The Kentucky Pharmacist Vol. 10, No. 6 by Kentucky Pharmacists Association

Y K C U T N E K THE T S I C A M R A PH

Vol. 10, No. 6 November/December 2015

See what you missed inside! CE Deadline for Pharmacists: Remember to get your 15 hours completed BEFORE December 31! News & Information for Members of the Kentucky Pharmacists Association

Table of Contents

November/December 2015 KPhA Emergency Preparedness Pharmacy Time Capsules Kentucky Renaissance Pharmacy Museum KPhA New and Returning Members Naloxone Certification Training Pharmacy Law Brief Pharmacy Policy Issues Pharmacists Mutual Cardinal Health KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted

Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective 2015 KPhA Legislative Conference From your Executive Director APSC Nov. 2015 CE — Antipsycotics in LTC November Pharmacist/Pharmacy Tech Quiz Dec. 2015 CE — Point-of-Care Testing December Pharmacist/Pharmacy Tech Quiz Bob Lichtefeld

2 3 5 6 8 9 14 15 22 23

24 26 27 28 31 32 34 36 37 38 39

Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy. I will consider the welfare of humanity and relief of human suffering my primary concerns. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve. I will keep abreast of developments and maintain professional competency in my profession of pharmacy. I will embrace and advocate change in the profession of pharmacy that improves patient care. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Kentucky Pharmacists Association The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.

Editorial Office: © Copyright 2015 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. Editor-in-Chief: Robert McFalls Managing Editor: Scott Sisco Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org. Website http://www.kphanet.org.

The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance. It is the goal of KPERF to ensure that pharmacy in Kentucky and throughout the nation may sustain the continuing need for sufficient and adequately trained pharmacists. KPERF will provide a minimum of 15 continuing pharmacy education hours. In addition, KPERF will provide at least three educational interventions through other mediums — such as webinars — to continuously improve healthcare for all. Programming will be determined by assessing the gaps between actual practice and ideal practice, with activities designed to narrow those gaps using interaction, learning assessment, and evaluation. Additionally, feedback from learners will be used to improve the overall programming designed by KPERF. 2

THE KENTUCKY PHARMACIST

President’s Perspective

November/December 2015 I-64. The new home and headquarters for KPhA will be located at 96 C. Michael Davenport Blvd. The cost to purchase this location is $625,000, but Mr. Davenport has agreed to allow the association to lease the property for at least two years with the intent to purchase once our building fund reaches the purchase price. Once we purchase the building, Mr. Davenport has agreed to donate one year of lease payments back to KPERF. There is a parcel of land adjacent to the property that we would like to eventually purchase too to accommodate additional parking and future needs. We can easily move into the building “as is” but will eventually want to make some renovations to make it our own.

PRESIDENT’S PERSPECTIVE Chris Clifton KPhA President 2015-2016

I hope that you will join me in becoming a leader in The Campaign for Kentucky Pharmacy’s Future. How do I do that, you may ask? There are numerous ways, and we want everyone to be a part of a successful campaign. I would like to highlight a few ways you can become involved:

What an exciting time for YOUR Kentucky Pharmacists Association!! As you know, last year KPhA’s Board of Directors set out to start thinking about the future of the Association’s headquarters. We are fortunate to own our own building as KPhA’s headquarters in the state’s capital city. However our building, started in 1967 and finished in 1968, is almost 50 years old. It is not ADA compliant, and it doesn’t meet all of our business needs for today. There was much discussion on whether to renovate our current site, move to another location or build a new building all together.

YOU are invited to join The Campaign for Kentucky Pharmacy’s Future by donating at any level that is within your budget. We have identified a comprehensive list of giving opportunities for OUR campaign! No donation is too small, and every donation will be recognized in a Book of Honor at KPhA headquarters.

The Board directed the staff to catalogue the maintenance  and renovation needs of the current building to make it a welcoming, functioning headquarters for our association. The staff also was tasked with searching for alternate locations in Frankfort, including land to build a new building and existing buildings that could meet our needs. In addition, our executive director met with an architect to determine how much it would cost to bring our existing building up to  standard. The architect estimated $927,550. The proposal to initiate a building Campaign for Kentucky’s Pharmacy Future: The Next 50 Years, was sent to the House of Delegates at our Annual Meeting & Convention earlier this year in Bowling Green, where it passed with overwhelming support. I am pleased to report that the Board of Directors has established a Building Campaign Goal of $1,000,000 to purchase and renovate a building and property to meet our immediate needs and needs for years to come. The building campaign will be conducted under the auspices of our closely affiliated Kentucky Pharmacy Education and Research Foundation, which shares the same board of directors that you elect as members. The board is in the process of negotiating a lease on an existing building in Prevention Park in Frankfort, with the hopes of purchasing within a year. Prevention Park offers quality, professional office, and retail space 1.5 miles off of 3

YOU are invited to join The Campaign for Kentucky Pharmacy’s Future to assure our collective success as a member of the Committee of 100 Pharmacy Founders. Donations or pledges at this level start at $5,000 and are payable in whole or in part over the next 5 years. AND, you can be a member of this Committee by helping KPhA BUILD a Wall of Excellence or a Wall of Presidential Leadership. Donations or pledges at this level start at $10,000 and are payable in whole or in part over the next 5 years.

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OR, YOU are invited to join The Campaign for Kentucky Pharmacy’s Future by helping to lay a Cornerstone. Donations or pledges at this level start at $3,000 and are payable in whole or in part over the next 3 years.

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OR, YOU are invited to join The Campaign for Kentucky Pharmacy’s Future as a Pharmacy Builder. Donations or pledges at this level are at the $1,000 level.

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OR, YOU can donate $1,000 and select one of the History of Pharmacy in Pictures prints to be framed and displayed in the new headquarters. There are 40 prints

THE KENTUCKY PHARMACIST

President’s Perspective

November/December 2015

The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years

96 C. Michael Davenport Blvd. Continued from Page 3



available, including variin the series, and currently three have been claimed. ous donation KPhA will include a plaque on the frame to commemo- levels and rate the donation. You can dedicate the donation to naming recogyourself, a colleague or another entity. nition opportunities. I ask OR, YOU can join the $20 by 2020 Club. Pledge $20 you to contact a month for the next five years and until we reach Conference room space in Bob McFalls to 2020 to the KPERF/KPhA Building Fund. 96 C. Michael Davenport Blvd. discuss these. OR, YOU can donate appreciated stock to KPERF for Your donation a tax deductible gift, which could represent a signifito KPERF will cant gift in today’s stock market . be given as a charitable contribution and is tax deductible OR, YOU can donate an amount to add your name to to the extent allowed by law. the new headquarters through one of many, many Our current location at 1228 US 127 South, in Frankfort, naming opportunities. Visit http://www.kphanet.org/? Ky., will be placed on the market with the intent of leasing page=buildingcampaign for more options and to track or selling the property to help with the relocation. This recthe progress of the Campaign. ommendation was put towards the House of Delegates at

AND, in addition, you can purchase a KPhA Roamey the 2015 Legislative Conference and passed with unanimous approval. Window cling for $5. Contact the KPhA staff or use the KPhA Online Store on the KPhA Website under the I hope that we can count on all of our members’ support in About tab. this campaign, as we look toward the future of Kentucky’s Pharmacists and their Association. UNITED WE STAND! These Campaign opportunities are not the only ones, but they are a few that we want to focus upon to get our cam- Thanks again for your continued support, and I hope you and your family have a joyous holiday season. paign jumpstarted. There are many other opportunities 

http://www.kphanet.org/?page=buildingcampaign 4

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2015 KPhA Legislative Conference

November/December 2015

Senator Damon Thayer and Representative James Kay joined Jan Gould and Shannon Stiglitz, our lobbyist partners, to talk about interacting with your legislator.

Laurel Taylor received the Cardinal Health Generation Rx Champion Award. Cardinal Health Customer Chad Corum assisted Cardinalâ&#x20AC;&#x2122;s David Kelly in presenting the award. Jan Gould was recognized for his 30+ years of working with KPhA as a contract lobbyist. The KPhA Meritorious Service Award, which he also received, was renamed in his honor. KPhA staff snuck his wife, Cheryl, in for the event!

Team Whirlaway (Phillip Adams and Cat Serratore from SUCOP and David Blair from UKCOP) won the 2015 NASPA/NMA Student Pharmacist Self-Care Championship. Thanks to Joseph Fink, Chris Harlow and Stacy Rowe for serving as judges and to President Chris Clifton for being an amazing host.

Heidi Ecker, Director of Government Affairs and Grassroots Programs for NACDS had to have her picture taken with Roamey, ED Bob McFalls and President Chris Clifton. 5

THE KENTUCKY PHARMACIST

From Your Executive Director

November/December 2015 MESSAGE FROM YOUR

EXECUTIVE DIRECTOR Robert “Bob” McFalls

JOIN THE CAMPAIGN! Fifty years ago, E.M. Josey was serving both as the Executive Secretary of the Kentucky Pharmacists (then Pharmaceutical) Association and the Kentucky Board of Pharmacy (BOP) when he passed away unexpectedly, leaving a void in both organizations. As the leaders worked to collect themselves and to pick up the pieces, members realized that the rented space in downtown Frankfort that housed KPhA and the BOP was woefully outdated and didn’t suit the needs of the growing organizations.

when the estimates reached a tipping point, the KPhA Board directed me as your executive director and our staff to begin looking for other options in terms of an alternate location.

The core business of YOUR Association is to protect the Pharmacy Practice Act. That’s why the headquarters has been in Frankfort for 137 years, and it will remain in Frankfort. Throughout its history, the Kentucky Pharmacists Association has maintained a positive and respected position That group decided that change was needed and develin the Commonwealth's political arena. To Kentucky legisoped a vision for a new building and headquarters to house lators and Kentucky executive branch officials, KPhA is the the Kentucky Pharmacists Association and the Kentucky voice of pharmacy concerning legislative and regulatory Board of Pharmacy that would make the membership matters. Pharmacists and pharmacy technicians are affectproud. The leadership identified a parcel of land, purchased ed by the decisions of government officials, insurance comit and set a Building Fund goal of raising nearly $90,000 to panies, the Board of Pharmacy, the governor, legislature build a new headquarters and decided to designate it as and other elected officials. Maintaining KPhA's presence in the E.M. Josey Memorial Building (Note: According to the the Capital is a high priority for the association. Political CNN Money Inflation Calculator, $90,000 in 1967 would advocacy for the profession of pharmacy is vital to preserve buy $629,749 in 2015! Coincidence? I think not!) a favorable and progressive environment for the practice of pharmacy throughout the Commonwealth. We believe proGround was broken on October 2, 1967 with nearly 75 peotecting and serving pharmacists is the most important funcple in attendance, and this building has served the profestion of KPhA. sion well in housing YOUR KPhA since its completion in July 1968. Donations came from all across the state from At the 2015 KPhA Annual Meeting and Convention, the KPhA members, businesses and friends—they continue to KPhA Board of Directors brought a request to the House of be memorialized at KPhA’s headquarters today as will new Delegates to begin a fundraising campaign for the future of donors as KPhA members, associates, partners and bene- the KPhA Headquarters. The House so approved, and the factors join together for the acquisition of a new headquar- Board subsequently set a goal to raise $1 million to ensure ters to serve the profession for the next 50 years. the stability of the KPhA Headquarters now and for the foreseeable future. Our current building has served the proOver the years, KPhA’s building has served its purpose fession well for almost 50 years. As President Clifton has well. Once co-located, the Kentucky Board of Pharmacy noted, though, the time is now for the profession to come subsequently moved out because the space was not ADA together by joining in The Campaign for Kentucky’s compliant and not accessible. KPhA has maintained and Pharmacy Future: The Next 50 Years. renovated the building, but the costs have begun to mount. Staff worked with the KPhA Board and its Budget & Audit Your assistance in helping YOUR KPhA to get our camCommittee to estimate the cost of repairs and renovations. paign off to a great start is appreciated. There are plenty of It wasn’t long before the amount needed to replace aging opportunities to participate, and no gift is too small. Now is fixtures and improve the building to make it functional a great time to think about how you can reduce your tax bill raised questions about the best path to take. Accordingly, by making a charitable gift to KPERF. Here are some plan6

THE KENTUCKY PHARMACIST

From Your Executive Director

November/December 2015

ning tips: 

Gifts to KPERF qualify as a charitable gift.

