The Kentucky Pharmacist Vol. 10, No. 5 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. 5 September/October 2015

October is Kentucky and American Pharmacists Month Pharmacists Care: Know your Pharmacist â&#x20AC;&#x201D; Know Your Medications Schedule inside Register today at www.kphanet.org News & Information for Members of the Kentucky Pharmacists Association

Table of Contents

September/October 2015 KPhA Emergency Preparedness atomAlliance Kentucky Reportable Disease regulation revision Pharmacist Anecdotes from Summer Camp Kentucky Renaissance Pharmacy Museum KPhA New and Returning Members 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 Advancing Pharmacy Practice in Kentucky Coalition From your Executive Director APSC Sept. 2015 CE — Stop! In the Name of Sleep September Pharmacist/Pharmacy Tech Quiz Oct. 2015 CE — Influenza Vaccination October Pharmacist/Pharmacy Tech Quiz

2 3 4 5 6 8 9 18 19 28

29 30 31 32 33 34 36 38 40 41 42 43

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

September/October 2015

Pharmacy and Medically Underserved Areas Enhancement Act.” Currently H.R. 592, the legislation in the House has elevated to a MAJORITY of the House of Representatives with 218 cosponsors (a 77 percent increase over last year’s efforts thus far) and S. 314, the companion bill in the SenChris Clifton ate has 31 cosponsors. Access to health care is a serious KPhA President issue in Kentucky, as 87 out of 120 counties include areas designated as “medically underserved.” If and when 2015-2016 H.R.592/S.314 becomes law, pharmacists – a qualified and underutilized health care provider – can help address the needs of Kentucky's medically underserved. According to a recent survey conducted for the American Pharmacists Association, 83 percent of voters agree that pharmacists have the education and professional training to do more for paIt has certainly been a busy first four months as President tients than just filling prescriptions, 81 percent agree that of YOUR KPhA. This is such an exciting time for pharmacy pharmacists should be considered part of each patient’s as we are continuing to see progress and increased tracoverall health care team and 66 percent of voters nationtion towards gaining provider status at the federal level. As wide said they think of pharmacists as “health care providI have mentioned in my previous article, now is the time for ers” though pharmacists are not currently recognized as ALL pharmacists to UNITE as one voice in order for us to such under federal law. Voters also believe pharmacists move forward and serve the best interests of our patients and their services improve health care quality, patients and our profession. And it’s going to take a UNITED front to would have fewer problems with medications if pharmacists get this DONE! were more involved as members of health care teams and 70 percent of voters believe that having a pharmacist work How about our successes thus far, including the passage of SB 192 and amendment of KRS 217.186, which author- more closely with doctors would help in the reduction of izes pharmacists to initiate the dispensing of naloxone un- overall patient and health care system costs. This seems like a “no brainer” but it takes a lot of hard work and a proder a physician approved protocol to prevent opioid overfession willing to put aside its “practice” differences to dose, where we were defined as a “licensed health-care provider.” This is a great opportunity for pharmacists to be UNITE for what’s best for its patients and the practice of pharmacy. involved in helping save lives and an important milestone for public health in our state, especially since Kentucky had It has been an absolute pleasure getting to go out and the second-highest age-adjusted overdose mortality rate in meet some of our members and see their area of practice. United States in 2013, and the state’s rate has almost dou- We have so many excellent members, whether it is pharbled that of the country’s overall rate. Increased access to macists, student pharmacists or technicians that are maknaloxone can prevent overdoses that result in death. This ing positive differences in their patient’s lives every day, is also the first time that pharmacists in Kentucky have and we should celebrate our successes and be proud of been defined in law as “health-care providers.” We should what you/we do. Now is our time to show our patients, our rally around this success led by KPhA and our lobbying legislators and all those pharmacy detractors how important muscle as we continue to show how powerful and important our profession is to the overall health care system. We are pharmacists are to the health care team and our patients. going to need your continued support and the support of KPhA continues to sponsor and promote the Advancing “all” pharmacists to be united throughout the state to help Pharmacy Practice in Kentucky Coalition in getting all phar- build on these successes and growth of this profession. macists certified to dispense naloxone throughout the state. Please don’t hesitate to reach out to KPhA with anything These events are taking place around the commonwealth, you may need. We are here for our members and rely on and pharmacists are encouraged to sign up and attend if your feedback and information to better YOUR association. possible. Or go online to www.kphanet.org and take the Get ready for the legislative session this year, as we will webinar on Naloxone Online Training, $5 for KPhA memcall on our members to support and UNITE on necessary bers and $10 for non-members. pharmacy issues to enhance the pharmacy profession.

PRESIDENT’S PERSPECTIVE

As far as the provider status on the national level, we are Thanks again for your support. STAND UNITED: GO entering an important legislative session for advancing “The PHARMACISTS!!

THE KENTUCKY PHARMACIST

2015 KPhA Legislative Conference

September/October 2015

Register today at www.kphanet.org Up to 10 hours of CE Available Hyatt Regency in Downtown Lexington Friday, November 13, 2015 KPhA Student Legislative Day in partnership with Sullivan University College of Pharmacy and University of Kentucky College of Pharmacy 8:30 a.m.

Registration Opens

**9:00-10:00 a.m.

The Role of the Pharmacist in Preventing Opioid Overdose: Perceptions of Kentucky Pharmacists —Trish Freeman, RPh, PhD, Clinical Associate Professor Director, Center for the Advancement of Pharmacy Practice, UKCOP (1 hour)

**10:15 -11:45 a.m.

2015 NASPA NMA Self Care Challenge (1.5 hour)

Noon

Lunch

**12:15-1:15p.m.

Effective Grassroots Involvement in the Policymaking Process – Heidi Ann Ecker, Director of Government Affairs and Grassroots Programs, National Association of Chain Drug Stores (1 hour)

**1:15-2:15 p.m.

Effective Legislative Engagement (featuring Q&A with Senate Floor Leader Damon Thayer and Rep. James Kay) – Jan Gould, Senior Vice President Government Affairs, Shannon Stiglitz, Vice President of Government Affairs, Kentucky Retail Federation (1 hour)

**2:30-3:30 p.m.

The Future of Healthcare in Kentucky: State Innovation Model Design & Other Opportunities, John Langefeld, M.D. Chief Medical Officer for Kentucky Medicaid (1 hour)

3:30-5:00 p.m.

House of Delegates Meeting featuring Legislative issues briefing and remarks from Kelly Kelly, Director of Health Policy and Utilization Review Branch for the Kentucky Department of Insurance regarding PBM Transparency — Speaker Chris Harlow, presiding

Saturday, November 14, 2015 7:30 a.m.

Registration Opens/Continental Breakfast

**8:00-11 a.m.

Substance Abuse Prevention/Combating Drug Abuse in Your Community: Train the Trainer, Laurel Taylor, PharmD, Community Pharmacy Resident, APSC (3 hours)

** 11:15 a.m.-12:45 pm.

Increasing Naloxone Access in Kentucky: Implementation of SB 192 by Pharmacist, Emma Palmer, PharmD, BCPS, BCPP, SUCOP; and Steve Hart, RPh, Executive Director, Kentucky Board of Pharmacy (1.5 hours)

**Continuing Education Programs. For objectives and more information, visit the event site at www.kphanet.org. The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

THE KENTUCKY PHARMACIST

Advancing Pharmacy Practice in Kentucky Coalition

September/October 2015

Advancing Pharmacy Practice in Kentucky Coalition Meetings The Advancing Pharmacy Practice in Kentucky Coalition is hosting meetings across the state. These special community events were spurred by recent legislation that allows certified pharmacists, acting under a physician-approved protocol, to fill naloxone orders in their communities without a physician’s prescription. At the events, Coalition partners provide updates of what each organization is working toward for the profession and the 1.5 ACPE Accredited CE program, “Increasing Nalxone Access in Kentucky: Implementation of SB 192 by Pharmacists” is presented. The meetings kicked off October 6 in Northern Kentucky. Additional dates, with registration links, are listed below and on the Calendar at www.kphanet.org. LEXINGTON

LONDON/CORBINAREA

Thursday, October 29, 6 pm – 8 pm

Thursday, November 12, 6 pm – 8 pm

UK College of Pharmacy

Location The Corbin Center

PIKEVILLE

LOUISVILLE

Tuesday, November 3, 6 pm- 8 pm

Thursday, November 19, 6 pm – 8 pm

Green Meadow Country Club

Sullivan University College of Pharmacy

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

From Your Executive Director

September/October 2015 MESSAGE FROM YOUR EXECUTIVE

DIRECTOR

Robert “Bob” McFalls “I wish it need not have happened in my time," said Frodo. "So do I," said Gandalf, "and so do all who live to see such times. But that is not for them to decide.” “All we have to decide is what to do with the time that is given us.” ― J.R.R. Tolkien, The Fellowship of the Ring I suspect that the phrase, “There is no time like the present,” is a frequent idiom in all of our vocabularies. “Time” is a powerful word, thought and concept — long studied by philosophers, theologians and scientists alike. And, while there have been provoking and admirable attempts, defining time in a manner applicable to all fields is a challenge that has consistently eluded scholars through the ages. Time simply is; it cannot do anything in and of itself. Once lived, the time that we spent doing an activity or creating a memory becomes the historic framework in which those things have happened — nothing more. And, yet, our simple assertion that, “It is time to...”, is both an implied and consistent reality in everyday living, linear or otherwise. In this spirit, I sincerely appreciate your time as we prioritize several KPhA opportunities.

matically change to and from Daylight Savings Time — two less things to take the time to do. They also provide some amusement in that they run about 90 seconds apart — not quite enough time to provide “scientific” justification should one be running behind in making an appointment but nonetheless an ironic observation.

Back in 1931, National Pharmacy Week honored the role of pharmacists in the field of medicine. For decade upon decade, pharmacists have been one of the few health care professionals lacking recognition as health care providers by CMS and within federal law. Nearly all health care professional services are rightfully addressed by Medicare legislation, including services provided by chiropractors, midwives, clinical social workers and dieticians, but not services provided by pharmacists (not yet!). KPhA memForemost, you believe that Membership Matters in YOUR bers have joined with the National Alliance of State PharKPhA as evidenced by your continuing engagement and macy Associations, the American Pharmacists Association, participation. Clearly, the stronger your state pharmacist the National Community Pharmacists Association, the Naassociation is, the more robust the profession of pharmacy tional Association of Chain Drug Stores and other national is and can become. The two are intricately tied. And there partners to call upon Congress to pass a bill that would is scientific evidence to support this premise. As reported amend section 1861(s)(2) of the Social Security Act to enaby Johns Hopkins behavioral neuroscientist Eric Fortune in ble Medicare beneﬁciaries to access pharmacist-provided services under Medicare Part B. These services would be the journal Science (November 2011), we are stronger when we are connected and working together in that the reimbursable under Medicare Part B if provided to patients brain is built for cooperative activity. “What we learned is in medically underserved communities and if the services that when it comes to the brain and cooperation, the whole are consistent with Kentucky’s scope of practice law. We is definitely greater than the sum of its parts,” said Fortune, have made much progress in this legislative effort through of the Department of Psychological and Brain Sciences at our unified advocacy. The time is now to continue the push the Krieger School of Arts and Sciences. “We found that to effect this needed change, to engage with our two U.S. the brain of each individual participant prefers the comSenators and to thank our six congressmen, as we adbined activity over his or her own part.” Along with Presivance pharmacists’ patient care services. dent Chris Clifton, I want to thank YOU for recognizing this “How did it get so late so soon?”, asked Dr. Seuss. KPhA is essential truth and for UNITING with your peers through happy to report that there’s still time — time to attend your membership and the time that you give to benefit your KPhA’s fourth consecutive Legislative Conference. An profession. agenda is included in this journal, and it is not too late to What time is it?! Many of us wear watches to keep up with participate. In addition, it is time to engage with your coltime or utilize our smart devices to quickly check it. Even leagues at the November 13 House of Delegates as legisour pets have an uncanny sense of what time it must be for lative priorities are discussed, debated and decided. It is a walk, nap, meal or treat. We have two Timex atomic time to be a part of the next 50 years as members decide clocks at home that I love for the mere fact that they autoabout your headquarter needs for the future. It is time to 6

THE KENTUCKY PHARMACIST

From Your Executive Director

September/October 2015

mark your calendar and plan to attend the 138th KPhA Annual Meeting & Convention on June 2-5 in Louisville. It is time to get engaged with KPhA’s grassroots efforts with the 2016 General Assembly as the legislature returns to Frankfort in a few short weeks. Early next year, it will be time for you to decide to run for elected office or on the Board in serving YOUR KPhA. You also will soon be given the opportunity to

nominate a colleague to serve on the Kentucky Board of Pharmacy as two seats will be open for appointment for terms that begin in early 2017. With these many challenges before us, I will close with a thought from Tennessee Williams, “Time doesn't take away from friendship, nor does separation.” Know that I look forward to seeing YOU soon and to discussing these strategic opportunities.

Gov. Beshear proclaims October as Kentucky Pharmacists Month Special thanks to Commissioner Tony Wilder, KY Department for Local Government for coming by the recent KPhA Board of Directors meeting to present the proclamation on behalf of Gov. Steve Beshear.

