the kentucky pharmacist vol. 7, #1

News & Information for Members

of the Kentucky Pharmacists Association

Vol. 7, No. 1

January 2012

TTHEHE KKENTUCKYENTUCKY

PPHARMACISTHARMACIST

KPhA Annual Meeting 2012

June 13-16

Marriott Griffin Gate, Lexington, KY

Registration form inside!

KPhA: Your link to Frankfort since 1879

January 2012

THE KENTUCKY PHARMACIST 2

Table of Contents

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

KPPAC Contribution Form 19 Pharmacy Quality Commitment 22 February CE-STOPP Using the Beers’ List and START Something New 25 February Pharmacist/Pharmacy Tech Quiz 30 KPhA Annual Meeting 2012 31 Advancing Pharmacy Practice In Kentucky 37 SCOP Drug Information Center 38 CPE Monitor 39 Pharmacy Policy Issues 40 KPhA Board of Directors 42 Frequently Called and Contacted/APSC 43

Oath of a Pharmacist

At this time, I vow to devote my professional life to the service of all humankind through the profession of

pharmacy.

I will consider the welfare of humanity and relief of human suffering my primary concerns.

I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy

outcomes for the patients I serve.

I will keep abreast of developments and maintain professional competency in my profession of pharmacy.

I will embrace and advocate change in the profession of pharmacy that improves patient care.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Kentucky Pharmacists Association

The mission of the Kentucky Pharmacists Associa-

tion is to promote the profession of pharmacy, en-

hance the practice standards of the profession, and

demonstrate the value of pharmacist services within the

health care system.

Editorial Office:

© Copyright 2012 to the Kentucky Pharmacists Asso-ciation. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of member-ship 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 [email protected]. Website http://www.kphanet.org.

The Kentucky Pharmacy Education and Research Foun-

dation (KPERF), established in 1980 as a non-profit sub-

sidiary corporation of the Kentucky Pharmacists Associa-

tion (KPhA), fosters educational activities and research

projects in the field of pharmacy including career coun-

seling, student assistance, post-graduate education, con-

tinuing and professional development and public health

education and assistance.

It is the goal of KPERF to ensure that pharmacy in Ken-

tucky and throughout the nation may sustain the continu-

ing need for sufficient and adequately trained pharma-

cists. KPERF will provide a minimum of 15 continuing

pharmacy education hours. In addition, KPERF will pro-

vide at least three educational interventions through oth-

er mediums — such as webinars — to continuously im-

prove 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 im-

prove the overall programming designed by KPERF.

January 2012


President’s Perspective

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 previous year and a time of anticipation and resolution for the upcoming year. For me, personally and professionally, 2011 has brought about significant change. Some of these changes have been rewarding and others have caused considerable life hardships and adjustments. I look forward to bringing in 2012 with anticipation and am resolute that it is going to be a great year filled with significant opportunity.

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 pharma-cists in the state. Students exiting pharmacy school are for the first time in years finding it more difficult to find a posi-tion. Outside forces, including other professions, continue to influence the practice of pharmacy. Clinical challenges exist with increased medication shortages, continued de-velopment 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 tech-nology into our profession can present additional challeng-es. 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.

Earlier this week while driving down the interstate, I noticed a bumper sticker which read “America Bless God”. I’m cer-tainly 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

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 [email protected]. 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 en-gage 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 way to protect and, I believe, shape our profession for the future. Phone calls and emails are important, but beyond that we need to support them, meet with them, and devel-op a relationship so that when a healthcare issue comes before them, you are the first person they pick up the phone and call.

Another opportunity to be engaged will occur this April 13th

and 14th when KPhA helps sponsor Advancing Pharmacy

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, my-self 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.

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 ad-vancement.

Lewis Wilkerson,

PharmD, CGP

KPhA President

2011-2012

KPhA Social Media Links

www.facebook.com/KyPharmAssoc

www.twitter.com/KyPharmAssoc

President’s Perspective

mailto:[email protected]

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

SUCOP Pancakes with Santa

January 2012


Pharmacists Mutual Companies

January 2012


Headache is one of the most common complaints encoun-

tered 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 pro-

cess or underlying condition (secondary headache), such

as those caused by infection, cerebral hemorrhage, or a

brain mass lesion.2 A thorough evaluation of the head-

ache 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 mi-

graine, 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 pathophysio-

logic mechanisms of migraine has led to the development

of medications capable of providing rapid relief from at-

tacks and improved prophylaxis.

Pathophysiology of Migraine

Previous vascular and neural theories of migraine devel-

opment have merged into a combined theory of neurovas-

cular 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 circum-

stances as a result of genetic factors that manage the bal-

ance 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 excita-

bility through the release of serotonin and other neuro-

transmitters.4,5

Other factors that affect the migraine

threshold and initiate cortical spreading depression include

low levels of magnesium or dopamine, increased levels of

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 mi-

graine 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.

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 im-

plicated as a potential mediator of migraine headache.

Acute migraine treatments targeting serotonin, such as

ergot alkaloids and triptan derivatives, are agonists of vas-

cular 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 head-

ache are identified in the Table on page 9. The presenta-

tion of migraines can usually be divided into several phas-

es: premonitory, aura, headache, and resolution.8 Pre-

monitory 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 symp-

toms should be avoided because this previous terminology

was often used mistakenly to include aura.8 Premonitory

symptoms may differ greatly among patients but are gen-

erally consistent within an individual. Although neurologic

premonitory symptoms are the most common, psychologi-

cal, autonomic, and constitutional premonitory symptoms

also occur. Common neurologic symptoms include

phonophobia, photophobia, hyperosmia, and difficulty in

concentration. Psychological symptoms can include anxi-

ety, depression, euphoria, irritability, drowsiness, hyperac-

tivity, and restlessness. Autonomic symptoms may pre-

sent 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 at-

tack, 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 vis-

ual field and can include both positive (scintillations, pho-

topsia, 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-

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. Oth-

er symptoms are generally absent, but mild photophobia

and phonophobia may be present.8,9

Medication overuse can be associated with migraine ther-

apy and is one of the most common causes of chronic

daily headache.10

Frequent or excessive use of acute mi-

graine medications can cause a pattern of increasing

headache frequency. This process, known as medication-

overuse 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 of-

fending agent leads to a gradual decrease in headache

frequency and severity with a return of the original head-

ache 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 mi-

graine attacks is the identification and avoidance of con-

sistent 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 identifica-

tion of migraine triggers, patients may benefit from regular

sleep, exercise, healthy eating habits, smoking cessation,

and limited caffeine intake. For patients who prefer a non-

drug therapy, behavioral interventions, such as relaxation

therapy, biofeedback, and cognitive therapy, can be used

for preventive treatment.11,12


January 2012


Acute Management

Acute migraine therapies should provide consistent, rapid

relief, and enable the patient to resume normal activities at

home, school, or work. Abortive therapies can be mi-

graine-specific, such as ergot derivatives or triptans, or

non specific, such as analgesics, antiemetics, nonsteroidal

anti-inflammatory drugs (NSAIDs), and corticosteroids.