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If you want to claim a charitable donation with the IRS, you must itemize your deductions.

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Charitable donations made by Dec. 31, 2015, are deductible on your 2015 tax return that you will file in 2016.

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For a cash gift to be considered “made by December 31,” KPERF must receive it by the end of the year. Thus, any charitable gift in the form of a check must be mailed by 12/31/15, even if it is not deposited by

KPERF until January 2016. KPERF will acknowledge your donation in writing for your records. All donations of $250 or more require a receipt to claim a charitable deduction. 

With the appreciation of stocks, this is a great time to consider a gift of stock. Consult your financial planner and know that KPERF qualifies as a charitable recipient.

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And this is just the start—we look forward to receiving gifts and donations in 2016 too as we work to complete The Campaign for Kentucky’s Pharmacy Future!

Merry Christmas & Happy Holidays!

The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years http://www.kphanet.org/?page=buildingcampaign

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APSC

November/December 2015

THE KENTUCKY PHARMACIST

November 2015 CE—Use of Antipsychotics in LTC

November/December 2015

Use of Antipsychotics in Long Term Care Patients with Dementia By: Allison Hugg, PharmD Candidate 2016; Charles Crecelius, MD; Sarah M. Lawrence, PharmD, MA, CGP PharMerica The authors declare no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-15-013-H01-P&T 1.5 Contact Hours (0.15 CEU)

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

Goal: To decrease the inappropriate use of antipsychotics in the long term care setting, as increased mortality is seen in elderly patients with dementia-related psychosis when taking antipsychotics. Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1. 2. 3. 4.

Discuss the rationale for CMS emphasis on antipsychotic use; Describe regulatory requirements in the long term care (LTC) setting with the use of these agents; Evaluate non-medication modalities for behavior management and appropriate use of antipsychotic therapy; Identify side effects and opportunities to reduce unnecessary use of antipsychotics.

Over the course of their disease progression, patients with dementia often develop neuropsychiatric symptoms. This set of clinical symptoms is most often referred to as “behavioral and psychiatric symptoms of dementia,” or BPSD. These symptoms include hallucinations, delusions, agitation, atypical motor behaviors and other symptoms related to mood, emotion, perception, thought and personality. Symptoms may present individually or concurrently, with 90 percent of dementia patients experiencing some sort of BPSD at some time during their illness. BPSD is associated with poor outcomes, long-term hospitalization, misuse of medication and increased health care costs.1 Commonly, atypical antipsychotics are prescribed to help control BPSD. While antipsychotics may be appropriate for some BPSD symptoms, they should not be used as across -the-board treatment.

Boxed Warning directly applies to the population most often residing in long term care facilities. While Boxed Warnings always should be taken seriously, it should be noted that this is not a contraindication for use in dementiarelated psychosis and antipsychotic therapy may be appropriate in some cases.

The Boxed Warning was added to atypical antipsychotic medications in 2005 based on the analyses of 17 placebocontrolled trials. Drug-treated elderly patients with dementia-related behavioral disorders were found to have a risk of death 1.6–1.7 times that of placebo-treated patients, with most deaths appearing to be either cardiovascular or infectious in nature. Other studies showed that conventional antipsychotics carried an even higher risk of death than atypical antipsychotics. The FDA considered study limitations and determined that the greater risk could not be Pharmacy technicians working in all settings should be proven, but conventional antipsychotics shared the inaware of the issues that may arise from the use of antipsy- creased risk of death with atypical antipsychotics. Therechotics in patients with dementia, and assist pharmacists in fore, in 2008, the FDA added the Boxed Warning to conmonitoring and managing these patients. Pharmacy techni- ventional antipsychotics.2 A list of both conventional and cians working in long term care who have contact with atypical antipsychotics can be seen in Table 1. nursing or other LTC facility personnel can serve as a reThe Centers for Medicare and Medicaid Services source to facilities and encourage facilities to make use of Efforts consultant pharmacist services to help manage antipsyAlthough atypical antipsychotics have carried a Boxed chotic therapy. Warning since 2005, they are commonly used in nursing Boxed Warning home residents with dementia. In fact, 23 percent of nursThe prescribing information for all antipsychotics includes a ing home residents with dementia and with no behavioral Boxed Warning for increased mortality in elderly patients problems were prescribed antipsychotics in 2006.3 Bewith dementia-related psychosis. This piece of information cause of the increased risks associated with using these is especially important in the long term care setting, as this agents in this patient population, the Centers for Medicare 9

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November 2015 CE—Use of Antipsychotics in LTC Table 1-FDA approved antipsychotics Conventional Antipsychotics (first generation, typical) prochlorperazine

Atypical Antipsychotics (second generation) aripiprazole

haloperidol

asenapine

loxapine

clozapine

thioridazine

iloperidone

molindone

lurasidone

thithixene pimozide

olanzapine olanzapine/fluoxetine

fluphenazine

paliperidone

trifluoperazine chlorpromazine

quetiapine risperidone

perphenazine

ziprasidone

Table 2- Medications that commonly cause psychiatric symptoms Drugs Linked to Anxiety Symptoms Corticosteroids B-adrenergic inhalers

prednisone, methylprednisolone, hydrocortisone, dexamethasone albuterol, levalbuterol

Sympathomimetics

phenylephrine, pseudoephedrine

Drugs Linked to Delirium and Other Cognitive Disorders Anticholinergics atropine Anticonvulsants Antiparkinson agents

carbamazepine, phenytoin, phenobarbital, topiramate amantadine, L-dopa

Cardiovascular drugs H2 antihistamines Muscle relaxants

digoxin cimetidine, ranitidine baclofen, methocarbamol, metaxalone NSAIDs indomethacin Psychotropics benzodiazepines, lithium, TCAs Drugs Linked to Mood Symptoms SSRIs Antihypertensives

fluoxetine, paroxetine, citalopram, escitalopram Clonidine, methyldopa

Drugs Linked to Psychotic Symptoms Sedative-hypnotics benzodiazepines Anti-arrhythmics procainamide Adapted from Desai AK. Primary Psychiatry. 2004;11(8):27-34.

November/December 2015

2015, and a reduction of 30 percent by the end of 2016.4 According to the CMS Survey and Certification Letter 15-31 -NH, other actions taken to enforce reduction include the addition of two new measures to the CMS Five Star Quality Rating System to calculate each nursing home’s quality measure score, and the piloting of a targeted Dementia Care survey. This new survey will “more thoroughly examine the process for prescribing antipsychotic medication and assess compliance with other federal requirements related to dementia care practices in nursing homes.”5 Finally, CMS has proposed the Mega Rule, a rule that would revise the requirements long term care facilities must meet to participate in Medicare and Medicaid programs, including a focus on the appropriate use of psychotropic medications.6 Along with these new goals and enforcements, CMS also provides guidance to surveyors of long term care facilities in the State Operations Manual, Appendix PP. The Appendix includes relevant long term care F-tags. F-tags are codes used to document areas in the State Operations Manual in which facilities are non-compliant. Among other deficiencies, facilities can be at risk for citation when not engaging the resident or family in decision-making, a common pitfall when it comes to antipsychotic prescribing. Abbreviated examples of these corresponding F-tags are listed here:   

F154 – Right to be informed in advance about care and treatment F155 – Right to refuse treatment F280 – Right to participate in planning care and treatment

Other important F-tags to be aware of are those pertaining to Quality of Care (F309) and Unnecessary Drugs (F329). 7 For each of F-tags listed here, the prescribing of antipsychotics in the elderly will require careful documentation to avoid citation. While BPSD may be difficult to distinguish from other diseases, appropriate use of antipsychotics in this population relies on making that differentiation. Consultant pharmacists working in long term care facilities play an important role in helping facilities use antipsychotic medications appropriately. Treatment Approach

In many cases, the use of an antipsychotic can be avoided and other approaches can be implemented. It is always important to search for other causes of behavioral or psyIn 2012, CMS launched the National Partnership to Imchological symptoms and correct these causes before beprove Dementia Care and, more recently, CMS established ginning drug therapy. Potential etiologies of such behaviors new national goals for reducing the use of antipsychotic and symptoms include, “delirium, untreated or undertreated medications in long term care residents. The updated namedical illnesses, overmedication, environmental triggers, tional goals are a reduction of 25 percent by the end of lack of engaging activities and misinterpretation of disease and Medicaid Services (CMS) is working hard to decrease the number of inappropriately prescribed antipsychotics.

