IPC Jan 2015, Vol 3, No 1

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PEDIATRIC

January 2015 VOL. 3 • NO. 1

20 Pertussis

Update

31 Five Tips

Health

to Prevent Childhood Obesity

35 Integrating

Behavioral Health into Retail Clinics

43 Clinical Challenge:

Polypharmacy

CE AVAILABLE PAGE 24

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Providing Care for Medically Complex Children with Special Healthcare Needs PAGE 13

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PHARMACY & CLINICS

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

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

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

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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

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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.

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PHARMACY & CLINICS

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.

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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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TRANSFORMING RETAIL PHARMACIES INTO HEALTHCARE DELIVERY COMPANIES

January 2015

TM

Volume 3 Number 1

PHARMACY & CLINICS

INSIDE

Pediatric Health

PEDIATRIC

COLUMNS

Health

17 CONSIDERATIONS WHEN DIAGNOSING, TREATING, AND CARING FOR SLEEP PROBLEMS IN CHILDREN WITH ADHD

PAGE

11

THE FIRST WORD

Donald J. Dietz, RPh, MS

It is key for community pharmacists and retail clinicians to understand the concerns of caregivers.

New Year’s Resolution: Improved Patient Care

20 PERTUSSIS UPDATE: PRACTICAL TIPS FOR PHARMACISTS AND PROVIDERS

2 CALL FOR SUBMISSIONS

Every clinician has the opportunity to be an important immunization resource.

6 EDITORIAL BOARD

Patient Care

23 INSIDE PATIENT CARE ONLINE

7 FROM THE TRENCHES 9 LETTER FROM THE EDITOR

31 FIVE TIPS TO PREVENT CHILDHOOD OBESITY

STARTS

It is important to educate patients and their caregivers about potential tips to improve their health.

33 SLE AND PREGNANCY: CONSIDERATIONS IN THE CARE OF HIGH-RISK POPULATIONS Healthcare professionals should be aware of issues related to systemic lupus erythematosus (SLE) in pregnancy.

35 INTEGRATING BEHAVIORAL HEALTH INTO RETAIL CLINICS

13

ON PAGE

Providing Care for Medically Complex Children with Special Healthcare Needs Understanding special considerations

❚

An overview of the symptoms, etiology, and treatment options for hiccups.

How to assess medication regimens in this patient population

❚

How to face the challenges in dispensing medications

The Pharmacy

❚

Educating patients and their caregivers

36 HICCUPS

39 QUESTIONS ANSWERED: PHARMACISTS ARE KEY TO ACHIEVING VALUE-BASED CARE 43 CLINICAL CHALLENGE: POLYPHARMACY

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46 DRUG UPDATE

COVER STORY I PEDIATRIC HEALTH

❚

There is a need for preventive services, especially in the emerging retail clinic market, to include behavioral health services.

24 FREE CE ACTIVITY

+

MORE ONLINE

Visit Inside Patient Care: Pharmacy & Clinics online

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.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

5

the Editorial Board

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

“ PAGE 11

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

6

We need to be aware of signs that

the product or service cost may be an issue for patients.”

—Donald J. Dietz, RPh, MS

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

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

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

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

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

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

Albert Garcia Executive Vice President Navarro Health Services Medley, FL

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

Kevin James, RPh, MBA Vice President, Payer Strategy US Bioservices AmerisourceBergen Phoenix, AZ

Alexandra Jung Principal, Advisory Services, Ernst & Young, LLP; former Senior Vice President, Corporate Strategy, Walgreens

Jack Kelly, RPh Chief Business Development Officer, Pharmacist Partners, CKO

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

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

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

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

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

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

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

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

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

ask us Have a question for our board members? E-mail your question to fevans@the-lynx-group.com

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from the

Trenches ”

“

To maintain a collection receptacle where ultimate users

can deposit their unwanted controlled medications, the retail pharmacy must first register as an authorized collector, not a reverse distributor.”

Authorized Collector versus Reverse Distributor To the Editor We appreciate the editorial published in Inside Patient Care: Pharmacy & Clinics pertaining to the role of retail pharmacy in controlled substance take-back programs.1 However, we believe that the assertion that retail pharmacies will have to register as reverse distributors in order to accept controlled substances is incorrect.

If a retail pharmacy maintains a collection receptacle where ultimate users can deposit their unwanted controlled medications, the retail pharmacy is not a reverse distributor, but rather an authorized collector.2 The distinction is important.

A retail pharmacy seeking to be an authorized collector needs to modify its Drug Enforcement Administration (DEA) registration. Once the registration is modified, the DEA Certificate of Registration (DEA Form 223) can be printed out and will indicate the words “retail pharmacy-collector” in the “business activity” section (see 1317.30 and 1317.40).2 A retail pharmacy that becomes an authorized collector is permitted to maintain a collection receptacle for con-

InsidePatientCare.com

Thomas McAbee, SOUTHAMPTON, NY

trolled and noncontrolled medications from ultimate users, but not from other DEA registrants (see 1317.40[c][2]).

A reverse distributor is a DEA registrant that is authorized to accept controlled substances from other DEA registrants. Therein lies the distinction: collected from ultimate users versus other DEA registrants (see 1317.15[a], which states “or otherwise authorized pursuant to this chapter”).2 A pharmacy is “otherwise authorized pursuant to” 1317.30, and therefore, a pharmacy is not required to register as a reverse distributor.

The distinction between an authorized collector and a reverse distributor is emphatically pronounced in their respective fees. A retail pharmacy now needs to pay a 3-year fee of $731 to be an authorized collector, whereas the fee to be a reverse distributor is $1523 annually. The Secure and Responsible Drug Disposal Act of 2010 and the DEA’s regulations prohibit the DEA from charging increased fees to register as an authorized collector.3 Requiring a retail pharmacy to register as a reverse distributor would violate the Secure and Responsible Drug Disposal Act of 2010.

Because the regulations are new

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

7

from the Trenches

“

This distinction is important not only

because it affects which forms need to be filed with the DEA, but also because it results in the reduced fees associated with being recognized as an authorized collector.”

Transforming Retail Pharmacies into Healthcare Delivery Companies

Pharmacists • Chain Headquarters • Independents • Physician Assistants • Nurse Practitioners InsidePharmacyOnline.com

October 2014 VOL. 2 • NO. 5

CARDIOMETABOLIC

8 Pharmacy Role

in Controlled Substance TakeBack Programs

19 Retail Health

Provides Access for General Primary Care Needs

Health Prediabetes: Practical Information for Retail Clinicians, Patient Education, and Type 2 Diabetes Prevention PAGE 10

29 Identifying

Accurate and Useful Information on Drug–Grapefruit Juice Interactions

40 Europay/

MasterCard/Visa Migration Status

DONALD J. DIETZ, RPH, MS, EDITOR-IN-CHIEF

© 2014 Novellus Healthcare Communications, LLC an affiliate of

CPE AVAILABLE PAGE 24

and somewhat “thick,” we are all going through a learning curve that will take some time to overcome. Southrifty Drug was the first retail pharmacy in the United States to register as an authorized collector on October 9, 2014.

Thomas McAbee EXECUTIVE DIRECTOR LLOYD MAGOTHY WATER TRUST, INC

References

TELL US

fevans@the-lynx-group.com Or mail to: Letters to the Editor Inside Patient Care: Pharmacy & Clinics 1249 South River Road Suite 202A Cranbury, NJ 08512 Letters may be edited for length and style. Unless you specify otherwise, we will assume your letter is for publication. Submission of a letter or e-mail constitutes permission of Inside Patient Care: Pharmacy & Clinics, its licensees, and its assignees to use it in the journal’s various print and electronic publications and in collections, revisions, and any other form of media.

8

1. Dietz D. Pharmacy role in controlled substance take-back programs. Inside Pharmacy. 2014;2(5):8-9.

2. US Department of Justice, Drug Enforcement Admini­ stration. Rules 2012: Disposal of Controlled Substances. www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8. htm. Accessed January 7, 2015.

3. Drug Enforcement Administration. Secure and Responsible Drug Disposal Act of 2010. www.deadiversion.usdoj.gov/ drug_disposal/non_registrant/s_3397.pdf. Accessed January 7, 2015.

In Reply I thank Mr McAbee for his comments regarding my editorial on the role of pharmacy in controlled substance take-back programs, including the proper Drug Enforcement Administration (DEA) registration process for pharmacies to accept controlled substances with the intent of destruction.

Pharmacies interested in participating as a site to collect controlled and noncontrolled medication from users (not other DEA registrants) will need to modify their DEA registration to become an authorized collector. As long as the pharmacy is not collecting controlled substances from other DEA registrants, only from ultimate users, the

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

pharmacy will not need to register as a reverse distributor.

This distinction is important not only because it affects which forms need to be filed with the DEA, but also because it results in the reduced fees associated with being an authorized collector. A pharmacy registered as an authorized collector will pay a 3-year fee of $731, versus the annual $1523 fee as a reverse distributor. With an annual fee of less than $250, the financial outlay is considerably less than a reverse distributor. Our hope is that this lessens the barrier for pharmacies considering participation.

Pharmacies will also need to consider new security procedures and training of employees when becoming an authorized collector to take back controlled substances from consumers. To cover certain costs, funding for Southrifty Drug as the first authorized collector was sponsored by the Southampton Business Alliance.

Inside Patient Care: Pharmacy & Clinics always welcomes feedback from readers and will receive submissions pertaining to this topic as well as any other comments from readers regarding other topics published in the issue.

Donald J. Dietz, RPh, MS EDITOR-IN-CHIEF, INSIDE PATIENT CARE: PHARMACY & CLINICS VICE PRESIDENT OF PHARMACY HEALTHCARE SOLUTIONS, INC

InsidePatientCare.com

Letter from the Editor Striving for Success in Patient Care and Business Growth

by FREDERIQUE H. EVANS, MBS, Editorial Director

The new year brings new opportunities for self-improvement and growth, and Inside Patient Care: Pharmacy & Clinics... }} }} WILL CONTINUE TO provide resources for the entire healthcare team as it relates to improving patient care and your business model.

In its third year, the contributors, the editorial board, and staff of Inside Patient Care: Pharmacy & Clinics will continue to provide practical information for the entire healthcare team.

Our goal is to provide the resources that you need to implement the best therapeutic options, navigate the healthcare system, and achieve professional success.

The theme of our January issue is pediatric health, and it includes articles from different stakeholders of the publication. Stacie Lampkin, PharmD, BCAP, AE-C, Assistant Professor, D’Youville College School of Pharmacy, Women and Children’s Hospital of Buffalo, NY, discusses providing care for medically complex children with special healthcare needs (see page 13). Natalie Drummond, MD, and Marc Drummond, PsyD, MBA, discuss considerations when diagnosing, treating, and caring for sleep problems in children with attention-deficit/hyperactivity disorder (see page 17), in addition to a pertussis update with practical tips for pharmacists and providers by Kim Curry,

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PhD, ARNP-C, Clinical Associate Professor, College of Nursing, Uni­ versity of Florida, Gainesville, (see page 20).

Put your knowledge to the test and solve the clinical challenge on polypharmacy.

As part of Inside Patient Care, Deanna Owens, MSN, RN, Director of the Infusion and Clinical Services, Low Country Rheumatology, Charles, SC, and member of the Board of Directors of the Rheumatology Nurses Society, discusses special considerations in the care of pregnant patients with lupus (see page 33). The section also includes insight from Joe Pyle, MA, President of the Thomas Scattergood Behavioral Health Foundation in Philadelphia, PA, who talks about how to integrate behavioral health into retail clinics (see page 35), and Joseph Bubalo, PharmD,

BCPS, BCOP, who provides a symptom overview of hiccups, including its etiology and treatment options (see page 36).

Inside the Retail Pharmacy, Robert Thompson, Executive Vice President of Pharmacy at Rite Aid, takes the time to discuss his responsibilities, as well as the evolution of pharmacies and innovative services currently available at Rite Aid (see page 39). In addition, we are pleased to provide the clinical challenge, including a commentary on the appropriate course of action (see page 43). Put your knowledge to the test and determine how you would have cared for the patient.

This issue also includes a free continuing education activity pertaining to the evolution of value-based care of rheumatologic diseases: a prospectus for managed care pharmacists (see page 24), as well as a letter to the editor (see page 7) regarding an editorial published in a previous issue. We welcome our readers’ feedback and hope you will take the time to send us comments on the articles in this issue.

We thank our editorial board and contributors for their continued efforts in 2015, and wish the readers of Inside Patient Care: Pharmacy & Clinics all the best for the new year. ❚

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

9

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RETAIL SFORMING

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The First Word New Year’s Resolution: Improved Patient Care

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

“

As we start the new calendar year, many

patients have new insurance coverage, changes to their existing insurance coverage, or an annual deductible that is reset in January.”

I

was surprised to read that according to recent data from the US Department of Labor, the average hourly wage per worker in the United States is less than $20 per hour, with approximately 50% of Americans earning less.1 As healthcare professionals, we are fortunate to have chosen a profession with pay rates in the top 5% of the hourly wage chart. We have been blessed with the ability to complete our education as a pharmacist, physician’s assistant, or nurse practitioner, be employed, and earn salaries at the top end of the wage scale.

Value-Based Care Based on our practice setting and location, many of us have clientele who mirror the US Department of Labor statistics or are below these wages. As we start the new calendar year, many patients have new insurance coverage, changes to their existing insurance coverage, or an annual deductible that is reset in January. For the 50% of wage earners who make under $20 per hour, this

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5 factors to consider: ❚ Patients’ financial circumstances ❚ Cost-friendly treatment options ❚ The deductible phase of insurance coverage ❚ Financial assistance programs ❚ Understanding patients’ clinical and financial needs

can impact their healthcare choices and treatment options in a variety of ways, leading to the following questions: • Is it worth it to seek medical help for an ailment knowing how much it will cost?

• Should I get this brand prescription filled, or can I go without it?

• Is there a generic or lower cost alternative for this medication?

• I am in the deductible phase of

my insurance coverage, how much will this cost?

All too often we first think clinically about the best treatment option for a particular patient. We need to be aware of signs that the product or service cost may be an issue for patients, especially early in the calendar year because of deductibles and the burden of paying off holiday bills.

Overcoming Barriers to Care and Compliance What can we do as healthcare professionals? If a patient needs an expensive brand prescription product, consider manufacturer-offered financial assistance programs, or copay cards that may reduce their out-of-pocket costs. If a generic medication is prescribed, does your pharmacy offer a discount program that could help your patient save money on the prescription? If an over-thecounter (OTC) product is needed, it is important for healthcare professionals to understand patient symptoms, comorbidities, allergies, and other medications currently being

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

11

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

“

The First Word

Retail pharmacies and clinics are quickly becoming an used. Suggest the best OTC product both clinically and is alsocare. important extension of It primary Inside Patientpatients’ Care:needs, Pharmacy available, and if it is available in a financially. Where possible, seek to private label & version at a lower price to to identifyoftreatment options they can Clinics is tailored meet the the entire validate thatgrowing the needs point, consider offering that option afford. In the early months of 2015, healthcare team provides practical information to treat to your patient.

It is a good idea to and consider focusing more on this conpatient is adherent offer choicesand to patients that patients they as more patients ” are in the caresofor inside the pharmacy andcern, retail clinics. are aware of different options at various price points.

It is also important to validate that the patient is adherent with their currently prescribed products.

Medication cost is one of the many reasons patients are noncompliant.

If the patient is asymptomatic, such as a patient with hypertension or elevated cholesterol, it is especially important to educate them on the benefits of remaining compliant

with their currently prescribed products.

deductible phase of their insurance coverage. ❚ Donald J. Dietz, RPh, MS Vice President Reference

1. US Healthcare Department of Labor. Wage Pharmacy Solutions, Inc.and hour division (WHD): minimum wage laws in the states–January Editor-in-Chief 2015. Care www.dol.gov/whd/minwage/america.htm.

Inside1,Patient

with their prescribed medications. In many situations, medication adherence is the lowest cost option for treating a chronic illness.

The take away message is that it is important to keep in mind your

Updated December 2014. Accessed January 5, 2015.

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

TRANSFORMING RETAIL PHARMACIES INTO HEALTHCARE DELIVERY COMPANIES TM

PHARMACY & CLINICS 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—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.

