Inside Pharmacy February 2014

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february 2014 • Vol 2 • No 1

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Empowering Community Pharmacists as Health Consultants in a Value-Based Healthcare System

THE FIRST WORD Understand the Consumer and Grow Your Business............................................. 6

INSIDE CARDIOMETABOLIC: STROKE Identifying Patients at Risk for Stroke...... 8 Educating Patients on the Risk Factors and Symptoms of Stroke.......................... 10

INSIDE PHARMACY MANAGEMENT Medication Synchronization: Helping Pharmacy Transform to a Patient-Centered Care Model................. 12 Medication Therapy Management: Embracing Opportunity, Facing Challenges, and Preparing for a World of Change..................................... 16

INSIDE CARDIOMETABOLIC: DIABETES Exercising to Better Health..................... 20

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inside

Pharmacy

February 2014 • Vol 2 • No 1 TM

Empowering Community Pharmacists as Health Consultants in a Value-Based Healthcare System

Strategic Editor Robert E. Henry Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Melissa Lawlor The Lynx Group President/CEO Brian Tyburski

Table of Contents the first word

6 Understand the Consumer and Grow Your Business Donald J. Dietz, RPh, MS

Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Associate Director, Content Strategy & Development John Welz

Inside healthcare

7 Pharmacists Have “Come from Behind the Counter” and Stepped Up to the Plate Charles E. Collins, Jr, MS, MBA

Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs

INSIDE CARDIOMETABOLIC: STROKE

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Identifying Patients at Risk for Stroke Maria A. Osborne, PharmD, BCACP

10 Educating Patients on the Risk Factors and Symptoms of Stroke Kevin James, RPh, MBA

Creative & Design Assistant Lora LaRocca

Continued on page 4

Director, Digital Media Anthony Romano Meeting & Events Planner Linda Sangenito Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

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Mission Statement Inside Pharmacy educates community pharmacists on wellness-based health principles and advances, equipping them to attract, retain, and engage customers as long-term health coaches who complete the immediate process of care begun by the physician’s prescription, and by answering customer questions on health, wellness, value-based healthcare, evidence-based healthcare, and navigating the healthcare system. An informed pharmacist encouraging customers to make productive health decisions at all stages of their lives and take responsibility for their own health, achieving optimal health and value through the knowledge and application of traditional and nontraditional wellness-based health wisdom is the vision of Inside Pharmacy.

Contact Information: For subscription information and editorial queries, please contact: fevans@the-lynx-group.com; tel: 732-992-1895; fax: 732-992-1881.

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february 2014 • Vol 2 • No 1 TM

Empowering Community Pharmacists as Health Consultants in a Value-Based Healthcare System

Table of Contents

(Continued from page 3)

INSIDE PHARMACY MANAGEMENT

12 Medication Synchronization: Helping Pharmacy Transform to a Patient-Centered Care Model Debbie Sheppard 16 Medication Therapy Management: Embracing Opportunity, Facing Challenges, and Preparing for a World of Change Matt Manning, PharmD

INSIDE CARDIOMETABOLIC: DIABETES

20 Exercising to Better Health Kevin Barton, PharmD, RPh

Inside Pharmacy, ISSN (requested), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512.

Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Inside Pharmacy is a trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

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POSTMASTER: CORRESPONDENCE REGARDING SUBSCRIPTIONS OR CHANGE OF ADDRESS should be directed to CIRCULATION DIRECTOR, Inside Pharmacy, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. YEARLY SUBSCRIPTION RATES: One year: $99.00 USD; Two years: $149.00 USD; Three years: $199.00 USD.

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The ideas and opinions expressed in Inside Pharmacy do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher.

Publication of an advertisement or other product mention in Inside Pharmacy should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned.

Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

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Editorial Advisory Board

Editor-in-Chief Donald J. Dietz, RPh, MS Vice President Pharmacy Healthcare Solutions, Inc. Pittsburgh, PA

James S. Beaumariage, RPh Chief Operating Officer NuScript Rx Nashville, TN

John O. Beckner, RPh District Manager Giant Food Stores Richmond, VA

Mitch Betses, RPh Senior Vice President Retail Pharmacy Services CVS Caremark Corporation Woonsocket, RI

Ami Bhatt Senior Director Operations Health & Wellness Wal-Mart Bentonville, AR

Thomas R. Bizzaro, RPh Vice President, Health Policy and Industry Relations, First Databank Indianapolis, IN

Rebecca Wheeler Chater, RPh, MPH, FAPhA Executive Healthcare Strategist Ateb, Inc. Raleigh, NC

Scott R. Drab Professor, Department of Pharmacy & Therapeutics School of Pharmacy University of Pittsburgh Pittsburgh, PA

Albert Garcia Executive Vice President Navarro Discount Pharmacies Medley, FL

Mark J. Gregory, RPh Senior Vice President of Store Operations Kerr Drug, Inc. Raleigh, NC

Kevin James, RPh, MBA Vice President, Managed Markets Avella Specialty Pharmacy Phoenix, AZ

Scott L. Kemme Vice-President/General Manager, Chain Segment McKesson Pharmacy Systems & Automation Livonia, MI

Stephen C. Mullenix, RPh Senior Vice President Public Policy & Industry Relations, NCPDP Scottsdale, AZ

Richard J. Ptachcinski, PharmD, FCCP President American Pharmacotherapy Pittsburgh, PA

Ernie Richardsen, RPh, MBA Group Vice President Pharmaceutical Purchasing and Clinical Services Senior Vice President, Operations Rite Aid Corporation Camp Hill, PA

Debbie Sheppard Vice President Sales and Marketing Ateb, Inc. Raleigh, NC

Elliott M. Sogol, PhD, RPh, FAPhA Vice President Professional Relations Pharmacy Quality Solutions Springfield, VA

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The First Word

Understand the Consumer and Grow Your Business

By Donald J. Dietz, RPh, MS, Editor-in-Chief

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o obtain an external view of our profession, I usually find it valuable to review articles about pharmacy that come from outside healthcare. Consumer Reports surveyed 33,000 consumers about their pharmacy selection, and recently published 10 reasons people consider when switching pharmacies.1 This may help pharmacists improve the services rendered to patients, provide insight into the factors that are important to patients when selecting a pharmacy, and provide tips for pharmacists to attract new patients.

The first reason listed was that patients were not able to easily consult with their pharmacist. Although most survey participants rated their pharmacists’ knowledge as “very good” or “excellent,” it is the availability of pharmacists to discuss patients’ questions about their prescription medications, over-the-counter (OTC) products, and even food and vitamin interactions that caused patients to consider switching pharmacies. One-third of respondents at chain and mass merchandiser pharmacies did not discuss personal medical concerns with their pharmacists, because they appeared too busy. This feedback is calling for pharmacists to find time and processes that minimally impact the prescription workflow to better answer patient inquiries, especially for new therapies.

The lack of a private area to discuss personal medical concerns was also an issue. Now is the time to examine your consultation area, see if you can remove clutter, make it more accessible, and invite patients to go over any questions they have about their prescriptions or OTC medications. Consider scheduling an appointment at a less busy time or a telephone call if you cannot commit the necessary time to the patient at that moment.

The cost of prescription medications was another reason reported by patients for switching pharmacies, as prescription costs vary between pharmacies, especially when including discount programs, 90 days’ supply, and other cost-containment strategies. Consumer Reports encourages consumers to shop around to address out-ofpocket expenses. With the large number of insurance plan changes, many people are experiencing unexpected

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deductibles, noncovered prescriptions, coinsurances, and higher copayments. Consider this an opportunity to engage with your patients, help them better understand their prescription benefit coverage, and examine ways to help reduce their prescription costs with copay cards or generic products.