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November 2015 CEâ&#x20AC;&#x201D;Use of Antipsychotics in LTC

November/December 2015

Table 3- Summary of Non-Pharmacological Interventions Non-Pharmacological Interventions Decrease confusion

explain tasks before performing ADLs, use calendars and clocks to orient to time, use lights at night for orientation

Decrease overstimulation

avoid noise, avoid glare from windows or mirrors, use distraction and redirection of activities to divert from problematic situation

Provide comfortable/typical environment

set a predictable routine, enforce a safe environment, allow resident to dress self, allow resident to keep possessions, avoid clutter

Other Therapy Options

music therapy, bright light treatment, aromatherapy, pet therapy, touch/ massage therapy Interventions from Muench J, Hamer AM. Am Fam Physician. 2010;81(5):617-22.

symptoms.â&#x20AC;?8 A list of some medications commonly causing psychiatric symptoms in the elderly can be found in Table 2. The consultant pharmacist serves as an important source of information about possible drug and non-drug related causes of behavioral or psychological symptoms in long term care residents. Once other etiologies of behavioral or psychological symptoms have been ruled out, non-pharmacological interventions should be considered first-line therapy for BPSD. In most cases, this includes decreasing confusion and overstimulation and providing a comfortable environment for the resident. Cummings et al. give the following examples: provide a predictable routine and a safe environment, allow resident to dress self and keep possessions, explain tasks before performing ADLs, use calendars and clocks to orient to time, avoid clutter, noise and glare from windows or mirrors, use lights to avoid confusion at night and use distraction and redirection of activities to divert from problematic situations. In addition to these tips, other therapies, such as music therapy, bright light treatment, aromatherapy, pet therapy and touch/massage therapy, have been found to be successful.11 These non-pharmacological interventions are summarized in Table 3. As stated earlier, in some cases, the use of antipsychotics in the elderly with dementia-related psychosis may still be warranted. Antipsychotics are not indicated for BPSD, but are often used off-label in these cases. It is always vital to consider the risk/benefit ratio before using an antipsychotic in elderly residents with dementia. If the above recommendations have been explored and other causes of symptoms have been excluded, CMS criteria for the use of antipsychotics should next be taken into account. CMS information for antipsychotic use in conditions or diagnoses where these medications may be appropriate is summarized in the following section. State Operations Manual Appendix PP

ses alone do not warrant the use of antipsychotics. These medications only should be used if the behavioral symptoms present a danger to the resident or others. In addition to this, the symptoms must be identified as being due to mania or psychosis and/or behavioral interventions must have been attempted and included in the plan of care, except in an emergency. Only after the above criteria are met should antipsychotics be used. As stated, in the case of an emergency situation, these criteria may change. In this instance, the treatment period with an antipsychotic is limited to seven days or less and a clinician (in conjunction with the interdisciplinary team) must evaluate and document the situation within seven days. If the behaviors persist beyond the emergency situation, nonpharmacological interventions must be attempted and documented. If the condition is non-acute, the target behaviors must be identified and documented before initiating or increasing an antipsychotic medication. Emphasis is placed again on ensuring that the behavioral symptoms are not due to environmental stressors, psychological stressors, or other medical conditions/problems expected to improve with treatment. Monitoring also must ensure that the symptoms are persistent. While all Medicaid-certified nursing facilities require careful screening of residents with mental illness or intellectual disabilities, new admission residents who do not require Preadmission Screening and Resident Review (PASRR) could be admitted on inappropriate antipsychotic therapy. For this reason, CMS requires re-evaluation of antipsychotic use at the time of admission and/or at the time of the initial Minimum Data Set assessment (MDS), a standardized primary screening and assessment tool of health status. Monitoring and Treatment Continuation

In all cases, the facility must continuously consider, through The following section paraphrases the antipsychotic section efficacy monitoring, whether the antipsychotic medication of Table 1 of the State Operations Manual Appendix PP may be tapered or discontinued. Additionally, adverse consequences of the antipsychotic therapy should be carefully In all cases where antipsychotics are considered, diagno11

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November 2015 CE—Use of Antipsychotics in LTC assessed. A wide range of adverse effects can arise with treatment, including neurological, cardiovascular and metabolic effects. Neurological effects include extrapyramidal symptoms-–pseudoparkinsonism, akathisia, acute dystonia and tardive dyskinesia – as well as seizures. Cardiovascular effects usually experienced include orthostatic hypotension and cardiac arrhythmias. Weight gain, worsening glycemic control, dyslipidemia and increased triglyceride levels are all common metabolic effects that should be monitored in patients receiving antipsychotics. Other common adverse consequences are anticholinergic effects, hyperprolactinemia and sedation.12

November/December 2015 lead to appropriate use of antipsychotics in the elderly population and will, in turn, advance toward the goal of 30 percent reduction of antipsychotic use in long term care residents by the end of 2016. References 1. Cerejeira J, Lagarto L, Mukaetova-ladinska EB. Behavioral and psychological symptoms of dementia. Front Neurol. 2012;3:73. 2. Information for Healthcare Professionals: Conventional Antipsychotics. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm124830.htm. Published: 2008 June 16; updated: 2013 Aug 15; accessed: 2015 Sept 28.

Muench and Hamer state, “[Primary Care Physicians] should be vigilant for the occurrence of adverse effects, be willing to adjust or change medications as needed (or work with psychiatric colleagues to do so) and be prepared to 3. Crystal S, Olfson M, Huang C, Pincus H, and Gerhard treat any resulting medical sequelae.”12 In any case that the T. Broadened use of atypical antipsychotics: Safety, benefit of treatment still outweighs risks and adverse coneffectiveness, and policy challenges. Health Affairs. sequences of use, the SOM states, “the facility and pre2009; 28(5):w770-w781. scriber must document the rationale for the decision and 4. National Partnership to Improve Dementia Care in also that the resident, family member or legal representaNursing Homes. Centers for Medicare & Medicaid Sertive is aware of and involved in the decision to continue the 7 vices website. https://www.cms.gov/Medicare/Providermedication.” Enrollment-and-Certification/ As continuous evaluation of the appropriateness of the SurveyCertificationGenInfo/National-Partnership-tomedication is carried out, it may be found that treatment Improve-Dementia-Care-in-Nursing-Homes.html. Pubwith an antipsychotic may no longer be suitable for a resilished: unknown; updated: 2015 April 14; accessed: dent. The State Operations Manual also addresses these 2015 Sept 28. cases and states that gradual dose reduction (GDR) should 5. Hamilton TE. Survey and Certification Letter 15-31-NH. be attempted. If the resident’s BPSD symptoms return or https://www.cms.gov/Medicare/Provider-Enrollment-and worsen after a recent GDR attempt, CMS mandates that -Certification/SurveyCertificationGenInfo/Downloads/ the prescriber must document the failed GDR. In addition, Survey-and-Cert-Letter-15-31.pdf. Published: 2015 the prescriber must give a clinical rationale for why reducMarch 27; accessed: 2015 Sept 28. tion would likely impair a resident’s function or cause psychiatric instability by exacerbating the underlying medical or 6. New CMS Proposed Rule Revises Long-Term Care psychiatric disorder.7 Facility Requirements for Medicare and Medicaid Program Participation. McDermott Will & Emery website. Conclusion http://www.mwe.com/New-CMS-Proposed-RuleThe role of consultant pharmacists in managing antipsyRevises-Long-Term-Care-Facility-Requirements-forchotic use in long term care facilities is multifaceted. The Medicare-and-Medicaid-Program-Participation-07-15pharmacist must help the facility ensure that all regulatory 2015/. Published: 2015 July 15; accessed: 2015 Sept requirements are met, adverse effects are monitored and 28. period dose reductions attempted. Managing antipsychotic 7. State Operations Manual: Appendix PP-Guidance to use begins with ruling out other causes of behavioral or Surveyors for Long Term Care Facilities (Revision 133) psychological symptoms in elderly patients with dementia https://www.cms.gov/Regulations-and-Guidance/ and first considering non-pharmacological options. If these Guidance/Manuals/downloads/ approaches do not adequately address the issue, the addisom107ap_pp_guidelines_ltcf.pdf. Published: 2015 Feb tion of antipsychotic therapy may be appropriate. In these 6; accessed: 2015 Sept 28. cases, CMS guidelines should be followed and the resident should be continuously monitored for efficacy of treatment, 8. Rabins PV, Lyketsos CG. Antipsychotic drugs in deadverse consequences and the possibility of discontinuamentia: what should be made of the risks?. JAMA. tion of treatment. Following these recommendations will 2005;294(15):1963-5. 12

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November 2015 CE—Use of Antipsychotics in LTC 9. Desai AK. Psychotropic side effects of commonly prescribed medications in the elderly. Primary Psychiatry. 2004;11(8):27-34.

November/December 2015 11. Hersch EC, Falzgraf S. Management of the behavioral and psychological symptoms of dementia. Clinical Interventions in Aging. 2007;2(4):611-621.

10. Cummings JL, Frank JC, Cherry D, et al. Guidelines for 12. Muench J, Hamer AM. Adverse effects of antipsychotic managing Alzheimer's disease: Part II. Treatment. Am medications. Am Fam Physician. 2010;81(5):617-22. Fam Physician. 2002;65(12):2525-34.

November 2015 — Use of Antipsychotics in Long Term Care Patients with Dementia 1. What percent of dementia patients will experience BPSD during their disease progression? A. 75 percent B. 30 percent C. 90 percent D. 25 percent

7. Which of the following is not one of the potential etiologies of behavioral or psychological symptoms listed? A. Delirium B. Engaging activities C. Overmedication D. Undertreated medical illnesses

2. The Boxed Warning for increased mortality in elderly patients taking antipsychotics is related to psychosis in which condition? A. Bipolar Disorder B. Schizophreniform disorder C. Dementia D. Depression 3. In the 17 placebo-controlled trials analyzed, most deaths in the antipsychotic-treated patients were ______ or ______ in nature. A. Cardiovascular, metabolic B. Neurological, infectious C. Neurological, metabolic D. Cardiovascular, infectious 4. Which of the following is a first-generation antipsychotic? A. Haloperidol B. Olanzapine C. Risperidone D. Aripiprazole 5. What percent reduction in antipsychotic use are nursing homes required by CMS to meet by the end of 2016? A. 30 percent B. 25 percent C. 15 percent D. 40 percent

8. Which of the following is not considered a non-pharmacologic treatment/consideration for behavior management? A. Pet Therapy B. Providing a predictable routine C. Avoiding clutter D. Removing patient possessions 9. Which of the following criteria warrant the use of an antipsychotic? A. Diagnosis where an antipsychotic medication may be appropriate B. Diagnosis where an antipsychotic medication may be appropriate and behavioral interventions have been attempted and included in the plan of care C. Diagnosis where antipsychotic medications may be appropriate, the symptoms present are a danger to the resident or others and the symptoms are identified as being due to mania or psychosis D. Diagnosis where an antipsychotic medication may be appropriate and the symptoms present are a danger to the resident or others 10. Which of the following is not an adverse consequence of antipsychotics that should be monitored in patients? A. Akathisia B. Weight loss C. Excessive sedation D. Orthostatic hypotension

6. F329 requirements focus on: A. The resident’s right to be informed in advance about treatment. B. The quality of care the facility must provide to the resident. C. The resident’s right to refuse treatment. D. Keeping resident’s drug regimens free from unnecessary drugs.

Send Potential CE topics to Scott Sisco at ssisco@kphanet.org 13

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November 2015 CE—Use of Antipsychotics in LTC

November/December 2015

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, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: November 17, 2018 Successful Completion: Score of 80% will result in 1.5 contact hour or .1 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. November 2015 — Use of Antipsychotics in Long Term Care Patients with Dementia (1.5 contact hour) Universal Activity # 0143-0000-15-013-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 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

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve 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 2015 — Use of Antipsychotics in Long Term Care Patients with Dementia (1.5 contact hour) Universal Activity # 0143-0000-15-013-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 Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________

Personal NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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

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December 2015 CE—Point-of-Care Testing

November/December 2015

Point-of-Care Testing within Community Pharmacy

By: Cortney M. Mospan, PharmD, East Tennessee State University Bill Gatton College of Pharmacy

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

There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-15-014-H04-P&T 2.0 Contact Hours (0.2 CEU) Goals: The purpose of this article is to increase the knowledge of point-of-care testing (POCT). Within the article, POCT will be defined, legal and regulatory considerations will be discussed and opportunities within community pharmacy practice will be suggested. The role of the pharmacist and pharmacy technician will be discussed. Objectives At the conclusion of this Knowledge-based article, the reader should be able to: 1. 2. 3. 4.

