IPC April 2015 | Vol 3 | No 4

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InsidePatientCare.com

April 2015 VOL. 3 • NO. 4

16 Questions

Answered with Allergy & Asthma Network

Allergies

New Allergic Rhinitis Guidelines Provide Clinicians Evidence-Based Summaries of Quality Improvement Opportunities PAGE 13

21 SSRIs and the

Risk for Upper Gastrointestinal Bleeding

25 Clinical Challenge:

It’s Sarah, not Stephen!

36 The Benefits

of Geriatric Certification

CE AVAILABLE © 2015 Novellus Healthcare Communications, LLC an affiliate of

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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: Pharmacy & Clinics 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: Pharmacy & Clinics™ 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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InsidePatientCare.com

April 2015 VOL. 3 • NO. 4

16 Questions

Answered with Allergy & Asthma Network

giies allerg

New Allergic Rhinitis Evidence-Based Guidelines Provide Clinicians vement Opportunities Summaries of Quality Impro PAGE 13

21 SSRIs and the

Risk for Upper Gastrointestinal Bleeding

25 Clinical Challenge:

It’s Sarah, not Stephen!

36 The Benefits

of Geriatric Certifications

CE AvAIlABlE pAGE 29

© 2015 Novellus Healthcare Communications, LLC an affiliate of

As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ 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—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 Inside Patient Care is a publication of Novellus Healthcare Communications, LLC, an affiliate of The Lynx Group. © 2015 All rights reserved.

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MISSION STATEMENT Inside Patient Care: Pharmacy & Clinics™ 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: Pharmacy & Clinics™ 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

Allergies InsidePatien

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

April 2015 VOL. 3 • NO. 4

16 Questions

Answered with Allergy & Asthma Network

21 SSRIs and the

Risk for Upper Gastrointestinal Bleeding

25 Clinic

tCare.com

New Allergic Rhinitis Guidelines Provide Clinicians Evidence Summaries of Quality -Based Improvement Opportun PAGE 13 ities

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April 2015 Volume 3 Number 4

Allergies

INSIDE

Allergies

COLUMNS PAGE

9

16 QUESTIONS ANSWERED

THE FIRST WORD

Tonya Winders, MBA, CEO & President of Allergy & Asthma Network, discussed the role of retail pharmacies and clinics in allergy and asthma care.

Donald J. Dietz, RPh, MS

Pharmacy’s Responsibility to Prevent Medical Identity Theft

Patient Care

20 FIVE TIPS TO PREVENT ASTHMA ATTACKS

5 INSIDE PATIENT CARE ONLINE

In addition to taking medication as prescribed by their physician, patients should be counseled to follow some simple tips to lessen their risk of an asthma attack.

6 EDITORIAL BOARD 7 LETTER FROM THE EDITOR 8 CALL FOR SUBMISSIONS

21 SELECTIVE SEROTONIN REUPTAKE INHIBITORS AND THE RISK FOR UPPER GASTROINTESTINAL BLEEDING

STARTS ON PAGE

13

Pharmacists and retail clinicians can benefit from having a better understanding of the mechanism of action of this class of drugs, and be aware of their indication, side effects, and the risk for adverse events.

25 CLINICAL CHALLENGE: IT’S SARAH, NOT STEPHEN!

The Pharmacy

36 GERIATRIC CERTIFICATIONS PROVIDE BENEFITS FOR RETAIL PHARMACISTS AND OLDER PATIENTS

4

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40 QUESTIONS ANSWERED

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Allergies InsidePatien

April 2015 VOL. 3 • NO. 4

16 Questions

Answered with Allergy & Asthma Network

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50 PRODUCTS & SERVICES SHOWCASE

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A n overview of updates in the guidelines A ssess patient needs B e aware of diagnostic tools and procedure L earn how to treat and counsel patients with allergic rhinitis C reate patient education tools

Inside Patient Care: Pharmacy & Clinics, 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: Pharmacy & Clinics 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.

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-Based New Allergic Rhinitis Clinicians Evidence ities Guidelines Provide Improvement Opportun Summaries of Quality PAGE 13

45 DRUG UPDATE

New Allergic Rhinitis Guidelines Provide Clinicians EvidenceBased Summaries of Quality Improvement Opportunities

❚

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29 FREE CE ACTIVITY

COVER STORY I ALLERGIES

Geriatric certification is valuable for pharmacists looking to improve their practice, move up within their current job, or switch practice areas altogether Michael Feehan, PhD, and Mark A. Munger, PharmD, FCCP, discuss how cutting-edge research can shape the design of primary care services in the retail pharmacy setting.

11 THE VITALS

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

InsidePatientCare.com

Inside Patient Care™ Is Now Available Online!

Features: • Latest Issue

• Article Submission

• Archives

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www.InsidePatientCare.com

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the Editorial Board

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

“ PAGE 9

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

Medical identity theft is on the rise,

and the Medical Identity Fraud Alliance reported a 21.7% increase in the past year alone.”

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

EDITORIAL CONSULTANTS PEDIATRICS Marc Drummond, PsyD, MBA Clinical Psychologist, Managing Partner Creekside Natural Therapeutics

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

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

GASTROINTESTINAL HEALTH

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

Mark J. Gregory, RPh Vice President Healthcare Solutions Ateb, Inc , Raleigh, NC

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

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

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

Albert Garcia Executive Vice President Navarro Health Services, Medley, FL

—Donald J. Dietz, RPh, MS

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

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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Allergies InsidePatien

April 2015 VOL. 3 • NO. 4

16 Questions

Answered with Allergy & Asthma Network

21 SSRIs and the

Risk for Upper ointestinal

tCare.com

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

InsidePatientCare.com

Letter from the Editor Introducing New Quality Measures in Retail Clinics

by FREDERIQUE H. EVANS, MBS, Editorial Director, Inside Patient Care: Pharmacy & Clinics

Similar to the Star Rating system by the Centers for Medicare & Medicaid Services, a new quality measure has been introduced for retail clinics and other healthcare professionals. }} }} IN A RECENT STATEMENT, the National Committee for Quality Assurance (NCQA) announced the launch of a new evaluation program, Patient-Centered Connected Care Recognition. The program was created in response to the growing number of choices available to consumers selecting care beyond the traditional primary care physician, including retail clinics, urgent care centers, and onsite employee health and schoolbased clinics.

The new program is said to align itself with other models that recognize the importance of value in the healthcare system, such as the patient-centered medical home model of care. In that model, care is centrally coordinated and tracked by one primary care provider; it has become the standard by which primary care can achieve better patient care and lower costs.

To receive an NCQA seal, eligible sites need to connect and share information with primary providers, as well as direct patients to appropriate providers when necessary. In addition, sites should use evidence-based decisions to support care delivery, collaborate with patients to make decisions,

and deliver culturally and linguistically appropriate services. Sites should also use electronic systems to collect data and execute tasks, as well as systematically monitor performance and carry out activities to improve clinical outcomes and patient experiences.

Working together as one to implement best practices.

Quality measures are an impor­ tant part of growing a business and achieving professional success. We are moving forward, seeking to provide continuity of care for patients and improve outcomes using value-based, patient-centered, evidence-based healthcare. In this issue of Inside Patient Care: Pharmacy & Clinics, we had the opportunity to speak with Michael Feehan, PhD, and Mark A. Munger, PharmD, FCCP, from the University of Utah, about the importance of cutting-edge research, and how it shapes the design of primary

care services in the retail pharmacy setting (see “Questions Answered: Cutting-Edge Research Shapes the Design of Primary Care Services in the Retail Pharmacy Setting,” on page 40). “This is an exciting time to explore changes in healthcare delivery models, especially with increased consumer choice, easily accessible internet-based information to inform those choices, and retail pharmacies and clinics redefining themselves as healthcare providers,” according to Dr Munger. Through their research, they hope to stimulate evidence-based interventions among pharmacies and clinics in partnership with local healthcare systems, and assess the impact on public health.

As a forum for the entire healthcare team working together as one to provide optimal access to care, implement best practices, and navigate the healthcare system, this issue of Inside Patient Care: Pharmacy & Clinics provides you with the resources you need to screen, diagnose, and treat patients; answer questions on prevention and wellness; manage chronic conditions; and attract, retain, and engage patients, shoppers, and customers. ❚ reta #1 am il cl ong inic ianS

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

April 2015 VOL. 3 • NO. 4

16 Questions

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21 SSRIs and the

Risk for Upper Gastrointestinal Bleeding

25 Clinic

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New Allergic Rhinitis Guidelines Provide Clinicians Evidence Summaries of Quality -Based Improvement Opportun PAGE 13 ities

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Call for submissions

?

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: Pharmacy & Clinics, that your fellow colleagues will want to read.

Submit to: info@InsidePatientCare.com IP submissions_Asize_030215

The First Word Pharmacy’s Responsibility to Prevent Medical Identity Theft

by DONALD J. DIETZ, RPH, MS, Editor-in-Chief, Inside Patient Care: Pharmacy & Clinics

“

Pharmacies can take precautions to ensure

that they are not unknowingly assisting medical identity theft.”

A

fter the Target Corporation credit card breach, which affected thousands of customers, people seem to be more leery of identity theft and the illegal use of their personal financial information.

Although it was always something in the back of peoples’ minds, this particular, large breach seemed to incite conversation among all Americans, and made a once abstract idea more tangent. The breach has cost Target approximately $162 million in expenses, but the harm to the consumer psyche is just as damaging. Although people may actively protect their financial information to avoid identity theft, they often neglect to exhibit the same level of diligence in protecting their medical information.

Medical identity theft is on the rise, and the Medical Identity Fraud Alliance reported a 21.7% increase in the past year alone.1 As pharmacists, we can play an active role in preventing the theft of our patients’ medical information. Medical identity theft is defined as the unauthorized use of an individual’s personal

5 factors to consider: ❚ The long-term impact of identity theft, including loss of patients’ trust ❚ The FTC Red Flags Rule to aid businesses in implementing theft protection programs ❚ Implementing employee access codes to limit access to patient records to company employees only ❚ Being diligent with patient data and using shred bins for any sensitive data ❚ Adjusting policies and procedures preventing identity theft as technology changes

information (eg, date of birth, Social Security number, and insurance policy number) to obtain or bill for medical services or medical goods.

Medical identity theft is considered a form of medical fraud, and it can be harmful to both a patient’s finances and overall health. Not only can

patients be subjected to false health insurance claims and pharmaceutical bills, but they can also have incorrect medical information in their files as a result of the thief’s conditions, thus jeopardizing their own health. As pharmacists on the front lines, we can help to not only prevent medical identity theft, but also detect it.

To decrease the incidence of identity theft, the Federal Trade Commission (FTC) has published the Red Flags Rule to aid businesses in implementing theft protection programs and detecting “red flags” of identity theft in their everyday operations.2 The Red Flags Rule may lay out a process for implementing a theft protection program, but for pharmacies, the first step is educating employees. Because of the easy access to healthcare and insurance information, a significant portion of medical identity theft is conducted by employees themselves. Employees should be instructed to only access patient records required to perform their job functions. Pharmacies should also consider implementing employee access codes to ensure that only company employees have access reta #1 am il cl ong inic ianS

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

April 2015 VOL. 3 • NO. 4

16 Questions

Answered with Allergy & Asthma Network

21 SSRIs and the

Risk for Upper Gastrointestinal Bleeding

25 Clinic

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The First Word to patient records. With employeespecific codes assigned, pharmacies can also track individual employee actions, should an incident occur.

Pharmacies can take precautions to ensure that they are not unknowingly assisting medical identity theft.

Being diligent with patient data and using shred bins for any sensitive data can go a long way in deterring thieves. Although physical precautions are important, technological safeguards should also be put into place. Pharmacies should never take possession of a patient’s Social Security card, or photocopy a patient’s insurance information to store a copy. Furthermore, pharmacies should refrain from using the “Notes” section of the dispensing software to enter personal and protected information about the patient that could be misused.

From a patient perspective, pharmacies should have a system in place for authenticating patient identities.

This may be as simple as asking for photo identification at the point of service, especially for new patients or those who are asking for copies of their prescription records. Lowtechnology approaches may also include asking patients to demonstrate knowledge of their demographic information, or details about previous prescriptions received. This

additional security step can deter many would-be thieves from using others’ insurance cards. According to the FTC, a major red flag is suspicious-looking documents, including identification documents that look altered or forged, or photo identification that does not match a person’s physical description.

From a patient perspective, pharmacies should have a system in place for authenticating patient identities.

Other red flags include suspicious account activity. For example, a patient may provide a change of address and telephone number, and then add or use a new credit card to pay for their prescriptions. Another red flag is a plethora of activity in a previously inactive account, and, although obvious, receiving information from the health plan or insurer about possible unauthorized charges or suspicion of fraudulent activity on an account is a clear red flag.

When a red flag is detected, pharmacies can respond appropriately and help curb medical identity theft.

Although actions will vary depending on the degree of severity, some responses that would be appropriate include contacting the patient whose identity you believe has been stolen, refusing to fill a prescription if the suspect is a new patient, closing an existing charge account, or notifying law enforcement. As technology changes and thieves adjust their tactics, your pharmacy should adjust their policies and procedures related to identity theft. Medical identity theft is not a problem that is going away any time soon. Although it may be an inconvenience for pharmacies to deal with, this is not a problem that can be solved by any one organization, and pharmacies must take an active role in preventing cases of medical identity theft. ❚

References

1. Medical Identity Fraud Alliance. Fifth annual study on medical identity theft. http://medidfraud.org/wp-con tent/uploads/2015/02/2014_Medical_ID_Theft_Study1. pdf. Published February 2015. Accessed April 16, 2015.

2. Federal Trade Commission. Fighting identity theft with the Red Flags Rule: a how-to guide for business. www.ftc.gov/tips-advice/business-center/guidance/ fighting-identity-theft-red-flags-rule-how-guide-business.

Published May 2013. Accessed April 16, 2015.

Mr Dietz is Editor-in-Chief of the journal, and Vice President of Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.

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 1 amon retail clinicg ianS #

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April 2015 VOL. 3 • NO. 4

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

InsidePatientCare.com

theVitals ADVERSE CHILDHOOD EXPERIENCES LINKED TO PEDIATRIC ASTHMA Recent research findings report a link between adverse childhood experiences (ACEs) and pediatric asthma among children who experience violence, or substance abuse at home.

To evaluate the relationship between single and cumulative ACEs, household dysfunction, and parental reports of lifetime asthma in children, Robyn Wing, MD, Emergency Medicine Physician, Hasbro Children’s Hospital, Providence, RI, and colleagues conducted a cross-sectional study using data from the 2011-2012 National Survey of Children’s Health, a nationally representative sample of children 0 to 17 years of age.

