, Gloria Doughty is an alumna who paved the way for women at the University of Kentucky. Just shy of her ninety-second birthday, Gloria H. Doughty, KPhA Member Doughty remembers her time at UK fondly. “I went to school almost before penicillin,” she jokes.

At a time when very few women graduated with advanced degrees, Doughty’s parents supported her choice to attend the University. Only about 5 percent of women in the United States had completed more than four years of college, according to the 1950 Census. Yet Doughty graduated from University of Kentucky with a degree in Chemistry in 1948, and then enrolled at UK College of Pharmacy where she graduated in 1951. She was one of two women in her pharmacy class of 80 students.

Doughty had originally decided to go further north for her graduate degree. Her mom was living in Illinois and Doughty planned to live at home while attending pharmacy school.

She arrived on campus in Illinois to visit with the dean of their pharmacy school. She tells the story with conviction, “The dean said, ‘What are you doing at the College of Pharmacy?’ And I said, ‘Well I have a degree in chemistry, I’ve gotten good grades, and I’m interested in pharmacy because I’m a people person and I don’t want to be a chemist.”

Doughty pauses for effect, “And you know what he said to me? He said, ‘You women just waste our time and our money because you eventually stop to get married.’”

Doughty was quick with her reply, “I told him, ‘Obviously, Dean, you don’t know me. Thank you very much. I’m leaving, and I’m going to go to the College of Pharmacy at Kentucky.’”

And so, she did. Doughty called the dean at the UK College of Pharmacy where she had also been accepted. Even though classes had started, Dean Earl Sloan told her she was welcome. “He told me to come on down,” Doughty says.

worked to put herself through school by interning at pharmacies or the hospital. “Women weren’t accepted as pharmacists,” Doughty remembers. “There were only two or three women practicing as pharmacists in Lexington at the time. If I got a job at the pharmacy, they wanted to put me out front selling sundries instead of actually working behind the counter.”

Eventually, Doughty found a family-owned pharmacy willing to hire her: Hubbard and Curry Pharmacy in Lexington, Ky. “They would have me work in the back office, and when it got busy in the pharmacy I could help. Since I had a chemistry background, I was able to compound medications for them. I loved mixing things.”

After graduating, Doughty worked to mentor both students and pharmacists at UK’s Chandler Medical Center. It was at UK where Doughty would also meet her husband, Richard (Dick) Doughty. “It’s a classic UK story,” says Doughty. “I was invited to the building dedication for the new pharmacy building and was introduced to this new faculty member— Dick Doughty. Two years later we were married,” she says with a smirk. “I was an old woman by then too,” she jokes. “I was 32.”

Even though the Doughtys had no natural children of their own, in the 35 years they were involved with the UK College of Pharmacy, they welcomed a number of students into their home. They offered free room and board to students who would not be able to attend the University otherwise.

In all, the Doughtys sponsored 11 UK students, not all of them studying pharmacy. “I still communicate with many of them,” Doughty says. She tells stories of her UK “children” like any proud parent. The Doughty home was where students from as far as Australia and as close as Kentucky could find a place to belong. And Doughty’s trailblazing spirit can still be seen even now at the UK College of Pharmacy, where women are now 62 percent of the student body.

Doughty was dedicated to pushing past the status quo and fighting for a better tomorrow. Her story is not just a Kentucky one, it’s a story about how we can all go beyond— beyond the script.

When asked about challenges she faced in school, she chuckles. “There were quite a few.” During the summers, Doughty |25| www.KPHANET.org

Campus Corner Sullivan Preceptor Highlight Sullivan University College of Pharmacy & Health Sciences’ Office of Experiential Education was able to award this year’s Preceptor of the Year awards to the following individuals:

Highlights of the rotation/site: My rotation is designed to bring students out of their comfort zone and challenge them to think outside the box. I teach the basics of pharmacy, but really want my students to utilize their therapeutic knowledge and skills to perform various tasks. From patient counseling to performing MTMs, my stuKimberly G. Elder, PharmD, BCPS- Faculty Preceptor dents learn very quickly how to communicate in patientof the Year 2017-2018 friendly language. I want my students to walk away every day Practice Site: Internal Medicine, Robley Rex VA Medi- from this site and feel like they have not only learned somecal Center, Louisville, Kentucky thing new, but provided a valuable service to their community.

