The Kentucky Pharmacist Vol. 7, #1

Y K C U T N E K E H T T S I C A PHARM Vol. 7, No. 1 January 2012

KPhA: Your link to Frankfort since 1879 KPhA Annual Meeting 2012 June 13-16 Marriott Griffin Gate, Lexington, KY Registration form inside!

News & Information for Members of the Kentucky Pharmacists Association

Table of Contents

January 2012 KPPAC Contribution Form Pharmacy Quality Commitment February CE-STOPP Using the Beers’ List and START Something New February Pharmacist/Pharmacy Tech Quiz KPhA Annual Meeting 2012 Advancing Pharmacy Practice In Kentucky SCOP Drug Information Center CPE Monitor Pharmacy Policy Issues KPhA Board of Directors Frequently Called and Contacted/APSC

Table of Contents Table of Contents— Oath— Mission Statement 2 President’s Perspective 3 Sullivan College of Pharmacy Pancakes with Santa 4 Pharmacists Mutual Companies 5 January CE- Migraine Headaches: Acute Management and Preventive Treatment 6 January Pharmacist/Pharmacy Tech Quiz 14 Pharmacy Time Capsule 15 Pharmacy Law Brief 16 Legislative Advocacy 18

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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.

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.

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.

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.

Editorial Office: © Copyright 2012 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bimonthly. 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.

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.

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THE KENTUCKY PHARMACIST

President’s Perspective

January 2012

President’s Perspective

Lewis Wilkerson, PharmD, CGP KPhA President 2011-2012

blessed. I’m not trying to negate the contributions of the many pharmacists that I personally know that have been a blessing back to pharmacy, but as a whole it is time for pharmacists to “bless” the profession.

I believe significant opportunities for this will exist in 2012, and I am resolute that we can accomplish great things. I continue to implore you to be engaged in your local, state, and national associations. I’ve tried to outline, in my two previous articles, the tremendous activity of KPhA’s Board, committees, local associations and academies; however, there is a lot of work to be done, and we continue to need more involvement. If you have concerns or questions about how to be involved, please email me at rphs2@aol.com.

We also need your continued support through membership in the association. If you have not renewed, please do so and ask colleagues, including technicians, to do the same.

During the current legislative session, our profession must be engaged. Hopefully you have seen and responded to the call by KPhA and KIPA for a grassroots effort to engage your individual legislator. This is important not only for the current issues facing our profession, but an individual dialogue and relationship with your legislator is the best As I sit down to write this article, it is the week between Christmas and New Year. This is a time of reflection on the way to protect and, I believe, shape our profession for the future. Phone calls and emails are important, but beyond previous year and a time of anticipation and resolution for the upcoming year. For me, personally and professionally, that we need to support them, meet with them, and devel2011 has brought about significant change. Some of these op a relationship so that when a healthcare issue comes before them, you are the first person they pick up the changes have been rewarding and others have caused considerable life hardships and adjustments. I look forward phone and call. to bringing in 2012 with anticipation and am resolute that it Another opportunity to be engaged will occur this April 13th is going to be a great year filled with significant opportunity. and 14th when KPhA helps sponsor Advancing Pharmacy As I reflect on our profession, we continue to encounter significant challenges. The introduction of three new MCOs into Kentucky to manage the majority of our Medicaid members would top the list of challenges for most pharmacists in the state. Students exiting pharmacy school are for the first time in years finding it more difficult to find a position. Outside forces, including other professions, continue to influence the practice of pharmacy. Clinical challenges exist with increased medication shortages, continued development of resistant organisms to current therapies, and the need to stay up to speed on a growing number of new medication entries, many of which are highly expensive and highly specialized. Even the advent of increased technology into our profession can present additional challenges. I mentioned in my President’s speech, that I thought apathy was one of the most significant challenges in our profession. I am happy to report that I have seen this changing; however, I still think it is the driving force for many of our challenges today.

Practice in Kentucky: A Summit to Chart the Course for the Future. This event, the most important meeting in Kentucky Pharmacy this century, will be hosted by the new Center for the Advancement of Pharmacy Practice (CAPP) at the UK COP. I’m extremely excited for this two-day event, which will begin to set a vision and roadmap for pharmacy over the next several years. As more details develop, myself and the KPhA office will communicate them. This will be one of the most significant meetings our profession will hold in the state, and I hope you will resolve to participate.

Earlier this week while driving down the interstate, I noticed a bumper sticker which read “America Bless God”. I’m certainly not going to get into the philosophy or theology of that one, but it did make me think about where we are as a profession. I think we can all agree, especially those of us that have been practicing for more than a few years, as to how blessed we have been by this profession. The rewards and opportunities it has presented should make us all feel

www.facebook.com/KyPharmAssoc

In reflection, we can learn and grow. In anticipation and resolution, we can advance and move forward. For you and for the profession, I hope and wish that we learn and grow from our past, and that 2012 brings enormous advancement.

KPhA Social Media Links

www.twitter.com/KyPharmAssoc

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SUCOP Pancakes with Santa

January 2012

Sullivan’s Pancakes with Santa Program The Sullivan College of Pharmacy Academy of Student Pharmacists hosted Pancakes with Santa and raised about $750 for their Patient Care Project, Operation Heart.

Top: Kristi Adair and Lauren Christian mix batter with help from Christine Hoffman, Bryana Swearingen and Lindsay Timmons.

Above: Ashley Calvert, David Curry and Lauryn Cyrus man the money table.

Left: Cyrus, Calvert and Gina Hall get into the holiday spirit.

Photos by: Maria Shin

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Pharmacists Mutual Companies

January 2012

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January 2012 CE-Migraine Headaches

January 2012

Migraine Headaches: Acute Management and Preventive Treatment By: Deborah S. Minor, PharmD and Rebecca E. Taylor, PharmD The University of Mississippi Medical Center Departments of Medicine and Pharmacy Reprinted with permission of the authors and the Mississippi Pharmacists Association where this article originally appeared.

There are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-9999-12-01-H01-P 1.5 Credit Hours (0.15 CEUs) The goal of this review is to discuss migraine headaches and options for both prevention and treatment of acute migraine headaches.

Objectives 1. Explain the pathophysiology of migraine headaches.

2. Identify the clinical presentation of patients with migraine headaches.

3. Discuss treatment options for patients with migraine headaches.

4. Differentiate between symptomatic and preventative treatment of migraine headaches.

Headache is one of the most common complaints encountered by healthcare practitioners.1 Most headaches occur without any underlying cause (primary headache) and are benign. Tension-type and migraine headache are the most common types of the primary headache disorders. Less often, headaches may indicate a distinct pathologic process or underlying condition (secondary headache), such as those caused by infection, cerebral hemorrhage, or a brain mass lesion.2 A thorough evaluation of the headache history and physical examination are essential to establish an accurate headache diagnosis and identify appropriate therapy for management.

Migraine headaches reach peak prevalence during the most productive years of life, at ages 20 through 55 years.2 According to the American Migraine Prevalence and Prevention Study, 17.1 percent of women and 5.6 percent of men in the United States experience one or more migraine headaches per year. Of those with migraine, 14 percent experience more than four attacks per month, 63 percent experience one to four attacks per month, and 23 percent experience less than one attack per month.3 Studies show that most headache sufferers do not seek appropriate care for their headache treatment though disability is common. Over 90 percent of those with migraine report some headache-related disability and 54 percent are severely disabled or require bed rest during an attack.3 A number of neurologic, psychiatric disorders,

and cardiovascular diseases — including stroke, epilepsy, major depression, sleep apnea, and anxiety disorder — also show increased co-morbidity with migraine.2,4 The presence of these disorders may guide both acute and prophylactic management of migraine. In recent years, an improved understanding of the diagnosis and pathophysiologic mechanisms of migraine has led to the development of medications capable of providing rapid relief from attacks and improved prophylaxis.

Pathophysiology of Migraine Previous vascular and neural theories of migraine development have merged into a combined theory of neurovascular mechanisms. Attack occurrence and frequency of migraines are governed by central nervous system (CNS) sensitivity to migraine-specific triggers or environmental factors. Patients with migraines appear to have a lowered threshold of response to specific environmental circumstances as a result of genetic factors that manage the balance of CNS excitation and inhibition at various levels. 5 This CNS hyper-responsiveness may be the result of an inherited abnormality in calcium and/or sodium channels and sodium/potassium pumps that regulate cortical excitability through the release of serotonin and other neurotransmitters.4,5 Other factors that affect the migraine threshold and initiate cortical spreading depression include low levels of magnesium or dopamine, increased levels of

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January 2012 CE-Migraine Headaches

January 2012

excitatory amino acids such as glutamate, and alterations in levels of extracellular potassium.6 Serotonin (5-hydroxytryptamine, 5-HT) has long been implicated as a potential mediator of migraine headache.

Acute migraine treatments targeting serotonin, such as ergot alkaloids and triptan derivatives, are agonists of vascular and neuronal 5-HT1 receptor subtypes.7 Medications used for migraine prophylaxis also target neurotransmitter systems.

Clinical Presentation of Migraine Highlights of the clinical presentation of migraine headache are identified in the Table on page 9. The presentation of migraines can usually be divided into several phases: premonitory, aura, headache, and resolution.8 Premonitory symptoms occur in the hours or days before the onset of headache and are experienced by approximately 20 percent to 60 percent of migraineurs.7,8 Use of the terms prodrome or warning instead of premonitory symptoms should be avoided because this previous terminology was often used mistakenly to include aura.8 Premonitory symptoms may differ greatly among patients but are generally consistent within an individual. Although neurologic premonitory symptoms are the most common, psychological, autonomic, and constitutional premonitory symptoms also occur. Common neurologic symptoms include phonophobia, photophobia, hyperosmia, and difficulty in concentration. Psychological symptoms can include anxiety, depression, euphoria, irritability, drowsiness, hyperactivity, and restlessness. Autonomic symptoms may present as polyuria, diarrhea, and constipation. Constitutional symptoms include stiff neck, yawning, thirst, food cravings, and anorexia.4,6-8 Migraine aura, a complex of positive and negative focal neurologic symptoms, is experienced by approximately 31 percent of migraineurs on at least some occasions. The aura typically evolves over 5 to 20 minutes and lasts less than 60 minutes. Aura may precede or accompany an attack, with symptoms beginning at the onset of headache or during the attack. Auras are most often visual and vary in complexity.8,9 Visual auras frequently affect half the visual field and can include both positive (scintillations, photopsia, teichopsia, or fortification spectrum) and negative (scotoma, hemianopsia) features. Sensory and motor aura symptoms, such as paresthesias or numbness involving the arms and face, dysphasia or aphasia, weakness, and hemiparesis, can also occur.7 Many patients experience a resolution phase character-

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ized by feeling tired, exhausted, irritable, or listless once the headache pain wanes. Mood changes (depression/ malaise or refreshed/euphoric), impaired concentration, and scalp tenderness may continue or be experienced.7 Tension-type headache is differentiated from migraine in that premonitory symptoms and aura are absent. With tension-type headache, the pain is usually bilateral and described as dull, nonpulsatile tightness or pressure. Other symptoms are generally absent, but mild photophobia and phonophobia may be present.8,9 Medication overuse can be associated with migraine therapy and is one of the most common causes of chronic daily headache.10 Frequent or excessive use of acute migraine medications can cause a pattern of increasing headache frequency. This process, known as medicationoveruse headache or rebound headache, is characterized by return of headache as the medication wears off, leading to increased consumption of drugs for relief. Medications used in the treatment of migraine that most commonly contribute to this syndrome are simple and combination analgesics as well as opiates. Triptans are less commonly involved and are usually associated with men with a high frequency of headaches.4,8,10 Discontinuation of the offending agent leads to a gradual decrease in headache frequency and severity with a return of the original headache characteristics, usually within 2 months.8 To aid in the prevention of medication-overuse headaches, patients are advised to limit use of acute migraine therapies to two to three days per week.7

Migraine Treatment Nonpharmacologic Therapy One of the most important steps in the prevention of migraine attacks is the identification and avoidance of consistent triggers in vulnerable individuals. Approximately 75 percent of migraine sufferers have triggers of an attack, with the most common being stress, hormones, not eating, weather, sleep disturbance, and perfume/odors. Other potential triggers include alcohol, smoke, light, exercise, or sexual activity.10,11 A headache journal that records the frequency, severity, and duration of attacks can aid in the identification of migraine triggers. In addition to identification of migraine triggers, patients may benefit from regular sleep, exercise, healthy eating habits, smoking cessation, and limited caffeine intake. For patients who prefer a nondrug therapy, behavioral interventions, such as relaxation therapy, biofeedback, and cognitive therapy, can be used for preventive treatment.11,12

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January 2012 CE-Migraine Headaches

January 2012

Acute Management

Clinical response to triptans can vary considerably among individual patients. If one triptan fails, a patient may be Acute migraine therapies should provide consistent, rapid successfully treated with another.7 Combination therapy relief, and enable the patient to resume normal activities at with another agent may improve response rates and dihome, school, or work. Abortive therapies can be miminish migraine recurrence. A combination of sumatriptan graine-specific, such as ergot derivatives or triptans, or 85 mg plus naproxen 500 mg in a single tablet was proven non specific, such as analgesics, antiemetics, nonsteroidal to be more effective than either agent alone.13,18 anti-inflammatory drugs (NSAIDs), and corticosteroids.

