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Call for submissions

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Do you have a best practice to share?

In your background as a retail pharmacist, chain executive, independent pharmacy owner, physician assistant, or nurse practitioner, it’s likely there’s one clinical and/or business experience – and maybe more – that other colleagues inside the pharmacy and clinics 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 pharmacies.

Send us your ideas!

Submit a 750- to 1500-word original article, previously unpublished and submitted exclusively to Inside Patient Care: Retail Clinic Healthcare Solutions, that your fellow colleagues will want to read.

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The ideas and opinions expressed in Inside Patient Care: Retail Clinic Healthcare Solutions do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher. Publication of an advertisement or other product mentioned in Inside Patient Care: Retail Clinic Healthcare Solutions should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

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MISSION STATEMENT Inside Patient Care: Retail Clinic Healthcare Solutions™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics. As primary care expands to provide optimal access to quality care, Inside Patient Care: Retail Clinic Healthcare Solutions™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success. Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care, including how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers. Contact information: For subscription information and editorial queries, please contact: info@insidepatientcare.com; tel: 732-992-1895; fax: 732-992-1881. RETA #1 AM IL CL ONG INIC IANS

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PATIENT CARE ❚ June 2015

June 2015 VOL. 3 • NO. 6

32 Five Tips to Keep

Children Healthy During the Summer

33 HPV Vaccination

for Boys and Young Men

36 Medical Care

2015 Standards for Diabetes

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Empowering Community Pharmacists as Health Consultants: Ten Hot Topics to Foster Delivery of Quality Patient Care A 10-PART SERIES

The publishers of Inside Patient Care are proud to present Empowering Community Pharmacists as Health Consultants: Ten Hot Topics to Foster Delivery of Quality Patient Care series.

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32 Five Tips to Keep Children Hea lthy During the Sum mer 33 HPV Vaccin ation for Boys and You ng Men 36 Medical Car e 2015 Standards for Diabetes

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Topics include: • Diabetes • Detection and Control of Hypertension: Role of the Community Pharmacist

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FREE CPE CREDIT

• Improving Women’s Health with Pharmacist-Led Osteoporosis Screening and Medication • Closing the Loop: Pharmacist-Assisted Management of Asthma • Pharmacist’s Perspective on the Management of Irritable Bowel Syndrome • Pharmacist Involvement in the Management of Chemotherapy-Induced Nausea and Vomiting • Community Pharmacist Intervention in Noncancer Pain Management • Common Dermatologic Conditions: Pharmacists’ Perspectives • Spectrum of Rheumatologic Diseases: Pharmacists’ Perspectives • Community Pharmacists’ Role in Medical Management: Case-Based Illustration of Polypharmacy in the Geriatric Population

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June 2015 Volume 3 Number 6

INSIDE

Health & Wellness

19 WEIGHT-LOSS INTERVENTIONS LINKED TO BETTER BODY IMAGE

And other concise reviews of studies on health and wellness

Patient Care

32 FIVE TIPS TO KEEP CHILDREN HEALTHY AND ACTIVE DURING THE SUMMER MONTHS

In addition to improving mental and physical health, these tips include suggestions for keeping your children healthy and active this summer.

33 HPV VACCINATION FOR BOYS AND YOUNG MEN: ADDRESSING MISCONCEPTIONS AND EXPANDING UPTAKE As one of the most common sexually transmitted infections in the United States, human papillomavirus (HPV) vaccination awareness is important in the community.

The Pharmacy 36 MEDICAL CARE 2015 STANDARDS FOR DIABETES

Three take-aways community pharmacists and clinicians can use in their practice today

Money

39 DISABILITY INSURANCE PLANNING FOR THE HEALTHCARE TEAM

This article briefly describes the steps necessary to begin shopping for individual disability insurance coverage, which features should be included in your policy, and areas where one carrier may differ from another.

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What’s Old Is New Again… Biosimilars Are a Repeat of Yesterday’s Generics

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9 LETTER FROM THE EDITOR 13 THE VITALS 23 FREE CE ACTIVITY 43 DRUG UPDATE 50 PRODUCTS & SERVICES

COVER STORY I WELLNESS

Changing Patients’ Health Behaviors with Clever Interventions Providing around-the-clock care to meet patients’ healthcare needs ❚R  eview the gaps in patient care to change

health behavior and the role of virtual health assistants ❚ Learn about the solutions available to providers to address gaps in care ❚ Understand health behavior, including different theories and models ❚ Remember the importance of the clinician– patient relationship ❚ Become familiar with companies specializing in consumer-focused virtual health assistants Inside Patient Care: Retail Clinic Healthcare Solutions, ISSN (requested), is published 12 times a year by Novellus Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Copyright © 2015 by Novellus Healthcare Communications, LLC. All rights reserved. Inside Patient Care: Retail Clinic Healthcare Solutions is a trademark of Novellus 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. RETA #1 AM IL CL ONG INIC IANS

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InsidePatientCare.com

RETAIL CLINIC HEALTHCARE SOLUTIONS

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Online First

QUESTIONS ANSWERED WITH PAMELA B. EDWARDS, EDD, MSN, RN-BC, FABC, CNE, CENP In this interview, Dr Edwards discusses the peer-to-peer projects at Duke University, and the role of the entire healthcare team in improving patient outcomes. Dr Edwards is Associate Chief Nursing Officer of Education at Duke University Health System, Duke Clinical Education & Professional Development; Associate Consulting Professor and Associate Director at the Institute for Educational Excellence at the Duke University School of Nursing; and Deputy Director of the Duke Area Health Education Center Program. Read more at InsidePatientCare.com. uu

Poll Results

Media Library

online

Top Headlines Trending Online

#1 Counseling Patients on the Use of Insulin Pen Devices Keri Medlin, PharmD, FASCP http://goo.gl/l4p8Jd

#2 Engaging Patients: Characteristics and Qualities Patients Seek of Their Pharmacists Elliott M. Sogol, BS Pharm, PhD, FAPhA http://goo.gl/3SwBXB

#3 Pharmacy Accreditation: Establishing Discipline and Consistency Matt Manning, PharmD http://goo.gl/Ts3v7x

#4 Diversifying Pharmacy Revenues: Opportunities for Growth and Differentiation Kevin C. Day, PharmD, and John O. Beckner, RPh http://goo.gl/fPX69b

#5 Questions Answered with David Neu, President of Good Neighbor Pharmacy http://goo.gl/9aXb7M

PHARMACY OPERATIONS: TAKING INITIATIVES IN THE WORKPLACE

100% of the voters voted yes 0% of the voters voted no Last month, we asked our readers whether they routinely consult with patients picking up prescriptions. The question was based on the May feature article on how to manage patients with miscarriages.

James S. Beaumariage, RPh, Principal at Beaumariage Consulting, LLC, Franklin, MA, and editorial board member of the journal, discusses the value of pharmacy staff members who show initiatives in the workplace. More webcasts available at InsidePatientCare.com

join us online

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Medical Directors • Physician Assistants • Nurse Practitioners • Pharmacists • Chain Headquarters • Independents

Retail pharmacies and clinics are quickly becoming an extension of primary care. Inside Patient Care : Retail Clinic Healthcare Solutions is tailored to meet the growing needs of the entire healthcare team and provides practical information to treat and care for patients inside the pharmacy and retail clinics.” Donald J. Dietz, RPh, MS

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

RETA 1 AMON IL CLIN G ICIAN #

Inside Patient Care: Retail Clinic Healthcare Solutions™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics.

S

InsidePatientCare.com

June 2015 VOL. 3 • NO. 6

32 Five Tips to Keep Children Healthy During the Summer

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33 HPV Vaccination for Boys and Young Men 36 Medical Care 2015 Standards for Diabetes 39 Disability Insurance Planning for the Healthcare Team

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© 2015 Novellus Healthcare Communications, LLC

As primary care expands to provide optimal access to quality care, Inside Patient Care: Retail Clinic Healthcare Solutions™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success.

CYCLING

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Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers.

InsidePatientCare.com PATIENT ❚ Group. June 2015 InsidePatientCare.com Inside Patient Care is a publication of Novellus Healthcare Communications, LLC, an affiliate of CARE The Lynx © 2015 All rights reserved.

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the Editorial Board

The board members contribute expertise and analysis that help shape the content of Inside Patient Care

“ PAGE 11

As time has shown, pharmacists are well-equipped to adapt to whatever changes they may face.”

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

James S. Beaumariage, RPh Principal Beaumariage Consulting, LLC Franklin, MA John O. Beckner, RPh Senior Director, Strategic Initiatives National Community Pharmacists Association Alexandria, VA Mitch Betses, RPh Senior Vice President Retail Pharmacy Services CVS Caremark Corporation Woonsocket, RI

Kevin James, RPh, MBA Vice President of Payer Strategy US Bioservices, Frisco, TX Alexandra Jung Principal, Advisory Services Ernst & Young, LLP; former Senior Vice President Corporate Strategy, Walgreens Jack Kelly, RPh National Director Managed Markets & Trade Relations Arbor Pharmaceuticals, LLC Scott L. Kemme Vice President/General Manager, Chain Segment McKesson Pharmacy Systems & Automation Livonia, MI

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

Kevin Letz, DNP, MBA Chairman/Founder Advanced Practice Provider Executives

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

Tripp Logan, PharmD Vice President Logan & Seiler, Inc, Charleston, MO

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

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

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

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

Albert Garcia Executive Vice President Navarro Health Services, Medley, FL Mark J. Gregory, RPh Vice President Healthcare Solutions Ateb, Inc , Raleigh, NC

Ernie Richardsen, RPh, MBA Group Vice President Pharmaceutical Purchasing and Clinical Services Rite Aid Corporation, Camp Hill, PA Debbie Sheppard Vice President, Sales and Marketing Ateb, Inc, Raleigh, NC

—Donald J. Dietz, RPh, MS

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

EDITORIAL CONSULTANTS PEDIATRICS Marc Drummond, PsyD, MBA Clinical Psychologist, Managing Partner Creekside Natural Therapeutics Erin J. Hoffman, MPAS, PA-C Assistant Professor Nebraska Medical Center, Omaha, NE

Stacie Lampkin, PharmD, BCPA, AE-C Assistant Professor D’Youville College School of Pharmacy Women and Children’s Hospital, Buffalo, NY

GASTROINTESTINAL HEALTH

Lisa Cervantes, PA-C

UW Health Clinics Digestive Health Center, Madison, WI WELLNESS

Barbara Campbell, RPh, CCN

Pharmacist and Certified Clinical Nutritionist People Rx, Austin, TX DERMATOLOGY

Debra Shelby, PhD, DNP

President National Academy of Dermatology Nurse Practitioners IMMUNIZATION

Kim Curry, PhD, ARNP-C

Clinical Associate Professor College of Nursing, University of Florida Gainesville, FL

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Letter from the Editor The Impact of Wellness on Healthcare by FREDERIQUE H. EVANS, MBS, Editorial Director, Inside Patient Care: Retail Clinic Healthcare Solutions

With summer just around the corner, many of us are trying to be better about sticking with our workout routines, healthier diets, and methods for improvement and upkeep of wellness. }} }} ACCORDING TO THE Centers for Disease Control and Prevention, approximately 900,000 Americans die prematurely every year from 1 of the 5 leading causes of death: heart disease, cancer, chronic lower respiratory diseases, stroke, and unintentional injuries.1 Twenty percent to 40% of the deaths from each of these causes are preventable. Some of the modifiable risk factors for heart disease, for example, include tobacco use, high blood pressure, high cholesterol, type 2 diabetes, poor diet, being overweight, and lack of physical activity. Other risks are related to additional factors, such as social, environmental, and economic influences. These risks may be avoided by first making, and then keeping up with, changes in personal behaviors. In this issue of the journal, our featured article pertains to wellness and the use of virtual health assistants (VHAs) as a clever means to changing patients’ health behaviors. “VHAs have the ability to reach patients on a daily basis—multiple times a day even—significantly expanding the reach of healthcare professionals, and allow patients to be informed about their own health, and make data-based choices,” Thomas Morrow, MD, explained (see “Changing Patients’ Health Behaviors with Clever Interventions,” on page 15). We also provide concise reviews of studies on wellness, as well as a

patient tip outlining ways to keep children healthy and active during the summer months. Wellness also comprises prevention of, and promoting awareness about, preventable diseases in the community. In this issue, Peter A. Newman, PhD, and Ashley Lacombe-Duncan, MSW, explain the importance of raising awareness of human papillomavirus (HPV) vaccinations for boys and young men. In particular, the authors discuss HPV prevention and treatment, as well as factors associated with low HPV vaccination rates, and how to address barriers to HPV vaccination in boys and young men (see “HPV Vaccination for Boys and Young Men: Addressing Misconceptions and Expanding Uptake,” on page 33). In another article, Samantha Yovanoff, PharmD, provides 3 takeaways pharmacists and retail clinicians can use in their practice today regarding the American Diabetes Association’s Standards of Medical Care in Diabetes. She urges healthcare professionals to reassess blood pressure goals, and to review the updated recommendations for preprandial glucose range and pneumococcal immunization. “The role of the pharmacist is ever expanding to include increased patient counseling and clinical services,” she stated (see “Medical Care 2015 Standards for Diabetes,” on page 36). We also have a great article fea-

turing practical information for the healthcare team about how to plan for disability insurance. This article includes an overview of the steps necessary to begin shopping for individual disability insurance coverage, as well as what should be included in your policy and how certain carriers may differ from one another (see “Disability Insurance Planning for the Healthcare Team,” on page 39). We are also introducing a new section in the journal showcasing our offerings at InsidePatientCare.com. This month, we are providing an interview with Pamela B. Edwards, EdD, MSN, RN-BC, FABC, CNE, CENP, who discusses the peer-to-peer projects at Duke University, and the role of the entire healthcare team in improving patient outcomes. This interview will be available online first, and appear in our upcoming issue. We also provide results from regular polls online, in addition to webcasts from key opinion leaders and editorial board members (see page 6). We hope that you enjoy reading through this issue of Inside Patient Care: Retail Clinic Healthcare Solutions, and look forward to receiving your comments about the journal, and specific articles we have published. ❚

Reference

1. Centers for Disease Control and Prevention. Up to 40 percent of annual deaths from each of five leading US causes are preventable. www.cdc.gov/media/releases/ 2014/p0501-preventable-deaths.html. Updated May 1, 2014. Accessed June 4, 2015. RETA #1 AM IL CL ONG INIC IANS

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Inside Patient Care™ Is Now Available Online! Features: • Latest Issue

• Article Submission

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The First Word What’s Old Is New Again… Biosimilars Are a Repeat of Yesterday’s Generics by DONALD J. DIETZ, RPH, MS; DAVE SCHUETZ, RPH; and ANN JOHNSON, PHARMD

I

The similarities between the first generic drugs and biosimilars are present not only in uptake and prescribing, but also in patient cost implications.”

n 1984, Congress adopted the Drug Price Competition and Patent Term Restoration Act of 1984— also known as the Hatch-Waxman Act1—and shaped the modern world of generic drugs as we know it. Before the act was passed, generic drug companies were required to perform the same time-consuming and costly clinical trials as brand manufacturers, and were often subjected to costly patent infringement lawsuits. Prior to the Hatch-Waxman Act, abbreviated new drug applications (ANDAs) did not exist, and all drugs were required to navigate the new drug application approval process.2 If this sounds familiar, you were either a practicing pharmacist in 1984, or you have noticed a similarity between the challenges generic drugs initially faced and what is occurring with biologics today. Prior to the creation of the 351(k) biosimilar drug application, bringing “generic” biologics (eg, tbofilgrastim) to market was time-consuming and expensive.3 With the 351(k) application process, what was old is new again.

3 factors to consider: ❚ The Orange Book has become the mainstay in many states’ pharmacy practice laws ❚ Unlike generic drugs, substituting for biosimilars will likely require patient and physician notification in most states ❚ The majority of plans today only provide 1 tier level for specialty drugs

History Repeats Itself When generic drugs were first introduced to the market in the 1980s, product uptake was slow. Physicians and pharmacists were concerned with the quality, sourcing, legality, and potential savings associated with generics. It took almost 5 years for generics to gain wide acceptance and become imbedded in prescribing culture. We are currently seeing the same initial apprehension with biosimilars, as physicians and pharmacists eval-

uate products’ similarities and savings potential for patients and payers. Much like with the first generic drugs, it may take some time before stakeholders determine whether products are the same. However, with the rapid dissemination of information about the potential cost-savings for biosimilars, we could anticipate a much shorter time frame until acceptance (eg, 1 or 2 years). Will manufacturer differences impact biosimilar products, and will batch variations cause relevant differences? Only time will tell.

The Purple Book A generation ago, to assist pharmacists and prescribers with becoming comfortable with generic products and their therapeutic equivalence, the US Food and Drug Administration (FDA) issued guidance documents4 and published the Orange Book.5 The Orange Book assured practitioners that generics were therapeutically equivalent and substitutable for corresponding brands. For biosimilars, the FDA has published the Purple Book6 (known as the Orange Book for biologRETA #1 AM IL CL ONG INIC IANS

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The First Word ics). Although some states currently use a positive or negative formulary for drug substitution, the Orange Book has become the mainstay in many states’ pharmacy practice laws. As more states begin to pass biologic and biosimilar substitution laws, it is likely that the Purple Book will begin appearing in legislative verbiage as well. Unlike generic drugs, substituting for biosimilars will likely require patient and physician notification in most states; but even now, many state laws require that pharmacies post signs notifying patients of generic substitution requirements.