To read the proclamation, visit http://www.kphanet.org/? KentuckyResources

THE KENTUCKY PHARMACIST

APSC

September/October 2015

THE KENTUCKY PHARMACIST

September 2015 CE—Stop! In the Name of Sleep

September/October 2015

Stop! in The Name of Sleep By: Krista Best, PharmD; Holly Byrnes, PharmD, BCPS; Emma Palmer, PharmD, BCPS, BCPP, Sullivan University College of Pharmacy

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

The authors declare no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-15-010-H01-P&T 1.0 Contact Hours (0.1 CEU) Goal: To aid pharmacists in understanding of insomnia diagnosis and parameters which differentiate available treatment options. Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1. 2. 3. 4. 5. 6.

List DSM-5 insomnia diagnostic criteria. Recognize the general approach to treatment of insomnia. Describe the role of cognitive behavioral therapy in insomnia treatment. Define cognitive behavioral therapy methods. Explain the neurobiology of sleep-wake balance. Compare pharmacotherapeutic options for the treatment of insomnia.

Sleep deprivation appears to affect mood, attention and other health outcomes. Despite the well accepted need for sleep, only half of American adults report good quality of sleep in the past week, according to the 2015 Sleep in America poll,1 while one-third state they experienced a sleep disturbance in the past week.1 It is estimated that up to 10 percent of adults have symptoms which meet diagnostic criteria for insomnia disorder.2

During this phase, the brain is active and muscles are atonic, which prevents acting of the dreams.5 REM sleep occurs for approximately 25 percent of the night and is driven by circadian rhythm. In a person with normal sleep architecture, they will enter through NREM sleep, progressing from stage 1 to 4, before reaching their first REM cycle at 90 minutes.4 This cyclic pattern continues throughout the night, alternating between NREM and REM sleep.4 During the first half of the night, NREM predominates with REM time lengthening during the second half of the night.6

It will probably not come as a surprise that insomnia is associated with an increase in workplace and motor vehicle accidents.3 However, not all consequences are transient. Studies show that persistent insomnia can lead to chronic psychiatric and medical disorders such as depression, hypertension and myocardial infarction.2 Conversely, psychiatric and medical disorders can cause insomnia as well.2

There is much debate over the function of the different stages of sleep. REM sleep was traditionally thought to be responsible for memory consolidation, storing all of the days memories.6 NREM sleep is now thought to play a role Sleep Architecture in declarative learning and REM is believed to be linked to procedural memory.4 Interestingly, some medications such Sleep architecture explains the structure and pattern of as monoamine oxidase inhibitors (MAOIs) can completely brain activity while asleep. It is generally divided into two abolish REM sleep with no apparent effect on functioning.5 categories: non-rapid eye movement sleep (NREM) and It is not clear if this is a result of underlying pathology of the rapid eye movement sleep (REM). disease state or evidence that REM sleep is not necessary. NREM sleep is generally thought of as “quiet brain, moveaWhile the physiologic function of the sleep phases is a subble body.” This is further subdivided into four stages. Stage ject of controversy, it is generally accepted that balanced 1 and 2 are “lighter sleep” which occurs for about half of sleep is needed for physical and mental restoration. the night; stage 3 and 4 are “deep sleep” which occurs for 25 percent of the night.4 Deep sleep is driven by homeoNeurobiology of Sleep-Wake Balance static pressure.4 This means that those who are sleep deBefore we can understand the pharmacologic therapies prived may have a greater balance of stage 3 and 4 sleep available for insomnia, we must understand the neurobioloto make up for this debt in the following nights. gy of the sleep-wake system. There are three areas within REM sleep is the phase where dreaming typically occurs. the brain which are responsible for maintaining the states 9

THE KENTUCKY PHARMACIST

September 2015 CE—Stop! In the Name of Sleep

September/October 2015 Table 1: DSM-V Diagnostic Criteria for Insomnia Disorder Dissatisfaction with sleep quantity or quality

Figure 1: Neuron’s Interaction in the Wake State

  

of sleep and wakefulness: the sleep center (ventral lateral preoptic nucleus-VLPO), the wake center (monoaminergic neurons) and the regulatory center (orexin neurons).6

Initiating sleep Maintaining sleep Early-morning awakenings

Clinically significant distress or impairment in functioning Three nights per week for 3 months Occurs despite adequate opportunity for sleep Not better explained by another sleep-wake disorder Not attributable to a substance. Coexisting mental disorders/medical condition do not explain predominant complaint, otherwise add specifier:  Medical comorbidity  Mental comorbidity Specify duration:

The three centers generally act to inhibit one another. The exception to this is the interaction between the regulatory center (orexin), which interacts with the wake centers in a negative feedback loop, acting as the “thermostat” to maintain a consistent state of wakefulness during the day.

  

There are many wake promoting centers with projections to the cerebral cortex which secrete stimulatory neurotransmitters like histamine, acetylcholine, norepinephrine and dopamine.6 These wake promoting centers inhibit the sleep centers (VLPO) and have a negative feedback loop in relation to orexin. (Figure 1).

Episodic: 1 to 3 months Persistent: 3 months or longer Recurrent: Two (or more) episodes within 1 year

American Psychiatric Association. Sleep-wake disorders. In: Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington DC: American Psychiatric Publishing. 2013. Available at dsm.psychiatryonline.org. Accessed March 1, 2015.

insomnia diagnostic criteria found in Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The classifications of primary and secondary insomnia found in DSM-IV have The sleep active neurons are found within the VLPO.6 They become active when sleep pressure is high. When the VLPO been eliminated to stress that insomnia is an independent disorder, and treatment will benefit both insomnia and cofires, it secretes a neurotransmitter, GABA, which has an 2 inhibitory effect on the wake centers as well as orexin’s regu- existing conditions. latory neurons.6 When the VLPO overcomes orexin, sleep According to DSM-5, to be diagnosed with insomnia there can proceed. must be nighttime sleep difficulties which results in daytime Orexin is known as the master regulator of the sleep-wake cycle, because without it there is a mutually inhibitory relationship between the sleep and wake centers. This would result in rapid switching between the states of sleep and wakefulness, otherwise known as narcolepsy.6 The key to orexin’s regulatory ability is a negative feedback loop with the wake centers.6 This interaction allows orexin to work as the “wake state thermostat.” (Figure 1) While awake, orexin neurons will fire to stimulate the monoaminergic neurons of the wake center which will then provide negative feedback to orexin neurons.6 However, when wake neurons become less active they provide less feedback to orexin, which in turn sends a stimulatory signal to maintain the wake state. Diagnostic Criteria

impairment.2 Insomnia can manifest in many ways including difficulty with falling asleep, maintaining sleep or earlymorning awakenings.2 This difficulty must be present at least three nights per week for three months.2 Also, there must be adequate opportunity to obtain the appropriate amount of sleep.2 Full diagnostic criteria for insomnia is listed in Table 1. This ensures that “insomnia” is not a result of poor sleep behaviors. For example, busy pharmacy students with early morning classes cannot be diagnosed with insomnia when somnolent because they frequently stay up late at night cramming for tests. To diagnose insomnia, the American Association of Sleep Medicine’s 2008 guidelines recommend a thorough physical exam (to assess for comorbid conditions) in addition to use of three core assessment tools4:

It is now accepted that there is a bidirectional and interactive relationship between insomnia and coexisting medical/  psychiatric disorders. This has lead to a paradigm shift in the

General medical, psychiatric and medication questionnaire

THE KENTUCKY PHARMACIST

September 2015 CE—Stop! In the Name of Sleep

September/October 2015



Epworth Sleepiness Scale

TABLE 2: Cognitive Behavioral Therapy



Two-week sleep log

Behavioral procedures

The Epworth Sleepiness Scale is an eight item questionnaire which is used to assess subjective sleepiness. 7 Scores range from 0-24 and a normal score is less than 10.7 This test has been prospectively validated and has demonstrated reliable internal consistency.7 This scale is available online for free at: http://epworthsleepinessscale.com/1997-version-ess/.

Stimulus control therapy  Goal is to recondition the body to associate the bedroom with sleep and develop a consistent sleep-wake schedule.  Go to bed only when tired.  Get out of bed when unable to sleep.  Use the bed only for sleep.  Get up at the same time every morning.  Do not nap.

There are many types of sleep logs available with the overall goal to determine sleep-wake times, general patterns and day-to-day variability. The National Sleep Foundation has an user friendly sleep diary available for free at http:// www.sleepfoundation.org/sleep-diary/SleepDiaryv6.pdf. Other objective assessments (polysomnography and actigraphy) are not routinely indicated.8 These may become necessary to rule out other sleep-related disorders, such as sleep apnea.

Sleep restriction therapy  Goal is to limit time spent in bed to actual sleep time; initially this will result in mild sleep deprivation but an increase in sleep efficiency. The sleep window will gradually be increased until optimal duration is achieved. Relaxation training Technique aimed at reduction of somatic tension (progressive muscle relaxation) or intrusive thoughts (imagery training, meditation) interfering with sleep.



Treatment Goals Irrespective of the type of treatment chosen, the goal of treatment is to improve satisfaction with sleep quantity and/ or quality and to improve functioning.8 More specifically, therapy should be aimed at improvement in the predominant complaint. This can be accomplished by improving sleep onset latency (SOL) for those with trouble falling asleep, wake time after sleep onset (WASO) for those with trouble staying asleep and/or sleep efficiency (hours slept out of total opportunity).8

Cognitive procedures

Psychotherapeutic method targeting misconceptions about sleep, insomnia, and daytime consequences. Sleep hygie ne e ducation

General guidance on health practices and environmental factors that may interfere with sleep:  Avoid stimulants (nicotine, caffeine) several hours before bedtime.  Avoid alcohol at bedtime, it can fragment sleep.  Exercise regularly, it can deepen sleep.  Do not watch the clock.  Keep the bedroom dark, cool and quiet.

General Approach to Treatment

Guidelines published by the American Academy of Sleep Medicine suggest first identifying the predominant complaint and tailoring therapy based on it and other patientspecific factors (preference, comorbidities, risk-benefit, etc.).8 Therapies for insomnia fall into two broad categories: Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar cognitive-behavioral therapy (CBT) and pharmacologic 24;379(9821):1129-41. therapy. Both therapies have demonstrated short and long Cognitive Behavioral Therapy term efficacy in clinical trials and can be used alone or in 8 combination. A multi-modal combination of psychological and behavioral therapies is used to create a patient specific CBT plan. 8 To assess sleep and progression towards goals, patients (See Table 2) Sleep hygiene education can be incorposhould keep a sleep diary prior to and during the course of rated into the treatment plan; however there is insufficient active treatment.4 This should be done alongside repeated evidence to support its use as monotherapy.8 Behavioral 8 administration of questionnaires and surveys. Treatment of therapies which shorten time spent in bed help with sleep insomnia is an active and longitudinal process for both the continuation and cognitive strategies reduce psychological practitioner and patient. Reevaluation is important to deterdistress.9 mine whether therapy is effective. If initial therapy is ineffective an alternative behavioral, pharmacologic or combi- Over time, a patient with insomnia will develop numerous nation therapy should be considered. psychological and behavioral factors which perpetuate the 11

THE KENTUCKY PHARMACIST

September 2015 CE—Stop! In the Name of Sleep

September/October 2015

problem. There is commonly a pre-occupation with the inability to sleep and the subsequent impairment, resulting in a vicious cycle.2 For example, a patient “tries hard” to fall asleep, lying in bed for hours, watching the clock. This results in more frustration and concern over being tired the next day. Eventually, the body is conditioned to associate the bedroom with arousal. Some may fall asleep more easily when not trying to do so (e.g. while watching television).2 Others have maladaptive behaviors (e.g. erratic sleep schedule or napping) to accommodate it.2 The aim of CBT is to correct this and get the patient to think and behave like a good sleeper.

cytochrome P450 isoenzyme CYP2D6 and has the potential to reduce clearance of medications metabolized via this route (e.g. metoprolol, venlafaxine, codeine).13

There is a high acceptability of CBT by patients.9 However, it is not feasible for all patients, who may not have the time, funding or access to a CBT provider. Also, this therapy is dependent on a patient’s willingness to comply with treatment recommendations. CBT is generally delivered over 6-8 sessions, but there is some evidence demonstrating efficacy of fewer sessions and internet delivery.10 Therefore, it is possible that a “self-help strategy” could stand alone or provide supplement to professional therapy.