12

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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InsidePatientCare.com

INSIDE

SLEEP Sleep problems in children with ADHD [17]

Pediatric Health

PERTUSSIS UPDATE Practical tips for pharmacists and providers [20]

Cover Story

Providing Care for Medically Complex Children with Special Healthcare Needs

by STACIE LAMPKIN, PHARMD, BCACP, AE-C

Medically complex children with special healthcare needs (CSHCN) are often described as having at least 1 chronic condition resulting in high family-identified service needs, }} }} FUNCTIONAL LIMITATIONS, which usually require medical equipment, functional disabilities, the involvement of multiple subspecialists, and increased use of healthcare services.1,2 This subgroup consists of patients with multiple diagnoses such as neuromuscular disorders, cardiac conditions, congenital or genetic defects, mental retardation, emotional problems, seizure disorders, autism, and cerebral palsy.1,3 Approximately 69% of these patients require technology assistance, such as a gastrostomy tube, cerebrospinal fluid shunt, and tracheostomy tube, that could impact medication delivery.3 In addition, CSHCN are frequently taking 8 to 10 prescription medications, and this number increases to approximately 20 as medical complexity increases.4-6 These children require high levels of specialized care and sub-

InsidePatientCare.com

stantially influence healthcare expenditures, even though they only make up 0.4% of all children in the United States.1,4 Currently, there are no studies assessing the impact of community pharmacists on medically complex CSHCN, but because of their numerous medications and complexity of care, it is logical that pharmacists can substantially impact these children and their families. Community pharmacists and retail clinicians can play an essential role in centralizing care and should strive to provide all medications for CSHCN, as these patients often have multiple providers prescribing medications. However, when encountering medically complex CSHCN, pharmacists and retail clinicians must be aware and willing to take on the challenges of assessing, dispensing, and counseling

KEY POINTS ❚ Pharmacists need to be aware of the numerous burdens faced by caregivers and be able to address varying medication challenges ❚ Medically complex CSHCN often have numerous specialists providing services and prescribing medications, and pharmacists can help centralize their care ❚ Assessing and providing medications for medically complex CSHCN require the attention to additional considerations

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

13

Inside Pediatric Health on uncommon medication regimens for less common disease states.

Unfortunately, a survey of pharmacists found that the less common a condition, the more likely pharmacists were to respond that they did not believe they had the knowledge and expertise to make recommendations for that condition.7

It is necessary to understand how the child’s disease states and medical equipment can impact medication pharmacokinetics and dosing.

Assessing Medication Regimens Assessing medications—prescrip­tion, herbal, or over-the-counter (OTC)— for medically complex CSHCN is similar to assessing those of the general pediatric population, but requires additional attention and considerations.8,9 This subgroup of the population is at increased risk for adverse drug events and medication errors because of the unique medication regimens used to treat multiple comorbid conditions, differences in pharmacokinetics, weight or body surface area impacting patient-specific dosing calculations, variations in delivery methods, and off-label medication use.8-11 The goal of assessment should be to determine the appropriate medication use with maximal benefits and decreased side effects.

It is necessary to understand how the child’s disease states and medical equipment can impact medication pharmacokinetics and dosing. For example, if a patient has medication administered via the jejunal part of a gastrojejunostomy tube in the small intestine, medications that are absorbed in the stomach will have minimal to no effect.12 With regard to dosing considerations, obtaining an accurate weight and calculating weight-based dosing is of the utmost

14

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

importance.8-11 A recent survey of community pharmacists found that it was uncommon for weight-based doses to be checked for appropriateness, and even more uncommon for a patient’s weight to be obtained if it is not provided.10 This result is alarming: if a weight is not provided, a standard weight for that age and gender should never be assumed.

A portion of medically complex CSHCN—such as premature infants or children who do not thrive—may fall outside the average weight range for their age or gender. Furthermore, older teenagers with various syndromes or genetic anomalies may still use pediatric weight-based dosing, even though most older teenagers typically reach adult dosing. Another important consideration is checking for drug interactions, therapeutic duplications, and omissions.

Above and beyond their primary care providers, these children see numerous specialists and transition through various healthcare settings, such as during emergency department visits or inpatient hospitalizations, which may alter medication regimens.13

Challenges for Dispensing Medications Pediatric patients often require medications that must be extemporaneously compounded by a pharmacist if a suitable formulation is not available.8,9 This is especially true for medically complex CSHCN, because they often have additional factors impacting medication administration such as gastrostomy tubes, or disorders that make medication administration difficult.

Unfortunately, several medication dosage forms are not readily compounded by community pharmacies, despite the fact that these recipes have stability data that can be found in references such as the Pediatric & Neonatal Dosage Handbook14 or Pediatric Drug Formulations.15 Pharmacies that do provide a specific medication may require caregivers to obtain them at multiple locations. This, combined with the

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Inside Pediatric Health involvement of multiple prescribers, would make it difficult to assess medication regimens as described above.

Therefore, it would be in the best interest of the child for the pharmacist to find innovative ways to aid caregivers in obtaining needed medications at 1 location. An added benefit is that “parents who need such specialized services will drive long distances to patronize the pharmacy, creating a loyal base of customers who tend to use the pharmacy repeatedly for many years,” according to researchers.9 Two other dispensing-related considerations are ensuring that medications are labeled for use in school, and helping families obtain OTC products.

Frequently, medically complex CSHCN require supplements or OTC products.

Prescribers may be unaware whether a medication is covered by insurance or if there is a high cost associated with a specific product. Families of patients in this subgroup already have high financial burdens, so it would be beneficial to help find and recommend the cheapest alternatives.1

Counseling Considerations Counseling and education should be directed toward both the child and their caregiver. Generally, it is recommended to tailor information to the developmental stage of the child.8,9 Although this holds true for medically complex CSHCN, most of these children have developmental delays. Therefore, know­ ing the child’s cognitive function and establishing rapport with the family will help determine how to provide education and counseling to meet the family’s needs.

All counseling sessions should first assess the family’s understanding of the purpose of the medication.16 Medications are commonly prescribed off-label or for less common uses. It would be disconcerting to counsel a family about a medication for an indication that the child does not exhibit. For instance, clonidine, which is typically a

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blood pressure medication, may be used to treat sleep or behavioral disturbances such as aggression. When discussing side effects, be aware that medically complex CSHCN will likely be unable to communicate signs and symptoms associated with an adverse effect. Thus, education should include methods to monitor side effects in an effort to prevent concerned caregivers from avoiding a needed medication.

Lastly, medication administration errors by caregivers are common.11 For that reason, it is important to provide proper education on administration techniques and appropriate measuring devices to caregivers and children.8,9 Administration techniques may vary depending on the location of administration and dosage form. If a child is to receive a capsule through a gastrostomy tube, it would be essential to ensure a caregiver is comfortable opening up the capsule, mixing it in with the recommended amount of water, and drawing the mixture up into a syringe for proper administration.

All counseling sessions should first assess the family’s understanding of the purpose of the medication.

Closing Remarks Based on experience working with this population, participating in the care of medically complex CSHCN is not easy. In addition to the factors discussed, it may be difficult to find required and comprehensive information in standard pharmacy references and medication databases. As medication experts, it is recommended to consider and become well informed about alternative uses for medications prior to consulting with the prescribing physician. Community pharmacists may also be relied on to provide recommendations, especially in cases where

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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Inside Pediatric Health STAKEHOLDER PERSPECTIVE A REWARDING CHALLENGE Amanda Persaud, MD, Jeffrey Yu, MD, PhD, and Tammy Tempfer, CPNP, MSN, comment on providing care for medically complex children with special healthcare needs Dr Lampkin's article is thorough in explaining the challenges faced by pharmacists when filling medications for medically complex children with special healthcare needs. The same is true for the physician when tasked with prescribing medications for various medical conditions in one patient— trying to limit adverse effects while maximizing the patient's health. It is evident that the partnership between physician and pharmacist is a vital one, with both relying on each other's expertise to reach the common goal of enhancing care for our patients and their families.

Dr Persaud and Dr Yu are Pediatricians, Women & Children’s Hospital of Buffalo, Buffalo, NY; Dr Tempfer is a Nurse Practitioner, University at Buffalo, Buffalo, NY.

Dr Lampkin is an Assistant Professor, D’Youville College School of Pharmacy, Clinical Pediatric Ambulatory Care Pharmacist, Women and Children’s Hospital of Buffalo, NY.

alternative medication delivery routes are required.

Nevertheless, being involved with medication assessment, dispensing, and counseling for medically complex CSHCN is a necessary undertaking for pharmacists, as families of this subgroup have a high care burden, numerous unmet needs, and immeasurable day-to-day challenges.1,17 Unmet needs that have been reported include dental care, therapy services, genetic counseling, home health services, and medications.1,17 Community pharmacists and retail clinics can positively impact this unmet need, and the reward will be enhanced care for the patient and immense appreciation from the child with medically complex healthcare needs and his or her family. ❚

References

1. Kuo DZ, Cohen E, Agrawal R, et al. A national profile of caregiver challenges among more medically complex children with special health care needs. Arch Pediatr Adolesc Med. 2011;165:1020-1026.

2. Cohen E, Kuo DZ, Agrawal R, et al. Children with medical complexity: an emerging population for clinical and research initiatives. Pediatrics. 2011;127:529-538.

3. Berry JG, Agrawal R, Kuo DZ, et al. Characteristics of hospitalizations for patients who use a structured clinical care program for children with medical complexity. J Pediatr. 2011;159:284-290.

4. Newacheck PW, Kim SE. A national profile of health care utilization and expenditures for children with special health care needs. Arch Pediatr Adolesc Med. 2005;159:10-17.

5. Fiks AG, Mayne S, Localio AR, et al. Shared decision-making and health care expenditures among children with special health care needs. Pediatrics. 2012;129:99-107.

6. Mathematica Policy Research, Inc. Prescription drugs for children with special health care needs in commercial managed care: patterns of use and cost, 1999-2001. www.mathematica-mpr.com/~/media/publications/PDFs/prescription. pdf. Published January 2004. Accessed October 29, 2014.

7. Munzenberger PJ, Thomas RL, Edwin SB, et al.

Pharmacists’ perceived knowledge and expertise in selected pediatric topics. J Pediatr Pharmacol Ther. 2011;16:47-54.

8. Benavides S, Huynh D, Morgan J, et al. Approach to the pediatric prescription in a community pharmacy. J Pediatr Pharmacol Ther. 2011;16:298-307.

9. Dundee FD, Dundee DM, Noday DM. Pediatric counseling and medication management services: opportunities for community pharmacists. J Am Pharm Assoc. 2002;42:556-566.

10. Condren ME, Desselle SP. The fate of pediatric prescriptions in community pharmacies [published online ahead of print September 3, 2013]. J Patient Saf. doi:10.1097/ PTS.0b013e3182948a7d.

11. Agency for Healthcare Research and Quality. Patient Safety Primers: Medication Errors. http://psnet.ahrq. gov/primer.aspx?primerID=23. Updated October 2012.

Accessed October 29, 2014.

12. Williams NT. Medication administration through enteral feeding tubes. Am J Health Syst Pharm. 2008;65:23472357.

13. Stone BL, Boehme S, Mundorff MB, et al. Hospital admission medication reconciliation in medically complex children: an observational study. Arch Dis Child.

2010;95:250-255.

14. Taketomo CK, Hodding JH, Kraus DM. Pediatric & Neonatal Dosage Handbook. 21st ed. Hudson, OH: LexiComp, Inc; 2014-2015.

15. Nahata MC, Pai VB, Hipple TF. Pediatric Drug Formulations. 5th ed. Cincinnati, OH: Harvey Whitney Books; 2004.

16. American Pharmacists Association. The art of patient counseling 2015. www.pharmacist.com/sites/default/files/ files/2015%20NPCC%20Booklet.pdf. Accessed October 29, 2014.

17. Miller JE, Nugent CN, Gaboda D, et al. Reasons for unmet need for child and family health services among children with special health care needs with and without medical homes. PLoS One. 2013;8:e82570.

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Considerations When Diagnosing, Treating, and Caring for Sleep Problems in Children with ADHD

by NATALIE DRUMMOND, MD, and MARC DRUMMOND, PsyD, MBA

In clinical practice, sleep concerns associated with the use of stimulant medications for attention-deficit/ hyperactivity disorder (ADHD) are common. }} }} PARENTS HAVE NUMEROUS concerns regarding the quantity and quality of their child’s sleep, as well as the known side effects of ADHD medications that interfere with sleep initiation and maintenance. It is key for community pharmacists and retail clinicians to understand these concerns and be able to address questions about possible solutions.

Diagnosis The first concern expressed by parents and treating professionals when faced with iatrogenic sleep disturbances is the inappropriate overuse and reliance on stimulant medication in children who have not undergone a thorough diagnostic regimen.

In a recent article published in Pediatrics, investigators reported that 93% of patients with ADHD are prescribed medication only and not offered other treatment options.1 The study also revealed that only one third of healthcare providers diagnosing the disorder are following criteria outlined in

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the Diagnostic and Statistical Manual of Mental Disorders.

The overreliance on nonspecific questionnaires by these healthcare providers results in many false positives, and cannot be used solely to make the diagnosis.

Some of the other psychological conditions that mimic ADHD symptoms include anxiety, depression, learning disabilities, and spectrum disorders.1 Psychological testing under the supervision of a trained psychologist or physician consists of 6 to 8 hours total, usually in multiple sessions using standardized tests to ensure that a true executive function disorder exists. A concurrent medical evaluation to rule out medical diagnoses that can mimic ADHD symptoms should be completed. Organic sleep disorders, including restless legs syndrome, sleep apnea, and neurologic diseases such as epilepsy and developmental abnormalities, should be ruled out. A multidisciplinary team of both medical and psychological providers is vital to a proper diagnosis.

KEY POINTS ❚ The most common overthe-counter medications for ADHD include antihistamines and melatonin ❚ It is important for patients to have a standard sleep ritual; consistent bedtimes and waking times may be helpful

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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Inside Pediatric Health Treatment Physicians have limited options when asked to help with sleep problems. Many parents are reluctant to give their children a prescription for a sleep disorder in addition to ADHD medication. The most common over-the-counter medications offered include antihistamines, melatonin, and lavender essential oilbased products.

Parents who choose a first-generation antihistamine for their children may be unaware that they cause significant performance deficits, including attention, vigilance, working memory, and speed, the following day.2 The antagonism between medications results in a treatment quagmire: use of an antihistamine helps with sleep initiation, but quality of sleep is poor, causing deficits in function the following day.

Many parents are reluctant to give their children a prescription for a sleep disorder in addition to ADHD medication.

Melatonin has been used heavily in adults and pediatric patients with sleep and iatrogenic issues. Most common dosages of melatonin available in pharmacies are too high as a starting dose for pediatric and geriatric patients (3-10 mg). The human body normally produces <0.3 mg of melatonin per day and is sensitive to exogenous suppression.

Although high doses of melatonin can be effective, it can perpetuate disrupted sleep by suppressing endogenous melatonin production through feedback inhibition and carry a higher risk of side effects. High doses of melatonin can also cause derangement of non-rapid eye movement sleep, leading to nightmares and night terrors in chronically sleep-deprived children; a few cases of seizures in neurologically compromised children have been documented.3 The pediatric

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INSIDE PATIENT CARE: PHARMACY & CLINICS â?&#x161; January 2015

and geriatric recommended dosage is 0.5 to 1 mg nightly, which can be difficult to locate in retail pharmacies.4 At the recommended dose of 0.5 mg, melatonin stimulates rather than suppresses the pineal gland to create more melatonin to aid in the restructuring of the sleep cycle.

Iron deficiency, specifically low serum ferritin, has been implicated in children with ADHD and impaired sleep. Serum concentrations of <45 Âľg/L have been associated with abnormal movements in sleep, including restless legs and sleepwake transition disorders in patients with ADHD.5 A simple blood test and replacement with elemental or heightened dietary iron has been helpful to achieve desired serum ferritin levels and re-establish normal sleep-wake cycles.

Other Options to Consider Essential oils are becoming very popular, and various oils have been shown to have calming effects in children.

Chamomile, ylang ylang, and lavender have a long history of inducing sleep.6 Chamomile flowers can be steeped for a pleasant tasting tea, and essential oils such as lavender can be diffused to help create an atmosphere conducive to sleep. Concerns regarding the androgenic effects of lavender have made diffusion the delivery method of choice in pediatric patients.7 Other herbal preparations used in adults have limited efficacy data and, to our knowledge, no safety data in children. Valerian and hops have been used for centuries but their effectiveness as sleep aids has not been validated.8 However, a meta-analysis evaluating the usefulness of the valerian root concluded that valerian could improve the quality of sleep without side effects.9 The challenge with these alternative treatment options, compared with pharmacologic preparations, is that not a great deal of consistent research or standardized products are available. One systematic review concluded that valerian was safe but not clinically efficacious for insomnia.10 Kava has also been used as a sleep

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Inside Pediatric Health aid, although most of the research pertains to its use as an anxiolytic with actions similar to those of benzodiazepines.11 Although not mediated through the benzodiazepine binding site on the GABA receptor, kava may act on limbic structures, promoting anxiolysis without sedation. There have been reports of liver damage and failure from hepatotoxicity in individuals who used kava-based products or supplements, making practitioners wary of its use.11

Known Triggers of Sleep Disorders There are numerous studies indicating that the blue light given off from the screens of common devices such as iPods, computers, and televisions simulates daylight, which confuses the pineal gland and throws off the natural sleep cycle.12 In children who are experiencing sleep problems, it is recommended that all screen time be cut off 2 hours before their expected bedtime.13 In older children where educational requirements necessitate computer use, there are programs available that naturally dim computer screens to avoid pineal interference, as well as blue light–blocking glasses and screen filters.14 The growing popularity of energy drinks has increased their availability to children and led to increased use in the teenage population.15 Counseling patients regarding their daily caffeine intake and caffeine use within the last few hours before going to sleep are an integral part of treatment for insomnia.