Cost Implications The similarities between the first generic drugs and biosimilars are present not only in uptake and prescribing, but also in patient cost implications. During the 1980s, most pharmacy benefits provided coverage for patients at a single-tier level (eg, all drugs cost $5, regardless of their brand or generic status). With time, payers evolved and created plans with multiple tier levels for generics, preferred brands, and nonpreferred brands.7 However, the majority of plans today only provide 1 tier level for specialty drugs. Thus, biologics and biosimilars will likely initially be covered at the same copay/coinsurance level—albeit for a much higher cost than the $5 of the 1980s. In time, it is expected that payers will create additional tier levels to further systemize their payment structure, and

it will not be uncommon to see plans with multiple specialty tiers that differentiate biosimilars and traditional biologics.

contracts with payers. As time has shown, pharmacists are well-equipped to adapt to whatever changes they may face. ❚

The similarities between the first generic drugs and biosimilars are present not only in uptake and prescribing, but also in patient cost implications.

References

Conclusion History seems to be repeating itself in the pharmacy world; the creation of the 351(k) application closely shadows the first ANDA approvals of the 1980s. From substitution, legislative, and payer perspectives, many of the similarities are uncanny. However, although the differences between a brand and generic drug in the 1980s may have produced a cost-savings of $20, the proposition today of a 30% biosimilar savings means that biosimilars could provide a cost-savings of hundreds or even thousands of dollars, which may speed up biosimilar acceptance. We should also expect brand manufacturers to compete with biosimilars by coordinating rebate

1. Congress.gov. S.Res.287 - Honoring the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 (the HatchWaxman Act). www.congress.gov/bill/111th-congress/ senate-resolution/287. Accessed May 18, 2015. 2. Congress.gov. S.2926 - Drug Price Competition and Patent Term Restoration Act of 1984. www.congress. gov/bill/98th-congress/senate-bill/2926?q=%7B%22 search%22%3A%5B%22Drug+Price+Competition+ and+Patent+Term+Restoration+Act+of+1984%22% 5D%7D. Accessed May 18, 2015. 3. US Department of Health & Human Services; US Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Guidance for industry reference: product exclusivity for biological products filed under Section 351(a) of the PHS Act. www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM407844.pdf. Published August 2014. Accessed May 18, 2015. 4. US Food and Drug Administration. Guidance documents for drug applications. www.fda.gov/Drugs/ DevelopmentApprovalProcess/ucm090361.htm. Updated December 10, 2014. Accessed May 18, 2015. 5. US Food and Drug Administration. Orange Book preface. www.fda.gov/Drugs/DevelopmentApprovalProcess/ ucm079068.htm. Updated March 14, 2014. Accessed May 18, 2015. 6. US Food and Drug Administration. Purple Book: lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/Approval Applications/TherapeuticBiologicApplications/ Biosimilars/ucm411418.htm. Updated April 30, 2015. Accessed May 18, 2015. 7. Blue Cross Blue Shield of Michigan. How do drug tiers work? www.bcbsm.com/medicare/help/under standing-plans/pharmacy-prescription-drugs/tiers.html. Accessed May 18, 2015.

Mr Dietz is Editor-in-Chief of Inside Patient Care: Retail Clinic Healthcare Solutions, and Vice President, Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA; Mr Schuetz and Dr Johnson are Consultants, Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.

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theVitals STATIN USE INCREASES RISK FOR DIABETES COMPLICATIONS Statins, which are used for the prevention of cardiovascular disease in healthy adults, may be linked to higher risks for diabetes, diabetes complications, and obesity, according to recent data. Although previous research has linked statin use to higher risks for diabetes, this is the first report to implicate its use with higher risk for diabetes complications. Ishak Mansi, MD, Department of Medicine, Veterans Affairs North Texas Health Care System, Dallas, and colleagues conducted a retrospective cohort study to evaluate the relationship between statin use and new-onset diabetes, diabetic complications, and being overweight/obese among healthy adults. Study participants were TRICARE beneficiaries evaluated between October 1, 2003, and March 1, 2012. Patients with preexisting cardiovascular conditions, elements of the Charlson comorbidity Index (eg, diabetes mellitus), or life-limiting diseases at baseline were excluded from the study. Among 25,970 healthy adults identified, 3982 were statin users, and 21,988 were non­ users. Patients taking statins had higher odds of new-onset diabetes (odds ratio [OR], 1.87), diabetes complications (OR, 2.50), and being overweight/ obese (OR, 1.14). The study authors noted that these results suggest that short-term clinical trials may not fully describe the risk/benefit of primary interventions with long-term statin use. Mansi I, Frei CR, Wang CP, Mortensen EM. Statins and new-onset diabetes mellitus and diabetic complications: a retrospective cohort study of US healthy adults. J Gen Intern Med. 2015 Apr 28. Epub ahead of print.

Examining the News Affecting Pharmacy & Clinics

GRIP STRENGTH PREDICTOR OF MORTALITY, CARDIOVASCULAR DISEASE Evaluating grip strength could be a simple and inexpensive method to determine all-cause mortality, cardiovascular death, and cardiovascular disease. Data from a recent study even suggest that it is a stronger predictor than systolic blood pressure. To evaluate the independent prognostic value of grip strength, Darryl P. Leong, PhD, from the Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada, and colleagues conducted a large, longitudinal population study including 17 countries with varying incomes and sociocultural settings: the Prospective Urban Rural Epidemiology (PURE) study. Patients were included in the study if ≥1 household members were aged 35 to 70 years, and if members of the household planned to stay at their address for another 4 years. Grip strength was evaluated using a Jamar dynamometer. Data pertaining to all-cause mortality, cardiovascular mortality, noncardiovascular mortality, myocardial infarction, stroke, diabetes, cancer, pneumonia, injury due to fall, and fracture were collected. Hospital admission for any respiratory disease (eg, asthma, chronic obstructive pulmonary disease [COPD], tuberculosis, pneumonia) was also evaluated. Overall, 142,861 participants were enrolled in the study between January 2003 and December 2009; median follow-up was 4 years, and 2% of the patients died (3379 of 139,691). Grip strength was inversely associated with all-cause mortality, cardiovascular mortality, noncardiovascular mortality, myocardial infarction, and stroke. No significant association was seen between grip strength and incident diabetes, risk of hospital admission for pneumonia or COPD, or injury from fall or fracture. However, grip strength was positively associated with cancer risk in highincome countries. Leong DP, Teo KK, Rangarajan S, et al; Prospective Urban Rural Epidemiology (PURE) study investigators. Prognostic value of grip strength: findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet. 2015 May 12. Epub ahead of print. RETA #1 AM IL CL ONG INIC IANS

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theVitals SMOKING, MENTAL HEALTH LINKED TO FREQUENT ED VISITS Smokers are 4 times more likely to frequently visit the emergency department (ED) than nonsmokers, according to researchers. In addition, psychiatric illness and substance abuse tripled the likelihood of patients visiting the ED 3 or more times annually. “There are 12 million [ED] visits each year related to behavioral health diagnoses,” Jessica Castner, PhD, RN, Assistant Professor, University at Buffalo School of Nursing, NY, and colleagues explained. “Frequent ED utilization among subpopulations, such as those with behavioral health diagnoses, flags the need for more accessible and effective healthcare delivery systems.” As part of this retrospective analysis, the investigators stratified patients by overall health complexity, and examined the relationship between behavioral health diagnoses (eg, psychiatric and substance abuse) and frequent treat-andrelease ED use in a cohort of >50,000 Medicaid patients (age, 18-64 years). Data were collected from 2009 Medicaid claims from 2 western New York State counties and patients were stratified into 4 cohorts based on underlying disease complexity (healthy, at risk for chronic disease, diagnosed with chronic disease, and diagnosed with a system failure). Overall, psychiatric diagnosis (odds ratio [OR], 1.4-2.3), substance abuse (OR, 2.4-3.8), and smoking (OR, 1.7-4.0) were significantly associated with increased odds of frequent treat-andrelease ED use across all 4 cohorts. These data demonstrate that Americans with chronic diseases visit their primary care providers and go to the ED. In addition, the investigators report that medical care visits have increased in the past few years. Patients may visit the ED more frequently as they get greater access to health insurance, and could impact health insurers, patients, and the healthcare systems as a whole, according to the study authors. Castner J, Wu YW, Mehrok N, et al. Frequent emergency department utilization and behavioral health diagnoses. Nurs Res. 2015;64:3-12.

TELEMEDICINE COST-EFFECTIVE IN PEDIATRIC PATIENTS Although telemedicine is costly to implement and maintain, recent research suggests that it provides significant cost-savings compared with telephone consultations to the healthcare providers of acutely ill children who visit rural emergency departments (EDs). The costs of telemedicine have not been comprehensively evaluated in this patient population, according to Nikki H. Yang, DVM, MPVM, PhD, Department of Pediatrics, University of California, Davis (UC Davis) Children's Hospital, and colleagues. They reviewed data from the Pediatric Critical Care Telemedicine Program at UC Davis, including interactions with 8 rural EDs between 2003 and 2009, and evaluated cost, effectiveness, and return on investment. Asthma, bronchiolitis, dehydration, fever, and pneumonia were the 5 diseases evaluated. Dr Yang and colleagues found that the average cost of a telemedicine consultation was $3641 per child, per ED, annually in 2013. Telemedicine resulted in 31% fewer patient transfers compared with telephone consultations; the cost reduction was $4662 per child/ED/year. In addition, cost-effectiveness analysis demonstrated that telemedicine consultations were less costly than telephone consultations in 57% of simulation iterations. Costsavings in many cases were associated with savings accrued from reduced transfers between hospitals, including via air ambulance. Overall, telemedicine reduced the number of patient transfers by 31%. Further analysis indicated a $1.96 return for each dollar invested in telemedicine. Yang NH, Dharmar M, Yoo BK, et al. Economic evaluation of pediatric telemedicine consultations to rural emergency departments. Med Decis Making. 2015 May 7. Epub ahead of print.

HEALTHCARE POLICY

5 FACTS ABOUT ESSB 5557 1/ The legislation Engrossed Substitute Senate Bill (ESSB) 5557 recognizes pharmacists as providers, and was signed into law by Jay Inslee, governor of the state of Washington. 2/ It requires that health insurance carriers include pharmacists as network providers.

3/ The legislation was passed with overwhelming bipartisan support, and is the first of its kind in the country to mandate coverage of pharmacists’ patient care services.

4/ Before this legislation, pharmacists were recognized for dispensing medication by most health insurance carriers, and patients were not covered for healthcare services they received from pharmacists.

5/ At the federal level, the Pharmacy and Medically Underserved Areas Enhancement Act was introduced to the House (H.R. 592) and the Senate (S. 314) early this year. (1) American Pharmacists Association. Washington state signs provider status legislation into law, recognizes pharmacists as providers. www.pharmacist.com/washington-state-signs-provider-status-legislation-law-recogniz es-pharmacists-providers. Published May 15, 2015. Accessed May 29, 2015. (2) Washington State Legislature. SB 5557 – 2015-16. http://app.leg.wa.gov/billinfo/summary.aspx?bill=5557. Updated May 29, 2015. Accessed May 29, 2015.

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INSIDE

HEALTH & WELLNESS

Concise reviews of studies on health and wellness [19]

Health & Wellness

Cover Story

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Changing Patients’ Health Behaviors with Clever Interventions

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DISTANCE CYCLING Providing around-the-clock care to meet patients’ 30:00 5.44 mi healthcare needs

by THOMAS MORROW, MD

Grounded in behavioral theory, powered by artificial intelligence, and nurtured with natural language processing, virtual health assistants (VHAs) are capable of conversing with a person about his or her health. }} }} THEY CAN PROVIDE education, assist in motivation, break down tasks so people will actually consider doing them, track and trend health data, provide summary graphs and charts, and talk about goals, feelings, barriers, fears, and effectively emulate a nurse or health coach. VHAs will soon become tomorrow’s motivators. With preventable and manageable chronic conditions such as diabetes or prediabetes affecting nearly 120 million Americans, and approximately twothirds of the nation now qualifying as either overweight or obese, few would argue that our overall health has deteriorated in the past quarter century. Left unaddressed, this epidemic of lifestyle-induced disease will bankrupt our great nation. VHAs have the ability to reach pa-

tients on a daily basis—multiple times a day even—significantly expanding the reach of healthcare professionals, and allow patients to be informed about their own health, and make data-based choices. Using motivational interviewing techniques, these tools can provide a daily coaching bridge between physicians, pharmacists, and patients.

Looking for Solutions Pharmaceutical companies focus on drug discovery as a solution, and thousands of smartphone applications are being developed to change our destructive health behaviors. But lacking in both of these approaches is a true solution that draws on the basic human desire for a relationship or companion in our search for better health. Health behaviors such as whether we

Dr Morrow is Chief Medical Officer at Next IT. RETA #1 AM IL CL ONG INIC IANS

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Inside Health & Wellness exercise or make healthy food choices are the result of a complex interaction of influences on a number of dimensions. If you ask people why they behave in a certain way, many cannot answer, or their answer does not hold up to observed practice (eg, how often have we been told by patients that they are taking their medication when in reality we see a medication possession ratio of 50%?). Negative influences on health are ever-present. Think of the millions of messages people are exposed to through advertisements during their lifetime, many of which are created by vendors of Big Tobacco and Big Food promoting unhealthy habits and unhealthy amounts of fat, salt, and/or sugar. These messages,

Interpersonal communication is one of the most critical factors in changing health behavior. advertisements, and even the taste and texture of unhealthy food use psychological manipulative techniques to influence daily behavior and therefore health; albeit in a less than desirable way. Psychologists have been studying health-influencing factors for decades, including dozens of theories and models to understand health behaviors, and hundreds of articles to help physicians and other healthcare professionals design effective methods to positively influence health behaviors.

Health Behavior Theories and Models Karen Glanz, PhD, MPH, a professor in the Department of Biobehavioral Health Sciences at the University of Pennsylvania Perelman School of Medicine, and lead editor of Health Behavior and Health Education: Theory, Research, and Practice, now in its fourth edition, suggested that the most dominant theories and models are the social cognitive

theory, the transtheoretical/stages of change, the health belief model, social support and networks, and good, old-fashioned patient–provider communication.1 From a 30,000-foot perspective, these health behavior theories and their accompanying models—which, when implemented properly, have been proved to work in clinical trials—focus on individual and interpersonal factors as well as individual stress and coping mechanisms. The number one behavior-related disease, diabetes, has continued to escalate beyond our imagination providing proof that these theories and models—which primary care physicians and ancillary providers have used as a basis to educate their patients on the need for exercise, lifestyle changes and exercise—have not worked. We need to be able to deploy a behavior change agent daily, not weekly or monthly as in the current models.

The Physician–Patient Relationship Interpersonal communication is one of the most critical factors in changing health behavior, and communication between physicians and patients has been studied extensively. Patients demonstrate enormous trust in this relationship, and accept their physician as the most knowledgeable person with whom to interact when it comes to healthcare. Psychologists have extensively researched this powerful relationship, and singled out several key factors affecting this bond between the physician and patient: fostering healing; information exchange; responding to emotions; managing uncertainty; making decisions; and enabling patient self-management. Although the physician–patient relationship is powerful, it has failed to keep pace with the growing needs of our nation. There are many reasons for this failure, including the shortage of physicians—especially in primary care, and even more so in underserved popula-

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Inside Health & Wellness tions—the access-barring cost of physician services, the dramatic change in the way patients gather Internet-based information, and the perceived conflict of physician financial incentives to “save money.” Most physicians agree that a primary reason for the deteriorating physician– patient relationship is the lack of time— which typically consists of only 10 to 15 minutes—during a standard office visit. We must face the fact that to change behavior, a patient needs more than just 1 office visit with their primary care provider every few months, or a visit to their pharmacy to pick up their prescription(s) every month. People spend only a few hours per year in the presence of a trained professional, and that is simply inadequate. They spend >5000 hours a year without direct professional supervision, stumbling their way through their disorders; what they need is an automated hovering approach using an avatar.2

VHAs in the Future of Medicine The United States needs a new delivery model for changing health behavior. B.J. Fogg, PhD, Director of the Persuasive Technology Lab at Stanford University, CA, uses a formula that simplifies the most effective theories of behavioral change.3 He states that to change behavior, a person must have motivation; the desired behavior must be broken down into achievable, bite-sized pieces; and then the behavior must be triggered. Again, using the case of obesity, prediabetes, diabetes, and other similar conditions—motivation, capability, and activation—need to occur simultaneously and repeatedly. I propose that a VHA can provide this model for change. What is a VHA? Film buffs will remember HAL 9000, the heuristically programmed algorithmic computer and artificial intelligence from 2001: A Space Odyssey, and J.A.R.V.I.S. (Just A Rather Very Intelligent System) from the Iron Man and Avengers franchises. Siri, a personal assistant and knowledge navigator found on Apple,

Inc.’s iPhone operating systems is also an example of a similar type of technology. Getting people to adopt healthy lifestyle choices requires a VHA that is focused on healthy behavior. Loading the VHA onto a smartphone and giving it the ability to process natural language opens up all kinds of opportunities to influence behavior.

