Inside Pharmacy December 2013

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Pharmacy

DECEMBER 2013 • Vol 1 • No 2

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

THE FIRST WORD

Helping Patients Overcome the Sticker Shock to Come............................. 6

INSIDE CARDIOMETABOLIC: DIABETES

A New Weapon in the Fight Against Diabetes: SGLT2 Inhibitors...................... 8 Counseling Patients on the Use of Insulin Pen Devices............................. 10 Pharmacists Empowering Patients to Determine Their Risk for Type 2 Diabetes....................................... 13 Nutrition and Exercise for Patients with Diabetes Mellitus............................. 15

INSIDE RETAIL PHARMACY

Great Expectations? Career Development in Healthcare.................... 18

INSIDE HEALTHCARE OPERATIONS Reducing Hospital Readmissions: A New Opportunity for Community Pharmacists.............................................. 24

INSIDE mental health

Counseling Patients on Stress Management............................................ 28

From the Publishers of THE PEER-REVIEWED FORUM FOR REAL-WORLD EVIDENCE IN BENEFIT DESIGN™

FOR PAYERS, PURCHASERS, POLICYMAKERS, AND OTHER HEALTHCARE STAKEHOLDERS

© 2013 Engage Healthcare Communications, LLC

an affiliate of

Talk to your patients about FlexPen®, the only prefilled pen available with basal, bolus, and premix insulin analogs

Individual results may vary.

FlexPen® is covered under most managed care plans for the same co-pay as vial and syringe* FlexPen® is compatible with NovoFine® 32G Tip [6mm] disposable needles, our thinnest needle (Also available in 30G [8mm]) Don’t forget to dispense NovoFine® needles * Intended as a guide. Lower acquisition costs alone do not necessarily reflect a cost advantage in the outcome of the condition treated because there are other variables that affect relative costs. Formulary data are provided by Fingertip Formulary® and are current as of September 2012.

Because formularies do change and many health plans offer more than one formulary, please check with the health plan directly to confirm coverage for individual patients. © 2012 Fingertip Formulary. All Rights Reserved.

Needles and FlexPen® must not be shared. Needles are sold separately and may require a prescription in some states.

FlexPen®, Levemir®, NovoLog®, and NovoFine® are registered trademarks of Novo Nordisk A/S. © 2012 Novo Nordisk Printed in the U.S.A. 0912-00010969-1 November 2012

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Executive VP/Managing Director Chuck Collins ccollins@engagehc.com Director, Client Services Ron Gordon rgordon@the-lynx-group.com Editorial Director Dalia Buffery dbuffery@the-lynx-group.com

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Pharmacy

DECEMBER 2013 • Vol 1 • No 2 TM

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

Managing Editor Lisa Neuman lneuman@the-lynx-group.com Strategic Editor Robert E. Henry Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Melissa Lawlor The Lynx Group

Table of Contents the first word

6 Helping Patients Overcome the Sticker Shock to Come Donald J. Dietz, RPh, MS

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

Inside healthcare

7 Insurers Are Rattled Going into 2014—What Will Be the Impact on Retail Pharmacy?

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 Creative & Design Assistant Lora LaRocca

INSIDE CARDIOMETABOLIC: DIABETES

8 A New Weapon in the Fight Against Diabetes: SGLT2 Inhibitors

Ben Culpepper, PharmD; and Lucas Berenbrok, PharmD 10 Counseling Patients on the Use of Insulin Pen Devices Keri Medlin, PharmD, FASCP 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 Manager Andrea Boylston Jini Gopalaswamy Project Coordinators Deanna Martinez Jackie Luma 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: ccollins@engagehc.com; tel: 732-992-1892; fax: 732-992-1881.

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Pharmacy

DECEMBER 2013 • Vol 1 • No 2 TM

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

Table of Contents

(Continued from page 3)

INSIDE CARDIOMETABOLIC: DIABETES

13 It Will Only Take a Minute: Pharmacists Empowering Patients to Determine Their Risk for Type 2 Diabetes Gretchen F. Jenkins, PharmD, BCACP 15 Nutrition and Exercise for Patients with Diabetes Mellitus Todd Paulsen, PharmD, CDE, BCPS

INSIDE RETAIL PHARMACY

18 Great Expectations? Career Development in Healthcare

An interview with a recent pharmacy school graduate

Robert E. Henry

INSIDE HEALTHCARE OPERATIONS

24 Reducing Hospital Readmissions: A New Opportunity for Community Pharmacists Toni Fera, BS, PharmD; and Richard J. Ptachcinski, PharmD, BCPS, FCCP

INSIDE mental HEALTH: STRESS MANAGEMENT

28 Counseling Patients on Stress Management Shannon Irene Burke, PharmD

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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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 © 2013 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.

Address all editorial correspondence to: ccollins@engagehc.com Telephone: 732-992-1892 Fax: 732-992-1881 Inside Pharmacy 1249 South River Rd, Suite 202A Cranbury, NJ 08512 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 mentioned 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.

December 2013

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Vol 1, No 2

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

Helping Patients Overcome the Sticker Shock to Come

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

R

etail pharmacists will find 2014 to be a very interesting and challenging year. In the face of declining third-party reimbursement rates, we expect more of our customers to have prescription benefit coverage through the new insurance exchanges. In addition to those who are new to healthcare insurance coverage, millions more with existing coverage will switch healthcare providers or will have their employer

Expect your patients to ask about the price of the medications they have been prescribed before you fill the prescription, and be prepared for the patients who will elect to abandon the prescription at pickup because of the high price. select a new prescription benefit provider. These changes will impact pharmacists as these new prescription benefit coverage designs will expand patient consumerism in ways we have not seen before.

Deductibles, coinsurance, and therapeutic inter-

change (alternatives) will be 3 areas where pharmacists have the opportunity to engage patients and help them to maximize the benefits of their prescription coverage.

The new exchange plans offer high deductibles and coinsurance that may very well create sticker shock as patients are exposed to the “actual cost” of the medication. Coinsurance will become more frequently seen with the more expensive specialty medications.

Expect your patients to ask about the price of the medications they have been prescribed before you fill the prescription, and be prepared for the patients who will elect to abandon the prescription at pickup because of the high price. High deductibles and coinsurance will prompt your patients to ask questions about formulary options, generic alternatives, partial quantities, and other ways to manage their out-of-pocket medication expenditures. Aside from generic substitution, these issues will result in additional prescriber calls to discuss therapeutic alternatives that may be covered, in a preferred tier, or that have a lower out-of-pocket cost to the patient.

Although this is yet another nonreimbursed activity, consider it a chance to bond with a new pharmacy visitor or cement a relationship with an existing patient.

Similar to the introduction of Medicare Part D 8 years ago, retail pharmacists will be called upon to smooth out the rough spots at the program’s introduction and help patients to make the most of their new prescription drug benefit coverage. n

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Vol 1, No 2

Inside Healthcare

Insurers Are Rattled Going into 2014— What Will Be the Impact on Retail Pharmacy?

By Charles E. Collins, Jr, MS, MBA

I

n our inaugural issue, I talked about our US healthcare delivery system bracing for a sea change in 2014. Well, it turns out my column for this issue will be no different, except that more changes have now been implemented as a result of the rocky rollout of the Affordable Care Act (ACA).

As reported by the Wall Street Journal, there have been a string of 7 deadlines that have shifted since the infamous October 1, 2013, start date, all in the attempt to “jump-start” a law that no one was truly ready to implement to the fullest extent in the first place. From the insurers’ perspective, what’s the real impact of the false starts, restarts, canceled policies, reinstated policies, new federal healthcare exchange options, private exchange options, and now the offering of “catastrophic” plans, as well as numerous deadline tweaks for signing up for coverage?

Sadly, it is the need to decipher the old coverage, the new coverage, or the old-new coverage, as well as the need for validation, verification, member attrition, member retention, and processing enrollments before all of the deadlines really hit. Not to mention the fact that the foundational rock of the individual mandate, the one that requires most Americans to carry health insurance or pay a penalty, may begin to crumble. We won’t even discuss the Medicaid expansion, which is expected to initially outpace the federal exchange enrollment by 9 million versus 7 million in 2014, according to the Congressional Budget Office.

That’s how the insurance world has been rattled by the ever-changing “tweaks” to the ACA. But what’s the impact on the world of retail pharmacy? After attending a few recent industry meetings, the outlook for the pharmacy industry will be a direct result of the chaos that has been created for the insurance industry. For retail pharmacists, it is rather normal for the first 2 weeks of January of any year to have to deal with changes in insurance for many of their customers—especially Medicare

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

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recipients, who have always had the option of choosing a new drug prescription benefit plan on an annual basis.

The sea change is about to hit retail pharmacists, and it will hit hard. After several discussions with the heads of corporate retail chains, it has become unmistakably clear that this will not be the normal 2-week process to get customers converted to their new prescription benefit plans but, instead, it will more likely be a 4-month process. Given the insurance industry changes that must be dealt with coupled with the fact that individuals still have until March 31 to get health insurance for 2014, our healthcare delivery system has created the perfect storm of absolute chaos.