Doxepin

Short term (less than 10 days) self treatment may be appropriate in a select population after addressing and correcting problematic sleep habits.13 The American Pharmacists Association Self Care Handbook13 recommends taking diphenhydramine for no more than three consecutive nights, then skipping a night to reevaluate sleep. Furthermore, if insomnia is not resolved after 10 days, then the patient should seek assistance from his or her healthcare provider.13 Approved in 2010 for the treatment of insomnia, doxepin is one of few options not designated as a controlled substance. Doxepin is a tricyclic antidepressant; however at low doses (3 -6 mg) it antagonizes histaminic receptors without additional activity at serotonergic and adrenergic receptors as seen in higher doses used for depression.4 It is indicated for sleep maintenance since trials show improvement in WASO and sleep efficiency but not sleep latency.10,13 Tolerance and rebound insomnia were not demonstrated in clinical trials.13

Pharmacotherapy

An important counseling point is to avoid taking this medication within three hours of a meal; food delays absorption and increases the potential for residual sedation. 13 Low dose doxepin had few significant adverse reactions in trials. However, since it is a tricyclic antidepressant, there is still some concern for anticholinergic effects, QT interval prolongation and mood changes.13 The adverse effect profile is more benign than high dose doxepin because when used at low doses it is more selective for histamine receptors, avoiding monoaminAntihistamines ergic, muscarinic and alpha-1 receptors.4 Although there was Over the counter antihistamines (diphenhydramine, doxylanot a worsened side effect profile in trials, the elderly (age > mine) are widely used for self treatment of insomnia. These 65) should be started on a lower dose of 3 mg initially.13 Interagents block the actions of the stimulatory neurotransmitters, estingly, fewer patients discontinued the active drug in studhistamine and acetylcholine. Both time to fall asleep and con- ies than placebo.14 Doxepin is metabolized by CYP 2C19 and tinuation of sleep may be improved.4 However, contemporary 2D6; an empiric dose reduction is necessary with cimetidtrials to support their use are lacking.8 Rapid development of ine.13 Do not administer doxepin with other sedatives or tolerance precludes long-term use.11 The potential for reMAOI inhibitors.13 bound insomnia upon therapy discontinuation should be conDoxepin has a role in the treatment of sleep maintenance sidered prior to using these agents as this may exacerbate 12 insomnia. Its niche populations include those with a history of the underlying problem. substance abuse and the elderly. However, it should not be While they are available over the counter, these medications used in those with severe urinary retention or glaucoma. are not benign. Next day sedation frequently occurs. Patients Trazodone should be cautioned to avoid tasks that require their full at13 tention or coordination until their response is known. The Despite absence of FDA approval, trazodone is widely used most common side effects are related to the anticholinergic in the treatment of insomnia. A review article by Pargol et properties of the medication and include dry mouth, dry eyes al.14 concluded that trazodone may reduce sleep latency and (blurred vision), urinary retention, constipation and tachycar- number of awakenings, but trials are of poor quality, containdia.13 ing less than 30 participants for one week or less. When used Medications for insomnia work by agonizing a sleep center, inhibiting the effects a wake center or blocking the actions of the regulatory center. It’s important to keep in mind a medication’s pharmacokinetic profile, as the onset and duration of action should be matched to the patient’s specific sleep related complaint. Other considerations include length of treatment, cost, age, history of alcohol or drug abuse, concomitant drug therapies and adverse effects.

Diphenhydramine has been shown to be an inhibitor of the

for insomnia, trazodone is typically given at lower doses of 50 12

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September 2015 CE—Stop! In the Name of Sleep

September/October 2015

-100 mg at bedtime.15 There is some evidence which demonstrates rebound insomnia and tolerance.15 Furthermore, the side effects are not benign: orthostatic hypotension, cardiac conduction disturbances, dizziness, psychomotor impairment, cognitive dysfunction and urinary retention.16 A rare but serious side effect is priapism. This side effect profile is especially concerning for elderly patients. Due to the insufficient efficacy data and relatively risky adverse effect profile, use of other pharmacologic agents is preferential.

ings when four hours of sleep remain.16,18 Zolpidem immediate release tablet and regular strength sublingual are indicated for sleep onset insomnia. There is some evidence to support using these formulations in those with difficulties maintaining sleep, but it is inconsistent.19 The extended half-lives of extended release zolpidem and eszopiclone allow for use in both sleep onset and maintenance insomnia.16 All three z-hypnotics have been studied for up to 12 months, demonstrating no withdrawal, tolerance or rebound insomnia.20 Generally, the side effect profile and abuse potential is less compared to the BZs. Their short half-lives lend to a decreased risk of daytime performance, memory and psychomotor tasks.20 The most commonly reported adverse effects are headache, drowsiness and dizziness.16 Up to one third of patients taking eszopiclone experience metallic taste.16

Benzodiazepines Benzodiazepines (BZs) bind to GABA receptors, potentiating GABA’s inhibitory action at wake and regulatory centers. The half-life of medications within this class determines its utility and potential for next day sedation. There are five agents FDA approved for treatment of insomnia, but temazepam is most widely used. Its half-life is 3-18 hours, giving it utility in the treatment of sleep maintenance insomnia. Triazolam is not considered a first line agent due to rebound anxiety.8 The remaining three BZs are rarely used because their extended half-lives cause carry over sedation: estazolam (10-24 hr), flurazepam (74-90 hr) and quazepam (39 hr).16 This class has limited utility due to tolerance, rebound insomnia, abuse potential and adverse effects. These medications should be avoided in those with a history of substance abuse due to their known addictive properties and potential to cause fatal respiratory depression, especially when used in combination with alcohol. Physiologic withdrawal is associated with chronic use of high dosage, with symptoms including anxiety, insomnia, autonomic instability and seizure.17 Tolerance rapidly develops to these agent’s hypnotic effects.17 Dose escalation can feed into a cycle of psychologic and physiologic dependence, which is further complicated by rebound insomnia and/or a worsening in sleep-related problems from baseline.17 Adverse effects include psychomotor retardation (motor incoordination, poor concentration and muscle weakness) and memory impairment.17 These make BZs especially risky in the elderly at risk of falls. Furthermore, BZs can result in emotional blunting and worsening of depressive symptoms.17 Nonbenzodiazepines Also called z-hypnotics or “z-drugs,” the nonbenzodiazepines work by selectively agonizing the alpha1 subunit of the GABA receptor, which is more specific to sedation, resulting in fewer side effects. Depending on the half-life and dosage form, these medications can be used for sleep onset, sleep maintenance or middle of the night awakenings. The shortest acting agents, zolpidem low dose sublingual and zaleplon, can be used for middle of the night awaken-

All z-hypnotics have warnings for abnormal thinking/ behavior (aggression, hallucinations, depersonalization) with an incidence of <1 percent from post-market surveillance studies.16 There also is potential for complex sleep behaviors like sleepwalking, eating and driving. 16 A medication guide is required at each dispense which emphasizes administration and the potential for complex sleep behaviors and abnormal thoughts/behaviors. The FDA changed dosing recommendations of zolpidem in women due to the risk of early morning impairment and motor vehicle accidents (MVA). This was based on pharmacokinetic data demonstrating women eliminate zolpidem more slowly and linking blood levels to impaired functioning.20 There also is data from population based studies which demonstrate patients who take BZs and z-hypnotics are at elevated risk of road traffic accidents; however, the risk is greatest with anxiolytic BZs.20 Since MVA can result from carry over sedation and sleep deprivation, some experts argue that the risk should be considered in the full context of the patient’s clinical profile.3 A matched cohort by Kripe et al.21 looked at the survival time of those who were and were not on hypnotics. Those who used less than 18 doses of hypnotic per year had increased mortality risk compared to the matched cohort who did not take hypnotics 3.60 (95 percent CI 2.92 to 4.44).21 Due to the design, this study cannot imply causality, and it has other limitations like selection bias. Ramelteon Melatonin has sleep-promoting and chronobiologic actions by acting on the melatonin receptor-1 (MT1) and MT2 in the suprachiasmatic nucleus (SCN).22 The SCN is connected to the VLPO (sleep centers) and orexin (regulatory center) via intricate multistage pathways.23 Ramelteon is a se-

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September 2015 CE—Stop! In the Name of Sleep

September/October 2015

lective agonist of MT1 and MT2, and has no affinity for GABA, serotonin dopamine, epinephrine, acetylcholine, nor opiate receptors.24 It is indicated for sleep-onset insomnia and has an ultra-short half-life of 1-2.5 hr.24 Ramelteon is not scheduled and clinical trials demonstrated no abuse potential when compared to placebo.24 Tolerance did not develop in six month trials, and there was no evidence of rebound insomnia or withdrawal.24 However, there are inconsistent subjective sleep latency findings across studies.

clinical trials demonstrated no significant effect on next day memory or balance compared to placebo.27 The fourth study found impairment on morning word recall when patients were administered 40 mg (note that the highest available dose is 20 mg).27 Middle of the night safety was assessed in elderly subjects given a 30 mg dose, finding no impairment on psychomotor performance, balance or memory (immediate or 4-hr delayed word recall).27 Effects on driving were studied through a lane position test, and impairment was found in non-elderly subjects taking a 20 Treatment emergent adverse events were only slightly elemg dose. Interestingly, elderly subjects were not affected.27 vated compared to placebo: somnolence, fatigue, dizziness, The package insert recommends that those taking the 20 nausea and insomnia exacerbation.24 There was a small mg dose should be cautioned against next-day driving im24 increase in prolactin levels in women, but not men. Subpairment and other activities requiring complete mental jective sedation was increased compared to placebo, but alertness.27 There is potential for inter-patient variability in not measurable cognition or recall.22 When compared to blood levels; higher levels were associated with female gentemazepam, ramelteon did not impair postural balance, reder, obese BMI and concomitant CYP 3A4 inhibitor use.27 call or recognition in the middle of the night or the next morning.24 Ramelteon did not impair middle of the night bal- The most common treatment emergent adverse effect was somnolence (suvorexant 7 percent; placebo 3 percent).27 ance in the elderly when compared to placebo and Otherwise, adverse effects occurred at <5 percent or did not zolpidem; however zolpidem did cause significant impair24 double the placebo rate (headache, dizziness, diarrhea, ment. abnormal dreams).27 Narcolepsy-like events have been reMelatonin ported in clinical trials (<1 percent), which is expected given This herbal supplement is readily available without a prethe drug’s mechanism of action.27 These include sleep pascription, and is considered by the Natural Medicines Data- ralysis (inability to move or speak in sleep-wake transitions) base to be “possibly effective” for the treatment of insomand hypnagogic/hypnopompic hallucinations (hallucination nia.25 The typical dose for insomnia is 0.3 to 5 mg taken be- in wake-sleep/sleep-wake transition, respectively). Narcofore bed.25 Melatonin reduces the time it takes to fall asleep lepsy is an absolute contraindication to use of suvorexant.27 by 12 minutes, which may not be clinically relevant.25 It Clinical trials showed a small dose dependent elevation in does not appear to significantly improve sleep efficiency, suicidal ideation (0.7 percent - higher doses than approved, 25 likely attributed to its very short half-life of 30-60 minutes. 0.2 percent - available doses, and 0.1 percent - placebo). There is no information available on tolerance, rebound and Interestingly, published trials do not show an increase in withdrawal effects. depressive symptoms.26,28 Certainly any increase in suicidal Melatonin is considered to be “likely safe” when used for up ideation is clinically relevant, especially since death due to suicide now outnumbers those from motor vehicle accito two months.25 The most common side effects include dents.29 In patients with pre-existing psychiatric disorders, it daytime drowsiness (20 percent), headache (7.8 percent) and dizziness (4 percent).25 Since natural supplements are is prudent to note the potential for hallucinations and innot regulated by the FDA, not all products are safe. Patients creasing suicidal ideation. should be encouraged to purchase products which are inde- Suvorexant’s advantages include its low potential to effect pendently laboratory tested and certified by organizations balance, memory and next day driving ability (except 20 mg such as the USP. dose). It may be a viable option in the elderly since it is relatively benign, with ADRs occurring at similar rates to the Suvorexant standard adult population. Most notably, it does not cause The first orexin antagonist, suvorexant, was FDA approved significant orthostatic hypotension, anticholinergic effects or in 2014 for the management of sleep maintenance or sleep memory impairment. Suvorexant is a Schedule-IV controlled onset insomnia. Orexin maintains a consistent state of substance, so there is potential for abuse. Some prescribers wakefulness and antagonism allows for sleep to proceed. may be leery to use this new medication due to the potential for narcolepsy like events. The greatest limitations include In an one year study tolerance did not develop.26 Furthermore, there has been no clear links to rebound insomnia or concerns for use in co-existing mental disorders (increase in suicidal ideation) and financial limitations, with a 10 mg tabwithdrawal.27 Suvorexant’s 12 hour half-life is much longer 16 let costing $10.50 each.30 than most insomnia medications. However, three of four 14

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September 2015 CE—Stop! In the Name of Sleep

September/October 2015 Accessed April 10, 2015.

Comparative Efficacy As discussed, both CBT and pharmacologic therapy have demonstrated short and long term efficacy in clinical trials. Additionally, they can be used alone or in combination. 8 A meta-analysis compared monotherapy with CBT and pharmacologic treatment.31 It demonstrates that CBT is at least as effective as pharmacologic therapies in the short term. 31 However, when post-treatment effects are studied, CBT is superior to hypnotics in improving sleep efficiency 6-24 months after completion of treatment.31 A second study by Morin et al.32 compared CBT (administered weekly for six weeks, then monthly for 6 month period) alone and in combination with an initial six week course of zolpidem 10 mg given every night at bedtime. At the six month follow up, remission was highest in the combination therapy group (68 percent [20/30] vs 42 percent [12/29]; p=.04).32 Combination therapy also provided patients with an increase in total sleep time during the initial six week period.32

2. American Psychiatric Association. Sleep-wake disorders. In: Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington DC: American Psychiatric Publishing; 2013. Available at dsm.psychiatryonline.org. Accessed March 1, 2015. 3. Bianchi MT, Westover MB. Insomnia and morning motor vehicle accidents: a decision analysis of the risk of hypnotics versus the risk of untreated insomnia. J Clin Psychopharmacol. 2014 Jun;34(3):400-2. 4. Avidan AY, Barkoukis TJ. Review of sleep medicine. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2011. 5. Carskadon MA. Normal Human Sleep: An Overview. In: Principles and Practice of Sleep Medicine. 5th ed. St. Louis, Missouri: Elsevier Health Sciences; 2011. 6. Tsujino N, Sakurai T. Orexin/Hypocretin: A Neuropeptide at the Interface of Sleep, Energy Homeostasis, and Reward System. Pharmacol Rev. 2009;61(2):162176.