The United States needs a new delivery model for changing health behavior. So, to describe the near future, a VHA will talk to you; remind you to take your medication; instantly calculate how many calories are in a meal; track your caloric intake and exercise; give you a breakdown on your overall nutritional status as measured by free sugar, saturated fat, vitamin, mineral and fiber content; prompt you to exercise; provide a healthy “tip of the day”; and encourage healthier substitutes at restaurants, fast food joints, and stores. It can break down your health goals into smaller, intermediate goals (eg, taking an additional 1000 steps daily vs running a marathon).

VHAs and Behavior Health Models The convergence of raw computational power, cloud-based data sharing, smart devices, and natural language processing technology that makes up a VHA gives providers a powerful new tool to improve health; one that takes advantage of a limitless number of opportunities to develop a relationship with each patient that is rooted in the most effective methods of behavior change: conversation. Drawing on the theories and models discussed above, VHAs have the unprecedented opportunity to change the behaviors of large populations, and change the course of our collective health. Through conversation and conRETA #1 AM IL CL ONG INIC IANS

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Inside Health & Wellness Companies Specializing in Consumer-Focused Virtual Health Assistants ❚ CodeBaby Corp ❚ Kognito ❚ Geppetto Avatars ❚ Medrespond ❚ Next IT Corporation

textually based programming, a VHA can establish a “personal, health-fostering relationship” with a person, and assist him/her with understanding their condition, managing uncertainty, responding to their emotional needs, determining barriers to behavioral change, self-management, and can even embed itself into our social structure to provide access to other patients working toward the same goals. These are forward-looking applications for a VHA, but currently apps such as fitbit are doing this. The VHA will do the same. Much of what I discuss is in development but could be available by the end of this year (see the Sidebar). The VHA can also incorporate other wearables and other data sources into its functionality. For example, a VHA could incorporate data from a glucometer, pedometer, sleep monitoring device, and smart pill bottle and graph adherence to a variety of goals that patients agreed to with their provider. It can also be integrated with copay assistance programs to assist with financial issues that can affect adherence. In addition, the VHA can include gamification, competition, and social support functions that allow people to encourage one another in a variety of ways. Large-scale clinical trials proving that VHAs will work are lacking, but numer-

ous academic studies have been done that demonstrate their efficacy. The leading US researcher in this field is Timothy Bickmore, PhD.4 The VHA is limited only by the imagination of the organization willing to engage in this strategy to improve health. The science and technology are advanced and available, and the need is present. The onus is on early adopters to develop these initiatives. Our medical system is going through enormous changes because the status quo is not sustainable. We have tried for nearly half a century to change behavior and have succeeded as individuals, but not as a population. The traditional behavioral modification approach of oneon-one is not scalable. We cannot continue to throw more money and professionals at a problem that requires more than what physicians, nurse practitioners, and other healthcare providers can provide. Only through the use of VHAs can we hope to solve the health behavior problems we are facing. ❚

References

1. Glanz K, Rimer BK, Viswanath K, eds. Health Behavior and Health Education: Theory, Research, and Practice. 4th ed. San Francisco, CA: Jossey-Bass, Inc; 2008. 2. Asch DA, Muller RW, Volpp KG. Automated hovering in health care—watching over the 5000 hours. N Engl J Med. 2012;367:1-3. 3. Fogg BJ. What causes behavior change? www.behavior model.org. Accessed May 26, 2015. 4. Relational Agents Group. Projects. www.relationalagents. com. Accessed May 26, 2015.

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Inside Health & Wellness

Weight-Loss Interventions Linked to Better Body Image And other concise reviews of studies on health and wellness

Obesity is a significant health problem in the United States, leading to conditions including diabetes and cardiovascular disease, and contributing to significant healthcare costs. }} }} HAI-LUN CHAO of the Department of Health Care Administration, ChungHwa University of Medical Technology, Tainan, Taiwan, conducted a systematic review and meta-analysis of studies examining the effect of weight-loss interventions on body image in obese and overweight individuals using MEDLINE, Current Contents, and the Cochrane Database. The search focused on comparative studies and clinical trials, including prospective and retrospective studies involving obese and overweight adults enrolled in weight-loss interventions where body image was quantitatively assessed. Studies that included participants with any coexisting chronic diseases, or that did not quantitatively assess body image, were excluded from the analysis. Changes in body shape concern, body size dissatisfaction, and body satisfaction were the outcomes measured. Data extraction and quality assessment were conducted by 2 independent reviewers, and a third reviewer was

consulted for disagreement resolution. Overall, 149 publications were identified during the initial search; 124 of these studies did not include relevant body image outcomes and were excluded. Of the remaining 25 articles that were reviewed, 7 were included in the systematic review (N = 931); 4 of these studies were included in the meta-analysis. Patient characteristics of the studies in the analysis included mostly women, with only 1 study evaluating both men and women. In addition, Dr Chao found that the type of weight-loss intervention varied between studies. However, all of the participants in these studies were overweight or obese (body mass index, 25-45). The number of patients included in the studies ranged from 31 to 144 in the intervention group, and 17 to 88 in the control group. Tools used to measure body image also varied between studies, including the Body Shape Questionnaire, which was used to assess body shape concern; the Body Image Assessment to assess body size dissatisfaction. RETA #1 AM IL CL ONG INIC IANS

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Inside Health & Wellness Several studies reported other methods to measure body satisfaction and body image avoidance, as well as attractiveness/self-confidence, accentuation of appearance, insecurity/concern, and physical/sexual misperception. Significantly pronounced differences in body image were seen in 4 studies; no significant difference in body image outcomes was seen in 3 studies. The metaanalysis demonstrated improvements in body shape concerns (95% confidence interval [CI], –1.04 to 0.00), body size dissatisfaction (95% CI, –0.88 to –0.45), and body satisfaction (95% CI, 0.09 to 1.38), which significantly favored the intervention group compared with the control group (P <.05). “The findings of our systematic review and meta-analysis support the notion that weight loss interventions may improve body image in obese/overweight adults,” the author reported in PLoS One. “This is important given that body image is an important mediator of psychological

OMEGA-3 SUPPLEMENTATION MAY PROMOTE COGNITIVE HEALTH IN OLDER ADULTS Healthy brain aging is an important part of wellness, and as the aging population expands, it is important

well-being and the capacity for an individual to maintain weight loss.” The effects of body image on psychological well-being and maintenance of weight loss have been evaluated, the study authors noted citing previously published studies. Researchers have also found that improvements in the investment dimension of body image may be more important than evaluative dimensions in improving self-eating regulation. In addition, researchers have observed that the investment dimension of body image is more significantly impacted by physical activity than the evaluative dimension. Further research is warranted in the form of large-scale randomized controlled trials to assess whether certain weight-loss interventions facilitate optimal outcomes in terms of improving body image, as well as facilitating and maintaining weight loss. Chao HL. Body image change in obese and overweight persons enrolled in weight loss intervention programs: a systematic review and meta-analysis. PLoS One. 2015;10:e0124036.

to have a better understanding of the role of different factors on the brain, including diet. Data from a recent study published in Frontiers in Aging Neuroscience suggest that optimal nutrition preserves cognitive function, slows the progression of aging, and reduces the incidence of debilitating diseases, such as Alzheimer disease, in healthy aging populations. Specifically, the investigators found that patients who consumed more omega-3 polyunsaturated fatty acids (O3PUFAs) performed better on cognitive flexibility tasks than patients who consumed less omega-3 fatty acids. “This is the first report of a specific and sensitive volumetric mediation between O3PUFA levels and a particular component of the executive functions, and is shown in an at-risk population of cognitively intact older adults,” according to Marta K. Zamroziewicz, BS, Decision Neuroscience Laboratory, Univer-

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Inside Health & Wellness sity of Illinois, Urbana, and colleagues. Previous research reported the benefits of omega-3 fatty acids on cognitive flexibility, or the link between cognitive flexibility and this specific region of the brain, but research was warranted to link the two. As part of this cross-sectional study, the investigators enrolled 95 elderly adults who were not cognitively impaired (Mini-Mental State Examination [MMSE] score <26). Criteria for exclusion included diagnoses of mild cognitive impairment, dementia, and psychiatric illness within the past 3 years. Of the initial group enrolled, 40 of the 52 patients who underwent apolipoprotein E (APOE) allele genotyping carried the APOE e4 allele, and were included in the analysis. The investigators measured levels of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid), and performed neuropsychological tests and volumetric brain magnetic resonance imaging. Overall, the study participants had a mean age of 68.80 years, and 72.5% were women. The mean O3PUFA levels were 102.30 nmol/mL in the low O3PUFA group and 216.00 nmol/mL in the high O3PUFA group. MMSE

and Delis-Kaplan Executive Function System Trail Making Test cognitive flexibility scores were 28.83 and 10.30, respectively. Ms Zamroziewicz and colleagues found that only gray matter volume in the left rostral anterior cingulate cortex partially mediated O3PUFA blood levels and cognitive flexibility. They also found individual relationships between O3PUFA levels and cognitive flexibility, O3PUFA levels and left rostral anterior cingulate, and left rostral anterior cingulate and cognitive flexibility. Previous research focused on other aspects of the brain such as memory, instead of cognitive flexibility and other executive functions such as planning, reasoning, paying attention, problemsolving, impulse control, and task switching, according to the study authors. These results add to the body of evidence pointing to a link between nutritional deficiencies and the incidence of cognitive impairment, as well as the link between cognitive impairment and degenerative neurologic disorders.

USE OF COMPLEMENTARY HEALTH APPROACH IN CHILDREN MOSTLY UNCHANGED SINCE 2007 Although the use of complementary health approaches in children has not been studied extensively at the national level, available data suggest higher rates of use among children with chronic health conditions, including anxiety, musculoskeletal conditions, and recurrent headaches, compared with children without these conditions. Similar data have been seen in adult populations. A group of researchers from the National Center for Health Statistics and the National Institutes of Health found that the use of complementary health approaches did not change significantly

since 2007. “This report presents national estimates of the use of complementary health approaches among children aged 4 [to] 17 years in the United States,” the study authors explained. “Taken together, the breadth and depth of the 2012 [National Health Interview Survey (NHIS)] child supplement on complementary health approaches provides the most comprehensive snapshot of the use of these approaches.” As part of this analysis, the investigators evaluated data from the 2007 and 2012 NHIS. The combined sample included 17,321 interviews with well-informed adults about children aged 4 to 17 years. In particular, they looked at the use of select modalities in the past 12 months;

These results add to the body of evidence pointing to a link between nutritional deficiencies and the incidence of cognitive impairment.

Zamroziewicz MK, Paul EJ, Rubin RD, et al. Anterior cingulate cortex mediates the relationship between O3PUFAs and executive functions in APOE e4 carriers. Front Aging Neurosci. 2015 Feb 20 [Epub ahead of print].

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use of nonvitamin, nonmineral dietary supplements in the past 30 days; and complementary health approaches used to treat health problems or conditions. The first population-based estimate of children’s use of complementary health approaches was provided by the 2007 NHIS. The investigators sought to update the findings from 2007 to provide the most current and compre-

The low cost and ability to be practiced in one’s own home may contribute to yoga’s growing popularity, the study authors noted. hensive picture of children’s use of complementary health approaches in the United States. In addition, the authors estimated the use of complementary health approaches by select demographic characteristics, and the use of complementary health approaches to treat specific conditions. Overall, the investigators found that

the use of complementary health approaches among children had not changed significantly since 2007 (12.0% in 2007 to 11.6% in 2012). However, they observed that the use of traditional healers significantly decreased (1.1% in 2007 to 0.01% in 2012), which may be due, in part, to questionnaire adjustments (ie, a decrease in the types of selectable traditional healers), they noted. No other significant decreases were identified. An increase in the use of yoga during this time period (2.3% in 2007 to 3.1% in 2012) was also observed. In addition, nonvitamin, nonmineral dietary supplements; chiropractic or osteopathic manipulation; and yoga, tai chi, or qigong were among the most commonly used complementary health approaches in 2007 and 2012. The low cost and ability to be practiced in one’s own home may contribute to yoga’s growing popularity, the study authors noted. Public school systems are also beginning to incorporate yoga into their fitness programs. Furthermore, the investigators added that meditation as a part of movement therapies were more common among children than meditation alone. There were also large decreases in the percentage of children who used nonvitamin, nonmineral dietary supplements or homeopathy to treat specific health conditions, but no changes for all other approaches. Overall, there was not much change in the top diseases or conditions treated with complementary health approaches. Complementary approaches in 2007 and 2012 were most frequently used for back or neck pain, head or chest cold, anxiety or stress, and other musculoskeletal conditions. “The descriptive statistics and highlights presented in this report are the foundation for future studies of complementary health approaches,” the study authors concluded. ❚ Black LI, Clarke TC, Barnes PM, et al. Use of complementary health approaches among children aged 4-17 years in the United States: National Health Interview Survey, 2007-2012. Natl Health Stat Report. 2015;(78):1-19.

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CONTINUING EDUCATION

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Supplement

Optimizing Medication Utilization and Adherence in Patients with Schizophrenia:

Continuing Education

A Perspective for Managed Care Pharmacists

Optimizing Medication Utilization and F Adherence in Patients with Schizophrenia: aculty

Peter J. Weiden, MD Matthew Mitchell, PharmD, MBA Robert Navarro, PharmD Director of Psychotic Disorders Program Pharmacy Director Clinical Professor Center for Cognitive Medicine SelectHealth Department of Pharmaceutical University of Illinois Medical Center Salt Lake City, UT Outcomes & Policy Chicago, IL University of Florida–College of Pharmacy Gainesville, FL by ROBERT NAVARRO, PHARMD, PETER J. WEIDEN, MD, and MATTHEW MITCHELL, PHARMD, MBA

A Perspective for Managed Care Pharmacists Release date: January 26, 2015 Expiration date: January 31, 2016 Estimated time to complete activity: 1.0 hour Target Audience This activity is directed toward pharmacists who are involved in the management of patients with schizophrenia. Educational Objectives After completing this activity, the participant should be better able to: • List the current management options in schizophrenia, especially in relapsed disease • Describe the significant economic burden associated with medication nonadherence and relapse in patients with schizophrenia • Discuss strategies that can be employed by managed care pharmacists to improve medication utilization and adherence by patients with schizophrenia • Review the relative clinical and economic value of evolving therapies for schizophrenia, particularly involving the use of long-acting injectables • Provide accurate and appropriate counsel as part of the treatment team. Faculty Robert Navarro, PharmD Clinical Professor, Department of Pharmaceutical Outcomes & Policy University of Florida–College of Pharmacy Gainesville, FL

MAC MAC OS X 10.6 or higher Flash Player v10.0 or higher Latest version of Firefox, Google Chrome, or Safari Adobe Acrobat Reader v7.0 or higher*

*Required to view printable (PDF) version of the lesson. Disclosure of Conflicts of Interest Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high-quality CME/CE activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity: Name of Faculty or Presenter

Reported Financial Relationship

Consultant for Alexion, AstraZeneca, Forest Laboratories, Novartis, Pfizer, Purdue, Sunovion, and Valeant; other: Catamaran PBM. Peter J. Weiden, Consultant for Delpor, Forum, Genentech, MD Johnson & Johnson (Janssen Pharmaceuticals), Lundbeck, Novartis, Otsuka, Reckitt Benckiser Pharmaceuticals, Sunovion, and Vanda; has received research support from AbbVie, Alkermes, Forum, Forest Laboratories, Genentech, Johnson & Johnson (Janssen Pharmaceuticals), Neurocrine, Novartis, Otsuka, Reckitt Benckiser Pharmaceuticals, and Takeda; Speaker’s Bureau for Forest Laboratories, Johnson & Johnson (Janssen Pharmaceuticals), Lundbeck, Novartis, Otsuka, and Sunovion; stockholder for Delpor. Matthew Mitchell, Nothing to disclose. PharmD, MBA Robert Navarro, PharmD

Peter J. Weiden, MD Director of Psychotic Disorders Program Center for Cognitive Medicine University of Illinois Medical Center Chicago, IL Matthew Mitchell, PharmD, MBA Pharmacy Director SelectHealth Salt Lake City, UT Pharmacist Continuing Education Accreditation Statement Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Credit Designation Postgraduate Institute for Medicine designates this continuing education activity for 1 contact hour(s) (0.1 CEU) of the Accreditation Council for Pharmacy Education. (Universal Activity Number 0809-9999-15-005-H01-P) Type of Activity: Application

System Requirements PC Windows 7 or above Flash Player v10.0 or higher Internet Explorer v9.0 or higher Latest version of Firefox, Google Chrome, or Safari Adobe Acrobat Reader v7.0 or higher*

The following PIM planners and managers—Laura Excell, ND, NP, MS, MA, LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP; and Jan Schultz, MSN, RN, CCMEP—hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

Center of Excellence Media, LLC: Susan Berry hereby states that she or her spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. Disclosure of Unlabeled Use This educational activity may contain discussion of published and/ or investigational uses of agents that are not indicated by the FDA. Postgraduate Institute for Medicine and Center of Excellence Media, LLC, do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Disclaimer Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Instructions for Credit There is no fee for this activity. To receive credit after reading this CE activity in its entirety, participants must complete the posttest and evaluation. The posttest and evaluation can be completed online at http://ce.lynxcme.com/COE177. Upon completion of the evaluation and scoring 75% or better on the posttest, you will immediately receive your certificate online. If you do not achieve a score of 75% or better on the posttest, you will be asked to take it again. Please retain a copy of the certificate for your records. If you have any questions regarding the CE certification for this activity, please contact Postgraduate Institute for Medicine at: information@pimed.com or 303-799-1930. Pharmacists: Upon successfully completing the posttest with a score of 75% or better and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks. Media: Printed report

To obtain a digital version, download a free QR code app on your SmartPhone and then scan this code.