Besides the normal process of telling customers how their insurance plans have changed, a more prominent specter will continue to emerge that will most likely change how the pharmacist will need to “come out from

Brace yourselves and your team, because the next 4 months—and perhaps beyond— will be filled with unpleasant conversations as we all prepare to navigate the turbulent waters of the implementation of the ACA. behind the counter.” I am referring to the meteoric rise in high-deductible health plans, which even the federal exchange offerings could not escape. Gone are the days when you, as a retail pharmacist, would tell your customers that they owed a $10, $15, or $25 copay or even a 25% coinsurance on their prescriptions. What you will now find yourself saying more often than not will be along the lines of “that will be $132 or $254 because you have not met your deductible.”

So brace yourselves and your team, because the next 4 months—and perhaps beyond—will be filled with unpleasant conversations as we all prepare to navigate the turbulent waters of the implementation of the ACA. n

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INSIDE CARDIOMETABOLIC: DIABETES

A New Weapon in the Fight Against Diabetes: SGLT2 Inhibitors

By Ben Culpepper, PharmD; and Lucas Berenbrok, PharmD

KEY POINTS There are 25.8 million patients with diabetes in the United States

➤

In addition, 79 million Americans are classified as having prediabetes

➤

Diabetes is a risk factor for cardiovascular disease, hypertension, kidney disease, blindness, neuropathy, and amputation

➤

Ben Culpepper

Lucas Berenbrok

D

iabetes is a disease state that is both psychologically and economically draining on the patient and on the economy as a whole. According to the American Diabetes Association (ADA), there are 25.8 million people in the United States living with diabetes, with an even greater prevalence in minority populations.1 An additional 79 million people are classified as having prediabetes.1 Long-term effects of the disease include cardiovascular disease, hypertension, kidney disease, blindness, neuropathy, and amputation.1 In addition to the physical burden that diabetes can bring, there is also a large financial burden that accompanies this disease. In 2012, the total cost of diabetes was $245 billion, which includes direct medical costs and reduced productivity.1 The medical expenditures of patients with diabetes are more than twice as much as those without the disease.1

The treatment options for diabetes are plentiful. However, despite the plethora of treatment options available, adequate glycemic control is still difficult to achieve.

A New Treatment Option The treatment options for diabetes are plentiful.

However, despite the plethora of treatment options available, adequate glycemic control is still difficult to achieve. According to the ADA and the American Association of Clinical Endocrinologists, treatment Dr Culpepper is a PGY-2 pharmacy resident and Dr Berenbrok is a PGY-1 pharmacy resident, University of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC.

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In 2012, the economic toll of diabetes on the US market was $245 billion in direct medical costs and reduced productivity

➤

Some patients may need to take multiple medications to help combat the disease

➤

A novel drug class was recently introduced to the US market when the FDA approved canagliflozin in March 2013

➤

starts with lifestyle changes. After that, medication therapy is initiated, mostly with metformin and then other agents added on when appropriate. Some patients may need to use multiple medications to help combat the disease.2 The common drug classes include biguanides, dipeptidyl peptidase (DPP)-4 inhibitors, sulfonylureas, and thiazolidinediones. Recently, a novel drug class was introduced to the US market, when the US Food and Drug Administration (FDA) approved canagliflozin (Invokana) in March 2013.3 Canagliflozin is the first FDA-approved drug in its class, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. It is dosed at 100 mg before the first meal of the day and may be titrated up to 300 mg daily. This medication class works in the proximal tubule of the kidneys and promotes the renal excretion of glucose, thereby lowering the blood glucose levels of the patient.4 In terms of ability to lower hemoglobin A1c levels, studies have shown that SGLT2 inhibitors decrease A1c levels by 0.5% to 0.7%, which is comparable to the DPP-4 inhibitors. In addition to lowering blood glucose, the benefits of SGLT2 inhibitors include reduced blood pressure, weight loss, increased high-density lipoproteins, and decreased triglycerides.5 Conversely, prescribers and pharmacists should be

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A New Weapon in the Fight Against Diabetes

aware of some significant side effects that are associated with SGLT2 inhibitors. Hyperkalemia has been seen, especially in patients using potassium-sparing diuretics and medications that inhibit the renin-angiotensinaldosterone system (ie, angiotensin-converting enzyme [ACE] inhibitors and angiotensin receptor blockers [ARBs]). This may be common because both ACE inhibitors and ARBs are common medication classes prescribed to patients with diabetes.

In addition to hyperkalemia, there is an increased incidence in vaginal candidiasis, genital infections, and urinary tract infections. This is because of the glycosuria that is precipitated by these medications. These infections should be monitored and treated appropriately.

Increased low-density lipoprotein levels have also been observed with this medication. Because canagli­ fl­ ozin works in the kidneys, it is contraindicated in patients with severe renal impairment, end-stage renal disease, or those on dialysis.4

Emerging SGLT2 Inhibitors Several other agents in the SGLT2 inhibitor class are seeking FDA approval in the United States. In 2011, the FDA chose not to approve dapagliflozin, citing reports of associated cases of breast and bladder cancer and liver injury. Since its initial denial by the FDA, dapagliflozin has been approved in Europe and is currently awaiting FDA approval after resubmitting a New Drug Application (NDA) in July 2013.6 Boehringer Ingelheim and Eli Lilly have also submitted an NDA for empagliflozin in March 2013.6 It is still unknown exactly where this new drug class will fit in, in terms of treating patients with diabetes.

Because of the associated side effects and the mechanism

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with other options that have equal efficacy. For now, it does not seem that this class is a game-changer, but it is simply another potential option to choose for patients with diabetes. Time will tell exactly where this medication will fall in the treatment of diabetes. n

References

1. American Diabetes Association. Economic costs of diabetes in the United States in 2012. Diabetes Care. 2013;36:1033-1046.

2. Garber AJ, Abrahamson MJ, Barzilay JI. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013;19(2):327-335.

3. US Food and Drug Administration. FDA approves Invokana to treat type 2 diabetes. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848. htm. Accessed September 12, 2013.

4. Invokana [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2013.

5. Musso G, Gambino R, Cassader M, et al. A novel approach to control hyperglycemia in type 2 diabetes: sodium glucose co-transport (SGLT) inhibitors: systematic review and meta-analysis of randomized trials. Ann Med. 2012;44:375-393.

6. Eli Lilly. Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment [press release]. March 25, 2013.

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It is still unknown exactly where this new drug class will fit in, in terms of treating patients with diabetes. Because of the associated side effects and the mechanism of action, prescribers should be careful when selecting patients for this class of medication.

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of action, prescribers should be careful when selecting patients for this class of medication. As more data become available on this drug class, long-term effects will be determined that may increase its use. Currently, there are other treatment options with more evidence behind them, and prescribers may be more comfortable

December 2013

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INSIDE CARDIOMETABOLIC: DIABETES

Counseling Patients on the Use of Insulin Pen Devices

By Keri Medlin, PharmD, FASCP

T

wo landmark studies, the Diabetes Control and Complications Trial and the United Kingdom Prospective Diabetes Study, have shown the importance of glycemic control in patients with type 1 or type 2 diabetes to help minimize macrovascular and microvascular complications.1 Insulin is the drug of choice in many patients with diabetes used to help achieve glycemic control. However, insulin use in the United States is often underutilized because of the stigma and other barriers associated with the use of vials and syringes.

Throughout the years, insulin delivery systems have been ever-changing as new technology is developed.

Insulin was first discovered in the 1920s and the delivery system utilized glass vials and reusable needles (sharpened with a pumice stone).1 Sterilization by boiling both the needles and syringes was required before use. Insulin vials and syringes were used for more than 60 years before the introduction of the insulin pen in 1985.1 The first insulin pen, NovoPen, was a metal reusable pen that was loaded with insulin cartridges.1 This allowed patients with diabetes to have the freedom to continue with their active lifestyles. Although there are a few reusable insulin pens still available, advancements in technology have since replaced the insulin reusable pen with disposable plastic prefilled pens (Table).2 Insulin pens are an option for many patients and can be simpler to administer compared with a vial and syringe. As insulin pen delivery devices are becoming more popular in the community, what do pharmacists need to know to tell their patients who are new to insulin pens?

Supplies Needed for Insulin Injection If patients have previously been using the insulin vial and syringe method, then they are used to injecting themselves several times a day. But what if they are new to injection? First, patients need to understand what supplies they will need for self-injection before they are ready for the injection, including: • Insulin pen (checking the label if prescribed more than 1 insulin pen) Dr Medlin is a clinical/consultant pharmacist with Kerr Health in Raleigh, NC.

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KEY POINTS Insulin pens are an option for many patients and can be simpler to administer compared with a vial and syringe

➤

Newer recommendations have suggested that initial insulin therapy should begin with shorter needles

➤

There is no clinical reason to recommend pen needles longer than 6 mm

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An insulin pen that is currently being used should be stored at room temperature (cooler than 86°F)

➤

Opened insulin is stored at room temperature and will last about 1 month

➤

• Pen needle • Alcohol swabs • Sharps container.