Mind and body practices (eg, guided meditation and progressive relaxation) are often helpful, free, and readily available through the Internet. A growing catalog of online and print resources for each age-group is an easy resource for parents to obtain and use.

It is also important to counsel patients to have a standard sleep ritual—consistent bedtimes and waking times are helpful. In addition, patients should aim to follow the same pattern for preparing for sleep each night, such as showering,

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reading a book for half an hour, meditating, and eventually turning the lights out.

Follow Up with a Pediatrician If the child continues to have sleep problems after multiple interventions, it is important that he or she follows up with his or her pediatrician to rule out any other sleep-related issues and to discuss the risk–benefit of stimulant medication for ADHD. Parents who have children with sleep problems are often experiencing sleep deficits themselves. It would be beneficial to encourage the parents to follow the same suggestions given to the child so that everyone in the family can have a good night’s sleep. ❚ References

1. Epstein JN, Kelleher KJ, Baum R, et al. Variability in ADHD care in community-based pediatrics. Pediatrics.

2014;134:1136-1143.

2. Kay GG. The effects of antihistamines on cognition and performance. J Allergy Clin Immunol. 2000;105:S622-S627.

3. Jan JE, Reiter RJ, Wasdell MB, et al. The role of the thalamus in sleep, pineal melatonin production, and circadian rhythm sleep disorders. J Pineal Res. 2009;46:1-7.

4. Hughes RJ, Sack RL, Lewy AJ. The role of melatonin and circadian phase in age-related sleep-maintenance insomnia: assessment in a clinical trial of melatonin replacement. Sleep.

1998;21:52-68.

5. Cortese S, Konofal E, Bernardina BD, et al. Sleep disturbances and serum ferritin levels in children with attention-deficit/hyperactivity disorder. Eur Child Adolesc Psychiatry. 2009;18:393-399.

6. Wheatley D. Medicinal plants for insomnia: a review of their pharmacology, efficacy and tolerability. J Psychopharmacol. 2005;19:414-421.

7. Kemper KJ, Romm AJ, Gardiner P. Prepubertal gynecomastia linked to lavender and tea tree oils. N Engl J Med. 2007;356:2541-2544.

8. Salter S, Brownie S. Treating primary insomnia - the efficacy of valerian and hops. Aust Fam Physician. 2010;39: 433-437.

9. Bent S, Padula A, Moore D, et al. Valerian for sleep: a systematic review and meta-analysis. Am J Med. 2006;119:10051012.

10. Taibi DM, Landis CA, Petry H, et al. A systematic review of valerian as a sleep aid: safe but not effective. Sleep Med Rev. 2007;11:209-230.

11. Rowe A, Zhang LY, Ramzan I. Toxicokinetics of kava.

Adv Pharmacol Sci. 2011;2011:326724.

12. Figueiro MG, Wood B, Plitnick B, et al. The impact of light from computer monitors on melatonin levels in college students. Neuro Endocrinol Lett. 2011;32:158-163.

13. Burkhart K, Phelps JR. Amber lenses to block blue light and improve sleep: a randomized trial. Chronobiol Int. 2009;26:1602-1612.

14. Wood B, Rea MS, Plitnick B, et al. Light level and duration of exposure determine the impact of self-luminous tablets on melatonin suppression. Appl Ergon. 2013;44:237-240.

15. Owens JA, Mindell J, Baylor A. Effect of energy drink and caffeinated beverage consumption on sleep, mood, and performance in children and adolescents. Nutr Rev. 2014;72 (suppl 1):65-71.

Natalie Drummond Dr Drummond (ND) is an Integrative Pediatrician and Vice President of Product Development, Creekside Natural Therapeutics; Dr Drummond (MD) is a Clinical Psychologist and Managing Partner, Creekside Natural Therapeutics.

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Inside Pediatric Health

Pertussis Update: Practical Tips for Pharmacists and Providers

by KIM CURRY, PHD, ARNP-C

To clinicians, few sights are more frightening than an infant gasping for air, with oxygen levels falling, struggling with paroxysms of constant coughing. }} KEY POINTS ❚ A resurgence in pertussis cases has resulted in a focus on how adults transmit the disease to infants ❚ Clinicians should be familiar with recent changes to vaccine schedules; educate and encourage patients to participate in immunizations

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}} THIS IS THE CONSEQUENCE of pertussis transmission, which, in 2013, affected more than 22,000 children and 6000 adults in the United States.1 Pertussis, also known as whooping cough, is a dangerous illness with an initial presentation that many healthcare providers fail to recognize. In its early stages, it mimics other respiratory illnesses and is often misdiagnosed. The danger created by this missed diagnosis is that appropriate antibiotic therapy is not promptly initiated, and the patient suffers greatly as a consequence. Toxins released by the Bordetella pertussis bacterium trigger the symptoms of this illness.2 The terrible cough of pertussis is a paroxysmal cough, often enough to cause emesis and hypoxia. The cough is not only very difficult to suppress, but once present can last for several weeks.

Infants less than 6 months of age who have not had the opportunity to complete their primary immunization series are the most at risk for fulmi-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

nant pertussis. Infants often get pertussis from older siblings, parents, and caregivers, including healthcare workers, who have not been vaccinated in many years and are no longer immune. Recently, a resurgence of pertussis, including a number of deaths, has occurred in the United States, highlighting the waning immunity from the childhood pertussis vaccine.2,3 This upward trend led to the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine for adolescents and adults, which was introduced in the United States in 2005.3 In August 2014, the Centers for Disease Control and Prevention (CDC) published a surveillance report highlighting the vaccination history of patients with pertussis.1 The report made it clear that many young children who are eligible for the vaccine are not receiving this important immunization in a timely manner. In fact, 42% of infants 6 to 11 months of age with

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Inside Pediatric Health pertussis were noted to have received 0 doses of the vaccine, or had an immunization status of “unknown.”1

How Pharmacists and Clinicians Can Advise Patients Children should receive a total of 5 doses of the diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, the childhood formula of the immunization.4 Specifically, they should receive doses at age 2, 4, and 6 months.

A fourth dose is given between age 15 and 18 months. A final booster dose is due between age 4 and 6 years.

For patients aged 11 years and older, one dose of Tdap is recommended for those who have not previously received the vaccine.5 In 2011, the Advisory Committee on Immunization Practices recommended an additional single dose of the Tdap vaccine for adults aged ≥65 years who anticipate having contact with infants.5 A good opportunity to give Tdap is during wound treatment, for patients requiring such care, as a replacement for tetanus and diphtheria toxoids (Td).

The Tdap vaccine should also be administered to women during pregnancy if it has not been previously administered. It may also be given immediately postpartum to protect the mother and infant.

Healthcare workers with direct patient contact are advised to receive this vaccine as well.5 Clinicians should especially stress the need for a pertussis immunization to expectant parents (mother and father) and grandparents. Sometimes what people will not do for themselves they will do to protect the children in their lives.

Get to know your customers, so that expectant parents and grandparents can receive education, and Tdap, prior to the arrival of the new family member.

Your Role in Improving Immunization Rates First and foremost, pharmacists and clinicians should be up to date on their own immunizations. It is difficult for

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patients to take our advice seriously when they ask whether we have received a particular vaccine and the answer is “Well, no, but….” We should be role models as well as advocates for immunization participation.

Healthcare professionals should maintain current knowledge of annual immunization updates and revisions to the recommended schedules for infants, children, adolescents, and adults. A good place to start is by reviewing the vaccine

First and foremost, pharmacists and clinicians should be up to date on their own immunizations. schedules and the numerous updates on vaccine-preventable diseases provided in the CDC’s Morbidity and Mortality Weekly Report.6 When viewing vaccine schedules, always remember that the footnotes are essential for understanding the indications and updates for each vaccination.

Another way to improve immunization rates is to take advantage of every opportunity to review the patient’s immunization status and to vaccinate whenever indicated. Each visit is an opportunity to vaccinate. Too often, minor illnesses are seen as contraindications to vaccination, when only acute illnesses with high fevers are contraindications for most patients.

If your facility or pharmacy does not stock or administer vaccines, consider creating a list of locations in the community where patients can receive immunizations. Telling a patient to go to the health department may not be the correct information in some geographic areas. In some communities, private medical clinics or clinics for international travelers may be better options. In some counties, immunization services are available more readily

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

21

Inside Pediatric Health

Dr Curry is a Clinical Associate Professor, College of Nursing, University of Florida, Gainesville, FL.

by sending the patient to a neighboring county health department with better access. It pays to investigate.

There is always a minority of parents who are vaccine objectors, and these individuals can be very vocal. In some parts of the United States, outbreaks of vaccine-preventable diseases, including deaths, have occurred because of a consciously underimmunized local population. This regrettable situation is often largely due to an educational deficit, with the rumor mill winning out over science. It is important to listen to concerns, provide encouragement, and supply evidence-based educational resources. If patients ask for additional information before making a vaccine decision, many educational resources are available through the Immunization Action Coalition.7 We are becoming increasingly aware that any individual vaccine is not 100% effective and is unlikely to convey immunity for the entire life span. The recent history of pertussis cases in this country provides but one example of these facts. In the future, we can anticipate seeing an expansion in the recommended age ranges for many immunizations,

vaccines extended to additional groups of people, and recommendations for repeated doses of certain vaccines that today are delivered as a one-time dose.

Every clinician has the opportunity to be an important immunization resource and to promote primary preventive measures, saving both the patient and society from undue suffering and lessening the burden on the healthcare system. ❚

References

1. Centers for Disease Control and Prevention. 2013 final pertussis surveillance report. www.cdc.gov/pertussis/down loads/pertuss-surv-report-2013.pdf. Published August 15, 2014. Accessed January 6, 2015.

2. Carbonetti N. Pertussis toxin and adenylate cyclase toxin: key virulence factors of Bordetella pertussis and cell biology tools. Future Microbiol. 2010;5:455-469.

3. Joint Commission on Accreditation of Healthcare Organizations. Tdap vaccination: strategies from research and practice. www.jointcommission.org/assets/1/6/Tdap_ Monograpgh.pdf. Published February 1, 2011. Accessed January 5, 2015.

4. Centers for Disease Control and Prevention.

Recommended immunization schedule for persons age 0 through 18 years. www.cdc.gov/vaccines/schedules/hcp/imz/ child-adolescent.html. Updated January 31, 2014. Accessed January 5, 2015.

5. Centers for Disease Control and Prevention.

Recommended adult immunization schedule, by vaccine and age group. www.cdc.gov/vaccines/schedules/hcp/imz/adult. html. Updated September 18, 2014. Accessed January 5, 2015.

6. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. www.cdc.gov/mmwr/mmwrsrch.htm.

Updated January 15, 2010. Accessed January 5, 2015.

7. Immunization Action Coalition. Handouts for patients & staff. www.immunize.org/handouts/. Accessed January 5, 2015.

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Evolution in the Value-Based Care of Continuing Education Rheumatologic Diseases: A Prospectus for Managed Care Pharmacists

Evolution in the Value-Based Care of F Rheumatologic Diseases: A Prospectus for Managed Care Pharmacists aculty

Jonathan Kay, MD Joseph F. Merola, MD, MMSC Director of Clinical Research, Director of Clinical Trials Rheumatology Co-Director, Center for Skin and Professor of Medicine Related Musculoskeletal Diseases University of Massachusetts Medical School Brigham and Women’s Hospital UMass Memorial Medical Center Instructor, Harvard Medical School

by DOUGLAS BURGOYNE, PHARMD, JOSEPH F. MEROLA, MD Worcester, MA Boston, MD, MA MMSC, and JONATHAN KAY, Douglas Burgoyne, PharmD President VRx Pharmacy Services, LLC Salt Lake City, UT

Release date: December 15, 2014 Expiration date: December 31, 2015 Estimated time to complete activity: 1.0 hour Target Audience This activity is directed toward pharmacists who are involved in the management of patients with rheumatologic diseases.

Educational Objectives After completing this activity, the participant should be better able to: • Review the current management options in rheumatoid arthritis and psoriatic arthritis • Discuss the potential clinical implications of existing and emerging novel biologic therapies on the treatment paradigm for rheumatologic diseases • Utilize optimal, value-based management approaches to patients with rheumatoid arthritis and psoriatic arthritis • Provide accurate and appropriate counsel as part of the treatment team Faculty Douglas Burgoyne, PharmD President, VRx Pharmacy Services, LLC Salt Lake City, UT Joseph F. Merola, MD, MMSC Director of Clinical Trials Co-Director, Center for Skin and Related Musculoskeletal Diseases Brigham and Women’s Hospital Instructor, Harvard Medical School, Boston, MA Jonathan Kay, MD Director of Clinical Research, Rheumatology Professor of Medicine University of Massachusetts Medical School UMass Memorial Medical Center, Worcester, MA 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 of Medicine designates this continuing education activity for 1 contact hour(s) (0.1 CEU) of the Accreditation Council for Pharmacy Education. (Universal Activity Number 0809-9999-14-227-H01-P) Type of Activity: application System Requirements PC Windows 7 or above Flash Player v10.0 or higher Internet Explorer v9.0 or higher

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*Required to view printable (PDF) version of the lesson.

Disclosure of Conflicts of Interest Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high-quality CME/CE activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CPE activity: Name of Faculty or Presenter

Reported Financial Relationship

Douglas Burgoyne, Consultant to AstraZeneca, BristolPharmD Myers Squibb, Novo Nordisk, Purdue, Sanofi, and XenoPort.

Joseph F. Merola, Advisory Board for AbbVie, Amgen, MD, MMSC Eli Lilly, and Novartis; Consultant to AbbVie, Amgen, Biogen Idec, Eli Lilly, and Novartis; Investigator for Amgen, Biogen Idec, and Pfizer; Licensed Outcome Measure for AbbVie; Research funding from Biogen Idec.

Jonathan Kay, MD Consultant to AbbVie, Alexion Pharmaceuticals, Amgen, AstraZeneca, Bristol-Myers Squibb, Crescendo Bioscience, Eli Lilly, Epirus Biopharmaceuticals, Genentech, Hospira, Janssen Biotech, PanGenetic B.V., Pfizer, Roche Laboratories, Samsung Bioepis, and UCB Inc. The following PIM planners and managers—Laura Excell, ND, NP, MS, MA, LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP; and Jan Schultz, MSN, RN, CCMEP—hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

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Instructions for Credit There is no fee for this activity. To receive credit after reading this CE activity in its entirety, participants must complete the posttest and evaluation. The posttest and evaluation can be completed online at http://ce.lynxcme.com/COE175. 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.