Abortive therapies are most effective at relieving pain and Triptan side effects, though common, are usually mild to associated symptoms when administered at the onset of moderate and of short duration. Adverse effects include the migraine.7,12-14 Using a stratified care approach based paresthesias, fatigue, dizziness, flushing, warm sensaon individual symptom severity and headache-related dis- tions, and somnolence. Minor injection-site reactions are ability, patients may be advised to use nonspecific agents reported with the subcutaneous route and taste perversion for mild to moderate headache without disability while re- and nasal discomfort with the intranasal route. “Chest serving migraine-specific medications for more severe symptoms,� described as chest tightness, pressure, heaviattacks.13,15 If an attack is accompanied by severe nausea ness, or pain in the chest, neck, or throat are relatively and vomiting, the efficacy of oral drugs may be comprocommon.14,16 Because triptans are partial 5-HT agonists mised. In these situations, pretreatment with antiemetic in coronary artery receptors, they have the potential to agents or the use of a non-oral treatment (i.e. suppositoproduce modest coronary artery vasoconstriction. This ries, nasal sprays, or injections) may be appropriate.7 constriction poses minimal risk in appropriately selected patients with healthy coronary arteries.14,16 Serotonin Receptor Agonists (Triptans) Triptans are contraindicated in patients with a history of Triptans are selective agonists of the 5-HT1B and 5-HT1D ischemic heart disease, uncontrolled hypertension, cerereceptors. Migraine relief results from vasoconstriction of brovascular disease, and hemiplegic or basilar migraine. pain-producing intracranial blood vessels through stimulaPatients at risk for unrecognized coronary artery disease tion of vascular 5-HT1B receptors, inhibition of vasoactive (i.e. postmenopausal women, men over 40 years of age, neuropeptide release from trigeminal perivascular nerves and patients with multiple risk factors) should undergo a through stimulation of presynaptic 5-HT1D receptors, and cardiovascular assessment prior to triptan use and have interruption of pain-signal transmission within the braintheir initial dose of a triptan administered under medical stem trigeminal nuclei through stimulation of 5-HT1D recepsupervision.13,18 Triptans should not be given within 24 tors.15-17 The triptans are appropriate as first-line therapy hours of the ergotamine derivatives. Also, administration for patients with moderate to severe migraine, or as resof sumatriptan, rizatriptan, and zolmitriptan is not recomcue therapy when nonspecific medications are ineffective.7 mended within 2 weeks of therapy with monoamine oxiSumatriptan, the first triptan, is the most extensively stud- dase inhibitors. Eletriptan should not be administered with ied antimigraine therapy and is available in the most dos- cytochrome P-450 3A4 inhibitors, such as macrolide antiage forms.17,18 Subcutaneous sumatriptan has the most biotics, antifungals, and some antiviral therapies. Conrapid onset (10 minutes) and is the most effective of the comittant therapy with the selective serotonin reuptake triptans. Intranasal sumatriptan and zolmitriptan usually inhibitors should be monitored closely due to isolated reprovide a faster onset of effect (15 minutes) than the oral ports of serotonin syndrome in sumatriptan-treated paformulations, and produce similar rates of response.7,17 tients.13,16,19 The newer or second-generation triptans offer improved pharmacokinetic and pharmacodynamic profiles compared to oral sumatriptan. Studies reveal that second-generation agents have comparable 2-hour response rates.7,14,17 These newer agents have higher oral bioavailability and longer half-lives, theoretically improving within-patient treatment consistency and reducing headache recurrence.

Despite the fact that oral absorption can be delayed during migraine attacks, most patients prefer oral formulations, primarily due to convenience.7,13,17 8

Ergot Alkaloids and Derivatives Ergotamine tartrate and dihydroergotamine are useful and may be considered for the treatment of moderate to severe migraine attacks. These drugs are nonselective 5hydroxytryptamine-1 (5-HT1) receptor agonists that constrict intracranial blood vessels and inhibit the development of neurogenic inflammation in the trigeminovascular system.7 Central inhibition of the trigeminovascular pathway as well as activity at adrenergic and dopaminergic

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January 2012 CE-Migraine Headaches

January 2012

Table: CLINICAL PRESENTATION OF MIGRAINE HEADACHE General • Migraine is a common, recurrent, severe headache that interferes with normal functioning. It is a primary headache disorder divided into two major subtypes, migraine without aura and migraine with aura.

Signs and Symptoms • Migraine is characterized by recurring episodes of throbbing head pain, frequently unilateral, that when untreated can last from 4 to 72 hours. Migraine headaches can be severe and associated with nausea, vomiting, and sensitivity to light, sound, and/or movement. Not all symptoms are present at every attack.

• A stable pattern, absence of daily headache, positive family history for migraine, normal neurologic examination, presence of food triggers, menstrual association, long-standing history, improvement with sleep, and subacute evolution are all signs of migraine headache. Aura can signal the migraine headache but is not required for diagnosis. receptors are also reported.14-16

vent this complication. 7

Ergotamine tartrate is available for oral, sublingual, and rectal administration. Oral and rectal preparations contain caffeine to enhance absorption and potentiate analgesia.

Dosage requirements should be titrated strictly to establish an effective but sub-nauseating dose for future attacks.7,15

Analgesics and NSAIDs Simple analgesics and NSAIDs offer a reasonable first-line choice for treatment of mild to moderate migraine attacks or severe attacks that have been responsive in the past to similar NSAIDs or non-opiate analgesics.15 Aspirin, ibuprofen, naproxen sodium, tolfenamic acid, and the combination of acetaminophen plus aspirin and caffeine have demonstrated the most consistent efficacy.7,13 Acetaminophen alone is generally not recommended due to lack of scientific support for any benefits.7,12

Dihydroergotamine is available for intranasal and parenteral administration by intramuscular, subcutaneous, and intravenous routes.7 Patients can be trained to selfadminister dihydroergotamine intramuscularly or subcutaneously. When compared with other migraine therapies, dihydroergotamine appears to be relatively safe and effec- NSAIDs appear to prevent neurogenically mediated intive.12 flammation in the trigeminovascular system through inhibi15 Nausea and vomiting, as a result of stimulation of chemo- tion of prostaglandin synthesis. Acute NSAID therapy is associated with gastrointestinal (i.e. dyspepsia, nausea, receptor trigger zone, are among the most common advomiting, and diarrhea) and CNS side effects (i.e. somnoverse effects of the ergotamine derivatives. Vasoconstriction also occurs with therapeutic doses. Ergotamine is lence and dizziness). NSAIDs should be used with caution more likely to cause these effects than dihydroergotamine. in patients with previous ulcer disease, renal disease, or hypersensitivity to aspirin.12,16 To combat the potential for these adverse effects, pretreatment with an antiemetic agent should be considered with ergotamine and intravenous dihydroergotamine. Other common side effects include abdominal pain, weakness, fatigue, paresthesias, muscle pain, diarrhea and chest tightness. Occasionally, severe peripheral ischemia (ergotism) may occur causing cold, numb, painful extremities; continuous paresthesias; diminished peripheral pulses and claudication. Gangrenous extremities, myocardial infarction, hepatic necrosis, and bowel and brain ischemia have also been reported.13,15,16 Ergotamine derivatives are contraindicated in patients with renal or hepatic failure; coronary, cerebral, or peripheral vascular diseases; uncontrolled hypertension; sepsis and in women who are pregnant or nursing.7,18 Dihydroergotamine does not appear to cause rebound headache, but dosage restrictions for ergotamine tartrate should be strictly observed to pre9

Aspirin and acetaminophen are available as a prescription combination containing a short-acting barbiturate (butalbital) or narcotic (codeine). These agents lack studies supporting their efficacy and should be used cautiously due to potential for overuse, medication-overuse headache, and withdrawal.7,15,16 Opiate Analgesics Narcotic analgesic medications, including meperidine, butorphanol, oxycodone, and hydromorphone, are effective but should be reserved for patients with moderate to severe infrequent headaches in whom standard therapies are contraindicated or as “rescue medication” after patients have failed to respond to conventional therapies. 7 An intranasal formulation of butorphanol is an available treatment option for patients with recurrent office or emer-

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January 2012 CE-Migraine Headaches

January 2012

gency department visits but use should be closely supervised because of the risk of overuse and dependence.13,14

The only Food and Drug Administration (FDA) approved drugs for the indication of migraine prophylaxis are propranolol, timolol, valproate and topiramate.11,22 Botox (botulinum toxin A) has recently been approved for prophylaxis in adult patients with chronic migraines, defined as headaches lasting for four or more hours on more than 15 days per month.23 The efficacy of these agents appears to be similar, although published data are limited. Medication selection is typically based on an agent’s side-effect profile and the patient’s co-morbid conditions.7 Therapy should usually be initiated with low doses, frequently lower than doses used for other indications and gradually increased until a therapeutic effect is achieved or side effects become intolerable.20 Patients should continue preventive therapy for two to six months to evaluate the therapeutic effect, but most will usually have some resolution of migraine attacks within one month of therapy initiation.7

Antiemetics Adjunctive antiemetic therapy is useful for nausea and vomiting associated with migraine headaches and acute treatment medications. A single dose of an antiemetic, such as metoclopramide, chlorpromazine, or prochlorperazine, administered 15 to 30 minutes before ingestion of an oral abortive migraine medication is often effective. If nausea and vomiting are particularly severe, a suppository should be used. Metoclopramide has an additional benefit of reversing gastroparesis and improving absorption from the gastrointestinal tract during severe attacks.12,13 Dopamine antagonists (prochlorperazine, metoclopramide, chlorpromazine, and domperidone) can also be used as monotherapy for the treatment of intractable headache and serve as an alternative to narcotic analgesics for refractory headaches.12,18

β-Adrenergic Antagonists (β-Blockers)

Propranolol, nadolol, timolol, atenolol, and metoprolol have been proven efficacious in reducing the frequency of migraine attacks. Although the precise mechanism of βCorticosteroids can be used for rescue therapy for status migrainous - a severe, continuous migraine that can last up blockers is unknown, it is proposed that the migraine threshold may be raised by modulation of adrenergic or to 1 week.7,12 Short courses of oral or parenteral predniserotonergic neurotransmission in cortical or subcortical sone, dexamethasone, and hydrocortisone also may be useful in the management of refractory headache that per- pathways. β-Blockers are particularly useful in patients with co-morbid anxiety, hypertension or angina. β-Blockers with sists for several days.12,18 intrinsic sympathomimetic activity are ineffective for miLimited studies suggest a role for intranasal lidocaine for graine prophylaxis.20,24 the treatment of acute migraine headache. Although inPotential side effects of β-blockers include drowsiness, fatranasal lidocaine provides rapid pain relief within 15 tigue, sleep disturbances, vivid dreams, memory disturbminutes of administration, headache recurrence is comance, depression, impotence, bradycardia and hypotenmon.12 sion. They should be used with caution in patients with conPreventive Therapy gestive heart failure, peripheral vascular disease, atriovenPreventive therapy is typically administered on a daily basis tricular conduction disturbances, asthma, depression and diabetes.7,20,24 to reduce migraine frequency, severity and duration of atMiscellaneous Nonspecific Medications

tack, but can also be used preemptively or intermittently when headaches recur in a predictable manner — for example exercise-induced migraine or menstrual migraines.7,20-22 Preventive migraine therapy should be considered in patients with recurring migraines that produce significant disability despite acute therapy; frequent attacks occurring more than twice per week with the risk of developing medication overuse headache; symptomatic therapies are ineffective, contraindicated or produce serious side effect; uncommon migraine variants that cause profound disruption and/or risk of permanent neurologic injury, such as hemiplegic migraine, basilar migraine and migraine with prolonged aura and patient preference to limit the number of attacks.7,14

Anticonvulsants Anticonvulsant medications (valproate, divalproex, topiramate, and gabapentin) are increasingly recommended for migraine prophylaxis. These agents appear to have multiple mechanisms of action, including enhancement of gamma aminobutyric acid mediated inhibition, modulation of the excitatory neurotransmitter glutamate and inhibition of sodium and calcium ion channel activity.22,25 Anticonvulsants are particularly useful in patients with co-morbid seizure, anxiety or bipolar disorders.20 Valproic acid and divalproex sodium have shown efficacy in multiple placebo-controlled studies, with the extendedrelease formulation of divalproex sodium (administered

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January 2012 CE-Migraine Headaches

January 2012

once daily) being better tolerated than the enteric-coated formulation.21 The most common adverse effects associated with therapy include nausea, vomiting, alopecia, tremor, asthenia, somnolence, and weight gain.7,14 Hepatotoxicity is the most serious side effect of valproate therapy, though irreversible hepatic dysfunction is extremely rare. Baseline liver function tests are needed but routine follow up studies are not necessary in asymptomatic adults on monotherapy.