Technology was another factor patients considered when switching pharmacies. Consumer Reports noted that although many of their readers are “old school” when ordering prescriptions (ie, phone, fax, or in person), patients can use computers, tablets, or smartphones to interact with the pharmacy website and computer systems. Undoubtedly, we have all experienced the learning curve with new technology and software updates in our pharmacy. Although it may be difficult to change our old habits, these new workflow improvements usually help us serve our patients more efficiently and with greater accuracy—2 attributes that Consumer Reports uses to evaluate pharmacies.

Refill synchronization was highlighted as a new service offered by a few pharmacies to help patients taking multiple medications. Not only is it a convenient service for patients, but it also helps improve medication adherence. With all prescriptions dispensed at one time, it also allows time for pharmacists to consult with patients and address any questions that arise regarding their medication regimen. If your pharmacy is not offering refill synchronization, take the time to investigate and determine whether this would work with your systems and workflow. For more information on medication synchronization, see Debbie Sheppard’s article in this issue (“Medication Synchronization: Helping Pharmacy Transform to a Patient-Centered Care Model” on page 12).

I encourage you to go online and read the report to see how patients evaluate their pharmacy based on factors such as speed and accuracy, courtesy and helpfulness, and pharmacists’ knowledge. I am confident that you will be able to find a pearl or 2 of information that can help grow your pharmacy business and better serve your patients. n

Reference

1. Consumer Reports. Finding the right pharmacy: our survey offers 10 reasons why you may want to switch drugstores. www.consumerreports.org/cro/magazine/2014/03/ finding-the-right-pharmacy/index.htm. January 2014. Accessed February 4, 2014.

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Pharmacists Have “Come from Behind the Counter” and Stepped Up to the Plate

By Charles E. Collins, Jr, MS, MBA

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n our last 2 issues, I focused on the turbulent times of health insurance coverage and the enormous impact it would have on the retail pharmacy landscape and the consumer. Indeed, the predicted difficulties did, in fact, happen.

Many consumers faced January 1 with major changes in their health insurance. They either lost coverage; gained coverage, but were forced to deal with high-deductible health plan costs; or signed up for health insurance through the public health exchanges, only to find they had no insurance cards to prove their coverage.

Enter the retail pharmacists to the rescue. In the midst of insurance coverage chaos—with some consumers unable to provide new insurance cards—retail pharmacists, from large chains to independents, put the health and well-being of their patients first and provided the necessary prescription medicines. With the fingerpointing, botched website launches, security issues, and, of course, enrollment issues surrounding the implementation of the Affordable Care Act, it would have been easy to “pass the buck” and let others deal with the proof-of-insurance issue. However, pharmacists across the country did their best to ensure that patients did not experience a gap in their prescription medications.

This action is nothing new in the retail pharmacy world. When sweeping changes came along with the new Medicare Part D program, retail pharmacists were there to assist seniors to make the transition as smooth as possible. B. Douglas Hoey, CEO, National Community Pharmacists Association (NCPA), stated that “During the 2006 implementation of the Medicare Part D drug benefit, community pharmacists helped patients with emergency supplies thousands of times. A 2006 survey of over 500 independent community pharmacists found that more than half (58%) provided 50 or more emergency supplies to seniors during the early days of Part D.” The annual January process today for seniors, as well as anyone else who has a change in healthcare insurance, faces the potential of prescriptions hitting the “black hole” of ambiguity and the chance of noncoverage.

Mr Collins is the Executive Vice President of Engage Managed Markets, a division of The Lynx Group, and Inside Pharmacy.

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However, for those who signed up through the public health exchanges, this year is definitely an anomaly in the usual January transition. Many consumers signed up—or at least thought they signed up—for healthcare insurance through the public health exchanges. However, major issues have surfaced around consumers not having identification cards from their new insurance plans in time for their next prescription refill. Yet, from Rite Aid, Kroger, Walmart, and Walgreens to the NCPA (representing the independent community pharmacist), all have joined together with a common purpose: to assist patients with their normal prescriptions and provide emergency prescription fills for up to a 30-day supply, with no upfront cost. “Every pharmacist knows how important it is for people to take their medications as prescribed, without any inter­ ruption,” Robert Thompson, Executive Vice President, Rite Aid, stated.

Adherence rates for prescription medicine in this country already suffer. We do not need a breakdown in the healthcare system to further exacerbate this problem. To that end, I applaud the proactive stance that retail pharmacists across the country have taken.

They are answering health plan coverage questions and providing prescription fills to keep patients adherent to their medications while websites get fixed and identification cards continue to get mailed out. In addition, Walgreens should be commended on recently announcing the extension of its program through April 15, since the public health insurance marketplace open enrollment deadline is March 31. I am sure other retailers will follow suit. The normal January 1-month transition has now become the “new normal” 4-month transition, at least for 2014. Next year could be a whole new story.

At Inside Pharmacy, we encourage and promote retail pharmacists to “come from behind the counter” and engage their patients and customers. In this case, not only did retail pharmacists accomplish this action, they definitely stepped up to the plate! Maybe that’s why pharmacists are highly rated when it comes to patient satisfaction and, above all, trust. n

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Inside Inside Cardiometabolic: Cardiometabolic: Stroke Stroke

Identifying Patients at Risk for Stroke

By Maria A. Osborne, PharmD, BCACP

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troke risk factors can be divided into 2 categories: nonmodifiable and modifiable. Nonmodifiable risk factors include age >55 years, heredity (family history of stroke), race (African American), gender (male), and previous history (stroke, transient ischemic attack, or heart attack).1 Understanding nonmodifiable risk factors is important, because these are the patients who have the most to gain from working on controlling modifiable risk factors.

Pharmacists are in a unique position to help patients manage medication therapy for modifiable risk factors and to identify medication nonadherence, which increase the risk for stroke.

Think about how many times a day community pharmacists interact with patients with any of the modifiable risk factors for stroke, including cigarette smoking, hypertension, hypercholesterolemia, diabetes,

Pharmacists are in a unique position to help patients manage medication therapy for modifiable risk factors and to identify medication nonadherence, which increase the risk of stroke. atrial fibrillation, and heart disease. For patients who smoke, it takes only a minute to engage them in a conversation when they are picking up prescriptions and ask about smoking cessation.

As pharmacists, we are here to help when that patient is ready to quit. Patients often perceive cost as a barrier to quitting smoking2 and may be unaware that many health insurance plans are starting to include coverage for smoking-cessation options as part of the changing healthcare landscape and the focus on preventive care. Pharmacists can communicate this to patients and help them research coverage options.

Dr Osborne is a clinical pharmacist at Margaret Family Practice offices, Pittsburgh, PA.

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KEY POINTS Pharmacists play a critical role on the healthcare team to help identify patients who are at risk of stroke

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Pharmacists working together with patients and prescribers can help ensure the effectiveness, safety, and adherence to medications for modifiable risk factors of stroke

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Medications are a cornerstone to chronic disease management, yet approximately 25% of patients do not adhere to prescribed medication therapy

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Community pharmacists have a wealth of information at their fingertips; using these data, they can engage their patients in a discussion

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Medication Nonadherence Medications are a cornerstone to chronic disease management, yet approximately 25% of patients do not adhere to prescribed medication therapy.3 Patients with multiple comorbidities and the elderly tend to be at an increased risk for nonadherence.4 Factors contributing to medication nonadherence in patients with hypertension include forgetfulness, cost, adverse effects, and difficulty understanding the importance of medication because of lack of symptoms.5 Most of these factors are often implicated in nonadherence in chronic diseases.

Before addressing nonadherence, pharmacists should ascertain (1) an appropriate indication for the medication, (2) that the medication is effective, and (3) that there is not a safety issue (ie, adverse effect).6 Addressing Side Effects Community pharmacists can determine the efficacy of medication by asking the patient and/or the prescriber for monitoring parameter data, particularly the last date that vitals or laboratory test results were checked, and the corresponding results.