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heumatologic diseases, such as rheumatoid arthritis (RA) and psoriatic arthritis (PsA), are chronic inflammatory disorders that are associated with severe disability and, consequentially, negative impact on quality of life (QOL). Dramatic advancements seen in the treatment of rheumatoid diseases largely stem from the advent of biologic agents. However, the costs of therapy are significant, underscoring the importance and need for the practice of value-based care. This educational activity provides highlights of a live symposium from the Academy of Managed Care Pharmacy meeting held in Boston, MA, on October 7-10, 2014, which focused on the evolution of value-based care of rheumatologic diseases, including clinical and pharmacoeconomic assessments of conventional and biologic disease-modifying antirheumatic drugs (DMARDs) in the treatment of patients with RA or PsA.

decades of clinical experience.3 In addition, the current treatment armamentarium of bDMARDs includes 5 US Food and Drug Administration (FDA)-approved tumor necrosis factor (TNF) inhibitors (adalimumab, certolizu­mab, etanercept, golimumab, and infliximab), the cytotoxic T-lymphocyte–associated protein-4 T-cell costimulation blocker abatacept, the anti-CD20 monoclonal antibody (mAb) rituximab, the interleukin (IL)-1 receptor antagonist inhibitor anakinra, the anti–IL-6 receptor mAb tocilizumab, and the oral Janus kinase/signal transducer and activator of transcription inhibitor tofacitinib (Table 1).4-11 Over the last decade, the treatment paradigms for RA have evolved significantly, with authoritative guidelines and emerging clinical data advocating the initiation of intensive therapy earlier in the course of disease and the use of a treat-to-target management strategy. To attain the treatment goal of remission or low disease activity, therapy should be adjusted when no improvement is noted

Optimization of Conventional and Biologic Disease-Modifying Antirheumatic Drug Use in Rheumatoid Arthritis RA is an autoimmune disease characterized Table 1. Biologic Disease-Modifying Antirheumatic Drugs Approved for by inflammation of the joints, accompanied Management of Rheumatoid Arthritis and Psoriatic Arthritis by proliferation of the synovium and the Drug Mechanism of action FDA approval year progressive erosion of cartilage and bone, 4-9 Rheumatoid arthritis leading to severe disability and premature 2002 Anti-TNF 1 Adalimumab mortality. In 2010, a collaboration between 2008 Anti-TNF the American College of Rheumatology Certolizumab pegol 1998 Anti-TNF (ACR) and the European League Against Etanercept 2009 Anti-TNF Rheumatism (EULAR) resulted in new clasGolimumab 1999 Anti-TNF sification criteria for RA that emphasized the Infliximab need for early diagnosis based on the extent 2005 CD28 Abatacept of joint involvement, serology (rheumatoid 1997 Anti-CD20 Rituximab factor and anticitrullinated protein antibody), 2001 IL-1 receptor Anakinra acute-phase reactants (erythrocyte sedimen2010 IL-6 receptor Tocilizumab tation rate [ESR] and C-reactive protein), 2012 JAK/STAT TKI Tofacitinib and duration of symptoms (<6 weeks or ≥6 4,5,10,11 Psoriatic arthritis weeks).2 2002 Anti-TNF Etanercept Based on the important pathogenic roles 2005 Anti-TNF Adalimumab of proinflammatory cytokines in RA, a num2005 Anti-TNF ber of powerful conventional DMARDs Infliximab 2009 Anti-TNF (cDMARDs) and biologic DMARDs Golimumab 2013 Anti-TNF (bDMARDs) have become available. In this Certolizumab pegol era of targeted biologic therapies, methotrex2014 PDE4 inhibitor Apremilast ate (MTX) still reigns as an “anchor drug” 2013 Anti–IL-12/IL-23 Ustekinumab and the gold standard for treatment of RA, FDA indicates US Food and Drug Administration; IL, interleukin; JAK, Janus kinase; either as monotherapy or in combination with PDE4, phosphodiesterase 4; STAT, signal transducer and activator of various biologic agents, attesting to its effitranscription; TKI, tyrosine kinase inhibitor; TNF, tumor necrosis factor. cacy, acceptable safety profile, low cost, and

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Continuing Education Table 2. Radiographic Progression During 2 Years in the TEAR Trial Patients, n

Baseline (mean ± SD)

Week 48 (mean ± SD)

Week 102 (mean ± SD)

Difference in modified Sharp score at week 102 (mean ± SD)

Immediate combination therapy

330

7.0 ± 14.9

7.9 ± 15.9

7.5 ± 15.7

1.1 ± 6.4

Step-up to combination therapy

236

6.2 ± 13.4

7.3 ± 14.6

6.2 ± 8.7

1.2 ± 4.1

MTX monotherapy

84

2.9 ± 3.5

2.9 ± 3.6

2.6 ± 2.9

0.2 ± 1.1

Treatment group

P values across treatment groups were significant at week 48 (P=.0321) and week 102 (P=.0074), as was the change in modified Sharp score at week 102 (P=.0467).

MTX indicates methotrexate; SD, standard deviation; TEAR, Treatment of Early Aggressive Rheumatoid Arthritis.

Sources: O’Dell JR, et al. Arthritis Rheum. 2013;65:1985-1994; Moreland LW, et al. Arthritis Rheum. 2012;64:2824-2435.

by at most 3 months after the start of treatment or when the target has not been reached by 6 months.12 The 2013 EULAR guidelines clarified that intensive therapy in early RA does not imply commencing therapy with bDMARDs before cDMARDs, and advised that cDMARD monotherapy or a combination of cDMARDs should be used in DMARD-naive patients, and that MTX should be part of the first treatment strategy.12 The guidelines further state that bDMARDs may be initiated in combination with MTX if treatment target is not achieved with cDMARD approaches or if poor prognostic factors are present.12 In addition, the EULAR guidelines broadly consider that abatacept, tocilizumab, rituximab, and the 5 FDA-approved TNF inhibitors exhibited similar efficacy and safety and recommended switching to another bDMARD upon failure of a first bDMARD. The guidelines further recommend the preferential use of a bDMARD in combination with MTX over bDMARD monotherapy,12 because the approved biologic agents have demonstrated reduction of disease activity, improvement of functional disability, and retardation of radiographic progression, either alone13 or in combination with MTX.14,15 Currently, tocilizumab is the only biologic agent that has demonstrated superiority as monotherapy over MTX in MTX-naive patients with RA.16 Several trials have assessed whether it is better to intensively treat all patients with early RA using combination therapy comprising bDMARD plus MTX or triple therapy with cDMARDs, such as MTX, sulfasalazine, and hydroxychloroquine immediately, or to delay administration of combination therapy following an inadequate response to

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MTX monotherapy.17-20 The 2-year follow-up assessment of the randomized SWEFOT (Swedish Farmacotherapy) trial involving patients with MTX-refractory early RA showed that the proportion of patients who achieved a EULARdefined good response was numerically higher in those who were treated with MTX plus infliximab compared with those who received cDMARD triple therapy, although this difference was not significant (38% vs 31%, respectively; P=.204).17 However, the radiologic disease progression was significantly greater in patients treated with conventional therapy compared with those who were treated with biologic therapy (change in modified Sharp score mean, 7.23 vs 4.00; P=.009).17 The randomized, 4-arm TEAR (Treatment of Early Aggressive Rheumatoid Arthritis) trial of 755 patients with early, poor-prognosis RA evaluated 2 immediate treatment approaches with either cDMARD triple therapy (MTX + sulfasalazine + hydroxychloroquine) or MTX plus etanercept combination therapy, and 2 delayed treatment approaches in which treatment escalation to one of the combination therapies was applied at 24 weeks after inadequate response to MTX monotherapy, based on a disease activity score in 28 joints using the ESR (DAS28-ESR) ≥3.2.18,19 Overall, no differences were seen in the mean DAS28-ESR between patients randomized to triple therapy and those randomized to MTX plus etanercept, regardless of whether patients received immediate combination therapy or step-up from MTX monotherapy. In this trial, approximately 28% of patients continued to use MTX monotherapy based on a DAS28-ESR ≤3.2, confirming that a subset of patients attain disease control with MTX

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Proportion of patients with ACR20 response, %

alone. However, at 102 weeks, immediate combinaFigure. Response Rates at 1 Year in the AMPLE Trial tion therapy with either strategy was more effective than initial MTX monotherapy, underscoring the 100 Primary end point benefits of combination therapy. Of note, patients 90 who received initial MTX monotherapy and subse80 quent step-up to combination therapy had DAS2864.8% 63.4% 70 ESR values at week 48 and radiographic progression 60 at week 102 similar to those who received immediate 50 combination therapy, which validated the traditional 18,19 40 step-up approach (Table 2).

Along the same vein, the 48-week, double-blind, 30 noninferiority RACAT (RA: Comparison of Active 20 Therapies) trial concluded that triple therapy (MTX 10 206/318 208/328 + sulfasalazine + hydroxychloroquine) was nonin0 ferior to MTX plus etanercept in terms of DAS28

Abatacept Adalimumab response at 48 weeks, in patients with active RA who ACR indicates American College of Rheumatology; AMPLE, Abatacept had an inadequate response to MTX (DAS28 ≥4.4).20 Versus Adalimumab Comparison in Biologic-Naive RA Subjects with In this study, patients who did not show an improveBackground Methotrexate. ment in DAS28 at 24 weeks (DAS28 decrease <1.2) Sources: Schiff M, et al. Ann Rheum Dis. 2014;73:86-94; Weinblatt ME, et al. Arthritis Rheum. 2013;65:28-38. were allowed to switch from one arm to the other, resulting in significant improvements in both groups.

Taken together, the findings from the TEAR and the RACAT trials support the use of cDMARD triple therapy with Background Methotrexate) trial concluded that subas a low-cost alternative to the combination of MTX plus cutaneous abatacept or adalimumab (administered with bDMARD. In addition, in patients with early RA, the MTX) showed comparable ACR improvement responses initial use of MTX monotherapy with a biologic or a non(Figure), as well as improvement in functional disability biologic DMARD added on as needed after 6 months of and inhibition of radiographic progression at 2 years.23,24 18-20 Although the rates of adverse events and serious adverse disease persistence is a rational approach.

Recently, in treating patients with bDMARDs, there events were similar between the 2 treatment groups, adalihas been interest in evaluating the potential withdrawal mumab therapy was associated with a higher rate of disof the biologic agent when reaching low disease activity continuation and a higher incidence of serious infections or remission. Understandably, this paradigm shift in the (including 2 cases of tuberculosis) compared with abatatreatment of RA would have favorable pharmacoecocept therapy.23 Conversely, the randomized, double-blind, phase 4 ADACTA (Tocilizumab Monotherapy Versus nomic implications in addition to obvious safety and Adalimumab Monotherapy for Treatment of Rheumatoid convenience benefits.21 For example, a systematic review of 10 eligible studies evaluating discontinuation of TNF Arthritis) trial reported that tocilizumab monotherapy was inhibitors in patients achieving low disease activity or superior to adalimumab monotherapy in producing a sigremission suggested that this approach was possible in 24% nificantly greater change from baseline in DAS28, DAS28 to 81% of patients without a resultant increase in disease remission, and DAS28 low disease activity at week 24 in activity; heterogeneous inclusion criteria and highly varipatients with RA for whom MTX was deemed ineffective able outcome definitions across studies contributed to the or inappropriate.25 The safety profiles were consistent with 22 those previously reported for these 2 agents.25 However, wide range of the results. However, there are currently no markers to predict which patients may be candidates it must be noted that a higher dose of tocilizumab (8 mg/ for discontinuation of anti-TNF therapy once desirable kg intravenous monthly) was used in this trial than the clinical outcomes are achieved. doses used in other trials with this agent, and adalimumab A number of studies have compared bDMARDs monotherapy is known to be less effective than adalimu­ directly. For example, the AMPLE (Abatacept Versus mab plus MTX; both of these factors may have skewed the Adalimumab Comparison in Biologic-Naive RA Subjects results in favor of tocilizumab.15,26

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Continuing Education Treatment Paradigms in Psoriatic Arthritis PsA is a chronic, systemic, inflammatory disease that is associated with significant joint involvement (peripheral and spinal) in conjunction with a spectrum of extra-articular manifestations, including enthesitis and dactylitis, as well as involvement of the skin and nails.27 Such broad articular and nonarticular phenotypes of PsA have a debilitating impact on patients’ function and QOL, which were shown to be nearly equivalent to the function and QOL scores reported by patients with RA.28 Although the general prevalence of PsA in the United States is estimated to be 0.25%, it is considerably higher among patients with

The heterogeneous clinical presentation of PsA is accompanied by a variable disease course, with some patients experiencing mild, chronic disease. psoriasis, with a prevalence rate of up to 42%.29,30 Skin disease typically precedes joint disease in patients with PsA, with approximately 75% to 80% of affected patients developing joint complications 7 to 12 years from the onset of psoriasis to the diagnosis of PsA, although in 10% to 15% of patients, PsA may precede psoriasis.30 Moreover, PsA is associated with an elevated risk for cardiovascular disease and metabolic syndrome, conferring an increased risk for mortality.31 In fact, the prevalence of metabolic syndrome among patients with PsA in one study was observed to be higher (58.1%) than the prevalence among the general population (35.2%) reported by the Third National Health and Nutrition Examination Survey.32 The heterogeneous clinical presentation of PsA is accompanied by a variable disease course, with some patients experiencing mild, chronic disease whereas others show severe, rapid, erosive joint disease.27 Timely diagnosis and appropriate therapeutic intervention are of paramount importance, because persistent inflammation, progressive joint damage, and marked functional impairment and disability can occur in the absence of effective therapy.17 However, the management of PsA can pose a clinical challenge as a result of diverse and often simultaneous clinical manifestations, requiring multidisciplinary treatment.

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Two treatment guidelines, 2012 EULAR and 2009 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, have been released for the management of PsA.33,34 Whereas the immediate treatment target is to achieve clinical remission or at least low disease activity, long-term treatment goals are to maintain health-related QOL, reduce skin and joint signs and symptoms, and prevent or attenuate structural damage. Treatment recommendations from both guidelines indicate that patients with mild-to-moderate disease may be treated with nonsteroidal anti-inflammatory drugs and intra-articular corticosteroid injections as adjunctive therapy for control of joint (but not skin) symptoms. For patients with more severe disease, cDMARD therapy (ie, MTX, sulfasalazine, leflunamide, or cyclosporine) is indicated at an early stage, whereas biologic agents with or without cDMARDs may be considered if the response to cDMARDs is considered inadequate, and as first-line therapy in patients with extensive involvement of skin and joints. The 2012 EULAR guidelines in particular recommend switching to a second anti-TNF agent in patients whose disease fails to improve after treatment with a TNF inhibitor.33 How­ever, in contrast to RA, current evidence does not support the use of a combination of TNF inhibitors and cDMARDs in patients with PsA.29,33 Currently, 5 TNF inhibitors (adalimumab, certolizu­ mab, etanercept, golimumab, and infliximab), the antiIL-12/23 mAb ustekinumab, and the phosphodiesterase 4 inhibitor apremilast have shown efficacy in PsA and have been approved by the FDA for this indication.30,33 The guidelines note that despite the lack of direct headto-head comparisons among the available TNF inhibitors, no apparent differences in efficacy for joint involvement have emerged with these agents, whereas the efficacy of etanercept on skin involvement may be lower than the other TNF antagonists.33 A meta-analysis of an indirect comparison of adalimumab, etanercept, golimumab, and infliximab in PsA revealed no significant differences in effectiveness among these agents.35 However, the study noted that golimumab yielded the highest relative risk for the PsA response criteria, whereas etanercept and infliximab showed the greatest benefit for Health Assessment Questionnaire improvements, and infliximab was most effective in yielding psoriasis area and severity index improvements.35 Taken together, these findings show that an individualized approach to drug selection, based on disease severity and tissue manifestations, is critical in the treatment of PsA.

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Continuing Education Clinical and Pharmacoeconomic Assessments in Value-Based Care of Rheumatologic Diseases Although bDMARDs have redefined the treatment paradigm in rheumatologic diseases, it is undisputed that the treatment costs incurred by these agents are substantial.

According to the 2014 CVS/Caremark Book of Business spending trend analysis, RA was the therapeutic category with the largest specialty drug spending.36 Currently, the 5 approved TNF inhibitors represent approximately $20 billion in annual sales.37 These facts have led to a growing interest in evaluating the value of bDMARDs in the treatment of RA and PsA, specifically, to determine whether the efficacy benefits, reductions in healthcare use, decreases in productivity losses, and improvements in QOL achieved with these agents warrant the increased drug costs compared with cDMARDs. Toward this end, several cost-effectiveness analyses of anti-TNF drugs for RA have been conducted.

Zalesak and colleagues recently published a systematic review of market research and cost-effectiveness studies designed to assess clinical, functional, and economic outcomes associated with specialty drug treatments versus the previous standard of care.38 They showed that compared with conventional DMARDs, bDMARDs had significant therapeutic benefit in addition to being costeffective, with incremental cost-effectiveness ratios (ICERs) of $47,500 per quality-adjusted life-year (QALY).38 Overall, whereas the costs of anti-TNF agents were clearly higher than those of traditional DMARDs, the former resulted in a higher number of QALYs.38 In another analysis that used the Birmingham Rheumatoid Arthritis Model, which takes into account QOL and mortality indices, TNF inhibitors were most costeffective when used as last active therapy after the use of less expensive conventional DMARDs, rather than first-line use.39 Comparing TNF inhibitors, the ICER for infliximab was significantly higher than the ICERs for etanercept or adalimumab, regardless of whether it was used as first-line therapy or later.39 In terms of first-line combination therapy, the ICERs associated with MTX plus a TNF inhibitor were considerably higher than those generated with monotherapy.39 Consistent with these results, the cost-effectiveness analysis of the SWEFOT trial showed that the infliximab-treated group accumulated higher drug and healthcare costs compared with the group randomized to conventional nonbiologic therapy, compounded by higher societal costs as a result of productivity losses being similar between the groups.40 Finally, sequential therapy

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with 2 TNF antagonists has been shown to have the same order of cost-effectiveness as single-agent therapy.39 Many of the conclusions from these cost-effectiveness analyses are consistent with emerging clinical data and guideline recommendations. A few persistent questions relevant to value-based care in rheumatologic diseases include: • Is there a significant clinical benefit of biologic agents over conventional agents?