For patients using mixed insulin, remind them that their insulin will be cloudy and the insulin pen should be rolled 10 times between their hands and then flipped 10 times to make sure it is mixed thoroughly.3

Attaching the Pen Needle There are several companies that manufacture pen needles. Pen needles are chosen by the healthcare provider based on their compatibility to the insulin pen, the gauge and length desired, and the cost. Newer recommendations have suggested that initial insulin therapy should begin with shorter needles. There is no clinical reason to recommend pen needles longer than 6 mm.4 (Remember: the bigger the gauge number, the thinner the needle.) The pen needle has several components: the outer shield, the inner shield, the pen needle, and the paper tab. The directions for installing the pen needle onto the insulin pen are5: 1. Wash hands 2. Pull cap off insulin pen 3. Wipe rubber stopper with alcohol swab 4. Remove the paper tab from the outer shield 5. Push the needle onto the pen and twist until it is tight 6. Pull the outer shield off and put it aside (it will be needed later to remove the needle from the pen) 7. Pull the inner shield off. Remind your patient that a

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Counseling Patients on the Use of Insulin Pen Devices

new pen needle should be used for each injection to help minimize the risk of infection and pain.

Priming the Pen The pen needs to be primed prior to each use, because it ensures that the pen is working properly and removes any trapped air bubbles.4 The patient should dial 2 units on the pen and then press the button to shoot some insulin into the air (this is often referred to as an “air shot�).

If the 2 drops of insulin are not seen after repeated priming and ensuring proper placement of the pen needle, the pen should not be used because this indicates that there may be a problem with the pen.

Sometimes when the pen needle is added to the pen some insulin drops may be seen, but this does not mean that the pen has been primed; priming still needs to be performed before the injection. Once the pen has been primed, the patient is ready to self-inject.

Steps for Injecting 1. Pick an injection site. The following sites are recommended for insulin injection because of the amount of subcutaneous tissue under the skin and the minimal number of nerve endings in these areas: the abdomen, the back of the arms, the outer thighs, and the upper buttocks or hips. Insulin absorption does differ depending on where it is injected. The fastest absorption occurs in the abdomen, followed by the back of the arms, the outer thighs, and the upper buttocks or hips. It is important to recommend that your patients rotate the injection sites daily. This will minimize the risk of hard lumps or extra fat deposits in the area forming as a result of repeated injection in the same area.5 2. Dial the dose. Using the dose knob, patients should dial the desired number of units to inject and view it in the dosing window. If the wrong dose is dialed, the dial can be turned in either direction until the correct number of insulin units are showing in the dosing window.5 3. Sterilize. Patients should wipe the injection area with an alcohol swab and allow the site to dry.5 4. To pinch or not to pinch? If the pen needle is 5 mm or less, then no pinching of the skin is required and the injection can go into the skin at a 90-degree angle.

If the pen needle is longer than 5 mm, pinching the skin to avoid injecting insulin into the muscle is recommended. Remind your patients to make sure that the skin is pulled up and not the muscle. The injection can be at a 90-degree angle or a 45-degree angle to avoid going into the muscle.4,5 5. Press the injection button. Patients should press the injection button in all the way. Patients should slowly count to 5 before the insulin pen is removed to ensure that the entire insulin dose is delivered.5

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Table Insulin Pens Available in the United States Manufacturer

Insulin used

Reusable or disposable?

AutoPen Classic

Owen Mumford

Humalog

Reusable

FlexPen

Novo Nordisk

Levemir; NovoLog; NovoLog Mix 70/30

Disposable

Humalog KwikPen

Eli Lilly

Humalog; Humalog Mix 75/25; Humalog 50/50

Disposable

HumaPen LUXURA HD

Eli Lilly

Humalog

Reusable

NovoPen 3

Novo Nordisk

NovoLog

Reusable

NovoPen Junior

Novo Nordisk

NovoLog

Reusable

Original Prefilled Pen

Eli Lilly

Humulin N; Humulin 70/30

Disposable

SoloSTAR Pen

SanofiAventis

Apidra; Lantus

Disposable

Pen (name)

Adapted from Consumer Guide 2014. Diabetes Forecast. January 2014. www.diabetesforecast.org/2014/Jan/images/insulin-penchart-2.pdf.

6. Remove the needle from the insulin pen.

Removing the pen needle from the insulin pen after the injection can prevent air from entering the insulin

The pen needs to be primed prior to each use, because it ensures that the pen is working properly and removes any trapped air bubbles. The patient should dial 2 units on the pen and then press the button to shoot some insulin into the air. pen, infection resulting from bacteria entering the pen, and any leakage of insulin. To remove the pen needle, patients should place the outer needle cap onto the pen needle, use it to unscrew the needle from the pen, and then replace the insulin cap on the pen. If needed, the outside of the pen can be wiped with a damp cloth only.5 7. Dispose of the needle. Patients should dispose of pen needles properly in an approved sharps container.

Local regulations should be followed for the proper disposal of used sharps containers.5

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Storage Injecting cold insulin can be painful. Therefore, storing the insulin pen that is currently being used at room temperature (cooler than 86°F) is recommended. If opened insulin is stored at room temperature, it will last about 1 month (some insulin will have different expiration dates—always check the package insert).6

It is a good idea for patients to date the insulin pen once it is opened and review it each time an injection is to occur to ensure that the expiration date has not passed.

It is a good idea for patients to date the insulin pen once it is opened and review it each time an injection is to occur to ensure that the expiration date has not passed. Once the insulin pen has been opened and stored at room temperature, it should not be put back in the refrigerator, as this can cause the insulin to shrink and air to enter the reservoir, resulting in the possibility that a proper dose may not be administered. Unopened insulin

pens should be stored in the refrigerator (36°F to 46°F) until they are ready to use. Instruct your patients to take the new insulin pen out of the refrigerator well ahead of the first use to allow it to warm to room temperature.

Conclusion As pharmacists, our role is to educate and encourage our patients. Insulin pens can be a great alternative for patients who are skeptical of insulin therapy. Knowing the proper injection technique will help patients minimize their fear of injecting and obtain greater glycemic control. n References

1. Selam JL. Evolution of diabetes insulin delivery devices. J Diabetes Sci Technol.

2010;4:505-513.

2. Consumer Guide 2014. Diabetes Forecast. January 2014. www.diabetesforecast. org/2014/Jan/images/insulin-pen-chart-2.pdf.

3. University of Pittsburgh Medical Center. Insulin Pens: How to Give a Shot. www.upmc.com/patients-visitors/education/diabetes/pages/insulin-pens-how-to-givea-shot.aspx. Accessed September 23, 2013.

4. BD Diabetes Professional Resources. www.bd.com/us/diabetes/hcp/main.aspx.

Accessed September 23, 2013.

5. Becton, Dickinson and Company. BD Getting Started: Using Insulin Pens and Pen Needles. 2009.

6. American Diabetes Association. Insulin Storage and Safety. www.diabetes.org/ living-with-diabetes/treatment-and-care/medication/insulin/insulin-storage-andsyringe.html. Accessed September 23, 2013.

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It Will Only Take a Minute: Pharmacists Empowering Patients to Determine Their Risk for Type 2 Diabetes

By Gretchen F. Jenkins, PharmD, BCACP

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t can take as little as 1 minute to make a difference in the life and future of your pharmacy customers. Learn more about a simple tool to get you started.

There are approximately 25.8 million people in the United States living with diabetes; that is 8.3% of the population.1 The alarming facts are that, of that number, approximately 7 million are undiagnosed, and an additional 79 million have prediabetes.1 Type 2 diabetes often goes undetected because of the lack of overt symptoms at the onset of the disease.

Diabetes is diagnosed by a medical provider using a fasting plasma glucose level, oral glucose tolerance test, or hemoglobin A1c value. Therefore, people who do not see their medical provider on a regular basis for screenings and blood work often go undiagnosed for many years. However, disease progression and the comorbidities of diabetes are best minimized through early detection and intervention.

The Pharmacist’s Role Pharmacists, the most accessible healthcare professionals, have the opportunity to raise awareness and educate patients regarding their diabetes risk. The Diabetes Risk Test is a simple tool that provides a risk score for type 2 diabetes, and the best part is that it can be completed in less than 1 minute.2 By reviewing the answers to this screening questionnaire, the pharmacist has a basis for providing therapeutic lifestyle recommendations and a guide for making referrals to medical healthcare professionals. This allows pharmacists to bridge the gap between patients and medical providers within the community.

Screening Tool Published by the American Diabetes Association, the Diabetes Risk Test is comprised of 7 simple questions that help to determine someone’s risk for type 2 Dr Jenkins is a pharmacist with Kerr Drug in Pittsboro, NC.

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KEY POINTS You can make a difference in the life of patients with diabetes by: Describing the rate of undiagnosed diabetes in the United States

➤

Learning about the Diabetes Risk Test for those at risk for type 2 diabetes

➤

Enumerating the risk factors for type 2 diabetes to your pharmacy customers

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Understanding the tool’s use in the community pharmacy setting

➤

Determining when to refer patients at risk to a medical provider

➤

diabetes.2 Each answer is given a point value, which is then used to calculate the overall score. An overall score of 5 or more is indicative of an increased risk for type 2 diabetes.2 This validated diabetes screening tool is not cohort-specific but generalized to the entire adult US population, making it appropriate for any adult encountered within a US pharmacy setting.3

It can take as little as 1 minute to make a difference in the life and future of your pharmacy customers. Learn more about a simple tool to get you started.