Describe the term point-of-care test; Identify opportunities for pharmacists and pharmacy technicians in point-of-care testing services; Explain the necessary resources, documentation and compliance requirements for point-of-care testing services; Recognize point-of-care testing opportunities within community pharmacy settings.

the National Community Pharmacists Association (NCPA) to develop entry-level competencies expected of today’s As community pharmacies continue to expand clinical serpharmacist. Part of these competencies require entry-level vices within their practice setting, implementation of a point graduates to be able to apply public health policy in clinical -of-care testing (POCT) program may be a viable service to situations with the specific objective to “collect, interpret enhance patient care opportunities. The average American and make recommendations based on the results of health lives within five miles of a community pharmacy; for those and wellness screenings and diagnostic tests” and living in metropolitan areas, this distance shrinks to 1.83 “describe the need for CLIA waiver and describe documenmiles.1 As of 2013, there were 69,169 community pharmatation of testing done in the community pharmacy.”8 cies in the US, employing 43 percent of an estimated 290,780 pharmacists.2,3 With an estimated 59,000-67,000 Legal and Regulatory Requirements pharmacies in the United States, there are roughly 250 milPOCT is subject to the requirements of the Clinical Laboralion visits to a pharmacy weekly, resulting in 13 billion visits tory Improvement Amendments (CLIA) that were passed in to a pharmacy in a year.4 Thus, availability of POCT at 1988 in an effort to ensure the accuracy, reliability and these locations could be an immensely convenient public timeliness of laboratory testing results in all testing locahealth tool. Not only are community pharmacies convenient tions.7 As part of these regulations, laboratories were reand accessible, it is expected that as the Patient Protection quired to undergo a rigorous certification process to be able and Affordable Care Act becomes fully implemented, our to perform laboratory tests on clinical specimens. Within delivery of health care will change immensely.5 the regulations, “waived” tests were allowed, which applied POCT has been defined as “diagnostic testing performed at to laboratory tests that could be performed with a minimal or near the site or near the site of patient care.”6 These level of complexity and possess a low risk for erroneous tests may be performed by a multitude of persons and at results. If these criteria are met, test manufacturers can varying locations. It may be performed by nurses in a forapply for a CLIA Certificate of Waiver.4,7 mal health care environment such as a hospital facility or Approval of the CLIA Certificate of Waiver indicates that the primary care clinic, by patients at home as they check their test can be performed in a nontraditional laboratory setting, own blood glucose or blood pressure, by community volunsuch as a pharmacy. The site must follow good laboratory teers at a health fair or within a screening program at a practices and posses a CLIA-waiver.4 CLIA waived tests community pharmacy.7 are tests or procedures that “are cleared by the United In 2012, a joint task force was created with the AccreditaStates Food and Drug Administration (FDA) for home use; tion Council for Pharmacy Education (ACPE), National As- employ methodologies that are so simple and accurate as sociation of Chain Drug Stores (NACDS) Foundation and to render the likelihood of erroneous results negligible; or Introduction

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December 2015 CE—Point-of-Care Testing

Table 1. Selecting the Appropriate Test Test Consideration Intended Use

Performance characteristics Patient population

Supplemental testing

Patient follow-up

Test system

Evaluation Criteria What is being measured by the test Type of sample test is approved for Final result interpretation: quantitative (number) or qualitative (positive/negative) Review manufacturer’s data on sensitivity, specificity, accuracy, precision and interferences Ensure test is accurate in patient population (some tests do not work in pediatric patients) Predictive value of a test may vary in different populations Tests may be used as screening only and required follow-up testing before confirmation of results or diagnosis (Hepatitis C, HIV, A1c in undiagnosed diabetes) What post-test counseling is needed regarding the meaning of test results (i.e. Follow-up diagnosis of reactive HIV and Hepatitis C tests; initiate pharmacotherapy) Simplicity of system Level of technical support provided by manufacturer Length of time to obtain results Specialized training (HIV tests) Quality assurance program Provision of information to patients

Adapted from “Selecting Tests” within CDC Resource To Test or Not to Test?12,13 pose no reasonable risk or harm to the patient if the test is performed incorrectly.”9 As a part of these regulations, the Centers for Medicare and Medicaid Services (CMS) issues three levels of certificates based upon complexity of the laboratory tests that are being performed. These must be applied for by all laboratories, and only can be granted by CMS. The CLIA Certificate of Waiver is the certificate required to conduct the most basic types of laboratory testing, including POCT.7

November/December 2015 Table 2. Selected CLIA-waived Tests for Use in Pharmacy Practice Anemia B-type natriuretic peptide (BNP) Borrelia burgdorferi (Lyme Disease)

Cholesterol Group A Streptococcus Helicobacter pylori (Peptic Ulcer Disease [PUD]) Hemoglobin A1c Hepatitis C

HIV Influenza type A and type B INR (Warfarin monitoring, coagulation deficiencies) Liver function (AAT, AST, ALT) Mononucleosis Renal function (blood urea nitrogen [BUN], serum creatinine) Thyroid stimulating hormone (TSH) Whole blood chemistries (e.g. sodium, potassium, glucose)

Adapted from CMS: Tests Granted Waived Status Under CLIA 25 automatically approved for CLIA Certificate of Waiver. Professional use versions of these home use tests are not automatically granted the CLIA Certificate of Waiver; however, they qualify for expedited waiver review since only the differences between the home use and professional use versions must be examined in determining if the professional version qualifies for waiver.10 Community pharmacies interested in offering POCT services must obtain a CLIA Certificate of Waiver from CMS, which requires completion of CMS form 116. Instructions for the Certificate of Waiver can be found online through CMS State Agency and Regional Office contacts.11 More information on how to obtain a Certificate of Waiver can be found online at http://www.cms.hhs.gov/CLIA/downloads/ HowObtainCertificateofWaiver.pdf Once the application is sent to the State Survey agency, the pharmacy must pay the biennial certificate fee. The application process typically takes 2-3 months, and pharmacies must allow announced inspections by CMS.7 As a result, following manufacturer guidelines (for procedure and quality control), maintaining a policies and procedure manual and documenting of all testing activities is critical. Table 1 describes evaluation criteria that should be used when selecting which POCT a pharmacist will use in his or her clinical service.

In November 1997, Congress revised CLIA waiver proviThere are currently 120 different CLIA-waived tests that are sions so that tests approved by the FDA for home use were available in the US. Table 2 describes POCT that are espe16

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December 2015 CEâ&#x20AC;&#x201D;Point-of-Care Testing

November/December 2015

cially relevant to pharmacy practice. The majority of these tests can be performed without specialized equipment and can provide results within 5-20 minutes.4 By utilizing POCT, pharmacists have the ability to have a positive impact on healthcare in a multitude of ways. Pharmacists can identify patients at risk for a condition who may need to be referred on further for diagnosis and treatment, involve patients in their care by providing monitoring, address therapeutic issues with a patient when lab results are provided and provide progression information on conditions between physician appointments.10 POCT can be divided into two general groups: (1) equipment designed to be operated by a patient; and, (2) equipment designed to be operated by a healthcare provider outside of a traditional laboratory. 10 Pharmacies also must follow Occupational Safety and Health Administration (OSHA) requirements to provide a safe and healthy work environment to save lives and prevent injuries. OSHA is housed within the US Department of Labor. Regulations cover all aspects of workplace hazard avoidance; when considering POCT, the most relevant precautions are those regarding healthcare workers and needlestick precautions.7 Pharmacists and pharmacy technicians involved in the collection of body fluids should be especially aware of OSHA requirements. OSHA regulations related to POCT services include work practice and engineering controls to prevent needlesticks through consistent and safe procedures while performing laboratory tests and use of personal protective equipment (i.e. gloves and protective eyewear). Additional requirements to consider involve employee training, creating and updating an easily accessible exposure control plan in event of a needlestick, provision of equipment for safe handling and disposal of biohazardous waste and recordkeeping. All needlestick precautions, such as Hepatitis B vaccination, must be provided at no cost to the employee. OSHA requirements also require separate refrigerators for testing supplies or samples from food or drink. Further, there should be no eating, drinking or applying makeup in areas where the samples are collected or where testing is performed.12

can occur, and it is important to develop a quality management process to ensure high-level patient care. Development of policies and procedures for POCT services and maintaining documentation is crucial.10 All parts of the process must be documented to assure quality. This includes equipment logs, maintenance logs, quality control, testing records for patients and results.13 It also is advisable to maintain individual HIPAA notification for POCT services performed within a community pharmacy setting as well as training records for employees. As part of safety regulations, there should be a written plan for exposure as well as a record of occupational injuries; both of these are part of OSHA regulations.12 A program coordinator should be identified who oversees these pieces. Documentation should be kept in one location, including instruction manuals for the POCT devices. POCT utilization is highly underutilized by the profession of pharmacy, due to varying challenges. Some states limit the ability of pharmacists to perform POCT tests. Only eight states directly address POCT within their pharmacy practice act; five of these states specify which POCT pharmacists can perform.14 Another location for pharmacists to evaluate ability to perform POCT is within collaborative drug therapy management (CDTM). In the US, 43 states have some type of CDTM provisions within regulation or statute. CDTM allows pharmacists to react to the results of the test to provide care and eliminates communication barriers in sharing recommendations resultant to the POCT performed.14

Pharmacists also must consult their state pharmacy practice act to ensure they are within their scope of practice. You can refer to your state board of pharmacy for this information.7 States allowing collaborative practice opportunities are ideal for implementation of POCT, as they allow for action based off Strep A or influenza tests.

Likely, the largest barrier to utilization is lack of recognition within the Social Security Act (SSA) of pharmacists as providers. Without recognition as providers, and without the reimbursement that would follow provider recognition, take up of these services will be limited. Patients are willing to pay for these services, but not at a price that would allow a sustainable business model. By recognizing pharmacists as providers, additional primary care access would be provided for a healthcare system that is facing a shortage of primary care providers and an increasing population of insured Americans. Opportunities for POCT within Pharmacy Practice

Chronic Disease State Screening and Monitoring. For patients with chronic conditions, POCT may be a valuable tool for disease state management or disease screening. These convenient, affordable and fairly quick tests allow pharmaPOCT is not without drawbacks. CLIA-waived tests are rap- cists to play a vital role in the healthcare team. Common idly changing, developing and improving; keeping up with POCT tests for disease state management, such as hemothe technology and maintaining a high level of efficiency globin A1c and blood glucose for diabetes; blood pressure and quality with minimal errors can be challenging. It is im- measurement for hypertension; INR monitoring for warfarin portant to remember that no device is â&#x20AC;&#x153;foolproof.â&#x20AC;? Errors therapy and cholesterol panels for hyperlipidemia allow 17

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December 2015 CE—Point-of-Care Testing pharmacists to work with patients in monitoring disease progression, and allow timely interventions to improve disease state management. There are currently 71 million Americans who have high “bad” LDL cholesterol. Only one-third of these patients have their condition controlled, and less than half of these patients receive treatment for their condition.15 Cholesterol screening and monitoring could vastly improve management of this condition with significant adverse outcomes on cardiovascular health.