Asking the patient leading questions can help to uncover potential safety issues of treatments, such as dizziness or lightheadedness (hypertension); any unusual muscle pain or weakness (hypercholesterolemia); any signs or symptoms of low or high blood sugar (diabetes); and any blood in the stool or urine, black tarry stools,

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nosebleeds, or gumbleeds (anticoagulation therapy for atrial fibrillation).

If identified, this information can be communicated by the pharmacist to the prescriber, along with potential recommendations of a dosage adjustment or a change in medication that may resolve the issue. For example, patients with a history of myalgia who are taking a particular statin may benefit from switching to a nonlipophilic statin or to alternate-day dosing.7

agement, including and whether tools such as a pillbox would be helpful.

Pharmacists play a critical role on the healthcare team to help identify patients who are at risk of stroke.

Pharmacists working together with patients and prescribers can help ensure effectiveness, safety, and adherence to medications for modifiable risk factors of stroke. n

Community Pharmacists “Drugs don’t work in people who don’t take them,” said C. Everett Koop, former US Surgeon General.

This is an issue particularly with some of the newer treatments for atrial fibrillation, such as the direct thrombin and factor Xa inhibitors, because their shorter half-lives leave little room for error from nonadherence. Community pharmacists have a wealth of information at their fingertips regarding patients’ medication refill history, often with alerts built into the dispensing system for late refills; using these data, pharmacists can engage nonadherent patients in a discussion to determine strategies for medication man-

1. American Heart Association, American Stroke Association. Understanding risk, stroke risk factors. www.strokeassociation.org/STROKEORG/AboutStroke/ UnderstandingRisk/Understanding-Stroke-Risk_UCM_308539_SubHomePage. jsp. Accessed November 17, 2013.

2. Gollust SE, Schroeder SA, Warner KE. Helping smokers quit: understanding the barriers to utilization of smoking cessation services. Milbank Q. 2008;86(4):601-627.

3. DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42(3):200-209.

4. Böhm M, Schumacher H, Laufs U, et al. Effects of non-persistence with medication on outcomes in high-risk patients with cardiovascular disease. Am Heart J. 2013;166(2):306-314.

5. Vawter L, Tong X, Gemilyan M, Yoon P. Barriers to antihypertensive medication adherence among adults—United States, 2005. J Clin Hypertens (Greenwich).

2008;10(12):922-929.

6. Cipolle RJ, Strand LM, Morley PC. Pharmaceutical Care Practice: The Clinician’s Guide, 2nd ed. New York: McGraw-Hill; 2004.

7. Reinhart KM, Woods JA. Strategies to preserve the use of statins in patients with previous muscular adverse effects. Am J Health Syst Pharm. 2012;69(4):291-300.

References

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Inside Inside Cardiometabolic: Cardiometabolic: Stroke Stroke

Educating Patients on the Risk Factors and Symptoms of Stroke

By Kevin James, RPh, MBA

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troke is the third leading cause of death in the United States. More than 700,000 Americans have a stroke each year, and approximately 25% of strokes are recurrent.1 Fifteen percent to 30% of patients who survive a stroke have permanent disabilities.2 Although retail pharmacists are well educated on the medications used to treat strokes, pharmacies can also play an important role beyond standard medication counseling. They can educate patients on risk factors and quick recognition of stroke symptoms. This is critical information, especially because the sooner patients are treated, the less likely they are to suffer severe disability or even death.

As a pharmacist, you are aware that education level, attitudes, and perceptions can all affect patients’ risks for heart disease and stroke.

Stress the Importance of Symptom Recognition and Timely Treatment Patients may be confused that the terms “stroke” and “transient ischemic attack” (TIA) are sometimes used interchangeably. Although both conditions result from a blockage in a blood vessel limiting blood flow to the brain, the main difference is the duration of symptoms.

TIAs are sometimes referred to as mini strokes, because symptoms usually only last a few minutes, and there is usually no long-term injury to the brain. Strokes are more severe, with symptoms lasting more than 24 hours, and often resulting in serious disability or death.

Because strokes are often preceded by 1 or more TIAs, it is important to recognize the symptoms quickly and obtain immediate treatment. Pharmacists have a great opportunity to identify patients at risk and educate them on recognizing symptoms that may require immediate Dr James is Vice President, Managed Markets, Avella Specialty Pharmacy, Phoenix, AZ.

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medical attention. This could save their lives.

Although the symptoms of stroke vary based on the part of the brain that is affected, they often include sudden numbness of the leg, arm, or face, or weakness of the body, especially on 1 side; sudden vision changes in 1 or both eyes, or difficulty swallowing; and sudden, severe headache with unknown cause. Other symptoms include sudden problems with dizziness, walking, or balance; and sudden confusion, difficulty speaking, or understanding others. The FAST acronym is a useful tool for patients to remember the symptoms (Table).

Brain cells begin to die within seconds of oxygen deprivation, further emphasizing the need for quick recognition and treatment. Patients and caregivers should be counseled on the potential severity associated with strokes, and should be instructed to call 911 immediately should they have symptoms.

Know the Risk Factors, Counsel Your Patients Identifying your patients who are at the greatest risk for stroke is the first step in prevention. The incidence of stroke increases with age, and the number of people affected doubles every 10 years after age 55.3 Patients with a history of TIA or stroke are at an increased risk for a subsequent stroke. The highest risk for a stroke is within the first week after the initial episode.

These patients are often managed with anticoagulants or antiplatelet therapy. In addition to counseling these patients on the importance of medication compliance, be sure to stress the importance of early recognition of stroke symptoms.

More than 70 million Americans have hypertension, which is a significant risk factor for stroke.4 Approximately 70% of patients with a stroke have hypertension. Both elevated systolic and diastolic blood pressure are associated with an increased risk for stroke. Encourage patients to consistently monitor and maintain their blood pressure <140/90 mm Hg (<130/90 mm Hg for patients with diabetes or coronary artery disease).3 Recommend the DASH (Dietary Approaches to Stop Hypertension) diet, which is low in sodium and saturated fat, and high in fruits, vegetables, whole grains, and fiber.

People who smoke are 2 to 3 times more likely to have a stroke than nonsmokers. Approximately 20,000 stroke deaths annually are attributed to smoking.3 Smoking

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cessation reduces the risk for stroke, and this information can be a motivational tool to help people quit. Another important risk factor is atrial fibrillation; up to 20% of patients with atrial fibrillation may have a stroke.5 Patients who are taking antithrombotic medications should be encouraged to stay compliant with therapy to lower their risk for stroke.

Diabetes can increase the risk for stroke by 2- to 6-fold.5 Approximately 10% of people with diabetes will have a stroke. Encourage patients with diabetes to follow treatment guidelines, such as using an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for blood pressure, and taking statins to lower cholesterol level and the risk for stroke.

Hyperlipidemia is another risk factor for stroke. Lowdensity lipoprotein contributes to atherosclerosis and plaque formation, which results in narrowing of the arteries and increased risk of platelet aggregation.

Make sure your patients understand that eating too much fat and food rich in cholesterol can lead to plaque formation in the arteries, and that too much salt can adversely affect blood pressure.

People with a body mass index of 25 kg/m2 also have an increased risk for stroke.3 Reducing weight and engaging in regular exercise reduce this risk. Make sure your patients understand that eating too much fat and food rich in cholesterol can lead to plaque formation in the arteries, and that too much salt can adversely affect blood pressure. Diets high in fruits, vegetables, whole grains, and fish may help lower the risk for stroke.

Family history is another important risk factor that patients should recognize. Men are more likely than women to have a stroke, but women have a higher mortality rate than men. Race is also a factor: African Americans, Native Americans, and Alaskan Natives are at a higher risk for stroke than people of other ethnicities.