Abortive therapies are most effective at relieving pain and

associated symptoms when administered at the onset of

the migraine.7,12-14

Using a stratified care approach based

on individual symptom severity and headache-related dis-

ability, patients may be advised to use nonspecific agents

for mild to moderate headache without disability while re-

serving migraine-specific medications for more severe

attacks.13,15

If an attack is accompanied by severe nausea

and vomiting, the efficacy of oral drugs may be compro-

mised. In these situations, pretreatment with antiemetic

agents or the use of a non-oral treatment (i.e. supposito-

ries, nasal sprays, or injections) may be appropriate.7

Serotonin Receptor Agonists (Triptans)

Triptans are selective agonists of the 5-HT1B and 5-HT1D

receptors. Migraine relief results from vasoconstriction of

pain-producing intracranial blood vessels through stimula-

tion of vascular 5-HT1B receptors, inhibition of vasoactive

neuropeptide release from trigeminal perivascular nerves

through stimulation of presynaptic 5-HT1D receptors, and

interruption of pain-signal transmission within the brain-

stem trigeminal nuclei through stimulation of 5-HT1D recep-

tors.15-17

The triptans are appropriate as first-line therapy

for patients with moderate to severe migraine, or as res-

cue therapy when nonspecific medications are ineffective.7

Sumatriptan, the first triptan, is the most extensively stud-

ied antimigraine therapy and is available in the most dos-

age forms.17,18

Subcutaneous sumatriptan has the most

rapid onset (10 minutes) and is the most effective of the

triptans. Intranasal sumatriptan and zolmitriptan usually

provide a faster onset of effect (15 minutes) than the oral

formulations, and produce similar rates of response.7,17

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

Clinical response to triptans can vary considerably among

individual patients. If one triptan fails, a patient may be

successfully treated with another.7 Combination therapy

with another agent may improve response rates and di-

minish migraine recurrence. A combination of sumatriptan

85 mg plus naproxen 500 mg in a single tablet was proven

to be more effective than either agent alone.13,18

Triptan side effects, though common, are usually mild to

moderate and of short duration. Adverse effects include

paresthesias, fatigue, dizziness, flushing, warm sensa-

tions, and somnolence. Minor injection-site reactions are

reported with the subcutaneous route and taste perversion

and nasal discomfort with the intranasal route. “Chest

symptoms,” described as chest tightness, pressure, heavi-

ness, or pain in the chest, neck, or throat are relatively

common.14,16

Because triptans are partial 5-HT agonists

in coronary artery receptors, they have the potential to

produce modest coronary artery vasoconstriction. This

constriction poses minimal risk in appropriately selected

patients with healthy coronary arteries.14,16

Triptans are contraindicated in patients with a history of

ischemic heart disease, uncontrolled hypertension, cere-

brovascular disease, and hemiplegic or basilar migraine.

Patients at risk for unrecognized coronary artery disease

(i.e. postmenopausal women, men over 40 years of age,

and patients with multiple risk factors) should undergo a

cardiovascular assessment prior to triptan use and have

their initial dose of a triptan administered under medical

supervision.13,18

Triptans should not be given within 24

hours of the ergotamine derivatives. Also, administration

of sumatriptan, rizatriptan, and zolmitriptan is not recom-

mended within 2 weeks of therapy with monoamine oxi-

dase inhibitors. Eletriptan should not be administered with

cytochrome P-450 3A4 inhibitors, such as macrolide anti-

biotics, antifungals, and some antiviral therapies. Con-

comittant therapy with the selective serotonin reuptake

inhibitors should be monitored closely due to isolated re-

ports of serotonin syndrome in sumatriptan-treated pa-

tients.13,16,19

Ergot Alkaloids and Derivatives

Ergotamine tartrate and dihydroergotamine are useful and

may be considered for the treatment of moderate to se-

vere migraine attacks. These drugs are nonselective 5-

hydroxytryptamine-1 (5-HT1) receptor agonists that con-

strict intracranial blood vessels and inhibit the develop-

ment of neurogenic inflammation in the trigeminovascular

system.7 Central inhibition of the trigeminovascular path-

way as well as activity at adrenergic and dopaminergic


January 2012


receptors are also reported.14-16

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

Dihydroergotamine is available for intranasal and paren-

teral administration by intramuscular, subcutaneous, and

intravenous routes.7 Patients can be trained to self-

administer dihydroergotamine intramuscularly or subcuta-

neously. When compared with other migraine therapies,

dihydroergotamine appears to be relatively safe and effec-

tive.12

Nausea and vomiting, as a result of stimulation of chemo-

receptor trigger zone, are among the most common ad-

verse effects of the ergotamine derivatives. Vasocon-

striction also occurs with therapeutic doses. Ergotamine is

more likely to cause these effects than dihydroergotamine.

To combat the potential for these adverse effects, pre-

treatment with an antiemetic agent should be considered

with ergotamine and intravenous dihydroergotamine. Oth-

er common side effects include abdominal pain, weak-

ness, fatigue, paresthesias, muscle pain, diarrhea and

chest tightness. Occasionally, severe peripheral ischemia

(ergotism) may occur causing cold, numb, painful extremi-

ties; continuous paresthesias; diminished peripheral puls-

es 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; un-

controlled hypertension; sepsis and in women who are

pregnant or nursing.7,18

Dihydroergotamine does not ap-

pear to cause rebound headache, but dosage restrictions

for ergotamine tartrate should be strictly observed to pre-

vent this complication. 7

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, ibu-

profen, naproxen sodium, tolfenamic acid, and the combi-

nation of acetaminophen plus aspirin and caffeine have

demonstrated the most consistent efficacy.7,13

Acetamino-

phen alone is generally not recommended due to lack of

scientific support for any benefits.7,12

NSAIDs appear to prevent neurogenically mediated in-

flammation in the trigeminovascular system through inhibi-

tion of prostaglandin synthesis.15

Acute NSAID therapy is

associated with gastrointestinal (i.e. dyspepsia, nausea,

vomiting, and diarrhea) and CNS side effects (i.e. somno-

lence and dizziness). NSAIDs should be used with caution

in patients with previous ulcer disease, renal disease, or

hypersensitivity to aspirin.12,16

Aspirin and acetaminophen are available as a prescription

combination containing a short-acting barbiturate

(butalbital) or narcotic (codeine). These agents lack stud-

ies supporting their efficacy and should be used cautiously

due to potential for overuse, medication-overuse head-

ache, and withdrawal.7,15,16

Opiate Analgesics

Narcotic analgesic medications, including meperidine, bu-

torphanol, oxycodone, and hydromorphone, are effective

but should be reserved for patients with moderate to se-

vere infrequent headaches in whom standard therapies

are contraindicated or as “rescue medication” after pa-

tients 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-

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 un-

treated can last from 4 to 72 hours. Migraine headaches can be severe and associated with nausea, vomit-

ing, 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 exami-

nation, 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 re-

quired for diagnosis.


January 2012


gency department visits but use should be closely super-

vised because of the risk of overuse and dependence.13,14

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 prochlorpera-

zine, administered 15 to 30 minutes before ingestion of an

oral abortive migraine medication is often effective. If nau-

sea 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

Miscellaneous Nonspecific Medications

Corticosteroids can be used for rescue therapy for status

migrainous - a severe, continuous migraine that can last up

to 1 week.7,12

Short courses of oral or parenteral predni-

sone, dexamethasone, and hydrocortisone also may be

useful in the management of refractory headache that per-

sists for several days.12,18

Limited studies suggest a role for intranasal lidocaine for

the treatment of acute migraine headache. Although in-

tranasal lidocaine provides rapid pain relief within 15

minutes of administration, headache recurrence is com-

mon.12

Preventive Therapy

Preventive therapy is typically administered on a daily basis

to reduce migraine frequency, severity and duration of at-

tack, but can also be used preemptively or intermittently

when headaches recur in a predictable manner — for ex-

ample exercise-induced migraine or menstrual mi-

graines.7,20-22

Preventive migraine therapy should be con-

sidered in patients with recurring migraines that produce

significant disability despite acute therapy; frequent attacks

occurring more than twice per week with the risk of devel-

oping medication overuse headache; symptomatic thera-

pies 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

The only Food and Drug Administration (FDA) approved

drugs for the indication of migraine prophylaxis are pro-

pranolol, timolol, valproate and topiramate.11,22

Botox

(botulinum toxin A) has recently been approved for prophy-

laxis 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

β-Adrenergic Antagonists (β-Blockers)