Valproate is contraindicated in pregnant women and patients with a history of pancreatitis or chronic liver disease.7

sants.20,24 Fluoxetine is the most studied but definitive benefit is lacking for this medication as well as other SSRIs.7,20,25 These agents should not be considered as first or second line medications for migraines, but can be used in addition to other preventive therapy in patients with comorbid depression or anxiety disorders.24 Recent studies have shown possible benefit of a serotonin and norepinephrine reuptake inhibitor (SNRI), venlafaxine, in migraine prophylaxis.21

Antidepressants

ing the frequency, severity and duration of migraine attacks, potential gastrointestinal and renal toxicity limits the daily or prolonged use of these agents.14,21 Consequently, NSAIDs may be used intermittently to prevent headaches that recur in a predictable pattern, such as menstrual migraine. For prevention, NSAIDs should be initiated one to two days prior to the expected onset of headache and continued during the period of vulnerability.24,26

Monoamine oxidase inhibitors, such as phenelzine, have Topiramate is widely used and has been recently approved been used for refractory headache, but their use is limited by the FDA for migraine prophylaxis. Weight loss associat- due to their complex adverse effect profiles and the need ed with topiramate may offer a distinct benefit since weight for strict adherence to a tyramine-free diet to avoid potengain is a common reason for discontinuation of other mitially life-threatening hypertensive crisis.11,20 graine prophylaxis medications. Other adverse effects with Calcium Channel Blockers topiramate are paresthesia, fatigue, anorexia, diarrhea, weight loss, memory difficulty and nausea. Kidney stones, The use of calcium channel blockers for migraine prophylaxis should be reserved for situations where other medicaacute myopia, acute angle-closure glaucoma and oligohidrosis have been infrequently reported with topiramate use. tions with established clinical benefit are ineffective or conTo minimize adverse effects, topiramate should be started traindicated. Verapamil is the most commonly used calcium channel blocker for migraine prevention. Evaluation of othat a much lower dose (i.e. 25 mg) than the targeted dose er calcium channel blockers (nifedipine, nimodipine, dilti(i.e. 100 mg daily). 20,21,26 azem and nicardipine) has provided unclear results for their Based on results of a recent trial, gabapentin may also be use in migraine prophylaxis. Patients with co-morbid hypereffective for migraine prophylaxis.20 Dizziness and drowsitension may benefit the most from the use of calcium channess were the most common adverse effects of gabapentin nel blockers. The most common adverse effect of verapamuse. Preliminary studies suggest a possible role for other il is constipation.7,14,20,21 anticonvulsants (tiagabine, levetiracetam, and zonisamide) but further clinical studies are needed to validate their use- NSAIDs fulness in migraine prophylaxis.20,22 Even though NSAIDs can provide modest benefit in reducThe beneficial effects of antidepressants in migraine may be related to downregulation of central 5-HT2 and adrenergic receptors rather than their antidepressant activity. 25 Amitriptyline is the most widely studied antidepressant for migraine prophylaxis, but other tricyclic antidepressants that have been used based on clinical or anecdotal experience include doxepin, notriptyline, protriptyline and imipramine. Anticholinergic side effects are common and often limit the use of these agents in patients with benign prostatic hyperplasia and glaucoma. Other potential side effects include increased appetite and weight gain, orthostatic hypotension and cardiac toxicity. Nortriptyline and protriptyline may be advantageous in patients who are particularly intolerant of the anticholinergic and sedative effects of amitriptyline.20

Miscellaneous Prophylactic Agents

Riboflavin (vitamin B2) 400 mg daily has shown efficacy for prevention of migraines, however, the benefits of therapy only became significant after 3 months.20,26 In recent studies, the angiotensin-converting enzyme inhibitor lisinopril and the angiotensin II receptor blocker candesartan provided effective migraine prophylaxis.26 Herbal medications such as feverfew (Tanacetum parthenium) have been evalThe selective serotonin reuptake inhibitors (SSRIs) have uated but further research is needed to establish the safety not been extensively studied for migraine prophylaxis and and efficacy for migraine prophylaxis. At least two studies are considered to be less effective than tricyclic antidepres- have concluded that petasites, an extract from the plant 11

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January 2012

Petasites hybridus, may be effective for migraine prophythe triptan era: lessons from epidemiology, pathophysiology, and clinical science. Headache 2009;49:S21-33. laxis. Coenzyme Q10 was effective for migraine prevention 20,26 and well tolerated in a small study.

5. Gardner KL. Genetics of migraine: An update. Headache 2006;46(Suppl 1):S19–24.

Various formulations of magnesium have been evaluated 6. Ramadan NM. Targeting therapy for migraine. Neurolofor migraine prevention but have yielded mixed results. gy 2005;64(Suppl 2):S4–8.

CNS levels of magnesium are known to be significantly low during migraine attacks. Magnesium supplementation may 7. Silberstein SD. Migraine. Lancet 2004;363:381–391. be particularly effective for prevention of menstrual mi8. Headache Classification Committee of the International graine and in migraine patients with aura.20,26 Recently, Headache Society. The international classification of headache disorders, 2nd ed. Cephalalgia 2004;24 localized injections of botulinum toxin type A were ap23 (Suppl 1):1–151. proved by the FDA for prophylaxis of chronic migraines.

9. Schreiber CP. The pathophysiology of primary headConclusion ache. Prim Care Clin Office Pract 2004;31:261–276.

10. Kelman L. The triggers or precipitants of the acute migraine attack. Cephalalgia 2007;27(5):394-402.

Pharmacists are a valuable resource for patients with headaches. Providing appropriate education regarding required behavioral changes and effective use of acute and prophylactic pharmacotherapy can improve outcomes for patient with migraine headaches. Ensuring effective migraine treatment can reduce the functional disability and productivity loss associated with a migraine attack.16,18

11. Buse DC, Rupnow FT, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc 2009;84 (5):422-435.

Based on the patient’s clinical presentation and medical history, acute and preventive pharmacotherapy for migraine should be stratified and individualized according to the response, tolerability of available agents, and presence of co-morbid conditions. Patients with stratified care targeted to their needs have higher headache response rates, shorter disability times, less health service utilization, and less loss of productivity.15 Analgesics and NSAIDs can be considered the drugs of choice for infrequent mild to moderate migraine attacks. The triptans or dihydroergotamine can be used if initial therapies prove ineffective or in patients with moderate to severe migraine headache. If a patient has recurring migraines and meets other criteria, preventive therapy should be considered. For patients using migraine prophylaxis therapy, a prolonged headachefree interval could allow for gradual dosage reduction and discontinuation of therapy. Efficacy of a prescribed regimen should be reassessed periodically and patient counseling is always necessary to allow for proper medication use.

References 1. National Center for Health Statistics. Health, United States, 2008 with chartbook. Hyattsville, MD, 2009:6263.

2. Lipton RB, Bigal ME. The epidemiology of migraine.

Am J Med 2005;18(Suppl 1):S3–10.

3. Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007;68:343-349.

12. Matchar DB, Young WB, Rosenberg JA, et al. Evidence-Based Guidelines for Migraine Headache in the Primary Care Setting: Pharmacological Management of Acute Attacks. The U.S. Headache Consortium. 2000, www.aan.com/professionals/practice/guidelines. Last accessed, September 15, 2009.

13. Smith TR. The pharmacologic treatment of the acute migraine attack. Clin Fam Pract 2005;7(3):423-444.

14. Bigal ME, Lipton RB, Krymchantowski AV. The medical management of migraine. Am J Ther 2004;11(2):130– 140.

15. Diamond M, Cady R. Initiating and optimizing acute therapy for migraine: The role of patient-centered stratified care. Am J Med 2005;118(Suppl 1):S18–27.

16. Martin VT, Goldstein JA. Evaluating the safety and tolerability profile of acute treatments for migraine. Am J Med 2005;118(Suppl 1):S36–44.

17. Matthew NT, Loder EW. Evaluating the triptans. Am J Med 2005;118(Suppl 1):S28–35.

18. Bajwa ZH, Sabagat A. Acute treatment of migraine in adults. UpToDate 2009;17.3:1-24. www.uptodate.com.

Last accessed November 27, 2009.

19. Center for Drug Evaluation and Research. FDA Public Health Advisory: Drug Combination May Result in Serotonin Syndrome. 2006, www.fda.gov/cder/drug/ advisory.

20. Bigal ME, Lipton RB. The preventive treatment of migraine. Neurologist 2006;12(4):204-213.

21. Evans RW, Bigal ME, Grosberg B, Lipton RB. Target doses and titration schedules for migraine preventive medications. Headache 2006;46:160–164.

4. Bigal ME, Ferrari M, Silberstein SD, et al. Migraine in 12

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January 2012

22. Rapoport AM, Bigal ME. Preventive migraine therapy: What is new. Neurol Sci 2004;25(Suppl 1):S177–185.

23. Allergan Pharmaceuticals. Botox® Prescribing Information. 2010 Oct. Available from: http:// www.accessdata.fda.gov/drugsatfda_docs/ label/2010/103000s5215lbl.pdf. Accessed on 2010 Nov 18.

cal approaches to managing migraine and associated comorbidities – clinical considerations for monotherapy versus polytherapy. Headache 2007;47:585-599.

25. Matthew NT. Dynamic optimization of chronic migraine treatment. Neurology 2009;72(Suppl 1):S14-20.

26. Bajwa ZH, Sabagat A. Preventive treatment of migraine in adults. UpToDate 2009;17.3:1-18.

24. Silberstein SD, Dodick D, Freitag F, et al. Pharmacologiwww.uptodate.com. Last accessed, November 27, 2009.

January 2012 — Migraine Headaches: Acute Management and Preventive Treatment 1. Which one of the following does not appear to affect migraine threshold?

6. Triptans are selective agonists at which of the following receptors?

A. High levels of dopamine

A. Dopamine

B. Low levels of magnesium

B. Norepinephrine

C. Increased levels of excitatory amino acids

C. 5-HT1B and 5-HT1D

D. Altered levels of extracellular potassium

D. Cholinergic

2. What percentage of patients have triggers of a migraine 7. Which of the following antiemetics have an added beneattack? fit of improving gastrointestinal absorption during a severe attack?

A. 25 percent A. Metoclopramide B. 50 percent B. Chlorpromazine C. 75 percent C. Promethazine D. 100 percent D. Prochlorperazine 3. Patients may benefit from adherence to a wellness program that may include all of the following except: 8. Which of the following would not be appropriate for migraine prophylaxis?

A. Regular exercise A. Beta-Blockers B. Increasing caffeine intake B. Beta-Blockers with intrinsic sympathomimetic activity C. Regular eating habits C. Anticonvulsants D. Smoking cessation D. Calcium channel blockers 4. Which one of the following drug or drug classes is not used in the acute treatment of migraine headaches?

9. What side effect of topiramate may be a distinct benefit over other medications used for migraine prevention?

A. Ergot Alkaloids A. Nausea B. NSAIDs B. Fatigue C. Serotonin Agonists C. Memory difficulty D. Antidepressants D. Weight loss 5. Which of the following is the most common adverse effect of the ergotamine derivatives?

10. Which of the following vitamins has demonstrated efficacy in migraine prophylaxis?

A. Painful extremities A. Riboflavin B. Nausea and vomiting B. Ascorbic acid C. Peripheral ischemia C. Cyanocobalamin D. Continuous paresthesias D. Pyridoxine

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THE KENTUCKY PHARMACIST

January 2012 CE-Migraine Headaches

January 2012

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601.

Expiration Date: January 31, 2015 Successful Completion: Score of 80 percent will result in 1.5 contact hours or 0.15 CEUs. Participants who score less than 80 percent will be notified and permitted one re-examination.

January 2012 — Migraine Headaches: Acute Management and Preventive Treatment TECHNICIANS ANSWER SHEET. Not ACPE approved for Technicians.

Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D

3. A B C D

5. A B C D

7. A B C D

9. A B C D

2. A B C D

4. A B C D

6. A B C D

8. A B C D

10.A B C D

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

Signature _________________________________________________ Date _________________________________ NABP #_________________________________ Birthdate _______________________________ January 2012 — Migraine Headaches: Acute Management and Preventive Treatment Universal Activity # 0143-9999-12-01-H01-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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

5. A B C D 6. A B C D

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

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

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No 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 Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature _________________________________________________ Date _________________________________ NABP #_________________________________ Birthdate _______________________________ The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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THE KENTUCKY PHARMACIST

Pharmacy Time Capsules

January 2012

Pharmacy Time Capsules 1987—Twenty-five years ago: Nova Southeastern University's College of Pharmacy admitted its first class, thus becoming the first college of Pharmacy in south Florida.

Fluoxetine (Prozac) approved for marketing as treatment for depression.

1962—Fifty Years Ago: Kefauver-Harris bill passed in response to thalidomide tragedy. Bill required manufacturers to prove effectiveness as a condition of FDA approval.