This activity isis supported supportedby byan anindependent independenteducational educational grant from Alkermes. This activity grant from Alkermes. Jointly provided by Postgraduate Institute for Medicine and Center of Excellence Media, LLC. Jointly provided by Postgraduate Institute for Medicine and Center of Excellence Media, LLC.

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Continuing Education

A

ntipsychotic medication is the primary intervention for stabilization of acute psychotic episodes and prevention of recurrences and relapses in patients with schizophrenia. However, oral medications may be difficult for patients to maintain on a daily basis. Nonadherence to medication places patients at risk for repeated relapse and rehospitalization and can lead to increased costs for the healthcare system. This educational activity provides highlights of a live symposium from the Academy of Managed Care Pharmacy meeting held in Boston, MA, on October 7-10, 2014, which focused on current treatment options with long-acting injectable (LAI) antipsychotic therapy for relapse prevention, pharmacist-driven strategies for optimal medication utilization and adherence to antipsychotic drugs, and assessment of the clinical and economic value of LAI therapies in the management of schizophrenia.

Antipsychotic drugs are the mainstay of treatment for symptom control in patients with schizophrenia. Risk of Relapse in Schizophrenia and Its Implications Schizophrenia is a chronic, debilitating disorder with a variable pattern affecting the perceptual, cognitive, and emotional aspects of patients, resulting in considerable psychosocial disabilities and social isolation.1,2 Signs and symptoms of schizophrenia include hallucinations, delusions, avolition, movement disorders, and cognitive impairment.1,2 The disorder has a complex etiology with multifactorial genetic, environmental, and psychosocial contributions. Its worldwide prevalence is approximately 1%, with approximately 2.2 million adults currently living with schizophrenia in the United States.1,3 Antipsychotic drugs are the mainstay of treatment for symptom control in patients with schizophrenia. The primary question in the selection of the initial antipsychotic medication or in switching to a new antipsychotic medication typically involves the choice between first-generation antipsychotic agents (referred to as “typical”) and second-generation antipsychotic agents (termed

“atypical”). The 2009 Schizophrenia Patient Outcomes Research Team (PORT) guidelines do not provide clear recommendations in this regard because existing evidence shows comparable efficacy and variable side effects of firstand second-generation antipsychotic agents. Therefore, medication choices are commonly based on individual preference and treatment-related factors such as prior treatment response, side effect profile, adherence history, risk factors, and long-term treatment planning.4 Firstgeneration antipsychotic drugs are high-affinity dopamine D2 receptor antagonists associated with high rates of neurologic side effects, such as extrapyramidal symptoms and tardive dyskinesia, whereas second-generation antipsychotic drugs are not associated with these effects but have a propensity to induce weight gain and increased serum prolactin and glycemic levels.2,5-7 However, results from a meta-analysis indicate that, individually, second-generation antipsychotic drugs were comparable to first-generation antipsychotic drugs in terms of study-defined relapse, overall treatment failure, and hospitalization rate, but that, as a group, second-generation antipsychotic drugs were associated with better outcomes compared with first-generation antipsychotic drugs for these same end points.8 The large, randomized CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study assessed the relative effectiveness, as measured by treatment discontinuation at 18 months, of several second-generation antipsychotic drugs (olanz­ apine, quetiapine, risperidone, ziprasidone) versus the first-generation antipsychotic drug perphenazine in patients with schizophrenia.7 The results of this National Institute of Mental Health–sponsored trial showed that, overall, 74% of patients discontinued their antipsychotic therapy, with olanzapine showing the lowest rate of discontinuation (64%). Olanzapine was also the most effective of the antipsychotic drugs, with significantly longer time to discontinuation attributed to all causes versus quetiapine or risperidone, but not perphenazine or ziprasidone.7 Although there were no significant differences in time to discontinuation caused by intolerable side effects among the antipsychotic agents, olanzapine had the highest rate of discontinuation attributed to weight gain or metabolic effects.7 Despite treatment with antipsychotic therapy, the majority of patients with schizophrenia experience numerous relapses, alternating with periods of full or partial remission.2,9,10 A prospective and systematic follow-up of patients revealed that the cumulative rate of first relapse

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Continuing Education following an initial response to treatment of the first episode of schizophrenia was 81.9% over a 5-year period and 53.7% over a 2-year period; the cumulative rate of second and third relapses during the 5-year follow-up was 78% and 86.2%, respectively.10 Moreover, relapses are associated with clinical deterioration, including decreased chances of recovery to previous levels of functioning, worsened disability, decreased responsiveness to treatment, and reduced duration and degree of remission with each subsequent relapse.11,12 In addition to these impacts on clinical outcomes, recurring relapses are associated with increased emergency department visits and hospitalizations. Schizophrenia is associated with hospitalization rates within the same range as those observed with myocardial infarctions (MIs).13 Data from the 2007 National Hospital Discharge Survey of nonfederal, general, and short-stay hospitals in the United States showed that the number of hospitalization discharges was 577,000 for acute MI and 324,000 for schizophrenia.13 These observations gain perspective when one considers that the population at risk for schizophrenia is only 1% of the general population, whereas the percentage of those at risk for acute MI is considerably higher. The risk of relapse may be diminished by maintenance antipsychotic drug treatment. One study reported a nearly 5-fold lower risk of relapse in patients with schizophrenia who were on continuous maintenance treatment versus those who discontinued medications.10 In addition, an analysis of 5 studies that compared continuous versus intermittent maintenance treatment showed that relapse rates after 1 year were higher in the intermittent treatment group. Gains in terms of improved psychosocial adjustment, diminished tardive dyskinesia, or enhanced well-being were also observed in the continuous maintenance group.2 Based on such evidence, the 2009 Schizophrenia PORT guidelines recommended that continuous antipsychotic coverage was needed to maintain symptom relief and to reduce the risk of relapse or worsening of positive symptoms, and discouraged the routine use of targeted, intermittent antipsychotic maintenance strategies.4,14

Medication Nonadherence and Utilization in Schizophrenia Medication nonadherence, which is rampant among patients with schizophrenia, has been significantly correlated with a higher risk of relapse and psychiatric hospi-

talization. One study reported that approximately 30% of partially or fully nonadherent patients were hospitalized during the 1 year following enrollment compared with 17% of adherent patients, with an average length of hospital stay of 30 days, 18 days, and 9 days for nonadherent, partially adherent, and adherent patients, respectively.15

Nonadherence to medication is a result of complex patient behaviors and ranges from complete treatment discontinuation to irregular use or partial change of daily medication doses. Moreover, the extent of the medication gap caused by nonadherence has been directly correlated with a higher risk for hospitalization.16 This was shown in a study by Weiden and colleagues that evaluated the relationship between adherence and the risk for hospitalization in a cohort of 4325 California Medicaid patients with schizophrenia who were prescribed antipsychotics between 1999 and 2001 and followed for 1 year. Results of the study showed that the presence of a medication gap as small as 1 to 10 days was associated with an increased risk for hospitalization (odds ratio [OR], 1.9), whereas longer medication gaps were associated with incrementally higher risks (11-30 days: OR, 2.81; >30 days: OR, 3.96).16 These results indicate that even short gaps in medication have detrimental effects, thus highlighting the need for continuous, uninterrupted treatment in patients with schizophrenia. Nonadherence to medication is a result of complex patient behaviors and ranges from complete treatment discontinuation to irregular use or partial change of daily medication doses. Partial adherence to medication is at least as frequent as complete nonadherence.17 It is estimated that approximately 20% to 80% of patients with schizophrenia are partially or totally nonadherent to their antipsychotic regimen, the range of nonadherence rates reflecting different assessment methods, observation periods, and definitions of adherence.18 RETA #1 AM IL CL ONG INIC IANS

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Continuing Education Table 1. Dose and Administration of FDA-Approved Second-Generation Long-Acting Injectable Antipsychotic Agents for Schizophrenia Available dose strength

Medication

Usual dose

Maximum dose

Loading dose

Oral medication before initiation

Aripiprazole

300 mg (CYP2D6 poor metabolizers) 400 mg

400 mg once monthly

400 mg once monthly

No

Suggested; overlap with oral antipsychotic drugs for 14 consecutive days

Olanzapine pamoate

210 mg 310 mg 405 mg

150 mg–300 mg every 2 weeks or 405 mg every 4 weeks

300 mg every 2 weeks or 405 mg every 4 weeks

Yes – Varies depending on starting oral olanzapine dose

Suggested; oral olanzapine

Paliperidone palmitate

39 mg 78 mg 117 mg 156 mg 234 mg

117 mg once monthly (39-234 mg)

234 mg once monthly

Yes – 234 mg on day 1, then 156 mg 1 week later

Suggested; overlap with oral paliperidone or oral risperidone

Risperidone microspheres

12.5 mg 25 mg 37.5 mg 50 mg

25 mg–50 mg every 2 weeks

50 mg every 2 weeks

No

Yes; overlap with oral antipsychotic drugs for 3 weeks

FDA indicates US Food and Drug Administration. Source: Gopalakrishna G, et al. Clin Schizophr Relat Psychoses. 2013;7:87-92.

Moreover, assessment of adherence behavior can be challenging in the real-life setting. This is largely because self- and physician-reporting are the most common methods used to assess adherence, and they are often unreliable and overestimate adherence.17 For example, results of the PREFER (Prevent First Episode Relapse) study showed that clinicians missed >50% of nonadherence episodes as defined by a >2-week medication gap among patients on oral therapy compared with adherence episodes identified by All Source Verification, which used multiple sources of adherence information.19

Long-Acting Injectable Antipsychotic Medications in Schizophrenia for Relapse Prevention LAI antipsychotic medications were developed specifically as an intervention to promote treatment adherence.20 The 2009 Schizophrenia PORT guidelines recommend offering LAI therapy as an alternative to oral antipsychotic medication for the maintenance treatment of schizophrenia when there is concern over noncompliance.4 Four US Food and Drug Administration (FDA)approved second-generation LAI antipsychotic agents are currently available in the United States for the treatment

of schizophrenia (Table 1).21 There are many potential advantages associated with LAI antipsychotic agents (Table 2). Prominent among these are guaranteed delivery of medication, reliable monitoring of treatment adherence, and knowledge of exact start of nonadherence, which eliminates guessing about adherence status, thus providing an increased opportunity for timely intervention.22 In contrast, gaps in medication may go undetected with oral medications, and given the difficulty in predicting the occurrence of exacerbation, relapses may not be as easily preventable. Another benefit of LAIs is in guiding treatment decision-making, where poor response can be directly correlated to medication efficacy without speculating about the contribution of nonadherence. Moreover, the improved pharmacokinetics of LAIs has provided more reliable drug delivery and reduced differences in peak and trough plasma levels of the drug.22 However, challenges with the use of LAIs include not only fewer drug options compared with oral antipsychotic medications, but also safety concerns, lag time between oral and LAI availability, and pharmacokinetic differences in formulation. The long half-life of LAIs necessitates ensuring safe and effective plasma levels when

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Continuing Education transitioning from oral to LAI therapy, which may be accomplished by either continuing oral medication until the LAI reaches therapeutic levels or using higher doses of the LAI initially.23 Although safety profiles of second-generation LAI antipsychotic medications have largely been consistent with those of their oral parent formulations, unexpected adverse events of concern have also emerged, which appear to be specific to each second-generation LAI antipsychotic agent and may contribute to nonutilization of therapy.5 For example, postinjection delirium/ sedation syndrome is a potentially serious adverse event that is mostly linked to the routine use of olanzapine-LAI, whereas worsening of psychotic symptoms and depression may be associated with the use of risperidone and paliperidone palmitate LAIs.5 In addition, patient and prescriber attitudes resulting from lack of familiarity with or reluctance to try the LAI formulation have been cited as major obstacles to LAI utilization.24 Despite the availability of LAIs, less than 30% of patients with schizophrenia are prescribed one, as evidenced by preferential endorsement of oral psychotic agents over LAI formulations.20,24 This underutilization may be attributable to physicians’ suboptimal knowledge as well as a mistaken assumption that their patients are more adherent than they actually are.20 Current evidence indicates that patients have less favorable views of LAIs compared with those of psychiatrists or caregivers.24 However, prior experience with LAIs mitigated such negative patient perspectives, as evidenced by data showing that 23% of LAI-naive patients, 45% of patients with previous LAI treatment, and 73% of those currently on LAIs had positive perceptions of these therapies.25 Current evidence regarding LAI therapy appears to be inconsistent, with some studies showing major benefits, and others showing no difference between LAI and oral therapy.23 In a randomized trial of 710 patients with schizophrenia, once-monthly intramuscular aripiprazole-LAI as maintenance therapy following stable disease with oral therapy demonstrated a significant delay in time to impending relapse compared with placebo.26 In a randomized open-label study, olanzapine-LAI and oral olanzapine were found to be similarly effective and well tolerated for up to 2 years of treatment in patients with schizophrenia.27 The median time to all-cause discontinuation, discontinuation rates, and relapse rates were similar between the 2 treatment groups.27 In addition, in a randomized, placebo-controlled study of 652 adults with acutely exacerbated schizophrenia, treatment with

Table 2. Potential Advantages of Using Long-Acting Injectable Antipsychotic Agents Reduces dosage deviations Eliminates guessing about adherence status Shows start date of nonadherence Helps disentangle reasons for poor response to medication Eliminates the need for patients to remember to take oral medications Enables prescribers to avoid first-pass metabolism by using lowest effective dose Results in predictable and stable plasma levels Eliminates abrupt loss of efficacy if dose is missed Many patients prefer them

paliperidone was shown to result in a significant doserelated and rapid improvement in symptoms (P ≤.034), as measured by the Positive and Negative Syndrome Scale (PANSS).28 The controversy regarding the relative effectiveness of LAI therapy to reduce relapse may be partly explained by the context in which LAI therapy is delivered, primarily on the clinical service platform of the study. In the randomized PROACTIVE relapse prevention study in 305 patients with schizophrenia or schizoaffective disorder at

Despite the availability of LAIs, less than 30% of patients with schizophrenia are prescribed one. 8 US academic centers, there were no differences in rates of relapse or rehospitalization between risperidone-LAI and physician’s choice of oral second-generation antipsychotic agent.29 In contrast, the 15-month, prospective, randomized, open-label, PRIDE trial, which compared paliperidone palmitate versus oral antipsychotic agents in a real-world setting of patients diagnosed with schizophrenia who had a recent history of incarceration and substance abuse, showed that LAI therapy significantly delayed time to treatment failure (median 416 days vs 226 days; P = .011) compared with oral therapy.30 Time to treatment failure in this study was defined as arrest or RETA #1 AM IL CL ONG INIC IANS

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Continuing Education Figure. Managed Care Pharmacist Interventions in Schizophrenia • Initial DUR to identify status • Number and diagnoses of patients • Antipsychotic drug use patterns - Patient–drug utilization - Correlate with care provider (HCP, MHP) • Assess comorbidities and hospitalizations (severity, risk) • Assign care management and program resources • Follow-up program for clinical and economic outcomes DUR indicates drug utilization review; HCP, healthcare provider; MHP, mental health professional.

incarceration, psychiatric hospitalization, discontinuation of treatment, supplementation with another antipsychotic agent, or need for extra services to prevent imminent psychiatric hospitalization; reduction of many or all of these aspects may indirectly impact overall relapse. In the setting of LAI maintenance therapy in early first-episode outpatients, the prospective randomized PREFER study, which evaluated switching to LAI risperidone microspheres or continuing oral antipsychotic treatment for up to 10 weeks, showed that the majority of patients stopped medication within the study period despite an initial adherence benefit.19

Nonpharmacologic Interventions for Improving Medication Adherence The factors most consistently associated with medication nonadherence in patients with schizophrenia are patient-related (eg, sociodemographics, attitude toward illness and treatment, alcohol or substance abuse), illness-related (type and severity of symptoms, poor insight, duration of illness), and treatment-related (eg, length/ complexity of treatment, side effects) variables, as well as environmental factors. Systematic reviews of nonadherence determinants have identified lack of patient insight, unfavorable patient and physician attitudes, distress associated with side effects, inadequate efficacy, misconception that medications are no longer needed, previous nonadherence, substance abuse, shorter illness duration,

inadequate discharge planning or aftercare environment, and poor alliance with therapist(s) as contributing factors.17,18 In a study from the Schizophrenia Guidelines Project, the most common patient-reported barriers were related to the stigma of taking medications, adverse drug reactions, forgetfulness, and lack of social support.31 The study also found that patients with high barriers had a significantly greater likelihood of being nonadherent, having alcohol or drug use, and having higher PANSS total scores.31 Identification of these risk factors for nonadherence highlights the need for targeted nonpharmacologic interventional strategies that may broadly be categorized as educational, behavioral, or affective.18 A systematic review of 39 studies found that adherence interventions that focused solely on education without behavioral modifications were usually ineffective; conversely, interventions that focused on nonadherence alone were more likely to be successful than more broadly focused interventions.32 Effective strategies included motivational interviewing, disease education, counseling, reinforcement and rewards skill building, behavioral modeling and contracting, dosage modifications, reminders, computer-­based patient interaction, appeal to emotions, as well as family interventions and support.18,33 Successful adherence intervention programs employed individualized combination interventions, with consistent interactions and follow-up, followed by assessment and refinement.33 Managed care pharmacists play a unique role in the multidisciplinary team and are often presented interventional opportunities to improve adherence in patients with schizophrenia. For example, they can conduct drug utilization reviews and assess hospitalizations to identify patients who need adherence interventions; implement individualized disease management programs that include motivational interviewing and patient engagement; monitor the impact of interventions; and arrange follow-up programs to reevaluate and personalize programs. This must happen as a cyclical, continual process (Figure). Indeed, multifocal pharmacy-driven interventions have been shown to increase antipsychotic drug adherence among patients with serious mental illnesses. In a study of 118 patients from 7 participating Veterans Affairs facilities who had serious mental illnesses, including schizophrenia, and who were deemed nonadherent to long-term antipsychotic drugs, pharmacy-led interventions significantly improved adherence rates at 6 months (medication possession ratios [MPRs]: 0.91 vs 0.64) compared with

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Continuing Education usual care that did not include any interventions.34 Moreover, since managed care pharmacists possess a deeper understanding of the relationship between pharmacokinetic, dose-response, and pharmacologic characteristics of medications including LAIs, they are ideally suited to educate and collaborate with mental health professionals to promote appropriate use of LAI therapy options. In essence, they must balance gatekeeper and advocacy roles in medication selection and maintain an administrative perspective on drug utilization.