Designed to enable the layperson to assess his or her own risk, the tool is very user-friendly and does not need to be administered by a healthcare professional.3 The tool is ideal for use in the community pharmacy setting, because it is noninvasive. This screening may be more widely accepted by patients and pharmacists, because it

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does not require a fingerstick, and pharmacies do not have to maintain a Clinical Laboratory Improvement Amendments waiver to provide this type of diabetes screening.

Pharmacists can provide education to patients in areas where they have identified risk. Making patients aware of the risk factors they cannot change, especially that the risk increases with age, allows them to understand the importance of doing something about the risk they can change.

Eductating Patients Taking this test allows a person to become aware of their modifiable and nonmodifiable risk factors.

Modifiable risk factors include physical activity and weight status. Nonmodifiable risk includes age, sex, family history, and any previous diagnosis of gestational diabetes or high blood pressure.2 Pharmacists can provide education to patients in areas where they have identified risk. Making patients aware of the risk factors they cannot change, especially

that the risk increases with age, allows them to understand the importance of doing something about the risk they can change. This may give patients the motivation to adopt a healthy lifestyle by staying or becoming physically active and maintaining their goal weight.

In addition, pharmacists can be a great resource for patients who want to learn about therapeutic lifestyle modifications by providing education on dietary changes or tips for increasing physical activity.

Conclusion Remember that the Diabetes Risk Test is just a risk-screening tool, and patients should be seen by their medical provider for further testing. People who obtain a score of 5 or more on this screening tool, those who report diabetes-related symptoms, or those who have specific concerns regarding diabetes risk should always be seen by their medical healthcare provider. 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.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed September 13, 2013.

2. American Diabetes Association. Are You At Risk for Type 2 Diabetes? Diabetes Risk Test. www.diabetes.org/diabetes-basics/prevention/diabetes-risk-test/. Accessed September 6, 2013.

3. Bang H, Edwards A, Bomback A, et al. Development and validation of a patient self-assessment score for diabetes risk. Ann Intern Med. 2009;151(11):775-783.

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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.

www.InsidePharmacyOnline.com Inside Pharmacy is a publication of Engage Healthcare Communications, an affiliate of The Lynx Group. © 2013 All rights reserved.

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Nutrition and Exercise for Patients with Diabetes Mellitus

By Todd Paulsen, PharmD, CDE, BCPS

T

here is confusion within the general population about which is the healthiest and most effective dietary regimen. Many “fad” diets—such as lowfat or high-protein—are promoted to cause abnormally large weight reductions, but the reality is that weight frequently returns without the proper amount of exercise.

The concern is compounded for patients with diabetes, because some dietary changes may actually be detrimental. In addition, there are considerations depending upon the patient’s weight, age, comorbidities, and type of diabetes. This section will summarize the current dietary recommendations balanced with exercise for patients with diabetes mellitus.

Visceral Fat and Diabetes The accumulation of abdominal (visceral) fat is highly associated with the development of type 2 diabetes mellitus. Additional consequences of this centralized obesity pattern include hyperlipidemia, hypertension, cardiovascular disease, depression, osteoarthritis, and some types of cancer. The primary source of the problem is continuous insulin resistance.1,2 In normal human physiology, insulin resistance is a protective mechanism that preserves glucose for the brain during periods of starvation. In extended periods without food intake, the liver produces glucose. Insulin is not required for glucose to enter the brain. Peripheral tissues, such as fat or muscle, do require insulin for glucose uptake. During starvation, free fatty acids (FFAs) are released from visceral fat and provide energy for these tissues. The excess FFAs also cause insulin resistance and, in turn, peripheral tissues may not uptake glucose and preserve it for the brain.

In today’s modern lifestyle, humans are often storing excessive visceral fat. This leads to a constant release of FFAs into the bloodstream, causing continuous insulin resistance. To overcome this resistance, pancreatic beta-cells release excessive amounts of insulin.

Ultimately, in susceptible individuals, the beta-cells Dr Paulsen is Senior Medical Liaison, Novo Nordisk, Inc; and Adjunct Assistant Professor, University of Nebraska Medical Center, College of Pharmacy, Omaha, NE.

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“burn out” and die, leading to blood accumulation of glucose and symptoms of diabetes mellitus.

Lifestyle Modifications for Patients with Diabetes To temper insulin resistance, lifestyle modifications that reduce excessive abdominal fat can have pronounced effects on the blood glucose levels of patients with diabetes mellitus, and may delay the onset of fullblown diabetes in individuals with prediabetes. The least invasive mechanism is to promote a healthy balance of reduced caloric intake in conjunction with moderate exercise.1-3 The American Diabetes Association (ADA) recom­ mends individualized therapeutic lifestyle changes in patients with diabetes depending upon their needs.

Those who are overweight can benefit from as little as a 5% to 10% reduction in body weight to reduce insulin resistance. If possible, this should be paired with an

To temper insulin resistance, lifestyle modifications that reduce excessive abdominal fat can have pronounced effects on the blood glucose levels of patients with diabetes mellitus. exercise program that achieves at least 150 minutes per week of moderate activity, including aerobic exercise, flexibility activities, and resistance training. No single dietary program is emphasized, so a reduction plan may include either low-carbohydrate, low-fat calorie-restricted, or Mediterranean-style diets for short-term weight loss for up to 2 years.1,3 Behavior modification with physical exercise and dietary changes together are important to maintain weight loss. Encouraging additional fiber is also recommended. Dietary fiber is minimally absorbed and provides a sense of “fullness.” The ADA endorses the US Department of Agriculture dietary recommendation of 14 g of fiber per 1000 calories. It is also recommended that individuals who are at risk for type 2 diabetes limit their intake of sugar-sweetened beverages.1

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KEY POINTS Type 2 diabetes is strongly associated with abdominal (visceral) fat and insulin resistance

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Exercise and calorie reductions can reduce body weight and, thus, reduce insulin resistance

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Various dietary strategies may be used in the short term for weight loss

➤

Type 1 diabetes generally requires more complex dietary regimens concomitant with multiple daily insulin injections

rated fat intake should be reduced to <7% of the total daily calories consumed, along with a minimal intake of trans fat. Supplementation with antioxidants, such as vitamins C and E, are not recommended, because a long-term benefit has not been established. Alcohol may be consumed in moderation, with a daily maximum of a 1-drink equivalent in women or 2 in men. Large quantities of alcohol can inhibit glucose production and may lead to hypoglycemia.1

➤

Dietary and lifestyle modifications for patients with diabetes mellitus must be individualized depending on weight, age, comorbidities, and the type of diabetes they have

➤

Carbohydrate monitoring is essential to regulating after-meal blood glucose levels and reaching glycemic goals. This can be achieved through carbohydrate counting, making proper dietary choices, or using carbohydrate exchange programs. This process may be confusing for the patient with diabetes and his or her family. For complex regimens, referral to a registered dietitian or nutritionist who is familiar with the components of medical nutritional therapy for patients with diabetes mellitus may be appropriate.

Type 1 diabetes often presents with weight loss because of the absolute lack of insulin.

In addition, type 1 diabetes frequently presents during adolescence, so normal growth and proper nutrition are important considerations.Dietary and lifestyle modifications require even greater caution.

Patients with diabetes who select low-carbo­hydrate diets should be aware of the concerns associated with these diets and their impact on diabetes. These concerns include monitoring lipid profiles, renal function, and protein intake (particularly in those with nephropathy). Hypoglycemic therapy also may need to be adjusted. It is noted that the recommended daily allowance for digestible carbohydrates is 130 g daily; the long-term metabolic effects of daily intake lower than this is unknown.1 To reduce potential atherogenic lipid profiles—such as elevated low-density lipoprotein cholesterol—satu-

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Insulin Regimens and the Patient with Type 1 Diabetes In contrast to most patients with type 2 diabetes mellitus, type 1 diabetes often presents with weight loss because of the absolute lack of insulin. In addition, type 1 diabetes frequently presents during adolescence, so normal growth and proper nutrition are important considerations. Dietary and lifestyle modifications require even greater caution, as the patient with type 1 diabetes produces no insulin at all and often requires more complex insulin regimens.

Most patients with type 1 diabetes will be using insulin regimens that include basal and mealtime (prandial) injections 3 or more times daily, or they may be using continuous subcutaneous insulin infusion. This requires education on how to match prandial insulin doses with carbohydrates, premeal blood glucose levels, and anticipated physical activity. An understanding of carbohydrate quantities associated with each food item is essential and could impact the amount of insulin that is injected with a given meal.

A patient who is receiving a complex dosing regimen of insulin will learn how much glucose reduction occurs with the injection of 1 unit of insulin, taking the premeal blood glucose and the amount of carbohydrates they will be ingesting into consideration.

Patients should know their insulin-to-carbohydrate ratio for meal dosing, as well as the amount of insulin needed as a correctional dose in relation to the premeal blood glucose.

In a hypothetical case, let’s assume that a patient’s insulin-to-carbohydrate ratio is 1 unit of insulin for each 15 g of carbohydrates with the meal. The patient is targeting a glucose level of <130 mg/dL before meals.

For this case, we will calculate a 30-mg/dL reduction for each unit of insulin. For example, before lunch, the glucose level is 161 mg/dL and the meal contains 60 g of carbohydrates. The recommended dose would be 1 unit of correctional dose insulin plus 4 units to control the 60 g of carbohydrates consumed. Thus, 5 units of mealtime insulin will be given. Note that each patient’s requirements and goals are different, and initial therapy often requires estimates.