Play an Active Role in Prevention As a pharmacist, you are aware that education level, attitudes, and perceptions can all affect patients’ risks for heart disease and stroke. In addition, access to screening

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Table The Symptoms of Stroke: FAST F = face drooping Ask the person to smile or “show me your teeth” Does one side of the face droop?

A = arm weakness Ask the person to raise both arms Does one arm drift downward?

S = speech difficulty Ask the person to say a simple sentence such as, “The sky is blue” or “Don’t cry over spilled milk” Is the sentence repeated correctly?

T = time to call 911 Call 911 immediately if a person has symptoms of stroke, even if the symptoms go away Other stroke symptoms to watch for include: Sudden numbness or weakness of the leg Sudden confusion Trouble seeing in one or both eyes Sudden trouble walking Loss of balance or coordination Sudden severe headache with no known cause Adapted from the National Stroke Association. Stroke warning signs. www.strokeassociation.org/STROKEORG/WarningSigns/ Stroke-Warning-Signs-and-Symptoms_UCM_308528_ SubHomePage.jsp.

programs and healthcare specialists can be a challenge for the elderly and for people in rural communities.

As one of the most accessible healthcare providers, pharmacists can play a key role in stroke prevention by educating patients and caregivers on stroke risk factors and lifestyle changes to minimize the risks. In addition to stressing the importance of medication compliance, encourage at-risk patients to maintain a healthy diet and weight, exercise often, quit smoking, and limit alcohol and salt intake. n

References

1. The Internet Stroke Center. Stroke Statistics. www.strokecenter.org/patients/ about-stroke/stroke-statistics. Accessed February 7, 2014.

2. Chock AWY, O’Brien KK, Stading JA, Shea JL. Educating Community Pharmacists About Stroke Risks and Primary Stroke Prevention. U.S. Pharmacist. www.uspharma cist.com/continuing_education/ceviewtest/lessonid/107233. Published February 1, 2011. Accessed September 30, 2013.

3. Gourley DR, Eoff, JC. Thromboembolic Disease. In: The APhA Complete Review for Pharmacy. 10th ed. Washington, DC: American Pharmacists Association; 2012.

4. Rosamond W, Flegal K, Friday G, et al. Heart disease and stroke statistics–2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007;115:e69–e1715.

5. Hester S. Drug Therapy for Treatment and Prevention of Strokes. Pharmacist’s Letter. www.pharmacistsletter.therapeuticresearch.com/ce/celtrinfo.aspx. May 1, 2013.

Accessed September 30, 2013.

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Inside Inside Pharmacy Pharmacy Management Management

Medication Synchronization: Helping Pharmacy Transform to a PatientCentered Care Model

By Debbie Sheppard

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mplementing a medication synchronization program is the most effective method for pharmacies to improve medication adherence, take control of their businesses, and improve patient health. The program enables pharmacies to time patients’ use of medications for chronic conditions and ensure prescription filling at the same time each month.

Medication synchronization not only improves patient care, but also increases prescription sales, improves patient loyalty, enhances patient satisfaction, and transitions pharmacy to a patient-centered, appointment-based model of care. This enables pharmacies to provide patients with personalized interventions that meet the complex needs associated with chronic conditions. Medication synchronization represents true pharmacy practice innovation and demonstrates that proactive patient intervention increases medication adherence and reduces overall healthcare costs.

Patient-Centered Care Model Medication synchronization moves pharmacy beyond the current just-in-time reactive dispensing workflow to a patient-centric process that proactively times the filling of prescriptions for chronic disease medication and facilitates an improved, appointment-based model of care. Pharmacies that have implemented medication synchronization programs capitalize on monthly patient visits to identify and resolve any medication-related barriers to adherence that patients may have.

Medication synchronization programs create active patient engagement between the pharmacy and the patient. The pharmacy can identify a patient’s needs, and allow pharmacists to guide patients through their medication therapy. In addition to promoting active pharmacist–patient engagement, medication synchroMs Sheppard is the Vice President of Sales and Marketing at Ateb, Inc.

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KEY POINTS Medication synchronization programs standardize processes across pharmacies to free up valuable time in pharmacy workflow.

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Patient-centered care helps provide consistent, significant, and meaningful patient interventions.

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Transitioning from a fee-for-service to a pay-forperformance model is a must to achieve ≥80% proportion of days covered scores and receive payer reimbursement.

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Measurements and analytics are the keys to identifying patient opportunities, tailoring interventions, and measuring overall patient impact.

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Patients get excited about making only 1 trip per month to the pharmacy, having dedicated face-toface time with their pharmacist, and establishing stronger relationships with the pharmacy staff.

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nization programs engender stronger patient–pharmacy relationships. Many pharmacies are leveraging this as an opportunity to incorporate additional pharmacy services and spend additional time with patients.

The medication synchronization process provides the foundation on which the pharmacy can build additional services, such as immunizations, comprehensive medication reviews, and disease state–specific programs. By having more control over time and workflow, pharmacies can maximize their time spent with patients for the benefit of patients and the pharmacy.

Benefits for Pharmacies Implementing a medication synchronization program: • Improves medication adherence and patient health outcomes • Provides prescription volume growth for the pharmacy • Encourages pharmacy inclusion in restricted payer networks. With restricted networks on the rise, the ability of pharmacy to positively impact proportion of

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Do you have a retail pharmacy best practice to share?

In your background as a retail pharmacy manager, it’s likely there’s one business experience – and maybe more – that pharmacy managers across the nation would want to read about.

High-interest topics include the solution you found to a pharmacy management challenge, reimbursement, patient counseling across different therapeutic areas, clinical advances, regulatory changes, and business impacts on retail pharmacy.

Step out from “behind the counter” and send us your ideas!

Submit a 750- to 1500-word original article, previously unpublished and submitted exclusively to Inside Pharmacy, that your fellow pharmacy managers will want to read.

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Inside Pharmacy Management

Figure 1 PDC Comparison: Medication Synchronization Enrolled versus Not Enrolleda 87%

84% 83%

86%

82%

85%

Enrolled Not Enrolled

120% 100% 80%

81%

84%

80%

60% 83%

79%

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80%

0%

Oral antidiabetes drugs

ACE inhibitors/ARBs

Statins

ACE indicates angiotension-converting enzyme; ARBs, angiotensin receptor blockers; PDC, proportion of days covered. a Aggregate results across multiple pharmacy organizations. Figure courtesy of Ateb, 2013.

days covered (PDC) scores and drive payers’ quality bonus payments is critical to preventing exclusion • Promotes an organized, more evenly distributed pharmacy workload and increases Central Fill capacity • Improves inventory control. As the number of patients enrolled in medication synchronization increases, the pharmacy can anticipate required inventory, eliminating excess on-hand quantities and improving inventory turns • Creates “found time” for other patient care activities.

Pharmacies with 70 or more patients enrolled in medication synchronization experience a significant change in their workflow. Instead of patients with multiple medications for chronic conditions visiting the pharmacy several times a month, they make a single trip. This affords the pharmacist more time for patient interaction and promotes a more holistic medication therapy management process, thereby improving adherence and overall patient care • Allows pharmacies to prepare for and participate in pay-for-performance remuneration models while still driving additional revenue in the more traditional fee-for-service model.

Benefits for Patients Medication synchronization program implementation yields improved patient satisfaction and healthcare outcomes. Although consolidating the number of pharmacy visits is a significant patient benefit, the primary benefit is

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the complete and continuous review of all of the enrolled patients’ medications by the pharmacy. This is accompanied by the appropriate pharmacist interventions to improve care and achieve better health outcomes.

The pharmacy drives the process by reaching out to patients well in advance of the refill due date to determine if they adhered to the regimen, had any recent primary care visits, and is on schedule to have their chronic medications refilled. The pharmacy also uses this time to determine if there have been any care transitions that would require medication reconciliation. If the patient is on schedule and has experienced no care transitions, the pharmacy will refill the prescription and confirm an appointment date, time for pickup, and pharmacist consultation.