Propranolol, nadolol, timolol, atenolol, and metoprolol have

been proven efficacious in reducing the frequency of mi-

graine attacks. Although the precise mechanism of β-

blockers is unknown, it is proposed that the migraine

threshold may be raised by modulation of adrenergic or

serotonergic neurotransmission in cortical or subcortical

pathways. β-Blockers are particularly useful in patients with

co-morbid anxiety, hypertension or angina. β-Blockers with

intrinsic sympathomimetic activity are ineffective for mi-

graine prophylaxis.20,24

Potential side effects of β-blockers include drowsiness, fa-

tigue, sleep disturbances, vivid dreams, memory disturb-

ance, depression, impotence, bradycardia and hypoten-

sion. They should be used with caution in patients with con-

gestive heart failure, peripheral vascular disease, atrioven-

tricular conduction disturbances, asthma, depression and

diabetes.7,20,24

Anticonvulsants

Anticonvulsant medications (valproate, divalproex, topir-

amate, and gabapentin) are increasingly recommended for

migraine prophylaxis. These agents appear to have multi-

ple mechanisms of action, including enhancement of gam-

ma aminobutyric acid mediated inhibition, modulation of the

excitatory neurotransmitter glutamate and inhibition of sodi-

um 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 extended-

release formulation of divalproex sodium (administered


January 2012


once daily) being better tolerated than the enteric-coated

formulation.21

The most common adverse effects associat-

ed 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 pa-

tients with a history of pancreatitis or chronic liver disease.7

Topiramate is widely used and has been recently approved

by the FDA for migraine prophylaxis. Weight loss associat-

ed with topiramate may offer a distinct benefit since weight

gain is a common reason for discontinuation of other mi-

graine prophylaxis medications. Other adverse effects with

topiramate are paresthesia, fatigue, anorexia, diarrhea,

weight loss, memory difficulty and nausea. Kidney stones,

acute myopia, acute angle-closure glaucoma and oligohi-

drosis have been infrequently reported with topiramate use.

To minimize adverse effects, topiramate should be started

at a much lower dose (i.e. 25 mg) than the targeted dose

(i.e. 100 mg daily). 20,21,26

Based on results of a recent trial, gabapentin may also be

effective for migraine prophylaxis.20

Dizziness and drowsi-

ness were the most common adverse effects of gabapentin

use. Preliminary studies suggest a possible role for other

anticonvulsants (tiagabine, levetiracetam, and zonisamide)

but further clinical studies are needed to validate their use-

fulness in migraine prophylaxis.20,22

Antidepressants

The beneficial effects of antidepressants in migraine may

be related to downregulation of central 5-HT2 and adrener-

gic 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 experi-

ence include doxepin, notriptyline, protriptyline and imipra-

mine. Anticholinergic side effects are common and often

limit the use of these agents in patients with benign prostat-

ic hyperplasia and glaucoma. Other potential side effects

include increased appetite and weight gain, orthostatic hy-

potension and cardiac toxicity. Nortriptyline and protripty-

line may be advantageous in patients who are particularly

intolerant of the anticholinergic and sedative effects of ami-

triptyline.20

The selective serotonin reuptake inhibitors (SSRIs) have

not been extensively studied for migraine prophylaxis and

are considered to be less effective than tricyclic antidepres-

sants.20,24

Fluoxetine is the most studied but definitive ben-

efit 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 co-

morbid depression or anxiety disorders.24

Recent studies

have shown possible benefit of a serotonin and norepi-

nephrine reuptake inhibitor (SNRI), venlafaxine, in mi-

graine prophylaxis.21

Monoamine oxidase inhibitors, such as phenelzine, have

been used for refractory headache, but their use is limited

due to their complex adverse effect profiles and the need

for strict adherence to a tyramine-free diet to avoid poten-

tially life-threatening hypertensive crisis.11,20

Calcium Channel Blockers

The use of calcium channel blockers for migraine prophy-

laxis should be reserved for situations where other medica-

tions with established clinical benefit are ineffective or con-

traindicated. Verapamil is the most commonly used calcium

channel blocker for migraine prevention. Evaluation of oth-

er calcium channel blockers (nifedipine, nimodipine, dilti-

azem and nicardipine) has provided unclear results for their

use in migraine prophylaxis. Patients with co-morbid hyper-

tension may benefit the most from the use of calcium chan-

nel blockers. The most common adverse effect of verapam-

il is constipation.7,14,20,21

NSAIDs

Even though NSAIDs can provide modest benefit in reduc-

ing the frequency, severity and duration of migraine at-

tacks, 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 mi-

graine. For prevention, NSAIDs should be initiated one to

two days prior to the expected onset of headache and con-

tinued during the period of vulnerability.24,26

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 stud-

ies, the angiotensin-converting enzyme inhibitor lisinopril

and the angiotensin II receptor blocker candesartan provid-

ed effective migraine prophylaxis.26

Herbal medications

such as feverfew (Tanacetum parthenium) have been eval-

uated but further research is needed to establish the safety

and efficacy for migraine prophylaxis. At least two studies

have concluded that petasites, an extract from the plant


January 2012


Petasites hybridus, may be effective for migraine prophy-

laxis. Coenzyme Q10 was effective for migraine prevention

and well tolerated in a small study.20,26

Various formulations of magnesium have been evaluated

for migraine prevention but have yielded mixed results.

CNS levels of magnesium are known to be significantly low

during migraine attacks. Magnesium supplementation may

be particularly effective for prevention of menstrual mi-

graine and in migraine patients with aura.20,26

Recently,

localized injections of botulinum toxin type A were ap-

proved by the FDA for prophylaxis of chronic migraines.23

Conclusion

Pharmacists are a valuable resource for patients with

headaches. Providing appropriate education regarding re-

quired behavioral changes and effective use of acute and

prophylactic pharmacotherapy can improve outcomes for

patient with migraine headaches. Ensuring effective mi-

graine treatment can reduce the functional disability and

productivity loss associated with a migraine attack.16,18

Based on the patient’s clinical presentation and medical

history, acute and preventive pharmacotherapy for mi-

graine should be stratified and individualized according to

the response, tolerability of available agents, and presence

of co-morbid conditions. Patients with stratified care target-

ed 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 mod-

erate migraine attacks. The triptans or dihydroergotamine

can be used if initial therapies prove ineffective or in pa-

tients with moderate to severe migraine headache. If a

patient has recurring migraines and meets other criteria,

preventive therapy should be considered. For patients us-

ing migraine prophylaxis therapy, a prolonged headache-

free 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, 2009:62-63.

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 prev-alence, disease burden, and the need for preventive therapy. Neurology 2007;68:343-349.

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

the triptan era: lessons from epidemiology, pathophysi-ology, and clinical science. Headache 2009;49:S21-33.

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

6. Ramadan NM. Targeting therapy for migraine. Neurolo-gy 2005;64(Suppl 2):S4–8.

7. Silberstein SD. Migraine. Lancet 2004;363:381–391.

8. Headache Classification Committee of the International Headache Society. The international classification of headache disorders, 2nd ed. Cephalalgia 2004;24(Suppl 1):1–151.

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

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

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

12. Matchar DB, Young WB, Rosenberg JA, et al. Evi-dence-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 strat-ified care. Am J Med 2005;118(Suppl 1):S18–27.

16. Martin VT, Goldstein JA. Evaluating the safety and tol-erability 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 Ser-otonin Syndrome. 2006, www.fda.gov/cder/drug/advisory.

20. Bigal ME, Lipton RB. The preventive treatment of mi-graine. 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.


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 Infor-mation. 2010 Oct. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5215lbl.pdf. Accessed on 2010 Nov 18.

24. Silberstein SD, Dodick D, Freitag F, et al. Pharmacologi-

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. www.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?