• Should biologic drugs be offered only after patients show inadequate response to less expensive conventional therapies?

• Can biologic drugs be discontinued once remission or low disease activity is achieved?

• Which patients should receive biologic agents instead of conventional therapies?

Taken together, these findings show that an individualized approach to drug selection, based on disease severity and tissue manifestations, is critical in the treatment of PsA. In addition to optimization of currently existing biologic agents to gain cost benefits, another approach is to develop effective but cheaper biologic alternatives. This has led to the development of biosimilars, which are biologic drugs that are structurally similar but not identical to the reference agent, and show no clinically meaningful differences in terms of safety, purity, and potency.41 This concept has taken root because the US patents for several biologic agents for RA (including abatacept, adalimumab, infliximab, rituximab, and tocilizumab) have expired or are expected to expire over the next few years.42 Although the efforts to introduce biosimilars for the treatment of RA are expected to provide cost-savings and, possibly, increased access to biologic agents, several hurdles remain to be overcome to achieve this goal. Foremost is the need to establish the clinical bioequivalence in terms of efficacy and safety of a biosimilar and its parent compound, followed by their interchangeability in clinical practice.41,42

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Continuing Education Conclusion The advent of biologic DMARDs has brought us closer to being able to achieve disease remission and repair of structural damage in RA and PsA, but these agents incur significant costs, necessitating further cost-effectiveness analyses. Balancing the cost considerations with the clinical outcomes suggests that cDMARDs should remain as first-line therapies in RA and PsA within a treat-totarget framework, whereas biologic agents should be used subsequent to the failure of treatment with cDMARDs, to achieve optimal clinical, functional, and economic outcomes in rheumatologic diseases. ❚ Acknowledgment Sabeeha Muneer, PhD, contributed to the development of this article.

References

1. McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011;365:2205-2219.

2. Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62:2569-2581.

3. Favalli EG, Biggioggero M, Meroni PL. Methotrexate for the treatment of rheumatoid arthritis in the biologic era: still an “anchor” drug? Autoimmun Rev. 2014;13:1102-1108.

4. Centerwatch. FDA Approved Drugs by Medical Condition. www.centerwatch. com/drug-information/fda-approved-drugs/medical-conditions/R. Accessed October 27, 2014.

5. Drugs.com. Drug Index A to Z. www.drugs.com/drug_information.html. Accessed November 6, 2014.

6. Cimzia (certolizumab pegol) for injection, for subcutaneous use [prescribing information]. Smyrna, GA: UCB, Inc; October 2013.

7. Enbrel (etanercept) solution for subcutaneous use [prescribing information].

Thousand Oaks, CA: Immunex Corporation; November 2013.

8. Rituxan (rituximab) for injection, for intravenous use [prescribing information].

South San Francisco, CA: Genentech, Inc; August 2014.

9. Kineret (anakinra) for injection, for subutaneous use [prescribing information].

Stockholm, Sweden: Swedish Orphan Biovitrum AB; October 2013.

10. Certolizumab pegol gains FDA approval for PsA and AS [press release]. Johns Hopkins Arthritis Center. www.hopkinsarthritis.org/arthritis-news/certolizumabpegol-fda-approval-psoriatic-arthritis-ankylosing-spondylitis/. Accessed November 29, 2014.

11. Stelara (ustekinumab) receives FDA approval to treat active psoriatic arthritis [press release]. Johnson & Johnson Web site. www.investor.jnj.com/releasedetail.cfm?ReleaseID=792461. Accessed November 29, 2014.

12. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492-509.

13. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000;343: 1586-1593.

14. Klareskog L, van der Heijde D, de Jager JP, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet.

2004;363:675-681.

15. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment.

Arthritis Rheum. 2006;54:26-37.

16. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010;69:88-96.

17. van Vollenhoven RF, Geborek P, Forslind K, et al. Conventional combination

30

treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial.

Lancet. 2012;379:1712-1720.

18. O’Dell JR, Curtis JR, Mikuls TR, et al. Validation of the methotrexate-first strategy in patients with early, poor-prognosis rheumatoid arthritis: results from a two-year randomized, double-blind trial. Arthritis Rheum. 2013;65:1985-1994.

19. Moreland LW, O’Dell JR, Paulus HE, et al. A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the Treatment of Early Aggressive Rheumatoid Arthritis trial. Arthritis Rheum. 2012;64:2824-2835.

20. O’Dell JR, Mikuls TR, Taylor TH, et al. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med. 2013;369:307-318.

21. Kavanaugh A, Smolen JS. The when and how of biologic agent withdrawal in rheumatoid arthritis: learning from large randomised controlled trials. Clin Exp Rheumatol.

2013;31:S19-S21.

22. Navarro-Millan I, Sattui SE, Curtis JR. Systematic review of tumor necrosis factor inhibitor discontinuation studies in rheumatoid arthritis. Clin Ther. 2013;35:1850-1861, e1.

23. Schiff M, Weinblatt ME, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014;73:86-94.

24. Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013;65:28-38.

25. Gabay C, Emery P, van Vollenhoven R, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381:1541-1550.

26. Besada E. Potential patient benefit of a subcutaneous formulation of tocilizumab for the treatment of rheumatoid arthritis: a critical review. Patient Prefer Adherence.

2014;8:1051-1059.

27. Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64:ii14-ii17.

28. Sokoll KB, Helliwell PS. Comparison of disability and quality of life in rheumatoid and psoriatic arthritis. J Rheumatol. 2001;28:1842-1846.

29. Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005;53:573-577.

30. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs.

2014;74:423-441.

31. Chang CA, Gottlieb AB, Lizzul PF. Management of psoriatic arthritis from the view of the dermatologist. Nat Rev Rheumatol. 2011;7:588-598.

32. Raychaudhuri SK, Chatterjee S, Nguyen C, et al. Increased prevalence of the metabolic syndrome in patients with psoriatic arthritis. Metab Syndr Relat Disord. 2010; 8:331-334.

33. Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis. 2012;71:4-12.

34. Ritchlin CT, Kavanaugh A, Gladman DD, et al. Treatment recommendations for psoriatic arthritis. Ann Rheum Dis. 2009;68:1387-1394.

35. Thorlund K, Druyts E, Avina-Zubieta JA, et al. Anti-tumor necrosis factor (TNF) drugs for the treatment of psoriatic arthritis: an indirect comparison meta-analysis.

Biologics. 2012;6:417-427.

36. CVS/Caremark. 7 Sure Things to Help You Know Where to Go Next With Your Prescription Benefit. http://investors.cvshealth.com/~/media/Files/C/CVS-IR/reports/ 2014-cvs-caremark-insights-report.pdf. Accessed October 26, 2014.

37. Willrich MA, Murray DL, Snyder MR. Tumor necrosis factor inhibitors: clinical utility in autoimmune diseases [published online ahead of print September 22, 2014].

Transl Res. doi: 10.1016/j.trsl.2014.09.006.

38. Zalesak M, Greenbaum JS, Cohen JT, et al. The value of specialty pharmaceuticals–a systematic review. Am J Manag Care. 2014;20:461-472.

39. Chen Y-F, Jobanputra P, Barton P, et al. A systematic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and an economic evaluation of their cost-effectiveness. Health Technol Assess.

2006;10:1-229.

40. Eriksson JK, Karlsson JA, Bratt J, et al. Cost-effectiveness of infliximab versus conventional combination treatment in methotrexate-refractory early rheumatoid arthritis: 2-year results of the register-enriched randomised controlled SWEFOT trial [online ahead of print April 15, 2014]. Ann Rheum Dis. doi: 10.1136/annrheumdis2013-205060.

41. Lapadula G, Ferraccioli GF. Biosimilars in rheumatology: pharmacological and pharmacoeconomic issues. Clin Exp Rheumatol. 2012;30:S102-S106.

42. Scheinberg MA, Kay J. The advent of biosimilar therapies in rheumatology—“O brave new world.” Nat Rev Rheumatol. 2012;8:430-436.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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Inside

Patient Care 5 TIPS TO PREVENT CHILDHOOD OBESITY As much as 17% of all children and adolescents in the United States are affected by childhood obesity.

Health risks associated with the condition include high blood pressure, impaired glucose tolerance, breathing issues, joint problems, as well as a greater risk for social and psychological problems. The following tips are general guidelines to improve patients’ health and prevent childhood obesity:

1 Provide Physical Activity

2 Make a Healthy Food Choice

3 Be Engaged

Include more physical activity as part of your child’s routine.

Children and adolescents should have 60 minutes or more of physical activity daily. Physical activity may include aerobic activity (brisk walking, running), muscle strengthening (gymnastics, pushups), and bone strengthening (jumping rope, running).

Educate yourself and your family about healthy choices, such as serving water instead of drinks with added sugar, providing fruits and vegetables, as well as limiting foods high in fat and sugar.

Take some time to visit the childcare centers and learn more about the foods and drinks they serve to determine if it includes healthier choices, as well as whether they limit TV and video time.

4 Monitor Media Time

5 Be a Voice in the Community

â

The American Academy of Pediatrics recommends that children get no more than 1 to 2 hours of quality programming daily—at home, school, or childcare.

As a member of the community, you can also work with schools to limit foods and drinks with added sugar, fat, and salt that can be purchased outside the school lunch program.

MORE ONLINE

More patient tips are available online at insidepatientcare.com Source: Centers for Disease Control and Prevention. Childhood overweight and obesity. www.cdc.gov/obesity/childhood/index.html. Accessed January 7, 2015.

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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TRANSFORMING RETAIL PHARMACIES INTO HEALTHCARE DELIVERY COMPANIES TM

PHARMACY & CLINICS

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: FEvans@the-lynx-group.com IP submissions_Asize_11215

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Patient Care Systemic Lupus Erythematosus and Pregnancy: Considerations in the Care of High-Risk Populations

by DEANNA L. OWENS, MSN, RN

SYSTEMIC LUPUS erythematosus (SLE), often seen in women of childbearing age, is an autoimmune disease that affects multiple organ systems. To ensure optimal maternal and fetal health outcomes, proper disease management is key when caring for this high-risk population. Ideally, providers and patients should work together to plan a pregnancy when the disease is in remission. Adequate disease control is crucial as the risk for a flare seems to relate to the level of maternal disease activity in the 6 to 12 months before conception.1 Healthcare providers should be well versed in pertinent issues related to SLE management throughout pregnancy because of the increased risk for disease-related mortality and morbidity. Immunologic and hormonal changes related to pregnancy may lead to increased frequency of SLE

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flares; however, the severity of symptoms remains unchanged. Increases in cortisol, progesterone, and estradiol during pregnancy may lead to Th1/ Th2 cytokine shifts.1 With SLE being a predominantly Th2-driven disease, some researchers believe these shifts contribute to symptomatic relapse during pregnancy.

One of the major risks for women with SLE during pregnancy is preeclampsia, marked by elevated blood pressure and proteinuria. Mothers are approximately 30% more likely to develop preeclampsia during pregnancy compared with 5% in the general population.2 Although lowering the risk for preeclampsia can be challenging, a recent review pertaining to the use of low-dose aspirin during SLE pregnancy suggests a 20% risk reduction for preeclampsia in patients with lupus.

Additional risks during

ONE OF THE MAJOR RISKS FOR WOMEN WITH SLE DURING PREGNANCY IS PREECLAMPSIA, MARKED BY ELEVATED BLOOD PRESSURE AND PROTEINURIA. SLE pregnancies in­clude preterm birth, hy­ per­ tension, premature rupture of membranes, diabetes mellitus, antiphospholipid syndrome, retina damage or detachment, deep vein thrombosis, and stroke. All SLE pregnancies are considered high risk, and labs should be obtained as soon as pregnancy is confirmed: 24-hour urine protein, urinalysis, complete blood count, creatinine, liver

function test, antideoxyribonucleic acid, anti-SSA/Ro and anti-SSB/ La antibodies, and antiphospholipid antibodies.

Antibody screening is an important predictor of potentially harmful maternal and fetal complications, including antiphospholipid syndrome (APS) and neonatal lupus. APS is an autoimmune thrombolytic syndrome with clinical manifestations that include recurrent miscarriage, fetal prematurity, maternal and/or fetal thrombosis, HELLP syndrome (H, hemolysis; EL, elevated liver enzymes; LP, low platelet count), fetal distress, and intrauterine growth restrictions.3 The preferred treatment regimen includes low-dose aspirin and heparin in combination with frequent prenatal visits for necessary monitoring. With appropriate management, >70% of patients will deliver a viable, live baby.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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Inside

Patient Care Infants born to SLE mothers with positive anti-SSA/Ro and anti-SSB/ La antibodies are at risk for symptoms associated with neonatal lupus. Maternal antibodies begin crossing the placenta as early as 11 weeks and can lead to rash, various blood or liver abnormalities, and permanent cardiac abnormalities in the infant.4 Congenital heart block develops in approx­imately 2% of infants and requires frequent fetal echocardiograms throughout the pregnancy to help determine if pacemaker implantation will be warranted postdelivery.

Ms Owens is Director, Infusion and Clinical Services, Low Country Rheumatology, Charleston, SC; and Member, Board of Directors, Rheumatology Nurses Society.

34

Medication Safety Common medications in the treatment of SLE include combinations of methotrexate, hydroxychloroquine, leflunomide, azathioprine, mycophenolate, corticosteroids, var­ ious nonsteroidal antiinflammatory drugs, and belimumab. Careful consideration should be taken when educating patients on the teratogenic effects of specific medications associated with the management of SLE. In particular, methotrexate must be discontinued at least 3 to 6 months prior to conception, and leflunomide should be stopped at least 2 years prior to pregnancy.5 Ideally, patients should discuss pregnancy

HEALTHCARE PROVIDERS SHOULD BE WELL VERSED IN PERTINENT ISSUES RELATED TO SLE MANAGEMENT THROUGHOUT PREGNANCY BECAUSE OF THE INCREASED RISK FOR DISEASERELATED MORTALITY AND MORBIDITY. options with their healthcare providers because of the delicate balance of maintaining low-disease activity and the discontinuation of potentially teratogenic medications.

Although corticosteroids are considered a Category C medication, low doses up to 15 mg daily are considered safe throughout pregnancy, and are often used to lessen the severity of SLE symptoms.5 Hydroxychloroquine— although compatible with pregnancy—is still considered Category C because of associated congenital malformations

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

seen with chloroquine.

Intravenous belimumab is a ß-lymphocyte–specific inhibitor used to treat adult patients with moderate-to-severe SLE who are also on a combination of disease maintenance medications. Providers should discuss the potential risks versus benefits of continuing belimumab (Category C) therapy with patients as there are no human studies or pregnancy data available.

Another teaching point for both providers and patients is the availability of pregnancy exposure registries. The Organization of Teratology Information Specialists is dedicated to providing evidence-based information to mothers, healthcare providers, and the general public about medication exposures dur­ ing pregnancy. ❚

References

1. Doria A, Incani A, Lockshin M. Challenges of lupus pregnancies.

Rheumatology (Oxford). 2008;47(suppl 3):iii9-12.

2. Stanhope TJ, White WM, Moder KG, et al. Obstetric nephrology: lupus and lupus nephritis in pregnancy. Clin J Am Soc Nephrol. 2012;7:2089-2099.

3. Fosca D, Valenti O, Hyseni E, et al. Antiphospholip­id syndrome during pregnancy: the state of the art. J Prenat Med. 2011;5:41-63.

4. Capone C, Buyon J, Friedman D, et al. Cardiac manifestations of neonatal lupus: a review of autoantibody-associated congenital heart block and its impact in an adult population. Cardiol Rev. 2012;20:72-76.

5. Hazes JM, Coulie PG, Geenen V, et al. Rheumatoid arthritis and pregnancy: evolution of disease activity and pathophysiological considerations for drug use. Rheumatology (Oxford).

2011;50:1955-1968.