There are no well-designed trials which compare all three scenarios (CBT, pharmacologic and combination therapy). From the above data, we can gather that CBT and pharma7. Johns M. What the Epworth Sleepiness Scale is and cologic therapy are equally effective in the short term, but how to use it. The Epworth Sleepiness Scale. Available CBT has a more lasting effect. Additionally, initial use of at http://epworthsleepinessscale.com/about-epworthzolpidem in combination with CBT may provide additional sleepiness. Published unknown. Accessed April 10, benefit. Of course, there is data supporting all options indi2015. vidually. The American Academy of Sleep Medicine’s insomnia algorithm demonstrates all three scenarios can be 8. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia used initially, but their consensus statements support use M. Clinical guideline for the evaluation and manageof CBT monotherapy initially (when conditions permit) and ment of chronic insomnia in adults. J Clin Sleep Med. supplementing pharmacologic therapy with CBT.8 Never2008 Oct 15;4(5):487-504. theless, treatment choice will be based on patient specific 9. Morin CM, Benca R. Chronic insomnia. Lancet. 2012 parameters. Mar 24;379(9821):1129-41. Conclusion 10. Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706Patients who present with insomnia complaints should 16. complete questionnaires, a two-week sleep log and physi11. Kirkwood CK, Melton ST. Insomnia. In: Handbook of cal exam to aid in the diagnosis. Comorbid conditions Nonprescription Drugs. 16th ed. Washington, DC: should be appropriately treated and contributing habits corAmerican Pharmacists Association; 2009. rected. Treatment choice is patient specific. However, CBT 12. Glass JR, Sproule BA, Herrmann N, Busto UE. Effects monotherapy is preferred unless patient specific circumof 2-week treatment with temazepam and diphenhydrastances dictate otherwise, and guidelines encourage supmine in elderly insomniacs: a randomized, placeboplementing pharmacologic therapy with CBT. Keep in mind controlled trial. J Clin Psychopharmacol. 2008 Apr;28 that treatment of insomnia is an active and longitudinal pro(2):182-8. cess, and periodic reevaluation of sleep logs and questionnaires is key to success. Citations

13. Silenor (doxepin) [package insert]. San Diego, CA: Somaxon Pharmaceuticals Inc; March 2010.

14. 1. National Sleep Foundation. 2015 Sleep in America Poll – Summary of Findings. National Sleep Foundation. Available at http://sleepfoundation.org/sleep-pollsdata/2015-sleep-and-pain. Published March 1, 2015. 15. 15

Nazarian PK, Park SH. Antidepressant management of insomnia disorder in the absence of a mood disorder. Mental Health Clinician. 2014;4(2):41-46. Mendelson WB. A Review of the Evidence for the Effi-

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September 2015 CE—Stop! In the Name of Sleep

September/October 2015

cacy and Safety of Trazodone in Insomnia. J Clin Psychiatry. 2005;66(4). 16. Lexi-Drugs [online database]. Hudson, OH: Lexi-Comp, Inc. 2015. Available at http://online.lexi.com. Accessed April 10, 2015. 17. Longo LP, Johnson B. Addiction: Part I. Benzodiazepines--side effects, abuse risk and alternatives. Am Fam Physician. 2000 Apr 1;61(7):2121-8.

antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79 (23):2265-74. 29. CDC Division of News & Electronic Media. CDC finds suicide rates among middle-aged adults increased from 1999-2010. Centers for Disease Control and Prevention. http://www.cdc.gov/media/releases/2013/p0502-suiciderates.html. Published May 2, 2013. Accessed April 10, 2015.

18. Walsh JK, Pollak CP, Scharf MB, et al. Lack of residual 30. Red Book Online [database online]. Greenwood Village, sedation following middle-of the-night zaleplon adminCO: Truven Health Analytics, Inc. Updated periodically. istration in sleep maintenance insomnia. Clin NeuropharAccessed April 10, 2015. macol. 2000;23:17-21. 31. Mitchell MD, Gehrman P, Perlis M, Umscheid CA. Com19. Morin AK, Jarvis CI, Lynch AM. Therapeutic options for parative effectiveness of cognitive behavioral therapy for sleep-maintenance and sleep-onset insomnia. Pharmainsomnia: a systematic review. BMC Fam Pract. 2012 cotherapy. 2007;27:89-110. May 25;13(40). 20. Heesch CB. The long-term use of sedative hypnotics in 32. Morin CM, Vallières A, Guay B, et al. Cognitive behaviorchronic insomnia. Mental Health Clinician. 2014;4(2):78al therapy, singly and combined with medication, for per81. sistent insomnia: a randomized controlled trial. JAMA. 21. Kripke DF, Langer RD, Kline LE. Hypnotics' association 2009 May 20;301(19):2005-15. with mortality or cancer: a matched cohort study. BMJ Open. 2012 Feb 27;2(1):e000850. 22. Mets MAJ, van Deventer KR, Olivier B, Verster JC. Critical appraisal of ramelteon in the treatment of insomnia. Nature and Science of Sleep. 2010:2;257-266. 23. Schwartz JRL, Roth T. Neurophysiology of Sleep and Wakefulness: Basic Science and Clinical Implications. Curr Neuropharmacol. 2008 Dec; 6(4): 367–378. 24. Silenor (doxepin) [package insert]. San Diego, CA: Somaxon Pharmaceuticals Inc; March 2010. 25. Melatonin. In: Natural Medicines Comprehensive Database. Stockton, CA: Therapeutic Research Faculty. Updated June 16, 2015. Accessed June 24, 2015. http:// naturaldatabase.therapeuticresearch.com/nd/ Search.aspx? cs=STUDENT&s=ND&pt=100&id=940&ds=&name=MEL ATONIN&searchid=52177542. 26. Michelson D, Snyder E, Paradis E, et al. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 May;13(5):461-71. 27. Belsomra (suvorexant) [package insert]. Whitehouse Station, NJ: Merck and Dohme Corp; August 2014. 28. Herring WJ, Snyder E, Budd K, et al. Orexin receptor

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

September 2015 CE—Stop! In the Name of Sleep

September/October 2015

September 2015 — Stop! In the Name of Sleep 1. What is necessary for the diagnosis of insomnia? A. Occurs two nights per week B. Not due to a medical condition C. Causes impairment or distress D. Results from inadequate opportunity

6. This neurobiologic interaction is key to maintain a consistent state of wakefulness during the day: A. Orexin’s negative feedback loop. B. Wake centers inhibiting VLPO. C. VLPO inhibiting orexin.

2. It is best practice to use this instrument to assist 7. A good option in a patient with sleep onset in the diagnosis of insomnia: insomnia and a history of substance abuse is: A. Two-week sleep log. A. Doxepin. B. Polysomnography. B. Temazepam. C. Wrist actigraphy. C. Zolpidem. D. Mini mental state exam. D. Ramelteon. 3. When conditions permit, the American Academy of Sleep Medicine’s insomnia guidelines recommend which first line treatment? A. Sleep hygiene measures B. Cognitive behavioral therapy C. Zolpidem D. Triazolam

8. Tolerance rapidly develops to which agent? A. Diphenhydramine B. Eszopiclone C. Suvorexant D. Ramelteon

9. An elderly patient has a history of falls and severe urinary retention. What is the best option for her 4. This is an example of a behavioral procedure used sleep maintenance insomnia? in CBT: A. Doxepin A. Sleep restriction therapy. B. Trazodone B. Keep the bedroom dark and cool. C. Temazepam C. Psychotherapy targeting sleep misconceptions. D. Suvorexant D. Napping frequently. 10. This medication has an ultra-short half life and 5. What is the primary neurotransmitter of the sleep can be used for middle of the night awakenings center? when four hours of sleep remain: A. Acetylcholine A. Doxylamine. B. Histamine B. Trazodone. C. Orexin C. Estazolam. D. GABA D. Zaleplon.

Have a topic in mind that you want to know more about? Send it to Scott Sisco at ssisco@kphanet.org 17

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September 2015 CE—Stop! In the Name of Sleep

September/October 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: September 10, 2018 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. September 2015 — Stop! In the Name of Sleep (1.0 contact hour) Universal Activity # 0143-0000-15-010-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

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___________________________

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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___________________________

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October 2015 CE—Influenza Vaccination

September/October 2015

Influenza Vaccination: Review of 2015-2016 Recommendations By: Tera McIntosh, PharmD, BCACP; Kelli Jones, PharmD candidate, Stacy A. Taylor, PharmD, MHA, BCPS University of Kentucky College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-15-011-H01-P&T 1.0 Contact Hour (0.1 CEU) Goals: To assist pharmacists and pharmacy technicians in understanding current recommendations for influenza vaccine and to assist with selection of vaccine for specific patients.

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

Objectives At the conclusion of this Knowledge-based article, the reader should be able to: 1. Provide current Advisory Committee on Immunization Practices (ACIP) recommendations for influenza vaccine for 2015-2016. 2. Differentiate the available influenza vaccine products and their indications. 3. Identify appropriate vaccine administration for intramuscular flu injections. vaccines will contain two A strains and two B strains as follows: A/California/7/2009-like (H1N1), As the 2015-2016 influenza season has approached, this A/Switzerland/9715293/2013-like (H3N2), continuing education article will summarize this year’s CenB/Phuket/3073/2013-like (Yamagata lineage) and ters for Disease Control (CDC) Advisory Committee on ImB/Brisbane/60/2008-like (Victoria lineage). The A-H1N1 munization Practices (ACIP) influenza immunization recomand the B-Yamagata lineage strains remain the same this mendations highlighting the key differences as compared to year while the A-H3N2 and B Victoria lineage strains repreprevious years. Additionally, this article will provide a sumsent a change from the 2014-2015 season’s vaccines. The mary of the newer types of influenza vaccine formulations, trivalent vaccines contain the same strains except for the outlining ones that are most appropriate for use in specific omission of the Victoria lineage B strain.1 populations. And finally, this document seeks to answer The ACIP recommendations provide information on the five some of the most frequently asked patient and provider questions a pharmacist may encounter when providing im- trivalent, inactivated vaccines available this season as compared to eight last season (Afluria®, Flucelvax®, Fluvirin®, munizations to patients. Fluzone® and Fluzone® High-Dose), four inactivated quadriGroups Recommended for Vaccination1 valent (Fluarix® Quadrivalent, FluLaval® Quadrivalent, FluThe ACIP continues to recommend annual influenza vaczone® Quadrivalent and Fluzone® Intradermal Quadrivacination for all persons aged six months and older. The lent), one live attenuated quadrivalent (FluMist® Quadrivavaccines should be offered in early fall, preferably by Octo- lent) and one recombinant trivalent vaccine (Flublok ®). Adber, prior to the onset of influenza activity in the community. ditionally this year, Afluria® was approved to be adminisA special emphasis should be placed on vaccinating pertered intramuscularly via a needle-free jet injector system sons at a higher risk for experiencing influenza-related among persons 18 to 64 years of age. ACIP expresses no complications, including people over 50 years of age, peo- preference for any given influenza formulation over another ple with chronic medical conditions, children aged 6-59 and emphasizes that vaccination should not be delayed if months, pregnant women, residents of long term care facili- an appropriate and indicated vaccine preparation is availaties, American Indians/Alaska natives and persons who are ble. This includes no preference for quadrivalent versus morbidly obese.1 trivalent vaccines; no preference for live attenuated versus inactivated vaccine; and no preference for high-dose verVaccine Composition 2015-20161 sus standard-dose vaccine in persons aged 65 and older.1 The antigenic composition of the 2015-2016 influenza vac1 cines has been altered this year to better align with the ge- Pediatric Vaccine Recommendation Changes During the 2014-15 season, ACIP recommended the live netically drifted strains anticipated to be the predominant ® 2,3 ones this season. According to the CDC, the quadrivalent attenuated Flumist vaccine as preferred over inactivated Introduction

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October 2015 CEâ&#x20AC;&#x201D;Influenza Vaccination

September/October 2015

Table 1 vaccines in children aged 2-8 years. This was based on initial efficacy studies that demonstrated an increased efficacy of the live vaccine in preventing laboratory-confirmed influenza in this population. Additional observational data have become available this year from the 2013-14 season that show mixed results. These data have shown neither live attenuated nor inactivated vaccines provided sufficient protection against the antigenically drifted H3N2 strain among children aged 2 through 17 years. Based on the mixed observational results, ACIP has changed the pediatric recommendation for the 201516 season. This year, ACIP is equally recommending either the live attenuated or inactivated (trivalent or quadrivalent) vaccines among healthy children aged 2 through 8 years. ACIP will continue to monitor vaccine efficacy and provide additional guidance as needed.1 Number of Pediatric Doses Needed1 According to ACIP, children between 6 months and 8 years of age who have never received an influenza vaccine need an initial two doses of influenza vaccine at least four weeks apart to optimize response. Studies have shown that children who receive two doses within the same season have a similar immune response to subsequent vaccination as children who receive a single dose in two separate seasons. Based on this study, children in the 6 month to 8 years age range who have received at least two doses of influenza vaccination prior to July 1, 2015 (which could have been administered as two doses within the same season or a single dose in each of two separate seasons) will only need to receive one dose of influenza vaccine this year. As mentioned previously, there is no longer any preference for live attenuated over inactivated vaccine among patients 2-8 years this year. Live Attenuated Vaccine Recommendations1 ACIP provides recommendations on the live attenuated influenza vaccine (LAIV) which is indicated among per-

sons age 2-49 years, but is not recommended in the following populations: children aged 2-17 years who are receiving aspirin-containing products; children age 2-4 years with asthma or a history of a wheezing attack within the past year; pregnant women; immunocompromised persons and persons who have taken anti-influenza virus medications in the past 48 hours. Additionally, due to the increased risk of wheezing caution should be used when considering LAIV administration in patients 5 years and 20

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October 2015 CE—Influenza Vaccination

September/October 2015

older with asthma. The safety of LAIV has not been fully evaluated in other patients with underlying medical conditions including other chronic pulmonary disorders besides asthma or cardiovascular, renal, hepatic, neurologic, hematologic or metabolic disorders.1

dose, quadrivalent, low-ovalbumin cell culture, egg-free recombinant, intradermal and needle-free vaccines. This section will provide an overview of efficacy and safety data to aid the clinician in discerning appropriate patient populations for whom each preparation is indicated and suitable.