The prevalence of asthma in the sample evaluated was 14.6%, and the prevalence of exposure to any ACEs was 29.2%. The authors found that an increased number of ACE exposures was associated with increased odds for developing asthma. In particular, the odds of reporting asthma were 1.28 in patients reporting exposure to 1 ACE, 1.73 in patients reporting exposures to 4 ACEs, and 1.61 in those reporting exposures to 5 or 6 ACEs, compared with patients who were not exposed to any ACEs. “This study supports the growing evidence for the biopsychological model of asthma onset,” the study authors concluded.

Future research is warranted to examine the association between ACEs and specific asthma-related health outcomes.

Source: Wing R, Gjelsvik A, Nocera M, McQuaid EL. Ann Allergy Asthma Immunol. 2015 Mar 31.

[Epub ahead of print]

Examining the News Affecting Pharmacy & Clinics

SMOKING CESSATION BENEFICIAL, EVEN AT 60 It’s never too late to discuss smoking cessation with patients. According to a recent study from the German Cancer Research Center, quitting smoking at age ≥60 years lowers the risk for developing cardiovascular disease within the first 5 years of cessation.

“Our study corroborates and expands evidence from previous studies in showing that smoking is a strong independent risk factor of cardiovascular events and mortality, even at [an] older age, advancing cardiovascular mortality by >5 years, and demonstrating that smoking cessation in these age groups is still beneficial [to] reducing the excess risk,” explained Ute Mons, PhD, Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany, and colleagues.

As part of a meta-analysis of 25 cohorts participating in CHANCES (Consortium on Health and Ageing: Network of Cohorts in Europe and the United States), the investigators sought to determine the impact of smoking and smoking cessation on cardiovascular mortality, and acute coronary and stroke events among patients age ≥60 years.

They also evaluated the risk advancement periods for cardiovascular mortality, and traditional epidemiological relative risk measures.

Of the 503,905 patients included in the analysis, 37,952 died from cardiovascular disease. Smoking status was associated with cardiovascular mortality for current smokers (hazard ratio [HR], 2.07) and former smokers (HR, 1.37), compared with participants who had never smoked. The excess risk in smokers increased with cigarette consumption in a dose-dependent manner, the authors found, and decreased continuously with time since smoking cessation in former smokers.

Source: Mons U, Muezzinler A, Schotter B, et al. BMJ. 2015 Apr 20;350:h1551. [Epub ahead of print] reta #1 am il cl ong inic ianS

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

April 2015 VOL. 3 • NO. 4

16 Questions

Answered with Allergy & Asthma Network

21 SSRIs and the

Risk for Upper Gastrointestinal Bleeding

25 Clinic

tCare.com

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theVitals HIGH-FRUCTOSE CORN SYRUP LINKED TO CVD IN YOUNG ADULTS The consumption of beverages containing high-fructose corn syrup, even in small amounts, significantly increases risk factors for cardiovascular disease (CVD) when consumed for just 2 weeks by young, healthy men and women.

“These results provide mechanistic support for the epidemiologic evidence that the risk of cardiovascular mortality is positively associated with consumption of increasing amounts of added sugars,” according to Kimber L. Stanhope, PhD, Associate Researcher, Department of Molecular Biosciences, University of California, Davis, and colleagues.

As part of a parallel-arm, nonrandomized, double-blind, intervention study, the investigators included 85 patients (age range, 18-40 years) who participated in 3.5 inpatient days of baseline testing, followed by 13 days of outpatient testing where patients consumed beverages sweetened with high-fructose corn syrup at 0% (n = 23), 10% (n = 18), 17.5% (n = 16), or 25% (n = 28) of their energy requirement. The beverages were also consumed during 3.5 days of intervention testing.

Data indicate that consumption of beverages with high-fructose corn syrup (10%, 17.5%, and 25%) was associated with significant linear dose-response increases in lipid/lipoprotein risk factors for CVD and uric acid. In addition, the authors found that all 3 doses of high-fructose corn syrup increased concentrations of postprandial triglycerides, with the 2 higher doses increasing fasting and/or postprandial concentrations of non–high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, apolipoprotein CIII, and uric acid.

This is the first study to show a direct, dose-dependent relationship between the amount of added sugar consumed in sweetened beverages and increased risk factors for CVD, according to the authors.

Source: Stanhope KL, Medici V, Bremer AA, et al. Am J Clin Nutr. 2015 Apr 22. [Epub ahead of print]

INFECTIOUS DISEASE

5 FACTS TO CONSIDER WITH EBOLA SURVIVORS In a recent observational study published in The Lancet Infectious Diseases, investigators included 49 probable and confirmed survivors of the 2007 Bundibugyo ebolavirus outbreak in Uganda, and 157 of their seronegative contacts. Conducted approximately 29 months after the outbreak, information was collected about their health status, functional limitations, and demographics. Blood samples were also collected for clinical chemistry, hematology, and filovirus antibodies.

1/ Ebola survivors had a significantly increased risk for ocular deficits, blurred vision, hearing loss, difficulty swallowing, difficulty sleeping, arthralgias, and various constitutional symptoms.

2/ Survivors were also twice as likely to report chronic health problems for >1 year, including back pain, pain in the abdomen and large joints, as well as impotence, fatigue, and severe headaches.

3/ The investigators also found that limitations associated with memory loss or confusion were approximately 6 times more prevalent among Ebola survivors.

4/ Long-term sequelae persist for >2 years after the Ebola virus, the authors concluded, adding that defining health consequences related to the Ebola virus could improve patient care for survivors and contribute to understanding the disease pathogenesis.

5/ More data are needed to evaluate the long-term effect of Ebola on children, as the effects of severe disease most likely differ from those seen in adults.

HOUSE PASSES HR 471

The Ensuring Patient Access and Effective Drug Enforcement Act of 2015 (HR 471) has been passed by the House of Representatives, bringing it one step closer to becoming a law, and bringing healthcare professionals together. HR 471 would help curb prescription drug abuse and protect patients in need of medications. The Bill would direct the US Department of Health & Human Services to work with the Drug Enforcement Administration and the Office of National Drug Control Policy. Their task would be to identify obstacles of legitimate patient access to controlled substances; issues with diversion of controlled substances; and how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances. The bill was originally introduced to the House by Rep Tom Marino (R-PA) in January of this year.

Source: Congress.gov. All Bill Information (Except Text) for H.R.471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015. www.congress.gov/bill/114th-congress/house-bill/471/all-info. Updated April 22, 2015. Accessed April 23, 2015.

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INSIDE

Allergies

QUESTIONS ANSWERED Interview with Allergy & Asthma Network [16]

Cover Story

New Allergic Rhinitis Guidelines Provide Clinicians Evidence-Based Summaries of Quality Improvement Opportunities

by BRADLEY PACELLA, PHARMDc

Allergic rhinitis (AR) is the fifth most common chronic disease in the United States, and the most common chronic disease in children.1 }} }} OVERALL, IT IS ESTIMATED THAT AR affects nearly 1 in 6 Americans, which results in $2 billion to $5 billion in direct health expenditures annually, as well as $2 billion to $4 billion in lost productivity annually.1 Rhinitis is an inflammation of the membrane lining in the nose. Associated symptoms include sneezing; itchy eyes, nose, or throat; watery eyes; rhinorrhea; nasal congestion; and postnasal drip.2 It is believed that most of these symptoms can be alleviated as clinicians follow the new AR treatment guidelines.

Treating Allergic Rhinitis Some of the most well-known methods for managing AR are nonpharmacologic in nature. These include environmental controls, which focus on avoiding

exposure to allergens.2 More precisely, these methods center on using devices with high-efficiency particulate air filters; habitual vacuuming of carpets, drapes, and upholstery; and washing bedding in hot water. Moreover, using nasal wetting agents or performing nasal irrigation with warm saline may reduce symptoms.

Furthermore, according to the “hygiene hypothesis,” it is also important to not oversanitize so children can build a healthy immune system.3

Updated Treatment Guidelines Recently, the American Academy of Otolaryngology–Head and Neck Surgery updated their AR treatment guidelines on the quality improvement opportunities deemed most important for clinicians.1

KEY POINTS ❚ AR affects nearly 1 in 6 Americans ❚ The American Academy of Otolaryngology–Head and Neck Surgery updated their AR treatment guidelines to include the most important quality improvement opportunities ❚ Most of the symptoms associated with AR may be alleviated as clinicians follow the new treatment guidelines

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Inside Allergies These new guidelines differ from the previous guidelines because they place increased emphasis on what a clinician should, should not, or may do in relation to a patient with AR. Furthermore, the updated guidelines emphasize the importance of nonpharmacologic management, and expand upon the potential role of subcutaneous or sublingual immunotherapy. The hope is that these guidelines will lead to more efficient and opti-

These guidelines differ from the previous guidelines because they place less emphasis on prescribing specific treatments based solely on symptoms. mal treatments for patients with AR. In addition, it is important to note that these guidelines differ from the previous guidelines because they place less emphasis on prescribing specific treatments based solely on symptoms.

The guidelines are segmented into a series of 14 statements. Each statement is followed by an action statement profile that focuses on qualitative and quantitative measures, which, most importantly, include aggregate evidence quality (ie, grade A, B, C, D, or X), which are determined based on the quality of evidence, and policy level (ie, strong recommendation, recommendation, option, or no recommendation).

Guideline Statements The first statement, Patient History and Physical Examination, focuses on AR diagnosis. According to the guidelines, clinicians should make a clinical diagnosis of AR when a patient presents with a history and physical examination consistent with an allergy in addition to nasal congestion, runny nose, itchy nose, or sneezing (grade C, recommendation).

Although a definitive diagnosis is dependent on the finding of an immunoglobu-

lin E (IgE)-mediated response to a specific allergen, the guideline authors suggested that it is generally reasonable to begin therapy based on the patient’s history and physical examination.

In the second statement, which discusses allergy testing, the guidelines more precisely address IgE-specific allergy testing, and recommend that clinicians should perform and interpret this test for patients with a clinical diagnosis of AR who do not respond to empiric therapy (grade B).

The third statement, Imaging, focuses on sinonasal imaging. The guidelines do not recommend the routine use of this type of imaging because of its potential costs and adverse effects (grade C).

Environmental factors are discussed in the fourth statement, including an optional recommendation on the clinician’s role in educating patients on environmental factors associated with AR. In particular, they suggest that clinicians may advise patients to avoid known allergens, or implement environmental controls (grade B).

The fifth statement, Chronic Conditions and Comorbidities, discusses treating patients with other chronic conditions and comorbidities who present with AR. More precisely, this statement recommends that clinicians should assess and document patients with AR who present with related conditions such as asthma, atopic dermatitis, sleep-disordered breathing, conjunctivitis, rhinosinusitis, and otitis media (grade B).

The sixth, seventh, and eighth statements (Topical Steroids, Oral Antihistamines, and Intranasal Antihistamines, respectively) address specific pharmacologic recommendations. The sixth statement strongly recommends the use of intranasal steroids upon the clinical diagnosis of AR in patients whose quality of life is affected by their symptoms (grade A). Similarly, the seventh statement strongly recommends the use of oral second-generation/less sedating antihistamines for patients with AR whose primary concerns are sneezing and itch-

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Inside Allergies ing (grade A). The eighth statement provides an optional recommendation that patients with seasonal, perennial, or episodic AR be offered intranasal antihistamines (grade A).

The ninth statement, Oral Leuko­ triene Receptor Antagonists, does not recommend the use of oral leukotriene receptor antagonists for patients with AR as primary therapy (grade A).

The tenth statement, Combination Therapy, addresses whether combination therapy is appropriate for patients with AR. According to this statement, patients with AR who inadequately respond to pharmacologic monotherapy may be offered combination pharmacologic therapy (grade A).

The eleventh statement, Immunotherapy, discusses options for patients who experience an inadequate response to symptoms with pharmacologic therapy, with or without environmental controls. The guidelines recommend that clinicians should offer sublingual or subcutaneous immunotherapy to patients who fall into this category (grade A).

The twelfth statement, Inferior Turbinate Reduction, addresses whether and when inferior turbinate reduction should be offered to patients with AR. This statement details that clinicians may offer—or refer to someone who can offer—such a procedure to patients with AR who also have nasal airway obstruction and enlarged inferior turbinates, and in whom medical management has not succeeded (grade C).

The thirteenth statement, Acupuncture, discusses whether it should be offered to patients with AR. More precisely, the thirteenth statement details that clinicians may offer acupuncture to

patients with AR who are interested in therapy that is nonpharmacologic (grade B).

The fourteenth statement, Herbal Therapy, focuses on the use and role of herbal therapy in the treatment of AR; no recommendation is provided because of a lack of evidence associated with their use.

These guidelines were created to provide clinicians with a tool on which to base diagnostic procedures, patient education, and treatment choices for patients with AR. Conclusion These guidelines were created to provide clinicians with a tool on which to base diagnostic procedures, patient education, and treatment choices for patients with AR. Moreover, although these guidelines are supported by relatively strong evidence, they are not intended to be a sole source of guidance, replace clinical judgment, nor establish protocol. These guidelines can enable pharmacists, nurse practitioners, and physician assistants in retail clinics to assist prescribers in the treatment of patients with AR. ❚ References

1. Seidman MD, Gurgel RK, Lin SY, et al. Clinical practice guideline: allergic rhinitis. Otolaryngol Head Neck Surg.

2015;152(suppl 1):S1-S43.

2. Tran NP, Vickery J, Blaiss MS. Management of rhinitis: allergic and non-allergic. Allergy Asthma Immunol Res. 2011;3:148-156.

3. Okada H, Kuhn C, Feillet H, Bach JF. The “hygiene hypothesis” for autoimmune and allergic diseases: an update.

Clin Exp Immunol. 2010;160:1-9.

Mr Pacella is a Doctor of Pharmacy candidate at the Lake Erie College of Osteopathic Medicine (LECOM), Bradenton, FL.

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Questions Answered with Tonya Winders, MBA, CEO & President of Allergy & Asthma Network In a recent interview with Inside Patient Care: Pharmacy & Clinics, Tonya Winders, MBA, CEO & President of Allergy & Asthma Network, discussed the role of retail pharmacies and clinics in allergy and asthma care, as well as questions healthcare professionals should ask patients to ascertain their goals, and how to best work with patients to meet these goals.

What is your background at Allergy & Asthma Network?

A: I have actually spent the past 16 years of my personal and professional life addressing allergies and asthma.

Personally, I am the mother of 5, 4 of whom have allergies and/or asthma, and who range in age from 10 to 15 years.

Professionally, I worked in the allergy and asthma space in pharmaceuticals, devices, and diagnostics. I actually came to lead Allergy & Asthma Network in 2013 when the president and founder, Nancy Sander, retired after 28 years of service.