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Inside

Patient Care Integrating Behavioral Health into Retail Clinics

“

This kiosk begins to address the existing gap in prevention

services, and calls attention to the need for the emerging retail clinic market to include behavioral health services.”

by JOE PYLE, MA

ACCORDING to recent reports, 26% of adults 18 years and older are living with a diagnosable mental health condition in any given year1 and more than 70% of those individuals do not seek treatment.2 Researchers suggest that patients may not seek treatment because of the associated stigma, lack of behavioral health literacy, and a shortage of community-based behavioral health providers.3 Early intervention is desperately needed because 25% of all years of life are lost as a result of disability and premature mortality related to behavioral health disorders.4 At the same time, retail clinics are becoming a major player in today’s healthcare system, with more than 2800 clinics expected to be in operation across the country by 2015.5 However, this emerging market for healthcare does not traditionally offer compre-

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hensive screening and referral services for behavioral health disorders. The Scattergood Foundation saw this as a significant gap in the system, and we decided to focus our 3rd Annual Design Challenge on filling this gap.

When the Scattergood Foundation partnered with The Family Practice & Counseling Network and their Qcare Clinic, we did not know what integrated behavioral healthcare would look like in a retail clinic, so we let the community decide. The foundation made a call for ideas, crowd-sourced the ideas that were submitted, and with the help of online voting and expert review, a winner was selected.

The Philadelphia De­ partment of Behavioral Health and Intellectual disAbility Services partnered with Screening for Mental Health, Inc, to submit the winning idea,

which was a behavioral health wellness kiosk.

Through funds raised using Indiegogo and with a small grant from the foundation, all of the partners worked to implement the behavioral health wellness kiosk at the Qcare Clinic located in the Fox Street ShopRite in north Philadelphia.

The retail clinic is now equipped with an iPad containing a comprehensive and evidence-based screening tool for several mental health conditions, including depression, generalized anxiety disorder, alcohol misuse, and several other disorders using the most upto-date resources available in the Philadelphia area. Through a series of short, anonymous questions, Qcare clients and ShopRite customers are now able to take a screening test and be connected to local neighborhood resources.

Although far from perfect, this kiosk begins to address the existing gap in prevention services, and calls attention to the need for the emerging retail clinic market to include behavioral health services. ❚

References

1. Kessler RC, Berglund P, Demler O, et al. Lifetime prevalence and age-ofonset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005; 62:593-768.

2. Henderson C, Evans-Lacko S, Thornicroft G. Mental illness stigma, help seeking, and public health programs. Am J Public Health. 2013; 103:777-780.

3. Corrigan PW. How stigma interferes with mental health care. Am Psychol.

2004;59:614-625.

4. World Health Organization. The world health report 2004 - changing history. www.who.int/whr/2004/en/.

Accessed October 14, 2014.

5. Nalle A, Boston D. Retail clinic counts will double between 2012 and 2015 and save $800 million dollars per year. www.accenture.com/ SiteCollectionDocuments/PDF/ Accenture-Retail-Medical-ClinicsFrom-Foe-to-Friend.pdf. Accessed October 14, 2014.

Mr Pyle is President, Thomas Scattergood Behavioral Health Foundation, Philadelphia, PA.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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Inside

Patient Care Hiccups

by JOSEPH BUBALO, PHARMD, BCPS, BCOP

Symptom Overview Hiccups are an under­ reported respiratory complication that can sig­ nificantly impair an individual’s quality of life.

Responsible for at least 4000 hospital admissions annually, they often are not considered significant in the need to care for a patient’s other pressing comorbidities such as malignancy.1 Etiology Hiccups occur secondary to an involuntary spasm of the diaphragm and intercostal muscles, which is followed by the sudden closure of the glottis generating the “hic” sound. These involuntary spasms occur at a rate of 4 to 60 per minute and predominantly involve the left hemidiaphragm.1 The pathogenesis of hiccups is complex with a variety of etiologies, resulting in the neurophysiologic effect of the condition (Table 1).1-4 The hiccup reflex arc is composed of efferent and afferent limbs, as well as a central hiccup center. The nerves

36

that are involved in this reflex include the vagus, phrenic, and elements of the sympathetic nervous chain—primarily in the thoracic region.1,5 This chain of nerves can be activated at multiple points, making the true cause of an individual’s hiccups hard to discern and treat. In addition, there is a male predominance of those with hiccups in most reports.1 Most hiccups are benign and self-limiting with cessation in minutes; however, some can last longer and become persistent or intractable hiccups, which are defined as lasting longer than 48 hours and 1 month, respectively.1,5 When diagnosing intractable hiccups, a careful physical and laboratory review should be performed to evaluate the myriad of possible causes. Intractable hiccups can result in anxiety, increased depression, sleep loss, impaired nutrition and fluid intake, aspiration, and induction of cardiac arrhythmias via activation of underly-

Table 1. Causes of Hiccups1-4 Cancer Multiple tumor types, especially those that may involve the abdomen, thoracic, or central nervous system Metabolic derangements Electrolyte disorders (especially hyponatremia), uncontrolled diabetes, uremia, or hypoadrenalism Central nervous system disorders Meningitis, encephalitis, stroke, hemorrhage Pulmonary and cardiothoracic disorders Myocardial infarction, pericardial disease, pneumonia, pleural inflammation/effusion, mechanical ventilation Gastric disease Esophagitis, gastric distension, ascites, subdiaphragmatic processes, obstruction, pancreatitis Surgical Anesthesia, epidural injections, thoracic procedures Medications Antibiotics, barbiturates, corticosteroids, anabolic steroids, antineoplastics (platinums, cyclophosphamide, taxanes, vinca alkaloids, topoisomerase inhibitors, gemcitabine), opioids, benzodiazepines, perphenazine, aripiprazole, clozapine, risperidone, and inhaled anesthetics

ing cardiac pathology.1,5 This may result in significant impairment, and more rarely, death of the patient.

Treatment Options Self-limited hiccups do not require intervention as they will generally resolve without causing significant distress. Although there is little scientific evidence

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

to support their use, it is common for people to try a variety of nonpharmacologic interventions to resolve their hiccups.

Common interventions include the pressure or stimulation of different body areas, sudden frightening experiences, ingestion of sugar or a glass of liquid, black pepper– induced sneezes, or breath-

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Inside

Patient Care Table 2. Treatments of Hiccups Agent

Evidence

Dose

Amantadine

Case reports

100 mg orally, twice daily

Amitriptyline2,11

Case reports

25-90 mg daily

Sedation, dry mouth, orthostatic hypotension

Use with caution in the elderly

Baclofen2,12,13,20

Case reports and series, 1 doubleblind placebocontrolled trial (4 patients)

5 mg (twice daily) to 10 mg (4 times daily) 15-30 mg daily usual range, maximum 60 mg

Sedation, confusion, EPS, hypotension

May be used in combination with other agents May take 2-3 days for full effect

Carvedilol14

Case report

6.25 mg (4 times daily)

Hypotension, bradycardia

Also managed tardive effects of chronic chlorpromazine and metoclopramide

Chlorpromazine2,5,6,12,15

FDA-approved, 50-patient uncontrolled report

12.5-50 mg every 4-6 hours as needed

Sedation, EPS, postural Increased risk for systemic hypotension or tardive effects in patients aged >55 years Effective 80% in 1 series

Gabapentin2,7,10,16

Case series and reports

900-1200 mg daily, dosed 3 times daily

Sedation

Haloperidol2,15

Multiple case reports

2-10 mg daily

Sedation, hallucinations, EPS

Methylphenidate9

Case report

5-20 mg daily, 5 mg twice daily

Dose early in the day to avoid sleep disturbances

Metoclopramide4,12,15,17

Multiple case reports

10 mg every 4-6 hours, up to 80 mg daily

Generally well tolerated.

Increased sedation and EPS above 60 mg daily

Midazolam2,8,15

Case reports

15 mg daily subcutaneously

Sedation

Sedating doses used initially followed by continuous infusion

Nifedipine18

Case report

10-20 mg 3 times daily

Hypotension

May need continuous use

Nimodipine

Case report

30 mg (orally, 3 times daily) or 10 mg intravenous continuous infusion

Olanzapine17,20

Multiple case reports

2.5-10 mg daily, as 1 or 2 doses

Sedation, EPS

Successfully combined with baclofen

10

19

Side effects

Comments Has shown benefits in patients with Parkinson disease

EPS indicates extrapyramidal symptoms.

ing into a paper bag.1 Patients with persistent or intractable hiccups often require pharmacologic intervention to alleviate the con-

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dition or complications.

The only US Food and Drug Administrationâ&#x20AC;&#x201C; approved hiccup remedy is chlorpromazine, which may not be useful in

many patients because of its associated side effects listed in Table 2.2,4-20 There are no randomized, adequately powered clinical trials to determine

the efficacy of pharmaceuticals for the treatment of hiccups. Many agents have been tried, with anecdotal success, and are hypothesized to work

INSIDE PATIENT CARE: PHARMACY & CLINICS â?&#x161; January 2015

37

Inside

Patient Care via a variety of neural mechanisms to decrease the activity of irritated nerves via sodium, calcium, or gamma-aminobutyric acid (GABA)enervated pathways (Table 2). Each agent has a different risk-to-benefit ratio, and when assessing which agent to use, it is important to consider the patient’s level of organ function, tolerance to side effects, and risk for drug interactions.

Older anticonvulsants such as phenytoin, valproic acid, and carbamazepine were previously used, but have largely been replaced with dopamine antagonists (eg, chlorpromazine, haloperidol, metoclopramide), GABA enhancers (baclofen, gabapentin), or calcium channel blockers (nifedipine, nimodipine).

In severe cases, intravenous lidocaine, which blocks sodium channels, has been used to resolve postoperative hiccups, although this practice is limited because of the risk for cardiac side effects.1 Nebulized lidocaine has also been used in the palliative care setting to manage refractory hiccups.1 Although diazepam is a well-documented cause of hiccups, midazolam has been used to terminate hiccups and may be useful in the setting of terminal sedation or delirium.8 Methylphenidate may be

38

useful to try in the sedated patient.6 Acupuncture has been an effective nonpharmacologic intervention in some patients, and the use of phrenic nerve blocks has been helpful in intractable hiccups.21 Multiple agents have been combined in attempts to manage hiccups with variable effects; however, the limiting factor is generally the additive side effects, especially sedation.20 Currently, there is little guidance on which agent should be used initially for hiccups of different etiologies. Because of the larger body of literature, most practitioners use chlorproma­ zine, metoclopramide, or baclofen as the initial treatment modality; a trial of multiple single agents or combinations of agents is also common. Some practitioners believe that baclofen may be the most effective agent, although it is slower to take effect than other agents.2 Most agents are continued for several days after cessation of hiccups, then weaned off as tolerated.

Some patients’ hiccups will recur, requiring the medication to be restarted. The goal is then to wean to the lowest effective dose.

In conclusion, although there are many reports of agents that help with the management of intracta-

ble hiccups, little current evidence exists regarding which agent, at what dose, and for which etiology should be used initially in patients. Agent and dose selection should be based on individual patient risks and comorbidities to achieve the best effect with minimal adverse consequences. ❚

References

1. Marinella MA. Diagnosis and management of hiccups in the patient with advanced cancer. J Support Oncol.

2009;7:122-127, 130.

2. Walker P, Watanabe S, Bruera E. Baclofen, a treatment for chronic hiccup. J Pain Symptom Manage.

1998;16:125-132.

3. Silverman MA, Leung JG, Schak KM. Aripiprazole-associated hiccups: a case and closer look at the association between hiccups and antipsychotics. J Pharm Pract. 2014;27:587-590.

4. Cersosimo RJ, Brophy MT. Hiccups with high dose dexamethasone administration: a case report. Cancer.

1998;82:412-414.

5. Rousseau P. Hiccups. South Med J. 1995;88:175-181.

6. Friedgood CE, Ripstein CB. Chlorpromazine (thorazine) in the treatment of intractable hiccups.

JAMA. 1955;157:309-310.

7. Moretti R, Torre P, Antonello RM, et al. Gabapentin as a drug therapy of intractable hiccup because of vascular lesion: a three-year follow up.

Neurologist. 2004;10:102-106.

8. Wilcock A, Twycross R. Midazolam for intractable hiccup. J Pain Symptom Manage. 1996;12:59-61.

9. Maréchal R, Berghmans T, Sculier P. Successful treatment of intractable hiccup with methylphenidate in a lung cancer patient. Support Care Cancer.

2003;11:126-128.

10. Wilcox SK, Garry A, Johnson MJ. Novel use of amantadine: to treat hiccups. J Pain Symptom Manage. 2009; 38:460-465.

11. Stalnikowicz R, Fich A, Troudart T. Amitriptyline for intractable hiccups. N Engl J Med. 1986;315:64-65.

12. Oneschuk D. The use of baclofen for treatment of chronic hiccups. J Pain Symptom Manage. 1999;18:4-5.

13. Ramírez FC, Graham DY. Treatment of intractable hiccup with baclofen: results of a double-blind randomized, controlled, cross-over study.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

Am J Gastroenterol. 1992;87:1789-1791.

14. Stueber D, Swartz CM. Carvedilol suppresses intractable hiccups. J Am Board Fam Med. 2006;19:418-421.

15. Moro C, Sironi P, Berardi E, et al. Midazolam for long-term treatment of intractable hiccup. J Pain Symptom Manage. 2005;29:221-223.

16. Tegeler ML, Baumrucker SJ. Gabapentin for intractable hiccups in palliative care. Am J Hosp Palliat Care.

2008;25:52-54.

17. Rizzo C, Vitale C, Montagnini M. Management of intractable hiccups: an illustrative case and review. Am J Hosp Palliat Care. 2014;31:220-224.

18. Mukhopadhyay P, Osman MR, Wajima T, et al. Nifedipine for intractable hiccups. N Engl J Med. 1986; 314:1256.

19. Hernández JL, Fernández-Miera MF, Sampedro I, et al. Nimodipine treatment for intractable hiccups. Am J Med. 1999;106:600.

20. Thompson AN, Ehret Leal J, Brzezinski WA. Olanzapine and baclofen for the treatment of intractable hiccups. Pharmacotherapy. 2014; 34:e4-e8.

21. Schiff E, River Y, Oliven A, et al.

Acupuncture therapy for persistent hiccups. Am J Med Sci. 2002;323:166-168.

Reprinted with permission from Bubalo J. Hiccups. Journal of Hematology Oncology Pharmacy. 2014;4(4):118-120.

Dr Bubalo is Assistant Professor of Medicine, Division of Hematology and Medical Oncology, Oncology Clinical Pharmacy Specialist, Oregon Health and Science University Hospital, OHSU Hospital and Clinics, Portland, OR.

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INSIDE

CLINICAL CHALLENGE Polypharmacy [43]

The Retail Pharmacy Questions Answered: Pharmacists Are Key to Achieving Value-Based Care In a recent interview with Inside Patient Care: Pharmacy & Clinics, Robert Thompson, Executive Vice President of Pharmacy at Rite Aid, discussed his responsibilities, the evolution of retail pharmacies, as well as innovative services offered at Rite Aid. What is your background in retail and role at Rite Aid? A: I became the Executive Vice President of Pharmacy at Rite Aid in 2009. Before holding this position, I worked in the chain drug industry offand-on since 1978, holding a variety of operational roles, including 20 years at Revco Drugstores as its Corporate Vice President of Pharmacy Operations.

After Revco, I worked outside of retail pharmacy, including a period of time as Senior Vice President and Chief Operating Officer at DentalCare Partners, and for 5 years I served as President and Chief Executive Officer of Complient Corporation in Cleveland, OH. Complient was sold to a public company called Cardiac Science, and after that, I came to Rite Aid, where I have held a variety of positions.

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As the Executive Vice President of Pharmacy at Rite Aid, I am responsible for the pharmacy functions, including pharmacy operations, clinical services and healthcare initiatives, government affairs, pharmacy purchasing, and managed care and pharmacy financial services. I also oversee our 2 subsidiaries, RediClinic and Health Dialog.

How have retail pharmacies evolved to accommodate changes in healthcare delivery?

A: I always say chain pharmacies are community pharmacies, too. We want— and our pharmacists want—to be members of the community, and we work very hard to ensure that our pharmacists are providing a level of care and service that the community not only deserves but needs. As you look at the evolution

Robert Thompson

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

39

Inside the Retail Pharmacy of healthcare in the United States, we believe that consumers are going to become increasingly engaged in managing their own healthcare, and that is probably going to be the biggest transformation that affects our industry and healthcare delivery overall.

If we can provide a proper store environment with the right resources, we will be able to deliver a variety of healthcare services that we think will bring big benefits not only to the consumers who use those services, but also in the overall effort to improve access to healthcare, to improve the quality of the healthcare that is delivered, and to drive affordability and lower overall population health costs.