At the scheduled appointment, the patient and pharmacist meet face-to-face for a medication review.

This gives the pharmacist dedicated time to reinforce the importance of adherence, answer any questions the patient may have, and provide the necessary patient education. This interaction fosters improved patient understanding, adherence, satisfaction, and overall health.

Measurements and Analytics Measurements and analytics are key to quantifying the impact of medication synchronization programs on medication adherence. Adherence scores, as measured by the PDC are consistently higher for patients enrolled in medication synchronization programs than for those

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Figure 2 Medication Synchronization Impact on PDC Across Multiple Therapiesa Enrolled Not Enrolled

90

Patient prescriptions that are adherent (PDC ≥80%), %

80 70 60 50 400 30 20 10 0

Cardiovascular

Diabetes

Hyperlipidemia

Hypertension

Mental health

Other

Respiratory

Ulcer

Enrolled

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56.86%

51.45%

50.81%

51.57%

43.19%

51.52%

33.85%

34.97%

PDC indicates proportion of days covered. a Aggregate results across multiple pharmacy organizations. Figure courtesty of Ateb, 2013.

not enrolled (Figure 1, Figure 2).

A significant benefit to medication synchronization is the reduction of first-fill abandonment. The industry is trying to determine ways to reduce first-fill abandonment, and pharmacy is the answer.

Pharmacies using a tool to standardize a medication synchronization program experience a 20% increase in the number of enrolled patients. There are several reasons for this, including the tool’s ability to predict and identify patients for enrollment who would benefit from enrolling into the program (Figure 3).

Enhanced Patient Care Healthcare is changing and pharmacy is uniquely positioned to dynamically change the way patient care is delivered. As part of the patient-centered model, medication synchronization offers continuity of care and provides the foundation for regular interventions with patients. In medication synchronization programs using measurements and analytics, pharmacists become empowered with valuable data and information that recognize individual patients and identify the appropriate patient-specific interventions. Moreover, pharmacists can encourage patients to overcome medication therapy barriers during monthly patient interventions,

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Figure 3 PDC Groups:aMedications Enrolled versus

Not Enrolled Not enrolled medications

Enrolled medications 1%

12%

13% 19%

69%

86%

One fill Gap ≥45 Others

One fill Gap ≥45 Others

PDC indicates proportion of days covered. a Aggregate results across multiple pharmacy organizations. Figure courtesty of Ateb, 2013.

offering a high-touch approach to caring for patients, increasing medication adherence, and reducing overall healthcare costs. n

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Inside Inside Pharmacy Pharmacy Management Management

Medication Therapy Management: Embracing Opportunity, Facing Challenges, and Preparing for a World of Change

By Matt Manning, PharmD

T

he Affordable Care Act has succeeded in creating momentum in the world of medication therapy management (MTM), and with Medicaid programs expected to take on millions of additional Americans, the healthcare industry will become more reliant on pharmacy services.

Through initiatives such as accountable care organizations and pay-for-performance models, the insurance marketplace is challenged to be­come more innovative and efficient.1 What does this mean for the community pharmacist?

It means that the industry will expect pharmacists to embrace a larger role and continually enhance their ability to manage medications. Ultimately, the goal is to increase therapeutic outcomes while decreasing healthcare costs. As the number of physicians per patient is expected to decrease, the industry will become more

As the number of physicians per patient is expected to decrease, the industry will become more reliant on pharmacy services, and pharmacists will have opportunities to become more involved in transitional care and have medication reconciliation. reliant on pharmacy services, and pharmacists will have opportunities to become more involved in transitional care and in medication reconciliation.

Barriers to MTM At the center of it all is MTM. Pharmacists are given Dr Manning is a pharmacist with Rite Aid Pharmacy, Elizabeth, PA.

the opportunity to promote safe medication use, decrease healthcare costs, and increase the quality of care.

In recent years, numerous studies demonstrated the economic costs associated with medication mismanagement. One recent study by the IMS Institute for Healthcare Informatics estimates that $200 billion in avoidable healthcare expenditures was attributed to irresponsible medication use in 2012.2 The report includes 6 areas of avoidable costs: nonadherence, misuse of antibiotics, delayed evidence-based treatment practices, medication errors, suboptimal use of generics, and mismanaged polypharmacy.

According to the study, there is an opportunity to eliminate $213 billion in healthcare costs with more responsible medication use; almost half of those costs were the result of medication nonadherence. One of the most effective ways for increasing adherence is simply by educating patients. The good news is that adherence is already improving. Since 2009, medication adherence in patients with diabetes, hypertension, or hyperlipidemia has increased from 3% to 7%.2 This can be attributed to decreasing costs of medications, as well as an increase in interventions by a multitude of healthcare professionals at varying levels in the healthcare system.

As a result of such studies, organizations have continued to develop ways for creating a more quality- versus quantity-focused system.3 The Centers for Medicare & Medicaid Services (CMS) is actively involved in the promotion of MTM services. For example, CMS will specifically monitor the completion success of comprehensive medication reviews, stating that “plan sponsors are expected to actively engage plan beneficiaries to increase the numbers of CMRs [comprehensive medication reviews] delivered to MTM enrollees, not just ‘offer’ CMRs.”1,4 Another initiative of the Affordable Care Act is the CMS Innovation Center, which includes MTM services as models to be tested, with the goal of testing innovative payment and delivery system models while slowing the rate of growth in program costs.4 Continued on page 18

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KEY POINTS The industry will expect pharmacists to embrace a larger role and continually enhance their ability to manage medications

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IMS Institute for Healthcare Informatics estimates that there were in excess of $200 billion in avoidable costs because of mismanaged medication

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There is an increasing interest tied to the development of pay-for-performance models versus the historical fee-for-service model of community pharmacy

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Contracting with MTM vendors such as OutcomesMTM or Mirixa are essential to the completion of MTM services within a retail setting

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Barriers including patient involvement, reimbursement, and pharmacist availability still interfere with MTM advancement, but are being addressed

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Pay-for-Performance Programs With each new policy and report highlighting the cost-saving opportunities tied to medication mismanagement, the future of pharmacy practice becomes increasingly more defined. The Asheville project, a hallmark study, showed how an increase in pharmaceutical care by community pharmacists can be tied to a decrease in direct medical costs and lead to an increase in quality of care for patients with diabetes.5 Despite increasing data, there continues to be an underutilization of pharmacy services because of a lack of reimbursement structure.5

The most important takeaway is that community pharmacy is going to continue to move away from its traditional environment.

In addition, while pay-for-performance (PFP) programs historically focus on physician performance, there will likely be an increase in pressure from CMS for organizations to develop a standardized approach for reimbursing pharmacy services.

PFP can be defined as a “payment system in which providers are rewarded financially for quality of care.

This is in contrast to the traditional fee-for-service system, which is based on quantity or volume of services provided, regardless of outcome.”5 This type of incentive is similar to CMS star ratings of the Medicare Part D programs, whereby increasing the payer’s quality of care

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leads to higher star status. Achieving a 5-star status is desirable, because the benefits for reaching and maintaining such status are tremendous (eg, year-end bonuses and year-long open enrollment, allowing payers to freely jump from a lesser rated plan to a 5-star plan at any point in the year).

How will CMS or other organizations develop a PFP model for pharmacy services? Will individual pharmacies have ratings similar to the stars program that determine reimbursement rates per pharmacy? Will pharmacists have their own rating? Only time will tell, but with the increasing interest in PFP models, things are likely to change. With traditional prescription reimbursement decreasing every year, it is crucial that pharmacies continue to expand MTM services and adjust their service models to accommodate for the changing environment.

Developing the line of communication between physicians and pharmacists is one of the most crucial changes that needs to take place.