Hospital Pharmacy Residency accreditation standards leading to a rapid expansion of clinical training programs were first approved by American Society of Hospital Pharmacists.

1937—Seventy-five Years Ago: American Journal of Pharmaceutical Education (Lyman’s Journal) was launched by American Association of Colleges of Pharmacy with Dean Lyman of Nebraska serving as the founding editor.

Cannabis sativa remains listed in the USP XI (official from 1936). The Marijuana Tax Act passed levying a fee on “every person who imports, manufactures, produces, compounds, sells, deals in, dispenses, prescribes, administers or gives away marihuana.”

1912—One hundred Years Ago: Journal of the American Pharmaceutical Association launched in January 1912 with James Hartley Beal serving as the editor.

Zada Mary Cooper (University of Iowa) was the first woman faculty member to attend an annual meeting of the American Association of Colleges of Pharmacy, (then American Conference of Pharmaceutical Faculties).

1887—One hundred twenty-five years ago: Florida Pharmacy Association formed in the Board of Trade Rooms in Jacksonville on June 8, 1887. Henry Robinson of Jacksonville was elected the first president.

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

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THE KENTUCKY PHARMACIST

Pharmacy Law Brief

January 2012

Pharmacy Law Brief: Professional Judgment and the Questionable Prescription Author: Peter P. Cohron, B.S.Pharm., J.D., Associate Professor (Part-time), Department of Pharmacy Practice and Science, UK College of Pharmacy Question: With all these pill mill clinics and fly-by-night pain treatment centers now showing up everywhere, what are my rights as to refusing to fill these controlled substance prescriptions? Do I have the right to refuse to honor them?

Response: The question has long been asked whether pharmacists have an absolute right to refuse to fill a prescription. Different issues — establishing a pharmacist-patient relationship, moral, ethical or religious problems with filling certain prescription and OTC medications — continue to arise that keep the question alive and kicking.

It is long established that any prescription giving rise to a professional judgment issue for the pharmacist can almost always be refused if the issue cannot be resolved. Here, the paramount example would be protecting the health and well-being of the patient. If a pharmacist could not, say, get a drug changed due to a dangerous interaction with an existing medication, refusal would be appropriate, at least until the issue could be resolved.

The issue of refusing to fill a prescription based on a moral or religious stance has not been directly addressed yet in this state. As Kentucky borders Illinois, many pharmacists are aware of former Governor Rod Blagojevich’s executive order requiring pharmacists to fill all legitimate prescriptions. This order has caused many problems for Illinois pharmacists seeking to turn away questionable prescriptions. Again, this has not been addressed in Kentucky and no such requirement exists here.

But what about the patient who shows up in your Kentucky pharmacy with two oxycodone and one alprazolam prescriptions from Florida or Georgia? Or worse, from a physician who rents a basement room in the next door building and shows up one evening every two weeks to treat people who mostly live 100 miles away. Most of these prescribers are actually performing the minimum necessary acts – physical examination, testing, record-keeping – to keep their practice barely legitimate.

And now I have heard of (1) threatened legal action by one pain treatment establishment against a chain for refusing to fill its prescriptions and (2) another such clinic having its attorney call around asking why prescriptions are being refused. While I do not currently see these tactics as winners for the pain pill mills, pharmacists should refer any attorney making such a contact to their own legal counsel, just to avoid any misstatement that could cause problems later.

Several legitimate responses are available to pharmacists, and most of them are widely known and used. In a survey of how pharmacists address questionable controlled substance prescriptions, this Spring thenPharmD Candidate Morgan Carnes at UK from Russell Springs, KY, collected a variety of useful responses: 1.

2.

3.

The lack of a pharmacist-patient relationship. This pretty much speaks for itself, and is linked to [2]; “Red Flags”, such as a patient who drives to Florida or Georgia or visits a doctor who shows up once every two weeks and who also lives a distance away; a patient who only wants to fill CS prescriptions; a history of numerous ER visits; multiple and/or questionable prescribers; etc.; A pharmacy or company policy against filling for customers who reside more than a certain distance from the pharmacy, unless there is a previous relationship with the chain or it is evident the patient is passing through;

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THE KENTUCKY PHARMACIST

Pharmacy Law Brief 4.

5.

6.

January 2012

Not keeping the “usual suspects” of drugs in stock; Saying “I am out of that drug” whether you have it in stock or not. This was no pharmacist’s favorite, as they said this just foisted the problem onto the next pharmacy down the street. Plus, the patient’s desire to get the medicine almost backfired in my face recently with this one. I used this response to a patient who lived over 100 miles away (the prescriptions were from Chattanooga) only to hear the patient respond that he would get a motel room and stay in town until I got the medication in!

Just say “No” and walk away. This usually works quite well but the occasional belligerent customer can take umbrage and make a loud scene.

In sum, pharmacists are well within their rights to exercise professional judgment to refuse to honor questionable prescriptions. We need to be careful to establish a sound basis for those who question that decision. Further, recognizing that this problem is probably not going away anytime soon, we need to be prepared for newer and more aggressive tactics by these prescribers and patients.

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.

Submit Questions: jfink@uky.edu

KPhA Government Affairs Contribution Name: _________________________________ Pharmacy: __________________________________________ Address: _________________________ City: ___________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs) Credit Card (AMEX; Discover; MasterCard; VISA) Account #: ____________________ Expiration date: _______ Address to which credit card statement is mailed (if different from above) ____________________________________________________________________________________________ Mail to: Kentucky Pharmacists Association 1228 US Highway 127 South Frankfort, KY 40601

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THE KENTUCKY PHARMACIST

Legislative Advocacy

January 2012

Who Advocates Best for Pharmacists?

By Robert McFalls, KPhA Executive Director Throughout its existence, the Kentucky Pharmacists Association has united pharmacists with a clear voice to address emerging opportunities for the profession along with pressing areas of concern. Advocacy is best viewed as simple and complex at the same time. Suffice it to say that it is certainly not something that one can toss in a few dollars, think the job is finished and that everything will go according to plan. Advocacy requires an ongoing commitment with legislative and regulatory environments being consistently monitored to assure KPhA members are fully informed and invested in the best possible outcomes. We all recognize what can happen if we ignore an invoice or bill that is due. I have come to know and recognize that advocacy is not much different than any other reoccurring expenses associated with life. We just pay in a different way.

Consider that the profession and business of pharmacy exists primarily because of advocacy and the investments made by our predecessors many years ago. They dreamed up the unpopular notion that only a licensed pharmacist should practice the profession and that these services can only be done within a facility that is registered and recognized by a government created oversight board, the Kentucky Board of Pharmacy.

all of our members informed and up to date about these items. Advocacy on critical issues serves to benefit all pharmacists as well as the profession of pharmacy throughout the Commonwealth. For example, KPhA is working on a bill to clarify the role of pharmacy technicians and interns in the fitting of shoes for diabetics. KPhA is serving on the newly appointed KASPER Advisory Council and keeping abreast of legislative proposals. KPhA is monitoring legislation on proposed solutions to regulate pain clinics. KPhA is working on a bill to further protect pharmacies from audit abuse. KPhA is working legislatively to regulate the activities of PBMs in the setting and administration of maximum allowable cost pricing mechanisms.

KPhA is a part of a health care provider coalition that is seeking legislation to require the MCOs that are providing services to Medicaid recipients to comply with the insurance code. And the list continues.

Having said what KPhA is doing, let us ask, Who really is KPhA? I recognize that we all know that answer — it's in our name, in our association together. In reality, these issues are YOUR issues. They come from you, and having them acted upon legislatively depends on you. Your involvement with your state legislators as these bills work their way through the legislature is critical to the common cause. We commit to keep you informed through KPhA’s weekly Legislative Updates. KPhA will continue issuing “calls to action" in terms of specific items to discuss when visiting with or calling your legislators. You have the power to influence. When possible, face-to-face discussions work best. Most legislators return home for the weekend or can be visited in Frankfort. A telephone call or email is the next best thing. When talking with your legislators, briefly tell them about yourself, what you do and why the issue is important to you. Try and avoid pharmacy terms that they will not understand by focusing on your work, discussing pharmacy as a profession and speaking to how the legislation will positively impact both your practice and patients. Ask for their support and offer to answer their questions. If you don't have the answer, tell them you will find out and get back with them. Legislators, like the rest of us, also like to be appreciated. Don't forget to thank them for their time and support, and ask them how you can further support them.

Who advocates best?

That would be YOU!

If you have ever asked yourself whether or not what you are doing is at risk for obsolescence, then you have a need for advocacy. If someone or something else is in control of what you get paid, what professional services you provide and what you are permitted to do with your profession and your business practice, then you recognize the critical need for advocacy. If you are disheartened due to changes caused by our state’s transition to managed care, then you have the need for advocacy. If your perception of quality services and positive outcomes is considered overrated by others, then you recognize the need for advocacy. If you do not know who your state legislators, Congressman and Senators are, then you need to know about advocacy. If your Congressman or your state legislators do not know who you are, then you are at serious risk and you must employ advocacy. If you are just beginning your professional career, you have the need for advocacy. In essence, we have a shared need to advocate, and we are at our best in this role when we are advocating as a team.

Currently, KPhA is working to address several critical issues of importance affecting pharmacists and the profession. We are issuing a weekly Legislative Report to keep

Together, as KPhA, we can and we will make a difference.

Who advocates best? That would be YOU!, especially when YOU are the united voice of Kentucky pharmacists.

Let's do it!

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THE KENTUCKY PHARMACIST

KPPAC Contribution Form

January 2012

KPPAC Contribution

Name: _________________________________ Pharmacy: __________________________________________ Address: _________________________ City: ___________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)

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. Contributions from a PAC to a school board candidate are limited to $200 per election.

Individuals may contribute no more than $1,500 per year to all PACs in the aggregate.

In-kind contributions are subject to the same limits as monetary contributions.

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

(This information is in accordance with KRS 121. 150)

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

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

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THE KENTUCKY PHARMACIST

Legislative Advocacy

January 2012

hubonpolicyandadvocacy

Demystifying the APhA–PAC for 2012 Americans are gearing up for the 2012 elections. It’s a big event, with 33 U.S. Senate seats, 435 U.S. House of Representatives seats, and the presidency up for grabs. With changes occurring since the last presidential election in the complex world of campaign finance, pharmacists advocating for their profession may want to be informed about the concept of the political action committee (PAC).

The APhA–PAC is governed by an 11-member Board of Governors, which oversees the PAC’s fundraising activities and decides who receives an APhA–PAC contribution.

The APhA–PAC was “crucial in helping to educate and support legislators during … the Obama administration’s attempt at health care reform,” John Pattison, BSPharm, CFT, Vice-Chair of the APhA–PAC Board of What’s a PAC? A PAC is a political Governors, and a Pharmacy Team committee registered with the Fed- Criteria used by the APhA–PAC Leader at a Giant Eagle Pharmacy eral Election Commission (FEC) to The APhA–PAC’s criteria to gauge a in Heath, OH, told Pharmacy Toraise and spend money to influence Member of Congress’s support for day. “Through financial support, site visits, and members hosting events political elections. pharmacy include the following: to support pharmacy-friendly legisla“People have the perception that  Position on key health care committees that deliberate on issues relevant tors, the APhA–PAC helped to PACs are ‘dirty,’when in reality to pharmacy (the Ways & Means and shape policy to advance the profesthey’re a way to get citizens enEnergy & Commerce Committees in sion of pharmacy.” gaged,” said Abbie Laugtug, APhA the U.S. House of Representatives Director of Government Affairs.

History, rules and the Finance Committee and the Health, Education, Labor, & Pensions “Other than word of mouth, literally Today, approximately 4,000 PACs Committee in the U.S. Senate) everything a candidate uses to get are giving money in federal elec Authored legislation for pharmacists elected—from business cards to tions, according to the website of the and pharmacy mailings to TV ads—costs money,” nonpartisan Center for Responsive said Brian Gallagher, BSPharm,  Made a difficult vote or voted to sup- Politics (www.opensecrets.org), JD, APhA Senior Vice President of port pharmacy initiatives which studies money in politics. The Government Affairs. “A candidate  Led a letter to an agency, leadership, first PAC was founded in 1944 by can have the best message in the the Congress of Industrial Organizaor committees world, but without the money to get tions to raise money to re-elect Pres Attended or spoke at pharmacy that message out to the people, ident Franklin D. Roosevelt. events they have no chance to win. So givMany rules and regulations govern ing money to candidates who sup-  Made a statement on the record in PACs; for example, APhA’s PAC support of pharmacy port your issues is essential to getcan contribute up to $5,000 per electing them elected.”  Offered an amendment in committee tion to political candidates seeking in support of pharmacists Members pooling resources federal office. Primaries and general  Offered an amendment on the floor in elections are counted separately, Because PACs are so important to support of pharmacists meaning that a candidate may rethe political process, nearly every trade and professional association  Consistently cosponsored legislation ceive up to $10,000 in a typical elecand cosigned letters of importance to tion year. Generally, contributions has one. APhA is no exception. pharmacists need to be from personal funds and Since 1985, APhA has had a PAC. not from corporate accounts.