Egg Allergy Vaccination Options1

High-Dose Vaccine

For 2015-2016, ACIP reaffirmed its recommendations for persons with a history of egg allergy. Severe allergic and anaphylactic reactions following influenza vaccination are rare and ACIP has outlined a strategy to encourage appropriate vaccination and decrease missed opportunities among egg-allergic individuals. Regardless of allergy history, it is standard practice that all vaccinations be administered in settings where personnel and equipment are available to respond to a potential anaphylaxis reaction. Note: Information differentiating the two available low- and noovalbumin vaccines is provided in the Newer Influenza Vaccine Preparations section. Recommendations are outlined below and in Table 1:1

The first high-dose inactivated vaccine was licensed in December 2009 for the immunization of persons 65 years of age and older. Each 0.5 mL dose of the high-dose formulation contains a total of 60 mcg of each strain of influenza virus hemagglutinin, which is four times the amount of influenza virus hemagglutinin contained in standard-dose formulations.4 In pre-licensure trials, high-dose vaccination induced significantly higher serum antibody responses against all three strains (A/H1N1, A/H3N2, and B) as compared to standard-dose vaccination among persons 65 years and older. The high-dose vaccine met pre-specified criteria for immunologic superiority to both A strains, but was non-inferior to the B strain.5 Whether the high-dose is superior to the standard dose vaccine in preventing clinical Persons who report having an allergy to eggs but can ly relevant sequelae of influenza infection such as pneumoeat lightly cooked eggs without reaction should be vacnia and hospitalizations continues to be studied. A summary cinated according to the standard immunization protoof outcomes of recently published studies is provided. A col. retrospective cohort study reported increased efficacy of  Persons whose egg-allergic response history is limited high dose vaccine in Medicare beneficiaries aged 65 and up to hives may receive inactivated trivalent or inactivated for prevention of probable influenza infections and influenza quadrivalent vaccines or the recombinant trivalent vac- related hospital admissions.6,7 A recent multicenter, rancine (RIV3). The available recombinant product, domized, double-blind, active-controlled trial performed by ® Flublok , is only indicated and recommended for perthe vaccine manufacturer also reported improved clinical sons aged ≥ 18 years. When inactivated vaccines are benefits with high dose vaccine. The study showed signifiadministered, the vaccine recipient must be observed cant increase in efficacy of high dose vaccine against labby a healthcare provider familiar with the manifestations confirmed influenza.8 A separate publication of that study of egg allergy for at least 30 minutes. reported reduction in risk of serious adverse events possibly related to influenza and reduction in risk of serious pneumo Persons who have experienced more severe reactions nia in high dose vaccine recipients; however all cause hosto egg (angioedema, cardiovascular changes such as pitalizations did not show a significant difference in favor of hypotension, respiratory distress, lightheadedness, high dose vaccine.9 After considering all evidence, CDC nausea or vomiting or other reaction requiring emergenfollowed ACIP recommendations for the 2015-2016 influency medical intervention) may receive the recombinant za season and does not indicate preference for the high vaccine if aged ≥ 18 years or be referred to a physician dose vaccine. Recommendations advise immunizers to with expertise in managing allergic conditions. continue to vaccinate with either an age-appropriate stand Persons with no known history of egg exposure but a ard-dose vaccine or high-dose vaccine.1 history of a positive response to egg allergy testing may Quadrivalent Vaccines receive the recombinant vaccine if aged ≥ 18 years or From 1978-2012, vaccines contained three influenza be referred to a physician with expertise in managing strains; two A strains and one B strain. However, beginning allergic conditions. in 1985, two antigenically distinct lineages of influenza B, Newer Influenza Vaccine Preparations Yamagata and Victoria, have co-circulated in varying proSeveral new vaccine preparations have been approved portions.10 Due to the difficulty in predicting the predominant since 2009, yielding an array of options from which to B lineage in any given season, there was a mismatch bechoose. These new preparations include the advent of high- tween the predominant circulating B lineage and the B line21

THE KENTUCKY PHARMACIST

October 2015 CE—Influenza Vaccination

September/October 2015

age contained in the vaccine in approximately 50 percent of influenza seasons from 2001-2012.11 While immunization against one lineage confers some crossover protection against other lineages, a quadrivalent seasonal influenza vaccine was developed to improve the match between strains contained in the vaccine and predominant circulating strains each season. In the United States, there are currently four licensed inactivated quadrivalent vaccines and one live attenuated quadrivalent vaccine.1 In pre-licensure studies, the quadrivalent vaccines were immunologically noninferior to trivalent vaccines against shared influenza strains and superior to trivalent vaccines against the B lineage present only in the quadrivalent vaccine. 12,13

with standard inactivated influenza vaccine.17

Flublok®, approved in January 2013, is a recombinant trivalent vaccine produced by cloning the hemagglutinin gene in a baculovirus expression vector and expressing it in an insect (caterpillar) cell line. Flublok® is licensed for use in adults aged 18 years and older. Each 0.5 mL dose contains 45 mcg of influenza virus hemagglutinin of each strain, which is three times the amount in standard influenza vaccines. The clinical efficacy was demonstrated against placebo in patients aged 18 to 49 years and immunologic noninferiority was demonstrated in patients aged 50 to 64 years as compared to standard inactivated influenza vaccine. Flublok® is the only influenza vaccine currently on the marThe transition from trivalent to quadrivalent vaccine is ocket that is considered to be egg-free, and thus, is the only curring over several seasons as manufacturers seek approduct currently recommended by ACIP for administration proval for quadrivalent versions and halt production of triva- to persons with severe egg allergy by non-physician vaclent versions. The impact of a quadrivalent vaccine will de- cine providers. If Flublok® is unavailable and an eggpend on the influenza B predominance and the degree of containing vaccine needs to be administered, it is recommatch between circulating B viruses in any given season. In mended that persons with severe egg allergy be referred to an evaluation of influenza seasons from 1979-2001, B viphysicians with expertise in managing allergic conditions ruses were predominant in 11 of 22 (50 percent) seasons.14 who may provide appropriate observation and monitoring.18 For the 2015-2016 influenza season there are insufficient Intradermal Vaccine quadrivalent doses to vaccinate all eligible persons. Additionally, ACIP has not expressed a preference for the quad- In 2011, an inactivated influenza vaccine for intradermal administration was approved for use in adults aged 18 to 64 rivalent versus trivalent vaccine so either vaccine preparayears.19 A quadrivalent intradermal formulation was aption may be used in indicated persons. proved in the fourth quarter of 2014 and replaced the trivaLow-ovalbumin Cell Culture and Egg-free Recombinant lent version for the 2015-2016 season. The intradermal forVaccines mulation contains 9 mcg of influenza virus hemagglutinin Prior to the approval of newer vaccines, all influenza vacper strain (lower than the 15 mcg in a standard intramuscucines were manufactured by inoculating the influenza virus lar dose) and is administered in a 0.1 mL dose. This lower into embryonated hen eggs. Vaccines manufactured using dose is possible due to the abundance of immunostimulatocell culture based technology may shorten the production ry antigen-presenting cells in the dermis. Each dose is adcycle thus enabling more rapid production of vaccine in the ministered using a microinjection system that is designed to event of a pandemic or need to incorporate emerging limit the depth of penetration and ensure proper perpendic15 strains. Egg-free cell culture vaccines also now provide an ular needle insertion. The efficacy of the intradermal formuimmunization option for those with severe egg allergy.1 lation was compared with standard dose, intramuscular administration and was found to be immunologically nonFlucelvax® was approved for use in adults 18 years of age inferior. Local reactions were documented more frequently and older in November 2012. It is manufactured via propawith the intradermal vaccine than the intramuscular vaccine. gation in Madin Darby Kidney Cells.16 Although created in The one exception was that pain and myalgia were reported cell culture, the initial virus material used to begin the propin a higher percentage of patients in the intramuscular agation contains egg protein. While the final product is estigroup.20 mated to contain only a small amount (estimated 5x10 -8 mcg of total egg protein), it is not considered egg-free. ACIP Needle-Free Jet Injector recommends persons with severe egg allergy be referred to In 2014, one inactivated trivalent vaccine, Afluria®, was apa physician with expertise in managing allergic conditions proved for persons aged 18 through 64 years for adminbefore receiving this vaccine.1 The vaccine efficacy against istration by the PharmaJet Stratis needle-free injection syslaboratory-confirmed influenza illness was comparable to tem. Afluria® may alternatively be administered via the tradithe clinical efficacy of standard inactivated influenza vactional needle and syringe method for persons 5 years and cine. 15 In patients aged greater than 18 years, pain at the older. The needle-free injection system uses a jet of air to injection site was reported more frequently as compared 22

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October 2015 CE—Influenza Vaccination

September/October 2015

administer the intramuscular injection. It is important to note that the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) approves biological vaccines specifically according to the patient population, dose and method/route of administration. As such, Afluria® is the only influenza vaccine currently approved for administration via the needle-free jet injector. The most commonly reported adverse events were injection site tenderness, swelling, pain and redness and were reported more frequently in the needle-free group as compared to the needle and syringe group. Immunogenicity of the vaccine was determined by assessing antibody levels in a subset of the study population and the needle-free injection was found to be non-inferior to the needle and syringe method.21

Table 2 Injection Site and Needle Size for Intramuscular (IM) Injection Gender/Weight

Needle Length

Female or male less than 130lbs

5/8 inch* to 1 inch

Female or male 130-152 lbs

1 inch

Female 153-200 lbs

1 inch to 1.5 inch

Male 153-260 lbs Female 200+ lbs

1.5 inch

Male 260+ lbs * A 5/8 inch needle may be used only if the subcutaneous tissue is not bunched and the injection is made at a 90 degree angle.

Vaccine Timing In recent years, some community vaccination sites have received vaccine shipments and offered vaccination as early as July. Many patients are hesitant about receiving vaccine early and elect to wait until October due to concerns about reduced immunity and, thus, effectiveness over time. There is conflicting evidence on this issue. A literature review conducted in 2008 did not support concerns that antibody response declines in the elderly. Findings from this review of 14 studies of antibody levels in those age 60 and over, found that adequate seroprotection from influenza type A viruses was maintained for greater than 4 to 6 months as long as initial antibody response to vaccine was adequate. Initial and 4-6 month antibody levels for influenza type B were less consistent.22

muscle. Many patients who develop SIRVA, which consists of onset of pain and very limited mobility in the shoulder, do so within 24-48 hours of vaccine administration and have no previous history of shoulder problems.25

The majority of inactivated injectable flu vaccines should be administered intramuscularly into the deltoid muscle, thus, correct administration and placement of flu vaccine into the deltoid muscle is essential to prevent SIRVA. To correctly administer an intramuscular vaccine, the vaccinator must select an appropriate needle size and ensure correct placement into the deltoid muscle. In Kentucky, pharmacists can immunize patients aged 9 and older via a prescriber approved protocol. According to the CDC, the needle size for deltoid injections for children age 9-18, range However other studies have reported various findings. In a from 5/8- to 1-inch. For younger children in this age range, 2010 Korean study, although seroprotection rates rewhen a 5/8 inch needle is used, the skin should be mained above criteria considered adequate for protection, stretched flat between thumb and forefinger. Most older there was a significant decline in antibody titers in the 65 children and adolescents will require a 1-inch needle. For years and older age group at 6 months following vaccinaadults, needle length can range from 5/8 to 1.5 inches and tion with standard dose trivalent inactivated vaccine.23 A can be based on weight of the patient as outlined in Table 2013 study conducted in Spain, suggested a decline in 2.26 SIRVA can be prevented by ensuring that the vaccine vaccine effectiveness (this was not statistically significant) is injected at a 90 degree angle into the correct area of the in the elderly; however, most characterized flu viruses did deltoid muscle, which is the central and thickest portion of not match the vaccine strain for that year.24 Results remain the deltoid — above the level of the armpit and 3 finger inconclusive and ACIP continues to monitor updates in this widths below the acromion as shown in Table 3. Some otharea. Current recommendations advise immunizers to offer er tips that could help pharmacists ensure correct placevaccination by October and to continue to offer it as long ment include avoidance of injecting into the upper third of as flu virus remains in circulation.1 the deltoid muscle. Pharmacists can request and ensure unobstructed access to the deltoid muscle instead of adSIRVA and Vaccine Administration ministering injections to patients who may want to pull a Shoulder injury related to vaccine administration (SIRVA) shirt down just a little to expose their upper arm. has been reported at an increasing rate in recent articles Simultaneous Administration of Vaccines and literature. SIRVA is thought to be a result of vaccine Simultaneous administration of vaccines is a question that that is injected too high on the shoulder into the deltoid 23

THE KENTUCKY PHARMACIST

October 2015 CEâ&#x20AC;&#x201D;Influenza Vaccination

September/October 2015

often arises in immunization practice when multiple vaccines are indicated for a single patient. It is important for immunizers to understand which vaccines may be administered at the same visit to prevent missed opportunities. In general, all vaccines that a person is eligible for can be administered at a single visit to increase the likelihood that they will be fully immunized.