I lead the organization from a strategic perspective, and ensure that our activities align with our mission, which is to end needless death and suffering associated with asthma, allergies, and related conditions. We do that through

4 core mission areas: outreach, education, advocacy, and research. We tailor all of those areas to patients and families, and healthcare professionals.

Allergy & Asthma Network is a multidisciplinary, patient-centered network. That is what we are all about.

Ninety percent of our members are patients and families. The other 10% is a committed group of healthcare professionals—pharmacists, nurse practitioners, asthma educators, school nurses, respiratory therapists, primary care physicians, pediatricians, specialists like allergists and pulmonologists, and patient advocates.

We are working on Capitol Hill to ensure families receive the care they need, in addition to conducting outreach, awareness, and education activities. We are here for you. We have a

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Inside Allergies toll-free help line that is manned by nurse practitioners and asthma educators who are here to help.

What is the role of retail pharmacies and clinics in allergy and asthma?

A: We believe that retail pharmacies and clinics are essential to the healthcare team. It is important that the healthcare team is aware of the goals of the patient. For some people, that may be to exercise without being impacted by symptoms. For others it may be to simply climb a flight of stairs or be able to live their normal daily lives without limitations associated with their symptoms. In fact, we often hear from people who are just focused on losing 10 lbs in order to breathe better.

What we try to do is address a person’s individual goals, and identify barriers to accomplishing those goals.

We believe that’s the very first step in achieving optimal health.

What questions should pharmacists and clinicians ask patients to ascertain these goals?

A: Healthcare delivery is changing rapidly and pharmacists are playing an ever-increasing, important role. I think it is something as simple as, when you see a newly diagnosed patient, just engaging them about what their goals are for treatment, and what they are hoping to accomplish.

Unfortunately, so many times we just go through the motions of, “Do you have any questions?” For a newly diagnosed patient, that is really opening up Pandora’s box, because they have a million questions, of course. I think it is important to establish a simple baseline goal, whatever it may be, and then ask the patient what barriers may exist to accomplishing that goal at the outset of treatment.

What is key information for patients with asthma starting a new prescription?

A: Again, chronic disease is a journey.

As patients start a new prescription, I

think it is important for them to understand what the medicine is, and when and how to appropriately take it, but it is just as important to know why they need to take it.

For example, many patients with asthma will get their quick reliever inhaler and controller inhaler confused. That is, your short-acting bron-

I think it is something as simple as, when you see a newly diagnosed patient, just engaging them about what their goals are for treatment, and what they are hoping to accomplish. chodilator albuterol and your inhaled corticosteroid, respectively, that are typically prescribed for a new asthma patient. Especially in asthma medication management, the technique used with inhalers is critically important. At Allergy & Asthma Network we have posters, magazines, and educational videos to help patients along the journey.

What innovations and key topics are you looking forward to in allergy and asthma?

A: This is a really exciting time for the allergy and asthma space. I think that there are a lot of breakthroughs—specifically in treatment—when we think about immunotherapy. Traditionally, immunotherapy has been delivered through shots administered by board-­ certified allergists.

As we look to the future there are new treatments, such as sublingual immunotherapy tablets that are FDA approved. Sublingual drops, as well as oral immunotherapy, for different food and environmental allergens, are also on the horizon.

In patients with severe asthma, there are innovative, new procedures and biologics in development; a new pro-

+ MORE ONLINE

To read the full interview, please visit our website. reta #1 am il cl ong inic ianS

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Inside Allergies cedure called bronchial thermoplasty, has actually been FDA approved for patients with severe asthma. These are the patients who have really run the gamut of every medication and treatment that is available today, and are still dealing with numerous limitations to their daily activities. New biologics and procedures can offer hope for many.

We are working to help educate nurse practitioners, physician assistants, and pharmacists because we know that they will play an increasing role in the healthcare of the 60 million Americans who live with allergies and asthma every day.

I think we dream of the day when there are cures for asthma and food allergies, things like the peanut patch that is in development, or food oral immunotherapy. It is too early to say whether these treatment modalities will be cures, as they have completed the full regulatory process of approval, but some of the initial studies are very, very promising. We look forward to these innovations.

How will retail clinics evolve in the next 5 to 10 years to accommodate patients with asthma and allergies?

A: I think this is one of the reasons why the Allergy & Asthma Network is partnering with retail clinic healthcare professionals across the United States.

We have formal partnerships within the Convenient Care Association, and with The Little Clinic organization.

We are working to help educate nurse practitioners, physician assistants, and pharmacists because we know that they will play an increasing role in the healthcare of the 60 million Americans who live with allergies and asthma every day. Families are demanding broader access and convenience.

We know that this is important to families, and we also know that retail clinics are a vital piece of that puzzle. We strongly believe that education is the key. We must provide support along the journey of chronic disease management, and pharmacists, as well as retail clinic healthcare professionals such as nurse practitioners and physician assistants, are vitally important to that journey.

They will be called upon more frequently by patients and families. They, too, must have access to accurate, easily understood education tools, as well as the support of a community of others like them. ❚

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

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Allergy & Asthma 5 TIPS TO PREVENT ASTHMA ATTACKS Asthma affects 18.7 million adults and 6.8 million children in the United States. Asthma attacks are associated with coughing, chest tightness, wheezing, and trouble breathing. In addition to taking your medication as prescribed by your physician, the following are tips for how to avoid asthma attacks:

1 Avoid Exposure to Allergens

2 Use HEPA Filters

If you are aware of what triggers your asthma attacks, avoid it.

Some known asthma triggers include tobacco smoke, dust mites, outdoor air pollution, as well as pets and mold.

If your asthma triggers cannot easily be avoided, consider using high-efficiency particulate air (HEPA) filters, which can trap pollutants associated with asthma and may bring some relief.

Vacuum or sweep your carpets, drapes, and upholstery once a week. Clean your bed, including your bedding, using hot water once a week. Clean damp areas in your bathroom, kitchen, and other areas around the house to keep mold spores from developing. Reduce pet dander.

3 Keep It Clean

4 Be Healthy

5 Cover Your Nose and Mouth

â

In addition to exercising regularly and eating a balanced diet, it is also important to maintain a healthy body weight and control heart and gastroesophageal reflux disease.

If your asthma is worsened by cold or dry air, wearing a face mask may help.

MORE ONLINE

More patient tips are available online at InsidePatientCare.com

Sources: Mayo Clinic Staff. Lifestyle and home remedies. The Mayo Clinic. www.mayoclinic.org/diseases-conditions/asthma/basics/lifestyle-home-remedies/con20026992. Published February 13, 2014. Accessed March 24, 2015; Centers for Disease Control and Prevention. Common Asthma Triggers. www.cdc.gov/asthma/ triggers.html. Updated August 20, 2012. Accessed March 24, 2015; WebMD. Allergies Health Center: HEPA filters for allergies. www.webmd.com/allergies/hepafilters-for-allergies. Accessed March 24, 2015.

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Gastrointestinal Health Selective Serotonin Reuptake Inhibitors and the Risk for Upper Gastrointestinal Bleeding

by NICOLE L. EAST, PHARMD, and SANDRA J. GIRGIS, PHARMD

ACCORDING TO a 2011 report from the National Center for Health Statistics, approximately 11% of Americans 12 years and older took an antidepressant between 2005 and 2008, with more than one-third of patients with current severe depressive symptoms taking antidepressants.1

Mechanism of Action Selective serotonin re­ uptake inhibitors (SSRIs) are a widely prescribed class of antidepressants.

Currently, there are 6 SSRIs available in the United States: citalopram, escitalopram, fluoxetine, fluvoxamine, pa­ roxetine, and sertraline.2 SSRIs work by inhibiting presynaptic serotonin reuptake via the serotonin transporters.3-8 There are varying levels of affinity for the serotonin transporters in this class of medication. SSRIs with

lower dissociation constants indicate a higher affinity for the serotonin transporters (Tables 1 and 2).3-10

Indication and Side Effects SSRIs have US Food and Drug Administration– labeled indications for the treatment of major depressive disorder, panic disorder, generalized anxiety disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, and obsessive-compulsive disorder.3-8,11 Side effects associated with this class of medication include nausea, vomiting, diar-

BLEEDING EVENTS ASSOCIATED WITH SSRIs ARE BELIEVED TO OCCUR AS A RESULT OF IMPAIRED PLATELET ACTIVITY. rhea, insomnia, sexual dysfunction, headaches, and an increased risk for falls.2 Bleeding events have also been reported with SSRI use, including upper gastrointestinal

bleeding (UGIB).12 Bleeding events associated with SSRIs are believed to occur as a result of impaired platelet activity.12 In particular, serotonin is stored within platelets and plays a role in the activation of platelet aggregation.11,13 By inhibiting platelet reuptake of serotonin, it is hypothesized that there may be a defect in platelet aggregation, resulting in a prolonged bleeding time.11,12 Studies have found that the serotonin concentration in platelets was reduced by 80% within 1 to 2 weeks of SSRI use.14-16 This adverse

Table 1. High-Affinity Serotonin Transportersa Brand Name

Generic Name

Kd, nmol/L

3,9

Fluoxetine

0.81

Paxil, Paxil CR4,9

Paroxetine hydrochloride

0.13

Zoloft

Sertraline hydrochloride

0.29

Prozac

5,9

High-affinity serotonin transporters; Kd <1 nmol/L. Kd indicates dissociation constant. a

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Gastrointestinal Health Table 2. Moderate-Affinity Serotonin Transportersa Brand Name Celexa

6,9

Generic Name

Kd, nmol/L

Citalopram hydrobromide

1.16

7,9

Escitalopram oxalate

—

Luvox, Luvox CR8,9

Fluvoxamine maleate

2.2

Lexapro

Moderate-affinity serotonin transporters; Kd, 1-10 nmol/L. Kd indicates dissociation constant.

a

effect may be of great concern when SSRIs are coadministered with nonsteroidal anti-inflammatory drugs (NSAIDs), because they inhibit the platelet activator thromboxane A2. NSAIDs are also well known for producing gastrointestinal complications, including ulcers and bleeding.11

CURRENT DATA REPRESENT CONFLICTING RESULTS ON THE RISK FOR UGIB RELATED TO THE USE OF SSRIs.

Upper Gastrointestinal Bleeding Current data represent conflicting results on the risk for UGIB related to the use of SSRIs. In one study, Wang and colleagues showed that shortterm SSRI use (28 days) was significantly associated with UGIB (adjusted odds ratio [aOR], 1.67; 95% confidence interval [CI], 1.34-2.08; P <.001).10 This association was only seen in patients taking an antidepressant with high or moderate affinity for the serotonin transporter.

Tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhi­ bi­tors, and other antidepressants were not asso-

ciated with an increased risk of UGIB. It should be noted that when calculating the risk associated with each specific SSRI, only fluoxetine (aOR, 1.68; 95% CI, 1.10-2.57) and sertraline (aOR, 1.87; 95% CI, 1.16-3.02) demonstrated an elevated risk of UGIB.10 In a systematic review and meta-analysis of 15 case-control studies and 4 cohort studies, Anglin and colleagues reported a modest increase in the risk for UGIB associated with SSRIs (odds ratio [OR], 1.66; 95% CI, 1.441.92) in the case-control studies and cohort studies (OR, 1.68; 95% CI, 1.132.50), as well as a further increased risk in the

case-control studies when used in combination with NSAIDs (OR, 4.25; 95% CI, 2.82-6.42).12 In another study by Mort and colleagues, an elevated risk for UGIB was observed with the concurrent use of an SSRI and NSAID.11 Although these studies suggest an increased risk for UGIB with the use of an SSRI with or without an NSAID, conflicting data exist. Some studies included more than just the SSRI class and evaluated the bleeding risk with any type of serotonin reuptake inhibitor. In a multicenter case-control study assessing the risk of major UGIB associated with various groups of drugs (cases, 2783; controls, 7058), Vidal and colleagues did not find an increased risk for UGIB with the use of a serotonin inhibitor, or an interaction when coadministered with an NSAID.17 No significant risk was seen when analyzing individual SSRIs, regardless of the degree of affinity for serotonin transporters.

In a population-based,

matched, case-control analysis, Targownik and colleagues evaluated the role of proton pump inhibitors in chronic SSRI users. A modestly increased risk of UGIB was associated with SSRI use; however, this risk was significantly reduced with proton pump inhibitor cotherapy. In addition, they reported that SSRI use was not a major risk factor for NSAIDrelated UGIB.18 Data by Maschino and colleagues did not indicate an association between bleeding adverse reactions and exposure to a serotonin reuptake inhibitor in combination with antiplatelet agents compared with antiplatelets alone.19

Take-Away Message for Pharmacists and Clinicians Because the absolute risk for UGIB associated with the use of an SSRI is unknown, pharmacists and clinicians should be aware of these concerns and identify patients who are at high risk for UGIB. Some risk factors for UGIB include alcohol consumption, advanced age, smoking, history of an UGIB, and concomitant use of other bloodthinning medications.10,11 Patients should also be aware of the potential risk, and counseled on the signs and symptoms

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Gastrointestinal Health of UGIB, such as dark, tarry stools, hematemesis (vomiting blood), and abdominal cramps.20 Pharmacists and clinicians should also note that a discussion on the choice of over-the-counter analgesics may be warranted based on an individual’s bleeding risk. One population-based, case-control analysis found that proton pump inhibitors reduced the risk of SSRI-related UGIB by approximately 61%.21 Proton pump inhibitors may be used with SSRIs to reduce the risk for recurrence in patients who have a history of UGIB. ❚

References

1. Pratt L, Brody D, Gu Q; Centers for Disease Control and Prevention.

Antidepressant use in persons aged 12 and over: United States, 2005-2008. www.cdc.gov/nchs/data/databriefs/ db76.htm. Updated October 19, 2011.

Accessed February 5, 2015.

2. American Psychiatric Association.

Major depressive disorder: practice guideline (November 2010). http://psy chiatryonline.org/guidelines. Published October 2010. Accessed February 12,

2015.

3. Prozac [package insert]. Indianapolis, IN: Eli Lilly & Co; 2014.

4. Paxil [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2013.

5. Zoloft [package insert]. New York, NY: Pfizer; 2014.

6. Celexa [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc; 2014.

7. Lexapro [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc; 2014.

8. Luvox [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc; 2008.

9. Tatsumi M, Groshan K, Blakely RD, et al. Pharmacological profile of antidepressants and related compounds at human monoamine transporters. Eur J Pharmacol. 1997;340:249-258.

10. Wang Y, Chen Y, Tsai C, et al.

Short-term use of serotonin reuptake inhibitors and risk of upper gastrointestinal bleeding. Am J Psychiatry. 2014; 171:54-61.

11. Mort J, Aparasu R, Baer R. Interaction between selective serotonin reuptake inhibitors and nonsteroidal antiinflammatory drugs: review of literature. Pharmacotherapy.