A. High levels of dopamine

B. Low levels of magnesium

C. Increased levels of excitatory amino acids

D. Altered levels of extracellular potassium

2. What percentage of patients have triggers of a migraine attack?

A. 25 percent

B. 50 percent

C. 75 percent

D. 100 percent

3. Patients may benefit from adherence to a wellness pro-gram that may include all of the following except:

A. Regular exercise

B. Increasing caffeine intake

C. Regular eating habits

D. Smoking cessation

4. Which one of the following drug or drug classes is not used in the acute treatment of migraine headaches?

A. Ergot Alkaloids

B. NSAIDs

C. Serotonin Agonists

D. Antidepressants

5. Which of the following is the most common adverse ef-fect of the ergotamine derivatives?

A. Painful extremities

B. Nausea and vomiting

C. Peripheral ischemia

D. Continuous paresthesias

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

A. Dopamine

B. Norepinephrine

C. 5-HT1B and 5-HT1D

D. Cholinergic

7. Which of the following antiemetics have an added bene-fit of improving gastrointestinal absorption during a severe attack?

A. Metoclopramide

B. Chlorpromazine

C. Promethazine

D. Prochlorperazine

8. Which of the following would not be appropriate for mi-graine prophylaxis?

A. Beta-Blockers

B. Beta-Blockers with intrinsic sympathomimetic activity

C. Anticonvulsants

D. Calcium channel blockers

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

A. Nausea

B. Fatigue

C. Memory difficulty

D. Weight loss

10. Which of the following vitamins has demonstrated effi-cacy in migraine prophylaxis?

A. Riboflavin

B. Ascorbic acid

C. Cyanocobalamin

D. Pyridoxine


January 2012




PHARMACISTS ANSWER SHEET

Name ________________________________________________ KY Lic. # __________________________________

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

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 _______________________________

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.

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

Pharmacy Education as a provider of continuing Pharmacy education.

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.


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


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 So-ciety 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, pre-scribes, 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 Facul-ties).

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. Mem-bership 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

Pharmacy Time Capsules

http://www.pbs.org/wgbh/aso/databank/entries/dh87pr.html

http://www.aihp.org

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 every-where, 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 danger-ous interaction with an existing medication, refusal would be appropriate, at least until the issue could be re-solved.

The issue of refusing to fill a prescription based on a moral or religious stance has not been directly ad-dressed 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 alprazo-lam 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 prescrip-tions are being refused. While I do not currently see these tactics as winners for the pain pill mills, pharma-cists should refer any attorney making such a contact to their own legal counsel, just to avoid any misstate-ment 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 then-PharmD Candidate Morgan Carnes at UK from Russell Springs, KY, collected a variety of useful responses:

1. The lack of a pharmacist-patient relationship. This pretty much speaks for itself, and is linked to [2];

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.;

3. 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;

Pharmacy Law Brief

January 2012


4. Not keeping the “usual suspects” of drugs in stock; 5. 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 pa-tient respond that he would get a motel room and stay in town until I got the medication in!

6. 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 question-able prescriptions. We need to be careful to establish a sound basis for those who question that deci-sion. 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: [email protected]

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

Pharmacy Law Brief

January 2012


Legislative Advocacy

Who Advocates Best for Pharmacists? By Robert McFalls, KPhA Executive Director

Throughout its existence, the Kentucky Pharmacists Asso-ciation has united pharmacists with a clear voice to ad-dress 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 dol-lars, think the job is finished and that everything will go ac-cording to plan. Advocacy requires an ongoing commit-ment 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 regis-tered and recognized by a govern-ment created oversight board, the Ken-tucky Board of Pharmacy.

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 profes-sional 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 is-sues of importance affecting pharmacists and the profes-sion. We are issuing a weekly Legislative Report to keep

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 admin-istration 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 insur-

ance 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 de-

pends 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 legisla-tors, 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 prac-tice 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.

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!

Who advocates

best?

That would be YOU!

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 candi-dates 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

KPPAC Contribution Form

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 [email protected]

January 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 presiden-tial 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).

What’s a PAC? A PAC is a political committee registered with the Fed-eral Election Commission (FEC) to raise and spend money to influence political elections.

“People have the perception that PACs are ‘dirty,’when in reality they’re a way to get citizens en-gaged,” said Abbie Laugtug, APhA Director of Government Affairs.

“Other than word of mouth, literally everything a candidate uses to get elected—from business cards to mailings to TV ads—costs money,” said Brian Gallagher, BSPharm, JD, APhA Senior Vice President of Government Affairs. “A candidate can have the best message in the world, but without the money to get that message out to the people, they have no chance to win. So giv-ing money to candidates who sup-port your issues is essential to get-ting them elected.”

Members pooling resources

Because PACs are so important to the political process, nearly every trade and professional association has one. APhA is no exception.

Since 1985, APhA has had a PAC. Its mission is to support candidates for federal office who have demon-strated support for pharmacy issues and recognize the value of pharma-cists in the health care system.

The APhA–PAC is a voluntary as-sociation of APhA members who share political objec-tives and pool their resources to increase the impact of their contributions to candidates who support the pro-fession so that they get and stay elected to Congress.

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 administra-tion’s attempt at health care reform,” John Pattison, BSPharm, CFT, Vice-Chair of the APhA–PAC Board of

Governors, and a Pharmacy Team Leader at a Giant Eagle Pharmacy in Heath, OH, told Pharmacy To-day. “Through financial support, site visits, and members hosting events to support pharmacy-friendly legisla-tors, the APhA–PAC helped to shape policy to advance the profes-sion of pharmacy.”

History, rules

Today, approximately 4,000 PACs are giving money in federal elec-tions, according to the website of the nonpartisan Center for Responsive Politics (www.opensecrets.org), which studies money in politics. The first PAC was founded in 1944 by the Congress of Industrial Organiza-tions to raise money to re-elect Pres-ident Franklin D. Roosevelt.

Many rules and regulations govern PACs; for example, APhA’s PAC can contribute up to $5,000 per elec-tion to political candidates seeking federal office. Primaries and general elections are counted separately, meaning that a candidate may re-ceive up to $10,000 in a typical elec-tion year. Generally, contributions need to be from personal funds and not from corporate accounts.

To qualify as as a PAC and be able to give funds to candidates, PACs must receive contributions from at least 51 individuals, be registered with FEC for at least 6 months, and

contribute to at least five federal candidates.

The newest type of PAC, independent expenditure–only committees with the popular nickname of “super PACs,” arose in the wake of two court cases in 2010.

hubonpolicyandadvocacy

Demystifying the APhA–PAC for 2012

Criteria used by the APhA–PAC

The APhA–PAC’s criteria to gauge a Member of Congress’s support for pharmacy include the following:

Position on key health care commit-

tees that deliberate on issues relevant to pharmacy (the Ways & Means and Energy & Commerce Committees in the U.S. House of Representatives and the Finance Committee and the Health, Education, Labor, & Pensions Committee in the U.S. Senate)

Authored legislation for pharmacists

and pharmacy

Made a difficult vote or voted to sup-

port pharmacy initiatives

Led a letter to an agency, leadership,

or committees

Attended or spoke at pharmacy

events

Made a statement on the record in

support of pharmacy

Offered an amendment in committee

in support of pharmacists

Offered an amendment on the floor in

support of pharmacists

Consistently cosponsored legislation

and cosigned letters of importance to pharmacists

Pledged support and demonstrated a

willingness to sponsor pharmacy initi-atives

Asked a question important to phar-

macy in committee


January 2012


An independent expenditure is money not spent in di-rect contributions to a political candidate.

In January 2010, the Supreme Court issued a contro-versial 5–4 ruling in the case of Citizens United v FEC. The decision allows unlimited independent expendi-tures by corporations. Then in March 2010, the DC Cir-cuit Court of Appeals ruled in the consolidated case of SpeechNow.org v FEC that individuals can give unlim-ited contributions to groups making independent ex-penditures only.

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 com-mittees from January 1 to June 30, 2011, according to a September 9 FEC news release. “These sums repre-sent … 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 elec-tion cycle,” the news release noted. During the same period, super PACs raised $26.6 million and spent $6.6 million.