Summary of Changes for 2015-2016

For the 2015-2016 influenza season, the ACIP continues to recommend annual influenza vaccination for all persons aged six months and older with special emphasis on persons at higher risk for experiencing influenza-related complications.1 The antigenic composition of the 2015-2016 influenza vaccines has been altered to better align with the Patients who are recommended to receive annual flu vac- strains anticipated to be the predominant ones this season cine often are candidates for additional vaccines as well. with the quadrivalent vaccines containing two A and two B Inactivated influenza vaccine may be administered during strains while the trivalent vaccines contain two A and only the same visit as other inactivated vaccines (e.g., PPSV23, one B strain.2,3 During the 2015-2016 season, the ACIP no PCV13, Tdap) or at any time before or after a different inlonger preferentially recommends the live attenuated influactivated vaccine has been given.27 Inactivated vaccines do enza vaccine (LAIV) over inactivated vaccines among chilnot interfere with the immune response to live vaccines and dren aged 2-8 years. Either vaccine type is equally recomtherefore may also be administered either simultaneously mended among healthy children in this age group this or at any time before or after live vaccines (e.g. Zoster, year.1 ACIP recommendations for patients with egg allergy MMR). Live, attenuated influenza vaccine (LAIV) may be remain unchanged. Additionally ACIP continues to provide administered on the same day as other inactivated or live no preferential recommendations for high-dose vaccine vaccines. If another live vaccine is to be administered on a over standard dose vaccine among patients greater than different day than LAIV then it should be given no earlier 65 years and provides no preferential recommendations for 27 than 4 weeks. quadrivalent over trivalent influenza vaccines.1

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October 2015 CEâ&#x20AC;&#x201D;Influenza Vaccination References

September/October 2015 11. Dolin R. The quadrivalent approach to influenza vaccination. J Infect Dis. Aug 15 2013;208(4):539-540.

1. Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and Control of Influ- 12. Kieninger D, Sheldon E, Lin WY, et al. Immunogenicity, enza with Vaccines: Recommendations of the Advisory reactogenicity and safety of an inactivated quadrivalent Committee on Immunization Practices, United States, influenza vaccine candidate versus inactivated trivalent 2015-16 Influenza Season. MMWR. Morbidity and morinfluenza vaccine: a phase III, randomized trial in tality weekly report. Aug 7 2015;64(30):818-825. adults aged >/=18 years. BMC infectious diseases. 2013;13:343. 2. Appiah GD, Blanton L, D'Mello T, et al. Influenza activity - United States, 2014-15 season and composition of 13. Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, et al. Immuthe 2015-16 influenza vaccine. MMWR. Morbidity and nogenicity, reactogenicity, and safety of inactivated mortality weekly report. Jun 5 2015;64(21):583-590. quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged 3. Flannery B, Clippard J, Zimmerman RK, et al. Early >/=18 years: a phase III, randomized trial. Vaccine. estimates of seasonal influenza vaccine effectiveness Mar 14 2014;32(13):1480-1487. United States, January 2015. MMWR. Morbidity and mortality weekly report. Jan 16 2015;64(1):10-15. 14. Thompson WW, Shay DK, Weintraub E, et al. Influenza -associated hospitalizations in the United States. Ja4. Fluzone High-Dose [package insert]. Swiftwater, PA: ma. Sep 15 2004;292(11):1333-1340. Sanofi Pasteur; 2014. 5. Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. Jul 15 2009;200(2):172180.

15. Frey S, Vesikari T, Szymczakiewicz-Multanowska A, et al. Clinical efficacy of cell culture-derived and eggderived inactivated subunit influenza vaccines in healthy adults. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. Nov 1 2010;51(9):997-1004.

16. Flucelvax [package insert]. Cambridge, MA: Novartis 6. Izurieta HS, Thadani N, Shay DK. Corrections. ComVaccines and Diagnostics; 2014. parative effectiveness of high-dose versus standarddose influenza vaccines in US residents aged 65 years 17. Szymczakiewicz-Multanowska A, Groth N, Bugarini R, and older from 2012 to 2013 using Medicare data: a et al. Safety and immunogenicity of a novel influenza retrospective cohort analysis. Lancet Infect Dis. subunit vaccine produced in mammalian cell culture. J 2015;15(3):263. Infect Dis. Sep 15 2009;200(6):841-848. 7. Izurieta HS, Thadani N, Shay DK, et al. Comparative 18. Flublok [package insert]. Meriden, CT: Protein Scienceffectiveness of high-dose versus standard-dose influes Corporation; 2014. enza vaccines in US residents aged 65 years and older 19. Fluzone Intradermal [package insert]. Swiftwater, PA: from 2012 to 2013 using Medicare data: a retrospecSanofi Pasteur, 2014. tive cohort analysis. Lancet Infect Dis. 2015;15(3):293300. 20. Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH. Intradermally-administered influenza virus 8. DiazGranados CA, Dunning AJ, Kimmel M, et al. Effivaccine is safe and immunogenic in healthy adults 18cacy of high-dose versus standard-dose influenza vac64 years of age. Vaccine. May 1 2013;31(19):2358cine in older adults. N Engl J Med. 2014;371(7):6352365. 645. 9. DiazGranados CA, Robertson CA, Talbot HK, Landolfi 21. FDA Updated Communication on Use of Jet Injectors with Inactivated Influenza Vaccines. Accessed SepV, Dunning AJ, Greenberg DP. Prevention of serious tember 8, 2015 at http://www.fda.gov/ events in adults 65 years of age or older: A comparison BiologicsBloodVaccines/Vaccines/ between high-dose and standard-dose inactivated inQuestionsaboutVaccines/ucm276773.htm. fluenza vaccines. Vaccine. 2015. 10. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Human vaccines & immunotherapeutics. Jan 2012;8(1):81-88.

22. Skowronski DM,Tweed SA, De Serres G. Rapid decline of influenza vaccine-induced antibody in the elderly: is it real, or is it relevant? J Infect Dis. Feb 15 25

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September/October 2015

2008;197(4):490-502.

November 29 2010; 28 (51): 8049–8052.

23. Song JY, Cheong HJ, Hwang IS, et al. Long-term immunogenicity of influenza vaccine among the elderly: Risk factors for poor immune response and persistence. Vaccine 2010;28:3929–35.

26. Centers for Disease Control and Prevention. Vaccine Administration; Epidemiology and Prevention of Vaccine-Preventable Diseases; The Pink Book: 13th Edition (2015)

24. Castilla J, Martínez-Baz I, Martínez-Artola V, et al. Decline in influenza vaccine effectiveness with time after vaccination. Euro Surveill. 2013;18 (5).

27. Kroger AT, Strikas RA. General recommendations for vaccination and immunoprophylaxis: recommendations of the Advisory Committee on Immunization Practices, United States. MMWR. Morbidity and mortality weekly report. Jan 28 2011;60(RR02):1-61.

25. Atanasoff, S, Ryan T, Lightfoot R, et al. Shoulder injury related to vaccine administration (SIRVA). Vaccine.

YOUR KPhA Needs YOU! Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines

The following broad guidelines should guide an author to completing a continuing education article for publication in The Kentucky Pharmacist.  

  



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



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

Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).  When submitting the article, you also will be Articles are generally written so that they are perasked to fill out a financial disclosure statement to tinent to both pharmacists and pharmacy techniidentify any financial considerations connected to cians. If the subject matter absolutely is not pertiyour article. nent to technicians, that needs to be stated clearly Articles should address topics designed to narrow at the beginning of the article. gaps between actual practice and ideal practice in Article should begin with the goal or goals of the overall program – usually a few sentences.

pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see Include 3 to 5 objectives using SMART and meas- previously published articles. urable verbs. Articles must be submitted electronically to the KPhA director of communications and continuing education Feel free to include graphs or charts, but please submit them separately, not embedded in the text (ssisco@kphanet.org) by the first of the month preceding publication. of the article.

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.

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October 2015 CE—Influenza Vaccination

September/October 2015

October 2015 — Influenza Vaccination: Review of 2015-2016 Recommendations 1. Annual influenza vaccine would be recommended for which of the following patients? A. A 6 year old healthy male B. A 14 year old female with type 1 diabetes C. A 44 year old male with hepatitis C D. All of the above

6. Which of the following flu vaccines does NOT contain egg protein? A. Flublok® B. Flucelvax® C. Fluarix® D. Afluria®

2. Which of the following children would need two doses of influenza vaccine? A. An 18 month old who received one dose of vaccine during the 2014-2015 flu season B. A 4 year old who received one dose of flu vaccine during the 2013-2014 season and one dose of vaccine during the 2014-2015 season C. A 10 year old who has never received flu vaccine D. None of the above

7. Which of the following is true regarding intradermal flu vaccine? A. It is indicated for use in adults only. B. Intradermal vaccine is more effective than the Intramuscular vaccine. C. Intradermal vaccine is associated with more frequent local reactions. D. Intradermal vaccine should be administered with a ½ inch standard vaccine needle and 3 mL syringe.

3. Which of the following patients would be a candidate for LAIV? A. A healthy 20 month old female receiving her first dose of flu vaccine B. A 15 year old male taking loratidine for seasonal allergy symptoms C. A 32 year old female who is 30 weeks pregnant D. A healthy 52 year old male

8. According to the CDC, the best time period to offer and administer flu vaccine to ensure efficacy is: A. As soon as flu disease begins circulation in the community and through March. B. Between October and January. C. Before October and as long as flu disease is in circulation. D. Between July and April.

4. A 22 year old patient with history of asthma presents to the pharmacy for influenza vaccine. During screening, the patient reports an egg allergy that resulted in hives and vomiting. The pharmacy has in stock the following vaccine: Fluzone® and Fluzone® High-Dose trivalent and Fluarix® Quadrivalent, inactivated injectable flu vaccines and FluMist® Quadrivalent live attenuated vaccine. The pharmacist should: A. Vaccinate with live attenuated flu vaccine per protocol. B. Vaccinate with either the standard dose trivalent or quadrivalent inactivated vaccine per protocol. C. Vaccinate with either standard dose trivalent or quadrivalent inactivated flu vaccine per protocol and ask the patient to stay for observation for 30 minutes after vaccination. D. Refer the patient to a physician with experience in identifying and managing severe allergic conditions for vaccination.

9. To avoid shoulder injury related to vaccine administration (SIRVA), the pharmacist should ensure all of the following during influenza vaccine administration into the deltoid muscle EXCEPT: A. Ask the patient for full access to the upper arm/deltoid muscle. B. Inject vaccine at a 45 degree angle into the muscle with a ½ inch needle. C. Inject vaccine into the thickest portion or middle third of the deltoid muscle. D. Consider the weight of the patient to select a needle size for administering vaccine.

10. A 66 year old patient presents to the pharmacy for a high dose influenza vaccine. If indicated, which of the following vaccines could also be administered to the patient at the same visit? A. Pneumococcal vaccine (PPSV23) B. Zoster vaccine C. Tdap 5. Which of the following is true regarding influenza D. All of the above vaccine in patients 65 years of age and over? A. High dose inactivated influenza vaccine has clearly demonstrated increased efficacy in preventing influenza disease and is the preferred flu vaccine. B. A flu vaccine is recommended annually for all patients age 65 years and older. C. Administration of flu vaccine should be delayed until late fall to ensure optimal vaccine efficacy during flu season. D. Quadravalent flu vaccine is preferred in the elderly to confer protection against the majority of flu virus strains.

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

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October 2015 CE—Influenza Vaccination

September/October 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: October 16, 2018 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. October 2015 — October 2015 — Influenza Vaccination: Review of 2015-2016 Recommendations (1.0 contact hour) Universal Activity # 0143-0000-15-011-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

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

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

Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) PHARMACISTS ANSWER SHEET October 2015 — October 2015 — Influenza Vaccination: Review of 2015-2016 Recommendations (1.0 contact hour) Universal Activity # 0143-0000-15-011-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

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

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

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

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KPhA Emergency Preparedness Training

September/October 2015

Emergency Preparedness Training in Morehead

KPhA Director of Pharmacy Emergency Preparedness Leah Tolliver presented a training session in Morehead on Oct. 8, 2015 at the Kentucky Folk Life Center. A group of dedicated volunteers learned more about the KPhA Emergency Preparedness Program.