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Nutrition and Exercise for Patients with Diabetes

Special Concerns Related to Elderly Patients with Diabetes It is important to understand that complex dietary and lifestyle changes may not be appropriate in elderly patients with diabetes. This is particularly true in the long-term care setting, where fall risk secondary to hypoglycemia can be an issue. It is also essential to remember that malnutrition can occur in this setting and, therefore, calorie restriction could be harmful. Balanced diets that provide appropriately portioned sizes are mostly recommended. The “diabetic diet” is no longer recognized as an appropriate physician order.4 Conclusion Pharmacists must understand the complexity of the various lifestyle and dietary regimens and their impact on the patient with diabetes. General knowledge of basic concepts is important. Some pharmacists in clinical settings may be involved with the modification of lifestyle habits to fit an individual patient’s needs. Referring a

patient with diabetes to a registered dietitian or nutritionist is also an option for those patients with greater glycemic control needs. n

Pharmacists must understand the complexity of the various lifestyle and dietary regimens and their impact on the patient with diabetes. General knowledge of basic concepts is important.

References

1. American Diabetes Association. Standards of medical care in diabetes—2013.

Diabetes Care. 2013;36(suppl 1):S11-S66.

2. Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011;17(suppl 2):1-53.

3. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364-1379.

4. American Medical Directors Association. Diabetes Management in the Long-Term Care Setting. Columbia, MD: American Medical Directors Association; 2008; revised 2010.

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Great Expectations? Career Development in Healthcare An interview with a recent pharmacy school graduate

By Robert E. Henry

H

ealthcare 2013. Despite the tremors rattling its foundations amidst major healthcare reform legislation, it is an immensely powerful and productive industry, accounting for 17% of the gross national product, employing countless professionals in a galaxy of stakeholder groups, and spawning countless innovations that save lives and sustain health, particularly when its vast resources are managed properly. The intelligent organization of resources and stakeholder collaboration can provide the very efficiencies sought by legislation and could indeed reduce the need for government intervention to force the right things to happen to curtail costs and to improve outcomes.

Retail pharmacy has long been the quiet giant among stakeholders, yet it has immense power to influence health and affect patients’ awareness of their ability to incorporate health-giving lifestyles. Inside Pharmacy was launched to help galvanize this potential into action. In general, we turn to the seasoned experts for their insights into how to reinvent the profession to remain relevant and to bring value to healthcare as it undergoes its massive paradigm shift. Key opinion leaders (KOLs) understand the science and its practical application, making them an obvious target for our editorial content. We seek their wisdom to advise you, our readers, in establishing the leadership in your field that keeps your eyes on the prize: patient wellness. Pharmacists have considerable untapped potential to “move the dial” in the healthcare system. One tactic is the mantra of Inside Pharmacy: “Come out from behind the counter” and interact with patients, following through on the physician’s initiative and turning a prescription into a passageway for wellness that the patient understands.

Thus, you might expect our interviews to be restricted to KOLs, assuming they have the answers worth hearing.

But a “tabula rasa” provided by recent pharmacy school Mr Henry is President of Glendalough Productions, Inc, and Founding Editor-in-Chief of American Health & Drug Benefits.

graduates brings a useful counterpart to the seasoned professional, indeed providing us with a starting point for addressing their very inexperience, thus bringing clarity of principles before they are hitched to short-term business pressures—and clarity of purpose is nothing to be taken lightly. These graduates are the recipients of today’s updated curricula (which are generated by KOLs). That offers value in hearing their perceptions, their knowledge base, their expectations for healthcare, and their career ambitions offered by the retail pharmacy field as it undergoes a reinvention to stay viable. Entering the field during this time of disruptive innovation must be a mixture of excitement and concern, and we want to capture that. These individuals belong to the future of retail pharmacy, and they should have a voice in the pages of Inside Pharmacy alongside the experts. This month, we interviewed Margo Demeter, PharmD, a highly motivated class of 2013 graduate of Duquesne University, and present her thoughts, aspirations, and concerns as she embarks on her career as a healthcare provider with such extraordinary ability to influence patient health and bring equilibrium to the healthcare system.

Robert Henry: What led you to pursue becoming a retail pharmacist, what opportunities do you see there, and how progressive can its activities be and remain “cutting edge” without becoming “leading edge”?

Margo Demeter: Well, to begin with, my career path may differ from others, for I had 3 years of experience in retail pharmacy work but had planned on doing a residency, not retail. Then I had a rotation at Johns Hopkins in October of last year before I had to decide whether I wanted to do a residency. While I was there, I realized this wasn’t the setting for me. Having worked in retail, I could see that this was where I wanted to stay, preferring the patient interaction it offers over the clinical aspect.

During the entire time I was in the hospital, I didn’t interact with any patients, and I found that this inter­ action mattered quite a lot to me.

Henry: At what point did you realize that retail would bring you the professional satisfaction you sought?

Demeter: The first week I was there, I realized that this wasn’t what I wanted to do. My preceptor also had a pharmacy resident there, and I was able to see everything the resident was going through. She explained to me the Continued on page 20

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VISIT THE NEW ONLINE RESOURCE FOR RETAIL PHARMACY MANAGERS AND THEIR STAFF

“The time is now for you to ‘step out from behind the counter’ and engage your patients.”

Donald J. Dietz, RPh, MS

Vice President Pharmacy Healthcare Solutions, Inc. Editor-in-Chief Inside Pharmacy

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

phArmAcy:

Season? .........................7

INSIDE pATIENT cArE

ristics and Qualities Engaging Patients: Characte ists ...............10 Pharmac Patients Seek of Their

INSIDE phArmAcy mANAGEmENT

Is ness in the US: What Emergency Prepared ...20 l Stockpile? .............. the Strategic Nationa

TABOLIc:

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Weight-Loss Medicat

TABOLIc:

INSIDE cArDIOmE DIABETES

Test for Patients with Demystifying the A1C .............................40 Diabetes ............................

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an affiliate of

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STAKEHOLDERS OTHER HEALTHCARE POLICYMAKERS, AND FOR PAYERS, PURCHASERS,

IN

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SU

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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.

www.InsidePharmacyOnline.com Inside Pharmacy is a publication of Engage Healthcare Communications, an affiliate of The Lynx Group. © 2013 All rights reserved.

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process, the assignments, and the work that she had to do while she was there. She was working very long hours, just as we do in retail, but I felt I wouldn’t be fulfilled by staying in an office and researching patient charts all day. That showed me that this wasn’t the route I wanted to take.

Henry: And what brings you enjoyment now in what you are doing in retail pharmacy?

Demeter: I have been at the same store for about 4 years now, so I know most of our patients that come into the store. I’m able to have conversations with them and know what’s going on in their lives aside from the medication that I’m bringing out to them. I really like being able to make those connections and form those relationships with patients, whereas in the hospital setting I didn’t feel like I could do that, especially because of constant patient turnover. You don’t see the same patients day after day as you do with retail.

Henry: What do you consider to be the greatest opportunities offered by a career in retail pharmacy?

Demeter: In my view, it comes back to what we discussed before, just having that interaction with the patient. This is my number one priority.

Henry: What’s your biggest fear about graduating and starting your pharmacy career? Is there one for you?

Demeter: I think my biggest fear is probably the same as every new pharmacist, and that’s making a mistake.

In some classes in school, we discussed that everyone is human and you are going to make a mistake at some point. But that doesn’t eliminate the fear of it, for I fear that this mistake will actually hurt somebody. So I know that it’s going to happen eventually; I just hope it isn’t anytime soon.

Henry: Is there a system in place in retail pharmacy to prevent mistakes?

Demeter: There absolutely is, at least at the pharmacy that I work at. We have a couple of workstations for people who are data entering the prescription into the system. We have barcode scanning to show the correct drug that was entered in is actually the one that’s being filled. Then, with our system, we’re able to look at the actual hard copy in the computer and see if the data entered into the computer match both to the hard copy and to what is in our system. So, there are several layers of validation that happen.

Henry: What do you consider to be the greatest

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opportunities offered by a career in retail pharmacy?

Demeter: In my view, it comes back to what we discussed before, just having that interaction with the patient. This is my number one priority. In the pharmacy school, one of the first questions they ask is, why did you choose pharmacy? Some people have bad responses like, “Oh, I’m in it for the money,” which is not a good response at all. But I think the main reason why people get into pharmacy is to help people. We’re viewed as drug experts, and we’re probably the most convenient medical healthcare provider for our patients and the most accessible. I think that they value that, and they value the convenience of coming to a pharmacy instead of having to schedule an appointment with their doctor.

I think that they really look to us for guidance for a lot of their healthcare needs.

Henry: Do you consider that the compensation retail pharmacists receive is sufficient for the contribution that they bring to healthcare?

Demeter: I absolutely think it’s sufficient for what we’re doing. I recognize that there is some disparity between different healthcare settings for pharmacists’ compensation, but I think in every setting we are a huge benefit to our patients and the team that we end up working with.

Henry: Do you have any apprehensions about the profession as a whole, given the volatile changes occurring in healthcare?