According to the Center for Responsive Politics web-site, 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 Demo-crats and 44 percent going to Republicans, and 95 health professional PACs so far raised a combined to-tal of $6,751,729 during the 2012 election cycle, with about 41 percent going to Democrats and 59 percent going to Republicans.

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 leg-islators, 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 Pro-

gram, known as the “Winter Is Cold … But Advocacy Is Hot” challenge. In January and February, APhA Acad-emy of Student Pharmacists chapters raise funds for the APhA–PAC and get involved in advocacy. The funds raised by the students will be matched by APhA members who are faculty and alumni of participating schools. Results will be announced at the 2012 APhA Annual Meeting & Exposition.

To learn about the APhA–PAC during APhA2012, stop by the Gov-ernment Affairs booth.

For more information about the APhA–PAC, visit pharmacist.com or contact Abbie Laugtug at [email protected].

—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 shap-ing the outcomes of this law, access the Government Af-fairs 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:

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:

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 regu-

lations 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 No-vember 14–20.

HHS: The final rule to implement the medical loss ratio pro-

visions 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 pharma-cist.com, Federal Register notices, and other useful web-sites can be accessed in the online version of the Hub, lo-cated at www.pharmacytoday.org.


http://www.pharmacytoday.org

http://www.pharmacist.com

January 2012


Pharmacy Quality Commitment: Putting Continuous

Quality Improvement into Action

By: Tara M. Modisett, Executive Director for the

Alliance for Patient Medication Safety

Implementing a sound quality assurance (QA) pro-gram takes time, but if you do it right, it may be the most valuable investment that you make all year.

The primary reason to maintain a QA program is to provide the safest, highest level of quality care possi-ble to your patients. It is also a sound business deci-sion to strive to reduce the pharmacy’s exposure to potential errors by implementing processes to moni-tor, analyze discovered weaknesses, and develop a plan for improvement. A solid QA program often re-sults in improvement in operations and eventually in a reduction in “redo” prescriptions. This ultimately translates into more free time for you to utilize else-where. Finally, if the pharmacy fills Medicare pre-scriptions it needs an operational Quality Assurance (QA) or Continuous Quality Improvement (CQI) pro-gram in order to meet third party contract require-ments.

What should you do if you are looking to implement or enhance a QA/CQI program in your pharmacy? First of all, you should make sure that you are partici-pating in a program that provides protection for the safety of quality and error data, also referred to as patient safety work product (PSWP). It is very im-portant to familiarize yourself with state reporting re-quirements and protections. Certain states require QA/CQI programs to be implemented and others provide protection for patient safety data and its sub-sequent review. However, there are states that re-main silent on this respective issue. The best way to ensure protection of the data is to arrange to report to a Patient Safety Organization (PSO). A PSO is a public and private entity, recognized by the Depart-ment of Health and Human Services, that is estab-lished to collect and analyze quality-related events (QRE). These QREs can include incidents that reach the patient whether they caused harm or not, near misses, and unsafe conditions reported by healthcare providers and healthcare entities. A

PSWP that is report-ed to an approved PSO is protected from discovery at both the state and federal level. A PSO is essential in improv-ing and moving pa-tient-centered, phar-maceutical care for-ward in the context of our changing healthcare system; pharmacists report data to a PSO, evaluate it and implement plans for improvement in their pharmacy. It offers definite safety and legal protections afforded by legislation. In addition, PSOs provide valuable feedback and re-sources to its reporters. For more information on PSOs, visit http://www.pso.ahrq.gov/.

For a QA/CQI program to thrive, owners and man-agement must make a conscious commitment to quality and embrace the change that is necessary to move beyond the traditional “name and blame” mind-set of medication errors. A positive culture change must come from the leadership. The staff must un-derstand that the pharmacy needs to work together in a non-punitive environment that rewards proactive cooperation in order to reduce the chance of a medi-cation error reaching the patient. The appointed QA supervisor should encourage participation from the staff and ensure training on maintaining confidentiali-ty of patient safety data within the pharmacy’s patient safety evaluation system. The program should be easy to use as collection and ongoing monitoring de-mands that the recording of data be a simple and quick task that requires minimal disruption and easy incorporation into the daily workflow. Incidents that reach the patient should be collected, but certainly do not overlook the value of recording the “near misses” that might have caused harm had they not been caught. The collection and analysis of all quali-ty-related event (QRE) data holds invaluable lessons to be learned for each pharmacy and can greatly contribute to reduction of error rates in pharmacy

Pharmacy Quality Commitment

http://www.pso.ahrq.gov/

January 2012


practice.

The Alliance for Patient Medication Safety™ (APMS™), a federally listed PSO, offers a continu-ous quality improvement and reporting program spe-cifically designed for pharmacies. Pharmacy Quality Commitment™ (PQC) provides the education and the process for pharmacies to securely report, study and protect patient safety data (Figure 1). The manu-al details suggested workflow guidelines for the “stations” in the prescription process and offers 20 “pharmacy best practices” to consider in order to re-duce the chance of a medication error. Pharmacies record any errors or near-miss QREs through a sim-ple, secure, web-based portal. Once a pharmacy starts reporting QREs, it will have instant access to charts and graphs of its data, which can provide ex-tremely valuable insight into various trends. The QA supervisor can use this data to improve the dispens-ing process and decrease the likelihood of costly er-rors. Reviewing this data progressively over time en-ables the pharmacy to determine where potential weaknesses might be and how the processes in the pharmacy’s workflow can be improved. The pharmacy can implement and experiment with new processes to lower the incidence of the type of QRE targeted. Over time, data are accumulated and can be analyzed to determine if there was an improvement. Through cycles of data-driven im-provement, the pharmacy can continue to revise the workflow. This will allow maintaining and adhering to safety standards at an excellent level with relative ease.

A pharmacy gets a two-fold benefit from reporting to APMS as their reported PSWP data is aggregated with thousands of reported patient safety data from other pharmacies across the country. The APMS cur-rently receives over 10,000 QRE reports each month, analyzes the aggregate, de-identified infor-mation and reports the national trends back to partic-ipating pharmacies. Pharmacies reporting through PQC™ receive recommendations on best practices and workflow processes to help reduce medication errors, improve medication use and enhance patient safety and health outcomes.

Access to the APMS resource and online reporting site is easy. The PQC™ participant is assigned a unique, encrypted password and username that al-lows entry. Once logged in, the pharmacy is directed to a robust Resource Area that includes recent news-letters with guidance and recommendations, aggre-gate trending information, and other patient safety tips. Also posted is a PQC™ Quality Assurance Poli-cy and Procedure template, a patient safety evalua-tion system for the pharmacy, reporting forms and tools, and ongoing resources for the Quality Supervi-sor. This includes instructions on how to set up a Peer Review process and how to maintain active re-porting status for the pharmacy.

Managed care organizations, regulatory bodies or other entities may have reason to want to know if a pharmacy is actively participating in a Continuous Quality Improvement program. APMS has developed criteria for determining if a pharmacy is considered “Continuous Quality Improvement – Verified” (CQI Verified) with the PQC program. Once training is

completed and data is being reported on a consistent basis, the pharmacy is able to print out a “CQI-Verified” certificate.

Implementation of the pro-gram is simple and straight-forward, but like any effec-tive management process will require some time, effort and a commitment to im-provement to be truly effec-tive. The experts on staff at APMS have helped thou-sands of pharmacists suc-

cessfully incorporate PQC™ into their workflow and are eager to help. Several PowerPoint training mod-ules are available that range from “Getting PQC Started” to “Compliance Training”. The pharmacy also has the option to set up as many free individual one-on-one online training sessions as needed. They provide a toll-free line (866) 365-7472 and online ac-cess at [email protected].