Value of Long-Acting Injectable Therapies for Schizophrenia Not only is schizophrenia a devastating illness for most individuals who are afflicted, but it is also associated with a significant economic burden. Based on administrative claims data from private and Medicaid insurance plans, the overall 2002 cost of schizophrenia in the United States was estimated to be $62.7 billion.35 Of this, the costs of excess direct healthcare were $22.8 billion (outpatient care, $7.0 billion; medication, $5.0 billion; inpatient care, $2.8 billion; and long-term care, $8.0 billion).35 Annual indirect excess costs were estimated to be $32.4 billion as a result of productivity losses resulting from unemployment, reduced workplace productivity, and diminished family caregiving.35 Importantly, as discussed earlier, nonadherence to antipsychotic medications results in relapse and rehospitalization, which are associated with additional costs.36 In fact, costs incurred for patients with schizophrenia who relapsed were found to be more than 4 times higher than the costs for those who did not relapse.37 In an analysis of patients from the Medicaid program who were rehospitalized related to antipsychotic drug nonadherence, the direct healthcare rehospitalization costs ranged from $1392 million to $1826 million in 2005.36 It is also notable that there has been a steady growth in prescription volume of antipsychotic medications (2009-2011) in the United States, with a 24% increase in expenditures. In 1998, Medicaid antipsychotic medication expenditures totaled $1.3 billion and 51% of the 11 million prescriptions were for atypicals.38 In the same year, prescriptions for antipsychotic medications accounted for 9% of Medicaid pharmaceutical prescriptions and nearly 19% of Medicaid pharmaceutical reimbursements.38 The cost of newer medications has clearly been identified as a key barrier to unrestricted access and utilization of newer antipsychotic agents.38 In this economic context, ques-

tions have been raised about the clinical advantages and cost-effectiveness of the currently available atypical antipsychotic agents; clearly, results from such assessments must inform practice of value-based care in patients with schizophrenia to ensure efficient resource use. Findings from the pharmacoeconomic literature conclude that new antipsychotic agents are associated with economic advantages compared with older antipsychotic drugs. An economic model compared the cost-effective-

It is also notable that there has been a steady growth in prescription volume of antipsychotic medications (2009-2011) in the United States. ness and direct treatment cost of olanzapine-LAI versus risperidone-LAI, paliperidone-LAI, haloperidol-LAI, and oral olanzapine, as measured by quality-adjusted life-years in the treatment of nonadherent and partially adherent patients with schizophrenia.39 The findings of the study showed that olanzapine-LAI treatment was more clinically effective and less costly than the LAI antipsychotic agents risperidone, paliperidone, and haloperidol; olanz­ apine-LAI was also more effective than oral olanzapine, but it was also more costly, with an estimated incremental cost/quality-adjusted life-years of $26,824.39 Moreover, in relapsed patients who are rehospitalized, findings of a retrospective hospital database analysis showed that switching to an LAI versus continuing with an oral antipsychotic drug was associated with a 19% to 12% lower likelihood of rehospitalization, as well as lower emergency department visit rates and fewer days in the hospital, all of which translate into lower costs.40

Conclusion The substantial clinical and socioeconomic burden of nonadherence in schizophrenia underscores the importance of medication adherence. In this setting, LAI therapy has emerged as an important maintenance treatment option for improving adherence in patients with the disease. In addition to comparable clinical effectiveness, long-acting therapy is associated with lower utilization of health resources compared with oral antipsychotic RETA #1 AM IL CL ONG INIC IANS

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Continuing Education therapy. In parallel, pharmacy-led nonpharmacologic interventions are also valuable in promoting adherence. Given that nonadherence is a complex, multifaceted issue, multifocal interventions focusing on patients, their families, and their healthcare providers are critical to achieving optimal outcomes in schizophrenia. ❚

Acknowledgment Sabeeha Muneer, PhD, contributed to the development of this article. References

1. Andreasen NC. Symptoms, signs, and diagnosis of schizophrenia. Lancet. 1995;346: 477-481. 2. Kane JM. Schizophrenia. N Engl J Med. 1996;334:34-41. 3. Schizophrenia facts and statistics. Schizophrenia.com Web site. http://schizo phrenia.com/szfacts.htm#. Accessed November 7, 2014. 4. Buchanan RW, Kreyenbuhl J, Kelly DL, et al. The 2009 Schizophrenia PORT psychopharmacological treatment recommendations and summary statements. Schizophr Bull. 2010;36:71-93. 5. Gentile S. Adverse effects associated with second-generation antipsychotic long-acting injection treatment: a comprehensive systematic review. Pharmacotherapy. 2013; 33:1087-1106. 6. Miyamoto S, Duncan GE, Marx CE, et al. Treatments for schizophrenia: a critical review of pharmacology and mechanisms of action of antipsychotic drugs. Mol Psychiatry. 2005;10:79-104. 7. Lieberman JA, Stroup TS, McEvoy JP, et al; for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353:1209-1223. 8. Kishimoto T, Agarwal V, Kishi T, et al. Relapse prevention in schizophrenia: a systematic review and meta-analysis of second-generation antipsychotics versus first-generation antipsychotics. Mol Psychiatry. 2013;18:53-66. 9. de Sena EP, Santos-Jesus R, Miranda-Scippa A, et al. Relapse in patients with schizophrenia: a comparison between risperidone and haloperidol. Rev Bras Psiquiatr. 2003;25:220-223. 10. Robinson D, Woerner MG, Alvir JM, et al. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 1999;56:241-247. 11. Emsley R, Nuamah I, Hough D, et al. Treatment response after relapse in a pla­cebo-controlled maintenance trial in schizophrenia. Schizophr Res. 2012;138:29-34. 12. Wyatt RJ. Neuroleptics and the natural course of schizophrenia. Schizophr Bull. 1991;17:325-351. 13. Hall MJ, DeFrances CJ, Williams SN, et al. National Hospital Discharge Survey: 2007 summary. Natl Health Stat Report. 2010;1-20, 24. 14. Kreyenbuhl J, Buchanan RW, Dickerson FB, et al. The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations 2009. Schizophr Bull. 2010;36:94-103. 15. Ascher-Svanum H, Zhu B, Faries DE, et al. Medication adherence levels and differential use of mental-health services in the treatment of schizophrenia. BMC Res Notes. 2009;2:6. 16. Weiden PJ, Kozma C, Grogg A, et al. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv. 2004;55:886-891. 17. Velligan DI, Weiden PJ, Sajatovic M, et al; Expert Consensus Panel on Adherence Problems in Serious and Persistent Mental Illness. The expert consensus guideline series: adherence problems in patients with serious and persistent mental illness. J Clin

Psychiatry. 2009;70(suppl 4):1-46. 18. Lacro JP, Dunn LB, Dolder CR, et al. Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: a comprehensive review of recent literature. J Clin Psychiatry. 2002;63:892-909. 19. Weiden PJ, Schooler NR, Weedon JC, et al. Maintenance treatment with longacting injectable risperidone in first-episode schizophrenia: a randomized effectiveness study. J Clin Psychiatry. 2012;73:1224-1233. 20. Patel MX, Taylor M, David AS. Antipsychotic long-acting injections: mind the gap. Br J Psychiatry Suppl. 2009;52:S1-S4. 21. Gopalakrishna G, Aggarwal A, Lauriello J. Long-acting injectable aripiprazole: how might it fit in our tool box? Clin Schizophr Relat Psychoses. 2013;7:87-92. 22. McEvoy JP. Risks versus benefits of different types of long-acting injectable antipsychotics. J Clin Psychiatry. 2006;67(suppl 5):15-18. 23. De Berardis D, Marini S, Carano A, et al. Efficacy and safety of long acting injectable atypical antipsychotics: a review. Curr Clin Pharmacol. 2013;8:256-264. 24. Jaeger M, Rossler W. Attitudes towards long-acting depot antipsychotics: a survey of patients, relatives and psychiatrists. Psychiatry Res. 2010;175:58-62. 25. Heres S, Schmitz FS, Leucht S, et al. The attitude of patients towards antipsychotic depot treatment. Int Clin Psychopharmacol. 2007;22:275-282. 26. Kane JM, Sanchez R, Perry PP, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73:617-624. 27. Detke HC, Weiden PJ, Llorca PM, et al. Comparison of olanzapine long-acting injection and oral olanzapine: a 2-year, randomized, open-label study in outpatients with schizophrenia. J Clin Psychopharmacol. 2014;34:426-434. 28. Pandina GJ, Lindenmayer J-P, Lull J, et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010;30:235-244. 29. Buckley PF, Schooler NR, Goff DC, et al. Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study [published online ahead of print May 27, 2014]. Schizophr Bull. doi:10.1093/schbul/sbu067. 30. Starr HL, et al. Paliperidone research in demonstrating effectiveness (PRIDE): managing schizophrenia patients with a history of incarceration and substance use. Presented at: American Psychiatric Association 167th Annual Meeting; May 3-7, 2014; New York, NY. Abstract NR8-150. 31. Hudson TJ, Owen RR, Thrush CR, et al. A pilot study of barriers to medication adherence in schizophrenia. J Clin Psychiatry. 2004;65:211-216. 32. Zygmunt A, Olfson M, Boyer CA, et al. Interventions to improve medication adherence in schizophrenia. Am J Psychiatry. 2002;159:1653-1664. 33. McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002;288:2868-2879. 34. Valenstein M, Kavanagh J, Lee T, et al. Using a pharmacy-based intervention to improve antipsychotic adherence among patients with serious mental illness. Schizophr Bull. 2011;37:727-736. 35. Wu EQ, Birnbaum HG, Shi L, et al. The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry. 2005;66:1122-1129. 36. Sun SX, Liu GG, Christensen DB, et al. Review and analysis of hospitalization costs associated with antipsychotic nonadherence in the treatment of schizophrenia in the United States. Curr Med Res Opin. 2007;23:2305-2312. 37. Almond S, Knapp M, Francois C, et al. Relapse in schizophrenia: costs, clinical outcomes and quality of life. Br J Psychiatry. 2004;184:346-351. 38. Harrington C, Gregorian R, Gemmen E, et al. Access and utilization of new antidepressant and antipsychotic medications. Falls Church, Va.: Lewin Group, 2000. http://aspe.hhs.gov/health/reports/Psychmedaccess/index.htm. Accessed November 8, 2014. 39. Furiak NM, Ascher-Svanum H, Klein RW, et al. Cost-effectiveness of olanzapine long-acting injection in the treatment of patients with schizophrenia in the United States: a micro-simulation economic decision model. Curr Med Res Opin. 2011;27:713-730. 40. Lafeuille M-H, Laliberté-Auger F, Lefebvre P, et al. Impact of atypical long-acting injectable versus oral antipsychotics on rehospitalization rates and emergency room visits among relapsed schizophrenia patients: a retrospective database analysis. BMC Psychiatry. 2013;13:221.

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Health & Wellness 5 TIPS TO KEEP CHILDREN HEALTHY AND ACTIVE DURING THE SUMMER MONTHS Parents care about their children keeping a healthy, active lifestyle, but may not be fully confident in their ability to influence healthy habits, according to a survey by the YMCA and the American Academy of Pediatrics Institute for Healthy Childhood Weight. In addition to improving mental and physical health, the following are tips for keeping your children healthy and active this summer: Take time to discuss the benefits of certain foods or physical activities with your child or teenager. Set a good example by engaging in physical activities such as walking or biking, and eating meals as a family.

1 Lead by Example

2 Encourage Exercise

Children and adolescents should get at least 1 hour of physical activity every day. Daily routines should include age-appropriate aerobic, muscle-strengthening, and bonestrengthening exercises, with most emphasis placed on moderate-tovigorous–intensity aerobics. Healthy eating in childhood and adolescence is imperative to proper growth and development. Limit consumption of solid fats, cholesterol, sodium, added sugars, and refined grains, and promote a diet rich in fruits and vegetables, whole grains, and fat-free/low-fat dairy products.

3 Promote Healthy Eating

4 Limit Screen Time

5 Provide Mental Stimulation

â

Engagement with high-quality–content media entertainment should occur for ≤1 to 2 hours a day for children and adolescents. Establish “screenfree” zones by ensuring no televisions, computers, or video games are in children’s bedrooms, and keep the television turned off during dinner. Create a summer reading list, and consider rewarding children for every book they finish reading. Make trips to the library, and encourage imaginative creativity through playtime with arts and crafts. For teenagers, recommend volunteer programs, part-time jobs, and preparation for college.

MORE ONLINE

More patient tips are available online at InsidePatientCare.com

(1) YMCA of the USA. YMCA releases Family Health Snapshot survey findings; kicks off awareness campaign to reduce learning and health gaps that could hold kids back. www.ymca.net/news-releases/national-survey-kids-healthy-habits-decline-during-summer. Published April 23, 2015. Accessed May 8, 2015; (2) National Institute of Diabetes and Digestive and Kidney Diseases; Weight-control Information Network. Healthy eating & physical activity across your lifespan. www.niddk.nih.gov/health-information/health-top ics/ weight-control/helping-your-child-tips-parents/Documents/helpingyourchild.pdf. Updated January 2012. Accessed May 8, 2015; (3) Centers for Disease Control and Prevention. Youth physical activity guidelines toolkit. www.cdc.gov/healthyyouth/physicalactivity/guidelines.htm. Updated March 5, 2014. Accessed May 8, 2015; (4) Centers for Disease Control and Prevention. Nutrition and the health of young people. www.cdc.gov/healthyyouth/nutrition/facts.htm. Updated October 6, 2014. Accessed May 8, 2015; (5) American Academy of Pediatrics. Media and children. www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/pages/media-and-children.aspx. Accessed May 8, 2015; (6) Dorothy Amatucci for US Department of Education. Stopping the summer slide. www.ed.gov/blog/2014/03/stopping-the-summer-slide/. Accessed May 8, 2015.