Ways to Enhance the Pharmacist–Patient Relationship To appropriately manage the newly insured, there needs to be a more coherent relationship between healthcare professionals and patients. One way of enhancing this relationship is by using MTM software, such as Mirixa (Mirixa Corp, Reston, VA) and OutcomesMTM (Outcomes Inc, West Des Moines, IA). Contracting with such vendors provides an excellent opportunity to enhance therapeutic outcomes in a community setting and promote the much-needed line of communication between patient, physician, and pharmacist. In 2012, as a part of an environmental scan reviewing current MTM trends, it was noted that the majority of candidates entering an MTM program were identified through such vendors.1 Both platforms offer the opportunity for pharmacists to perform a comprehensive medication review of beneficiaries’ medication profile, and maintain a list of their medications along with other patient-specific information. However, key restrictions in providing MTM services within a community setting still remain.

These include a deficiency in patient interest, lack of staff support, and pharmacists simply not having enough time.1 It is important to note that these issues are not only being addressed by pharmacies through increasing clinical staff support, but vendors are also making platforms that are easily implemented into workflow. For example, OutcomesMTM creates “Tip claims” that the pharmacist can easily address when patients pick up their medication and later bill the insurance company for the provided service. These tip claims can range from

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contacting the patient’s physician and recommending a therapy change, to simply investigating the reason a patient has not been adherent. The pharmacist also has the ability to create a self-identified claim, such as an over-the-counter recommendation, or suggest a dosage increase to the patient’s physician.

Engaging the Patient The most important takeaway is that community pharmacy is going to continue to move away from its traditional environment. Pharmacists will be expected to engage with their patients more, and insurance plans are going to demand a higher level of service. Opportunities continue to develop, and it is a very exciting time in the industry that we hope will be embraced by all pharma-

cists. This is a chance to further engage with patients and become a more integrated part of the healthcare system. n

References

1. American Pharmacists Association. Medication Therapy Management Digest: Pharmacists Emerging as Interdisciplinary Health Care Team Members. www. pharmacist.com/sites/default/files/files/MTMDigest_2013.pdf. March 2013. Accessed February 3, 2014.

2. Aitken M, Valkova S; for the IMS Institute for Healthcare. Avoidable Costs in U.S. Healthcare: The $200 Billion Opportunity from Using Medicines More Responsibly. IMS Institute for Healthcare Informatics. www.imshealth.com/deployed files/imshealth/Global/Content/Corporate/IMS%20Institute/RUOM-2013/IHII_ Responsible_Use_Medicines_2013.pdf. June 2013. Accessed February 5, 2014.

3. Koenigsfeld C, Horning K, Logemann C, Schmidt G. Medication Therapy Management in the Primary Care Setting: A Pharmacist-Based Pay-for-Performance Project. J Pharm Practice. 2011;25:89.

4. Guterman S, Davis K, Stremikis K, Drake H. Innovation in Medicare and Medicaid will be central to health reform’s success. Health Aff (Millwood). 2010;29(6):1188-1193.

5. Fenter TC, Lewis SJ. Pay-for-performance initiatives. J Manag Care Pharm. 2008;14 (6):S12-S15.

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INSIDE cardiometabolic: diabetes

Exercising to Better Health

By Kevin Barton, PharmD, RPh

O

ur fast-paced, task-oriented society demands more and more from us each and every day, eating up the free time we strive to obtain and creating obstacles that we attempt to conquer. Having too many tasks to accomplish, too little free time to do them, a decreased quality of life as a result, and the barriers caused by chronic diseases place exercise on the back burner for most people.

As the prevalence of various disease states steadily increases in our culture, along with the amount of money currently spent on healthcare, never before have preventive measures been more important. To be sure, medications can help to lower or prevent many health risks, but one of the most important means of preventing and/ or reducing the negative outcomes of chronic diseases is by incorporating modifiable lifestyle changes, such as exercise, into a daily routine.

One of the most important means of preventing and/or reducing the negative outcomes of chronic diseases is by incorporating modifiable lifestyle changes, such as exercise, into a daily routine.

The Value of Exercise for Patients with Diabetes Although physical activity can improve many aspects of someone’s quality of life, one population that can benefit dramatically from a regular exercise routine is patients with diabetes. The Centers for Disease Control and Prevention (CDC) indicated in the National Diabetes Fact Sheet, 2011, that the chances of heart disease–related death and experiencing a stroke are both 2 to 4 times higher in patients with diabetes.1 The CDC also reported that from 2005 to 2008, 67% of adults aged 20 years or older with self-reported diabetes had blood pressure ≥140/90 mm Hg, the standard Dr Barton is a PGY-1 community pharmacy resident, Walmart Home Office/University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR.

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KEY POINTS The benefits of exercising for patients with diabetes include decreases in A1c and weight loss

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Weight loss through exercise improves insulin sensitivity that may be secondary to increased fat tissue in patients with type 2 diabetes

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The American Diabetes Association recommends that patients with diabetes participate in 150 minutes of moderate-intensity physical activity on a weekly basis

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Exercise sessions can be broken down into 30 minutes daily, 5 days weekly

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guideline for high blood pressure (eg, hypertension), or used prescription medications for hypertension.1 What do all of these disease states have in common?

The risks for each can be reduced and/or prevented by exercising. A few benefits of exercising for patients with diabetes include reductions in blood pressure, decreases in A1c, increases in healthy cardiac activity, and weight loss. The benefit of weight loss through exercise also includes improving insulin sensitivity that may be secondary to increased fat tissue in patients with type 2 diabetes.

The US Food and Drug Administration (FDA) has recommended that adults aged 18 to 64 years should invest in at least 150 minutes of moderateintensity physical activity per week, or 75 minutes weekly of vigorous-intensity physical activity. The American Diabetes Association (ADA) parallels the FDA, further recommending that 150-minute, moderate-intensity physical activity be broken down into 30 minutes daily, 5 days weekly.2

A Safe Exercise Plan When initiating a safe exercise plan, it is important for the patient with diabetes to know his or her limitations. If walking for 10 minutes daily is one’s limit, the patient should be advised not to push further than that.

Instead, the patient should be encouraged to start at what is achievable and slowly increase his or her activity by a few minutes per day as recommended by the ADA.2 As the saying goes, “It’s better to do some than none.”

For patients with diabetes who have chronic com-

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plications such as neuropathy, or are obese, the limitations to exercise can be extensive; however, exercise is still important, as well as feasible. Exercises known as “chair exercises” can be used to maintain the recommendations of the FDA and the ADA. Not only is a chair used for balance to decrease the risk of falling, but essentially each main muscle group can be worked by just using a chair for a variety of exercises. More information on specific chair exercises can be found on www.diabetes.org and www.cdc.gov.3,4 Strength training is also recommended by the FDA, but only if the patient is capable of doing so. Safety is important. In fact, if a patient is worried that not being able to perform strength training or high-intensity workouts will hinder his or her ability to achieve maximum health benefits, you can reassure the patient that studies have shown that 150 minutes weekly of moderate-intensity physical activity is just as beneficial as 75 minutes weekly of vigorous-intensity physical activity. This is precisely why the FDA provides an “either/or” recommendation for physical activity.

Planning goals ahead of time can help the patient with diabetes to keep a consistent routine of exercising.

The patient should write down goals, such as how many times he or she is going to work out in a given week, how long he or she is going to work out for each session, and what he or she needs to prepare for the exercising sessions. If being busy is a barrier, help the patient to contemplate how he or she can divide the 30-minute daily exercise session into smaller segments throughout the day. For example, 30 minutes of walking can be spread out over 3 sessions of 10 minutes.

Patients may also think that cost is a barrier to starting an exercise routine, whether it is joining a fitness club or purchasing exercise equipment. Remind your patient that exercise and money are independent of each other. Running, walking, hiking, and even dancing are all free ways to decrease health risks. Any physi-

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cal activity is better than not exercising at all.