Demeter: No, I really don’t. I do think that our career is changing very quickly, whereas in the past decade or 2 it was pretty stagnant. But with different advances and paths the pharmacist can take, I think that we are in an environment that is changing constantly. Especially with new healthcare laws, we’re going to have to adapt very quickly to those types of changes and be there for our patients who don’t necessarily understand what’s going on. I think we need to be prepared for that. But I don’t think that’s necessarily an apprehension; I just think that’s where the industry is going.

Henry: In terms of progress or stagnation, how would you say innovation in new molecular entities is faring?

Demeter: I think that there have been huge advances, even within the past couple of years, in new medications, such as personalizing medication for specific patients based on their genome. We aren’t there yet, but that’s where things are heading. Some patients with cancer, for example, can have drugs selected that treat the exact kind of cancer based on the patients’ cellular details, what mutation they have, and how their body will respond to that treatment.

Henry: For a number of disease states, the pharmacist has approximately 85% of small-molecule drugs that are off patent. Where does that leave pharma? What is

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your view of pharma as an innovator of new molecular entities?

Demeter: I think they are going to have to start tackling some of the more complicated disease states now to stay innovative in various types of treatment methods.

But whatever they do to remain useful, just relying on extended-release versions of existing drugs is not the answer. That flies in the face of the kind of new drug innovation that existed back in 1975.

Henry: So where is drug innovation most needed and able to grow?

Demeter: I think that the innovations in biologictype medications is where innovation is going, and that tackling more complex disease states like the cancers and orphan diseases will be their mainstay for the foreseeable future. I think we’re entering the era of more complex disease states such as rheumatoid arthritis, multiple sclerosis, and different cancers.

Henry: What advice would you give to students just beginning pharmacy school?

Demeter: For myself personally, I think going into pharmacy school, I didn’t really know what to expect.

Our first year of pharmacy school, they attempted to weed out a lot of us, scaring us with all of the course work that we had to do, and that was absolutely our hardest year. My most important advice is that if you can get through that year, you can definitely make it through pharmacy school; it isn’t as scary as it seems. But you also need to be aware of what you’re interested in. If you realize early on that you want to take one path or another, you should get involved and try to mold yourself to becoming the best pharmacist that you can be by getting involved in things that you’re interested in. There are many different pharmacy organizations that can help students along the way. My best advice is to get involved, and try to figure out exactly what you want to do before your last year.

Henry: What does your typical day look like now?

Demeter: In a retail setting, the majority of the time is spent checking prescriptions and getting them out to the patients. The pharmacy where I work is working on medication therapy management (MTM), but we aren’t billed for MTM. We make a lot of phone calls to patients to ensure that they are getting the medications they need on time. If they’re past due, we get an alert saying this medication should have been filled, and we contact the patient to see if they need it refilled. We go out of our way to make sure that our patients are staying adherent to their medications to ensure better health outcomes. I think that a lot of our time, besides filling prescriptions, is spent on trying to contact these patients and making sure that they’re getting all the medications they need.

We also have other programs in place. One is a pro-

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gram for adapting care, so if we have a diabetic patient who is not on an angiotensin-converting enzyme or an angiotensin receptor blocker, we get a flag. We then have to call the prescriber to see if this was an oversight and if they should be on either type of medication. The rest of the day we spend calling doctors for refills, calling them regarding high-dose alerts, and then just talking with our patients when they come in to pick up their medications.

Henry: Does it follow that the pharmacist of tomorrow, or even of today, should be looking for ways to continue the dialogue that’s been initiated by the physician? Is that a valid way of regarding how the role of the pharmacist might be changing over time?

Demeter: I absolutely think so, and I know when I first started in pharmacy school, our professors kept saying, “In retail pharmacy, you won’t be needed as much, and they might just change to technicians to check prescriptions.” I think that retail pharmacists have been moving more toward just being able to talk with their patients about their medications in light of the MTM process. I think that being able to discuss with them all of the issues, concerns, or problems that they have with their medicine will be very valuable to them. I definitely think the future pharmacists are leaning that way.

At least with my store, patients love going online and being able to see all the prescriptions they have, what refills they need, when they should get their refill, and being able to call them in.

Henry: Perhaps technology could be very useful in equipping you to reach out to your patients. I can foresee keeping in touch with your patients through smartphone technology, apps, and the like that just require a little direction from the pharmacist community. Could this, perhaps, be where the future of pharmacist career modification is going to be headed?

Demeter: Yes, I definitely think so. I think that tech­ nology is a huge thing that our patients look for and appreciate. I know that, at least with my store, patients love going online and being able to see all the prescriptions they have, what refills they need, when they should get their refill, and being able to call them in. I think that the automation of doing that is something they definitely like, and if a pharmacist is available through technology, through smartphones and things like that, that they would definitely utilize that.

Henry: Aside from obvious areas such as adherence, are there any other areas of knowledge that you would

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envision being able to help the patient understand that they have a bearing on their health?

Demeter: I think that being knowledgeable about the different legislation that is occurring right now would absolutely benefit our profession, especially the patient-centered medical home. I did a project on that at one of my rotations, and that was the first time that I really delved into the topic and figured out what it was and how it could help patients. Once Medicare starts deciding that they are going to pay for this type

As pharmacists, we need to be at the forefront of that and explain to them that this side effect happened in 1 in 1000 patients. It must be put into perspective— not trivialized, but made realistic. Every step you take to be treated or healed will bring an element of risk, but so too is doing nothing. of service, I think that the pharmacist, in talking with the physician, is the best relationship that patients can have—one that will ultimately impact their outcomes and definitely optimize their therapy just by having those open lines of communication. I think one of the biggest downfalls of our healthcare system is that it is so hard for a patient to be able to talk to any type of healthcare provider at their doctor’s office, even if they just have a question. I know whenever I’m trying to make doctor calls at the pharmacy, they have those automated prompts and you have to choose a number for whatever you need, but then it turns into a voicemail. If in this patient-centered medical home system, they’re going to be available 24 hours/7 days a week for their patients, I think that is something that definitely needs to be started and implemented, and I think pharmacy will definitely be a huge part of that.

Henry: For the past 50 years or so, adherence had been looked at as a problem that physicians around the globe were trying to resolve, yet nobody seems to have gotten through to patients as to its importance. Is it more a matter of distrust that patients have toward the side effects of medications, or is it just that they are trying to save money? Is it because they think that they’ve actually been healed and are better?

Demeter: You know, I think it’s a combination of all those things, and I think that’s why it’s so hard for us to make sure that all of our patients are adherent. I know that, with the copays and the price of the medications, it is definitely a huge deterrent for keeping these patients

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adherent, especially ones who have trouble making monthly copays. I also think that with the amount of counseling we have to do, and the amount of information we need to give our patients about these medications that they’re taking, it definitely scares them away sometimes. I’ve had patients who have come in and said, “I just went online and saw that this is the side effect of this medication. I don’t want to take it anymore. I called my doctor to switch me to something else.” So I think especially in this day and age with the technology and the access that patients have to things on the Internet, they can definitely get scared away from things that will actually help them.

As pharmacists, we need to be at the forefront of that and explain to them that this side effect happened in 1 in 1000 patients. It must be put into perspective—not trivialized, but made realistic. Every step you take to be treated or healed will bring an element of risk, but so too is doing nothing, and the patient has to learn how to deal with both types of risk. They have to know that it exists, but that it’s not necessarily going to happen to all or most patients.

Henry: Taking good care of the patient will be good for business, but only if it does not interfere with the processing of prescriptions, too—it must be a balancing act. Are there areas where pharmacists can be penalized for taking the time to talk with patients, and could that be an impediment to the patient getting that interaction that we have been discussing? In short, must the decision to interact with the patient have managerial, even corporate, support before attempting it?

Demeter: I absolutely think so. I don’t know if it’s a blatant penalization of the pharmacist, but I know that, at least at my pharmacy, we have certain metrics that we need to meet, which include our wait times and making sure the prescriptions are out on time. So, if a pharmacist is being graded on that, and your bonus depends on whether you get the prescriptions out or not, I think that will become more of a focus for them throughout the day than necessarily counseling every patient who walks in the door. I think that if that is a focus of the retail companies, then we might need to have 2 pharmacists on duty—1 who can check and 1 who can counsel—just so we offer our patients everything they need.

Henry: And again, never forgetting, always hanging in the background, is technology. How it can help reduce the amount of time that would come out of attending to each individual patient. Hence the need for technology to help take some of the strain off the pharmacists, enabling them to use that technological ally to help them do the special services you’re talking about. So it’s getting interesting, isn’t it?

Demeter: It certainly is. n

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INSIDE HEALTHCARE OPERATIONS

Reducing Hospital Readmissions: A New Opportunity for Community Pharmacists

By Toni Fera, BS, PharmD; and Richard J. Ptachcinski, PharmD, BCPS, FCCP

A

ccording to the Centers for Medicare & Medicaid Services (CMS), about 1 in 5 patients receiving Medicare who are discharged from a hospital are readmitted within 30 days.1 A portion of these readmissions are believed to be preventable, although estimates vary widely. An analysis of 2005 Medicare claims data by the MedPAC (Medicare Payment Advisory Commission) concluded that about three quarters of readmissions within 30 days were potentially preventable, representing an estimated $12 billion in Medicare spending.1 Hospitals have implemented numerous strategies to reduce preventable readmissions, including better preparing patients for discharge, improving patient education about home medications, and improving communication about care transitions. Some interventions have shown improvements, but the changes have been slow and the results have been variable. Despite these efforts, between 2008 and 2010 there was little change in the 30-day readmission rate for 3 conditions (Table).