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Immunization HPV Vaccination for Boys and Young Men: Addressing Misconceptions and Expanding Uptake by PETER A. NEWMAN, PHD, and ASHLEY LACOMBE-DUNCAN, MSW

Human papillomavirus (HPV) is among the most common sexually transmitted infections in the United States.1 The Centers for Disease Control and Prevention estimates that most sexually active men and women will contract HPV at some point in their lives. }} }} ALTHOUGH MOST CASES of HPV resolve on their own, several HPV types are causally associated with genital warts and cervical cancer.1-3 Highrisk HPV types are also causally linked with anal, penile, and oropharyngeal cancers. An estimated 75% to 95% of anal cancers in men and women,2,4,5 and 40% to 50% of penile cancers are caused by highrisk HPV types.2,5 Men as well as women experience a substantial disease burden associated with HPV infection. Mounting evidence in the case of oral HPV infection indicates that HPV has replaced tobacco as the primary cause of oropharyngeal

cancer,6 with 4-fold higher oropharyngeal cancer incidence in the United States among men than women.7

HPV Prevention and Treatment HPV vaccines are safe and highly efficacious in both boys1,8 and girls.1,3 Building on its earlier recommendations for routine use of the bivalent HPV (HPV2) or quadrivalent HPV (HPV4) vaccine for girls, in 2011 the Advisory Committee on Immunization Practices (ACIP) recommended the HPV4 vaccine for routine vaccination of boys aged 11 or 12 years to prevent genital warts and HPV-associated cancers.9

The HPV4 vaccine is also recommended for unvaccinated adolescent boys and men aged 13 to 21 years, as well as for men who have sex with men and immunocompromised patients aged ≤26 years who are at disproportionate risk for HPV infection and associated cancers.10 HPV4 has demonstrated >90% efficacy in preventing the incidence of external genital lesions associated with HPV 6, 11, 16, or 18 in boys and men aged 16 to 26 years.8 Most recently, a 9-valent HPV (HPV9) vaccine was licensed by the US Food and Drug Administration and included by ACIP as 1 of 2 HPV vaccines that

can be used for routine vaccination of boys.10 Despite ACIP recommendations, HPV vaccine coverage in the United States remains well below public health targets. In 2013, 3-dose HPV vaccine coverage was 37.6% for girls and 13.9% for boys in the United States.9

Factors Associated with Low HPV Vaccination Rates Because of the low rates of HPV vaccine coverage—particularly among boys and young men—it is important to identify factors associated with uptake, as well as missed opportunities for HPV RETA #1 AM IL CL ONG INIC IANS

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Immunization vaccine administration. Among the most influential factors, perceived benefit of HPV vaccination strongly correlates with acceptability among men.11 Importantly, a significant barrier to HPV vaccinations for men is an enduring belief—including among boys/young men and their parents— that HPV is a woman’s disease.12 Another highly influential factor in HPV vaccine coverage is healthcare provider recommendation.11 A national survey in the United States revealed that more than one-fifth of parents reported that the main reason that their boys did not receive the HPV4 vaccine was because of a lack of recommendation from their clinician: 72% of parents of vaccinated boys reported receiving recommendations from their clinician, while only 26% of parents of unvaccinated boys reported receiving a clinician’s recommendation.9 Amid an increase in reported clinician recommendations for HPV vaccines documented from 2012 to 2013, parents of girls were still 50% more likely to report receiving a recommendation compared with parents of boys.9 Thus, it appears that clinicians may be subject to the same linger-

AN ADDITIONAL BARRIER IS THAT PARENTS APPEAR MORE LIKELY TO VACCINATE OLDER VERSUS YOUNGER CHILDREN AGAINST HPV, PARTICULARLY AMONG GIRLS. ing misconceptions revealed among parents and young men: the belief that HPV is a woman’s disease. An additional barrier is that parents appear more likely to vaccinate older versus younger children against HPV, particularly among girls; however, this is counter to ACIP recommendations that the vaccine be administered at age 11 or 12 years, prior to sexual debut, to optimize its effectiveness. Although parents’ understandable difficulty envisioning their children as eventually becoming sexually active is sometimes reported as a barrier to receiving the HPV vaccine—as is the less common concern that vaccination will somehow encourage children to engage in earlier sexual debut—it appears that most parents’ primary focus is on protecting their children from harm.

Parents’ lack of awareness of the risks of HPV for boys, coupled with lack of knowledge about the HPV4 vaccine and the absence of clinician recommendations, contribute to missed opportunities for receipt of HPV4 vaccines among boys and young men.9

Addressing Barriers to HPV Vaccination of Boys and Young Men The challenges identified to HPV vaccination of boys and young men span multiple levels, from individual knowledge and perceptions about HPV risk and HPV vaccine benefits for men, to parental concerns about HPV vaccination, to lack of healthcare provider recommendation. However, each of these factors may be mitigated, in part, by promoting a singular focal message: HPV vaccines help to prevent multiple cancers in both men and women. Emerging evidence suggests that a balanced approach to sharing this information, characterized by transparency and completeness—such as imparting that most HPV types are not oncogenic and are cleared from the system, versus appearing to erroneously suggest that all HPV infection leads to cancer— may be most effective in improving knowledge of HPV risk and HPV vac-

cines; it also results in a greater likelihood that reported intentions to be vaccinated result in actual vaccination.13 It is also incumbent on those engaged across the spectrum of patient care to correct the misperception that HPV vaccination is not for boys. This may be achieved by making parents aware of the risks of HPV for boys and men, sharing information about the high efficacy and safety of the HPV4 and HPV9 vaccines, and highlighting the unique availability of a vaccine that contributes to cancer prevention in men and women. In addition to the direct benefits of HPV vaccination for boys and men, because of the suboptimal HPV vaccine coverage among girls and young women in the United States, vaccinating boys contributes to herd immunity, and thereby preventing HPV in girls, too. Appeals for both self-protection and altruism may contribute to parents’ and children’s acceptance of the vaccine.14

HPV Vaccine Cost Concerns Importantly, the relatively high cost of HPV vaccination ($130/dose for 3 doses),15 in addition to logistic barriers, also presents substantial obstacles to HPV vaccination

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Immunization for both boys and girls. Increased HPV knowledge and awareness across young people, parents, and clinicians, although important, may not be sufficient to achieve widespread coverage.16 Expanding points of HPV vaccine access and reducing logistic barriers (eg, travel and waiting times) may make a further contribution to HPV vaccine uptake. Ultimately, emerging evidence of the noninferiority of 2-dose coverage17-19 along with further efforts to reduce the costs of HPV vaccines and provide universal public insurance coverage for routine HPV vaccinations, may make the most substantial contribution to ensuring high rates of HPV vaccine coverage in boys as well as girls.16 In turn, we may make the most effective use of this unique opportunity to advance cancer prevention. ❚

References

1. Centers for Disease Control and Prevention. HPV vaccine information

for clinicians – fact sheet. www.cdc. gov/std/hpv/stdfact-hpv-vaccine-hcp. htm. Reviewed July 8, 2012. Accessed May 20, 2015. 2. Parkin MD. The global health burden of infection-associated cancers in the year 2002. Int J Cancer. 2006;118:3030-3044. 3. Cutts FT, Franceschi S, Goldie S, et al. Human papillomavirus and HPV vaccines: a review. Bull World Health Organ. 2007;85:719-726. 4. De Vuyst H, Clifford GM, Nascimento MC, et al. Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva, vagina and anus: a meta-analysis. Int J Cancer. 2009;124:1626-1636. 5. Giuliano AR, Tortolero-Luna G, Ferrer E, et al. Epidemiology of human papillomavirus infection in men, cancers other than cervical and benign conditions. Vaccine. 2008;26(Suppl 10):K17-K28. 6. The Oral Cancer Foundation. OCF’s opinions about HPV and oral cancer. http://oralcancerfoundation.org/hpv/ ocf-hpv-opinions.php. Accessed May 13, 2015. 7. Jemal A, Simard EP, Dorell C, et al. Annual report to the nation on the status of cancer, 1975-2009, featuring the burden and trends in human papillomavirus (HPV)-associated cancers and HPV vaccination coverage levels. J Natl Cancer Inst. 2013;105:175-201. 8. Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med. 2011;364:401-411. 9. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report (MMWR). www. cdc.gov/mmwr/pdf/wk/mm6329.pdf. 2014;63:620-633. 10. Petrosky E, Bocchini JA Jr, Hariri S, et al. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly

Rep. 2015;64:300-304. 11. Newman PA, Logie CH, Doukas N, et al. HPV vaccine acceptability among men: a systematic review and meta-analysis. Sex Transm Infect. 2013;89:568-574. 12. Liddon N, Hood J, Wynn BA, et al. Acceptability of human papillomavirus vaccine for males: a review of the literature. J Adolesc Health. 2010;46:113-123. 13. Wegwarth O, KurzenhäuserCarstens S, Gigerenzer G. Overcoming the knowledge-behavior gap: the effect of evidence-based HPV vaccination leaflets on understanding, intention, and actual vaccination decision. Vaccine. 2014;32:1388-1393. 14. Quadri-Sheriff M, Hendrix KS, Downs SM, et al. The role of herd immunity in parents’ decision to vaccinate children: a systematic review. Pediatrics. 2012;130:522-530. 15. The Henry J. Kaiser Family Foundation. The HPV vaccine: access and use in the U.S. http://files.kff. org/attachment/fact-sheet-the-hpvvaccine-access-and-use-in-the-u-s. Published February 2015. Accessed May 13, 2015. 16. Newman PA, Lacombe-Duncan A. Human papillomavirus vaccination for men: advancing policy and practice. Future Virol. 2014;9:1033-1047. 17. Kreimer AR, Rodriguez AC, hildesheim A, et al. Proof-ofprinciple evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst. 2011;103:1444-1451. 18. Romanowski B, Schwarz TF, Ferguson LM, et al. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study. Hum Vaccin Immunother. 2014;10:1155-1165. 19. Dobson SR, McNeil S, Dionne M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013;309:17931802.

Peter A. Newman

Ashley Lacombe-Duncan Dr Newman is a Professor and Canada Research Chair in Health and Social Justice, and Ms LacombeDuncan is a PhD student, Factor-Inwentash Faculty of Social Work, University of Toronto, Ontario, Canada.

DO YOU HAVE A CLINICAL CHALLENGE TO SHARE? We are currently accepting clinical challenges, including a case and a commentary explaining best practice. We want to hear from pharmacists, nurse practitioners, physician assistants, and medical directors about how they have managed patients/customers. Contact: info@insidepatientcare.com with your clinical challenge RETA #1 AM IL CL ONG INIC IANS

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The Retail Pharmacy Medical Care 2015 Standards for Diabetes Three take-aways pharmacists and other retail clinicians can use in their practice today by SAMANTHA YOVANOFF, PHARMD

Every January the American Diabetes Association (ADA) publishes the Standards of Medical Care in Diabetes.1 }} }} THIS PUBLICATION includes guidelines for the diagnosis and treatment of diabetes, management of diabetes-related complications, and management of diabetes in special populations, as well as ways to advocate for the disease.

The first major update to the standards was the change in blood pressure goals for patients with diabetes. The standards that were published in January 2015 included several updates that align with other treatment guidelines and changes based on results of several studies and expert opinion. Some of these updates can have an impact on pharmacy practice and the way pharmacists provide care to their patients.

1/ Reassessing Blood Pressure

Goals The first major update to the standards was the change in blood pressure goals for patients with diabetes. The 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults, published by the Eighth Joint National Committee, set the blood pressure goals for patients aged ≥18 years as <140/90 mm Hg.2 Based on several randomized trials, the ADA followed suit and also updated their goals from <130/80 mm Hg in 2013 to <140/90 mm Hg in 2014.3,4 The ADA recommendation (Grade A) was based on several randomized controlled trials, including the results of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which indicated no benefit of lowering systolic blood pressure to <120 mmHg, compared with <140 mm Hg.5

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Inside the Retail Pharmacy For pharmacists, taking blood pressure readings is common practice. Patients often come in to have their blood pressure checked on the monitor, or by the pharmacist between physician visits. These recommendations will allow us as pharmacists to better counsel patients on their blood pressure numbers, make suggestions to guide lifestyle changes, or refer them to their physician to discuss changes in blood pressure or additions to their medication regimen.

2/ Preprandial Glucose Range

The ADA guidelines also included updated recommendations regarding the blood glucose range goal for preprandial glucose. The new minimum goal is 80 mg/dL, versus 70 mg/dL in the previous guidelines4; the upper range remains 130 mg/dL. The minimum range was raised to better meet the average blood glucose levels, which reflect A1c levels.4 It is recommended that A1c levels be checked at least twice a year because they can give physicians a broader perspective on the patient’s glucose control.1 For example, an A1c of 7%, which the ADA recommends as a reasonable A1c goal, correlates to an average plasma glucose level of 154 mg/dL and a mean preprandial glucose level of 152 mg/dL.6 These numbers fall above the ADA’s recommended goal range of <7% (which is still considered good), although recent guidelines suggest that treatment goals be individualized based on age, comorbidities, and disease duration.6 In addition to providing A1c testing, pharmacists can help patients keep track of their goals and blood glucose levels, as well as provide information about symptoms such as hyperglycemia and hypoglycemia.

3/ Pneumococcal Immunization

A more recent task that has been integrated into pharmacists’ workflows is administering immunizations. Most major retail pharmacies now offer pharmacist-administered vaccines, where

patients can either walk in or make an appointment to get a variety of vaccinations (eg, annual flu and shingles shots, and specific travel immunizations). In particular, the ADA guidelines recommend that patients with diabetes receive the pneumococcal vaccine, but until 2015 the guidelines never specified which pneumococcal vaccine. The guidelines have been updated to reflect the Centers for Disease Control and Prevention immunization schedule, and now recommends that all patients aged ≥2 years with diabetes get the pneumococcal polysaccharide vaccine 23 (PPSV23).1 Adults aged ≥65 years who have not received any pneumococcal

The role of the pharmacist is ever expanding to include increased patient counseling and clinical services. As the most accessible healthcare provider in the community, our role in patient care is crucial. vaccines should first get the pneumococcal conjugate vaccine 13 (PCV13), followed by PPSV23 after 6 to 12 months. Patients aged ≥65 years who have already received PPSV23 should receive the PCV13 after ≥12 months. Although, to my knowledge, no major studies have shown increased rates of morbidity or mortality in patients with diabetes and influenza, observational studies have shown increased rates of hospital admissions, hospitalizations, and complications in this patient population.7

Conclusion The role of the pharmacist is ever expanding to include increased patient counseling and clinical services. As the most accessible healthcare provider in the community, our role in patient care is crucial. RETA #1 AM IL CL ONG INIC IANS

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Inside the Retail Pharmacy Medical Directors • Physician Assistants • Nurse Practitioners • Pharmacists • Chain Headquarters • Independents

Most patients go to the pharmacy other disease states and disease-related much more often than they go to their complications, I urge all practicing pharprimary care physician’s office, which macists to familiarize themselves with Retail pharmacies and clinics are quickly becoming gives us an opportunity to take action the 2015 Standards ofan Medical Care in on our health. The Inside updates Patient Diabetes,Care and to continue to read the extension ofpatients’ primary care. : Retail that are discussed in this article include yearly updates published every January. ❚ Clinic Healthcare is can tailored 3 ways Solutions that pharmacists have an to meet the growing on patient care. Referencespractical needs of theimpact entire healthcare team and provides 1. American Diabetes Association. Standards of medical care Working in a retail pharmacy, I often in diabetes—2015. Diabetes Care. 2015;38(Suppl 1):S14-S80. information to treat and care for patients inside theOparilpharmacy see people check their blood pressure 2. James PA, S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: on the”machine located just outside the and retail clinics. report from the panel members appointed to the Eighth Joint pharmacy. Quite often, these machines National Committee (JNC 8). JAMA. 2014;311:507-520. Donald J. Dietz, MS Standards of medical care American DiabetesRPh, Association. are not calibrated correctly and give Vice3.President in diabetes—2013. Diabetes Care. 2013;36(Suppl 1):S11-S66. patients a surprising blood pressure read- Pharmacy Healthcare Solutions, Inc. 4. Standards of medical care in diabetes—2015: summary of revisions. Diabetes Care. 2015;38(Suppl 1):S4. ing. By manually checking patients’ Editor-in-Chief Inside Patient WC, CareEvans GW, Byington RP, et al; ACCORD 5. Cushman blood pressure, we have the chance to Study Group. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010;362:1575-1585. counsel and answer any other questions 6. Wei N, Zheng H, Nathan DM. Empirically establishing they may have. blood glucose targets to achieve HbA1c goals. Diabetes Care. Dr Yovanoff is a recent grad2014;37:1048-1051. It is important that pharmacists stay uate of Duquesne University 7. Smith SA, Poland GA. Use of influenza and pneumoup-to-date on all emerging guidelines, Mylan School of Pharmacy, coccal vaccines in people with diabetes. Diabetes Care. Pittsburgh, PA. but because diabetes encompasses many 2000;23:95-108.

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Inside Patient Care: Retail Clinic Healthcare Solutions™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics.

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As primary care expands to provide optimal access to quality care, Inside Patient Care: Retail Clinic Healthcare Solutions™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success.

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39 Disability Insurance Planning for the Healthcare Team

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Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers.

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Money Disability Insurance Planning for the Healthcare Team by LAWRENCE B. KELLER, CFP, CLU, CHFC, RHU, LUTCF

Whether you are a physician assistant, medical director, nurse practitioner, pharmacist, executive, or working in another capacity, protecting one’s own income in the event of a disability is one of the core elements of financial planning. }} }} THIS ARTICLE briefly describes the steps necessary to begin shopping for individual disability insurance coverage, which features you should include in your policy, as well as a few areas where one carrier may differ from another.

Disability Insurance Disability insurance can be purchased on an individual or group basis. Group insurance is usually provided by an employer, or purchased individually from a sponsoring association. Although they are initially low in cost, group policies have several limitations. They can be canceled by the sponsoring association or insurance company, rates increase as you grow older, and premiums are subject to adjustments based on

the claims filed by the group. In addition, group and association contracts often contain restrictive definitions of disability, as well as less generous contract provisions.