2006;26:1307-1313.

12. Anglin R, Yuan Y, Moayyedi P, et al. Risk of upper gastrointestinal bleeding with selective serotonin reuptake inhibitors with or without concurrent nonsteroidal anti-inflammatory use: a systematic review and meta-analysis.

Am J Gastroenterol. 2014;109:811-819.

13. Smyth SS, Whiteheart S, Italiano JE Jr, et al. Chapter 114. Platelet Morphology, Biochemistry, and Function. In: Williams Hematology, 8th ed. New York, NY: McGraw-Hill; 2010.

14. Hergovich N, Aigner M, Eichler HG, Entlicher J, Drucker C, Jilma B. Paroxetine decreases platelet serotonin storage and platelet function in human beings. Clin Pharmacol Ther.

2000;68:435-442.

15. Kotzailias N, Marker M, Jilma B. Early effects of paroxetine on serotonin storage, plasma levels, and urinary excretion: a randomized, double-blind, placebo-controlled trial. J Clin Psychopharmacol. 2004;24:536-539.

16. de Abajo FJ. Effects of selective serotonin reuptake inhibitors on platelet function: mechanisms, clinical outcomes, and implications for use in elderly patients. Drugs Aging.

2011;28:345-367.

17. Vidal X, Ibáñez L, Vendrell L, et al; Spanish-Italian Collaborative Group for the Epidemiology of Gastrointestinal Bleeding. Risk of upper gastrointestinal bleeding and the degree of serotonin reuptake inhibition by antidepressants: a case-control study. Drug Saf. 2008;31:159-168.

18. Targownik LE, Bolton JM, Metge CJ, et al. Selective serotonin reuptake inhibitors are associated with a modest increase in the risk of upper gastrointestinal bleeding. Am J Gastroenterol.

2009;104:1475-1482.

19. Maschino F, Hurault-Delarue C, Chebbane L, et al. Bleeding adverse drug reactions (ADRs) in patients exposed to antiplatelet plus serotonin reuptake inhibitor drugs: analysis of the French Spontaneous Reporting Database for a controversial ADR. Eur J Clin Pharmacol. 2012;68:1557-1560.

20. National Institute of Diabetes and Digestive and Kidney Diseases.

Bleeding in the digestive tract. www. niddk.nih.gov/health-information/ health-topics/digestive-diseases/bleed ing-in-the-digestive-tract/Pages/facts. aspx#sec4. Updated September 17, 2014. Accessed February 5, 2015.

21. Dall M, dePont Christiansen R, Schaffalitzky de Muckadell OB, et al. Re-prescribing of causative drugs in persons discharged after serious drug-induced upper gastrointestinal bleeding. Aliment Pharmacol Ther.

2012;35:948-954.

Nicole L. East Dr East is a PGY2 Psychiatric Pharmacy Resident; and Dr Girgis is Neuropsychiatric Pharmacy Resident, Rutgers, The State University of New Jersey.

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It’s Sarah, not Stephen!

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Clinical Challenge It’s Sarah, not Stephen!

How would you have managed this patient?

Commentary by URMIMALA SARKAR, MD, MPH

The Case An 8-year-old child, born male who identified as and expressed externally (eg, clothing, haircut, behavior) as a girl, presented for a new patient appointment. The patient’s mother, aware that her child’s preferred name was not consistent with her legal name and sex, had alerted the clinic of the child’s preferred name at the time of making the appointment. When the patient and her mother arrived for the clinic visit, the medical staff was unaware of the registration documentation regarding the patient’s preferred name and called for the patient in the waiting room using her legal (masculine) name.

The mother and child felt embarrassed and humiliated by this course of events. Both were visibly upset and the provider had to spend additional time during the clinical visit addressing the emotional impact of inappro-

priately calling this patient a masculine name.

The clinic staff had received prior training in addressing transgender and gender-variant people by their preferred names but had not developed communication processes to best convey this information.

The clinician acknowledged the error when it occurred, apologized for the harm done, and reassured both mother and child that it was not the intention of the clinic to have the child feel her identity was questioned or undermined. The provider sug-

gested that the parent contact the ombudsperson’s office directly to comment specifically on what was done well at that visit and what specific behaviors could be improved in the future care of her child. The patient’s mother did just that.

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Clinical Challenge The Commentary Gender identity is a person’s private sense of one’s own gender. Gender expression refers to how a person expresses one’s gender identity—it is illustrated through one’s external characteristics and behaviors. Gender variance is gender expression that does not conform to dominant gender norms of male and female.1 In the medical community, gender identity disorder (GID) or gender dysphoria are the formal terms used to describe individuals who experience discontent with the sex they were assigned at birth and/or the gender roles associated with that sex. This term is less than ideal, but a formal diagnosis may be required for medical care and conveys that this is a medical condition and not the individual’s choice. Affected individuals are often called transgender.

Unfortunately, this case describes a common experience for transgender individuals, who often report acute discomfort when addressed according to a gender that is discordant with their self-identity. When use of the incorrect name/pronoun occur in healthcare settings, patients report lower satisfaction and are less likely to continue to seek care at that setting.2,3

TRANSGENDER INDIVIDUALS OFTEN DO NOT DISCLOSE THEIR GENDER IDENTITY BECAUSE OF STIGMA AND RISK OF HARASSMENT. We lack precise estimates for the incidence of gender variance, for several reasons. First, there is no routine surveillance of gender minorities in the United States. Moreover, transgender individuals often do not disclose their gender identity because of stigma and risk of harassment. The National Center for Transgender Equality estimates that between 0.25% to 1% of the population is transgender.4 A recent study that drew from four national and 2 state-level population-based surveys suggests that there are nearly 700,000 transgender individuals in the United States.5 The classic estimate for prevalence of GID comes from the 1994 DSM-IV, which reported 1:30,000 natal males and 1:100,000 natal females as transgender.6 Transgender health raises a number of patient safety issues: lack of access to healthcare, increased

risk factors, and difficulty transitioning. Transgender individuals commonly encounter a wide variety of discriminatory barriers.

They also face difficulties accessing basic needs (getting a job, housing), which exacerbates health disparities.

Discrimination Transgender individuals experience increased rates of discrimination, violence, and harassment.7-9 Of importance, transgender populations face discrimination and harassment across a variety of critical social settings, including schools, workplaces, and healthcare systems.10 Significant discrimination in healthcare settings may lead patients to avoid healthcare settings and delay seeking needed care.

Lack of access to healthcare Transgender populations experience specific challenges with the healthcare system. The clearest and most troubling patient safety issue for transgender individuals is refusal of medical care. In one survey of transgender adults, participants reported that when they were sick or injured, they postponed medical care because of discrimination or inability to afford it. Respondents

described serious hurdles to accessing healthcare, including refusal of care and harassment in medical settings. In addition, the majority of US health insurers do not cover hormone replacement therapy or sexual reassignment services.11 Health system barriers for transgender individuals include problems with identification forms (eg, driver’s license or health insurance card) that indicate assigned rather than preferred gender, a lack of a systematic approach by hospitals and clinics to collect current gender and preferred pronoun, and limited access to gender-neutral bathrooms.

A national survey found that of those who presented identification that did not match their gender identity in healthcare settings, 40% reported being harassed, 3% reported being attacked or assaulted, and 15% reported being asked to leave.12

Health risks Transgender individuals are not only a vulnerable and underserved part of the community, but they are also at increased risk for a number of issues.

Lack of awareness about gender identity exacerbates family and societal rejection and stigmatization. Unfortunately, this leads to self-harming

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Clinical Challenge behaviors. Transgender communities in the United States are among the groups at highest risk for human immunodeficiency virus (HIV) infection.13 In 2009, the rate of newly identified HIV infection was 2.6% among transgender persons, compared with 0.9% for men and 0.3% for women.14 Similarly, there are higher rates of drug use,12 homelessness,15 depression, and suicide among transgender populations. One in 5 transgender people in the United States have been refused a home or apartment, and more than 1 in 10 have been evicted because of their gender identity.15 A survey of San Francisco youth found that one-third of transgender youth have attempted suicide16 and a recent national report revealed that 41% of transgender adults have attempted suicide.12

Transitioning “Transitioning” refers to the process of using hormonal and/or surgical treatment to align preferred gender with appearance. Transitioning transgender individuals face a number of patient safety issues. Non-prescribed hormone use (“street hormones” such as estradiol and esterified, available under various trade names) is widespread

throughout the United States; the prevalence of non-prescribed hormone use ranges from 30% to 71%.13,17-19 These findings are worrisome because non-prescribed hormone users may be at increased risk for health problems resulting from improper dosing and a lack of monitoring. Adverse effects include hormone-related cancers20 and increased weight, decreased insulin sensitivity, poor lipid profile, and elevated hematocrit levels, raising concerns for cardiac and thromboembolic events.21

Recommendations Patients should be able to identify sex at birth, current gender identity, and preferred gender pronoun separately during healthcare intake.22 Staff should also be routinely trained, and clear com-

NON-PRESCRIBED HORMONE USE IS WIDESPREAD THROUGHOUT THE UNITED STATES. munication across different providers and sites within a health system should be encouraged to address patients respectfully and in accordance with their wishes. In addition to addressing patients

Take-Home Points • Transgender identity is a medical condition, not a person’s choice, and care should focus on the patient's wishes.

• Healthcare teams should be trained to interact with transgender individuals in a courteous and patientcentered manner.

• Registration and other intake processes should capture information about general preference, and systems should be in place (including through the electronic medical record) to ensure that this information is available to all providers and is used in the care of the patient.

• Providers should pay particular attention to prevention screening in transgender patients.

by their preferred name/ pronoun, if a patient’s gender is unclear, using gender-neutral phrasing such as “your next patient is here” is a suggested strategy. Allowing individuals to use the bathroom of the gender with which they identify is also recommended.

Best practices specific to electronic health records (EHRs) were developed by the World Professional Association for Transgender Health EMR Working Group.23 These recommendations included (1) preferred name, gender identity, and pronoun preference should be incorporated as structured demographic variables within the EHR; (2) the EHR should include an inventory of a

patient’s medical transition history and current anatomy; (3) the EHR system should allow a smooth transition from one listed name, anatomical inventory, and/or sex to another, without affecting the integrity of the remainder of the patient’s record; and (4) the EHR system should alert providers and clinic staff of a patient’s preferred name and/or pronoun.

An area of particular confusion for many providers is prevention screening in transgender patients. In general, transgender persons who have not undergone gender-affirmative surgeries or used hormonal therapy should be screened according to the guidelines established for their reta #1 am il cl ong inic ianS

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Clinical Challenge birth sex. However, for those patients who have undergone surgery or hormonal treatments, screening recommendations must be modified.

A great starting point for providers is the UCSF Center of Excellence for Transgender Health’s Web site. This site provides information for those interested in learning more about general prevention and screening for transgender patients. It includes a section emphasizing the areas of special consideration in which transgender-related medical treatments may have an impact on a patient’s well-being.22 Guiding principles in caring for transgender populations are compassion and respect for the patient’s expressed gender identity. Specific best practices include co-location of mental health services, peer support, and clinician training in transgender and gender-variant health issues. ❚

References

1. Forcier MM, Haddad E. Health care for gender variant or gender non-conforming children. R I Med J. 2013;96: 17-21.

2. JSI Research and Training Institute, Inc. Access to health care for transgendered persons in greater Boston.

Boston, MA: JSI Research and Training Institute, Inc. and GLBT Health Access Project; July 2000.

3. Lombardi E. Enhancing transgender health care. Am J Public Health. 2001; 91:869-872.

4. National Center for Transgender Equality. Understanding transgender: frequently asked questions about transgender people. Washington, DC: National Center for Transgender Equality; May 2009.

5. Gates GJ. How many people are lesbian, gay, bisexual, and transgender? Los Angeles, CA: The Williams Institute, UCLA School of Law; April 2011.

6. Olson J, Forbes C, Belzer M. Management of the transgender adolescent. Arch Pediatr Adolesc Med. 2011;165:171-176.

7. Clements-Nolle K, Marx R, Guzman R, Katz M. HIV prevalence, risk behaviors, health care use, and mental health status of transgender persons: implications for public health intervention.

Am J Public Health. 2001;91:915-921.

8. Nuttbrock L, Hwahng S, Bockting W, et al. Psychiatric impact of gender-related abuse across the life course of male-to-female transgender persons.

J Sex Res. 2010;47:12-23.

9. Lombardi EL, Wilchins RA, Priesing D, Malouf D. Gender violence: transgender experiences with violence and discrimination. J Homosex. 2001;42:89101.

10. Grant JM, Mottet LA, Tanis J, Herman JL, Harrison J, Keisling M. National transgender discrimination survey—report on health and health care. Washington, DC: National Center for Transgender Equality and the National Gay and Lesbian Task Force; October 2010.

11. National Coalition for LGBT Health. An overview of U.S. trans health priorities: a report by the

Eliminating Disparities Working Group. Washington, DC: National Coalition for LGBT Health; 2004.

12. Grant JM, Mottet LA, Tanis J, Harrison J, Herman JL, Keisling M. Injustice at every turn: a report of the National Transgender Discrimination Survey. Washington, DC: National Center for Transgender Equality and National Gay and Lesbian Task Force; February 3, 2011.

13. Clements-Nolle K, Marx R, Guzman R, Katz M. HIV prevalence, risk behaviors, health care use, and mental health status of transgender persons: implications for public health intervention. Am J Public Health. 2001;91: 915-921.

14. HIV among transgender people.

Atlanta, GA: Centers for Disease Control and Prevention; 2010.

15. Housing and homelessness.

Washington, DC: National Center for Transgender Equality; 2010.

16. Clements-Nolle K, Marx R, Katz M. Attempted suicide among transgender persons: the influence of gender-based discrimination and victimization. J Homosex. 2006;51:53-69.

17. Garofalo R, Deleon J, Osmer E, Doll M, Harper GW. Overlooked, misunderstood and at-risk: exploring the lives and HIV risk of ethnic minority male-to-female transgender youth. J Adolesc Health. 2006;38:230-236.

18. Xavier J, Honnold JA, Bradford J. The health, health-related needs, and lifecourse experiences of transgender Virginians: Virginia Transgender Health Initiative Study Statewide Survey Report. Richmond, VA: Virginia Department of Health, Division of Disease Prevention; 2007.

19. Xavier J. Final Report of the Washington Transgender Needs Assessment Survey. Washington, DC: Administration for HIV and AIDS. Government of the District of Columbia; 2000.

20. Mueller A, Gooren L. Hormonerelated tumors in transsexuals receiving treatment with cross-sex hormones.

Eur J Endocrinol. 2008;159:197-202.