November/December 2015 for infectious diseases of public health concern (i.e. HIV and Hepatitis C). Certain infectious diseases must have positive test results reported. Pharmacists should check with their local health departments for the most up-to-date information on required reporting procedures; these change over time and vary by state.13

Currently, more than 1.2 million people in the US are living with HIV, and an estimated 12.8 percent are living unaware they have the disease.18 It has been previously demonstrated that people living with HIV/AIDS who are aware of their diagnosis are much less likely to spread the disease According to the 2014 Diabetes Report Card, there is an through high-risk behaviors; thus, the CDC recently recomestimated 29 million Americans who have diabetes; 8.1 mended that all individuals ages 13-64 be screened and all million of these Americans are undiagnosed and do not HIV positive individuals begin antiretroviral therapy immediknow that they have diabetes. Further, 86 million Ameriately.19 Nearly 50,000 new HIV infections occur each year cans (one-third of the population) are living with prediabein the US, with approximately 50 percent resulting from pates.16 Utilization of POCT for diabetes screening within the tients unaware of their HIV status. There are many barriers community pharmacy provides a clinical service opportunileading to lack of awareness, such as lack of primary care ty, but also would hopefully identify patients who need to be provided for at-risk patients and expense of screening in referred to their primary care provider for diagnosis and traditional settings.19 This presents a public health opporearlier treatment. tunity for community pharmacies. Previous pilot projects Waitzman et al. previously found that 30 percent of patients have shown convenience and accessibility of community on Warfarin did not view their physician office as a conven- pharmacies as significant motivators to be screened for ient setting to have their INR tested monthly. Half of the HIV.20 In developing an HIV testing service, local health patients would be interested in having their INR performed departments can be valuable partners in developing testing by a trained community pharmacist within their local compolicies and referral lists for confirmatory HIV testing and munity pharmacy. Further, 43 percent of patients respond- care.21 ed that they would be willing to pay out-of-pocket for INR Hepatitis C virus (HCV) screening is another opportunity for monitoring at a community pharmacy.17 community pharmacies. The CDC has recently updated Acute Care for Infectious Conditions. Timely diagnosis is screening recommendations to include all people born from critical for treatment, prevention of complications and pre1945 to 1965 or the “baby boomer” generation due to high vention of spread for infectious diseases like influenza and incidence. Additional patient populations at high risk for Group A Streptococcus. Each year, 6-20 percent of US res- HCV include injection drug users, HIV-infected patients, idents are infected with influenza. While influenza is gener- those who received a blood transfusion prior to 1992, ally self-limiting, serious complications or death can result. chronic hemodialysis patients and healthcare workers with More than 200,000 individuals are hospitalized due to influ- exposure risks. It is estimated that approximately 3.2 million enza and related complications each year.5 By identifying people are living in the US with HCV, many patients remain infections and initiating appropriate therapy in the commu- asymptomatic until late states of the disease.22 Pharmacies nity setting, healthcare dollars can be saved and inapprowho offer HIV screening should especially consider HCV priate use of antimicrobial therapy may be reduced.14 It has screening as there is high rate of co-infection. been demonstrated that rapid-diagnostic tests for influenza Strategies for Implementation assessment can be successfully incorporated into a workflow at a community pharmacy with minimal disruption. This The Centers for Disease Control and Prevention (CDC) was especially true with use of well-trained pharmacy tech- have developed two resources that are beneficial in ensuring all aspects of your POCT have been considered: nicians who collected patient histories and vital signs.5 “Ready! Set? Test!” and “To Test or Not to Test?”12,13 Availability to enter a collaborative practice agreement for appropriate prescribing following positive or reactive test When providing POCT as part of a Collaborative Practice results is essential for a valuable service to enhance patient Agreement (CPA) or Collaborative Drug Therapy Managecare for these infectious diseases. ment (CDTM) agreement, pharmacists need to be aware that there will be greater liability associated with their pracPublic Health Screening. It is important to research public health reporting requirements prior to implementing POCT tice. Generally, the supervising physician is not liable for 18

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December 2015 CE—Point-of-Care Testing

November/December 2015

the pharmacist’s actions, just like in the administration of a vaccine. Pharmacists should contact their liability insurance carrier to determine if the pharmacy or individual policy covers performing and/or interpreting POCT results. Insurance companies cannot ensure an illegal activity (if state does not allow pharmacists to conduct POCT); if legal, the insurer may still decide not to underwrite it. State pharmacy boards may be a valuable ally in this discussion.14

for continuity of care when more than one staff member or pharmacist is involved in the service. It also provides legal evidence, and when submitting to payers, specific documentation will be required.7 As mentioned previously, patients should be provided with a Health Insurance Portability and Accountability Act (HIPAA) disclosure with each POCT service. Patients also must sign a consent form before completion of a test. This will reduce associated liability of the test by describing potential benefits and risks of Prior to implementation of POCT services, a thorough the test; the consent form can be test specific or can be SWOT analysis and cost-to-benefit ratio should be congeneral for all tests. A consultation and medical history ducted. Previously, POCT services have been implementform must also be completed, and there should be docued in a frenzy, especially in hospital settings or hospital mentation of the encounter in the pharmacy records.7 Pamanaged clinics, which can lead to testing errors or service tients should be provided with a visit note describing their pitfalls.10 In the community pharmacy setting, pharmacists test results and course of action. should carefully evaluate implementation costs to determine a breakeven point, service fee and determine if that Pharmacy Technician Role price will be acceptable to patients. Pharmacy technicians have played a critical role in the proWhile CLIA-waived testing in pharmacies can be beneficial, gression of the profession of pharmacy practice, and have if there is not a market for the service, infrequent testing demonstrated their role as a key factor for the success of may result in concerns about staff ability to correctly perclinical services within community pharmacies (including form the test. Infrequent testing also can have increased Medication Therapy Management and adherence monitoroperating costs due to reagents and controls becoming ing).7,23,24 The role of the pharmacy technician has begun outdated before being completely used. Consider the folto expand beyond traditional roles and responsibilities, inlowing factors prior to implementing POCT in your practice: cluding managing inventory, data entry, the preparation of compounded medications and dispensing of medications.24 (1) Test oversight: Who will be responsible for managing Pharmacy technicians are beginning to take on more patesting and decision making to ensure quality? 12 tient-centered tasks, and are a critical factor in a successful (2) Regulatory requirements: What are the federal and POCT program.23,24 state requirements for safety, testing, confidentiality and An often forgotten step within development of a clinical serprivacy? What does the state practice act allow? Is CDTM vice is the role of a pharmacy’s support staff. Pharmacy an option in the state?12 technicians are a foundation of the development of strong patient relationships, and can enhance marketing of the (3) Location: Is there room in the pharmacy? Testing service when they are involved in development and are should be performed in a location with adequate space, 7,23,24 Incorporating appropriate physical environment and accommodations for aware of all of the steps and processes. 12 pharmacy technicians into the workflow of a POCT proproper disposal of biohazardous waste. gram will increase the overall efficiency. The development (4) Test selection: Consider test characteristics, sample of a POCT program is an extensive process and may rerequirements, time and cost.12 quire several months; pharmacy technicians can decrease (5) Personnel: Who will perform the service? What will the the burden of development by assisting with research and completing necessary documentation with CMS for CLIAworkflow look like? Must determine training and periodic waived testing or with development of the pharmacy’s poliassessment on ability to perform quality testing.12 cies and procedures. With previous experience in inventory (6) Testing: Ensure manufacturer’s instructions are availamanagement, a natural way to engage pharmacy technible, are understood and are followed in conducting the cians would be management of test strips/cartridges/ test.12 reagents as well as other necessary materials such as cot(7) Quality Assurance: Develop a plan to monitor, evaluate ton swabs, bandages, cleaning supplies, single-use lancets and identify opportunities for improvement.12 and other needed supplies. Documentation is a vital component of POCT services. “If it The role of the pharmacy technician in the management of isn’t documented, you didn’t do it.” Documentation allows POCT workflow is essential. Pharmacy technicians should

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December 2015 CE—Point-of-Care Testing

November/December 2015

be utilized for all of the administrative functions of a POCT Task Force. Entry-Level Competencies Needed for service, including scheduling appointments (keeping in Community Pharmacy Practice. Spring-Summer 2012. mind morning appointments may be necessary if the test is 9. Commission on Laboratory Accreditation. Laboratory fasting); reminder calls; completion of paperwork; collection Accreditation program Point-of-Care Diagnostic Testing of medication histories; collection of demographic inforChecklist, College of American Pathologists, Oct 31, mation; preparation of the testing site; collection of consent 2006. and completion of any necessary paperwork for billing pur10. Lippi G, Plebani, Favaloro EJ, Trenti T. Laboratory testposes.23,24 ing in pharmacies. Clin Chem Lab Med. 2010;48(7):943 Conclusion -953. POCT provides an opportunity for enhanced patient care 11. Centers for Medicare and Medicaid Services. Clinical within the community pharmacy setting. Community pharLaboratory Improvements Amendments (CLIA). Web. macists are well positioned to provide access to valuable Accessed 22 Oct 2015. Available at: screening tools as an additional point of health care access http://www.cdc.gov/clia. for patients. In developing a POCT service, several factors must be considered before service implementation such as 12. “To test or not to test? Considerations for waived testing.” Centers for Disease Control and Prevention. business plan development, CMS 116 form submission, 2012. OSHA compliance and state pharmacy practice act as well as collaborative practice opportunities. Pharmacy technicians can play a valuable role in service workflow and documentation.

13. “Ready? Set? Test! Patient testing is important. Get the right results.” Centers for Disease Control and Prevention. 2011.

References

14. Gubbins PO, Lepser ME, Dering-Anderson AM. Pointof-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy. J Am Pharm Assoc. 2014;54(2):163-171.

1. RxIMPACT. By the numbers: how community pharmacists measure up. Drug Store News. 2015;4:8-9. 2. National Community Pharmacists Association: annual report 2014 In: 2014 NCPA Digest. Alexandria, Va; National Community Pharmacists Association; 2014.

15. “Cholesterol Fact Sheet”. Centers for Disease Control and Prevention. Web. Accessed 22 Oct 2015. Available at: http://www.cdc.gov/dhdsp/data_statistics/ 3. Occupational Employment Statistics: 29-1051 Pharmafact_sheets/fs_cholesterol.htm. cists. http://www.bls.gov/oes/current/oes291051.htm. Accessed June 2, 2015. 16. Centers for Disease Control and Prevention. Diabetes 4. Burley E, Klepser S, Klepser M. Opportunities for pharmacists to improve access to primary care through use of CLIA-waived tests. Michigan Pharmacist. 2014;52 (2):8-11. 17. 5. Klepser D, Dering-Anderson A, Morse J, et al. Time and motion study of influenza diagnostic testing in a community pharmacy. INNOVATIONS in pharmacy. 2014;5(2):Article 159.

Report Card 2014. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2015. Waitzman J, Hiller DP, Marciniak MW, Ferreri S. Assessment of patient perceptions concerning a community pharmacy-base warfarin monitoring service. INNOVATIONS in pharmacy. 2012;3(1):Article 65.