Group insurance is usually provided by an employer, or purchased individually from a sponsoring association. Disability Insurance Limits Insurance companies don’t want you to earn a higher income when you are disabled compared with when you were working. For this reason, most insurance companies will limit the amount of disRETA #1 AM IL CL ONG INIC IANS

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Inside Money ability insurance available. In the event of a disability, you would ideally have 60% to 80% of your earned income replaced. However, when you have a group insurance plan in place, this will limit the amount of individual coverage available, even if you are willing to pay for a larger amount of coverage. For this reason, when shopping for an individual disability insurance policy, it is best to provide your insurance agent or financial advisor with a copy of your employer-provided long-term disability insurance plan, if any, for review, along with your annual income, a description of your job duties, and whether you have any health issues and/or are taking any prescription medications. Then he or she can present you with descriptions of coverage from several insurance companies, and help you compare the pros and cons of each option in terms of costs versus benefits.

Many disability insurance carriers offer a “multilife” discount when several employees working for the same employer purchase individual policies at the same time. The Cost of Disability Insurance Premium rates are based on several factors, including your age, sex, available monthly benefit, and optional riders— which offer added coverage and protection to a basic policy for an additional charge—selected. The younger you are when the purchase is made, the lower the cost of the insurance. Therefore, you should purchase a policy as early in your career as possible to lock in lower premium rates. Although women are considered better risks for life insurance, this is not the case with disability insurance. Rates for women are substantially higher, and their policies generally cost 50% to 60% more than rates for men. Fortunately, many disability insurance carriers offer

a “multilife” discount when several employees working for the same employer purchase individual policies at the same time. Although these programs typically produce a savings of 10% to 15% for men, this strategy allows women to save ≤60% on the cost of their disability insurance. Another option is to secure a discount through a professional association of which you are a member, or eligible to join.

What to Look for in an Individual Disability Insurance Policy

1/

Noncancelable and Guaranteed Renewable. If you purchase a policy that is noncancelable and guaranteed renewable, you are assured that the premium rates and policy provisions will not be changed or canceled. This combination provides the greatest degree of consumer protection.

2/ Definition of Total Disability. Look

for a policy that contains a true, “own-occupation” definition of total disability. If you become totally disabled from your regular occupation and choose to work in another occupation, you will receive full benefits, regardless of the income you earn from the other occupation.

3/ Residual Disability Rider. Although

“own-occupation” provides the most liberal definition of disability, it is not the end-all. What happens if your physician states that you can still work in your occupation, but that he or she requires you work fewer days per week or hours per day? The residual disability rider protects your income by providing benefits, proportional to your loss of income, in the event that you are not completely disabled. To qualify for residual disability benefits, you generally must experience an income loss of 15% to 20% or more compared with your predisability earnings. In addition, if your loss of earnings is greater than 75% to 80%, then you would be paid 100% of your monthly disability benefit.

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Inside Money This rider is also extremely important if you start off completely disabled and then return to your occupation with a limited schedule as you recover, or if you experience a continued loss of income because you were previously disabled, even if you are back to working full-time. Finally, it is imperative that you do not purchase a policy that requires you to be completely disabled first in order to collect benefits under the residual disability rider. Although this is not the case with individual policies, it is very common among group policies offered by professional associations.

4/ Cost-of-Living Adjustment (COLA)

Rider. A COLA rider is designed to help your benefits keep pace with inflation after you have been disabled for 12 months. This adjustment can be a fixed percentage or tied to the Consumer Price index. Ideally, you want a COLA that is adjusted annually on a compound interest basis, with no cap on the monthly benefit. Although expensive, the COLA rider can provide significant increases to your monthly benefit if you are disabled young. However, if cutting the cost of coverage is an issue, consider excluding the COLA rider from your policy, or using the additional premium associated with this rider to purchase a larger monthly benefit—if you are not already contemplating the purchase of the maximum monthly benefit for which you qualify—based upon your earned income and other disability insurance in force, if any.

5/ Future Increase Option Rider. This

rider is a must-have for young professionals. It gives you the ability to increase your disability coverage as your income rises, without providing evidence of good health. This guarantees that any medical conditions that develop after the purchase of your original policy would be fully covered, and not subject to new medical underwriting (eg, medical examination, blood and urine tests, or answering any medical questions).

It is important to know when, and by what increments, you can increase your coverage on any given option date. Some companies may allow you to use the entire increased option amount in any given 1 year, as long as your then current income warrants the increase; others, however, may limit the amount you can purchase in any given year.

It is important to know when, and by what increments, you can increase your coverage on any given option date. 6/

Catastrophic Disability Benefit (CAT) Rider. If you become catastrophically disabled under the terms of the CAT policy and lose the ability to perform ≥2 activities of daily living without assistance, become cognitively impaired, or become presumptively disabled, you would receive a monthly benefit in addition to the base monthly benefit purchased.

Comparing Policies When Shopping for Coverage Other than cost, the following provisions may help you decide which disability insurance policy (or policies) to purchase:

1/

Occupational Classification and Pricing. Proper classification of occupations is a primary factor in establishing the premium rate that you will be charged by the insurance company. In general, the higher the occupational classification assigned to your profession, the lower your premium rate. It is also important to note that different insurance companies may assign a different occupational class to the same occupation, and, as a result, the premium rates may vary greatly from one company to another. Therefore, it is important to shop for the coverage that you will be RETA #1 AM IL CL ONG INIC IANS

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Inside Money purchasing, or to employ the services of an insurance agent or financial planner who specializes in this type of coverage, and represents several companies.

2/

Mr Keller is the founder of Physician Financial Services. a New York–based firm specializing in income protection and wealth accumulation strategies for physicians.

Foreign Residence and Travel. Some carriers allow insured people to receive coverage while traveling to or residing in countries outside of the United States, the District of Columbia, or Canada, but the majority of carriers will limit payments for this type of claim. Therefore, if you consider working outside of the United States in the future, or choose to leave the United States in the event that you became disabled, you should make sure that any disability insurance policy you purchase does not contain a limitation for this type of claim.

3/ Mental, Nervous, and/or Substance

Abuse Disorders. Some carriers will treat claims for mental, nervous, and/or substance abuse disorders in the same

way as any other accident or illness, but the majority of companies limit these claims to a lifetime maximum of 24 months if the primary cause of disability is solely a psychiatric or substance abuse disorder or diagnosis (eg, posttraumatic stress disorder, anxiety, depression, and/ or alcohol abuse/addiction). Although many insured persons would opt to purchase the disability coverage with the least amount of restrictions, some willingly accept a policy with this limitation to take advantage of the cost-savings associated with it.

Summary Protecting one’s income in the event of a disability is a core element of financial planning. This article briefly describes what to look for when shopping for individual disability insurance coverage, riders you should and shouldn’t include in your policy, as well as a few areas that may differ from one carrier to another. ❚

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Drug Update Keytruda (Pembrolizumab): First PD-1 Inhibitor Approved for Previously Treated Unresectable or Metastatic Melanoma by LISA A. RAEDLER, PHD, RPH

Melanoma, although not the most common skin cancer in the United States, is the most deadly.1 }} }} BASED ON DATA collected between 2004 and 2010, the 5-year survival rate for Americans with metastatic melanoma remains very low—only 16%—for all ages and races, and both sexes.2 The National Cancer Institute has estimated that 21.3 in 100,000 people will be diagnosed with melanoma of the skin in the United States in 2014.2 More than 9700 patients are estimated to die from melanoma in the same time frame.2 The incidence of melanoma is increasing in the United States, particularly among children and adolescents.2,3 An analysis of first-time melanoma diag-

noses in patients aged 18 to 39 years between 1970 and 2009 showed that the incidence of melanoma increased 8-fold among young women and 4-fold among young men.3 A study analyzing data from 1973 to 2009 documented an average increase of 2% annually in melanoma in children aged between 0 and 19 years, particularly in girls and those aged between 15 and 19 years.4 These trends in melanoma diagnosis rates are concerning in light of their potential impact on healthcare resource consumption. An assessment of Medicare claims data from 1991 to 2005 demonstrated that patients with

Copyright © 2014 American Health & Drug Benefits. All rights reserved.

melanoma, particularly those with metastatic disease, utilize substantial healthcare resources.5 In this study, patients with metastatic melanoma con­­ sumed an average of more than $11,000 monthly in total healthcare costs, the majority of which was related to inpatient hospital services.5 Of note, this cost analysis was conducted before the new targeted therapies for metastatic melanoma became available. Because tumor cells can spread to distant lymph nodes and to other organs, metastatic melanoma can be difficult to cure.6 Surgery and radiation therapy can be considered for tumors on the skin or for tumors that are localized to the lymph nodes. Metastases in internal organs can be

surgically removed, de­­ pending on their number and location.6 The development of novel agents has significantly altered the management of patients with advanced disease. Today’s armamentarium of systemic treatments for metastatic melanoma includes immunotherapies, BRAF inhibitors (ie, vemurafenib, da­ brafenib, trametinib), and chemotherapy.6 Many of these newer agents offer superior efficacy compared with chemotherapy.6 Specifically, immune checkpoint blockade with immuno-oncology agents that are directed toward cytotoxic T-­lymphocyte anti­ gen (CTLA)-4 (eg, ip­ il­imumab), as well as programmed death (PD)-1 and PD-ligand 1 (PD-L1), RETA #1 AM IL CL ONG INIC IANS

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Drug Update has emerged as a s­ uccessful treatment ap­­proach.7 Ipilimumab was the first CTLA-4 inhibitor to demonstrate an overall survival benefit and durable objective responses in patients with metastatic melanoma.7 In patients with metastatic melanoma and BRAF V600 mutation, a striking contrast has been observed between BRAF inhibition, which offers higher response rates with limited response durability, and CTLA-4 inhibition, which offers a relatively low response rate but very durable responses.7 To increase the number of patients with melanoma who benefit from durable responses with immunotherapy, researchers are exploring potential synergies between immune checkpoint inhibitors that target CTLA-4, PD-1, and PD-L1, and kinase-targeted therapies, as well as the concurrent and sequential use of CTLA-4 and PD-1/ PD-L1 inhibitors.7

Pembrolizumab Approval On September 4, 2014, the US Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck Sharp & Dohme Corp) for the treatment of patients with unresectable or metastatic melanoma and disease progression after receiving

“PEMBROLIZUMAB IS…A CLEARLY EFFECTIVE DRUG THAT WILL PROLONG SURVIVAL FOR MANY PATIENTS WITH METASTATIC MELANOMA. THIS APPROVAL IS A REAL ADVANCE AND A MAJOR MILESTONE IN THE TREATMENT OF THE DISEASE.” ipilimumab and, in pa­ tients with BRAF V600 mutation melanoma, a BRAF inhibitor.8 Pembro­ lizumab is the first human PD-1–blocking antibody approved for use in the United States.9 Pembrolizumab, which is administered via intravenous infusion, was approved under the accelerated approval program based on surrogate end points of confirmed overall response rate (ORR) and duration of response.8 Improvements in survival or disease-related symptoms have not yet been established.10 According to Jeffrey S. Weber, MD, PhD, Director of the Donald ­ ­­A. Adam Comprehensive Mel­anoma Research Cen­

ter of Excellence at the Moffitt Cancer Center, Tampa, FL, “Pembrolizu­ mab is…a clearly effective drug that will prolong survival for many patients with metastatic melanoma. This approval is a real advance and a major milestone in the treatment of the disease.”11 As a condition for this accelerated approval, the manufacturer is required to conduct a multicenter, randomized trial to establish the superiority of pembrolizumab over standard therapy and to verify its clinical benefit in patients with metastatic melanoma.8 Currently, 2 ongoing multicenter, randomized, controlled, therapeutic con­­firmatory trials are under way in patients with metastatic melanoma: Trial P002 in ipilimumab-refractory patients and Trial P006 in ipilimumab-naïve patients. In both trials, the coprimary end points are progression-free survival and overall survival.8

Dosing and Administration The recommended dosage of pembrolizumab is 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks; it should be reconstituted and diluted before infusion. Pembrolizumab should be used until disease progression or until unacceptable toxicity.10 No dose adjustment of pembroliz­umab is needed for patients with renal impairment or for patients with mild hepatic impairment, defined as a total bilirubin of the upper limit of normal or less, and aspartate aminotransferase (AST) of more than the upper limit of normal, or a total bilirubin of >1 to 1.5 times the upper limit of normal and any AST. Pembrolizumab has not been studied in patients with moderate or severe hepatic impairment.10

Mechanism of Action Pembrolizumab is a mono­clonal antibody that binds to the PD-1 receptor and blocks interaction with its ligands, PD-L1 and PD-L2. This binding results in the activation of T-cell–mediated immune responses against tumor cells. Blocking PD-1 activity resulted in de­­ creased

KEYNOTE-001 Clinical Trial: Relapsed Metastatic Melanoma The accelerated approval of pembrolizumab was based on the results of a multicenter, openlabel, randomized, dose-­ comparative, activity-estimating cohort conducted within the phase 1b

tumor growth in genetically identical mouse tumor models.10

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Drug Update KEYNOTE-001 trial (Trial P001).10 Of the 411 patients with treatment-­ naïve or with previously treated unresectable or metastatic mela­­noma who enrolled in the KEY­ NOTE-001 trial, 173 had disease progression within 24 weeks of the last dose of ipilimumab and, in those with BRAF V600 mutation melanoma, after previous treatment with a BRAF inhibitor. These 173 patients were random­ ized to receive 2 mg/kg (N = 89) or 10 mg/kg (N = 84) of intravenous pembrolizumab once every 3 weeks until disease progression or until unacceptable toxicity.10 The primary efficacy end points were confirmed ORR according to Re­­ sponse Evaluation Criteria in Solid Tumors (RE­­ CIST) v1.1 as assessed by a blinded independent central review and duration of response.10,11 The patients’ tumor status was assessed every 12 weeks.10 The secondary outcome measures included investigator-assessed immunerelated response criteria.11 The KEYNOTE-001 trial excluded patients with autoimmune disease, medical conditions that required immunosuppression, or a history of severe immune-mediated adverse events with ipilimumab. The latter was defined as any grade 4 toxicity requir-

ing treatment with corticosteroids or grade 3 toxicity requiring corticosteroid treatment for ≥12 weeks.10

Patient Population Among the 173 pa­ tients with previously treated unresectable or metastatic melanoma in KEYNOTE-­­001, the median age was 61 years (61% were aged <65 years).10 Most patients were male (60%) and white (97%). All of the patients in the trial had an Eastern Cooperative Oncology Group performance status of 0 or 1. The patients’ disease characteristics in­cluded stage M1c (82%), having had ≥2 previous therapies for advanced or metastatic disease (73%), elevated lactate dehydro­genase (39%), BRAF V600 mutation (17%), and brain metastases (9%).10 Efficacy The ORR associated with 2-mg/kg pembroliz­ umab was 24% (95% confidence interval, 15%34%) in patients with unresectable or metastatic melanoma who were previously treated with ipi­ limumab and, if relevant, a BRAF inhibitor.10 Of the 21 patients with an objective response to pembrolizumab, 1 patient achieved a complete re­ sponse and 20 patients achieved a partial re­ sponse.10 Of these 21 pa­

THE MOST COMMON SERIOUS ADVERSE DRUG REACTIONS REPORTED IN ≥2% OF THE 411 PATIENTS RECEIVING PEMBROLIZUMAB WERE RENAL FAILURE, DYSPNEA, PNEUMONIA, AND CELLULITIS. tients, 3 (14%) patients had disease progressions 2.8 months, 2.9 months, and 8.2 months (respectively) after the initial response to pembrolizumab therapy. The remaining 18 (86%) patients had ongoing responses after the initial response to therapy, with response duration ranging from ≥1.4 months to ≥8.5 months; this group included 8 patients with ongoing responses of ≥6 months. Objective re­ sponses were observed in patients with and without BRAF V600 mutation melanoma.10 The ORR associated with 10-mg/kg pembroliz­ umab was similar (26%) to the ORR with 2-mg/kg pembrolizumab.10,12

Safety The cohort of 89 patients with previously treated unresectable or metastatic melanoma in KEYNOTE-001 who re­ ceived pembrolizumab (2 mg/kg) had a median of 9 doses (range, 1-23 doses).10 The median duration of exposure for this cohort was 6.2 months (range, 1 day-15.3 months). Of these 89 patients, 51% were exposed to pembroliz­ umab for >6 months, and 21% were exposed for >1 year.10 The Table summarizes the adverse reactions that occurred in ≥10% of patients in this cohort. Among the 411 pa­ tients who received pembrolizumab in KEYNOTE-­ ­­001, serious adverse reactions occurred in 36%. The most common serious adverse drug reactions reported in ≥2% of the 411 patients receiving pembrolizumab were renal failure, dyspnea, pneumonia, and cellulitis.10,12 Pembrolizumab was discontinued because of ad­ verse reactions in 9% of the 411 patients receiving 2-mg/kg or 10-mg/kg doses in KEYNOTE-­­­001. Among the 89 patients with unresectable or metastatic melanoma who received 2 mg/ kg of pembrolizumab, the discontinuation rate associated with adverse reactions was 6%. The adverse reactions that led to the discontinRETA #1 AM IL CL ONG INIC IANS

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Drug Update Table. Adverse Reactions in ≥10% of Patients with Unresectable or Metastatic Melanoma Receiving Pembrolizumab 2 mg/kg Pembrolizumab 2 mg/kg every 3 weeks (N = 89) All grades, %

Grade 3,a %

General disorders and administration site conditions Fatigue

47

7

Peripheral edema

17

1

Chills

14

0

Pyrexia

11

0

Nausea

30

0

Constipation

21

0

Gastrointestinal disorders

Diarrhea

20

0

Vomiting

16

0

Abdominal pain

12

0

Respiratory, thoracic, and mediastinal disorders Cough

30

1

Dyspnea

18

2

Pruritus

30

0

Rash

29

0

Vitiligo

11

0

26

0

Skin and subcutaneous tissue disorders

Metabolism and nutrition disorders Decreased appetite Musculoskeletal and connective tissue disorders Arthralgia

20

0

Pain in extremity

18

1

Myalgia

14

1

Back pain

12

1

Nervous system disorders Headache

16

0

Dizziness

11

0

14

5

14

0

11

1

Blood and lymphatic system disorders Anemia Psychiatric disorders Insomnia Infections and infestations Upper respiratory tract infection

No grade 5 adverse reactions were reported. Of the ≥10% adverse reactions, none was grade 4. Source: Keytruda (pembrolizumab) for injection prescribing information; September 2014. a

uation of pembrolizu­mab included pneumonitis, renal failure, and pain.10 Pembrolizumab has no contraindications.