21. Moore E, Wisniewski A, Dobs A. Endocrine treatment of transsexual

people: a review of treatment regimens, outcomes, and adverse effects. J Clin Endocrinol Metab. 2003;88:3467-3473.

22. Center of Excellence for Transgender Health. Primary care protocol for transgender patient care. San Francisco, CA: University of California, San Francisco, Department of Family and Community Medicine; April 2011.

23. Deutsch MB, Green J, Keatley J, Mayer G, Hastings J, Hall AM; World Professional Association for Transgender Health EMR Working Group. Electronic medical records and the transgender patient: recommendations from the World Professional Association for Transgender Health EMR Working Group. J Am Med Inform Assoc. 2013;20:700-703.

Dr Sarkar is Assistant Professor in Residence, School of Medicine, University of California, San Francisco.

Disclosure: Dr Sarkar has declared that neither she, nor any immediate member of her family, has a financial arrangement or other relationship with the manufacturers of any commercial products discussed in this continuing medical education activity. In addition, the commentary does not include information regarding investigational or off-label use of pharmaceutical products or medical devices.

Reprinted with permission of AHRQ WebM&M. Sarkar M. It’s Sarah, not Stephen! [Spotlight].

AHRQ WebM&M [serial online].

October 2013. Available at: http:// webmm.ahrq.gov/case.aspx?caseID=308.

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.

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Continuing Education Empowering Community Pharmacists as Health Consultants: Asthma

by JENNIFER BARROW, PHARMD

Release date: May 5, 2015 Expiration date: May 31, 2016 Estimated time to complete activity: 0.8 hours Jointly provided by Postgraduate Institute for Medicine and Center of Excellence Media, LLC.

This activity is supported by an independent educational grant from AstraZeneca.

TARGET AUDIENCE This activity has been designed to meet the educational needs of community clinical and retail pharmacists.

EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Explain the role of community pharma­cists in ensuring safe and effective medication use • Review factors that can impact clinical outcomes, including patient, disease, and medication • Utilize strategies to improve patient care, including patient education and medication adherence counseling • Describe the ways that community pharmacists can help their patients achieve optimal health and value through the knowledge and application of traditional and nontraditional care • Provide accurate and appropriate counsel as part of the treatment team FACULTY Jennifer Barrow, PharmD Pharmacy Clinical Specialist, Adult Medicine UNC Healthcare, Main Campus Chapel Hill, NC 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 0.8 contact hour(s) (0.08 CEUs) of the Accreditation Council for Pharmacy Education.

(Universal Activity Number - 0809-9999-15-119-H01-P) Type of Activity : Knowledge

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 COIs 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.

evaluation can be completed online at http://ce.lynx cme.com/COE176-5. 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.

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 CE activity:

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.

Name of Faculty or Presenter Jennifer Barrow, PharmD

Reported Financial Relationship Nothing to disclose

The planners and managers 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 CE activity: The following PIM planners and managers—Laura Excell, ND, NP, MS, MA, LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP; Jan Schultz, RN, MSN, CCMEP; and Judi Smelker-Mitchek, RN, BSN—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.

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

If you have any questions regarding the CE certification for this activity, please contact Postgraduate Institute for Medicine at: information@pimed.com or 303-7991930.

Media: Printed report 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. The planners of this activity 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 the planners. 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 or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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Continuing Education

A

sthma is a chronic disease of the lungs that is characterized by episodes of reversible airflow obstruction. Its underlying factors are inflammation, which results in airway edema and increased mucus production, and bronchial hyperreactivity, leading to bronchospasm. Individuals with asthma are susceptible to certain exposures, also known as triggers, including allergens (eg, pollen, animal dander), tobacco smoke, occupational exposures, and exercise. Classic symptoms of asthma are shortness of breath, wheezing, cough, and chest tightness.1

Impact In the United States, the prevalence of asthma has increased during the first decade of this century and now stands at nearly 9%. It has been reported that an estimated 25.9 million people have asthma, including 7.1 million children.2 The highest prevalence rates are found in children, women, and blacks.2 Poverty may also play a role in rates of asthma.2 Unfortunately, poorly controlled asthma leads to absenteeism from work or school, unscheduled medical visits, emergency department visits, and hospitalizations. Data from 2008 show that, on average, children missed 4 days of school and adults missed 5 days of work due to asthma.3 Asthma deaths are uncommon, occurring at a rate of 1.1 per 100,000 people; however, these rates are higher among women, blacks, and those ≥65 years of age.2,4 In 2010, 3404 deaths in the United States were attributed to asthma.4

At the time of diagnosis, asthma is classified according to severity as intermittent, mild persistent, moderate persistent, or severe persistent.

Guidelines National and international guidelines for the management of asthma have been developed to improve its diagnosis and treatment.5,6 In the United States, the current guidelines from the National Heart, Lung,

Table 1. Reasons for Poor Asthma Control5,6 Patient factors • Lack of knowledge about the condition and its treatment • Poor adherence with medications and other management strategies • Suboptimal technique with inhalation device • Failure to avoid asthma triggers • Lack of access to prescribed therapies Clinician factors • Lack of knowledge about evidence and management strategies • Failure to: - P rovide an asthma action plan - Provide appropriate patient education - Control other conditions that affect asthma - Recommend immunizations Adapted with permission from the National Heart, Lung, and Blood Institute.

and Blood Institute (NHLBI) is known as Expert Panel Report 3 and was published in July 2007.5 The Global Initiative for Asthma, a collaboration between the NHLBI and the World Health Organization, was last updated in 2014.6 Recommendations in these guidelines are largely concordant but there are a few differences that reflect practice variations between countries.

At the time of diagnosis, asthma is classified according to severity as intermittent, mild persistent, moderate persistent, or severe persistent.5 The emphasis then shifts to achieving control through proper management of the condition; patients are further categorized as being well controlled, not well controlled, or poorly controlled.5 Ultimately, the goal of asthma management is to improve asthma care through proper treatment, and to enhance the quality of life for these patients (eg, reduce limitations and risks associated with the disease).5

Management Strategies The 4 primary strategies for the management of asthma include assessment and monitoring (including self-monitoring), patient education to encourage a partnership in asthma care, avoidance of triggers, and use of pharmacotherapy.5 It is recommended that all patients with a persistent form of asthma have a self-monitoring plan, referred to as a written asthma management plan, based on symptoms or peak flow results. The stepwise approach to managing asthma with medications is well

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Continuing Education Figure. Stepwise Approach for Managing Asthma in Youths >12 Years of Age and Adults5 Intermittent Asthma

Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3.

Step 6 Step 5 Step 3 Step 2

Step 1 Preferred: SABA PRN

Preferred: Low-dose ICS Alternative: Cromolyn, LTRA, nedocromil, or theophylline

Preferred: Low-dose ICS + LABA OR Medium-dose ICS Alternative: Low-dose ICS + either LTRA, theophylline, or zileuton

Step 4 Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS + either LTRA, theophylline, or zileuton

Preferred: High-dose ICS + LABA

Preferred: High-dose ICS + LABA + oral corticosteroid

AND

AND

Consider omalizumab for patients who have allergies

Consider omalizumab for patients who have allergies

Step up if needed (first, check adherence, environmental control, and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months)

Each step: Patient education, environmental control, and management of comorbidities.

Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma (see notes).

Quick-relief medication for all patients • SABA PRN for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals PRN. Short course of oral systemic corticosteroids may be needed.

• Use of SABA >2 days a week for symptom relief (not prevention of exercise-induced asthma) generally indicates inadequate control and the need to step up treatment.

Reprinted with permission from the National Heart, Lung, and Blood Institute.

ICS indicates inhaled corticosteroid; LABA, long-acting beta agonist; LTRA; leukotriene receptor antagonist; PRN, as needed; SABA, inhaled short-acting beta 2-agonist.

established and supported by scientific and clinical evidence.5 Pharmacotherapy is used to control inflammation, prevent and treat bronchospasm, and reduce symptoms.

Despite the availability of guidelines and substantial evidence for management strategies, many patients do not achieve adequate control of their asthma. Factors contributing to this problem are shown in Table 1.5,6 There are a number of opportunities for community pharmacists to help optimize outcomes in patients with asthma.

Pharmacotherapy Summary Medications for asthma are generally targeted toward treating or reducing inflammation or bronchospasm.

Their use in a stepwise approach to treatment is summarized in the Figure.5 All patients with asthma should have access to a rescue therapy, typically a short-acting

beta 2-agonist. These agents are used as needed for acute asthma symptoms because they have a rapid onset of effect. For patients with intermittent asthma, short-acting beta 2-agonists are typically the only therapy.5 For patients with persistent forms of asthma, the most effective therapy is inhaled corticosteroids (ICSs).5 This is independent of patient age or asthma severity. For patients with mild persistent asthma, low doses of ICS as a single long-term control medication is recommended.

Leukotriene modifiers are an acceptable alternative to ICSs based on evidence of their efficacy as monotherapy.5 For patients with moderate persistent asthma, there are 2 preferred treatment options. The first is an ICS, at low doses, combined with a long-acting beta agonist (LABA). The second is medium doses of an ICS alone.

For patients with more severe asthma, or when sympreta #1 am il cl ong inic ianS

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Continuing Education Table 2. Actions Pharmacists Can Take to Improve Care and Outcomes for Patients with Asthma5 • Encourage and monitor adherence • Educate and observe regarding inhaler technique and self-monitoring • Advise patients on how to avoid asthma triggers • Recommend and provide appropriate immunizations • Ensure patient is receiving appropriate pharmacotherapy • Collaborate with patients and other clinicians to develop an asthma action plan • Monitor the patient and recommend appropriate step-up or step-down of medications based on asthma control • Assist the patient to ensure access to medications and medical care • Use proven strategies to educate and counsel patients Adapted with permission from the National Heart, Lung, and Blood Institute.

toms remain uncontrolled, the combination of an LABA with a higher dose of ICS is recommended.5 Systemic steroids are indicated during acute exacerbations, but can be used chronically for patients with asthma that is difficult to control; however, long-term use should generally be avoided. Finally, omalizumab is a monoclonal antibody against immunoglobulin E that is indicated for severe allergic asthma.5

Problems with the proper use of inhalation devices are well documented and become more complex with the availability of different technologies.

Once therapy is initiated, control should be evaluated during periodic assessments. If the patient’s asthma is not well controlled, actions should be taken to improve control. This may include making changes to the pharmacotherapy regimen. If good control has been maintained for at least 3 months, consideration should be given to stepping down the pharmacotherapy regimen (Figure).5,7,8 One of the controversies in asthma management is

related to the safety of LABAs. A postmarketing study suggests that salmeterol may be associated with an increased risk of death or severe episodes of asthma, especially in black patients.9 These data, along with similar results from smaller studies with formoterol, prompted the US Food and Drug Administration (FDA) to stipulate that a black box warning be added to the package inserts for all products containing LABAs. In addition, the FDA is requiring that these products be part of a Risk Evaluation and Mitigation Strategy program, which will include revised medication guides specifically targeted to patients.10 The FDA also stressed that LABAs should never be used alone for patients with asthma; they should always be combined with an asthma controller medication, such as an ICS.10 However, some disparity still exists among clinicians, as not all agree that LABAs are safe when used with ICSs. Ongoing studies are currently in progress to address this important clinical question.

Recent studies demonstrate a role for tiotropium, a long-acting muscarinic antagonist. The use of tiotropium with ICSs in place of a LABA, or added to an ICS/LABA combination, improves asthma control.11,12 Treatments expected in the future include LABAs with an extended duration of action, new muscarinic antagonists, and monoclonal antibody products directed against new targets (eg, interleukin 5).13,14

Opportunities for Pharmacists to Improve Care and Outcomes Despite the availability of evidence-based guidelines and numerous resources for education and management, a significant number of patients with asthma do not achieve optimal control. This creates opportunities for community pharmacists to improve care and outcomes for this population (Table 2).5 Pharmacists should assess asthma control at every refill visit using available assessment tools. These include validated asthma control and quality-of-life instruments.5,15,16 For patients with asthma that is not well controlled or very poorly controlled, pharmacists are in a good position to assess the possible reasons for this, including exposure to environmental triggers, adherence to prescribed medications, and suboptimal inhalation technique. These factors should be assessed before considering changes in medication. Common triggers to explore include allergens and tobacco smoke. Other concomitant conditions to look for when assessing potential causes include allergic rhinitis, sinusitis, gas-

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Continuing Education troesophageal reflux disease, or obesity.5,6 Problems with the proper use of inhalation devices are well documented and become more complex with the availability of different technologies (metered-dose inhaler [MDI], dry-powder inhaler, and nebulizers).17-19 Knowledge about proper use of devices is a pervasive problem for patients and clinicians. In one study, 63% of patients missed at least 3 steps in MDI use.19 Community pharmacists should maintain knowledge and competence using these devices and utilize available resources to educate and monitor patients.20-23 Patients may have a preference for one device over another. Although there are numerous resources available online, they should not replace the periodic visual assessment of inhaler technique by the pharmacist.20,22 Opportunities for education on device use extend beyond inhalers, including peak flow monitoring devices and injectable pens for emergency situations. Each device requires education, review, and observation to ensure that the patient is using it correctly. In a recent report, only 16% of patients demonstrated the correct technique with an epinephrine autoinjector. Of the remaining 84%, 56% missed 3 or more steps.19 Suboptimal technique with these devices has the potential to put patients at risk for life-threatening emergencies.

It has become increasingly commonplace for pharmacists to recommend and provide vaccines to patients.

Pharmacists can also recommend and provide vaccines for patients with asthma, according to the scope of practice in their individual states. Vaccines that are specifically indicated for asthma patients include influenza (inactivated) for all patients 6 months of age and older and pneumococcal polysaccharide vaccine for patients 19 years of age and older.5

Collaboration with Other Healthcare Providers Although there are numerous services that pharmacists provide directly to patients, there are also areas for collaboration with other healthcare providers. These include the development of written asthma action plans, ensuring appropriate pharmacotherapy according to asthma control, and stepping up or down pharmacotherapy.24,25 Written asthma action plans are recommended for all patients with persistent asthma.5 These are helpful to provide patients with a road map in managing their condition, either through the use of symptom monitoring or peak flow measurements. The red light analogy (green, yellow, and red zones) is helpful in providing

patients with a visual image for good control, worsening asthma, and when to seek emergent care.5,26 Pharmacists can also serve as a source of referral to specialist care when the situation warrants.

Improving Adherence and Access to Care Community pharmacists are often aware of issues related to medication access. Asthma medications are expensive and their costs are expected to rise significantly in the future.27,28 The costs of basic medications may prevent many patients from being fully adherent to their prescribed regimens. For example, typical monthly costs for ICSs range from $139 up to nearly $800.29 Even with adequate coverage, copays for medications may be a barrier. Pharmacists can help by providing patients with information about local and state resources to explore for financial assistance as well as pharmaceutical company support for indigent patients.