18. “HIV in the United States: At a Glance.” Centers for Disease Control and Prevention. Web Accessed 23 Oct 6. Kost GJ. Guidelines for point-of-care testing: improving 2015. Available at: http://www.cdc.gov/hiv/statistics/ patient outcomes. Am J Clin Pathol. 1995;104(sup basics/ataglance.html. 1):S111-S127. 7. Rodis JL, Thomas RA. Stepwise approach to developing point-of-care testing services in the community/ ambulatory pharmacy setting. J Am Pharm Assoc. 2006;46(5):594-604.

19. Dugdale C, Zaller N, Bartberg J, Berk W, Flanigan T. Missed opportunities for HIV screening in pharmacies and retail clinics. J Manag Care Spec Pharm. 2014;20 (4):339-345.

8. National Association of Chain Drug Stores (NACDS), National Community Pharmacists Association (NCPA,) Accreditation Council for Pharmacy Education (ACPE)

20. Gorostiza I, Elizondo Lopez de Landache I, Braceras Izagirre L. HIV/AIDS screening program in community pharmacies in the Basque Country (Spain). Gac Sanit. 20

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November/December 2015

2013;27(2):164-66. 21. Weidle PJ, Lecher S, Botts LW, et al. HIV testing in community pharmacies and retail clinics: a model to expand access to screening for HIV infection. J Am Pharm Assoc. 2014;54(5):486-492.

and point of care testing. J Pharm Tech. 2015;31(4):143 -148. 24. Kadia NK, Schroeder MN. Community pharmacy-based adherence programs and the role of pharmacy technicians: a review. J Pharm Tech. 2015;31(2):51-57.

22. D’Angelo RG, Klepser, Woodfield R, Patel H. Hepatitis C virus screening: a review of the OraQuick hepatitis C virus antibody test. J Pharm Tech. 2015;31(1):13-19.

25. “Tests granted waived status under CLIA”. Centers for Medicare and Medicaid Services. Web. Accessed 23 Oct 2015. Available at: https://www.cms.gov/ Regulations-and-Guidance/Legislation/CLIA/downloads/ 23. Keller ME, Kelling SE, Bright DR. Pharmacy technicians waivetbl.pdf.

December 2015 — Point-of-Care Testing within Community Pharmacy 1. Which of the following pharmacy organizations was not part of a task force recommending competency in CLIA waivers? A. NACDS B. APhA C. NCPA D. ACPE

7. Which of the following is NOT a current barrier to implementation of POCT within community pharmacies? A. Lack of recognition as a provider in the SSA B. Lack of patient interest C. Potential lack of ability to perform according to state practice act

2. Which form must be submitted to CMS in order for a pharmacy to become a CLIA-waived laboratory? A. CMS form 116 B. CMS form 1500 C. CMS form 1561 D. CMS form 10114

8. Pharmacy technicians can be involved in paperwork collection for POCT services such as patient history and consent. A. True B. False

3. As part of OSHA needlestick precautions, which immunization must be offered to any pharmacy staff in contact with bodily fluids? A. Hepatitis A vaccine B. Hepatitis B vaccine C. Hib vaccine D. Influenza vaccine 4. All of the following would be considered a POCT EXCEPT: A. Rapid-diagnostic influenza test performed at a community pharmacy. B. Cholestech LDX® screening at a state fair. C. TSH screening via venipuncture at a primary care office. D. Blood glucose test performed in an Emergency Room. 5. According to CDC recommendations, which of the following correctly represents patient population(s) for which HIV screening is recommended? A. “Baby boomers” B. Infection drug users and MSM (men who have sex with men) C. All persons 13-64 6. Which of the following patient populations does the CDC recommend HCV screening for currently? A. “Baby boomers” B. Chronic dialysis patients C. HIV infected patients D. All of the above

9. Pharmacists are able to provide POCT services according to the authority of which body? A. CMS B. OSHA C. NACDS D. State Board of Pharmacy 10. All of the following must be collected to complete a POCT within a community pharmacy EXCEPT: A. HIPAA disclosure. B. Patient consent. C. Patient assessment and history. D. Written physician consent. 11. Point-of-care tests exist for all of the following conditions EXCEPT: A. TSH. B. Lyme disease. C. Sickle cell disease. D. PUD. 12. When uncertain if a test possesses a certificate of waiver, one should verify with which of the following organizations? A. CMS B. State Board of Pharmacy C. Test Manufacturer D. OSHA

THE KENTUCKY PHARMACIST

December 2015 CE—Point-of-Care Testing

November/December 2015

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, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: November 17, 2018 Successful Completion: Score of 80% will result in 2.0 contact hours or .2 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. December 2015 — Point-of-Care Testing within Community Pharmacy (2.0 contact hours) Universal Activity # 0143-0000-15-014-H04-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C 2. A B C D 4. A B C D 6. A B C D

7. A B C 8. A B

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

11. A B C D 12. A B C D

Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) PHARMACISTS ANSWER SHEET December 2015 — Point-of-Care Testing within Community Pharmacy (2.0 contact hours) Universal Activity # 0143-0000-15-014-H04-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C 2. A B C D 4. A B C D 6. A B C D

7. A B C 8. A B

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

11. A B C D 12. A B C D

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

THE KENTUCKY PHARMACIST

Bob Lichtefeld

November/December 2015

Former executive director passes Robert J. Lichtefeld, 87, who served as executive director of the Kentucky Pharmacists Association from 1965 to 1978, died Oct. 23 after a brief illness. The son of a pharmacist, Mr. Lichtefeld was a 1953 honors graduate of the University of Kentucky, earning a bachelors of science in pharmacy. He received a masters in public health degree from the University of California Berkeley in 1959. In 1965, he was working as an inspector for the Board of Pharmacy when the long-time executive director of the pharmacists association died suddenly. Mr. Lichtefeld was chosen as his successor. "Bob stepped into a leadership void," said Robert McFalls, who is the current executive director. He cited construction of a new association building among Mr. Lichtefeld's major achievements. The association named him Kentucky's "Pharmacist of the Year" in 1966. Mr. McFalls interviewed Mr. Lichtefeld in 2014 for a video that can be viewed at bit.ly/BobLichtefeld.

only 15 Lifetime Memberships in the association, a significant honor in a state with 8,000 registered pharmacists. Mr. McFalls said the group hoped to surprise Mr. Lichtefeld Gloria Doughty, a retired pharmacist who worked with Mr. with the award at the KPhA Board of Directors meeting in Lichtefeld 50 years ago, described him as a leader who October, but that he had not responded to phone messag"saw potential in people" and put them to work. She said es. The Association sent a copy of the certificate to Mr. his encouragement was crucial to her becoming the first female member of the Board of Pharmacy. A life-long bach- Lichtefeld's family this week. It was dated the day he died. elor who lived in the same modest apartment in Frankfort Survivors include two nephews in addition to Mr. Keenan, for 50 years, Mr. Lichtefeld was a Cincinnati Reds fan who H. John Lichtefeld of Boardman, Ohio and James watched a lot of baseball on TV. He was also a car buff Lichtefeld of Louisville; two nieces, Martha DeJaco of Louwho kept years of back issues of Car and Driver Magazine isville and Carol Mitchell of Boston, Ma.; and the widow of within easy reach of his favorite chair. "Until recently, he nephew Brendan Keenan, Karen Keenan of Cincinnati. always had a car of his own special choosing," said one of his nephews, Geoff Keenan of Cincinnati. "He could tell Services were private. The family suggests donations to you exactly why he bought the car he bought." the American Cancer Society. Mr. Keenan recalled how Mr. Lichtefeld and his siblings cared for their mother, Martha, before she died at 98 in 1994. "He was very attentive, tender and caring," he said.

Ratterman and Sons, 3800 Bardstown Road was entrusted with arrangements. - See more at: http://www.legacy.com/ obituaries/louisville/obituary.aspx?n=Robert-JEarlier this year, KPhA voted to award Mr. Lichtefeld one of Lichtefeld&pid=176270244#sthash.c67KKg5c.dpuf

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to eramey@kphanet.org . Deceased members for each year will be honored permanently at the KPhA office. 23

THE KENTUCKY PHARMACIST

KPhA Emergency Preparedness

November/December 2015

For more information on how you can be involved in the KPhA Pharmacy Emergency Preparedness Initiative, contact Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness at 502-227-2303 or by email at ltolliver@kphanet.org. KPhA is a partner with the Kentucky Department for Public Health for emergency preparedness and disaster response.

For more resources, visit YOUR www.kphanet.org and click on Resourcesâ&#x20AC;&#x201D;Emergency Preparedness.

KPhA Pharmacy Emergency Preparedness Initiative Interest Form

Name: ______________________

Status (Pharmacist, Technician, Other): ___________________

Email: ______________________________ Phone: ___________________________ Interest in serving as a volunteer: Yes____ No ____ Interest in serving as a Volunteer District Coordinator: Yes____ No _____ You also may join the Medical Reserve Corps by following the KHELPS link on KPhA Website to register (www.kphanet.org under Resources) Please send this information to Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness via email at ltolliver@kphanet.org, fax to 502-227-2258 or mail at KPhA, 1228 US 127 South, Frankfort, KY 40601.

The Kentucky Pharmacist is online! Go to www.kphanet.org, click on Communications and then on The Kentucky Pharmacist link.

Would you rather receive the journal electronically? Email ssisco@kphanet.org to be placed on the Green list for electronic delivery. Once the journal is published, you will receive an email with a link to the online version. 24

THE KENTUCKY PHARMACIST

Pharmacists Mutual Surety Bond

November/December 2015

Pharmacists Mutual Insurance offers Medicare Surety Bond In 2009 the Centers for Medicare and Medicaid Services (CMS) implemented Surety Bond Requirements for suppliers of Durable Medical Equipment, Prosthetics and Supplies (CMS-6006-F). This ruling requires that each existing supplier must have a $50,000 surety bond to CMS.

the bond from $1,500 down to $250 for qualifying risks. To see if you qualify for a $250 Medicare Surety Bond, or would like information regarding our other products, please contact us:   

Pharmacists Mutual Insurance Company, through its subsidiary PMC Advantage Insurance Services, Inc. d/b/ a Pharmacists Insurance Agency (in California), led the way to meet this requirement by negotiating the price of 

Call 800.247.5930 Extension 4260 E-mail medbond@phmic.com Contact a Pharmacists Mutual Field Representative or Sales Associate http://www.phmic.com/phmc/ services/ibs/Pages/Home.aspx In Kentucky, contact Bruce Lafferre at 800.247.5930 ext. 7132 or 502.551.4815

138th KPhA Annual Meeting and Convention June 2-5, 2016 Louisville Marriott Downtown

THE KENTUCKY PHARMACIST

Pharmacy Time Capsules

November/December 2015

Pharmacy Time Capsules 2015 (Fourth Quarter) 1990 

There were 174,000 pharmacists in US



31 percent of actively practicing pharmacists are women according to a study in JAPhA (2006;46:322-330)

1965 

The average cost for a prescription was around $3.50 according to 1965 Lilly Digest ($26.34 in 2015 dollars).