Pursuant to provisions in the Affordable Care Act, CMS has identified avoidable readmissions as 1 of the leading problems facing the US healthcare system.

Congestive heart failure, acute myocardial infarction, and pneumonia were identified as the top 3 diagnoses contributing to readmissions.2 In 2012, CMS began to penalize hospitals with high rates of readmissions related to these 3 conditions. The penalty is calculated using a complex formula based on the amount of Medicare payments received by the hospital for the excess readmissions. The penalty cap is set at 1% of payments for the first year, 2% for the second year, and 3% for each year thereafter.

For the first 2 years (fiscal years 2013 and 2014), the penalty applies to readmissions of Medicare patients aged 65 years and older with diagnoses of congestive heart failure, acute myocardial infarction, or pneumonia. In 2015, these will be expanded to include patients who are Dr Fera is an independent healthcare consultant with American Pharmacotherapy, Inc; Dr Ptachcinski is the president of American Pharmacotherapy, Inc.

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KEY POINTS Approximately 1 in 5 Medicare beneficiaries who are discharged from a hospital are readmitted within 30 days

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Almost 75% of readmissions within 30 days are potentially preventable, representing an estimated $12 billion in Medicare spending

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Improved patient education can help transition to home self-care and reduce readmissions

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Pharmacists can help prepare patients for hospital discharge by educating them about home medications

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A hospital or accountable care organization can profit by investing in pharmacy resources to prevent readmission

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Pharmacists should partner with health plans and providers to develop programs to improve care quality and reduce readmissions

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admitted for acute exacerbation of chronic obstructive pulmonary disease, as well as for patients admitted for elective total hip and knee replacements.3 In an effort to increase transparency, there are also public reporting requirements that will make this information available to health plans and patients.

Hospitals, health plans, and quality improvement organizations have all implemented programs that have successfully reduced hospital readmissions. There seems to be general agreement that there is a significant op­ portunity to reduce readmissions and realize a positive return on investment by integrating pharmacist services into the care-transition process. Historically, however, financial incentives have not provided payment for these services. As payment models, such as shared savings programs associated with accountable care organizations (ACOs) evolve, there are new opportunities for pharmacists to contribute to improved patient care and reduced costs. Some key points to consider are: • Medication adherence is an important factor in the

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management of chronic disease, and a significant number of patients do not adhere to the medication regimens they are prescribed • There are many effective traditional and evolving roles of pharmacists in medication management supported by published results, including medication reconciliation, discharge counseling services, medication therapy management/adherence, and patient self-management programs • A variety of successful care transition models exist, and several published models have included pharmacists. The models that have included pharmacists have generally had an impact on decreased hospital admissions, readmissions, and emergency department visits4-7 • There is some potential benefit to establishing innovative care transition models that include both hospital- and community-based pharmacists.

In 2010, America’s Health Insurance Plans published a report that described several new programs that health plans have implemented to address problems with readmissions, particularly for patients with chronic diseases.8 Several of the successful programs described the integration of pharmacists, and 1 key trend that was noted was that the pharmacists’ role was becoming even more important as time goes on.

In some cases, it may be more desirable and profitable for a hospital or an ACO to invest in their own pharmacy resources to develop similar readmission prevention programs that would be staffed with an ambulatory care pharmacist who could coordinate that part of care with discharge planning and home care nurses. However, in a recent article published in Health Affairs, Smith and colleagues describe a pharmacy network model where “a pharmacist or group of pharmacists [is] contracted by the ACO or payer to provide medication management services for specific patients. A contracted pharmacist may meet with a patient in person in the medical home, a community pharmacy, or the patient’s home or via an interactive video connection, depending on the complexity of the patient’s drug regimen and the intensity of pharmacist services required.”9 It would seem that this vision supports an expanded role for community pharmacists in new models of care and care transitions.

Examples of community pharmacists collaborating with healthcare organizations and health plans are becoming more common; for example, Walgreens offers its WellTransitions program. The program offers a prescription review process, bedside medication delivery, a follow-up phone call within 9 days of discharge, and outcomes reporting.

Early results indicate that WellTransitions has been effective. Walgreens reports that, within the first 6

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Change in 30-Day Readmission Rates Following Table Discharge for 3 Causes of Hospitalization, 2008-2010 Percentage of Readmissions Condition

2008

2010

Relative change, %

Congestive heart failure

21.4

21.1

–1.4

Acute myocardial infarction

18.7

18.1

–3.2

Pneumonia

15.3

15.3

<0.5

months of the program’s implementation at 5 hospitals, patients had a 9.4% unadjusted rate of 30-day readmission, compared with a 14.3% 30-day readmission rate for patients eligible for but not participating in the program.10 CVS Caremark also offers an integrated readmission prevention program for its members in partnership with Dovetail Health, a healthcare management company based in Massachusetts. The group recently contracted with Aetna for these services.11,12 One advantage of these types of partnerships is that they provide a broad reach and the ability to manage large numbers of patients. A limitation of health plan partnerships is that services will be limited to only those patients covered under the plan.

The “bedside pharmacy” program implemented at the Western Maryland Health System in collaboration with PharmaCare, a local retail pharmacy chain, is an example of a hospital organization and community pharmacy collaboration.13 The focus of the program is on educating patients at discharge about the importance of medication adherence. The pharmacist visits patients in their rooms—thus coining the new term “bedside pharmacy”—and checks each patient’s chart to review key information and reconcile home and hospital medications. The pharmacist counsels each patient about their medication regimen and contacts the patients after discharge. Patients are also given the option to receive their discharge medications from PharmaCare or from another pharmacy. Results have thus far been positive; readmissions decreased 28% in the first year of the program. Also, patient satisfaction results with discharge instructions improved from about 65% to more than 90%.

There are other examples of independent pharmacies partnering with hospitals to address the problem of readmissions. Grove City Medical Center, a small community hospital in Grove City, PA, has created a “Home with Meds” program that provides patients with

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a 1-month supply of medications at discharge, with their local pharmacist following up. Of note, the hospital met the standard for readmissions and did not see any readmission penalties in 2013.14 It is anticipated that these models will continue to grow and evolve, and the financial incentives are beginning to align to support the expansion of partnerships between community pharmacists, healthcare organizations, and health plans. While not necessarily designed to address readmissions alone, 16 of 107 CMS Health Care Innovation Awards include mention of a role for pharmacists; 2 specify collaborations with community pharmacists.15

The Pharmacy Society of Wisconsin received an award that expands the successful Wisconsin Pharmacy Quality Collaborative.

Participating pharmacists will work collaboratively with physicians and other prescribers to target patients with diabetes, chronic heart failure, asthma, and geriatric syndromes.

The Pharmacy Society of Wisconsin received an award that expands the successful Wisconsin Pharmacy Quality Collaborative. Participating pharmacists will work collaboratively with physicians and other prescribers to target patients with diabetes, chronic heart failure, asthma, and geriatric syndromes. Regional implementation specialists and clinical pharmacists will train community pharmacists across the state. The results of this and other innovations will hopefully support continued expansion of pharmacist integration into new care and payment models.

Under current payment models, making the business case for community pharmacist involvement is challenging. There are opportunities to collaborate with a local hospital or health system, existing pharmacy network, pharmacy schools, and health plans that may be willing to outsource versus hiring additional staff to provide pharmacy care transition services. Existing programs

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primarily include a fee-for-service model or increasing prescription volume by including a discharge prescription counseling and delivery service.

Conclusion The current focus on improved care transitions and readmission reduction efforts offers an opportunity to develop or expand community pharmacist services.

Pharmacists should seek opportunities for collaboration with health plans and provider organizations and develop programs to reduce readmissions and improve quality of care. n References

1. Health Affairs. Health Policy Briefs: Medicare Hospital Readmissions Reduction Program. November 12, 2013. www.healthaffairs.org/healthpolicybriefs/brief.php? brief_id=102. Accessed December 17, 2013.

2. Goodman DC, Fisher ES, Chang C-H. The Revolving Door: A Report on Hospital Readmissions. Robert Wood Johnson Foundation; February 2013. www.rwjf.org/ content/dam/farm/reports/reports/2013/rwjf404178. Accessed December 17, 2013.

3. Centers for Medicare & Medicaid Services. Readmissions Reduction Program.

August 2013. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Acute InpatientPPS/Readmissions-Reduction-Program.html. Accessed December 17, 2013.

4. Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178187.

5. Al-Rashed SA, Wright DJ, Roebuck N, et al. The value of inpatient pharmaceutical counseling to elderly patients prior to discharge. Br J Clin Pharmacol. 2002;54:657-664.

6. Stewart S, Pearson S, Horowitz JD, et al. Effects of a home-based intervention among patients with congestive heart failure discharged from acute hospital care. Arch Intern Med. 1998;158:1067-1072.