Its mission is to support candidates  Pledged support and demonstrated a willingness to sponsor pharmacy initiTo qualify as as a PAC and be able for federal office who have demonatives to give funds to candidates, PACs strated support for pharmacy issues  Asked a question important to pharmust receive contributions from at and recognize the value of pharmamacy in committee least 51 individuals, be registered cists in the health care system. with FEC for at least 6 months, and The APhA–PAC is a voluntary ascontribute to at least five federal candidates. sociation of APhA members who share political objectives and pool their resources to increase the impact of The newest type of PAC, independent expenditure– their contributions to candidates who support the pro- only committees with the popular nickname of “super fession so that they get and stay elected to Congress. PACs,” arose in the wake of two court cases in 2010.

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THE KENTUCKY PHARMACIST

Legislative Advocacy

January 2012

An independent expenditure is money not spent in direct contributions to a political candidate.

gram, known as the “Winter Is Cold … But Advocacy Is Hot” challenge. In January and February, APhA Academy of Student Pharmacists chapters raise funds for In January 2010, the Supreme Court issued a controthe APhA–PAC and get involved in advocacy. The versial 5–4 ruling in the case of Citizens United v FEC. funds raised by the students will be matched by APhA The decision allows unlimited independent expendimembers who are faculty and alumni of participating tures by corporations. Then in March 2010, the DC Cirschools. Results will be announced at the 2012 APhA cuit Court of Appeals ruled in the consolidated case of Annual Meeting & Exposition.

SpeechNow.org v FEC that individuals can give unlimTo learn about the APhA–PAC during APhA2012, stop by the Govited contributions to groups making independent exernment Affairs booth. penditures only.

For more information about the APhA–PAC, visit pharmacist.com or contact Abbie Laugtug at alaugtug@aphanet.org.

How much money?

Federal PACs registered with FEC raised a combined $328 million, spent $253.7 million, and contributed $148.3 million to candidates, parties, and other committees from January 1 to June 30, 2011, according to a September 9 FEC news release. “These sums represent … increases of 20.7 percent, 11.8 percent, and 9.8 percent, respectively, over the same period in 2007, the first six months of the last presidential election cycle,” the news release noted. During the same period, super PACs raised $26.6 million and spent $6.6 million.

—Diana Yap Reprinted with permission from the Hub on Health Care Reform column in the January 2012 issue of Pharmacy Today (www.pharmacytoday.org). For more information about the Affordable Care Act and pharmacy’s role in shaping the outcomes of this law, access the Government Affairs section of APhA’s website, www.pharmacist.com.

Copyright © 2011, American Pharmacists Association. All rights reserved.

Regulatory scorecard: What is happening NOW! Requests for information receiving public applications or comments:

According to the Center for Responsive Politics website, 135 health professional PACs raised a combined total of $26,356,343 during the 2010 election cycle, with about 56 percent of the money going to Democrats and 44 percent going to Republicans, and 95 health professional PACs so far raised a combined total of $6,751,729 during the 2012 election cycle, with about 41 percent going to Democrats and 59 percent going to Republicans.



CMS: Applications due by January 27 on the Health Care Innovation Challenge from the Center for Medicare and Medicaid Innovation



FDA: Comments due by February 23 on a retrospective review of a 2004 bar code final rule that requires certain human drug products and biological products to have a bar code

Requests for information for which comment periods have closed:

Supporting legislators As support for pharmacist-provided medication therapy management services grows, the number of office holders with records favorable to pharmacy increases.

“We are working hard to help those office holders get re-elected,” Laugtug said. “Once we have Members of Congress who are educated on and supportive of pharmacy, we need to try to keep them in office.” (See sidebar for criteria used by the APhA–PAC in deciding whom to support.)

“It is the APhA–PAC’s duty to help educate [Members of Congress] on pharmacy issues and to show support in a financial manner for the legislators who support issues that have a positive effect on the profession,” Pattison said. “Most of the general public, let alone legislators, do not think of pharmacy issues on a regular basis, so it is vital that the APhA–PAC helps to remind Washington that, ‘Hey, we’re still here and we have something to say.’”

APhA has kicked off the 2012 APhA–PAC Match Pro21



FDA: Draft blueprint for prescriber education for long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategies



CMS: Proposed rule revising Medicare Parts C and D regulations for contract year 2013 and considering requiring the independence of long-term care consultant pharmacists

Etc: 

CDC: The fourth annual Get Smart About Antibiotics Week to raise awareness about antibiotic resistance was held November 14–20.



HHS: The final rule to implement the medical loss ratio provisions in the Affordable Care Act was announced by the Office of Consumer Information and Insurance Oversight on December 2.



For a complete list of all the issues and regulations being monitored and acted on by APhA, access the Government Affairs section of pharmacist.com. Hyperlinks to pharmacist.com, Federal Register notices, and other useful websites can be accessed in the online version of the Hub, located at www.pharmacytoday.org.

THE KENTUCKY PHARMACIST

Pharmacy Quality Commitment

January 2012

Pharmacy Quality Commitment: Putting Continuous Quality Improvement into Action By: Tara M. Modisett, Executive Director for the PSWP that is reported to an approved Alliance for Patient Medication Safety PSO is protected from discovery at Implementing a sound quality assurance (QA) proboth the state and gram takes time, but if you do it right, it may be the federal level. A PSO most valuable investment that you make all year. is essential in improving and moving paThe primary reason to maintain a QA program is to provide the safest, highest level of quality care possi- tient-centered, pharble to your patients. It is also a sound business deci- maceutical care forward in the context of sion to strive to reduce the pharmacy’s exposure to potential errors by implementing processes to moni- our changing healthcare system; pharmacists report tor, analyze discovered weaknesses, and develop a data to a PSO, evaluate it and implement plans for plan for improvement. A solid QA program often re- improvement in their pharmacy. It offers definite sults in improvement in operations and eventually in safety and legal protections afforded by legislation.

In addition, PSOs provide valuable feedback and rea reduction in “redo” prescriptions. This ultimately translates into more free time for you to utilize else- sources to its reporters. For more information on PSOs, visit http://www.pso.ahrq.gov/. where. Finally, if the pharmacy fills Medicare prescriptions it needs an operational Quality Assurance (QA) or Continuous Quality Improvement (CQI) program in order to meet third party contract requirements.

For a QA/CQI program to thrive, owners and management must make a conscious commitment to quality and embrace the change that is necessary to move beyond the traditional “name and blame” mindWhat should you do if you are looking to implement set of medication errors. A positive culture change must come from the leadership. The staff must unor enhance a QA/CQI program in your pharmacy?

First of all, you should make sure that you are partici- derstand that the pharmacy needs to work together in a non-punitive environment that rewards proactive pating in a program that provides protection for the cooperation in order to reduce the chance of a medisafety of quality and error data, also referred to as cation error reaching the patient. The appointed QA patient safety work product (PSWP). It is very important to familiarize yourself with state reporting re- supervisor should encourage participation from the staff and ensure training on maintaining confidentialiquirements and protections. Certain states require ty of patient safety data within the pharmacy’s patient QA/CQI programs to be implemented and others provide protection for patient safety data and its sub- safety evaluation system. The program should be easy to use as collection and ongoing monitoring desequent review. However, there are states that remain silent on this respective issue. The best way to mands that the recording of data be a simple and quick task that requires minimal disruption and easy ensure protection of the data is to arrange to report to a Patient Safety Organization (PSO). A PSO is a incorporation into the daily workflow. Incidents that reach the patient should be collected, but certainly public and private entity, recognized by the Departdo not overlook the value of recording the “near ment of Health and Human Services, that is estabmisses” that might have caused harm had they not lished to collect and analyze quality-related events (QRE). These QREs can include incidents that reach been caught. The collection and analysis of all quality-related event (QRE) data holds invaluable lessons the patient whether they caused harm or not, near to be learned for each pharmacy and can greatly misses, and unsafe conditions reported by contribute to reduction of error rates in pharmacy healthcare providers and healthcare entities. A

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THE KENTUCKY PHARMACIST

Pharmacy Quality Commitment

January 2012

Access to the APMS resource and online reporting site is easy. The PQC™ participant is assigned a The Alliance for Patient Medication Safety™ unique, encrypted password and username that al(APMS™), a federally listed PSO, offers a continulows entry. Once logged in, the pharmacy is directed ous quality improvement and reporting program speto a robust Resource Area that includes recent newscifically designed for pharmacies. Pharmacy Quality letters with guidance and recommendations, aggreCommitment™ (PQC) provides the education and gate trending information, and other patient safety the process for pharmacies to securely report, study tips. Also posted is a PQC™ Quality Assurance Poliand protect patient safety data (Figure 1). The manucy and Procedure template, a patient safety evaluaal details suggested workflow guidelines for the tion system for the pharmacy, reporting forms and “stations” in the prescription process and offers 20 tools, and ongoing resources for the Quality Supervi“pharmacy best practices” to consider in order to resor. This includes instructions on how to set up a duce the chance of a medication error. Pharmacies Peer Review process and how to maintain active rerecord any errors or near-miss QREs through a simporting status for the pharmacy. ple, secure, web-based portal. Once a pharmacy starts reporting QREs, it will have instant access to Managed care organizations, regulatory bodies or charts and graphs of its data, which can provide ex- other entities may have reason to want to know if a tremely valuable insight into various trends. The QA pharmacy is actively participating in a Continuous supervisor can use this data to improve the dispens- Quality Improvement program. APMS has developed ing process and decrease the likelihood of costly er- criteria for determining if a pharmacy is considered rors. Reviewing this data progressively over time en- “Continuous Quality Improvement – Verified” (CQI ables the pharmacy to determine where potential Verified) with the PQC program. Once training is weaknesses might be completed and data is being and how the processes in reported on a consistent the pharmacy’s workflow basis, the pharmacy is able can be improved. The to print out a “CQI-Verified” pharmacy can implement certificate. and experiment with new Implementation of the proprocesses to lower the gram is simple and straightincidence of the type of forward, but like any effecQRE targeted. Over time, tive management process data are accumulated will require some time, effort and can be analyzed to and a commitment to imdetermine if there was an provement to be truly effecimprovement. Through tive. The experts on staff at cycles of data-driven imAPMS have helped thouprovement, the pharmacy Figure 1 sands of pharmacists succan continue to revise the cessfully incorporate PQC™ into their workflow and workflow. This will allow maintaining and adhering to are eager to help. Several PowerPoint training modsafety standards at an excellent level with relative ules are available that range from “Getting PQC ease.

Started” to “Compliance Training”. The pharmacy A pharmacy gets a two-fold benefit from reporting to also has the option to set up as many free individual APMS as their reported PSWP data is aggregated one-on-one online training sessions as needed. They with thousands of reported patient safety data from provide a toll-free line (866) 365-7472 and online acother pharmacies across the country. The APMS cur- cess at info@pqc.net. rently receives over 10,000 QRE reports each In summary, the PQC™ program provides three month, analyzes the aggregate, de-identified inforthings no other continuous quality improvement promation and reports the national trends back to particgram offers: ipating pharmacies. Pharmacies reporting through PQC™ receive recommendations on best practices Access to forms, manuals, and ongoing training and workflow processes to help reduce medication assistance (toll free number and online superrors, improve medication use and enhance patient port) that makes sure PQC™ becomes a safety and health outcomes. meaningful and ongoing program for improvepractice.

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Pharmacy Quality Commitment

January 2012

ment in the pharmacy - not simply another manual on a shelf.

PQC™ can be ordered through a link on the state pharmacy association website or at www.pqc.net.

The first year license fee is $300 and annual renewA secure, password-protected Patient Safety Oral is $200. APMS™ is dedicated to encouraging volganization (PSO) web portal for each pharuntary reports of patient safety work product and to macy to enter patient safety data; to protect it performing analysis of aggregate information to imfrom discovery so none of the patient safety prove quality of care provided by the pharmacy data can be used against the pharmacy in a workforce. In support of these goals, APMS™ prolegal proceeding. vides funding to state pharmacy associations to proA quick and easy way to print proof-of-use of a mote PQC™ and to provide QA/CQI education to continuous quality improvement program. pharmacists in their states.

Questions Lead to Answers In the Pharmacy Quality Commitment™ (PQC™) program, any mistake, or “near miss”, which is caught by the system before it reaches the patient, is called a “success story” because quality assurance is judged to have worked and the pharmacy has data to study. Data are good, but it does not provide automatic answers. This will lead to the right questions being asked that can lead to answers. Pharmacies are encouraged to review generated charts at staff meetings in order to formulate questions and facilitate effective discussions on how to develop solutions.

Let us consider the PQC™ “Where in the Process” chart from one hypothetical pharmacy over a 3 month period. In this pharmacy 31 percent of all of the quality related events (QREs) were made during computer entry process. We know “where” but we don’t know why or how the process is breaking down. There does not seem to be a trend in the type of mistake, just where they are occurring. What could you do if this was your pharmacy? What questions come to mind to investigate? What solutions could be put into place?