KPhA Headquarters Rebuilding Campaign Watch eNews and subsequent editions of The Kentucky Pharmacist for more information on ways YOU can help rebuild YOUR KPhA Headquarters! 29

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atomAlliance

September/October 2015

atom Alliance Can Help You Improve Medication Safety by Reducing Adverse Drug Events As pharmacists, we all know people harmed by adverse drug events: 

The patient admitted to the hospital due to bleeding while on warfarin.



The grandmother who can’t always afford the foods she needs and so has frequent hypoglycemia due to insulin she gets from your pharmacy.



The neighbor who stopped breathing because of a prescription opioid overdose.

We know that these problems are common and significantly affect the lives of those we care about and serve.

need pharmacists in all of our coalitions to provide the expertise needed to improve safe use of medications and specifically to decrease the harm to patients taking anticoagulants, hypoglycemics and opioids. What’s in it for you? Of course, there is the satisfaction of helping patients and others you care about. Beyond that, it is an opportunity to show what we are capable of as a profession. It’s another way to show that we deserve to be recognized as healthcare providers, and another way to show that we are indispensable members of the healthcare team.

The good news is that these problems are often preventaIt’s also a way to form relationships with stakeholders ble, and pharmacists are the key to providing solutions. outside of our own organization and improve communicaAs drug experts, we have the skills necessary to improve tion about patients’ medications. We’ve all been in a situamedication safety, but often it’s hard to know how to best tion where we can’t get the information we need to safely use our skills to help. care for a patient. Working with atom Alliance and in community coalitions allows us to form relationships and creThat’s where atom Alliance comes in. ate new ways to share information so that it happens less Contracted by the Centers for Medicare & Medicaid Seroften. vices, atom Alliance is a Quality Innovation NetworkIn the end, we win, our communities win and our patients Quality Improvement Organization that works to improve the quality of healthcare for Medicare patients. There are win. 14 QIN-QIOs in the nation. atom Alliance represents AlaPlease visit http://atomalliance.org/download/medicationbama, Indiana, Kentucky, Mississippi and Tennessee. safety-fact-sheet/ to download a flier on how to become involved with medication safety and the atom Alliance QIN atom Alliance is forming community coalitions with an in-QIO. You also can email Cindy Todd, Quality Improveterest in improving medication safety. Community coalitions consist of healthcare providers, patients and families ment Advisor in Kentucky at cindy.todd@area-g.hcqis.org, or Amanda Ryan, pharmacist for atom Alliance at amanand anyone interested in improving the care of patients, da.ryan@area-g.hcqis.org. especially during transitions between care settings. We

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 BY NOVEMBER 13, 2015 to be included in the final edition of The Kentucky Pharmacist for 2015. Deceased members for each year will be honored permanently at the KPhA office.

THE KENTUCKY PHARMACIST

Kentucky Reportable Diseases

September/October 2015

Kentucky Reportable Diseases regulation revised, requiring pharmacist reporting An amendment to the Kentucky reportable diseases regulation, now called "902 KAR 2:020. Reportable disease surveillance" has added new reporting requirements for pharmacists for tuberculosis (TB).

(2) A report of tuberculosis shall be considered priority and shall be reported to the local health department serving the county in which the patient resides. (3) If the local health department cannot be reached, notification shall be given to the Kentucky Department for PubThe full regulation is available here: http://www.lrc.ky.gov/ lic Health. kar/902/002/020.htm (4) The report shall include: The section dealing with pharmacists is below: (a) Information required in Section 4(16) of this administra"Section 15. Tuberculosis. (1) A pharmacist shall give no- tive regulation; and tice if two (2) or more of the following medications used for (b) Names of the medications dispensed." the initial treatment of active tuberculosis are dispensed to A reporting form can be found at http://www.kphanet.org/? an inpatient in a health facility or to an ambulatory patient KentuckyResources. in a health facility or a pharmacy: There is a newer treatment regimen for latent TB infection that uses Isoniazid and Rifapentine. "Rifapentine" was not listed among the drugs in the regulation, but a pharmacist could decide to report the dispensing of Isoniazid and Rifapentine.

(a) Rifampin or rifabutin; (b) Isoniazid; (c) Pyrazinamide; and (d) Ethambutol.

THE KENTUCKY PHARMACIST

Pharmacist Anecdotes from Summer Camp

September/October 2015

Pharmacist Anecdotes From Summer Camp Jocelyn VanOpdorp, PharmD PGY2 Ambulatory Care Pharmacy Resident University of Louisville Hospital/KentuckyOne Health As pharmacists make their way further into the patient care arena, a myriad clinical opportunities from hospital to outpatient clinic positions allow us to provide care to our patients. For part of my Ambulatory Care PGY2 Pharmacy Residency at University of Louisville Hospital, I was able to spend a week at Counselors Stephanie Franer, Jocelyn VanOpdrorp and Ariel Chachoff . Camp Korelitz, an American Diabetes Association summer camp for children with type 1 diabetes, held teenage group of campers and was the personal medical at Camp Joy in Cincinnati, Ohio. The week I spent at camp provider for these children. Daily monitoring for each child this summer provided me with the opportunity to participate included managing the insulin for mealtime carbohydrate in one of the most challenging and rewarding patient care coverage, pre-meal and nightly blood glucose correction experiences of my life. Reflecting on this time brought forand basal insulin rate adjustments. The variety of insulins, ward an understanding of what unique aspects pharmapumps, injections and availability of continuous glucose cists bring to the healthcare team, including both our medi- monitoring for individual campers provided the opportunity cation knowledge and a unique perspective on patientto gain experience with each of these devices and prodcentered care. This experience also opened my eyes to ucts. From a medical perspective, complete immersion in many of the medical, social and environmental challenges the management of type 1 diabetes broadened my that accompany a long-term chronic disease, leaving me knowledge base and greatly enhanced my confidence in with lasting memories that will help shape my practice in treating my own clinic patients. the future. While the medical experience gained from camp was unparalled, the personal and emotional growth for both the For many children and adolescents, attending a summer camp is the highlight of the season. For some children with campers and myself is what will have the most impact on type 1 diabetes, however, the experience of summer camp my future practice. Because of the physical activity and meal planning at camp, many campers went through signifis simply not an option because of the safety challenges that surround insulin therapy. Attending a camp like Camp icant blood glucose changes throughout the week. I will Korelitz allows children to experience camp, and parents to never forget the first night in our cabin, sitting beside a camper to talk her through the lowest blood glucose she have the comfort and confidence that their child will be safe. The invaluable medical staff at camp includes physi- had experienced in months. The personal fear in watching cians, nurses and psychologists in addition to highly trained a child deal with the discomfort of hypoglycemia and the pure relief as it slowly resolved afforded me with a new revcounselors, many of whom are living with diabetes themselves. As a new addition to this group, my pharmacy back- erence for every parent who feels this fear countless times. ground provided me with the experience to work alongside Campers with uncontrolled blood glucose at home had the the medical team throughout the week of camp. My partici- additional challenge of adjusting to a normal blood glucose pation included checking in all counselor and camper medi- set point, and their desire to work through the shakiness and discomfort to improve their control was truly inspiracations to organize scheduling of medications while at tional. camp, providing dose recommendations and providing instruction on what to do in the inevitable event of missing a dose of medication in the excitement and whirlwind that defines summer camp. Additionally, I was grouped with a

Nightly discussions centered around personal challenges of the campers, from the difficulty of blood glucose control, the acceptance of what it means to actively take care of 32

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Kentucky Renaissance Pharmacy Museum your health every day and overcoming the frustrations of diabetes stereotypes from those who are uninformed. Hearing the campers share their thoughts helped me to understand their perspectives on life and the demands of having type 1 diabetes. The most heartwarming part of this experience came during the last night of camp while reminiscing about the week with the campers. One of the campers commented on how much she appreciated having someone in healthcare treat her as an individual and care about involving her in decisions about her diabetes,

September/October 2015 rather than just treating the number on the blood glucose meter. To me, this embodies the most important part of being a healthcare provider: involving the patient in his or her care. Patients live with their health conditions everyday and can provide valuable insight into what the best therapy option for them may be. With this in mind, I move forward into the next phase of my career and continuously strive to provide the best support and care for my patients, cherishing the experience that Camp Korelitz imparted to me.

Kentucky Renaissance Pharmacy Museum launches two Facebook pages during American Pharmacists Month The Kentucky Renaissance Pharmacy Museum Facebook page will share information about the Museum activities, initiatives, events and historical information about the profession and pharmacy professional in Kentucky.

sion and it’s legacy of care of the years for the citizens of our state.

The Board of Directors of Kentucky Renaissance Museum is asking all within the profession to "like" our pages as your salute to the profession Friends of Kentucky Pharmacy History is a group in Kentucky. It would be great to get all individuwhere individuals can share information about als who are involved with the profession to partictheir personal pharmacy history, ask questions ipate. We also strongly encourage you to share about items in their collection or pharmacists in these sites with your friends and colleagues. their families. Pictures of visits to our events and gatherings can be shared. This page is important We invite you to visit the Museum’s display at the as it helps us learn even more about the profes- KPhA Building during regular business hours. 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. 33

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KPhA New and Returning Members

September/October 2015

KPhA Welcomes New and Renewing Members July-August 2015 Brittany Antle Jamestown

Teresa Collison Summersville

Andrew Goble Louisa

Samuel Armes Crossville, Tenn.

Erin Conkright Owensboro

Wayne Gravitt Wheelwright

Jeffrey Arnold Crescent Springs

Marcelle Curtis Shelbyville

Daniel Gray London

Deronda Back Jackson

Johnnie Dando Liberty

Erik Grove Madison, Ind.

Ashutosh Barde Louisville

Michael Daniels Taylor Mill

Jennifer Grove Madison, Ind.

Brenda Barnes Ft. Mitchell

Kimberly Daugherty Louisville

Kelsey Hall Louisville

To YOU, To YOUR Patients To YOUR Profession!

Whitney Blackwell Clay City

Molly Deaton Fort Thomas

Lynn Harrelson Louisville

Jerry Knifley Columbia

Katherine Blain Louisville

Eddie Duff Booneville

Jeffrey Harrison Tompkinsville

Joe Lewis Hyden

Jacqueline Blair Mason, Ohio

James Dunaway Henderson

Lisa Hart Frankfort

Kenneth Lipscomb London

Larry Blandford Goshen

Debra Dunaway Henderson

Steve Hart Frankfort

Leslie Little Richmond

Nick Boggess Flatwoods

Michael Durbin McKee

Daniel Hein Cincinnati, Ohio

Ashley Luttrell Woodburn

Lanny Branstetter Horse Cave

Harold Ellis Frankfort

Shirley Henson Smithland

Nicholas Maroudas Williamson, W.Virg.

Robert Buckner Campbellsville

Sasha Flinchum Stanton

Kevin Higgins Benton

John Marshall Henderson

Breanna Capps Middlesboro

Michelle Flynn Independence

H. Harper Housman Paducah

Matt Martin Crestwood

Don Carpenter Olive Hill

Timothy Ford Campbellsville

James Howze St. Augustine, Fla.

Aleshea Martin Crestwood

Joseph Carr Owensboro

Veronica Foster Munfordville

Ashley Hubbard Manchester

Sheldon McCreary Louisa

Michelle Casto-Litton Zionsville, Ind.

Julian Frank Paris

Robert Hughes Lexington

Jennifer McCreary Louisa

Vickie Chaudry Corbin

Joyce Gardner Hodgenville

Bill Hurley Simpsonville

Gail Mcdaniel Union

William Chauvin Elizabethtown

Gale Garner Paducah

Jacob Hutti Louisville

George McDannold Eminence

MEMBERSHIP MATTERS:

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KPhA New and Returning Members

September/October 2015

Gary McGuffey Glasgow

Myron Pass Louisville

Denise Rueff Louisville

Audra Swearingen Louisville

Aaron Mcintosh Midway

Vikram Patel Bowling Green

Bonnie Russell Elizabethtown

Mary Thacker Louisville

Bobby McQueen Booneville

Brittany Pauly Union

Larry Russell Elizabethtown

Patricia Thornbury Lexington

Pamela Meddings Crum, W.Virg.

Charles Peal Lexington

Phillip Sandlin Louisville

Jennifer Turner Beattyville

Lewis Michael Louisa

Andrea Pearson Bowling Green

Angela Sandlin Louisville

John Paul Vaal Edgewood

Mark Milburn Louisville

Charles Pearson Bowling Green

Stanley Scates Lexington

Stuart Waldman Louisville

Jeff Mills Louisville

Michael Perdue Catlettsburg

Janelle Seitz Mount Vernon, Ind.

Kelly Walker Philpot

Janet Mills Louisville

Bernard Poe Owenton

Nancy Shepherd Paducah

Robert Wallace Dry Ridge

Roger Minnich Mount Sterling

David Potts Louisville

Thomas Shively Owensboro

Jeffrey Warner Jamestown

Peggy Moody Beattyville

Jeremy Price Beattyville

Sherri Short Richmond

L. Dwayne Watson Paducah

David Morgan Manchester

John Prine Bowling Green

Joe Silvers Monticello

Kelly Whitaker Mayfield

Ann Murphy Princeton

Meghann Randolph Somerset

Patricia Slone Hindman

David Whitley Russellville

James Murphy Whitley City

Thomas Ranz Louisville

Hope Smith Campton

Jessica Williams Lexington

David Nation Owensboro

Judith Rech Mount Sterling

Linda Soper Carlisle

Franklin Wishnia Louisville

William Nebel Eddyville

Ashton Reynolds Florence

Francis Southall Lebanon

Simon Wolf Louisville

Ronald Nix Louisville

James Rickett Williamsburg

Stephanie Southern Paducah

Heejung Woo Lexington, Tenn.