Older American Act passed. Services to the aged include disease prevention/health promotion services

1940 

Lilly Digest reported that 13 percent of pharmacies in the 1940 survey were operating at a loss. An additional 12 percent had less than 2 percent net profit.



Woodruff and Waksman isolated and purified actinomycin from Actinomyces griseus

By: Dennis B. Worthen, PhD, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America's history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org

The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years

Watch eNews and subsequent editions of The Kentucky Pharmacist for more information on ways YOU can help replace YOUR KPhA Headquarters! Visit http://www.kphanet.org/?page=buildingcampaign for more information. 26

THE KENTUCKY PHARMACIST

Kentucky Renaissance Pharmacy Museum

November/December 2015

The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy. While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration.

Friend of the Museum $100  Proctor Society $250 Damien Society $500 Galen Society $1,000 Name______________________________________ Specify gift amount________________________ Address ____________________________________ City____________________Zip______________ Phone H____________________W________________ Email___________________________________ Employer name_____________________________________________________for possible matching gift. Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually.

Questions: Contact Lynn Harrelson @ 502-425-8642 or Lharrelsonky@aol.com

For more information on the Kentucky Renaissance Pharmacy Museum, see www.pharmacymuseumky.org or contact Gloria Doughty at g.doughty@twc.com or Lynn Harrelson at lharrelsonky@aol.com.

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

November/December 2015

KPhA Welcomes New and Renewing Members September-October 2015 Jamal Aboulhosn Louisville

Bradley A. Boone Marion

Robert E Cull Owenton

Michael Akers Grayson

Chris Bowling Barbourville

Angela Dean Ft. Mitchell

Cynthia Akers Grayson

Deborah Lee Brewer Sandy Hook

Alfred L Diebold Louisville

Charla Ann Applegate Nicholasville

James C Brown Bowling Green

Kristie Doan Louisville

Robin Applegate Nicholasville

Jimmy W Buchanan Prospect

Brittany Thomas Downing Pine Knot

Thomas L Arnold Nicholasville

Johnny Walker Burke Prestonsburg

Derek Downing Pine Knot

To YOU, To YOUR Patients To YOUR Profession!

Michael Kent Baker Louisville

Scott E Burris Partridge

Michael Glenn Downs Lexington

Jane J Fletcher Leitchfield

Verlon Banks Whitesburg

Robert Burton Hazard

Whitney DuBois Cincinnati, Ohio

Shane Fogle Central City

Nancy Horn Barker Winchester

Kenneth D Calvert Glasgow

David Dubrock Arlington

Tom Roe Frazer Sturgis

Jennifer Barker Morehead

Marietta L Campoy Pikeville

Jennifer Dyer Albany

Milton Dale Frizzell Murray

Kerri L Barman Scottsville

Mashawna Caudill Isom

Bruce T Eckerle Louisville

Barry N Frost Columbia

Ronald E Barned Glasgow

John Chaney Hazard

Mark Edwards Richmond

Kelli Funk Louisville

Keith Barnes Elizabethtown

Donald Dale Clark Rockfield

Cathy Edwards Richmond

Peggy Gibson Elkton

Kristen Nicole Bell Union

Richard G Clement Cadiz

Rita Etter Williamson, W.Virg.

Amy Gordon Louisville

Justin Bell Georgetown

Charles R. Clifton Fort Thomas

Brian E Fingerson Louisville

Charles Len Gore Nicholasville

Jim R Bell Sebree

Rhonda Cochran Liberty

Jennifer L Fitch Lexington

Linda L Gormley Villa Hills

Thomas M Beringer Sparta

Elizabeth Cole Louisville

Laura H Fleener Leitchfield

John Gorrell Morehead

Christopher Betz Louisville

Kimberly Lynn Corley Owensboro

William K Fleming Prospect

Marsha Greer-Arnold Louisville

Joseph A Bickett Louisville

Randy D Crawford Franklin

Charles R Fletcher Monticello

Jack B Gross Louisville

MEMBERSHIP MATTERS:

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

November/December 2015

Rodney Haddix Lexington

David E Kemplin Lexington

Aaron Lohnes Stanville

Lance Murphy Louisville

Pamela Haeberlin Louisville

Jennifer Kidwell Covington

Robert Long Louisville

Daniel Nall Louisville

Kimberly Hardeman Clearfield

Erin Kingrey Austin

Molly Peck Lucas Erlanger

Troy Neagle Glasgow

Kyle Harris London

Alex Klingenbeck Ft. Thomas

Terry Manley Mount Sterling

James Rodney Neat Louisville

Amanda Helton Pathfork

Kerry Knochenmus Louisville

William Pat Mattingly Lebanon

Clarinda Newell Greenup

Emily C. Henderson Shelbyville

Robert Knott Paducah

Ronald D McClish Simpsonville

Jamie Norman Russellville

Julie Hinkel Fort Thomas

Dhaval Kotak Oak Forest, Ill.

Charlene McCown Grayson

Kenneth Norwood Louisville

Amanda Holder Bowling Green

Andrea Kramer Covington

Sheldon M. Mccreary Louisa

Fred Nowak Independence

Michael D Horne Georgetown

Molly H Kulp Louisville

Christopher McGlone Vanceburg

Robert S Oakley Louisville

Jerry J Horwitz Cincinnati, Ohio

Michael Kupper Louisville

William I. McMakin La Grange

Jeff O'Connor Frankfort

Celina Howell Pikeville

Judith B Lawson Monticello

John McMeans Ashland

Dennis Parker Glasgow

Bryan Howze St. Augustine, Fla.

Nick Ledgerwood Nicholasville

Nicole Maroudas McNamee Forest Hills

Willie Patton Grayson

Gerard M. Hyland Manchester

Jill E Lee Frankfort

William Merrick Louisville

Vincent Peak Louisville

Patrick James Louisville

Sheila Diane Lee Simpsonville

Jesica Mills Owensboro

Robert Perkins Clinton

Jessica Johnson Louisville

Robert Lester Elkhorn City

Parvin Mischel Kathleen, Ga.

Andrea Potter-Adams Isom

Phillip Johnson Georgetown

Lisa Ellen Lewis Lexington

Emily Morton Hardinsburg

Walter William Powell Louisville

Kim Jones Williamsburg

Donna Lile Campbellsville

Steven J Mueller Petersburg

Amanda Rapson-McCoy Hebron

Karen Knight Jones Gilbertsville

Douglas Linger Georgetown

Stephanie Mullins Fisty

Nicholas Rawe WIlder

Megan Kappes Fort Mitchell

Emily Lodwick Newport

Shelia Mullins Richmond

James Ray Hopkinsville

KPhA Honorary Life Members Ralph Bouvette Leon Claywell R. David Cobb Gloria Doughty Kenneth Roberts Ann Amerson Mazone 29

Wendy Renfrow Barlow C. Levi Rice Beaver Dam

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

November/December 2015

Brian Matthew Rickert Florence

Mary Roberts Scott Robinson Creek

Jack Stone Mayfield

Todd Walters Pineville

Eugene Carroll Riley Russellville

Susanna Sexton Cornettsville

Cindy D Stowe Louisville

Julie Warren Gamaliel

Stewart Riley Elkton

Michael Sheets Fisherville

Tracy Sullivan Paducah

Kim Wheatley Bardstown

Kristie Roark Whitesburg

Jarrod Shirley Glasgow

Richard Sutton LaCenter

Ronald Whitmore Alvaton

Brandy Marie Robertson Barlow

Kelli Shirley Glasgow

Brittany A Taylor Lancaster

Lewis Wilkerson Frankfort

James Robinette London

JD Shoulders Bowling Green

Gloria J Taylor Louisville

Kim Wilkerson Frankfort

Lynda Romeo Louisville

Angela Shoulders Bowling Green

Deborah B Thorn Bowling Green

Lisa Williamson Nicholasville

Elizabeth Routh Louisville

Joe Simmons Glasgow

Joel Thornbury Pikeville

Jacob Wishnia Louisville

Stacy Rowe Louisville

Angela Rose Slaughter Covington

Sandy Thornbury Pikeville

Carol Wishnia Louisville

Ashley Nicole Saling Mammoth Cave

William Smallwood Independence

David K Triplett Louisville

William D Wooden Leitchfield

Gregory John Sanders Lexington

Lois Smith Blackey

Brenda Turner Jackson

Glenn B Wooden Leitchfield

Alex Schickli Lexington

Glenn W Stark Frankfort

Jonathan D. Van Lahr Webster

Ellen Louise Schueler Franklin

Sandra Staton Albany

Lorne Virgin Grayson

Know someone who should be on this list? Ask them to join YOU in supporting YOUR KPhA! Donate online to the Kentucky Pharmacists Political Advocacy Council! Go to www.kphanet.org and click on the Advocacy tab for more information about KPPAC and the donation form.

THE KENTUCKY PHARMACIST

Naloxone Training

November/December 2015

Naloxone Certification Training Continues KPhA and its partners in the Advancing Pharmacy Practice in Kentucky Coalition (KSHP, Board of Pharmacy, SUCOP, UKCOP and APSC), continued to tour the Commonwealth through October and November, meeting with pharmacists, student pharmacists and pharmacy technicians and providing the Naloxone training course. Nearly 500 pharmacists, student pharmacists and pharmacy technicians have completed the training so far. The Fall 2015 tour wrapped up on November 19 in Louisville. The next scheduled stop is at the February 18 KPhA District 4 meeting in Bowling Green. Watch eNews for further dates and more details!

Kentucky Board of Pharmacy President Joel Thornbury, Kentucky Society of Health System Pharmacists President Mike Herald, KPhA ED Robert McFalls, SUCOP Dean Cindy Stowe, Kentucky Board of Pharmacy ED Steve Hart and KPhA President-Elect and UKCOP professor Trish Freeman pose with Roamey before the event in Pikeville in early November.

The online training program can be found at the following link on the KPhA website: http://www.kphanet.org/?page=NaloxoneCert2015 The cost of the training is $5 for KPhA members, and $10 for non-KPhA members. After successfully completing the course, credit will be applied to your CPE Monitor Profile and you will be emailed a certificate of completion.