There are 4 areas we are focusing on in our effort to deliver on our goal of providing the best experience possible for our pharmacy customers. Number one, we think about expanding the role of the Rite Aid pharmacist. We seek the best

We seek the best trained, most professional, most clinically oriented people to be the pharmacists in our stores. trained, most professional, most clinically oriented people to be the pharmacists in our stores. We certainly agree with all the Gallup polls regarding the high trust that patients put in their pharmacists. We believe that our accessibility, and having a highly skilled professional pharmacist available to engage with the patient and to help manage their healthcare, is paramount. And so, expanding the role of the pharmacist to deliver more services is very important to Rite Aid. The second area is providing services that meet the needs of different patient populations. There are a lot of people who are interested in wellness, but there are also a lot of people who have 1 or more chronic diseases and need our help. We need to be able to meet their needs based on the level of care that

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

they need. Rite Aid Health Alliance is a new program that is designed specifically to address the needs of chronic and polychronic patients. Rite Aid pharmacists work with specially trained Care Coaches and physicians on an ongoing basis to help patients develop the skills they need to better understand and manage their disease. Our care team members collaborate with the patient to establish health goals, eliminate barriers, and create a personalized healthcare action plan in coordination with the patient’s physician—based on objectives established by the physician. If we are successful, these people will have healthier lives, and we will help lower overall healthcare costs.

To date, we have 7 physician groups participating in Rite Aid Health Alliance and offer the service at more than 60 Rite Aid pharmacies.

The third area is RediClinic, or the retail convenient care clinic. We acquired RediClinic in April 2014 and we are very excited about it, because it is another service we can provide our patients with. Currently available inside select Rite Aid stores in the greater Philadelphia, PA, and Baltimore, MD, areas, RediClinics offer care for common conditions and preventive wellness services through board certified nurse practitioners and physician assistants. We are very pleased that we could become aligned with RediClinic and look forward to bringing this care model to additional Rite Aid customers in the future.

Lastly, we are taking a close look at telehealth, because we really believe it is here to stay—it is the way of the future.

Our work with telehealth began a few years ago, through a pilot with Optum Health and NowClinic. We learned a lot through that partnership and refined our telehealth strategy as a result. Most recently, we announced an exciting new partnership with HealthSpot, an innovator in patient- and provider-driven healthcare technology. HealthSpot stations offer convenient healthcare services via private, walk-in HealthSpot stations, using high-definition video

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Inside the Retail Pharmacy conferencing and interactive medical devices. We are excited to introduce the HealthSpot stations to our customers in Akron, Canton, Cleveland, Dayton, and Springfield, OH, in the first quarter of 2015.

What innovative services do Rite Aid pharmacists provide patients?

A: On a broad scale, the primary area of focus has been immunization, and we have worked very hard to make a broad range of immunizations accessible and affordable in all the communities we serve.

Rite Aid pharmacists have done a great job building our immunization program. We provide a broad range of immunizations, including 13 different immunizations depending on state regulation. The more work we do on immunization, the more we find that there is still a great deal of misunderstanding and misinformation surrounding immunizations in the community. Statistics indicate that vaccination rates are dropping, and we are committed to doing everything we can to ensure that immunizations are widely available, and that people can get them at their convenience, but most importantly that they actually get them. To this end, last fall we introduced Vaccine Central, a multifaceted online platform designed to help raise awareness about vaccines and promote vaccinations. Available at riteaid.com, visitors can complete an immunization evaluation, track their personal immunization history, and find other educational resources on immunizations.

In addition to immunizations, another innovative program we have undertaken is medication therapy management, which includes comprehensive medication reviews. We are designing our own programs and services to make sure that we have the opportunity to close gaps in care and identify opportunities to improve medication compliance and adherence. We participate in all of the available medication therapy management programs like Mirixa and

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Outcomes, and work with our pharmacists to deliver those interventions.

Our pharmacists really have to be at the forefront of driving appropriate medication use, and we are working very hard to educate them on how to deliver these interventions in an effective way. Every Rite Aid pharmacist has also attended motivational interviewing training, because we believe that these conversation techniques help our pharmacists identify obstacles patients may be encountering.

We have a lot of innovative programs and services we are exploring, all with the goal of expanding the role of the pharmacist.

We have also invested in new technology in our pharmacies to support additional medication therapy management program interventions.

Recently, we rolled out quite a unique program called “Quit for You.” It is a consultative approach to determine patients’ readiness to change or quit tobacco products, and it is delivered by the pharmacist. It offers patients a variety of options about how to approach smoking cessation based on their individual readiness and prior quitting attempts.

We have a number of other pilot programs in place around the country, including pharmacogenomic testing. In this pilot program, the pharmacist is trained to collect a DNA sample using a buccal swab. Our pharmacist then works with the physician in the event that the patient does not have the proper geno­ mic profile for the particular medication, in making the appropriate therapeutic change.

We are excited about opportunities like these. We have a lot of innovative programs and services we are exploring, all with the goal of expanding the role of

+ MORE ONLINE

To read the full interview, please visit our website.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

41

Inside the Retail Pharmacy the pharmacist, making best use of technology, improving access to healthcare services, and providing affordable and convenient options for the patients in our communities.

How do retail clinics contribute to disruptive healthcare innovation?

A: The time for the convenient care retail clinic model, like RediClinic, has finally come. I think consumers are beginning to understand the value of the model. What we are trying to do is be part of an overall healthcare delivery network. Given the accessibility problem and the shortage of primary care physicians in the United States, we know that RediClinic can be part of the solution.

To be clear, we do not want to displace our patients from their primary care physicians, and that’s why we work hard to ensure that our approach is one rooted in collaboration—not competition. However, there is opportunity; if a patient’s primary care physician is not available—because there is a flu epidemic, for instance, and they are not available for 2 days—our clinics present an attractive alternative.

In addition, we think that if we are collaborative with physicians, then hopefully we can be a gateway for those people looking to find a primary care physician. We want to make sure that if a patient comes in, is new to the community, and needs a primary care relationship, that we can meet their immediate needs and perhaps help them find the right primary care relationship to help manage their health going forward.

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

A: We are aiming to create a network of RediClinics that are integrated into the overall healthcare system within a particular community, with the ability to easily exchange electronic medical records, and ensure a continuum of care between RediClinics and primary care

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

or specialty care.

Today, the nurse practitioner clinic model or the convenient care clinic model is focused on acute care. That is really important. It is a very cost-effective way to provide acute care treatment.

Going forward, I believe we will see a shift in care models, with chronic care management opportunities moving closer to where the patient actually lives.

Ultimately, this should lead to more effective overall management of those patients.

Once electronic medical record interoperability issues are solved, there is going to be a dramatic transformation of healthcare delivery, and improved care coordination. Improved exchange of medical records will position nurse practitioners to support additional chronic care management activities in addition to our pharmacists. In the same way, improved medical device technology will lead to improved diagnostic and biometric capabilities.

Simply put, today, healthcare exists in a lot of silos. The healthcare delivery system of tomorrow is ideally without silos. That means everyone has to really have the same motivation and the same idea about how care is best delivered and best managed. That’s going to be challenging, but it is achievable. ❚

“Everything we are working on, from immunizations to medication therapy management, disease management, and health coaching, is all about trying to constantly improve health outcomes for patients, and measure them,” Robert Thompson concluded. “Pharmacists are key to solving the cost of healthcare problem in the United States.

If we can get patients to take their medicines, stay on their therapies, and help them avoid medication misadventures, we can not only improve their health and well-being, but we can help save billions of dollars in healthcare costs every year.”

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Inside the Retail Pharmacy

Clinical Challenge: Polypharmacy

How would you have managed this patient?

Commentary by B. JOSEPH GUGLIELMO, PHARMD

The Case A 65-year-old man with schizophrenia receives his routine outpatient psychiatric care through an agency.

His case manager visits him weekly regarding medication adherence, which includes biweekly visits to his clinic for administration of his risperidone depot injection. He receives all his oral medications dispensed in weekly blister packs from his local pharmacy; however, the risperidone is provided by a separate “specialty pharmacy” that dispenses all long-acting injectable antipsychotics for the agency.

At his usual visit to his local pharmacy to obtain his oral medications, his pharmacist dispensed not only the usual oral medications but also the risperidone depot injection kit. The patient accepted the risperidone without disclosing this fact to his caregiver or case manager. On return to home, he reconstituted the powdered medication and self-administered the risperidone into his gluteus.

Two days later, when contacted with a reminder regarding his upcoming injection (at the clinic), he reported his self-administration of the risperidone.

The pharmacist at his local pharmacy was contacted and verified that the

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risperidone had been dispensed directly to the patient, even though it had never been previously filled by this pharmacy.

This was a near miss, in that the patient did not receive the duplicate injection.

The local pharmacy was advised to not dispense the injectable medication to the patient in the future.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

43

Inside the Retail Pharmacy Take-Home Points • The community pharmacy is the most likely site for a complete, accurate medication list; however, this list is fully accurate only 25% of the time.

• Using multiple pharmacies (unless it involves a chain with an integrated medication list) is likely to further reduce the likelihood that a medication list will be accurate.

• The use of specialty pharmacies results in the inevitable use of multiple pharmacies in the provision of medications.

• An inaccurate community pharmacy medication list and using multiple pharmacies are sources for medication error.

• Patients should preferentially use a single pharmacy (or a pharmacy chain that maintains an integrated medication profile), request pharmacist consultation, and collaboratively ensure the accuracy of the medication list upon receipt of prescribed medications.

The Commentary While duplicate medication administration was avoided and the patient reported no adverse effect from his self-administered risperidone, a different scenario could have resulted in patient harm. A number of lessons can be learned from this medication error, including those associated with optimal outpatient management of

How accurate is the community pharmacy medication profile? mental illness. However, the focus of this discussion centers upon errors associated with an incomplete medication profile and the risk associated with the use of multiple pharmacies.

Community pharmacies maintain patient medication records; the use of such records helps eliminate the administration of unnecessary drugs, avoids serious drug–drug interactions, and enhances medication safety. Medication reconciliation has been mandated by The Joint

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

Commission and other agencies in an effort to ensure that patients have accurate, actionable, and up-to-date medication lists. In a perfect world, the community pharmacist is in an optimal position to ensure the quality of this list.

But, how accurate is the community pharmacy medication profile? Although one recent evaluation determined that outpatient pharmacy medication lists were significantly more likely to be accurate compared with that compiled by primary care providers, they were still frequently flawed. In fact, the community pharmacy had a fully accurate list only 25% of the time (versus only 8% with primary care providers).1 In an evaluation of patients using primary care providers and community pharmacies outside a university healthcare system (i.e., providers with no access to the hospital’s electronic medical record [EMR]), patients with prescribers outside the university healthcare system had a greater number of medication discrepancies than patients exclusively with healthcare system prescribers.2 This demonstrates that the already low degree of accuracy of a physicians’ medication lists is further compromised if primary care providers do not have access to a hospital EMR. Although community pharmacies offer an improved, albeit still often inaccurate, medication list, what is the likelihood this list will be accurate in patients who use multiple pharmacies? One study found that 67% of patients obtained medications from one pharmacy, 29% from two, and 4% from three pharmacies.1 The use of more than one community pharmacy can only reduce the likelihood that the medication list will be accurate. An additional issue is the fact that some expensive drugs (like the depot injections of risperidone) are provided via a specialty pharmacy, as was the case in this patient. Specialty pharmacies are intended to oversee medications with special handling, storage, and distribution requirements.

In most instances, medications man-

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Inside the Retail Pharmacy aged by specialty pharmacies are associated with high cost or with special requirements for handling. Other reasons for using a specialty pharmacy include: using a medication to treat a rare disease, special requirements for assessment of response, unique drug administration training, monitoring of adverse effects, or FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) programs.3 The reason the patient received the risperidone from the specialty pharmacy centered on the intramuscular depot route of administration. Because the risperidone was provided by the specialty pharmacy and all other medications were from the local pharmacy, the medication list was incomplete and inaccurate. The lack of a complete accurate medication list and the use of multiple pharmacies resulted in the described medication error.

To avoid these types of errors, patients should, whenever possible, utilize one pharmacy for all their medication needs. When multiple pharmacies are employed, patients should preferentially use those in whom the medication profile is shared throughout the system.

Many chain community pharmacy networks utilize such integrated systems.

In addition, upon receipt of a filled prescription, the patient should request consultation with the pharmacist and

review not only the specifics of the filled prescription but also the currency and accuracy of the entire active medica-

To avoid these types of errors, patients should, whenever possible, utilize one pharmacy for all their medication needs. tion list. Similarly, healthcare providers should advocate that patients use a primary pharmacy, pharmacist consultation, and collaborative clarification of the current medication list. â?&#x161; Dr Guglielmo is Dean, School of Pharmacy, Professor of Clinical Pharmacy, University of California, San Francisco.

References

1. Balon J, Thomas SA. Comparison of hospital admission medication lists with primary care physician and outpatient pharmacy lists. J Nurs Scholarsh. 2011;43:292-300.

2. Johnson CM, Marcy TR, Harrison DL, Young RE, Stevens EL, Shadid J. Medication reconciliation in a community pharmacy setting. J Am Pharm Assoc (2003).

2010;50:523-526.

3. EMD Serono Specialty Digest, 8th Edition. 2012.

Reprinted with permission of AHRQ WebM&M. Guglielmo BJ. Polypharmacy AHRQ WebM&M [serial online]. May 2013. Available at: http:// webmm.ahrq.gov/case.aspx?caseID=300

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: fevans@the-lynx-group.com with your clinical challenge

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INSIDE PATIENT CARE: PHARMACY & CLINICS â?&#x161; January 2015

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Inside

Drug Update Sivextro (Tedizolid Phosphate) Approved by the FDA for the Treatment of Adults with Acute Bacterial Skin and SkinStructure Infections

by LORETTA FALA, Medical Writer

An acute bacterial skin and skin-structure infection (ABSSSI) is a bacterial infection of the skin with a lesion size of ≥75 cm2, which is measured by the area of redness, edema, or induration.1 }} }} THE TYPES OF infections that comprise ABSSSIs include cellulitis or erysipelas, major cutaneous abscesses, and wound infections1; these infections can be lifethreatening and may require hospitalization and surgery.2 Streptococcus pyogenes and Staphylococcus aureus, including methicillinresistant S aureus (MRSA), are the most common bacterial pathogens responsible for ABSSSIs. The less common ABSSSI-causing pathogens include other Streptococcus

species, Enterococcus faecalis, and gram-negative bacteria.1 In the United States, more than 2 million individuals are infected with antibiotic-resistant bacteria annually, and at least 23,000 die annually as a direct result of these infections.3 Cellulitis, a skin infection that is primarily attributed to streptococci, is most often caused by Streptococcus and Staphylococcus; however, the incidence of MRSA as the cause of cellulitis is increasing.4 The prevalence rate of leg erysipelas or

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

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cellulitis, which can occur anywhere on the body but usually affects the lower leg, is estimated to be more than 1 per 1000 persons annually.5 S aureus, particularly MRSA, is associated with major health complications and mortality. Furthermore, S aureus infections are particularly challenging to treat because of their potential for resistance to antimicrobial drugs.6 In addition, S aureus imposes a substantial economic burden on patients and on hospitals. In intensive care units, an estimated 59.5% to 64.4% of S aureus strains are methicillin-resistant.6 A study

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

sponsored by the Centers for Disease Control and Prevention (CDC) showed that S aureus–related hospitalizations increased 62% between 1999 and 2005, and MRSA-related hospitalizations more than doubled during this period.6 Furthermore, S aureus– related deaths averaged 10,800 and MRSA-related deaths averaged 5500 annually.6 Most MRSA infections involve ABSSSI.7 MRSA continues to be a major public health concern in the United States. According to the CDC, an estimated 75,309 individuals in the United States are infected with invasive

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Drug Update MRSA infections annually.8 Despite its high in­ cidence, life-threatening, hospital-acquired MRSA infections declined 54% between 2005 and 2011, with 9000 fewer MRSAassociated deaths among hospitalized patients in 2011 than in 2005.8 Recent evidence indicates that communityacquired MRSA strains are spreading into healthcare institutions.9 Consequently, there is an urgent need to reduce the inappropriate use of antimicrobial agents and to increase awareness about MRSA in the community setting, including in daycare centers, schools, and environments with at-risk individuals (eg, the elderly, immunodeficient persons).6,9 More expensive to treat than susceptible infections, antimicrobial drug-resistant infections are associated with a 30% to 100% increase in mortality, illness, and direct costs.10 In a study that assessed 1,472,965 hospitalization episodes, of which 23,026 had skin and skin-structure infections as a secondary diagnosis, patients with skin and skin-structure infections had significantly (5 days) longer hospital stays, a higher mortality rate (5.4% vs 3.5%, respectively), and higher (excess of >$21,000) hospital costs compared with matched controls.11

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The management of ABSSSIs presents several challenges. For example, aside from its link to drugresistant gram-positive pathogens, an ABSSSI often requires antimicrobial or antibiotic therapy.