One suggestion is that for the next month the pharmacy concentrate on the computer entry process and incorporate at least one “best practice” that could either stop a QRE from occurring or would catch it be-

fore it reached the patient. This pharmacy could consider using the best practice “Take 5.” “Take 5” is the first step in a process, whereby the person’s first job is to check what occurred in the immediate step before. In this case, use “Take 5” in the new prescription filling process, which usually immediately follows computer entry and label generation. The person filling the prescription first takes a short amount of time (5 seconds) to compare the prescription against the label for accuracy before they go to the next step in the process. Are the patient’s name, drug name, strength and directions correct? It has been estimated that “Take 5” will catch 95 percent of all mistakes occurring up to that point as it serves to focus the brain on a task for a short time for a specific goal.

Train the staff, remind the staff and evaluate in a few weeks whether there was an effect.

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THE KENTUCKY PHARMACIST

February 2012 CE Beers’ List

January 2012

STOPP Using the Beers’ List and START Something New By: Dr. BC Childress, Director of the InterNational Center for Advanced Pharmacy Services (INCAPS) and Assistant Professor; Samuel Reader and Mark Court, PharmD Candidates at Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-12-002-H04-P 1.0 Credit Hours (0.1 CEUs)

Objectives 1. Identify the dangers of medication use in the elderly.

2. Describe the Beers’ List Criteria.

3. Distinguish the STOPP/START criteria from the Beers’ List.

4. Outline ways to apply the STOPP/START criteria in clinical pharmacy practice. system—pain relievers, anxiolytics, and hypnotics, in particular. Of these older adults who visited the ED In advanced age, the body goes through many physifor adverse drug reactions, nearly one third were adological changes that hinder medication elimination mitted to the hospital.1 and metabolism. The two major sites for drug metabolism are the liver and kidneys. In the elderly, both The elderly are one of the most overly prescribed hepatic and renal functions are reduced, resulting in populations. With an increase in healthcare costs and decreased drug elimination. Generally phase one of a need for multiple providers, many seniors fall into metabolism is affected, which involves much of drug the trap of polypharmacy and, as such, suffer from a metabolism — including the infamous Cytochrome pill burden leading to noncompliance. Another issue P450 enzymes. This leads to changes in the way that they face is the pharmacy cascade. The most drugs are metabolized. Additionally, many “prescribing cascade” begins when an adverse drug drugs are eliminated from the body via the kidneys, reaction is misinterpreted as a new medical condition and decreased renal function causes prolonged elimi- (See Figure 1.) An additional medication is then prenation of drugs and drug metabolites. Both of these scribed to treat the new issue. This increases the patient’s risk of developing additional adverse effects scenarios may lead to potential drug toxicity. related to the newly added agent.2 For example: A Besides alterations in hepatic and renal function, the patient is prescribed a chronic NSAIDs, such as ibuelderly may also face reduced body stature and alprofen, and then develops secondary hypertension. tered fat distribution. Such changes lead to variation The patient may then be placed on an antihypertenof drug distribution, as well as a decrease in overall sive to correct the blood pressure. Polypharmacy and health due to organ aging. Another barrier that arises the “prescribing cascade” lead to more drug interacwith age is forgetfulness, which leads to noncomplitions, adverse drug events, noncompliance, and inance with medication therapy. When it comes to adcreased healthcare costs to the patient.2 verse drug events (ADE) in the elderly, all of these factors play a contributory role.

What the Beers List Meant Dangers of Medication Use in the Elderly

In 2008, an estimated 1.1 million emergency department (ED) visits were made by adults age 50 or older due adverse reactions to pharmaceuticals. More than half of these visits were made by adults 65 years of age or older. The medications that were most involved were drugs that act on the central nervous

In 1991, Dr. Mark H. Beers led a team of 12 clinicians with expertise in geriatrics to create a medication list for clinicians. Known as the Beers’ list, it was designed to be a quick reference to determine which medications should be avoided in the elderly (≥65 years of age) in nursing homes.3 Since its initial intro-

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February 2012 CE Beers’ List

January 2012 Creation of the START/STOPP Criteria In 2009, a panel of geriatric experts in Cork, Ireland set out to create a new tool for geriatric care. The 18person panel consisted of nine physicians in geriatric medicine, three clinical pharmacologists, two senior academic primary care physicians, one geriatric psychiatrist, and three senior hospital pharmacists with an interest in geriatric pharmacotherapy. Their work resulted in the formation of the STOPP (Screening Tools of Older Person’s potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) criteria (See Figure 3). Their goals were to improve medication appropriateness, prevent ADEs, and reduce costs.

Figure 12

duction, the Beers’ list has grown to include potentially inappropriate medications that all geriatric patients should avoid, regardless of their level of care or residence. Though it was not the intent of the panel, in 1999, the Centers for Medicare & Medicaid Services (CMS) adapted the Beers’ criteria to apply them to nursing home regulatory guidelines (See Figure 23).

What the Beers’ List Lacked A Canadian consensus panel, in 2000, published a new set of guidelines to use in avoiding potentially inappropriate prescribing (PIP) practices in geriatrics.

Expanding on the previous standards, they created the Improving Prescribing in the Elderly Tool (IPET).

Basing their recommendations on published literature, they hoped to improve elderly care in the hospital inpatient setting. Creating the IPET set the stage for the next decade of geriatric care, but a more comprehensive list, including all patient care settings, could service a much more fulfilling purpose.4 The last time the Beers’ list was updated, the space shuttle Columbia headed off into space for its final mission. Since then, a great deal has changed in medicine. Practice guidelines grow and change.

Standards of care have been adapted for various disease states. In 2003, 66 new drugs/classes were identified to be high risk to elderly patients and were added to the list.5 Although the Beers’ list served as a great reference tool over the years, it has failed in two respects: 1. The infrequent updates were not able to stay abreast of changes in the drug market of today. 2. It was simply a list of medications that were potentially inappropriate, without helping practitioners realize how to determine appropriateness.6 As therapeutic guidelines develop and change, screening tools for determining the appropriateness of therapy must develop as well.

In an attempt to correct the deficiencies of the Beers’ criteria, they set the following seven concepts as the foundation for their new criteria: 1. Capture common and important instances of PIP; 2. Be organized according to physiological systems, as in the case with most drug formularies; 3. Give special attention to drugs that adversely affect elderly patients at risk of falls; 4. Give special attention to opiate use in older people; 5. Highlight duplicate drug class prescriptions (e.g. two ACE inhibitors or two proton pump inhibitors); 6. Address potentially serious errors of prescribing omission in older people; 7. Represent the consensus views of a panel of experts in prescribing for older people.7 Applying the STOPP/START Criteria to Clinical Pharmacy Practice Applying the STOPP/START criteria to clinical pharmacy practice begins with an honest look at its strengths and weaknesses. When examining its use at various practice sites, it was found to be useful in all areas tested (hospital, community, and academic settings).7,8 Being developed outside of the United States, it should serve more as a clinical tip sheet than a true standard of care or therapeutic guideline.

Whether it succeeds by remaining relevant, as the Beers’ criteria has failed to do, remains to be seen.

Like the Beers’ List, it will need to be updated regularly in order to be useful in clinical medication reviews, incorporated into clinical software, and be utilized as an educational tool for pharmacists and prescribers.

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THE KENTUCKY PHARMACIST

February 2012 CE Beers’ List

January 2012

Figure 2: Drugs and Classes Potentially Inappropriate for Use in the Elderly 3

Amiodarone

Estrogens

Amitriptyline

Ethacrynic acid

Amphetamines (excluding methylphenidate HCL and anorexics) Barbiturates Benzodiazepines, long-acting (chlordiazepoxide, diazepam, flurazepam, oxazepam, temazepam)

Ferrous sulfate >325 mg/day Fluoxetine Gastrointestinal antispasmodics (belladonna alkaloids, clidiniumchlordiazepoxide, dicyclomine, hyoscyamine, propantheline—all)

Chlorpheniramine

Guanadrel

Chlorpropamide Cimetidine

Guanethidine Hydroxyzine

Clonidine

Indomethacin

Clorazepate

Isoxsuprine

Cyproheptadine Desiccated thyroid Digoxin >0.125 mg/day Diphenhydramine Dipyridamole, short acting

Ketorolac Meperidine Meprobamate Mesoridazine Methyldopa and methyldopa/ hydrochlorothiazide

Disopyramine Doxazosin Doxepin

Nifedipine, short-acting Nitrofurantoin NSAIDs, long-term use of fulldose, longer half-life, non -COXselective types (naproxen, oxaprozin, and piroxicam) Oxybutynin, short-acting Pentazocine Perphenazineamitriptyline Promethazine Propoxyphene Reserpine

Stimulant laxatives, long-term use except with opiate analgesics (bisacodyl, cascara sagrada, and Neoloid) Thioridazine Ticlopidine Trimethobenzamide Tripelennamine

Methyltestosterone Mineral Oil Muscle relaxants (carisoprodol, chlorzoxazone, cyclobenErgot mesyloids zaprine, dantrolene, methocarbamol, orphenadrine—all A more robust list of medications to avoid, the safety concerns, and possible alternatives may be found at: [http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?pt=2&dd=210209].

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February 2012 CE Beers’ List

January 2012

Conclusion The risk of ADEs in the elderly is especially high because of increased prescription use and agerelated metabolism and excretion changes. Unlike the Beers’ list, the STOPP/START criteria tend to focus more on the common avoidable instances of inappropriate prescribing, rather than just list potentially inappropriate medications. Recent studies have shown the STOPP/ START criteria to be beneficial in all areas of patient care, but its future relativity to practice remains to be seen.10,11 References: 1. The DAWN Report: Emergency PressAnnouncements/ucm278383.htm. Accessed Department Visits Involving Adverse Reactions to January 8, 2012.

Medications among Older Adults. Substance Abuse and Mental Health Services Administration, 7. O’Mahony D., Gallagher P., Ryan C., Byrne S., Center for Behavioral Health Statistics and QualiHamilton H., Barry P., O’Connor M., Kennedy J. ty. Available at: http://www.oas.samhsa.gov/2k11/ STOPP & START criteria: A new approach to deDAWN013/ tecting potentially inappropriate prescribing in old AdverseReactionsOlderAdults_HTML.pdf. Acage. http://www.em-consulte.com/article/245669 cessed January 09, 2012.

8. Gallagher P, O'Mahony D. STOPP (Screening 2. Rochon PA, Gurwitz JH. Optimising drug treatTool of Older Persons' potentially inappropriate ment for elderly people: the prescribing cascade.

Prescriptions): application to acutely ill elderly paBMJ 1997;315:1096–9. tients and comparison with Beers' criteria. Age and Ageing 2008;37:673-9.

3. Wick, JY. The Beers Criteria: Red Flags for Elders (06/01/2006). Pharmacy Times Web site. Availa- 9. Barry PJ, Gallagher P, Ryan C, O'Mahony D. ble at: http://www.pharmacytimes.com/ START (screening tool to alert doctors to the right publications/issue/2006/2006-06/2006-06-5624. treatment)—an evidence-based screening tool to Accessed January 09, 2012. detect prescribing omissions in elderly patients.

Age and Ageing 2007;36:632-8.

4. Nauglet CT, Brymer C, Stolee P, et al. Development and validation of an improving prescribing in 10. Cristin R, O'Mahony D, Byrne S. Application of the elderly tool. Can J Clin Pharmacol 2000;7:103STOPP and START Criteria: Interrater Reliability 7.

Among Pharmacists. Ann Pharmacother 2009;43 (7):1239-44.

5. Fick DM, Cooper JW, Wade WE, et al. Updating 11.

Gallagher P, Baeyens JP, Topinkova E, et al. Inter the Beers criteria for potentially inappropriate -rater reliability of STOPP (Screening Tool of Oldmedication use in older adults. Arch Intern Med er Persons' Prescriptions) and START (Screening 2003;163:2716-24.

Tool to Alert doctors to Right Treatment) criteria 6. FDA: 35 innovative new drugs approved in fiscal amongst physicians in six European countries. year 2011(11/03/2011). US Food and Drug AdAge Ageing. 2009 Sep;38(5):603-6. ministration Web site. Available at: http:// www.fda.gov/NewsEvents/Newsroom/

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February 2012 CE Beers’ List

January 2012

February 2012 — STOPP Using the Beers’ List and START Something New

1. Elderly patients are at a higher risk of experiencing

5. Unlike the Beers’ list, the STOPP/START criteria

adverse effects with prescription medications because: are divided based on: A. Impaired cognitive function

A. Age

B. Physiological changes

B. Anatomical systems

C. Polypharmacy

C. Ethnicity

D. All of the above

D. Disease states

2. Which of the following is a correct example of a pre- 6. The primary goal(s) of the STOPP/START criteria scription cascade?

are:

A. A patient takes naproxen, develops hypertension, and is placed on HCTZ to control their hypertension.

A. Improve medication appropriateness regardless of practice site

B. A patient experiences altered mental status while taking Chantix for smoking cessation.

B. Prevent adverse drug events C. Reduce patient healthcare cost

C. A patient is switched to a combination medication to D. All of the above for cost savings purposes.

D. A patient develops angioedema while taking Lisinopril to control her hypertension.

7. True or False: The STOPP/START criteria should be used as a substitute for therapeutic guidelines.

3. The Beers’ list was originally developed for elderly

A. True

patients in which healthcare setting?