Asthma medications are expensive and their costs are expected to rise significantly in the future.

Pharmacists have much experience and skill in educating and counseling patients. However, it is important to maintain competency in counseling and education techniques that have been found to be most effective.

Skills in motivational interviewing, coaching, the use of teach back, and problem-solving techniques to improve adherence can be helpful when engaging patients with asthma.30-33

Conclusion Community pharmacists are in a unique and pivotal position to help patients improve and maintain control of their asthma. There are numerous and valuable services in education and monitoring that are within the scope of practice for pharmacists, and evidence exists of their value.34,35 Important services and advice can be provided in the pharmacy setting. In addition, collaboration with other healthcare professionals will benefit patients by optimizing their health and outcomes. â?&#x161; reta #1 am il cl ong inic ianS

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Continuing Education References

1. Global Initiative for Asthma Web site. Pocket guide for asthma management and prevention. www.ginasthma.org/local/uploads/files/GINAPocket05Clean_1.pdf.

Accessed April 9, 2015.

2. American Lung Association Web site. Trends in asthma morbidity and mortality. www.lung.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf.

Published September 2012. Accessed December 30, 2014.

3. CDC Web site. Vital signs: asthma in the US. www.cdc.gov/vitalsigns/asthma.

Updated May 8, 2013. Accessed January 11, 02015.

4. Murphy SL, Xu JQ, Kochanek KD. Deaths: final data for 2010. National vital statistics reports; vol 61 no 4. Hyattsville, MD: National Center for Health Statistics. 2013.

5. The National Heart, Lung, and Blood Institute Web site. Guidelines for the diagnosis and management of asthma (EPR-3). www.nhlbi.nih.gov/health-pro/guidelines/ current/asthma-guidelines. Published July 2007. Accessed January 11, 2015.

6. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2014. www.ginasthma.org. Accessed September 29, 2014.

7. Hagan JB, Rank MA. Assessing the risks and benefits of step-down asthma care: a case-based approach. Curr Allergy Asthma Rep. 2015;15:503.

8. Rank MA, Branda ME, McWilliams DB, et al. Outcomes of stepping down asthma medications in a guideline-based pediatric asthma management program. Ann Allergy Asthma Immunol. 2013;110:354-358.

9. Nelson HS, Weiss ST, Bleecker ER, et al; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129:15-26.

10. US Food and Drug Administration (FDA) Web site. FDA drug safety communication: new safety requirements for long-acting inhaled asthma medications called LongActing Beta-Agonists (LABAs). www.fda.gov/drugs/drugsafety/postmarketdrugsafety informationforpatientsandproviders/ucm200776.htm. Accessed January 2015.

11. Kerstjens HA, Engel M, Dahl R, et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med. 2012;367:1198-1207.

12. Peters SP, Kunselman SJ, Icitovic N, et al. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. N Engl J Med. 2010;363:1715-1726.

13. Dunn RM, Wechsler ME. Anti-interleukin therapy in asthma. Clin Pharmacol Ther.

2015;97:55-65.

14. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet.

2012;380:651-659.

15. Asthma Control Test. www.asthmacontroltest.com. Accessed January 11, 2015.

16. Asthma Impact Survey (AIS-6™) © 2002, 2007 QualityMetric Incorporated. All rights reserved.

17. Ibrahim M, Verma R, Garcia-Contreras L. Inhalation drug delivery devices: technology update. Med Devices (Auckl). 2015;8:131-139.

18. Casset A, Meunier-Spitz M, Rebotier P, et al. Asthma management and inhalation techniques among community pharmacists in 2009: a comparison with the 1999 survey. J Asthma. 2014;51:964-973.

19. Bonds RS, Asawa A, Ghaza AI. Misuse of medical devices: a persistent problem in self-management of asthma and allergic disease. Ann Allergy Asthma Immunol.

2015;114:74-76.

20. Press VG, Arora VM, Shah LM, et al. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012;27:1317-1325.

21. Basheti IA, Qunaibi EA, Hamadi SA, et al. Inhaler technique training and healthcare professionals: effective long-term solution for a current problem. Respir Care.

2014;59:1716-1725.

22. Basheti IA. The effect of using simulation for training pharmacy students on correct device technique. Am J Pharm Educ. 2014;78:177.

23. Interactive Guidance & Management Web site. How to use inhalers. http://use-in halers.com. Accessed January 11, 2015.

24. Gums TH, Carter BL, Milavetz G, et al. Physician–pharmacist collaborative management of asthma in primary care. Pharmacotherapy. 2014;34:1033-1042.

25. Krieger J, Song L, Philby M. Community health worker home visits for adults with uncontrolled asthma: the HomeBASE Trial randomized clinical trial. JAMA Intern Med. 2015;175:109-117.

26. NIH Web site. Asthma Action Plan. www.nhlbi.nih.gov/files/docs/public/lung/ asthma_actplan.pdf. Accessed January 2015.

27. Managed Care Web site. U.S. asthma drug costs to jump 50% by 2023. www.man agedcaremag.com/archives/2014/10/us-asthma-drug-costs-jump-50-2023. Accessed April 10, 2015.

28. Rosenthal E. The soaring cost of a simple breath. The New York Times. October 12, 2013. www.nytimes.com/2013/10/13/us/the-soaring-cost-of-a-simple-breath.html?_ r=0. Accessed April 10, 2015.

29. Consumer Reports-Best Buy Drugs Web site. Treating asthma with inhaled steroids: comparing effectiveness, safety, and price. www.consumerreports.org/cro/2013/11/ treating-asthma-with-inhaled-steroids/index.htm. Accessed April 10, 2015.

30. Braido F, Baiardini I, Blasi F, et al. Adherence to asthma treatments: ‘we know, we intend, we advocate’. Curr Opin Allergy Clin Immunol. 2015;15:49-55.

31. Weinstein AG. Asthma adherence management for the clinician. J Allergy Clin Immunol Pract. 2013;1:123-128.

32. Lavoie KL, Moullec G, Lemiere C, et al. Efficacy of brief motivational interviewing to improve adherence to inhaled corticosteroids among adult asthmatics: results from a randomized controlled pilot feasibility trial. Patient Prefer Adherence. 2014;8:1555-1569.

33. Apter AJ, Wang X, Bogen DK, et al. Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011;128:516-523.

34. Garcia-Cardenas V, Sabater-Hernandez D, Kenny P, et al. Effect of a pharmacist intervention on asthma control. A cluster randomised trial. Respir Med. 2013;107: 1346-1355.

35. van Boven JF, Stuurman-Bieze AG, Hiddink EG, et al. Medication monitoring and optimization: a targeted pharmacist program for effective and cost-effective improvement of chronic therapy adherence. J Manag Care Spec Pharm. 2014;20:786-792.

Dr Barrow is a Pharmacy Clinical Specialist, Adult Medicine, UNC Healthcare, Main Campus, Chapel Hill, NC.

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The Retail Pharmacy Geriatric Certifications Provide Benefits for Retail Pharmacists and Older Patients

by ELIZABETH HAUSS, PHARMD, CGP

Although patients of all ages are seen in the retail pharmacy setting, older adults make up a large portion of that population. }} KEY POINTS ❚ Geriatric pharmacy focuses on treating the entire patient, not just looking at each drug or disease individually ❚ Personalized care for geriatric patients leads to more tailored recommendations and a lower risk for adverse events ❚ Geriatric certification is valuable for pharmacists looking to improve their practice, move up within their current job, or switch practice areas altogether

}} PATIENTS OLDER THAN 65 YEARS of age are often taking multiple maintenance medications, and they rely on their pharmacist for guidance and advice when they begin taking a new medication, have to switch medications, or are diagnosed with a new disease. Geriatric patients (age ≥65 years) who have low health literacy, limited income, and vision or hearing difficulties require even more attention and help from their pharmacist.

I became a Certified Geriatric Pharmacist (CGP) to address the needs and concerns of a growing older population. Obtaining geriatric certification provides retail pharmacists with a great opportunity to expand their expertise and better serve their patients.

Treating Geriatric Patients Geriatric pharmacy focuses on treating the entire patient, not just looking at each drug or disease individually. In the retail setting, it is easy to focus on 1 prescription at a time, but that is not

what these patients need. Polypharmacy, multiple disease states, and decreased organ function demand that geriatric patients get specialized attention from pharmacists.

As a retail pharmacist, the majority of my daily practice is spent dispensing medications. Using the Beers criteria during data entry and product review has enhanced my ability to identify possible dangerous interactions. My expanded knowledge has also improved my recommendations to prescribers. As a CGP, I am now better equipped to make specific recommendations for my geriatric patients that take into account their specific needs.

For example, for a younger patient with anxiety issues, a benzodiazepine is often used as a quick and easy fix by prescribers, especially for short-term use; however, benzodiazepines come with a great risk for dizziness, sedation, and falls. For a younger patient, a fall may not be seen as a serious risk or event with major consequences, but for an

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Inside the Retail Pharmacy older patient, a fall could mean internal 70-year-old patient a better candidate bleeding if the patient is on warfarin, for saline nasal rinses and analgesics or a delay in treatment if the patient instead of the popular combination cold is isolated and unable to move. The and flu products. most devastating consequence of a fall in elderly Medical patients is a fracture; Directors • Physicianafter Assistants • Nurse Practitioners • Pharmacists • Chain Headquarters • Independents experiencing a hip fracture, 20% of patients die in the following year.1 With this statistic in mind, the potential for falls should always be a Retail top priority pharmacies and clinics are quickly becoming an when managing medications for older extension of primary care. Inside Patient Care: Pharmacy patients. & Clinics tailored to meet the growing needs of the entire Over-the-counter (OTC) is recomProviding mendations are a vital aspect of team retail and healthcare providesMedication practical Therapy information to treat Management pharmacy. By takingand geriatric concerns care for patients inside the pharmacy and retail clinics.”

Because medication therapy maninto account for my older patients, they agement is a growing aspect of retail receive more tailored recommendations Donald J. Dietz, RPh, MS pharmacy practice, having advanced and therefore have a decreased risk for Vice President knowledge of geriatric pharmacy is Solutions, Inc. adverse events. For example, a 70-yearPharmacy Healthcare an invaluable resource inEditor-in-Chief the treatold man asking for a cold and flu medInside Patient Care ment of older patients. As dispensing ication recommendation is more likely rates decrease, pharmacies and pharto experience confusion from an antimacists are realizing the value of feehistamine, or urinary retention from a for-service programs. After becoming a decongestant compared with a younger CGP, I am better equipped to conduct patient. Advanced age may make a

The potential for falls should always be a top priority when managing medications for older patients.

“

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Inside Patient Care: Pharmacy & Clinics™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics.

om

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of Geriatric Certifications

CE AvAIlABlE pAGE 29

© 2015 Novellus Healthcare Communications, LLC an affiliate of

As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ 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—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 Inside Patient Care is a publication of Novellus Healthcare Communications, LLC, an affiliate of The Lynx Group. © 2015 All rights reserved.

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Dr Hauss is a Certified Geriatric Pharmacist, Dover, DE.

Comprehensive Medication Reviews and Drug Utilization Reviews for my older patients. By working with patients individually and reviewing their complete medication lists—including OTC medications and supplements—I am able to identify a variety of safety concerns. Oftentimes, elderly patients are experiencing unnecessary side effects from medications that can be avoided by switching to more geriatric-appropriate medications. Prescribing cascades occur when medications are prescribed to treat side effects of other medications.

This often leads to the use of multiple unnecessary medications. Identifying and replacing offending agents can eliminate the need for several medications, and reduce pill burden.

My employer also offers patients a Medicare Part D review session every year during open enrollment. Patients bring their medication lists, and by using a computer program, the pharmacy staff is able to show them plans based on their preferred pharmacies, estimated premiums, and projected out-of-pocket costs for medications. This insurance review allows patients to choose the plan that is right for them, and presents a valuable opportunity for pharmacists to look at complete medication lists, and possibly identify any duplicate therapies or inappropriate choices. In addition, when treating elderly patients on limited income, prescribing ideal drug choices is irrelevant if the patient is unable to afford the medication, and therefore unable to follow through with therapy.

This review session is a chance for pharmacists to identify any drugs that can be switched, with the prescribers’ consent, to safer or more affordable options.

Branching outside of retail pharmacy, the most obvious market for CGPs is within long-term care settings.

Whether they are dispensing or consulting, nursing homes and assisted living facilities will always need pharmacists with geriatric knowledge to keep their patients safe and improve medication efficacy. Acute care can also bene-

fit from geriatric specialists, because older people make up a larger portion of the patients. In hospitals, geriatric patients account for 53.1% of drug-related adverse events.2 The opportunity for geriatric pharmacists to improve the quality of patient care in all pharmacy-related fields is plentiful.

Any pharmacist currently licensed and with a minimum of 2 years of experience practicing pharmacy is eligible to take the CGP examination through the Commission for Certification in Geriatric Pharmacy. The examination is offered in 2-month blocks 4 times annually, at various locations. The test comprises 150 multiple choice questions on a variety of geriatric pharmacy topics, ranging from socioeconomic concerns to pain management and statistical analysis. Pharmacists who pass the examination are certified for 5 years.3 During those 5 years, pharmacists can choose to complete 75 designated continuing education credits, or retake the CGP examination to be recertified.4

Conclusion Whether you are looking to improve your practice, move up within your current job, or switch practice areas altogether, having the additional geriatric certification is a valuable asset. It shows employers and patients that you are committed to providing patients with exceptional care through your skills and geriatric knowledge. We are committed as healthcare professionals to provide our elderly patient population with exceptional patient care. ❚ References

1. Centers for Disease Control and Prevention. Hip fractures among older adults. www.cdc.gov/HomeandRecreational Safety/Falls/adulthipfx.html. Updated September 18, 2014.

Accessed March 4, 2015.

2. Lucado J, Paez K, Elixhauser A. Medication-related adverse outcomes in US hospitals and emergency departments, 2008.

Healthcare Cost and Utilization Project. www.hcup-us. ahrq.gov/reports/statbriefs/sb109.jsp. Published April 2011.

Accessed March 4, 2015.

3. Commission for Certification in Geriatric Pharmacy. Recertification process. www.ccgp.org/recertification. Accessed March 4, 2015.

4. Commission for Certification in Geriatric Pharmacy. Certified Geriatric Pharmacist recertification. www.ccgp.org/sites/ default/files/CGP_Recertification.pdf. Accessed March 4, 2015.

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Call for submissions

?

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: Pharmacy & Clinics, that your fellow colleagues will want to read.