In summary, the PQC™ program provides three things no other continuous quality improvement pro-gram offers:

Access to forms, manuals, and ongoing training assistance (toll free number and online sup-port) that makes sure PQC™ becomes a meaningful and ongoing program for improve-


Figure 1


January 2012


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

A secure, password-protected Patient Safety Or-ganization (PSO) web portal for each phar-macy to enter patient safety data; to protect it from discovery so none of the patient safety data can be used against the pharmacy in a legal proceeding.

A quick and easy way to print proof-of-use of a continuous quality improvement program.

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 renew-al is $200. APMS™ is dedicated to encouraging vol-untary reports of patient safety work product and to performing analysis of aggregate information to im-prove quality of care provided by the pharmacy workforce. In support of these goals, APMS™ pro-vides funding to state pharmacy associations to pro-mote PQC™ and to provide QA/CQI education to 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 be-fore it reaches the pa-tient, 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 auto-matic 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 for-mulate questions and fa-cilitate effective discus-sions 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 quali-ty 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 pharma-cy concentrate on the computer entry process and incorporate at least one “best practice” that could ei-ther stop a QRE from occurring or would catch it be-

fore it reached the patient. This pharmacy could con-sider 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 be-fore. In this case, use “Take 5” in the new prescription filling process, which usually immediately follows computer entry and label generation. The person fill-ing 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 estimat-ed 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.


http://www.pqc.net/

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.


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.

Dangers of Medication Use in the Elderly

In advanced age, the body goes through many physi-ological changes that hinder medication elimination and metabolism. The two major sites for drug metab-olism are the liver and kidneys. In the elderly, both hepatic and renal functions are reduced, resulting in decreased drug elimination. Generally phase one of metabolism is affected, which involves much of drug metabolism — including the infamous Cytochrome P450 enzymes. This leads to changes in the way most drugs are metabolized. Additionally, many drugs are eliminated from the body via the kidneys, and decreased renal function causes prolonged elimi-nation of drugs and drug metabolites. Both of these scenarios may lead to potential drug toxicity.

Besides alterations in hepatic and renal function, the elderly may also face reduced body stature and al-tered fat distribution. Such changes lead to variation of drug distribution, as well as a decrease in overall health due to organ aging. Another barrier that arises with age is forgetfulness, which leads to noncompli-ance with medication therapy. When it comes to ad-verse drug events (ADE) in the elderly, all of these factors play a contributory role.

In 2008, an estimated 1.1 million emergency depart-ment (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 in-volved were drugs that act on the central nervous

system—pain relievers, anxiolytics, and hypnotics, in particular. Of these older adults who visited the ED for adverse drug reactions, nearly one third were ad-mitted to the hospital.1

The elderly are one of the most overly prescribed populations. With an increase in healthcare costs and a need for multiple providers, many seniors fall into the trap of polypharmacy and, as such, suffer from a pill burden leading to noncompliance. Another issue that they face is the pharmacy cascade. The “prescribing cascade” begins when an adverse drug reaction is misinterpreted as a new medical condition (See Figure 1.) An additional medication is then pre-scribed to treat the new issue. This increases the pa-tient’s risk of developing additional adverse effects related to the newly added agent.2 For example: A patient is prescribed a chronic NSAIDs, such as ibu-profen, and then develops secondary hypertension. The patient may then be placed on an antihyperten-sive to correct the blood pressure. Polypharmacy and the “prescribing cascade” lead to more drug interac-tions, adverse drug events, noncompliance, and in-creased healthcare costs to the patient.2

What the Beers List Meant

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 de-signed 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-

February 2012 CE Beers’ List

January 2012


duction, the Beers’ list has grown to include potentially inappropriate medications that all geriatric patients should avoid, regardless of their level of care or resi-dence. 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 in-patient setting. Creating the IPET set the stage for the next decade of geriatric care, but a more comprehen-sive list, including all patient care settings, could ser-vice 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 dis-ease 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 appropri-ateness.6 As therapeutic guidelines develop and change, screening tools for determining the appropri-ateness of therapy must develop as well.

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 18-person panel consisted of nine physicians in geriatric medicine, three clinical pharmacologists, two senior academic primary care physicians, one geriatric psy-chiatrist, 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 Pre-scriptions) and START (Screening Tool to Alert doc-tors to Right Treatment) criteria (See Figure 3). Their goals were to improve medication appropriateness, prevent ADEs, and reduce costs.

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 af-fect elderly patients at risk of falls;

4. Give special attention to opiate use in older peo-ple;

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 ex-perts in prescribing for older people.7

Applying the STOPP/START Criteria to Clinical

Pharmacy Practice

Applying the STOPP/START criteria to clinical phar-macy 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 regular-ly in order to be useful in clinical medication reviews, incorporated into clinical software, and be utilized as an educational tool for pharmacists and prescribers.


Figure 12

January 2012


Figure 2: Drugs and Classes Potentially Inappropriate for Use in the Elderly3

Amiodarone Estrogens Nifedipine, short-acting

Amitriptyline Ethacrynic acid Nitrofuranto-in

Amphetamines (excluding methylphenidate HCL and an-orexics)

Ferrous sulfate >325 mg/day

NSAIDs, long-term use of full-dose, longer half-life, non-COX-selective types (naproxen, oxaprozin, and piroxi-cam)

Barbiturates Fluoxetine

Benzodiazepines, long-acting (chlordiazepoxide, diaze-pam, flurazepam, oxazepam, temazepam)

Gastrointestinal anti-spasmodics (belladonna alka-loids, clidiniumchlor-diazepoxide, dicy-clomine, hyoscya-mine, pro-pantheline—all)

Chlorpheniramine Guanadrel Oxybutynin, short-acting

Chlorpropamide Guanethidine Pentazocine

Cimetidine Hydroxyzine Perphena-zine-amitriptyline

Clonidine Indomethacin Prometha-zine

Clorazepate Isoxsuprine Propoxy-phene

Cyproheptadine Ketorolac Reserpine

Desiccated thyroid Meperidine

Digoxin >0.125 mg/day Meprobamate

Diphenhydramine Mesoridazine Stimulant laxatives, long-term use except with opiate analgesics (bisacodyl, cascara sa-grada, and Neoloid)

Dipyridamole, short acting Methyldopa and me-thyldopa/hydrochlorothiazide

Disopyramine Methyltestosterone Thioridazine

Doxazosin Mineral Oil Ticlopidine

Doxepin Muscle relaxants (carisoprodol, chlor-zoxazone, cycloben-zaprine, dantrolene, methocarbamol, or-phenadrine—all

Trimetho-benzamide

Ergot mesyloids Tripelenna-mine

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].


http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?pt=2&dd=210209

January 2012


Conclusion

The risk of ADEs in the elderly is especially high because of in-creased prescription use and age-related metabolism and excretion changes. Unlike the Beers’ list, the STOPP/START criteria tend to fo-cus more on the common avoidable instances of inappropriate prescrib-ing, 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 Department Visits Involving Adverse Reactions to Medications among Older Adults. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quali-ty. Available at: http://www.oas.samhsa.gov/2k11/DAWN013/AdverseReactionsOlderAdults_HTML.pdf. Ac-cessed January 09, 2012.

2. Rochon PA, Gurwitz JH. Optimising drug treat-ment for elderly people: the prescribing cascade. BMJ 1997;315:1096–9.

3. Wick, JY. The Beers Criteria: Red Flags for Elders (06/01/2006). Pharmacy Times Web site. Availa-ble at: http://www.pharmacytimes.com/publications/issue/2006/2006-06/2006-06-5624. Accessed January 09, 2012.

4. Nauglet CT, Brymer C, Stolee P, et al. Develop-ment and validation of an improving prescribing in the elderly tool. Can J Clin Pharmacol 2000;7:103-7.

5. Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716-24.