As pharmacists, we must strive to collaborate with our patients on lifestyle changes, understanding that barriers and constraints are unique to each individual.

Ask your patients open-ended questions and dive deeper into their exercising habits. If they are not exercising, find out why. It may be because of physical constraints or lack of motivation, or because the patient may not have been educated on the importance of physical activity.

Motivate your patients.

As pharmacists, we must strive to collaborate with our patients on lifestyle changes, understanding that barriers and constraints are unique to each individual.

There are ways for all patients to fit their FDArecommended amount of exercise into their daily routine. If a patient has just initiated their path to exercising, promote positivity. From a patient perspective, hearing that you are doing something right from one of the most trusted professionals can go a long way. It can create the motivation that the patient needs to keep pursuing their goals for exercising. n

References

1. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, 2011. www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed December 12, 2013.

2. American Diabetes Association. Food & Fitness Fact Sheet. www.diabetes.org/ food-and-fitness/fitness/. Accessed December 12, 2013.

3. US Department of Health and Human Services. 2008 Physical Activity Guidelines for Americans. Washington, DC: US Department of Health and Human Services.

Updated March 11, 2013. www.health.gov/paguidelines/guidelines/default.aspx.

Accessed September 2013.

4. Centers for Disease Control and Prevention. Division of Nutrition, Physical Activity, and Obesity/National Center for Chronic Disease Prevention and Health Promotion. Physical Activity. www.cdc.gov/physicalactivity/. Accessed September 2013.

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BRIEF SUMMARY

ESOMEPRAZOLE STRONTIUM delayed-release capsules 49.3 mg For oral use only Rx Only BRIEF SUMMARY of Prescribing Information INDICATIONS AND USAGE Treatment of GERD in Adults: Esomeprazole strontium is indicated for the short-term treatment (4 to 8 weeks) for healing and symptomatic resolution and maintenance (controlled studies do not extend beyond 6 months) of confirmed erosive esophagitis (EE), the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Risk Reduction of NSAID-Associated Gastric Ulcer in Adults, H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults, and Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome in Adults.

CONTRAINDICATIONS Esomeprazole strontium is contraindicated in patients with known hypersensitivity to proton pump inhibitors (PPIs). Hypersensitivity reactions, e.g., angioedema and anaphylactic shock, have been reported with esomeprazole use. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole strontium, refer to the CONTRAINDICATIONS section of their package inserts.

WARNINGS AND PRECAUTIONS Concurrent Gastric Malignancy: Symptomatic response to therapy with esomeprazole strontium does not preclude the presence of gastric malignancy.

Atrophic Gastritis: Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer.

Clostridium difficile Associated Diarrhea: Published observational studies suggest that PPI therapy like esomeprazole strontium may be associated with an increased risk of Clostridium difficile associated diarrhea. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with esomeprazole strontium, refer to WARNINGS and PRECAUTIONS sections of those package inserts.

Interaction with Clopidogrel: Avoid concomitant use of esomeprazole strontium with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg esomeprazole reduces the pharmacological activity of clopidogrel. When using esomeprazole strontium, consider alternative anti-platelet therapy.

Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.

Hypomagnesemia: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures.

In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.

Concomitant Use of esomeprazole strontium with St. John’s Wort or Rifampin: Drugs which induce CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease esomeprazole concentrations. Avoid concomitant use of esomeprazole strontium with St. John’s Wort or rifampin.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop esomeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high.

If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

Concomitant Use of esomeprazole strontium with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/ or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of esomeprazole strontium has been established from adequate and wellcontrolled studies of esomeprazole magnesium.

Adults: The safety of esomeprazole magnesium was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6-12 months. In general, esomeprazole magnesium was well tolerated in both short and long-term clinical trials.

The safety in the treatment of healing of erosive esophagitis was assessed in 4 randomized comparative clinical trials, which included 1,240 patients on 22.3 mg of esomeprazole magnesium (equivalent to 20 mg of esomeprazole), 2,434 patients on 44.6 mg of esomeprazole magnesium (equivalent to 40 mg of esomeprazole), and 3,008 patients on 20 mg of omeprazole daily. The most frequently occurring adverse reactions (≥1%) in all three groups were headache (5.5%, 5%, and 3.8%, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking esomeprazole magnesium or omeprazole. Additional adverse reactions that were reported as possibly or probably related to esomeprazole magnesium with an incidence <1% are listed below by body system: Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors; Cardiovascular: flushing, hypertension, tachycardia; Endocrine: goiter; Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting; Hearing: earache, tinnitus; Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia; Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased; Metabolic/ Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease; Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica; Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect; Reproductive: dysmenorrhea, menstrual disorder, vaginitis; Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis; Skin/Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria; Special Senses: otitis media, parosmia, taste loss, taste perversion; Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria; Visual: conjunctivitis, vision abnormal.

Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration.

In two placebo-controlled studies, 710 patients were treated symptomatic GERD and the most common adverse reactions possibly or probably related to esomeprazole magnesium were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%). Combination Treatment with Amoxicillin and Clarithromycin: In clinical trials using combination therapy with esomeprazole magnesium plus amoxicillin and clarithromycin, no additional adverse reactions specific to these drug combinations were observed. Adverse reactions that occurred were limited to those observed when using esomeprazole magnesium, amoxicillin, or clarithromycin alone. The most frequently reported drug-related adverse reactions for patients who received triple therapy for 10 days were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%). No treatment-emergent adverse reactions were observed at higher rates with triple therapy than were observed with esomeprazole magnesium alone. For more information on adverse reactions with amoxicillin or clarithromycin, see their package inserts, refer to ADVERSE REACTIONS sections.

Postmarketing Experience The following adverse reactions have been identified during post-approval use of esomeprazole magnesium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system: Blood and Lymphatic: agranulocytosis, pancytopenia; Eye: blurred vision; Gastrointestinal: pancreatitis, stomatitis, microscopic colitis; Hepatobiliary: hepatic failure, hepatitis with or without jaundice; Immune System: anaphylactic reaction/ shock; Infections and Infestations: GI candidiasis; Clostridium difficile associated diarrhea; Metabolism and nutritional disorders: hypomagnesemia; Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture; Nervous System: hepatic encephalopathy, taste disturbance; Psychiatric: aggression, agitation, depression, hallucination; Renal and Urinary: interstitial nephritis; Reproductive System and Breast: gynecomastia; Respiratory, Thoracic, and Mediastinal: bronchospasm; Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal).

DRUG INTERACTIONS Interference with Antiretroviral Therapy: Concomitant use of atazanavir and nelfinavir with PPIs is not recommended. Coadministration of atazanavir with PPIs is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance. Coadministration of saquinavir with PPIs is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction. Omeprazole, of which esomeprazole is an enantiomer, has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP2C19. Reduced concentrations of atazanavir and nelfinavir: For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg daily), AUC was decreased by 36% and 92%, Cmax by 37% and 89% and Cmin by 39% and 75%, respectively for nelfinavir and M8. Following multiple doses of atazanavir (400 mg, daily) and omeprazole (40 mg, daily, 2 hr before atazanavir), AUC was decreased by 94%, Cmax by 96%, and Cmin by 95%. Concomitant administration with omeprazole and drugs such as atazanavir and nelfinavir is therefore not recommended. Increased concentrations of saquinavir: For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported, with an increase in AUC by 82%, in Cmax by 75%, and in Cmin by 106%, following multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily coadministered days 11 to 15. Clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with esomeprazole. Dose reduction of saquinavir should be considered from the safety perspective for individual patients.

Drugs for Which Gastric pH Can Affect Bioavailability: Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, atazanavir, iron salts, and erlotinib can decrease, while the absorption of drugs such as digoxin can increase during treatment with esomeprazole. Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (30% in two subjects). Esomeprazole is an enantiomer of omeprazole. Coadministration of digoxin with esomeprazole is expected to increase the systemic exposure of digoxin.