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Inside the Retail Pharmacy

Questions Answered: CuttingEdge Research Shapes the Design of Primary Care Services in the Retail Pharmacy Setting In a recent interview with Inside Patient Care: Pharmacy & Clinics, Michael Feehan, PhD, Visiting Professor, and Mark A. Munger, PharmD, FCCP, Professor, Department of Pharmacotherapy, College of Pharmacy, University of Utah, discussed the increasing focus on providing primary healthcare services in retail pharmacies, and how this evolution can be informed by novel, large-scale research, with consumers, pharmacists, and reimbursement decision makers.

Michael Feehan

Mark A. Munger

What is the premise of your research?

Mark A. Munger [MM]: Our research effort, the Optimal Pharmacy Services Research Program, is a collaboration with myself and Dr Feehan, a former clinical psychologist, public health researcher, and global marketing science consultant in the pharmaceutical industry. I am a pharmacist, clinical researcher, and educator in the University of Utah’s PharmD program.

During the past couple of years, we have conducted surveys on major trends potentially impacting the pharmacy profession, including documenting the significant occupational stress experienced by many community pharmacists—particularly those with PharmD degrees1— and the growing trend for physicians to bypass pharmacies to a large degree and directly dispense medications, which is

something that holds appeal for some members of the community.2 Our previous research highlighted challenges in the workflow of community pharmacists who often express a desire to provide more direct patient care, but who are challenged by timecrunch imperatives. These include filling prescriptions and more administrative matters such as patients’ insurance. This research is not static; it has occurred against a backdrop of significant change in the breadth of services offered in retail pharmacies, and as pharmacists increasingly acknowledge the profound role they can play in improving the public’s health by essentially becoming healthcare delivery companies.

In these times of budgetary constraint for research at the federal level, we were very fortunate to receive a significant

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Inside the Retail Pharmacy grant from the philanthropic Skaggs Foundation for Research to conduct a research program this year that has the potential to inform decision-making by both retail pharmacies and healthcare systems as they develop new healthcare service offerings. We will build a model that will hold the greatest appeal for consumers, with services that pharmacists will be willing to provide, and reimbursement decision makers will be likely to reimburse. By designing services that meet the needs of all 3 constituencies, these services could have the greatest frequency of use by consumers, the likelihood to improve their health outcomes, and the likelihood to improve the occupational satisfaction of pharmacists.

How are pharmacies transforming to become healthcare delivery companies?

Michael Feehan [MF]: When disruptive change occurs in any industry, it is often driven by commercial interests: when a company identifies a potential, new product service offering that can differentiate its brand from competitors in the minds of consumers; provide a “first-mover” advantage; and generate increased revenue.

In traditional healthcare delivery models, decisions about what services to offer, by whom to whom, and under what conditions can very often be driven by the provider clinicians’ and organizations’ perceptions of what consumers need, what services they are willing to provide, and by those involved in reimbursement for services as to what they may cover. We are seeing new initiatives in delivery models in the retail setting appearing at an increasing pace.

For example, Walmart opened health clinics in some of its stores where employees can receive basic acute care and wellness checks for a nominal sum.

As an employer of approximately 1.3 million Americans, the financial benefits to the company and potential health improvements for its employees could be dramatic. As we have seen recently, CVS Health, formerly known as CVS

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Caremark, removed all tobacco products from its stores, and is offering walk-in services at their MinuteClinic, which are staffed by nurse practitioners and physician assistants, without appointments.

Industry-driven initiatives like these have the potential to be at odds with the increased societal focus on consumers making better-informed choices about their own healthcare. Whatever people’s perceptions are of the Affordable Care Act, we should acknowledge its core principle, which “puts consumers back in charge of their [healthcare]. Under the law, a new ‘Patient’s Bill of Rights’ gives the American people the stability and flexibility they need to make informed choices about their health,” according to the US Department of Health & Human Services.3 Of course, a choice where the options available to consumers are set by the organizing providers, with minimal consumer input, is no choice at all. Companies, such as Walmart and CVS Health, have undoubtedly conducted proprietary market research to inform their decisions to become healthcare delivery companies.

However, as public health researchers, we would like to see some of the decisions about primary care services that could be offered in the retail setting be informed by broader, nonproprietary science—listening directly to the voices of consumers—with a quantifiable understanding of what the worth or value of each service is to those individuals who will be increasingly making their own choices about what health services they want to receive, from whom, and where.

What changes in retail pharmacies and clinics would impact the consumer most?

MM: As we think about the breadth of services that is currently available—or could be available—in retail pharmacies and clinics, we need to tease out a host of factors that could impact consumers’ demands: Where should services be located? When should they be available?

Who are the preferred providers or team composition offering those services—

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

41

Inside the Retail Pharmacy nurse practitioners versus pharmacists, for example? Across a continuum of care, what assessment and diagnostic services should be offered? What treatments should be provided? Other questions that arise pertain to counseling and educational services, follow-up and monitoring services, as well as payment methods for these services.

If we can provide the best answers to all those questions, and design services accordingly, we should see strong consumer use of those services, with measurable improvements in health, and reductions in follow-up healthcare costs, including less frequent hospital admissions.

MF: You may recall the episode of The Simpsons where Homer Simpson designed his dream car with multiple features, and only after it was made into a prototype did the manufacturer realize its exorbitant cost: “D’oh!” To design and promote a car, the manufacturer must make trade-offs: Is the incremental cost of adding 6 more cup holders worth it?

If we ask consumers what they want from, any health-related services, without some form of trade-off, they will tell you it has to be efficacious, safe, and as cheap as possible. They will also tell you what they want based on their attitudes and beliefs and, in some cases, may tell you what they think you want to hear.

These issues also apply to pharmacists when we ask them what services they would want, or are willing, to provide. In research interviews, healthcare providers can be prone to social desirability—giving the ostensibly “right” answer—when responding to questions about their professional lives. For example, they may say, “I would certainly want to provide care on weekends to patients who need it,” but in practice, not want to work extended hours, or if they did, find it stressful and have it impact their job satisfaction.

MM: In our research, we get around Homer’s car design issue by not directly asking people what they want, but rather

by getting them to make trade-off decisions when choosing healthcare services.

We will survey approximately 10,000 consumers and 300 pharmacists across the country, along with a sizable group of reimbursement decision makers, and pre­ sent experimental scenarios where people choose their preferred pharmacy or clinic, and make a trade-off decision. Consumers will be shown a series of scenarios describing 2 pharmacies, and be asked which they would prefer to use. Pharmacists will be asked which of these 2 settings they would prefer to work in. Reimbursement decision makers will be asked to indicate which setting would be more likely to have its services reimbursed.

Behind the scenes, these scenarios will consist of a host of service attributes that are systematically varied.

We will then model the drivers of the choices people make, and illustrate how much each is worth to the consumer and pharmacist. For example, hypothetically we could find that “consumers may strongly desire the ability to receive examinations after hours for minor injuries, and don’t have any preference whether this should be provided by a physician’s assistant, a nurse practitioner, or a qualified pharmacist.”

Although we obviously have some hypotheses that consumers will value certain services—as evidenced by the public’s use of the Walmart and CVS Health consumer-health programs—it will be exciting to see what this large group of nationally representative consumers actually value and will use.

MF: Importantly, our large sample will allow us to explore variations of what the optimal service packages might be in African American or Hispanic populations, or how services might differ for pharmacies and clinics serving urban populations versus rural communities.

How do you think the model for retail pharmacies and clinics will evolve in the next 5 to 10 years?

MM: This is an exciting time to explore

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Inside the Retail Pharmacy changes in healthcare delivery models, especially with increased consumer choice, easily accessible Internet-based information to inform those choices, and retail pharmacies and clinics redefining themselves as healthcare providers.

We see our research contributing to the discussion about what may be considered optimal service options. Hopefully, this may get us a little ahead of the curve of what is unquestionably a groundswell of support for bringing primary healthcare closer to the locations where people engage in common activities that support their health and the health of those they care for.

Consider the following case of an elderly woman with limited mobility who waits 3 weeks for an appointment to see her physician. She asks her daughter to take time off from work to drive her there, and gets a hard copy of a prescription that she has to physically take to a pharmacy. She has to wait for her pharmacist to fill said prescription—a pharmacist who has no time to speak with her about the medication she is picking up, since the pharmacist hasn’t even had time to take a break during the day.1 She realizes the medication has to be taken with food only after the fact, and then has to be taken to the local market to purchase her groceries. If we were designing a healthcare model, would we really design a system like the one described in this case?

Probably not.

MF: There is an inherent logic in an alternate model, where the same woman, as she purchases her groceries for the week at her local market, can see a nurse practitioner for a walk-in examination, get a diagnosis of her condition, and have a prescription filled then and there.

In this scenario, the pharmacist in the care team has his or her workflow organized so that he or she is free to explain the medication comprehensively and to give advice ensuring adherence for refills, which the pharmacy can then monitor as the woman returns to that

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location each week for her basic needs.

However, any organizational change can meet resistance because practitioners can be wedded to their belief systems that have been reinforced by their professional training and occupational practice and experiences. To facilitate change, it is very helpful to have data that are incontrovertible. If we can demonstrate that certain service designs hold greater utility for consumers, that healthcare providers such as pharmacists are willing to provide them, and that they are sustainable through likely reimbursement, then there is little risk in making systemic change.

It is our hope that the research we are conducting will stimulate evidence-based pilot interventions to be implemented across a range of pharmacy and clinic settings in partnership with local healthcare systems, and that they be thoroughly evaluated to see what gains in public health can be made.

Do you have any concluding remarks?

MF: We can learn a lot from movies. In Field of Dreams, Burt Lancaster’s character, Dr Archibald “Moonlight” Graham, said, “We just don’t recognize life’s most significant moments while they’re happening. Back then I thought, ‘Well, there’ll be other days.’ I didn’t realize that that was the only day.”

A transformation in the “retailization” of healthcare is a significant moment that is already happening. By conducting strong research we hope to be able to proactively shape that transformation, because 5 to 10 years from now it will have occurred, and there may not “be other days” on which to design these services optimally to maximize their utility and better improve people’s lives. ❚

References

1. Munger MA, Gordon E, Hartman J, et al. Community pharmacists’ occupational satisfaction and stress: a profession in jeopardy? J Am Pharm Assoc. 2013;53:282-296.

2. Munger MA, Ruble JH, Nelson SD, et al. National evaluation of prescriber drug dispensing. Pharmacotherapy.

2014;34:1012-1021.

3. US Department of Health & Human Services. About the law. www.hhs.gov/healthcare/rights/. Updated November 14, 2014. Accessed April 17, 2015.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

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

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• 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

View the series online at:

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Drug Update Breo Ellipta (Fluticasone Furoate/ Vilanterol): Fixed-Dose Oral Inhaler Used for Long-Term Maintenance Treatment of COPD

by LORETTA FALA, MEDICAL WRITER

Chronic obstructive pulmonary disease (COPD) is a common, lifethreatening disease characterized by a persistent blockage of airflow from the lungs.1,2 COPD encompasses a range of chronic obstructive lung diseases, including chronic bronchitis and emphysema.1 }} }} IN 2010, an estimated 14.8 million people were diagnosed with COPD in the United States.3 Yet, as many as 12 million additional people are estimated to have COPD that has not been diagnosed.3 COPD is a major cause of disability and the third leading cause of mortality in the United States, responsible for more than 124,000 deaths annually.4,5 Although COPD can occur in younger people, it has a pronounced im-

pact on the elderly population. Moreover, whereas in the past men were 6 times more likely than women to die of COPD, today more women than men die from COPD annually.1 Deaths attributed to COPD are projected to rise by more than 30% globally over the next decade, unless urgent steps are taken to reduce risk factors, including tobacco use and exposure, and other environmental

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

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factors.2 However, it has come to light in recent years that as many as 10% to 20% of patients with COPD have never smoked, indicating that genetic and environmental factors play a larger role than previously thought.1 Recent research also suggests that COPD may have a strong inflammatory and immune component.1 According to recent data from the Centers for Disease Control and Prevention, the prevalence of COPD has increased and now affects

>11.6% of people aged ≥65 years.6 For elderly patients with COPD, polypharmacy for multiple medical conditions may present challenges for COPD treatment adherence.7 In general, nonadher­ ence to COPD therapy, pharmacologic and nonpharmacologic, is com­ mon and may contribute to adverse health outcomes and higher healthcare costs.8 In ad­dition, underuse, overuse, and improper use of treatments contribute to suboptimal adherence

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Drug Update Table 1. Confirmatory Trial 1: Change from Baselinea in Weighted Mean FEV1 (0-4 Hours) and Trough FEV1 at 6 Months Weighted mean FEV1 (0-4 hours)b

Trough FEV1c

Difference from

Difference from

Placebo, mL

Fluticasone furoate 100 mcg, mL

Fluticasone furoate 200 mcg, mL

Breo Ellipta (fluticasone furoate 100 mcg/vilanterol 25 mcg) (N = 204)

214 (95% confidence interval, 161-266)

168 (95% confidence interval, 116-220)

Fluticasone furoate 200 mcg/vilanterol 25 mcg (N = 205)

209 (95% confidence interval, 157-261)

—

Treatment

Placebo, mL

Vilanterol 25 mcg, mL

—

144 (95% confidence interval, 91-197)

45 (95% confidence interval, –8-97)

168 (95% confidence interval, 117-219)

131 (95% confidence interval, 80-183)

32 (95% confidence interval, –19-83)

NOTE: Serial spirometric evaluations were performed predose and up to 4 hours after dosing. a Least squares mean change. b At day 168. c At day 169.

FEV1 indicates forced expiratory volume in 1 second.

Source: Breo Ellipta (fluticasone furoate/vilanterol) prescribing information; 2013.

to therapy for COPD.9 Adherence to treatments for COPD may be further complicated, given the chronic nature of COPD, the presence of comorbidities (ie, hypertension, diabetes, cardiovascular disease, lung cancer, and depression), the use of multiple medications, and periods of symptom remission.9,10 COPD is associated with substantial respiratory-related and total healthcare costs. In 2010, the total annual cost of COPD in the United States was an estimated $49.9 billion, of which $29.5 billion accounted for direct costs, $8 billion for indirect costs for associated morbidity, and $12.4 billion for indirect costs related to COPD mortality.4

46

COPD is frequently misdiagnosed and may go undetected for years.11 The early diagnosis and appropriate management of COPD are essential, because COPD may worsen over time. Effective management can help control symptoms, reduce the risk of exacerbations and complications, slow disease progression, and, in some cases, can improve a person’s ability to lead an active life.11 Therapeutic goals for COPD include prevent­ ing and treating exacerbations, reducing hospitalizations and mortality, relieving dyspnea that restricts activity, and increasing exercise tolerance and health-related quality of life.12 Smoking cessation is crucial for smokers with COPD.11

Pharmacologic treatments include bronchodilators (short-acting and long-acting), inhaled steroids, oral steroids, combination inhalers, phosphodiesterase-4 inhibitors, theophylline, and antibiotics. Other therapies include oxygen therapy and lifestyle changes.