Warnings and Precautions Immune-mediated pneumonitis. Pneumon­i­ tis occurred in 12 of the 411 patients with unresectable or metastatic melanoma who received pembroliz­ umab in the KEYNOTE-001 trial. The median time to the development of pneumonitis was 5 months (range, 2 days-9.9 months), and the median duration of pneumonitis was 4.9 months (range, 1 week-14.4 months). In 5 of the 8 patients with grade 2 pneumonitis and 1 patient with grade 3 pneumonitis, initial treatment with high-dose systemic corticosteroids (≥40 mg prednisone or equivalent daily) was required and was followed by a corticosteroid taper. Pembro­ lizumab was discontinued in 3 patients with pneumonitis. In 7 of the 9 patients with grade 2 or 3 pneumonitis, the condition completely resolved.10 Patients receiving pembrolizumab should be monitored for signs and symptoms of pneumonitis and should undergo radiographic imaging if pneumonitis is suspected. Corti­ costeroids are appropriate if grade ≥2 pneumonitis is

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Drug Update detected. Pembro­lizumab should be withheld for moderate (grade 2) pneumonitis, and should be permanently discontinued for severe (grade 3) or life-threatening (grade 4) pneumonitis.10 Immune-mediated colitis. Colitis, including microscopic colitis, oc­­ curred in 4 of the 411 patients in the KEY­ NOTE-001 trial. Grades 2 and 3 colitis were observed in 1 and 2 patients, respectively. The median time to onset of colitis was 6.5 months (range, 2.3-9.8 months). All 3 patients with grade 2 or 3 colitis were treated with highdose corticosteroids followed by a corticosteroid taper. One patient permanently discontinued pembrolizumab as a result of colitis. All 4 patients with colitis experienced complete resolution of the condition.10 Patients receiving pem­­ brolizumab should be monitored for signs and symptoms of colitis. Cor­ ticosteroids should be used for grade ≥2 colitis. Pembrolizumab should be withheld for moderate (grade 2) or severe (grade 3) colitis, and should be permanently discontinued for life-threatening (grade 4) colitis.10 Immune-mediated hepatitis. In the KEY­ NOTE-001 trial, hepatitis, including autoimmune

hepatitis, occurred in 2 of the 411 patients, including 1 patient with grade 4 hepatitis. The time to onset was 22 days after initiating pembrolizumab for the patient with grade 4 hepatitis. This patient permanently discontinued pembrolizumab and was treated with high-dose systemic corticosteroids followed by a corticosteroid taper. Both patients with hepatitis experienced complete resolution of the event.10 Patients receiving pem­­ brolizumab should be monitored for changes in liver function. Cortico­ steroids should be ad­­ ministered for grade ≥2 hepatitis. Pembro­lizumab should be withheld or discontinued based on the severity of liver enzyme elevations.10 Immune-mediated hypophysitis. Inflam­mation of the pituitary gland (hypophysitis) oc­­curred in 2 of the 411 patients in the KEY­NOTE-001 trial. One of these events was grade 2 and 1 was grade 4. The time to onset was 1.3 months for the patient with grade 2 hypophysitis and 1.7 months for the patient with grade 4 hypo­ physitis. Both pa­tients were treated with high-dose corticosteroids followed by a corticosteroid taper and continued receiving physiologic replacement doses of glucocorticoids.10

PATIENTS RECEIVING PEMBROLIZUMAB SHOULD BE MONITORED FOR SIGNS OF HYPOPHYSITIS. Patients receiving­ pembrolizumab should be monitored for signs of hypophysitis. Cortico­ steroids should be used for grade ≥2 hypo­physitis. Pembrolizumab should be withheld for moderate (grade 2) hypophysitis, withheld or discontinued for severe (grade 3) hypophysitis, and permanently discontinued for life-threatening (grade 4) hypophysitis.10 Renal failure and immune-mediated nephritis. In the KEYNOTE-001 trial, nephritis occurred in 3 of the 411 patients, including 1 case of grade 2 autoimmune nephritis and 2 cases of interstitial nephritis with renal failure (1 case of grade 3 and 1 case of grade 4). In the patient with autoimmune nephritis, the time to onset was 11.6 months after the first dose of pembrolizu­ mab and 5 months after the last dose. This patient did not undergo a kidney biopsy. Acute interstitial ne­­phritis was confirmed by biopsy in 2 patients with

grade 3 or 4 renal failure.10 All 3 patients with nephritis fully recovered their kidney function after treatment with high-dose corticosteroids followed by a corticosteroid taper.10 Patients receiving pembrolizumab should be monitored for changes in renal function. Cortico­ steroids should be administered for grade ≥2 nephritis. Pembro­lizumab should be withheld for moderate (grade 2) nephritis and should be permanently discontinued for severe (grade 3) or life-threatening (grade 4) nephritis.10 Immune-mediated hyperthyroidism and hypothyroidism. Hyper­ thy­roidism occurred in 5 of the 411 patients (2 patients with grade 1, 2 with grade 2, and 1 with grade 3) receiving pembrolizumab. The median time to onset was 1.5 months (range, 0.5-2.1 months) after pembroliz­ umab initiation, and the median duration was 2.8 months (range, 0.9-6.1 months). One of the 2 patients with grade 2 hyperthyroidism and the patient with grade 3 hyperthyroidism required treatment with high-dose corticosteroids followed by a corticosteroid taper. Only 1 patient permanently discontinued pem­ broliz­umab as a result of hyperthyroidism. Hyper­ thyroidism resolved comRETA #1 AM IL CL ONG INIC IANS

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Drug Update pletely in all 5 patients.10 Hypothyroidism oc­­ curred in 34 (8.3%) of the 411 patients who re­ ceived pembrolizumab in the KEYNOTE-001 trial. The median time to the onset of hypothyroidism was 3.5 months (range, 5 days-19 months). All but 2 patients with hypo­ thyroidism were treated with long-term thyroid hormone replacement therapy. The other 2 pa­ tients required short-term thyroid hormone replacement therapy. None of the patients received corticosteroids or discontinued pembrolizumab secondary to hypothyroidism.10 Because thyroid disorders can occur at any t­ ime during treatment with pembrolizumab, patients should be monitored for changes in thyroid function at the initiation of treatment, periodically during treatment, and as indicated based on clinical evaluation.10 Isolated hypothyroidism can be managed with thyroid hormone replacement therapy without treatment interruption and without corticosteroids. Cortico­steroids should be administered for grade ≥3 hyperthyroidism. Pembro­­lizumab should be withheld for severe (grade 3) hyperthyroidism and should be permanently discontinued for life-­ threatening (grade 4)

THE SAFETY AND EFFICACY OF PEMBROLIZUMAB ARE ALSO BEING EVALUATED IN OTHER SOLID AND LIQUID TUMORS. ­hyperthyroidism.10 Other immune-mediated adverse reactions. Other clinically important immune-mediated adverse reactions can occur while patients with unresectable or metastatic melanoma are receiving pembrolizumab.10 Clinically significant, immune-mediated ad­­ verse reactions that occurred in <1% of the 411 patients treated with pembrolizumab in the KEYNOTE-001 trial in­ cluded exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, he­ molytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, and adrenal insufficiency.10 In clinical studies of 2000 patients with various diagnoses who re­ ceived pembrolizumab, other clinically significant immunemediated ad­­verse reactions included myasthenic syndrome, optic neuritis, and rhabdomyolysis.10 If an immune-mediated adverse reaction is

s­ uspected, patients receiving pembrolizumab must be evaluated to exclude other causes. Pembro­ lizumab should be withheld and corticosteroids should be administered based on the severity of the reaction. Upon im­­ provement of the reaction to grade ≤1, a corticosteroid taper can be initiated and continued for at least 1 month.10 Pembrolizumab can be restarted if the adverse reaction remains at grade ≤1. Pembrolizumab should be permanently discontinued for any severe or grade 3 immune-mediated adverse reaction that recurs and for any life-­ threatening immune-mediated adverse reaction.10 Embryofetal toxicity. Pembroliz­umab may cause fetal harm when administered to a pregnant woman. If pembrolizumab is used during pregnancy, or if a patient becomes pregnant while taking the drug, she should be made aware of the potential hazard to the fetus. Women of childbearing age should use effective contraception during treatment with pembro­­lizu­mab and for at least 4 months after the last dose of the drug.10

Specific Populations Pediatric patients. The safety and efficacy of pembrolizumab in pediatric patients have not been

established.10 Geriatric use. Of the 411 patients with relapsed unresectable or metastatic melanoma who received pembroliz­umab, 39% were aged ≥65 years. No meaningful differences in efficacy were observed among the age cohorts.10 Pregnancy. Pembro­ lizumab has been assigned pregnancy category D. Women should avoid becoming pregnant while being treated with pembrolizumab.10 Nursing mothers. Nursing should be discontinued during treatment with pembrolizumab.10

Conclusion Pembrolizumab, the first FDA­approved PD-1 inhibitor, is a safe and effective immunotherapy for patients with unresectable or metastatic melanoma and disease progression after ipilimumab and, if BRAF V600 mutation melanoma, after a BRAF inhibitor. The FDA approved pembrolizumab under its accelerated approval program based on tumor response rate and duration of response data. As a condition of this accelerated approval, the FDA required that a multicenter, randomized trial be conducted to establish pembrolizu­ mab’s survival superiority over standard therapy, and to verify its clinical benefit

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Drug Update

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September 4, 2014. http://online.wsj. and metastatic melanoma in the elderin patients with metastatic carcinoma, recurrent head com/­­a rticles/fda-approves-mercks-­ ly: evidence from the SEER-Medicare 8 Retail pharmacies and clinics are quickly becoming an melanoma. and neck cancer, and cancer-drug-1409856320. Accessed linked database. Appl Health Econ 13 October 17, 2014. Health Policy. 2009;7:31-41. The 2 ongoing trials multiple extension ofmyeloma. primary❚ care. Inside Patient Care : Retail 10. Keytruda (pembrolizumab) for 6. American Cancer Society. Treatment ­­of pembroliz­umab, Trial injection [prescribing information]. of melanoma skin cancer by stage. Re­­ Clinic Healthcare Solutions is tailored to 5,meet the growing Whitehouse Station, NJ: Merck Sharp vised September 2014. www.cancer. References P002 in ipilimumab-re& Dohme Corp; September 2014. org/cancer/skincancer-melanoma/ 1. Skin Cancer Foundation. Melanoma. fractory patients and Trial needs of thewww.skincancer.org/skinentire healthcare team and provides practical 11. Inman S. FDA approves pembro­ detailedguide/melanoma-skin-cancer-­ ­c ancerlizumab for advanced melanoma. treating-by-stage. Accessed October information/melanoma. Ac­­cessed Octo­ P006 in ipilimumab-naïve OncLive. September 4, 2014. www. 17, 2014. information to treat inside the pharmacy ber 17, 2014. and care for patients patients, are currently onclive.com/web-exclusives/FDA-­Ap 7. Ott PA, Hodi FS, Robert C. CTLA-4­ 2. National Cancer Institute. SEER proves-Pembrolizumab-for-Advanced-­ and PD-1/PD-L1 blockade: new im­ stat fact sheets: melanoma of the skin. ” and retail clinics. investigating the potential Melanoma#sthash.hAnbLPqJ.dpuf. munotherapeutic modalities with http://seer.cancer.gov/statfacts/html/ survival benefit with pemDietz, RPh, MS Accessed October 17, 2014. durable clinical Donald benefit inJ. melanoma melan.html. Accessed October 17, 2014. 12. National Cancer Institute. Melanopatients. Clin Cancer Res. 2013;19: Vice President 3. Reed KB, Brewer JD, Lohse CM, et brolizumab in patients ma treatment (PDQ ): unresectable 5300-5309. al. Increasing incidence of melanoma Pharmacy Healthcare Solutions, Inc. with advanced melanoma. 8. US Food andEditor-in-Chief Drug Administration. stage III, stage IV, and re­­current melaamong young adults: an epidemiolog­ Drugs: pembrolizumab. UpdatedCare Sep­ noma treatment. Up­­­dated September ical study in Olmsted County, Inside Patient The safety and efficacy tember 5, 2014. www.fda.gov/Drugs/ 19, 2014. www.cancer.­­gov/cancertopics/ Minnesota. Mayo Clin Proc. 2012;­87: of pembro­ lizumab are InformationOnDrugs/ApprovedDrugs/ pdq/treament/melanoma/ HealthProfes 328-334. ucm412861.htm. Accessed October sional/Page9#­Section_896. Accessed 4. Wong JR, Harris JK, Rodriguezalso being evaluated in ­­ 17, 2014. October 20, 2014. Galindo C, Johnson KJ. Incidence of other solid and liquid 9. Loftus P. FDA approves Merck’s 13. ClinicalTrials.gov. Pembrolizumab. childhood and adolescent melanoma new-wave cancer drug: new treatment, Search results. http://clinicaltrials.gov/ ­­in the United States: 1973–2009. tumors, including ad­­ which costs $150,000 a year, is aimed ct2/results?term=pembrolizumab Pediatrics. 2013;131:846-854. vanced non–small-cell at bolstering the body’s immune sys&Search=Search. Accessed October 5. Davis KL, Mitra D, Kotapati S, et al. tem. Wall Street Journal. Updated 21, 2014. Direct economic burden of high-risk lung cancer, renal-cell ®

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Inside Patient Care: Retail Clinic Healthcare Solutions™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics.

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As primary care expands to provide optimal access to quality care, Inside Patient Care: Retail Clinic Healthcare Solutions™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success.

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Products and Services And other news from the US Food and Drug Administration

New Drugs/Devices The following are some of the recent approvals announced by the US Food and Drug Administration (FDA): • Viberzi (eluxadoline) and Xifaxan (rifaximin) were approved for the treatment of adult men and women with irritable bowel syndrome with diarrhea (IBS-D). Viberzi is taken orally twice daily with food, and is indicated for the treatment of adults with IBS-D. Common side effects included constipation, nausea, and abdominal pain. Xifaxan can be taken orally 3 times daily for 14 days, and is indicated for the treatment of abdominal pain and diarrhea in patients with IBS-D. Common side effects include nausea and an increase in alanine aminotransferase. • Senza system, a spinal cord stimulation system that treats pain without producing a tingling sensation, was approved by the FDA. The system aids in the management of chronic intrac­

RAPAMUNE IS THE FIRST DRUG APPROVED FOR THE TREATMENT OF PATIENTS WITH LAM. table pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain, and leg pain. The Senza system reduces pain without producing a tingling sensation by providing highfrequency stimulation at 10 kHz, and low-stimulation amplitudes. • Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant, was approved to help control bleeding from small blood vessels during surgery when standard surgical techniques (eg, suture, ligature, or cautery) are ineffective or impractical. Common adverse events associated with the use of Raplixa were surgical pain, nausea, constipation, fever, and decreased blood pressure.

• Rapamune (sirolimus) is the first drug approved for the treatment of patients with lymphangioleiomyomatosis (LAM). The drug is available as a tablet and an oral solution. Common side effects include mouth and lip ulcers, diarrhea, abdominal pain, and nausea. The drug was originally approved as an immunosuppressive agent for the prevention of organ rejection in patients aged ≥13 years receiving kidney transplants. • Avelox (moxifloxacin) was approved for the treatment of patients with plague, including pneumonic plague and septicemic plague, as well as for the prevention of plague in adults. Common side effects associated with treatment include nausea, diarrhea, headache, and dizziness. ❚ (1) US Food and Drug Administration. New and generic drug approvals. www.fda.gov/Drugs/News Events/ucm130961.htm. Updated May 29, 2015. Accessed May 29, 2015; (2) US Food and Drug Administration. Press announcements. www.fda. gov/NewsEvents/Newsroom/PressAnnounce ments/default.htm. Updated May 29, 2015. Accessed May 29, 2015.

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Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers.

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IPC June 2015 | Vol 3 | No 6  

Inside Patient Care: Retail Clinic Healthcare Solutions, June 2015, Volume 3, Number 6

IPC June 2015 | Vol 3 | No 6  

Inside Patient Care: Retail Clinic Healthcare Solutions, June 2015, Volume 3, Number 6

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