6. FDA: 35 innovative new drugs approved in fiscal year 2011(11/03/2011). US Food and Drug Ad-ministration Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/

PressAnnouncements/ucm278383.htm. Accessed January 8, 2012.

7. O’Mahony D., Gallagher P., Ryan C., Byrne S., Hamilton H., Barry P., O’Connor M., Kennedy J. STOPP & START criteria: A new approach to de-tecting potentially inappropriate prescribing in old age. http://www.em-consulte.com/article/245669

8. Gallagher P, O'Mahony D. STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions): application to acutely ill elderly pa-tients and comparison with Beers' criteria. Age and Ageing 2008;37:673-9.

9. Barry PJ, Gallagher P, Ryan C, O'Mahony D. START (screening tool to alert doctors to the right treatment)—an evidence-based screening tool to detect prescribing omissions in elderly patients. Age and Ageing 2007;36:632-8.

10. Cristin R, O'Mahony D, Byrne S. Application of STOPP and START Criteria: Interrater Reliability Among Pharmacists. Ann Pharmacother 2009;43(7):1239-44.

11. Gallagher P, Baeyens JP, Topinkova E, et al. Inter-rater reliability of STOPP (Screening Tool of Old-er Persons' Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) criteria amongst physicians in six European countries. Age Ageing. 2009 Sep;38(5):603-6.


http://www.theannals.com/search?author1=Cristin+Ryan&sortspec=date&submit=Submit

http://www.theannals.com/search?author1=Denis+O'Mahony&sortspec=date&submit=Submit

http://www.theannals.com/search?author1=Stephen+Byrne&sortspec=date&submit=Submit

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gallagher%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Baeyens%20JP%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Topinkova%20E%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed/19435757?dopt=Abstract

January 2012


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

1. Elderly patients are at a higher risk of experiencing

adverse effects with prescription medications because:

A. Impaired cognitive function

B. Physiological changes

C. Polypharmacy

D. All of the above

2. Which of the following is a correct example of a pre-

scription cascade?

A. A patient takes naproxen, develops hypertension,

and is placed on HCTZ to control their hypertension.

B. A patient experiences altered mental status while

taking Chantix for smoking cessation.

C. A patient is switched to a combination medication to

for cost savings purposes.

D. A patient develops angioedema while taking Lis-

inopril to control her hypertension.

3. The Beers’ list was originally developed for elderly

patients in which healthcare setting?

A. Hospital

B. Nursing home

C. Hospice

D. All healthcare settings

4. Which of the following medications should be avoid-

ed in elderly patients based on the Beers’ criteria?

A. Fluoxetine

B. Diphenhydramine

C. Promethazine

D. All of the above

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

are divided based on:

A. Age

B. Anatomical systems

C. Ethnicity

D. Disease states

6. The primary goal(s) of the STOPP/START criteria

are:

A. Improve medication appropriateness regardless of

practice site

B. Prevent adverse drug events

C. Reduce patient healthcare cost

D. All of the above

7. True or False: The STOPP/START criteria should

be used as a substitute for therapeutic guidelines.

A. True

B. False

8. The emphasis of the STOPP/START criteria is

placed on:

A. Drug-drug interactions

B. Use of novel drugs

C. Duplicate drug class prescribing

D. A and C

E. All of the above


January 2012


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 3. A B C D 5. A B C D 7. A B 2. A B C D 4. A B C D 6. A B C D 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 _______________________________

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.

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

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 3. A B C D 5. A B C D 7. A B 2. A B C D 4. A B C D 6. A B C D 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 _______________________________


January 2012


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 Email Address

Registration Fees: Please circle applicable Fee

Student- Free Member Non-Member Technician/Resident

Full Registration:

By June 1 $200 $375 $85 $25

After June 1 $250 $425 $110 $35

Single Day Registration:

By June 1 $105 $195 $55 $20

After June 1 $130 $220 $80 $30

Circle Day: Thursday Friday 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 $ _______ Total Enclosed $_________

Credit Card Information: AMEX Discover MasterCard 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 Association 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 [email protected].

134th KPhA Annual Meeting

https://resweb.passkey.com/go/KYPharmacistAssoc

https://resweb.passkey.com/go/KYPharmacistAssoc


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 Ken-tucky 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 [email protected] 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 [email protected] or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South,

Frankfort, KY 40601 no later than March 31, 2012.


January 2012


KPhA 2012 Professional Award Criteria

and Past Recipients

Bowl of Hygeia Award

Criteria – To recognize an individual who has demon-strated outstanding community service in pharmacy.

Eligibility – The recipient must be an Active or Honor-ary Life member of the Association. The recipient must be a pharmacist with a current valid license to practice in Kentucky. The recipient must be living; awards are not presented posthumously. The recipi-ent has not previously received the award and is not currently serving nor has he/she served within the past two years on the selection committee or as an officer of the Association in other than ex-officio ca-pacity. The recipient has compiled an outstanding record of community service that apart from his/her specific identifications as a pharmacist reflects well on the profession.

Bowl of Hygeia Recipients

William I. McMakin, III 2011 Kim Croley 2010 Patricia Thornbury 2009 Dave Peterson 2008 Charles Fletcher 2007 Gloria Doughty 2006 Larry Hadley 2005 Harold Cooley 2004 Brian Fingerson 2003 Simon Wolf 2002 Richard Ross 2001 Tom Houchens 2000 Phil Losch 1999 Lucy Easley 1998 Nick Schwartz 1997 Michael Cayce 1996 Bill Borders 1995 Gerald Deom 1994 Kenneth Calvert 1993 Joseph G. Bessler 1992 Michel A. Burleson 1991 Lynn Harrelson 1990 William A. Conyers, Jr. 1989 Daniel R. Kovar, Jr. 1988 Martin W. Nie 1987 Ralph Schwartz 1986 Dwaine K. Green 1985 W. Vance Smith 1984

Richard L. Roeding 1983 William J. Farrell, Sr. 1982 Joseph L. Scanlon 1981 Joseph T. Elmes, Jr. 1980 H. Joe Russell 1979 Alvin R. Bertram 1978 Norman C. Horn 1977 H. Joseph Schutte 1976 D.H. "Sonny" Ralston 1975 Arthur G. Jacob 1974 James M. Brockman 1973 Richard E. Murray 1972 Randolph N. Smith 1971 Oliver E. Mayer 1970 Donald C. Morwessel 1969 James Phillip Arnold 1968 William D. Morgan 1967 Ernest M. Davis 1966 W.F. Bettinger 1965 Arvid E. Tucker 1964 Vernon B. Hager 1963 Sidney Passamaneck 1962 John H. Voige 1961 E. Crawford Meyer 1960 James J. Hamilton 1959

Distinguished Service Award

Criteria- To recognize individual members who have made significant contributions to the Association or the profession at large over an extended period of time.

Eligibility – Only Active or Honorary Life members of the Association shall be eligible for the award. No individual shall be a recipient of the award more than once.