Surgery may also be an option for some patients with severe disease who do not respond to other treatments.11

Breo Ellipta: A Fixed-Dose Combination Inhaler Approved for COPD On May 10, 2013, the US Food and Drug Administration (FDA) approved fluticasone furoate/vilanterol inhalation powder (Breo Ellipta;

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ April 2015

GlaxoSmithKline) as oral inhalation for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Fluticasone furoate/vilanterol is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Fluticasone furoate/ vilanterol is not indicated for the relief of acute bronchospasm or for the treatment of asthma, and is not recommended in patients younger than age 18 years.13,14 Curtis J. Rosebraugh, MD, MPH, Director, Office of Drug Evaluation II, Center for Drug Evaluation and Research at the FDA, stated, “The availability of new long-

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Drug Update Table 2. Confirmatory Trial 2: Change from Baselinea in Weighted Mean FEV1 (0-4 Hours) and Trough FEV1 at 6 Months

Treatment Breo Ellipta (fluticasone furoate 100 mcg/vilanterol 25 mcg) (N = 206)

Weighted mean FEV1 (0-4 hours)b

Trough FEV1c

Difference from

Difference from

Placebo, mL

Fluticasone furoate 100 mcg, mL

Fluticasone furoate 200 mcg, mL

173 (95% confidence interval, 123-224)

120 (95% confidence interval, 70-170)

—

Placebo, mL

Vilanterol 25 mcg, mL

115 (95% confidence interval, 60-169)

48 (95% confidence interval, –6-102)

NOTE: Serial spirometric evaluations were performed predose and up to 4 hours after dosing. a Least squares mean change. b At day 168. c At day 169.

FEV1 indicates forced expiratory volume in 1 second.

Source: Breo Ellipta (fluticasone furoate/vilanterol) prescribing information; 2013.

term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”13 The safety and efficacy of fluticasone furoate/ vilanterol were evaluated in studies that included 7700 patients with a clinical diagnosis of COPD.13 As part of the approval, the FDA required that fluticasone furoate/vilanterol be accompanied by a patient medication guide with instructions for use and information about the potential risks of taking the drug.13 The prescribing information for fluticasone furoate/vilanterol includes a Boxed Warning stating that long-­ acting beta-adrenergic agonists (LABAs), such as vilanterol, one of the ingredients in this combination, are associated with an increased risk of

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asthma-related death. It also states that the safety and efficacy of fluticasone furoate/vilanterol in patients with asthma have not been established, and that it is not indicated for the treatment of asthma.14

Mechanism of Action Fluticasone furoate/ vilanterol contains 2 different classes of drugs— fluticasone furoate, a synthetic trifluorinated corticosteroid, and vilanterol, a LABA. Each of these 2 drugs has a different mechanism of action.

Fluticasone Furoate Fluticasone furoate, a synthetic trifluorinated corticosteroid, has anti-inflammatory activity and has been shown in vitro to have a binding affinity for the glucocorticoid receptor that is approximately 29.9 times that of dexameth-

asone and 1.7 times that of fluticasone propionate.

The clinical relevance of these in vitro results is unknown.14 The precise mechanism through which flu­ ticasone furoate affects the symptoms of COPD is not known. Cortico­ steroids have been shown to have a wide range of actions on multiple cell types and mediators. In vitro and in vivo models have demonstrated specific effects of fluticasone furoate, including activation of the glucocorticoid response element, inhibition of proinflammatory transcription factors (eg, nuclear factorkappa beta), and inhibition of antigen-induced lung eosinophilia in sensitized rats.14

Vilanterol Inhalation Powder Vilanterol inhalation

powder was shown to have a functional selectivity similar to salmeterol based on in vitro tests.

The clinical relevance of this in vitro finding is unknown. The pharmacologic effects of beta2 adrenoceptor agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of aden­osine triphosphate to 3ʹ, 5ʹ-cyclic-adenosine monophosphate (cAMP).

Increased cAMP levels cause relaxation of bronchial smooth muscle and inhibition of the release of mediators of immediate hypersensitivity from cells, especially from mast cells.14

Dosing Fluticasone furoate/ vilanterol is indicated for oral inhalation only. The

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Drug Update recommended dosage for maintenance treatment of COPD is 1 inhalation of fluticasone furoate 100 mcg/vilanterol 25 mcg once daily.

The fluticasone furoate/vilanterol inhaler contains 2 double-foil blister strips of powder formulation for oral inhalation: one strip contains fluticasone furoate 100 mcg per blister, and the other contains vilanterol 25 mcg per blister.14

Clinical Studies The FDA approval of fluticasone furoate/vilanterol was based on 4 confirmatory trials (of 6- and 12-months’ duration), 3 active comparator trials (of 12 weeks’ duration), and dose-ranging trials of shorter duration.14 Findings from 2 of the confirmatory trials related to lung function are highlighted below. Of the 2254 patients enrolled in these 2 trials, 70% were male and 84% were Caucasian (mean age, 62 years), with an average smoking history of 44 pack-years; 54% of the patients were identified as current smokers. In these 2 trials, all treatments were administered as 1 inhalation once daily.14 Confirmatory Lung Function Trial 1 Trial 1 was a 24-week, randomized, double-blind,

FLUTICASONE FUROATE/ VILANTEROL WAS SHOWN TO IMPROVE LUNG FUNCTION AND REDUCE EXACERBATIONS COMPARED WITH PLACEBO IN SEVERAL CLINICAL TRIALS. placebo-controlled study that evaluated the efficacy of 2 strengths of fluticasone furoate/vilanterol on lung function in patients with COPD (Table 1).

In this study, fluticasone furoate/vilanterol demonstrated rapid and significant sustained improvement in forced expiratory volume in 1 second (FEV1) in patients with moderate-to-severe COPD, which was not influenced by the dose.14,15

Confirmatory Lung Function Trial 2 In trial 2, a 24-week, randomized, double-blind, placebo-controlled study, combination therapy with fluticasone furoate 100 mcg/vilanterol 25 mcg significantly improved the weighted mean FEV1 (173 mL) and trough FEV1

(115 mL) versus placebo (P <.001) in patients with moderate-to-severe COPD (Table 2).14,16 All treatments in this study were well-tolerated.16 Overall, fluticasone furoate 100 mcg/vilanterol 25 mcg resulted in a larger increase in the weighted mean FEV1 (from 0 hours to 4 hours) compared with placebo and with fluticasone furoate 100 mcg at day 168. At day 169, trials 1 and 2 showed a significant increase in trough FEV1 for all strengths of fluticasone furoate/vilanterol compared with placebo.14

Adverse Events and Contraindications The most common adverse reactions (incidence, ≥3%) associated with fluticasone furoate/ vilanterol are nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis.14 Fluticasone furoate/ vilanterol is contraindicated in patients with severe hypersensitivity to milk proteins or those who have demonstrated hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients.

Warnings and Precautions Fluticasone furoate/ vilanterol should not be initiated in patients during rapidly deteri-

orating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm, which should be treated with an inhaled, short-acting beta-2 agonist.14 Fluticasone furoate/ vilanterol should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, because an overdose may result.

Oropharyngeal candidiasis has occurred in patients treated with flu­ ticasone furoate/vilanterol. Patients should be monitored periodically and be advised to rinse the mouth without swallowing after inhalation of this agent to help reduce this risk of infection.

There is an increased risk for pneumonia in patients with COPD who are taking fluticasone furoate/vilanterol. Patients should be monitored for signs and symptoms of pneumonia.

Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.

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Drug Update There is an increased risk of impaired adrenal function when patients are transferred from systemic corticosteroids.

Patients should be tapered slowly from systemic corticosteroids when being transferred to fluticasone furoate/vilanterol.

Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, fluticasone furoate/vilanterol should be discontinued slowly.

Inhaled medications can produce paradoxical bronchospasm, which may be life-threatening.

Vilanterol, the LABA in the fluticasone furoate/ vilanterol combination, can produce clinically significant cardiovascular effects in some patients.

Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, as have glaucoma, increased intraocular pressure, and cataracts.

It is recommended that patients be monitored for decreased bone mineral

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density, glaucoma, and cataracts.

Fluticasone furoate/ vilanterol should be used with caution in patients with cardiovascular disorders, especially those with coronary insufficiency, cardiac arrhythmias, and hypertension, because of beta-adrenergic stimulation.

Caution should be exercised when considering the coadministration of fluticasone furoate/vilanterol with long-term ketoconazole and other known strong CYP3A4 inhibitors, because in­ creased systemic corticosteroid and cardiovascular adverse effects may occur.

Fluticasone furoate/ vilanterol should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

Clinicians should also be alert to hypokalemia and hyperglycemia.

Conclusion A new treatment option for COPD became available in May 2013 when fluticasone furoate/ vilanterol received FDA approval for the longterm, once-daily mainte-

nance treatment of airflow obstruction and for reducing exacerbations in patients with COPD. Breo Ellipta is a fixeddose combination of fluticasone furoate 100 mcg, an inhaled corticosteroid, and vilanterol 25 mcg, a LABA. Fluticasone furoate/ vilanterol was shown to improve lung function and reduce exacerbations compared with placebo in several clinical trials that included a total of 7700 patients with a clinical diagnosis of COPD. The most common adverse reactions reported with fluticasone furoate/vilanterol in clinical trials were naso­pharyngitis, upper respiratory tract infection, headache, and oral candidiasis. ❚

References

1. National Institutes of Health.

Chronic obstructive pulmonary disease (COPD). NIH Research Timeline fact sheet. Updated March 29, 2013. http://report.nih.gov/NIHfactsheets/ ViewFactSheet.aspx?csid=77. Ac­cessed June 19, 2013.

2. World Health Organization. Chronic obstructive pulmonary disease (COPD). Fact sheet. Updated November 2012. www.who.int/media centre/ factsheets/fs315/en/index.html. Ac­cessed June 20, 2013.

3. National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. February 2012. www.nhlbi.nih.gov/resources/

docs/2012_ChartBook.pdf. Accessed June 19, 2013.

4. American Lung Association.

Chronic obstructive pulmonary disease (COPD) fact sheet. February 2011. www.lung.org/lung-disease/copd/ resources/facts-figures/COPD-FactSheet.html. Accessed June 20, 2013.

5. National Heart, Lung, and Blood Institute. What is COPD? www.nhlbi. nih.gov/health/public/lung/copd/whatis-copd/index.htm. Accessed June 20, 2013.

6. Centers for Disease Control and Prevention (CDC). Chronic obstructive pulmonary disease among adults— United States, 2011. MMWR Morb Mortal Wkly Rep. 2012;61:938-943.

7. Hanania NA, Sharma G, Sharafkhaneh A. COPD in the elderly patient. Semin Respir Crit Care Med. 2010;31:596-606.

8. Bourbeau J, Bartlett SJ. Patient adherence in COPD. Thorax.

2008;63:831-838.

9. Restrepo RD, Alvarez MT, Wittnebel LD, et al. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis. 2008;3:371-384.

10. Crockett AJ, Price D. Co-morbid disease in COPD—more than a coincidence. Int J Chron Obstruct Pulmon Dis. 2007;2:399-400.

11. Mayo Clinic. COPD. February 1, 2013. www.mayoclinic.com/health/ copd/DS00916. Accessed June 20, 2013.

12. Armstrong C. Practice guidelines: ACP updates guideline on diagnosis and management of stable COPD. Am Fam Physician. 2012;85:204-205.

13. US Food and Drug Administration.

FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease.

Press release; May 10, 2013. www. fda.gov/News Events/Newsroom/ PressAnnouncements/ucm351664. htm. Accessed June 20, 2013.

14. Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; May 2013.

15. Martinez FJ, Boscia J, Feldman G, et al. Fluticasone furoate/vilanterol (100/25; 200/25 µg) improves lung function in COPD: a randomised trial.

Respir Med. 2013;107:550-559.

16. Kerwin EM, Scott-Wilson C, Sanford L, et al. A randomised trial of fluticasone furoate/vilanterol (50/25 µg; 100/25 µg) on lung function in COPD. Respir Med. 2013;107:560-569.

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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): • Corlanor (ivabradine) has been approved to reduce hospitalization of patients experiencing worsening heart failure. It is indicated for patients with symptoms of heart failure who are stable, who have a normal resting heart rate ≥70 beats per minute, and who are also taking beta-blockers at the highest dose tolerable.

• Gastric Emptying Breath Test (GEBT) is a noninvasive test to aid in the diagnosis of delayed gastric emptying (gastroparesis).

The test is conducted over a 4-hour period after an overnight fast, and is designed to show how fast the stomach empties solids by measuring carbon dioxide in patients’ breaths.

• KAMRA inlay is the first implantable device approved by the FDA for the correction of presbyopia in patients who have not had cataract surgery. It is implanted in the cornea of one eye to improve certain patients’ near vision.

New Generic The following is a recent first-time generic drug approval by the FDA:

• The first generic version of Copaxone (glatiramer acetate injection) has been approved to treat patients with relapsing forms of multiple sclerosis. Sandoz received FDA approval to market generic glatiramer acetate in 20mg/mL daily injections. The most common adverse reactions reported in clinical trials for Copaxone included skin problems at the injection site (eg, redness, pain, swelling, and itching); flushing (vasodilation); rash; shortness of breath; and chest pain.

New Rulings, Announcements The following are some recent FDA rulings and announcements: • The FDA has issued a warning urging healthcare professionals and patients to not use products made and distributed by the Prescription Center pharmacy (915 Hay St, Fayetteville, NC). State inspectors observed significant deficiencies raising concerns about the company’s ability to assure the sterility, stability, and potency of their sterile and non sterile products. Healthcare professionals should check their medical supplies, quarantine any drug products from this company, and should not administer them to patients.

• US Marshals seized unapproved prescription drug products valued at >$1.5 million from Stratus Pharmaceuticals, Inc, in Miami, FL. The company marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc, Carlstadt, NJ. Pharmacists and healthcare professionals should be able to consult with patients about discontinuing their use and identifying alternative treatment options.

• The FDA has issued a warning to stop using Tri-Methyl Xtreme, a dietary supplement for muscle growth that has been linked to serious liver injury. The product was distributed by Extreme Products Group, Las Vegas, NV, and claims to contain anabolic steroids; it is sold on the Internet and some retail stores and gyms.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA. ❚ Sources: (1) Food and Drug Administration. New and generic drug approvals. www.fda.gov/Drugs/ NewsEvents/ucm130961.htm. Updated April 20, 2015. Accessed April 22, 2015; (2) US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/Newsroom/Press Announcements/default.htm. Updated April 21, 2015. Accessed April 22, 2015.

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