Pharmacy School: University of Kentucky College of

Pharmacy (2010) Residency Training: PGY1 Pharmacy Practice Indiana University Health; PGY2 Pharmacotherapy Community Health Network/Butler University College of Pharmacy & Health Sciences

Pictured from Left to Right: Dr. Jamie Nash, Associate Dean of Experiential Ed; Dr. Kim Elder; Dr. Vinh Nguyen

Kristin Smith, PharmD- Preceptor of the Year 2017-2018 Area of Practice: Community retail, Walgreens Store #3547, 9616 Highway 403, Charlestown, Indiana 47111 How long have you been a preceptor? 7 years Where did you go to pharmacy school? Sullivan University College of Pharmacy (Inaugural Class of 2011) Any certifications/specialty areas? Medication Therapy Management certification – APhA; Certified Immunizing Pharmacist – APhA;Naloxone Certification - KY BOP How long has the experience been available as a rotation/ site? 7 years

What unique opportunities are available for a student on this rotation/site?

As a preceptor, I want my students to experience the full spectrum of retail pharmacy. I start with teaching the basics of filling prescriptions, and go from data entry to production.

They learn the importance of applying a drug label correctly, comparing it to the original prescription and then making sure the correct medication Pictured from Left to Right: Dr. Jamie is in the vial. I also exNash, Associate Dean of Experiential Ed; press to them the value Dr. Kristin Smith; Dr. Vinh Nguyen we, as pharmacists, play in the healthcare field. We are the last line of defense prior to the patient receiving their medication to make sure everything is safe and accurate. Also, during my rotation I allow my students to participate in performing MTMs (Medication Therapy Management). They will do everything involving targeted intervention program (TIPs) to complete medication reviews (CMRs), both over the phone and in person. I believe the experience of extensively counseling the patient on their medications, discussing needed immunizations and/or therapy changes, helps the students utilize their knowledge and skills in a hands on, real world, kind of way. When the students become certified immunizers, I allow them to provide immunizations in the store and accompany me to clinics. The students also have the opportunity to work with patients on choosing appropriate OTC products, helping patients wade through the fluff to find what will really treat their problem correctly and effectively.

|26| Kentucky Pharmacists Association | November/December 2018

Upcoming Events ASHP Midyear – Anaheim, CA (Dec. 2 – Dec. 6) Kentucky reception information Sunday, December 2, 2018 6:00 – 7:30 PM Bubba Gump Shrimp Company 321 W. Katella Avenue, Suite 101 Anaheim, CA 92802

When we receive a new prescription for a specialty medication that we are unable to dispense at our location, we call the specified specialty department to fill the medication ensuring the continuity of care for the patient. We’ve also been active with performing adherence counseling on statins and blood pressure medications. Our goal is to continually expand our services to fall in line with the Walgreen Co. brand.

What do you love about being a preceptor?

As a young girl, I dreamt of being a pharmacist. I relished the idea of being able to take care of people and building a trusting relationship with my patients. I started working in pharmacy over 22 years ago, and when I became a pharmacist it was a dream come true. I love being a pharmacist and having the ability to better someone’s quality of life. I enjoy sharing my passion for the profession with my students and always Pancakes with Santa strive to present real world, everyday situations to them. I only have my students for a limited time and know I cannot posSaturday Dec. 1 sibly teach them everything they need to know, but I want 8:00 AM – 1:00 PM them to see things and to practice things they may not see on their other rotation sites. I want them to understand that being What are some clinical services that are currently being ofa pharmacist is so much more than filling prescriptions. Our fered? profession has grown so much over the years, that we are truly We offer various MTM services through Mirixa and Outbeing recognized as an integral part of the healthcare team. comes, counseling patients on their medications, screening for My hope is to leave my students with the burning desire to needed immunizations, and doing full medication reviews for become the best pharmacist they can be. duplicate, dangerous or needed therapies. We provide different immunizations, including, flu, shingles, pneumonia, tetanus and hepatitis series, that patients can walk in and receive ASHP Clinical Skills Competition same day. We also perform blood pressure screenings, as well On Friday, October 5, Sullivan University held its local ASHP as private pharmacist counseling upon request for smoking cessation, diabetes, blood pressure and cholesterol among oth- clinical skills competition. Congratulations to the winning team of Ashley Jatczak and Purna Patel and to the second ers. place team of Mary Bluthardt and Sarah Fox. This year’s event had a record 11 teams compete. Ashley and Purna will Where are you growing or expanding services/ represent Sullivan University at the national ASHP Clinical opportunities?

Skills Competition held in Anaheim, CA at ASHP midyear As a new cutover store from Rite Aid to Walgreens, we are on Sunday, Dec. 2, at 1 PM. A special thanks to Dr. Palmer, incorporating new services that Walgreens offers such as fulDr. Hobbs, Dr. Smith, and Dr. Krabacher for helping judge/ filling orders for Specialty Medication. grade the competition. Good luck Ashley and Purna!