B. False

A. Hospital B. Nursing home

8. The emphasis of the STOPP/START criteria is

C. Hospice

placed on:

D. All healthcare settings

A. Drug-drug interactions B. Use of novel drugs

4. Which of the following medications should be avoid- C. Duplicate drug class prescribing ed in elderly patients based on the Beers’ criteria?

D. A and C

A. Fluoxetine

E. All of the above

B. Diphenhydramine C. Promethazine D. All of the above

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THE KENTUCKY PHARMACIST

February 2012 CE Beers’ List

January 2012

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601.

Expiration Date: January 31, 2015 Successful Completion: Score of 80 percent will result in 1.0 contact hour or 0.10 CEUs. Participants who score less than 80 percent will be notified and permitted one re-examination.

February 2012 — STOPP Using the Beers’ List and START Something New TECHNICIANS ANSWER SHEET. Not ACPE approved for Technicians.

Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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

5. A B C D 6. A B C D

7. A B 8. A B C D E

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

Signature _________________________________________________ Date _________________________________

NABP #_________________________________ Birthdate _______________________________ February 2012 — STOPP Using the Beers’ List and START Something New Universal Activity # 0143-0000-12-002-H04-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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

5. A B C D 6. A B C D

7. A B 8. A B C D E

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

Signature _________________________________________________ Date _________________________________

NABP #_________________________________ Birthdate _______________________________ The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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THE KENTUCKY PHARMACIST

January 2012

134th KPhA Annual Meeting

134th Kentucky Pharmacists Association Annual Meeting Registration Form June 13-16, 2012 Marriott Griffin Gate, Lexington, KY

Please Type or Print the following: __________________________________ ________ __________________________ First Name

MI

Last Name

____________________________________________________ PharmD

RPh

CPhT

Other

Business Affiliation

_____________________________________________ _________________________ ______ ­ _____ Street Address

City

State

Zip

__________________________ _______________________________________________________________ Daytime Phone

Student- Free Full Registration:

By June 1 After June 1 Single Day Registration:

By June 1 After June 1

Email Address

Registration Fees: Please circle applicable Fee Member Non-Member Technician/Resident $200 $250 $105 $130 Circle Day:

$375 $425 $195 $220 Thursday

Friday

$85 $110

$25 $35

$55 $80

$20 $30 Saturday

Meal Events: Please indicate the total number that will be attending each meal event.

Welcome Luncheon: Thursday ____yes ____ no _____ additional guest $30 Kroger Luncheon: Friday ____yes ____ no _____ additional guest $30 Ray Wirth Awards Banquet: Friday ____yes ____ no _____ additional guest $45 Luncheon: Saturday ____yes ____ no _____ additional guest $30 Guest Name(s): ______________________________________________________________________________ Please include your guests’ name(s) if you have purchased additional event tickets Registration $ _______ Additional Meal Tickets $ _______ Credit Card Information: AMEX Discover MasterCard

Total Enclosed $_________ Visa

Number: ___________________________________________ Expiration Date:______________ NOTE: If billing address is different than above, please include on back of sheet, or separate sheet.

Please make checks payable to KPhA Annual Meeting.

Mail to: KPhA Annual Meeting 1228 US 127 South Frankfort, KY 40601.

For overnight accommodations: Contact Marriott Griffin Gate via the KPhA custom web reservation site at https:// resweb.passkey.com/go/KYPharmacistAssoc, or call1-800-266-9432 and reference Group Code KY Pharmacists Associa­ tion for the special rate of $129/night. Cut-off for this rate is May 22, 2012. Lodging rate includes parking on site and wireless internet access.

Special Assistance. If you require special assistance or diet to attend, please indicate need on back of this sheet, call 502.227.2303 or email ssisco@kphanet.org.

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134th KPhA Annual Meeting

January 2012

KPhA 2012 Professional Awards The Kentucky Pharmacists Association annually recognizes individuals from across the Commonwealth that exhibit exceptional service to patients and their community, continuously promote the profession of pharmacy, and demonstrate innovative pharmacy practice. The KPhA Organizational Affairs Committee is accepting nominations for the professional awards below: Bowl of Hygeia

Distinguished Service Award

Pharmacist of the Year

Professional Promotion Award

Young Pharmacist of the Year

Excellence in Innovation Award

Technician of the Year

Cardinal Health Generation Rx Champions Award

To nominate an individual, please submit a letter of nomination including the award information and the nominee’s accomplishments with regard to the award criteria. Multiple letters of support are accepted and highly encouraged. Individuals and recognized pharmacy organizations in Kentucky are encouraged to submit nominations. Individual nominators need not be a member of the Association; however, pharmacist and technician nominees must be a member of KPhA. Nominations: Nominations may be submitted electronically to the Organizational Affairs Committee Chair, Joey Mattingly at joeymattingly@gmail.com or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South, Frankfort, KY 40601 no later than March 31, 2012.

The KPhA President, President-Elect, and the Chairman of the Board, participating in any voting for awards shall not be eligible for nomination or selection for any award.

Conferral of any of the awards of the Association shall be at the discretion of the Organizational Affairs Committee and is not mandatory on an annual basis.

KPhA Board of Directors Nominations for 2012-13 The Kentucky Pharmacists Board of Directors is accepting nominations for the following positions to serve on the KPhA Board for the 2012-13 year: 

President-Elect



Secretary



Director (3 open spots)

Nominations: Nominations may be submitted electronically to the Organizational Affairs Committee Chair, Joey Mattingly at joeymattingly@gmail.com or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South, Frankfort, KY 40601 no later than March 31, 2012.

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134th KPhA Annual Meeting

January 2012

KPhA 2012 Professional Award Criteria and Past Recipients Richard L. Roeding 1983 William J. Farrell, Sr. 1982 Criteria – To recognize an individual who has demon- Joseph L. Scanlon 1981 strated outstanding community service in pharmacy. Joseph T. Elmes, Jr. 1980 H. Joe Russell 1979 Eligibility – The recipient must be an Active or HonorAlvin R. Bertram 1978 ary Life member of the Association. The recipient Norman C. Horn 1977 must be a pharmacist with a current valid license to H. Joseph Schutte 1976 practice in Kentucky. The recipient must be living; D.H. "Sonny" Ralston 1975 awards are not presented posthumously. The recipiArthur G. Jacob 1974 ent has not previously received the award and is not James M. Brockman 1973 currently serving nor has he/she served within the Richard E. Murray 1972 past two years on the selection committee or as an Randolph N. Smith 1971 officer of the Association in other than ex-officio caOliver E. Mayer 1970 pacity. The recipient has compiled an outstanding Donald C. Morwessel 1969 record of community service that apart from his/her James Phillip Arnold 1968 specific identifications as a pharmacist reflects well on William D. Morgan 1967 the profession.

Ernest M. Davis 1966 Bowl of Hygeia Recipients W.F. Bettinger 1965 Arvid E. Tucker 1964 William I. McMakin, III 2011 Vernon B. Hager 1963 Kim Croley 2010 Sidney Passamaneck 1962 Patricia Thornbury 2009 John H. Voige 1961 Dave Peterson 2008 E. Crawford Meyer 1960 Charles Fletcher 2007 James J. Hamilton 1959 Gloria Doughty 2006 Larry Hadley 2005 Harold Cooley 2004 Distinguished Service Award Brian Fingerson 2003 Simon Wolf 2002 Criteria- To recognize individual members who have Richard Ross 2001 made significant contributions to the Association or Tom Houchens 2000 the profession at large over an extended period of Phil Losch 1999 time.

Lucy Easley 1998 Eligibility – Only Active or Honorary Life members of Nick Schwartz 1997 the Association shall be eligible for the award. No Michael Cayce 1996 individual shall be a recipient of the award more than Bill Borders 1995 once.

Gerald Deom 1994 Kenneth Calvert 1993 Distinguished Service Award Recipients Joseph G. Bessler 1992 Kenneth Roberts 2011 Michel A. Burleson 1991 Ann Amerson & Lynn Harrelson 2010 Lynn Harrelson 1990 Larry Hadley 2009 William A. Conyers, Jr. 1989 Dwaine Green 2008 Daniel R. Kovar, Jr. 1988 John Brislin 2007 Martin W. Nie 1987 Donnie Riley 2005 Ralph Schwartz 1986 Gloria Doughty 2004 Dwaine K. Green 1985 Coleman Friedman 2003 W. Vance Smith 1984

Bowl of Hygeia Award

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134th KPhA Annual Meeting Joe Fink III Melinda Joyce David Jaquith R. Paul Easley & Jeff Osman Ralph Bouvette Pat Chadwell Jordan Cohen and Marty Nie Mike Montgomery Richard Ross Thomas Weisert R. David Cobb Joseph G. Bessler & Arthur G. Jacob Paul E. Davis Norman Horn & Robert E. Lee Sandlin Joseph V. Swintosky J.H. (Jack) Voige Charles T. Lesshafft, Jr. Jerry Budde William H. Nie R.N. (Randy) Smith

January 2012 2002 2002 1999 1998 1997 1996 1995 1994 1993 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981

Pharmacist of the Year Award Criteria – To recognize a pharmacist for outstanding professional activities undertaken during the current or previous calendar year, which resulted in demonstrable benefit to the profession of pharmacy.

Eligibility – Only Active or Honorary Life members of the Association shall be eligible for nominations and receipt of this award.

Pharmacist of the Year Recipients William Grise Holly Byrnes Dave Sallengs Kelly Smith Joseph Bickett Paul Easley John Anneken Kim Croley Ralph Bouvette David Jaquith Melinda Joyce Michael Wyant Phil Losch Tom Houchens & Bob Kuhn Don Ruwe Mark Edwards C. Dave Peterson Brian Fingerson Martin W. Nie Judy Minogue Paul Ruwe

2011 2010 2009 2008 2007 2006 2005 2004 2003 2001 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989

Joseph L. Fink III Steven R. Adams William J. Farrell Harold G. Becker Dwaine K. Green R. David Cobb Richard E. Murray Richard Rolfsen Gloria H. Doughty Joseph G. Bessler Emil Baker Robert L. Barnett Joseph L. Scanlon John B. Anneken Alvin R. Bertram Patricia A. Donahue H. Joseph Schutte Willard Alls Joe D. Taylor Richard L. Ross Ralph J. Schwartz George W. Grider Robert J. Lichtefeld E.M. Josey Julius T. Toll Charles E. Otto Charles F. Rosenberg R.N. Smith E. Crawford Meyer Charles A. Walton Ernest C. Williams George W. Grider Ray Wirth Nathan Kaplin Marion Hardesty

1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954

Professional Promotion Award Criteria – To recognize individuals or organizations who have exhibited outstanding efforts to demonstrate the importance of pharmacy as a health care profession, and which promote proper application of pharmacists’ professional services.

Eligibility – Open to persons or organizations.

Professional Promotion Recipients Lynne Eckmann 2011 Gloria Doughty & Lynn Harrelson 2010 Jordan Covvey 2009 Jeff Mills 2008 Trish Freeman 2007 Sherry DeCuir 2006 Pete Orzali 2005 John Armistead, Don Kupper & Willie Newby2004 Kroger Pharmacy Mid South Division, Holly Divine, Randy Gaither, Bill Grise & Laura Jones 2003 34

THE KENTUCKY PHARMACIST

January 2012

134th KPhA Annual Meeting Jefferson County Academy of Pharmacy, Dean Ken Roberts, Ph.D 2002 Paul Easley, Bob Oakley and Michael Wyant 2001 Judy Minogue 2000 Ralph Bouvette 1999 Rodger Smith, Barbara Woerner, Mary Ann Wyant, and Rick Vissing 1998 Larry Spears 1997 John B. Anneken 1996 Phil Losch 1995 Jordan Cohen 1994 Judy Minogue 1994 Kentucky Academy of Student of Pharmacy 1993 Celeste Flick & Clarence Sullivan III 1988 William H. Nie 1987 Student Kentucky APhA 1986 Northern KY Pharmacists Association 1986

Jeffrey W. Danhauer Mark S. Edwards Susan Murray Kathman Melinda Cummins Joyce

Excellence in Innovation Award Sponsored by Upsher-Smith Laboratories Criteria – To recognize a pharmacist who has demonstrated innovative pharmacy practice resulting in improved patient care in the previous year or over an extended period of time.

Eligibility – A recipient must be a pharmacist who is an Active or Honorary Life member of the Association. A recipient may receive the award more than once.