J. P. Nixon Tompkinsville

Amanda Robinson Edgewood

J Drane Stephens Eminence

David Wren Louisville

Bobbi O'Neal West Liberty

Denise Robison Louisville

Larry Stovall Scottsville

Sue Wynn Whitley City

Jennifer Parker Florence

Lindsay Rousseau Union

Joseph Strano Louisville

Andrey Yazykov Frankfort

KPhA Honorary Life Members Ralph Bouvette Leon Claywell Bob Lichtefeld Kenneth Roberts 35

R. David Cobb Gloria Doughty Ann Amerson Mazone THE KENTUCKY PHARMACIST

Pharmacy Law Brief

September/October 2015

Pharmacy Law Brief:

Legalization of Marijuana Use - Civil Law Issues-II 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 keep seeing on television and reading in the newspaper about states taking steps to legalize the use of marijuana, usually for “medicinal purposes.” A lot of the coverage relates to the criminal law aspects of the issue. But I saw a segment on “60 Minutes” about the marijuana “dispensaries” having issues with banking their flow of cash along with other unusual business law issues. What are those issues we hear so much less about?

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.

Response: There are quite a few non-criminal law issues facing operators of marijuana dispensaries in states where such activity has been legalized. In fact, there are so many that they have been divided into two groups for consideration. In the prior installment, we considered issues related to money and finances. This column will focus on consideration of a variety of other legal issues facing those who operate marijuana dispensaries.

the owner takes steps to protect its exclusivity. There are several major advantages to having federal registration of a trademark when it comes to enforcing the exclusivity but securing federal registration for an illicit product can be a major challenge. So, registration through state-level mechaAs pharmacists, an issue in this area of principal interest is nisms might be the best way to proceed. the regulatory classification of products containing marijuana. Is a particular product a drug, a food or a dietary sup- Employee use of marijuana in states where that is legal can plement? All three categories are regulated but with differ- arise in three contexts: use while at work; use while not at ing patchwork quilts of schema. If a drug, has the product work but under the influence while working; and use while been evaluated for safety and efficacy and does it actually not at work but testing positive at work. The majority of contain the amount of active ingredient claimed in any la- states that have legalized use of marijuana have expressly beling? If marketed as a food, certain labeling requirements stated in their laws that employers do not need to accomapply but are such products really a food? The edibles may modate possession or use of medical marijuana on the really be dosage forms being promoted for their active in- firm’s premises during working hours. Next, a number of gredient so FDA has issued a warning letter indicating that courts in variety of states have ruled that employers may such products may well be classified as drugs because discipline employees for being under the influence of marithey do not fall within the statutory exception from drug reg- juana while at work. And on the final issue, off-duty use ulation applied to foods. To date, FDA has largely deferred resulting in a positive test at work, the states are split. In to the U.S. Department of Justice and U.S. Drug Enforce- some states a positive test alone is insufficient to support ment Administration for rulings in this area, but that may employee discipline while others have adopted a “zero tolchange with time. Regulation as a dietary supplement re- erance” approach, stating that a positive test at work may quires that medical claims be avoided and the principal reg- lead to disciplinary action. ulatory framework is the Dietary Supplement Health and Workplace policies in this area will likely continue to be Education Act of 1994, not the Federal Food, Drug and evaluated by courts. For example, a case in Colorado preCosmetic Act. sents the issue of whether an employee who suffered from An additional issue that implicates federal law is use of trademarks for such products. A trademark is a word, name, symbol or device, or combination of those, that identifies the source of a product. A trademark is attractive because it has no pre-established finite term as would a patent or a copyright; it can run a very long time so long as

debilitating muscle spasms and had a valid marijuana prescription could be dismissed from employment for testing positive for the agent even though he was never under the influence at work. A New Mexico court ruled that an employer and its workers’ compensation carrier must reimburse an employee for the cost of medical marijuana. In

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Pharmacy Law Brief

September/October 2015

Michigan a court ruled that an employee was entitled to with a client whose business activities in this area turn out unemployment benefits following termination for testing to be illegal could face prosecution as an accomplice or copositive for marijuana despite being a registered user under conspirator. the Michigan Medical Marijuana Act. Given the number of jurisdictions that have acted in this A final point is certainly deserving of mention. Working with area to date along with those considering statutory action your attorney on these topics and issues can be a chal- that differs from the federal regulatory scheme, it would be lenge for the counselor. The American Bar Association prudent for the pharmacist to keep attuned to developModel Rules of Professional Conduct state that “a lawyer ments in this interesting area. shall not counsel a client to engage…in conduct the lawyers knows is criminal…but a lawyer may discuss the legal consequences of any proposed course of conduct with a client….[Model Rule 1.2(d)]. The specific Kentucky rule parallels that wording [S.C.R. 3.130(d)]. At least one commentator has raised the possibility that an attorney working

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Pharmacy Policy Issues

September/October 2015

PHARMACY POLICY ISSUES:

THE NEW USP CHAPTER <800> Author: Sabrina K. Haskell is a third year PharmD student at the UK College of Pharmacy and also is in the MBA degree program at the Gatton College of Business and Economics. Originally from Wilmington, Ill., she completed her B.S. in biology at the University of Illinois at Urbana-Champaign before making the move to Kentucky.. Issue: The United States Pharmacopeia (USP) has released the first draft of a new chapter <800> that will impact all pharmacies' and pharmacists' handling of hazardous drugs. What does this chapter require and how will it affect the pharmacy field? Discussion: The existing Chapters <795> and <797> Have an Idea?: have a new cousin joining the USP family. The first draft of This column is designed to address timely and practical Chapter <800> was released in March 2014, and is the issues of interest to pharmacists, pharmacy interns and biggest change since Chapter <797>. Since it falls in the pharmacy technicians with the goal being to encourage category of chapters under 1000, its propositions are man- thought, reflection and exchange among practitioners. datory. Keep in mind, the USP is a non-government, nonSuggestions regarding topics for consideration are profit organization and does not enforce their standards welcome. Please send them to jfink@uky.edu. itself. Rather the Food and Drug Administration is given jurisdiction via the Federal Food, Drug and Cosmetic Act of 1938.1 However, it is the state boards of pharmacy that are Control is required. Also, the chapter details the Personal more likely to ensure compliance.2 Protective Equipment (PPE) that should be employed when handling HDs. The type of PPE required depends on the Chapter <800> was developed to give more uniform guidedosage form and what activity is being performed lines for the handling of hazardous drugs (HDs). It applies (compounding, cleaning a spill or just stocking).3 to any and all facilities where HDs are stored or used. The chapter relies much on the already established National Another change mentioned in the chapter includes Medical Institute for Occupational Safety and Health (NIOSH) Surveillance, or monitoring of employee health. At the time guidelines for both the definition and the list of HDs. NIOSH of hiring, a full history and physical of the employee should defines a HD as a drug that has any of the following six be documented, then follow-ups performed throughout emcharacteristics: "carcinogenicity, teratogenicity or develop- ployment. The goal is to ensure efficacy of the engineering mental toxicity, reproductive toxicity in humans, organ tox- controls and early discovery of any health effects. Similarly, icity at low doses in humans or animals, genotoxicity or routine environmental testing should be done to confirm new drugs that mimic existing hazardous drugs in structure HD contamination is well contained.3 or toxicity." They can further be classified into three groups As with any major change in guidelines, there are both posbased on their relative risk ranging from most hazardous â&#x20AC;&#x201C; itives and negatives. The clear positive is increased safety which always require special handling by all individuals â&#x20AC;&#x201C; to for those who handle HDs.4 On the other hand, the renovapotentially hazardous to those actively trying to conceive or tions and additional space and equipment required to comwomen who are breastfeeding.3 ply is an increased financial burden for the facilities. Some The major changes of the new chapter are the new facility and equipment requirements. It is important to note that all <795> and <797> requirements still apply. The biggest changes are the facility requirements. HDs must always be separated from non-HDs and must always be in a negative pressure environment. This includes receiving shipments, storage and any preparation or manipulation. The negative pressure protects individuals and prevents potentially contaminated air from reaching other non-HD areas. This means separate rooms for storage and dedicated buffer rooms for compounding HDs will be necessary. There also are special equipment requirements. A special type of ventilated device called a Containment Primary Engineering

argue that access to necessary HDs could be inhibited if a smaller facility cannot afford to comply.5 Overall, the goal of Chapter <800> is to protect not only personnel, but also the environment, the patient and the preparation itself. Despite the potential issues it presents, it should be hoped that a middle ground can be found to help Chapter <800> become a success. References: 1. United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings: open microphone meeting [slide]. Rockville (MD); 2014 June 12. 30 slides: color. Availa38

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September/October 2015

KPhA Government Affairs/KPPAC ble from: http://www.usp.org/sites/default/files/usp_pdf/ EN/USPNF/2014-06-12_800_openmic.pdf.

American Society of Health-System Pharmacists, Bethesda, MD). Letter to: Ronald T. Piervincenzi (U.S. Pharmacopeial Convention, Rockville, MD). 2014 July 31. 10 leaves. Located at: http://www.ashp.org/ DocLibrary/ASHP-Comment-USP-800.pdf.

2. Thompson, Cheryl A. American Society of HealthSystem Pharmacists. USP Chapter 797 Enforceable But Not Often Enforced. Internet. 2006 May 12. Accessed 2015, Jan 3. Available from: http:// www.ashp.org/menu/News/PharmacyNews/ NewsArticle. aspx?id=2187.

5. Batshon, Lynne (American Society of Consultant Pharmacists, Alexandria, VA). Letter to: Compounding Expert Committee (U.S. Pharmacopeial Convention, Rockville, MD). [2014?]. 4 leaves. Located at: https:// 3. United States Pharmacopeia. USP <800>. Pharmacowww.ascp.com/sites/default/files/ASCP% peial Forum. 2014 May 1; 40(3). 20Comments%20re%20Proposed%20USP% 4. Benjamin, Bona (Medication Use Quality Improvement, 20Chapter%20800_FINAL.pdf.

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 cashierâ&#x20AC;&#x2122;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)

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September/October 2015

Pharmacists Mutual

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Cardinal Health

September/October 2015

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KPhA Board of Directors/Staff

September/October 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

Matt Carrico, Louisville matt@boonevilledrugs.com

Chris Palutis, Lexington chris@candcrx.com

Treasurer

Kim Croley, Corbin kscroley@yahoo.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

Kimberly Daugherty, Louisville kdaugherty@sullivan.edu Christen S Bruening cschenkenfelder@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

KPhA sends email announcements weekly. If you arenâ&#x20AC;&#x2122;t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the list. 42

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50 Years Ago/Frequently Called and Contacted

September/October 2015

50 Years Ago at KPhA FROM “BITS” NEW PHARMACY BILL: As most of you know, we have been trying to pass a Pharmacy Bill in the State of Kentucky for quite some time. Also, as you know, we have not been successful. We would further point out that it is never easy to succeed. In the case of pharmacy, it has become more and more difficult. The Pharmacy laws under which we now operate were passed many years ago and at that time were considered adequate for our profession in Kentucky. Today, however, we must realize that pharmacy has continued to grow and grow and what was once adequate is no longer adequate today. We don’t feel that many of you are aware of the position we are placed in, in trying to operate under a law that can no longer fulfill the needs of our profession. In order for our profession to remain abreast of the times we must have a pharmacy law that fulfills the needs of our times. We urge you therefore, each and every pharmacist in Kentucky, to talk to the candidates who will run for election in November—and after the election talk to them again. We simply must make ourselves aware of the years of professional education, the cost of that education, the tedious hours of internship, the long hours behind the prescription counter today—all of these are a part of the time honored profession of pharmacy – but they are not the profession itself. We can only say that when college classes are past, when the exactness is so well learned it is no longer tedious, when the education is finally paid for, the cost grows dimmer and dimmer. BUT we can also say that the long hours of loyalty to suffering humanity that are spent behind the prescription counter today are not growing dimmer. AND NEITHER IS PHARMACY GROWING DIMMER—INSTEAD WITH COLLECTIVE CREATIVE RESEARCH, PHARMACY IS GROWING BIGGER AND BRIGHTER. And Pharmacy belongs to the pharmacists. It is yours to have and to protect. SO WE STRONGLY URGE YOU TO PROTECT IT NOW—TO STAND BEHIND THE PHARMACY BILL IN ONE UNITED PROFESSIONAL BODY. - From The Kentucky Pharmacist, October 1965, Volume XXVIII, Number 10.

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

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September/October 2015

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

Show your Pharmacist Pride with a KPhA Roamey Window Cling ($5) or your own personalized Roamey ($25)! All proceeds benefit the KPhA Building Fund Available at the KPhA Online Store www.kphanet.org, click on About Tab, Online Store

For more upcoming events, visit www.kphanet.org. 44

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