The Campaign for Kentucky’s 141st KPhA Annual Meeting and Convention June 20-23, 2019 | Lexington Griffin Gate Marriott Resort & Spa |27| www.KPHANET.org

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

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

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

2. Advance Patient Care

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

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

9. Make the Connection

3. Network with Others in Your Field

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

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

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

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

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

5. Proclaim Your Professionalism Adding your name to the ranks of your colleagues who are members declares your pride in the profession. Support KPhA’s advocacy efforts as we work with policy makers to implement health care reform legislation and as we continue to advocate for regulations that positively impact the profession. |28| Kentucky Pharmacists Association | November/December 2018

JOIN TODAY WWW.KPHANET.ORG

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

The list reflects new memberships received from September 1, 2018— October 31, 2018 Eric Atwell Aaron Barber John Burke David Conyer William Cooke Joseph Hirschi Diem Huynh Barbara Kemp Micah Lehring Andrew Losch Lance Mansfield

Jill McCormack LeeAnna Miller John Manning-Ashcroft Nicholas Theresa Baker Porter Lauren Riney Taylor Rostova Amanda Shimfessel Scott Simon Danielle Smith Ayonna Tolbert

Megan Wagner Brian Yap

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

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

|29| www.KPHANET.org

Pharmacy Policy Issues The Impact of Clinical Laboratory Improvement Amendments (CLIA) and Point of Care Testing in Submit Questions: jfink@uky.edu Pharmacy Practice Author: Leah W. Ginter is a 2018 graduate of the PharmD program at the University of Kentucky College of Pharmacy. A native of Louisville, Kentucky, she completed her pre-professional degree work while earning a degree in health communication at the University of Kentucky.

Issue: During my time in pharmacy, I have seen an exponential growth in the amount of hands-on patient care that pharmacists have become able to participate in. Under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, there are CLIA-waived tests that allow testing to be completed in the pharmacy rather than a full-blown clinical laboratory. The pharmacist’s roles have expanded greatly, so how do CLIAwaived tests fit into the pharmacist’s role in disease-state management?

and hepatitis, as well as chronic disease monitoring of A1C and INR are all possibilities for pharmacists to contribute to patient care in the future.

The National Association of Chain Drug Stores (NACDS) has announced the introduction of an old concept with a new twist, the Community PharmacyBased Point-of-Care Certificate Program. The newly renovated program is accredited by the Accreditation Council for Pharmacy Education for a total of 20 hours Discussion: Since 1988, pharmacists have become one of Continuing Pharmacy Education (CPE) credit.

Training for this CPE will educate the pharmacist about of the most accessible healthcare providers and there“disease states, physical assessments, point-of-care tests, fore have taken a frontline role in point of care testing collaborative practice models and business models.”2 outside of laboratory settings. Pharmacists have been completing laboratory tests such has hemoglobin (A1C) The change in CLIA-waived tests opens a new door to and cholesterol screenings for many years. The need for an enhance patient-care model. With collaborative care agreements, pharmacists will have the ability to play a healthcare providers continues to grow as our population grows and our mean age of those within the popu- greatly enhanced role in assisting patients using the lation continues to rise. Due to the upcoming changes, standard operations outlined between the practitioners and one can fully expect that certain lab tests performed the Department of Health and Human Services in the pharmacy will be an important part of that. “expects our shortage of primary care physicians to reach 20,000 by 2020.”1 Pharmacists are the perfect References: solution to meet this upcoming need and CLIA-waived 1. Timmons E, Norris C. Pharmacists Can Provide the Right tests are a large part of this role.

Allowing point-of-care testing by pharmacists provides pharmacies a means to increase revenue while boosting patient outcomes. Patients can be diagnosed and treated in a single visit instead of waiting weeks between lab exams and appointments. Testing for serum creatinine, electrolytes, thyroid stimulating hormone, and international normalized ratio (INR), among others, may allow pharmacists to help patients maximize their drug therapies, avoid adverse reactions, and improve disease states. Acute testing for influenza and strep, chronic disease screening for human immunodeficiency virus

Prescription for a Projected Crisis in Health Care.

RealClearHealth. October 26, 2016. Available at https:// www.realclearhealth.com/articles/2016/10/26/ pharmacists_can_provide_the_right_prescription_for_a_projected_cri sis_in_health_care__110192.html. 2.

National Association of Chain Drug Stores. NACDS Rolls Out Enhanced Point-of-Care Testing Program. February 6, 2018. Available at https://www.nacds.org/news/nacds-rollsout-enhanced-point-of-care-testing-program/.

|30| Kentucky Pharmacists Association | November/December 2018

Pharmacy Law Brief Advance Directives Author: Joseph L. Fink III, BSPharm., JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I’ve had some questions from patients about advance directives – are they a good idea, do they need to get an attorney involved in preparing the documents, etc. I have a slight familiarity with the issues but can you expand on what I know?