7. Walker PC, Bernstein SJ, Jones JN, et al. Impact of a pharmacist-facilitated hospital discharge program; a quasi-experimental study. Arch Intern Med. 2009;169:2003-2010.

8. Americaâ&#x20AC;&#x2122;s Health Insurance Plans Center for Policy and Research. Innovations in Reducing Preventable Hospital Admissions, Readmissions, and Emergency Room Use: An Update on Health Plan Initiatives to Address National Health Care Priorities. June 2010. www.ahip.org/uploadedFiles/Content/Departments/Policy_ and_Research/Innovations_Report_Series/Innovations-2010-Report.pdf. Accessed December 17, 2013.

9. Smith M, Bates DW, Bodenheimer TS. Pharmacists belong in accountable care organizations and integrated care teams. Health Aff (Millwood). 2013;32:1963-1970.

10. Walgreens. Services for Businesses. www.walgreens.com/healthcare/business/ ProductOffering.jsp?id=wellTransitions. Accessed December 17, 2013.

11. Aetna collaborates with CVS Caremark and Dovetail health to help members manage their prescriptions [press release]. Needham, MA: Dovetail Health; August 22, 2013. www.dovetailhealth.com/newsroom/articles-and-press-releases/bid/70432/ Aetna-Collaborates-With-CVS-Caremark-and-Dovetail-Health-to-help-membersmanage-their-prescriptions. Accessed December 17, 2013.

12. Dovetail Health. Dovetail Programs/Transition Management. www.dovetail health.com/our-programs/transition-management/. Accessed December 17, 2013.

13. Balch J, Pirolozzi J. Community and Hospital Pharmacy Collaborate to Reduce Readmissions. Dublin, OH: Cardinal Health. www.cardinalhealth.com/us/en/ essential-insights/best-practices/community-hospital-pharmacy. Accessed December 17, 2013.

14. Twedt S. Few hospitals meet standards for reducing readmissions. Pittsburgh Post Gazette. January 18, 2013. www.post-gazette.com/businessnews/2013/01/18/ Few-hospitals-meet-standards-for-reducing-readmissions/stories/201301180196.

Accessed December 17, 2013.

15. American Pharmacists Association. Pharmacy well represented in Innovation Center awards. Pharmacy Today. July 2012. www.pharmacist.com/node/28185.

Accessed December 17, 2013.

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

Call for submissions

TM

?

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.

Submit to: lneuman@the-lynx-group.com IP step out_Asize_010814

INSIDE mentAL HEALTH: STRESS MANAGEMENT

Counseling Patients on Stress Management

By Shannon Irene Burke, PharmD

S

tress is something that most people deal with on a routine basis. In some instances, stress is seen as good, because it provides the drive and energy to accomplish goals.

However, prolonged stress that goes unaddressed or untreated can lead to a host of side effects that can affect physical, emo­ tional, and mental health.

When you are speaking with patients, it is impor­ tant to identify what triggers their stress. Is it an inter­ nal stressor, such as an infection, illness, or excessive worry? Or is it an external stressor, such as an abusive relationship, pain, or deteriorating working conditions?

Identifying the root cause of your patients’ stress will help you to steer them in the right direction for stress management.

How Stress Affects the Body By demonstrating how stress affects the different systems in the body, you can convey to your patient its profound and lasting effects. For example, acute stress can

The first step to managing stress is to identify the triggers. Distinguishing between an internal stressor and an external stressor will change your recommendation for stress management methods

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Sometimes the best way to get patients to manage their stress is by pointing out how it is affecting their body. Over time, stress can cause long-lasting effects, such as heart attacks, migraines, and impotence

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Stress management should be handled through lifestyle changes and restructuring priorities

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Exercising, meditation, relaxation techniques, and cognitive behavioral therapy are some recommended stress reduction methods

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Some over-the-counter medications claim to relieve stress, but they tend to come with many side effects and a potential for drug interactions

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Most drugs only have indications for anxiety, not stress

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cause the heart rate to increase, resulting in more force­ ful contractions of the heart muscle. Blood vessels then dilate as more blood is pumped to other organs in the body. Over time, the continuous dilation of the coronary arteries and prolonged stress on the cardiovascular system

may lead to an increased risk of having a heart attack.

Stress can also trigger muscles to tense, resulting in headaches and migraines. What many people do not know is that chronic stress can also cause changes in cor­ tisol levels, which impacts many systems, including the reproductive system. In men, this can result in decreased testosterone levels and sperm count, potentially resulting in such consequences as impotence. In women, cortisol changes can lead to irregularities in the menstrual cycle and decreased sexual desire.1-3 Stress can also alter a person’s emotions, resulting in mood and behavioral fluctuations that can affect work and family relationships. Examples include decreased work efficiency or productivity, hiding poor performance from others, excessive defensiveness or suspiciousness, problems with communication and sharing, social with­ drawal, and isolation.1-3

Dr Burke is a clinical pharmacy specialist with Evolent Health, LLC, Arlington, VA.

Stress Management Techniques Once the patient has identified that there is a

When you are speaking with patients, it is important to identify what triggers their stress. Is it an internal stressor, such as an infection, illness, or excessive worry? Or is it an external stressor, such as an abusive relationship, pain, or deteriorating working conditions?

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problem, there are many strategies available to reduce stress that do not include medication. Some examples of stress management mechanisms are as simple as restructuring one’s priorities and making some simple lifestyle changes.

Exercising is a great way to reduce stress, because it releases endorphins in the brain, benefiting the patient’s overall physical health, and acting as a distraction from the stressors. Cognitive behavioral therapy is another option that includes identifying the sources of patients’ stress, restructuring their priorities, changing their response to stress, and then finding methods for managing and reducing their stress.

Relaxation techniques are a helpful way to reduce stress and can help patients work through stressful situ­ ations. Some examples of relaxation techniques include deep breathing exercises, meditation, biofeedback, and massage therapy.

Finally, sometimes the easiest way to reduce stress is to adhere to healthy habits. Encourage your patients to invite humor into their lives. Although finding humor in a stressful situation is not easy, laughing has been proven to reduce stress hormone levels. You can also suggest that patients express their feelings with family and friends, try to accept that there are things in life that cannot be changed, try not to sweat the little things in life, help others, and get enough sleep.2-4

Warn Your Patients about Natural Remedies Herbal remedies claim to help lower stress, but their clinical effects have not been proven. As pharmacists, it is important that we stress to our patients that any herbal medications they take can interact with their disease states, as well as any medications they take for those disease states, potentially causing devastating side effects.

One natural remedy is aromatherapy, specifically lavender, which has been recognized to have a calm­ ing effect. However, some patients should be cautious when using this herb, because some of the lavender oils have ingredients that have been linked to skin allergies.

Another natural remedy is the herb valerian because of its sedating properties; however, it also can have delete­ rious effects, such as altering the effects of other sedatives or causing vision changes and abnormal heart rhythms.

Kava has been frequently used for stress, but in recent years it has been shown to cause liver damage. Patients should be wary of over-the-counter (OTC) products that promise quick-fix cures, and they should always

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consult with their physician before starting any new medications.3

Prescription Medications for Anxiety Should Be Used as a Last Resort There will be some patients who attempt lifestyle modifications and OTC medications but do not achieve adequate results. While coping methods and preventive measures are always preferred, there are prescription medications available to treat anxiety. These include benzodiazepines and antidepressants, such as tricyclic antidepressants, selective serotonin reuptake inhibi­ tors, and serotonin-norepinephrine reuptake inhibitors.

Beta-blockers are used off-label as well, along with hydroxyzine and barbiturates. Because of the potential for abuse, however, barbiturates are rarely used today.

It is important for the patient to understand the difference between stress and anxiety, and that while medications are helpful for many health conditions, stress is not typically one of them.

It is important for the patient to understand the difference between stress and anxiety, and that while medications are helpful for many health conditions, stress is not typically one of them.3 Most important, make sure that your patient under­ stands that there is no “quick fix” for stress. Regardless of the remedy that the patient chooses, it will take time—and sometimes several rounds of trial and error— to adequately control the symptoms of stress. Encourage your patients to keep you updated on their progress and to check in with you regularly so that you can continue to assist them in managing their stress. n

References

1. The American Institute of Stress. 50 Common Signs and Symptoms of Stress. Fort Worth, TX: The American Institute of Stress. www.stress.org/stress-effects/. Accessed November 3, 2013.

2. Simon H. Stress. Baltimore, MD: University of Maryland Medical Center. 2013. http://umm.edu/health/medical/reports/articles/stress. Accessed November 3, 2013.

3. American Heart Association. Fight Stress with Healthy Habits. Dallas, TX: American Heart Association. 2011. www.heart.org/HEARTORG/GettingHealthy/ StressManagement/FightStressWithHealthyHabits/Fight-Stress-with-HealthyHabits_UCM_307992_Article.jsp. Accessed November 3, 2013.

4. American Heart Association. Four Ways to Deal with Stress. Dallas, TX: American Heart Association. 2011. www.heart.org/HEARTORG/GettingHealthy/ StressManagementFourWaystoDealWithStress/Four-Ways-to-Deal-with-Stress_ UCM_307996_Article.jsp. Accessed November 3, 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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Products are not to scale and color may vary. ©2014 Amneal Pharmaceuticals LLC. All rights reserved. ESPA-0114bPH