Distinguished Service Award Recipients

Kenneth Roberts 2011 Ann Amerson & Lynn Harrelson 2010 Larry Hadley 2009 Dwaine Green 2008 John Brislin 2007 Donnie Riley 2005 Gloria Doughty 2004 Coleman Friedman 2003


January 2012


Joe Fink III 2002 Melinda Joyce 2002 David Jaquith 1999 R. Paul Easley & Jeff Osman 1998 Ralph Bouvette 1997 Pat Chadwell 1996 Jordan Cohen and Marty Nie 1995 Mike Montgomery 1994 Richard Ross 1993 Thomas Weisert 1991 R. David Cobb 1990 Joseph G. Bessler & Arthur G. Jacob 1989 Paul E. Davis 1988 Norman Horn & Robert E. Lee Sandlin 1987 Joseph V. Swintosky 1986 J.H. (Jack) Voige 1985 Charles T. Lesshafft, Jr. 1984 Jerry Budde 1983 William H. Nie 1982 R.N. (Randy) Smith 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 demon-strable 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 2011 Holly Byrnes 2010 Dave Sallengs 2009 Kelly Smith 2008 Joseph Bickett 2007 Paul Easley 2006 John Anneken 2005 Kim Croley 2004 Ralph Bouvette 2003 David Jaquith 2001 Melinda Joyce 1999 Michael Wyant 1998 Phil Losch 1997 Tom Houchens & Bob Kuhn 1996 Don Ruwe 1995 Mark Edwards 1994 C. Dave Peterson 1993 Brian Fingerson 1992 Martin W. Nie 1991 Judy Minogue 1990 Paul Ruwe 1989

Joseph L. Fink III 1988 Steven R. Adams 1987 William J. Farrell 1986 Harold G. Becker 1985 Dwaine K. Green 1984 R. David Cobb 1983 Richard E. Murray 1982 Richard Rolfsen 1981 Gloria H. Doughty 1980 Joseph G. Bessler 1979 Emil Baker 1978 Robert L. Barnett 1977 Joseph L. Scanlon 1976 John B. Anneken 1975 Alvin R. Bertram 1974 Patricia A. Donahue 1973 H. Joseph Schutte 1972 Willard Alls 1971 Joe D. Taylor 1970 Richard L. Ross 1969 Ralph J. Schwartz 1968 George W. Grider 1967 Robert J. Lichtefeld 1966 E.M. Josey 1965 Julius T. Toll 1964 Charles E. Otto 1963 Charles F. Rosenberg 1962 R.N. Smith 1961 E. Crawford Meyer 1960 Charles A. Walton 1959 Ernest C. Williams 1958 George W. Grider 1957 Ray Wirth 1956 Nathan Kaplin 1955 Marion Hardesty 1954

Professional Promotion Award Criteria – To recognize individuals or organizations who have exhibited outstanding efforts to demon-strate 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


January 2012


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

Young Pharmacists of the Year Award sponsored

by Pharmacists Mutual Insurance Company

Criteria – To recognize a young pharmacist’s out-standing contribution to the profession and/or com-munity.

Eligibility – The recipient must be an Active member of the Association. The recipient must be licensed to practice for nine years or less. The recipient must have a valid, active license to practice in Kentucky. The recipient must have demonstrated participation in a national pharmacy association, professional pro-gram(s) and/or community service.

Distinguished Young Pharmacist Award Recipients Aimee Ruder 2011 Karen Hubbs 2010 Matt Martin 2009 Tiffany Self 2008 Angela Parrett 2007 Janet Mills 2006 Alyson Schwartz 2005 Nancy Horn 2004 Jennifer O’Hearn 2003 Karen Altsman 2001 Kim Wilson 1999 Kim Harned 1998 Michael Box 1997 Dan Yeager 1996 Dan Minogue 1995 Pan Haeberlin 1994 Kim Croley 1993 Phillip Sandlin 1992

Jeffrey W. Danhauer 1991 Mark S. Edwards 1990 Susan Murray Kathman 1989 Melinda Cummins Joyce 1987

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 Associa-tion. A recipient may receive the award more than once.

Innovative Pharmacy Practice Award Recipients

James Nash & BC Childress 2011 Lynne Eckmann & Cathy Hanna 2010 Ann Albrecht 2008 Lisa Short 2005 Holly Divine, Amy Nicholas 2004 Judy Minogue 2003 Trish Freeman 2002 Mary Ann Wyant 2001 Joyce Korfhage Rhea 2000 Cathy Edwards 1999 Celeste Flick 1998 Jeanne Zeis 1997 Dave Wren 1996 Preston Art 1995 W. Michael Leake 1994

New Award for 2012:

Cardinal Health Generation Rx Champions Award

Criteria – This award program recognizes excellence in community-based prescription drug abuse preven-tion at state pharmacy associations. This award hon-ors 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.


January 2012



January 2012


Advancing Pharmacy Practice in Kentucky

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 conjunc-tion 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 estab-lished, 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 Common-wealth 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: [email protected] 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.

Sullivan College of Pharmacy DIC

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

Please keep KPhA informed by sending this information to [email protected].

Deceased members for each year will be honored permanently

at the KPhA office with a White Coat.


http://www.sullivan.edu/pharmacy/drug_information.asp

January 2012


CPE Monitor:

Information for Pharmacists and Pharmacy Technicians

What is CPE Monitor?

CPE MonitorTM is a national, collaborative effort by the Ac-creditation 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 phar-macist 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 com-pleted 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 e-Profile ID and DOB in MMDD format will be required by those providers to receive credit for any ACPE-accredited 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 [email protected] Tel: 847-391-4406 Fax: 847-391-4502

Hours: Monday - Friday, 9 AM to 5 PM central time

CPE Monitor

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!

http://www.MyCPEmonitor.net


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 Octo-

ber, 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 report-

ed 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 electro-

lyte and nutrition drugs. These drugs are particularly at risk for supply shocks and shortages due to their com-

plex 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 manu-

facturers to report production interruptions to the FDA. However, under current law, even if the FDA is not no-

tified 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 oth-

er 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

Pharmacy Policy Issues

January 2012


even if the notification is not required by law. Along with the increased notifications, the President also ex-

panded 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; there-

fore, 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/FDLI-

Article-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 Decem-

ber 2011. Available at: http://www.whitehouse.gov/the-press-office/2011/10/31/we-can-t-wait-obama-

administration-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 pharma-

cists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflec-

tion and exchange among practitioners. Suggestions regarding topics for consideration are welcome.

Please send them to [email protected].

Pharmacy Policy Issues

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

[email protected] with a brief description of your story.

January 2012


KPhA BOARD OF DIRECTORS

Clay Rhodes, Louisville Chairman

[email protected] 502.476.1796

Lewis Wilkerson, Frankfort President


Frankie Hammons, Barbourville Secretary


Duane Parsons, Richmond Treasurer


Kimberly Croley, Corbin President-Elect


Leon Claywell Past President

[email protected]

Kelley Ratermann Student Representative

[email protected]

Amanda Jett Student Representative

[email protected]

Amanda Burton, Lexington

[email protected]

Chris Clifton, Erlanger

[email protected]

Trish Freeman, Lexington

[email protected]

Joey Mattingly, Prospect

[email protected]

Matt Martin, Louisville

[email protected]

Jeff Mills, Louisville

[email protected]

Glenn Stark, Frankfort

[email protected]

Sam Willett, Mayfield

[email protected]

Leah Tolliver, Lexington

[email protected]

Richard Sloan, Hindman

[email protected]

HOUSE OF DELEGATES

Tyler Whisman, Florence Speaker of the House

[email protected]

Matt Martin, Louisville Vice Speaker of the House

[email protected]

KPERF ADVISORY COUNCIL

Ann Amerson, Lexington

[email protected]

Kim Croley, Corbin

[email protected]

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

[email protected]

Matt Worthy, PharmD

Director of Professional & Clinical Services

[email protected]

Scott Sisco

Director of Communications and Continuing Education

[email protected]

Kelli Sheets

Office Manager

[email protected]

Christine Richardson

Clinical Pharmacist

[email protected]

Darcie Nixon

Administrative Coordinator & Billing Specialist

[email protected]

KPhA Board of Directors

January 2012


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 [email protected]

Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

Frequently Called and Contacted

Frequently Called and Contacted

January 2012


THE

Kentucky PHARMACIST

1228 US 127 South

Frankfort, KY 40601


Griffin Gate Marriott Resort and Spa

Lexington, KY

Visit www.kphanet.org for updates.

June 13-16, 2012

SAVE THE DATE

the kentucky pharmacist vol. 7, #1

Documents

kentucky pharmacy education

profession of pharmacy

field of pharmacy

advancing pharmacy practice

pharmacy time capsule

pharmacy law brief

pharmacy policy issues

pharmacy quality commitment