Response: The phrase “advance directives” includes two items with different purposes. A living will is a document used to communicate one’s preferences about health care if the individual is unconscious or too incapacitated to communicate. The preferences expressed in that document do not become “active” as long as the patient is able to communicate. The general, overarching principle is patient autonomy – each person has a right to make decisions about his or her health care. If you object, no services may be rendered and, on the other hand, health services may not be ceased or withheld if the patient objects to that discontinuance.

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

attorney is called that because a standard or traditional power of attorney grant of authority is invalidated if one loses mental capacity to revoke it. Other phrases used from time to time to describe this part of the advance directives are “health care proxy” or “medical power of attorney.”

A copy of the document should be given to your primary care provider and should be stored in a secure yet Kentucky law allows a patient to communicate instruc- accessible spot at home. Be certain your family knows tions in four critical end-of-life issue areas: [1] designate you have completed such a form and where it can be a Health Care Surrogate to make decisions; [2] request located. It should be noted that preferences expressed in or refuse treatments that can prolong life; [3] request or a living will or a durable power of attorney cannot be refuse artificial feeding or hydration; and [4] express the honored by emergency medical technicians who might be called to a patient’s home or scene of an accident. patient’s wishes regarding organ donation.

Advance directives have no pre-designated finite life; they do not expire. It is recommended that the person completing such forms to communicate preferences review those wishes identified in the document from time to time. It is also a good idea not only to document The second part of “advance directives” is designation these preferences through the advance directives but of a health care surrogate to make important treatment also to have a discussion about it when family members decisions if you are unable to do so. This individual you are gathered so everyone knows what one would prefer. identify and select “stands in your shoes” with regard to health care decision making. That can be a heavy bur- Wording for a document that contains all the matters to den to place on someone and the selection should be of be considered is available through the Kentucky Legislative Research Commission’s website – someone best qualified to serve in that role. This individual may need to be willing to make very difficult de- http://www.lrc.ky.gov/KRS/311-00/625.pdf. If when cisions sometimes with vocal opposition from relatives reviewing this form you wish to make changes then it and friends of the patient. Sometimes this is referred to would be appropriate to consult an attorney before doing so. as a durable power of attorney. “Durable” power of It is important to note that all preferences expressed in a living will are suspended if the patient is pregnant. A living will may be completed by those 18 years old or older.

|31| www.KPHANET.org

|32| Kentucky Pharmacists Association | November/December 2018

|33| www.KPHANET.org

2018—2019 KPhA BOARD OF DIRECTORS

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

Chris Harlow, Louisville cpharlow@gmail.com

Chair

Chris Palutis, Lexington chris@candcrx.com

President

Don Kupper, Louisville donku.ulh@gmail.com

President-Elect

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Bob Oakley, Louisville rsoakley21@gmail.com

Chair

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Joel Thornbury, Pikeville jthorn6@gmail.com

Past President Representative

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Chris Palutis, Lexington chris@candcrx.com

President, KPhA

Directors Angela Brunemann, Union Angbrunie@gmail.com

KPERF BOARD OF DIRECTORS

Kimberly Croley, Corbin kscroley@yahoo.com

Matt Carrico, Louisville* matt@boonevilledrugs.com

Kevin Lamping, Lexington klamping@riteaid.com

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

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

University of Kentucky Student Representative

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

Chad Corum, Manchester pharmdky21@gmail.com

KPERF ADVISORY COUNCIL

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

Sullivan University Student Representative

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

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

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

|34| Kentucky Pharmacists Association | November/December 2018

“A new instructional program leading to a professional Doctor of Pharmacy degree has been approved by the Board of Trustees of the University of Kentucky.”

- From The Kentucky Pharmacist, December 1968, Volume XXXI, Number 12

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

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

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

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

KPhA Staff Mark Glasper Executive Director mglasper@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Pharmacy Emergency Preparedness jjaggers@kphanet.org Sydney Hull Office Assisant/Member Services Coordinator shull@kphanet.org

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

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

|35| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601

Join the KPhA Team!

Director of Pharmacy Emergency Preparedness KPhA Seeks Full-time Pharmacist to serve as Director of Emergency Preparedness.

This position will work with KPhA to conduct outreach activities to inform and engage pharmacists to serve special populations following a disaster while enhancing the visibility and public image of the Association as a partner in emergency preparedness and response.

Director of Pharmacy Education Services KPhA Seeks Full-time Pharmacist to serve as Director of Pharmacy Education Services.

This position will work with KPhA and the Kentucky Department for Public Health (KDPH) to conduct outreach activities to inform prescribers and pharmacists regarding the opioid crisis, including up-to-date numbers and statistics, best prescribing practices, emerging pharmaceutical treatment options and other pertinent topics, while enhancing the visibility and public image of the Association as a partner in the opioid crisis and response.

To apply, submit a cover letter and your CV/resume to Angela Gibson

by November 30, 2018.