Antibiotic resistance and adverse effects may limit the use of some antibiotic agents—factors that underscore the need for novel therapies to help combat drug-resistant pathogens.2,7

ANTIMICROBIAL DRUG-RESISTANT INFECTIONS ARE ASSOCIATED WITH A 30% TO 100% INCREASE IN MORTALITY, ILLNESS, AND DIRECT COSTS.

Tedizolid Phosphate: A New Treatment Option for ABSSSIs On June 20, 2014, the US Food and Drug Administration (FDA) approved tedizolid phosphate (Sivextro; Cubist Pharmaceuticals) for the treatment of adults with an ABSSSI that is caused by designated susceptible bacteria.12 To reduce the development of drugresistant bacteria and maintain the effectiveness of tedizolid phosphate and other antibacterial drugs, tedizolid phosphate should only be used to treat or to prevent infections that are proved or strongly suspected to be caused by bacteria.12,13 According to Edward Cox, MD, MPH, Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, “Today’s approval provides physicians and pa-

tients with a new treatment option for serious skin infections.”12 Barbara Murray, MD, Professor and Director of the Division of Infectious Diseases, University of Texas Health Science Center Medical School, Houston, and President of the Infectious Diseases Society of America, commented that this news is “encouraging.” She added, “We still have a great deal more work to do to combat antibiotic resistance and ensure we have the tools necessary to help the patients who need it the most.”14 Tedizolid phosphate was approved by the FDA under its expedited review process. Based on its designation as a qualified infectious disease drug for the treatment of serious or life-threatening infections, tedizolid phosphate was also granted an additional 5-year exclusivity

period in addition to its currently specified exclusivity period.12

Dosing and Administration Tedizolid phosphate is available in 2 dosage forms—as a 200-mg, sterile, lyophilized powder in a single-use vial for reconstitution for intravenous (IV) infusion, and as a 200-mg tablet.13 The oral tablet of tedizolid phosphate is administered once daily for 6 days, and the IV infusion is administered once daily for 1 hour for a duration of 6 days.13 Mechanism of Action Tedizolid phosphate is the prodrug of tedizolid, which is a member of the oxazolidinone class of antibacterial agents.13 Tedizolid’s antibacterial activity is mediated by binding to the 50S subunit of the bacterial ribosome, resulting in the inhibition of protein synthesis. Tedizolid inhibits bacterial protein synthesis through a mechanism of action different from that of other nonoxazolidinone classes of antibac­ terial drugs; therefore, cross-resistance between tedizolid and other classes of antibacterial drugs is unlikely. The results of in vitro time-kill studies show that tedizolid is bacteriostatic against entero-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

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Inside

Drug Update Table 1. Early Clinical Response in the ITT Patient Population: Tedizolid Phosphate versus Linezolid (Trials 1 and 2) Patients/responders

Tedizolid phosphate 200 mg

Linezolid 1200 mg

Treatment difference (2-sided 95% CI)

No increase in lesion surface area from baseline and oral temperature of ≤37.6°C, confirmed by a second temperature measurement within 24 hrs at 48-72 hrsa Trial 1, N • Responder, N (%) Trial 2, N • Responder, N (%)

323

326

256 (79.3)

258 (79.1)

332

334

286 (86.1)

281 (84.1)

0.1 (–6.2 to 6.3) 2.0 (–3.5 to 7.3)

≥20% decrease from baseline in lesion area at 48-72 hrsb Trial 1, N • Responder, N (%) Trial 2, N • Responder, N (%)

323

326

252 (78.0)

246 (75.5)

332

334

283 (85.2)

276 (82.6)

2.6 (–4.0 to 9.1) 2.6 (–3.0 to 8.2)

Primary end point for Trial 1; sensitivity analysis for Trial 2.

Primary end point for Trial 2; sensitivity analysis for Trial 1.

CI indicates confidence interval; ITT, intent-to-treat.

Source: Sivextro (tedizolid phosphate) prescribing information; June 2014. a

b

Table 2. Clinical Response at Posttherapy Evaluation: Tedizolid Phosphate versus Linezolid (Trials 1 and 2) Tedizolid phosphate 200 mg, n/N (%)

Linezolid 1200 mg, n/N (%)

Treatment difference (2-sided 95% CI)

• Intent-to-treat

277/323 (85.8)

279/326 (85.6)

0.2 (–5.3 to 5.6)

• Clinically evaluable

257/270 (95.2)

260/273 (95.2)

‒–0.0 (–3.9 to 3.7)

• Intent-to-treat

292/332 (88.0)

293/334 (87.7)

0.3 (–4.8 to 5.3)

• Clinically evaluable

268/290 (92.4)

269/280 (96.1)

‒–3.7 (–7.7 to 0.2)

Patient population, by trial Trial 1

Trial 2

CI indicates confidence interval.

Source: Sivextro (tedizolid phosphate) prescribing information; June 2014.

cocci, staphylococci, and streptococci.13

Key Clinical Studies The safety and efficacy of tedizolid phosphate were evaluated in 2 multicenter, multinational, double-

48

blind, noninferiority clinical trials that involved 1315 adults with ABSSSIs.2,15 In both studies, tedizolid 200 mg once daily for 6 days was compared with linezolid 600 mg every 12 hours for 10 days.

Patients with cellulitis or erysipelas, major cutaneous abscess, or wound infection were enrolled in the clinical trials. Patients with wound infections could have received aztreonam and/or metronidazole as

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

adjunctive therapy for gram-negative bacte­rial coverage, if needed. The intent-to-treat (ITT) patient population included all randomized patients.2,15

The ESTABLISH-1 Clinical Trial The ESTABLISH-1 clinical trial (Trial 1) showed that tedizolid phosphate 200 mg once daily for 6 days was noninferior to linezolid 600 mg every 12 hours for 10 days in early clinical response (ie, 48-72 hours after initial treatment for an ABSSSI), indicating that tedizolid phosphate may be a useful alternative to linezolid for appropriate patients.2,13 In Trial 1, patients received oral tedizolid phosphate. A total of 323 patients with ABSSSI were randomized to tedizolid phosphate, and 326 patients were randomized to linezolid. The majority (91%) of the patients who received tedizolid phosphate were aged <65 years; the median age was 43 years. In these patients, the overall median surface area of infection was 190 cm2.2,13 The infection types included cellulitis or erysipelas (40%), wound infection (30%), and major cutaneous abscess (30%).

In addition to the local signs and symptoms of infection, patients were also required to have at least 1

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Drug Update Table 3. Early Clinical Response by Baseline Pathogen in the MITT Population: Tedizolid Phosphate versus Linezolid (Trials 1 and 2) No increase in lesion surface area from baseline and oral temperature of ≤37.6°Ca

≥20% decrease from baseline in lesion areab

Tedizolid phosphate 200 mg, n/N (%)c

Linezolid 1200 mg, n/N (%)

Tedizolid phosphate 200 mg, n/N (%)c

Linezolid 1200 mg, n/N (%)

Staphylococcus aureus

274/327 (83.8)

276/339 (81.4)

279/327 (85.3)

273/339 (80.5)

• MRSA

111/140 (79.3)

112/144 (77.8)

114/140 (81.4)

109/144 (75.7)

• Methicillin-susceptible S aureus

163/187 (87.2)

166/197 (84.3)

165/187 (88.2)

166/197 (84.3)

Streptococcus pyogenes

27/33 (81.8)

18/20 (90.0)

25/33 (75.8)

16/20 (80.0)

Streptococcus anginosus

22/30 (73.3)

26/28 (92.9)

22/30 (73.3)

25/28 (89.3)

Streptococcus agalactiae

6/9 (66.7)

8/10 (80.0)

6/9 (66.7)

7/10 (70.0)

Enterococcus faecalis

7/10 (70.0)

3/4 (75.0)

6/10 (60.0)

1/4 (24.0)

Baseline pathogen

NOTE: Pooled analysis: n = number of patients in the specific category; N = number of patients with the specific pathogen isolated from the ABSSSI population. a Primary end point of Trial 1. b Primary end point of Trial 2. c Baseline bacteremia in the tedizolid arm with relevant pathogens included 2 patients with MRSA, 4 patients with methicillin-sensitive S aureus, 2 patients with S pyogenes, and 1 patient with Streptococcus constellatus; all of these patients were responders at 48 to 72 hours.

ABSSSI indicates acute bacterial skin and skin-structure infection; MITT, microbiologic intent-to-treat; MRSA, methicillin-resistant S aureus.

Source: Sivextro (tedizolid phosphate) prescribing information; June 2014.

regional or systemic sign of infection at baseline, defined as lymphadenop­ athy (87% of patients), a temperature of ≥38°C (16%), a white blood cell (WBC) count of >10,000 cells/mm3 or <4000 cells/ mm3 (43%), or ≥10% band forms on a WBC differential (4%).2,13 The primary end point of the study was early clinical response, defined as no increase from the baseline lesion area at 48 to 72 hours after the first dose of tedizolid phosphate and an oral temperature of ≤37.6°C, to be confirmed by a second temperature measurement within 24 hours in

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the ITT population.2,13 The key findings from Trial 1 are shown in Table 1.

The ESTABLISH-2 Clinical Trial In the ESTABLISH-2 clinical trial (Trial 2), tedizolid phosphate 200 mg for 6 days was shown to be noninferior to twice-daily linezolid 600 mg for 10 days, demonstrating that tedizolid phosphate may be a useful therapeutic option for the treatment of an ABSSSI in the hospital and the outpatient settings.13,15 In Trial 2, patients could have received oral tedizolid phosphate thera-

py after a minimum of 1 day of IV tedizolid phosphate therapy. A total of 332 patients with an ABSSSI were randomized to tedizolid phosphate, and 334 patients were randomized to linezolid.

The majority (87%) of the patients who received tedizolid phosphate were aged <65 years; the median age was 46 years. The patients’ overall median surface area of infection was 231 cm2.13,15 The infection types included cellulitis or erysip­ elas (50%), wound infection (30%), and major cutaneous abscess (20%).

In addition to the local signs and symptoms of in-

fection, patients were also required to have at least 1 regional or systemic sign of infection at baseline, defined as lymphadenopathy (71% of patients), temperature of ≥38°C (31%), WBC count of >10,000 cells/mm3 or <4000 cells/ mm3 (53%), or ≥10% band forms on a WBC differential (16%).13,15 The primary end point of this study was early clinical response, which was defined as a ≥20% decrease from the baseline lesion area at 48 to 72 hours after the first dose in the ITT population.13,15 The key findings from Trial 2 are also shown in Table 1.

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Drug Update Investigator Assessment of Clinical Response An investigator assessment of clinical response was conducted at the posttherapy evaluation (ie, 7-14 days after the end of therapy) in the ITT population and in the clinical­ly evaluable population.

Clinical success was defined as the resolution or near resolution of most disease-specific signs and symptoms; the absence or near resolution of systemic signs of infection if present at baseline (eg, lymphadenopathy, fever, >10% immature neutrophils, abnormal neutrophils, abnormal WBC count); and no new signs, symptoms, or complications attributable to an ABSSSI that would require further treatment of the primary lesion (Table 2).2,13,15 Clinical Success, by Baseline Pathogens Early clinical response by baseline pathogens from the primary infection site or blood cultures for the microbiologic ITT patient population in Trials 1 and 2 are shown in Table 3.2,13,15 Adverse Events The most common (≥2%) adverse reactions associated with tedizolid phosphate are nausea, headache, diarrhea, vomiting, and dizziness.13

50

Tedizolid phosphate has no contraindications.

Warnings and Precautions Patients with neutropenia. The safety and efficacy of tedizolid phosphate in patients with neutropenia (ie, neutrophil counts of <1000 cells/ mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of tedizolid was reduced in the absence of granulocytes. An alternative therapy should be considered in patients with neutropenia.13 Clostridium difficile– associated diarrhea.

Treatment with antibacterial agents can alter the normal flora of the colon and may permit overgrowth of C difficile, which contributes to the development of C difficile–associated diarrhea (CDAD).

Patients who present with diarrhea after taking antibiotics should be evaluated for CDAD. If CDAD is suspected or confirmed, antibacterial medications not directed against C difficile should be discontinued, if possible. Appropriate measures should be instituted as clinically indicated.13 Use in Specific Populations Pregnancy. No adequate and well-controlled

BASED ON ITS EARLY AND SUSTAINED CLINICAL RESPONSE, TEDIZOLID PHOSPHATE WAS SHOWN TO BE AS EFFECTIVE AS LINEZOLID FOR THE TREATMENT OF AN ABSSSI. studies were conducted with tedizolid phosphate in pregnant women. Tedizolid phosphate should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.13 Nursing mothers. It is not known whether tedizolid phosphate is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when tedizolid phosphate is administered to a nursing woman.13 Pediatric use. The safety and effectiveness of tedizolid phosphate in pediatric patients aged <18 years have not been established.13 Geriatric use. Clinical studies of tedizolid phos-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ January 2015

phate did not include sufficient numbers of patients aged ≥65 years to determine whether they respond different from younger patients. No overall differences in pharmacokinetics were observed between elderly patients and younger patients.13

Conclusion A new treatment option for ABSSSIs became available in June 2014 when the FDA approved tedizolid phosphate. The safety and efficacy of tedizolid phosphate were evaluated in 2 clinical trials that involved 1315 patients with an ABSSSI. Based on its early and sustained clinical response, tedizolid phosphate was shown to be as effective as linezolid for the treatment of an ABSSSI. Tedizolid phosphate is available as an injection for IV use and in tablet form for oral administration. The most common adverse reactions associated with tedizolid treatment include nausea, headache, diarrhea, vomiting, and dizziness. ❚ References

1. Center for Drug Evaluation and Research. Guidance for industry. Acute bacterial skin and skin structure infections: developing drugs for treatment.

October 2013. www.fda.gov/down loads/Drugs/.../Guidances/ucm071185. pdf. Accessed July 22, 2014.

2. Prokocimer P, De Anda C, Fang E, et al. Tedizolid phosphate vs linezo­ lid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial.

JAMA. 2013;309:559-569.

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Drug Update 3. Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013.

Updated June 2, 2014. www.cdc.gov/ drugresistance/threat-report-2013/pdf/ ar-threats-2013-508.pdf. Accessed July 22, 2013.

4. Mayo Clinic staff. Diseases and conditions: cellulitis. February 23, 2012. www.mayoclinic.org/diseases-con ditions/cellulitis/basics/causes/con20023471?p=1. Accessed July 23, 2014.

5. Gabillot-Carré M, Roujeau J-C. Acute bacterial skin infections and cellulitis. Curr Opin Infect Dis. 2007; 20:118-123.

6. Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused

by methicillin-resistant Staphylococcus aureus, United States, 1999-2005.

Emerg Infect Dis. 2007;13:1840-1846.

7. O’Riordan W, Green S, Mehra P, et al. Tedizolid phosphate for the management of acute bacterial skin and skin structure infections: efficacy summary. Clin Infect Dis. 2014;58(suppl 1):S43-S50.

8. Centers for Disease Control and Prevention.

Methicillin-resistant Staphylococcus aureus (MRSA) infections: MRSA tracking. Updated April 30, 2014. www.cdc.gov/mrsa/tracking/ index.html. Accessed July 22, 2014.

9. Carleton HA, Diep BA, Charlebois ED, et al. Community-adapted methicillin-resistant Staphylococcus aureus

(MRSA): population dynamics of an expanding community reservoir of MRSA. J Infect Dis. 2004;190:17301738.

10. Cosgrove SE, Carmeli Y. The impact of antimicrobial resistance on health and economic outcomes. Clin Infect Dis. 2003;36:1433-1437.

11. Hatoum HT, Akhras KS, Lin S-J. The attributable clinical and economic burden of skin and skin structure infections in hospitalized patients: a matched cohort study. Diagn Microbiol Infect Dis. 2009;64:305-310.

12. US Food and Drug Administration.

FDA approves Sivextro to treat skin infections. Press release. June 20, 2014. www.fda.gov/NewsEvents/Newsroom/

PressAnnouncements/ucm402174. htm. Accessed July 3, 2014.

13. Sivextro (tedizolid phosphate) tablet or for injection [prescribing information]. Lexington, MA: Cubist Pharmaceuticals US; June 2014.

14. Smith M. FDA OKs tedizo­lid for skin infections. June 21, 2014. MedPage Today. www.medpagetoday.com/Infec tiousDisease/General InfectiousDisease/ 46430. Accessed July 22, 2014.

15. Moran GJ, Fang E, Corey GR, et al. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial.

Lancet Infect Dis. 2014;14:696-705.

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