THE KENTUCKY PHARMACIST

Pharmacy Law Brief

November/December 2015

Pharmacy Law Brief:

Developments Related to TeleHealth Author: Joseph L. Fink III, B.S.Pharm., J.D., 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 have seen advertisements on television for a major hospital and health care services network in Central Kentucky touting their new service whereby a patient can contact a practitioner by telephone or Skype® to describe symptoms and have a consultation without personal contact. It states flat out that the “encounter” may even result in having a prescription issued. Then I read something in the professional literature about some developments in this area related to state medical boards. What’s going on there? Response: During the fall of 2013, KentuckyOne Health announced it was launching KentuckyOne Anywhere Care, a program available to patients around the clock using the telephone or Web camera. Promising a response within 30 minutes by a physician or a nurse practitioner, the charge was announced as $35. The announcement noted that the practitioners “may prescribe medications, recommend over-the-counter medications or provide home care options. They will not prescribe or refill prescriptions for controlled substances.” Kentucky defines telehealth as meaning the use of interactive audio, video or other electronic media to deliver health care and includes the use of electronic media for diagnosis, consultation, treatment, transfer of medical data and medical education. [KRS 311.550(17)]. One persistent question with regard to telehealth activities relates to professional licensure when such activities cross state lines. What is the locus of focus – does the practitioner need to be licensed in the state where currently located or licensed in the state where the patient is located? The short answer is that the prescriber must be licensed in the state where the patient is located. For the Commonwealth, the Kentucky Board of Medical Licensure has made it clear with a policy adopted in 1997 that practitioners living outside Kentucky but actively practicing medicine upon patients located within Kentucky are required to have an active Kentucky license and meet Kentucky-derived standards of practice. At the federal level, action in this area was prompted by the demise of Ryan Haight, a 17-year-old boy who easily acquired prescription narcotics from an online Web site by simply completing a questionnaire. A physician who never saw the teen issued the prescription and the medications

Submit Questions: jfink@uky.edu 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.

were mailed directly to his house. On Feb. 12, 2001, Haight overdosed on the narcotic and died at the young age of 18. In response, Congress enacted the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 [21 U.S.C. §829(e)] which requires an “in-person medical evaluation,” which means one that is conducted with the patient in the physical presence of the practitioner, before issuing a request for dispensing controlled substances. In response to the federal Ryan Haight Act, the Kentucky statutes bear a provision stating that an electronic, online or telephonic evaluation by questionnaire is inadequate for the initial evaluation of a patient or for any follow up evaluation. The Kentucky Medical Practice Act prohibits a physician from issuing a prescription in response to any electronic communication where the prescriber has not established a proper physician-patient relationship. Further, KRS 311.5975 requires that a physician using telehealth shall ensure informed consent and confidentiality of patient information. A parallel provision in KRS 315.310 applies to pharmacists. Another provision of interest in Kentucky statutes is that a health benefit plan may not exclude a service from coverage solely because the service was provided through telehealth and not through a face-to-face consultation if the consultation was provided through the telehealth network [KRS 304.17A-138]. The telehealth network referred to there was established by KRS 194A.125(3)(b). During April 2014, the Federation of State Medical Boards, the medical parallel of NABP in pharmacy, issued guidelines that some observers felt would cast a pall over telehealth developments for patients in rural areas. The Feder-

THE KENTUCKY PHARMACIST

Pharmacy Law Brief

November/December 2015

ation changed the definition of telemedicine to care that “typically involves the application of secure videoconferencing…to provide or support healthcare delivery by replicating the interaction of a traditional encounter in person between provider and a patient.” The guideline excluded “an audio-only, telephone conversation, em-mail/instant messaging conversation or fax.” Such guidance statements are issued to assist licensure boards when developing policies and standards. This one was entitled “Model Policy for the Appropriate Use of telemedicine Technologies in the Practice of Medicine.” For those interested in more information on this topic, a good state level resource is the Kentucky TeleCare Health Network (www.mc.uky.edu/ kytelecare) while at the national level great information can be found through the American Telemedicine Association (www.americantelemed.org).

138th KPhA Annual Meeting and Convention June 2-5, 2016 Louisville Marriott Downtown

Are you connected to YOUR KPhA?

Facebook.com/KyPharmAssoc Facebook.com/ KPhANewPractitioners

@KyPharmAssoc @KPhAGrassroots

KPhA Company Page 33

THE KENTUCKY PHARMACIST

Pharmacy Policy Issues

November/December 2015

PHARMACY POLICY ISSUES: GENERIC DRUG PRICING Author: Rebecca C. Juhl, a fourth professional year student at the UK College of Pharmacy, is a native of Louisville, Ky. She completed her pre-professional education at Centre College while majoring in chemistry. Issue: Recent increases in generic drug prices at the wholesale level have been receiving a great deal of attention in both the professional press and the media directed at patients. What is behind that sudden up-tick in charges for some generic medications? Discussion: Why is my prescription for Simvastatin so expensive? I didn’t used to pay this much for captopril; why has it gone up in price? These are the questions many consumers have been asking lately as the result of a dramatic increase in generic drug pricing. According to federal records used in a recent Senate healthcare subcommittee hearing, the prices of more than 1,200 generic medications increased an average of 448 percent between July 2013 and July 2014. These drugs included albuterol sulfate, which rose from $11 to $434 per two tablets and doxycycline hyclate, which went from $20 to $1,849 per bottle between October 2013 and April 2014. So what is the cause behind pharmaceutical manufacturers increasing the prices of their generic medications? Is it problems acquiring raw material, an FDA slowdown in approving new drugs, manufacturers exiting the market or the merging of companies – what is going on?

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

established supply is not able to keep up with demand, then the FDA slowdown in the generic drug approval process could be a contributing factor to the recent rising cost of generic drugs. Exiting and Merging

Currently, there are only a few manufacturers making generic medications. Mylan, Actavis and Teva Pharmaceutical Industries are three of the largest companies, and they have been hastily buying out other smaller manufacturers Shortages of Raw Material in recent years. In July 2014, Mylan announced that it Any disruptions in the supply of raw materials can quickly would buy out Abbott Laboratories' generics business outbe the source of drug shortages and consequent price inside the U.S. in a deal valued at $5.3 billion. This gives creases. It is common for multiple drug manufacturers to Mylan even more influence over prices in an already low contract with the same supplier of a raw material; therefore, competition environment. Some small manufacturing comany disruption in the supply of that substance will affect all panies also have chosen to leave the market because they of the manufacturers of the final drug product. These raw can’t keep up with the larger companies. In the past few materials are often imported from other countries making years, FDA inspections also have led many companies to a the American drug market also dependent upon the global voluntary shutdown because the cost to comply with the drug market. FDA’s regulatory actions on production is too high. Two examples of these exits include Ben Venue Laboratories, FDA Action one of the country’s largest producers of generic injectaFor marketing in interstate commerce, the U.S. Food and bles, in 2011 and Ameridose in 2012. Drug Administration must approve Abbreviated New Drug Applications (ANDAs) filed by generic drug companies. The Congress has recently taken on a more active role in investigating what may be the primary reason behind the recent Generic Drug User Fee Amendments (GDUFA) of 2012 were designed by Congress to guarantee faster approval of rise of generic drug pricing. Some researchers, econogeneric drugs, leading to lower costs to manufacturers and mists, and healthcare professionals believe there is one lower prices for new drugs. However, since the introduction root cause behind the change while others identify multiple factors as the cause. Is there a shortage in raw material? Is of GDUFA, the FDA has slowed down ANDA approval. At an FDA meeting on Sept. 17, 2014, David R. Gaugh, RPh, there a monopoly forming within the generic drug market? Senior Vice President for Sciences and Regulatory Affairs Is the FDA’s ANDA approval process too slow or has the FDA driven competitors out of the market through overof the Generic Pharmaceutical Association (GPhA), said regulation of manufacturing facilities? that in 2013, the median time for generic drug approvals jumped to 36 months and is now up to 43 months. If the Unlike other countries, the United States does not regulate 34

THE KENTUCKY PHARMACIST

November/December 2015

KPhA Government Affairs/KPPAC drug pricing, which in years past has created a competitive marketplace with low cost generic medications. However, with this recent rise in prices, lawmakers are looking for new ways to counter this rise whether it is through government regulation or promoting a more competitive marketplace that has declined in recent years.

Sources 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278171/



http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264670/



http://www.fda.gov/Drugs/DrugSafety/ucm281782.htm



http://www.fda.gov/drugs/drugsafety/drugshortages/ ucm324842.htm



http://www.latimes.com/business/la-fi-lazarus20141021-column.html

KPhA Government Affairs Contribution Name: _______________________________Pharmacy: _____________________________

Email: ______________________________________________________________ Address: _____________________________________________________________ City: ___________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: _____________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs)

Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601

Kentucky Pharmacists Political Advocacy Contribution Form Name: _________________________________ Pharmacy: ___________________________ Address: _______________________ City: ________________ State: _____ Zip: ________ Phone: ________________ Fax: __--_______________ E-Mail: __________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)

Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601

CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election. Individuals may contribute no more than $1,500 per year to all PACs in the aggregate. In-kind contributions are subject to the same limits as monetary contributions.

Cash Contributions: $50 per contributor, per election. Contributions by cashier’s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4) Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election. (This information is in accordance with KRS 121. 150)

THE KENTUCKY PHARMACIST

November/December 2015

Pharmacists Mutual

THE KENTUCKY PHARMACIST

Cardinal Health

November/December 2015

THE KENTUCKY PHARMACIST

KPhA Board of Directors/Staff

November/December 2015

KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES

Bob Oakley, Louisville Boakley@BHSI.com

Chair

Chris Harlow, Louisville cpharlow@gmail.com

Chris Clifton, Villa Hills chrisclifton@hotmail.com

President

Lance Murphy, Louisville Vice Speaker of the House lancemurphy84@gmail.com

Trish Freeman trish.freeman@uky.edu

President-Elect

KPERF ADVISORY COUNCIL

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Christen S Bruening cschenkenfelder@sullivan.edu

Chris Palutis, Lexington chris@candcrx.com

Treasurer

Matt Carrico, Louisville matt@boonevilledrugs.com

Duane Parsons, Richmond dandlparsons@roadrunner.com

Past President Representative

Matt Carrico, Louisville* matt@boonevilledrugs.com

Mary Thacker, Louisville mary.thacker@att.net

Chad Corum pharmdky21@gmail.com

KPhA/KPERF HEADQUARTERS 1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc

Tony Esterly, Louisville tonye50@hotmail.com Matt Foltz, Villa Hills mfoltz@gomedcare.com Chris Killmeier, Louisville cdkillmeier@hotmail.com University of Kentucky Student Representative

Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Catherine Serratore cserra4007@my.sullivan.edu

Kim Croley, Corbin kscroley@yahoo.com Kimberly Daugherty, Louisville kdaugherty@sullivan.edu

Directors

Kevin Mercer kevin.mercer@uky.edu

Speaker of the House

Sullivan University Student Representative

Richard Slone, Hindman richardkslone@msn.com Mary Thacker, Louisville mary.thacker@att.net Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee

Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org

THE KENTUCKY PHARMACIST

50 Years Ago/Frequently Called and Contacted

November/December 2015

50 Years Ago at KPhA FROM “KENTUCKY AT A GLANCE” Robert R. Wallace, RPh, Dry Ridge, owner of Grant County Drug, will be married in January to Miss Jaqueline Wilson of Florence. Wallace is a graduate of the University of Kentucky College of Pharmacy and a member of Kappa Psi and Rho Chi fraternities. - From The Kentucky Pharmacist, November 1965, Volume XXVIII, Number 11.

In Memoriam The Pharmacy Profession in Kentucky has lost several members in 2015. KPhA offers sincere condolences to the families of these members. Bob Lichtefeld

Jimmie Lockhart

Bill Marsh Larry Herzog Ernest Carl Schifferdecker

Carolyn Wolf (wife of Simon Wolf)

Frequently Called and Contacted Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 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 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 Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu Kentucky Regional Poison Center (800) 222-1222

KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the list. 39

THE KENTUCKY PHARMACIST

November/December 2015

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

138th KPhA Annual Meeting and Convention June 2-5, 2016 Louisville Marriott Downtown

THE KENTUCKY PHARMACIST