Patients may need to be monitored when digoxin is taken concomitantly with esomeprazole.

Effects on Hepatic Metabolism/Cytochrome P-450 Pathways: Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, quinidine, clarithromycin, or amoxicillin. Although drug interaction studies have not shown that esomeprazole has a clinically significant interaction with warfarin, post-marketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may potentially interfere with CYP2C19, the major esomeprazole metabolizing enzyme. Coadministration of esomeprazole 30 mg and diazepam, a CYP2C19 substrate, resulted in a 45% decrease in clearance of diazepam. Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of esomeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant administration of esomeprazole strontium with clopidogrel.

When using esomeprazole strontium, consider use of alternative anti-platelet therapy.

Omeprazole acts as an inhibitor of CYP2C19. Omeprazole, given in doses of 40 mg daily for one week to 20 healthy subjects in a cross-over study, increased Cmax and AUC of cilostazol by 18% and 26% respectively. Cmax and AUC of one of its active metabolites, 3,4-dihydrocilostazol, which has 4-7 times the activity of cilostazol, were increased by 29% and 69% respectively. Coadministration of cilostazol with esomeprazole is expected to increase concentrations of cilostazol and its above mentioned active metabolite. A dose reduction of cilostazol from 100 mg twice daily to 50 mg twice daily should be considered.

Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure. Dose adjustment of esomeprazole is not normally required. However, in patients with Zollinger-Ellison’s Syndrome, who may require higher doses up to 240 mg/day, dose adjustment may be considered. Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampin) may lead to decreased esomeprazole serum levels. Omeprazole, of which esomeprazole is an enantiomer, has been reported to interact with St. John’s Wort, an inducer of CYP3A4. In a cross-over study in 12 healthy male subjects, St. John’s Wort (300 mg three times daily for 14 days) significantly decreased the systemic exposure of omeprazole in CYP2C19 poor metabolisers (Cmax and AUC decreased by 37.5% and 37.9%, respectively) and extensive metabolisers (Cmax and AUC decreased by 49.6 % and 43.9%, respectively). Avoid concomitant use of St. John’s Wort or rifampin with esomeprazole strontium.

Interactions with Investigations of Neuroendocrine Tumors: Drug-induced decrease in gastric acidity results in enterochromaffin-like cell hyperplasia and increased Chromogranin A levels, which may interfere with investigations for neuroendocrine tumors.

Tacrolimus: Concomitant administration of esomeprazole and tacrolimus may increase the serum levels of tacrolimus.

Combination Therapy with Clarithromycin: Coadministration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of

esomeprazole and 14-hydroxyclarithromycin. Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions [see WARNINGS and PRECAUTIONS in prescribing information for clarithromycin]. Because of these drug interactions, clarithromycin is contraindicated for coadministration with certain drugs [see CONTRAINDICATIONS in prescribing information for clarithromycin].

Methotrexate: Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.

SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C: There are no adequate and well controlled studies of esomeprazole strontium delayed-release capsules in pregnant women.

Teratogenicity was not observed in an embryofetal developmental study in rats with either esomeprazole strontium or esomeprazole magnesium at equimolar oral doses up to 280 mg esomeprazole/kg/day (about 57 times the daily maximum recommended human dose (MRHD) of 40 mg on a body surface area basis). When administered as either the strontium or magnesium salt, changes in bone morphology and physeal dysplasia were observed in pre- and postnatal developmental toxicity studies in rats at doses equal to or greater than 138 mg esomeprazole/kg/day (approximately 33.6 times the daily MRHD of 40 mg on a body surface area basis). Because of the observed effect at the high doses of esomeprazole strontium on developing bone in rat studies, esomeprazole strontium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Limited published data indicate that esomeprazole and strontium are present in human milk. Because of the effect of esomeprazole strontium observed at high doses on developing bone in rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of esomeprazole strontium delayed-release capsules have not been established in pediatric patients. Strontium is known to compete with calcium for intestinal absorption and is incorporated into bone. Use in pediatric patients is not recommended because adequate safety studies have not been performed.

Geriatric Use: No overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Use in Patients with Renal Impairment: No dosage adjustment is necessary in patients with mild to moderate renal impairment. The pharmacokinetics and safety of strontium in patients with severe renal impairment has not been studied and, therefore, use in this patient population is not recommended.

OVERDOSAGE A single oral dose of esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. The symptoms described in connection with deliberate esomeprazole overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert - ADVERSE REACTIONS). No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose contact a Poison Control Center at 1-800-222-1222.

Please see package insert for full prescribing information.

More detailed information is available upon request.

For more information about esomeprazole strontium contact: Amneal Pharmaceuticals at 1-877-835-5472.

Date of Issue: December 2013 Licensed from: Hanmi Pharm. Co. Ltd., Seoul, Korea Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141

© Amneal Pharmaceuticals LLC. All rights reserved. ESPA-0114bPH

Amneal Pharmaceuticals has Important News for Pharmacists INTRODUCING

Esomeprazole therapy at an easy-to-swallow price Esomeprazole, one of the top-selling therapies in the US,1 is now available as Esomeprazole Strontium delayed-release capsules 49.3 mg. This strontium salt is a pharmaceutical alternative with the same indication in adults as Nexium® (esomeprazole magnesium) delayed-release capsules; it is not approved for patients under 18 years old. Esomeprazole Strontium provides the same dose of esomeprazole therapy as Nexium® 40 mg at a potentially more attractive cost.

NEW

ESOMEPRAZOLE STRONTIUM Learn more at esomep.com

Indications and Usage Esomeprazole Strontium is a proton pump inhibitor (PPI) indicated for adults for: ● Treatment of gastroesophageal reflux disease (GERD) ● Risk reduction of NSAID-associated gastric ulcer ● H. pylori eradication to reduce the risk of duodenal ulcer recurrence ● Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The safety and effectiveness of esomeprazole strontium have not been established in pediatric patients. Esomeprazole strontium is not recommended for use in pediatric patients.

The safety of esomeprazole strontium has not been studied in patients with severe renal impairment. Esomeprazole strontium is not recommended for use in patients with severe renal impairment.

Nursing mothers should consider discontinuing esomeprazole strontium.

There are no studies in pregnant women. Esomeprazole Strontium should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

Important Safety Information Esomeprazole strontium is contraindicated in patients with known hypersensitivity to PPIs. Hypersensitivity reactions, e.g., angioedema and anaphylactic shock have been reported with esomeprazole use.

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in biopsies from patients treated long-term with omeprazole.

PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.

Avoid concomitant use of esomeprazole strontium with clopidogrel, because the metabolism of clopidogrel can be impaired. When using esomeprazole strontium consider alternative anti-platelet therapy.

Long-term and multiple daily dose PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine.

Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Serious events included tetany, arrhythmias, and seizures, and may require discontinuation of the PPI. Most common adverse reactions in adults (≥18 years) (incidence ≥1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.

Avoid concomitant use of esomeprazole strontium with drugs which induce CYP2C19 or CYP3A4, such as with St. John’s Wort or rifampin, due to the potential substantial reduction in esomeprazole levels.

Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, and digoxin).

Drug-induced decreases in gastric acidity may increase serum chromogranin A (CgA) levels and may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop esomeprazole treatment before assessing CgA levels.

Concomitant use with atazanavir and nelfinavir is not recommended; Concomitant use of saquinavir with PPIs is expected to increase saquinavir concentrations, which may increase toxicity.

Please see the Brief Summary of the full Prescribing Information on the next page.

Reference: 1. Top 100 Drugs for Q3 2013 by Sales. Drug Information Online. November, 2013.

Available at: http://www.drugs.com/stats/top100/sales?printable=1. Accessed 11/06/2013.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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