Innovative Pharmacy Practice Award Recipients

James Nash & BC Childress Young Pharmacists of the Year Award sponsored Lynne Eckmann & Cathy Hanna

by Pharmacists Mutual Insurance Company Ann Albrecht Lisa Short Criteria – To recognize a young pharmacist’s outHolly Divine, Amy Nicholas standing contribution to the profession and/or comJudy Minogue munity.

Trish Freeman Eligibility – The recipient must be an Active member Mary Ann Wyant of the Association. The recipient must be licensed to Joyce Korfhage Rhea practice for nine years or less. The recipient must Cathy Edwards have a valid, active license to practice in Kentucky.

Celeste Flick The recipient must have demonstrated participation Jeanne Zeis in a national pharmacy association, professional pro- Dave Wren gram(s) and/or community service.

Preston Art W. Michael Leake Distinguished Young Pharmacist Award Recipients Aimee Ruder Karen Hubbs Matt Martin Tiffany Self Angela Parrett Janet Mills Alyson Schwartz Nancy Horn Jennifer O’Hearn Karen Altsman Kim Wilson Kim Harned Michael Box Dan Yeager Dan Minogue Pan Haeberlin Kim Croley Phillip Sandlin

1991 1990 1989 1987

2011 2010 2009 2008 2007 2006 2005 2004 2003 2001 1999 1998 1997 1996 1995 1994 1993 1992

2011 2010 2008 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994

New Award for 2012: Cardinal Health Generation Rx Champions Award Criteria – This award program recognizes excellence in community-based prescription drug abuse prevention at state pharmacy associations. This award honors a pharmacist who has demonstrated outstanding commitment to raising awareness of the dangers of prescription drug abuse among the general public and among the pharmacy community. The award is also intended to encourage educational prevention efforts aimed at patients, youth and other members of the community. In addition to the award, to honor the pharmacist’s work to fight prescription drug abuse, APMS, state pharmacy associations and the Cardinal Health Foundation will donate $500 to a charity of the award recipient’s choice.

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134th KPhA Annual Meeting

January 2012

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Advancing Pharmacy Practice in Kentucky

January 2012

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Sullivan College of Pharmacy DIC

January 2012

Sullivan University College of Pharmacy Drug Information Center (DIC) provides services to Healthcare Professionals Sullivan University College of Pharmacy (SUCOP) Drug Information Center (DIC) offers clinical services to all healthcare professionals and collaborates with Kentucky Regional Poison Control Center. The center was established in conjunction with the establishment of the College of Pharmacy.

Medication Information, also known as Drug Information, made its debut in the early part of the 1960s. As a result, the first Drug Information Center, currently closed, was established at the University of Kentucky Medical Center in 1962.

A number of centers in different pharmacy settings have since been established, including but not limited to hospitals, industries, managed care, and academia. The primary aim of SUCOP DIC is to train professional pharmacy students and to offer services to healthcare professionals within the Commonwealth of Kentucky.

The SUCOP DIC provides complete and unbiased information to requests relating to the following: Adverse Drug Reactions/Side effects Drug Compatibility Drug Dosing and Administration Interactions Herbal Medications Product Identification Pregnancy and Lactation Pharmacokinetics Pregnancy and Lactation/others Hours of operation are from 8:30am till 4:30pm Monday through Friday.

Phone: 866-272-2215 Fax: 502-413-8971 E-mail: druginfo@sullivan.edu Website: http://www.sullivan.edu/pharmacy/drug_information.asp Sullivan University College of Pharmacy Drug Information Center is just a phone call away and ready to serve you.

KPhA Remembers KPhA desires to honor members who are no longer with us.

Please keep KPhA informed by sending this information to ksheets@kphanet.org.

Deceased members for each year will be honored permanently at the KPhA office with a White Coat.

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CPE Monitor

January 2012

Attention all KY Pharmacists and Pharmacy Technicians!!!!

KPhA will be transitioning to CPE Monitor in early 2012 for all ACPE accredited CE programs. You MUST sign up for a NABP e-Profile ID to receive CE credit from KPhA. Watch for Member Updates from your Kentucky Pharmacists Association!

CPE Monitor: Information for Pharmacists and Pharmacy Technicians What is CPE Monitor?

CPE MonitorTM is a national, collaborative effort by the Accreditation Council for Pharmacy Education (ACPE) and the National Association of Boards of Pharmacy (NABP) to provide an electronic system for pharmacists and pharmacy technicians to track their completed continuing pharmacy education (CPE) credits. It will also offer boards of pharmacy the opportunity to electronically authenticate the CPE units completed by their licensees, rather than requiring pharmacists and pharmacy technicians to submit their proof of completion statements (i.e. statements of credit) upon request or for random audits.

How CPE Monitor Works Pharmacists and pharmacy technicians will receive a unique identification number (ID), known as the NABP e-Profile ID, after setting up their e-Profile with NABP (see How to Register for CPE Monitor). Many ACPE-accredited CPE providers are now requiring pharmacist and pharmacy technician participants to provide their NABP e-Profile ID and date of birth (DOB in MMDD format) to the ACPE-accredited provider when they register for a CPE activity or submit a request for credit. It will be the responsibility of the pharmacist or pharmacy technician to provide the correct information [i.e. ID and DOB (in MMDD format)] in order to receive credit for participating in a CPE activity.

The CPE Monitor system will direct electronic data from ACPE-accredited providers to ACPE and then to NABP, ensuring that CPE credit is officially verified by the providers. Once information is received by NABP, pharmacists and pharmacy technicians will be able to log in to access information about their completed CPE activities.

How to Register for CPE Monitor Pharmacists and pharmacy technicians are asked to obtain their NABP e-Profile ID now at www.MyCPEmonitor.net to ensure their e-Profile is properly setup prior to implementation of CPE Monitor.

As ACPE-accredited providers begin transitioning their systems to CPE Monitor throughout 2012, the eProfile ID and DOB in MMDD format will be required by those providers to receive credit for any ACPEaccredited CPE activities. By the end of 2012, all ACPE-accredited CPE providers will require the e-Profile ID and the DOB in MMDD format to receive CPE credit.

NABP Customer Service custserv@nabp.net Tel: 847-391-4406 Fax: 847-391-4502 Hours: Monday - Friday, 9 AM to 5 PM central time

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Pharmacy Policy Issues

January 2012

PHARMACY POLICY ISSUES:

The Current State of Drug Shortages

By Casey M. Combs Author: Casey Combs is a third professional year Pharm.D. student at the UK College of Pharmacy. A native of Honaker, Va., she obtained a B.S. in Biology at the University of Virginia prior to beginning pharmacy school.

Issue: The federal government has become more involved in the pharmaceutical and pharmacy industry as pharmacists face an increasingly severe drug shortage problem on a daily basis.

Discussion: Drug shortages are adversely affecting the practice of pharmacy on various levels. The added stress is costing a lot of time and money and most importantly, it is negatively impacting patient care. In October, President Barak Obama issued an executive order to call attention to this growing problem.

The number of drug shortages annually has tripled from 61 in 2005 to 178 in 2010, and 208 have been reported thus far in 2011.1 Drug shortages are not only becoming increasingly frequent, but the lack of medications poses several additional challenges: managing the issue is labor-intensive for pharmacists and their staff; it leads to adverse patient outcomes and health care costs rise as drugs are in short supply. Of the reported shortages, the majority of the drugs are sterile injectables, including oncology drugs, antibiotics and electrolyte and nutrition drugs. These drugs are particularly at risk for supply shocks and shortages due to their complex production process, special production lines and the necessity to maintain sterility.

In response to this growing problem, on Oct. 31, 2011, President Obama issued an Executive Order directing the Food and Drug Administration (FDA) to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging.2 At the same time, the President announced his support for bipartisan legislation (H.R. 2245 and S. 296), the Preserving Access to Life Saving Medications Act. These two bills will augment the Executive Order to strengthen the FDA’s ability to prevent prescription drug shortages.

Current legislation requires that companies inform the FDA six months in advance for discontinuations of medically necessary drugs that are produced by only one manufacturer.3 In addition, no law requires manufacturers to report production interruptions to the FDA. However, under current law, even if the FDA is not notified in these instances, the administration has no power to penalize the manufacturer for not reporting the production interruption. The new Executive Order directs the FDA to broaden reporting of potential shortages of certain life saving prescription drugs. The FDA reported that it was able to avoid 38 drug shortages in 2010 and 99 in 2011 when the organization was properly notified about production disruptions by encouraging other suppliers to increase production to offset the single manufacturer’s loss.1 The President’s Executive Order is a promising start to addressing a far-reaching and increasingly-complex problem. But without passing legislation as soon as possible, our government’s resources will continue to be inadequate to fight drug shortages in the United States. President Obama sent a letter to drug manufacturers encouraging the companies to voluntarily notify the FDA about potential drug shortages of prescription drugs

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Pharmacy Policy Issues

January 2012

even if the notification is not required by law. Along with the increased notifications, the President also expanded the staffing resources for the FDA’s Drug Shortages Program to help with the increased workload.

The President understands that early notification is not a panacea for fixing the drug shortage problem; therefore, he has noted the critical need for additional manufacturing capacity to the private sector.

It is imperative that all professionals within the field of pharmacy collaborate and show cohesive support for H. R. 2245 and S. 296, the Preserving Access to Life Saving Medications Act. Drug shortages have negative effects on all pharmacists and patients; thus, we all have an obligation to call our representatives to ask for their support of this vital piece of legislation.

References: 1. Hill, J., Reilly, C. Can the United States Ensure Adequate Supply of Critical Medications? Food and Drug Policy Forum. 2011: 1(16). Available at: http://www.ashp.org/DocLibrary/Policy/DrugShortages/FDLIArticle-on-Drug-Shortages.aspx 2. The White House. We Can’t Wait: Obama Administration Takes Action to Reduce Prescription Drug Shortages, Fight Price Gouging. Office of the Press Secretary. 31 October 2011. Accessed: 21 December 2011. Available at: http://www.whitehouse.gov/the-press-office/2011/10/31/we-can-t-wait-obamaadministration-takes-action-reduce-prescription-drug.

3.

U.S. Food and Drug Administration. Frequently Asked Questions About Drug Shortages. 14 October 2011. Accessed: 21 December 2011. Available at: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ ucm050796.htm.

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

Please send them to jfink@uky.edu.

Do you have a story to tell?

Coming in future editions of The Kentucky Pharmacist My Story: A Profile of a KPhA Member The Kentucky Pharmacists Association is looking for members with a story to tell. Have a patient success story to share? Find a new way to provide a service to the community?

What makes you stand out in a crowd? Why did you become a pharmacist?

If you would like to be featured in The Kentucky Pharmacist, email Scott Sisco at ssisco@kphanet.org with a brief description of your story.

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KPhA Board of Directors

January 2012

KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES

Clay Rhodes, Louisville crhodes1@humana.com

Chairman 502.476.1796

Tyler Whisman, Florence tyler.whisman@gmail.com

Speaker of the House

Lewis Wilkerson, Frankfort rphs2@aol.com

President 502.695.6920

Matt Martin, Louisville matt67martin@gmail.com

Vice Speaker of the House

Frankie Hammons, Barbourville frankiehammons@gmail.com

Secretary 606.627.7575

KPERF ADVISORY COUNCIL

Duane Parsons, Richmond dandlparson@roadrunner.com

Treasurer 502.553.0312

Kimberly Croley, Corbin kscroley@yahoo.com

President-Elect 606.304.1029

Leon Claywell claywell24@gmail.com

Past President

Kelley Ratermann klrater200@uky.edu

Student Representative

Amanda Jett ajett1706@my.sullivan.edu

Student Representative

Amanda Burton, Lexington amandastarkburton@gmail.com Chris Clifton, Erlanger chrisclifton@hotmail.com Trish Freeman, Lexington trish.freeman@uky.edu Joey Mattingly, Prospect joeymattingly@gmail.com Matt Martin, Louisville matt67martin@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Glenn Stark, Frankfort glennwstark@aol.com Sam Willett, Mayfield duncancenter@bellsouth.net

Ann Amerson, Lexington amerson@insightbb.com Kim Croley, Corbin kscroley@yahoo.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 Robert McFalls Executive Director rmcfalls@kphanet.org Matt Worthy, PharmD Director of Professional & Clinical Services mworthy@kphanet.org Scott Sisco Director of Communications and Continuing Education ssisco@kphanet.org Kelli Sheets Office Manager ksheets@kphanet.org Christine Richardson Clinical Pharmacist crichardson@kphanet.org Darcie Nixon Administrative Coordinator & Billing Specialist dnixon@kphanet.org

Leah Tolliver, Lexington leahtolliver@tollivergroup.net Richard Sloan, Hindman richardksloan@msn.com

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Frequently Called and Contacted

January 2012

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 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org Kentucky Society of Health Systems Pharmacists 1501 Twilight Trail Frankfort, KY 40601 (502) 223-5322 www.kshp.org

Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

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January 2012

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

SAVE THE DATE June 13-16, 2012 134th KPhA Annual Meeting Griffin Gate Marriott Resort and Spa Lexington, KY Visit www.kphanet.org for updates.

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