IPC Dec 2014 | Vol 2 | No 6

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December 2014 VOL. 2 • NO. 6

INFECTIOUS

18 Five Tips to

Prevent the Flu This Season

19 Questions

Disease

Answered: Immunization in the Community Setting

38 Specialty

Pharmacy: 5 Steps to Consider Before Changing Your Business Model

Facing Concerns About the Ebola Virus PAGE 10

41 Ten Tips

to Cut Your 2014 Taxes

© 2014 Novellus Healthcare Communications, LLC an affiliate of

CPE AVAILABLE PAGE 24

TRANSFORMING RETAIL PHARMACIES INTO HEALTHCARE DELIVERY COMPANIES TM

PHARMACY & CLINICS

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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Submit a 750- to 1500-word original article, previously unpublished and submitted exclusively to Inside Patient Care: Pharmacy & Clinics, that your fellow colleagues will want to read.

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

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

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

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TRANSFORMING RETAIL PHARMACIES INTO HEALTHCARE DELIVERY COMPANIES

December 2014

TM

Volume 2 Number 6

PHARMACY & CLINICS

INSIDE

Infectious Disease

INFECTIOUS

COLUMNS

Disease

13 THE ROLE OF THE PHARMACIST AND RETAIL CLINICIANS IN TRAVEL HEALTH

PAGE

8

THE FIRST WORD

Pharmacists are in an excellent position to offer travel health services, because of their visibility and accessibility to the public.

Donald J. Dietz, RPh, MS

The Impact of Changing Color or Pill Shapes on Medication Persistence

Patient Care

18 FIVE TIPS TO PREVENT THE FLU 2 CALL FOR SUBMISSIONS

19 QUESTIONS ANSWERED: IMMUNIZATION IN THE COMMUNITY SETTING

6 EDITORIAL BOARD 7 LETTER FROM THE EDITOR

Jonathan L. Temte, MD, PhD, Chair of the US Advisory Committee on Immunization Practices, discusses the importance of the retail healthcare team.

24 CONTINUING EDUCATION

STARTS

21 PERSONALIZED MEDICINE: ARE WE THERE YET?

31 THE SHIFT TO VALUE-BASED CARE

34 WHAT HAPPENS WHEN HEALTHCARE MEASUREMENTS DON’T KEEP UP WITH GUIDELINES? A closer look at the Appropriate Treatment of Hypertension in Diabetes Medicare Part D star rating.

COVER STORY I INFECTIOUS DISEASE

Facing Concerns About the Ebola Virus in the Community Setting ❚

❚

38 THE SPECIALTY PHARMACY CONUNDRUM

Five steps to consider before changing your business model.

43 DRUG UPDATE

ON PAGE

The Pharmacy The unique position of pharmacists in the community setting provides excellent opportunities to improve medication adherence and safety.

10

41 MONEY

❚

H ow to use patient education as a way to contain the Ebola outbreak How to recognize the signs and symptoms of the disease, and understand how they differ from influenza symptoms B ecome familiar with frequently asked questions to effectively communicate the facts to patients

Inside Patient Care: Pharmacy & Clinics, ISSN (requested), is published 6 times a year by Novellus Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Novellus Healthcare Communications, LLC. All rights reserved. Inside Patient Care: Pharmacy & Clinics is a trademark of Novellus Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

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DISPENSE Albuterol Sulfate HFA as PROAIR HFA Inhalation Aerosol

NO GENERIC ALBUTEROL INHALER CURRENTLY EXISTS

ProAir® is a registered trademark of Teva Respiratory, LLC. ©2014 Teva Respiratory, LLC PRA-40585

the Editorial Board

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

“ PAGE 8

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

6

Changing the drug product

appearance could lead to patient confusion and concern about product safety and efficacy.”

—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 ❚ December 2014

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

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Letter from the Editor Launching Inside Patient Care: Pharmacy & Clinics: Practical Information for the Entire Retail Team

by FREDERIQUE H. EVANS, MBS, Editorial Director

We are pleased to announce the relaunch of Inside Pharmacy to Inside Patient Care: Pharmacy & Clinics. }} }} THE JOURNAL will seek to provide 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 will offer a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including pharmacists, medical directors, physician assistants, nurse practitioners, and C-level executives, to implement their best therapeutic options, navigate the healthcare system, and achieve professional success.

“Retail pharmacies and clinics are quickly becoming an extension of primary care. Inside Patient Care: Pharmacy & Clinics is tailored to meet the growing needs of the entire healthcare team and provides practical information to treat and care for patients inside the pharmacy and retail clinics,” according to our Editorin-Chief, Donald J. Dietz, RPh, MS. As retail pharmacies transform into healthcare delivery centers, the journal will provide a forum for phar-

InsidePatientCare.com

macists, medical directors, physician assistants, nurse practitioners, and C-level executives to achieve professional success. Each issue of the journal will enable the retail healthcare team to provide optimal patient care,

“Retail pharmacies and clinics are quickly becoming an extension of primary care.”

—Donald J. Dietz, RPh, MS

including how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; efficiently use healthcare resources; and attract, retain, and engage patients, shoppers, and customers.

Inside Patient Care: Pharmacy & Clinics will provide a balanced, high-level overview of value-based health drivers—cost, quality, and

access—and the impact of healthcare sector initiatives—clinical, business, and policy—that are reshaping the responsibilities of the new primary care providers and other stakeholders.

The journal will provide practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics.

“This journal is specifically tailored to the entire healthcare team inside the retail pharmacies and clinics—it provides practical information for all the stakeholders of primary care,” the publisher of the journal stated. “Inside Patient Care: Pharmacy & Clinics is an essential resource as retail pharmacies transform into healthcare delivery companies.”

Inside Patient Care: Pharmacy & Clinics will publish 12 times in 2015 and mail to more than 77,000 medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives. We are currently accepting manuscripts for 2015. For more information, please refer to our author guidelines. The official website of Inside Patient: Pharmacy & Clinics is www.InsidePatientCare.com. ❚

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

7

The First Word The Impact of Changing Color or Pill Shapes on Medication Persistence

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

T

“

It is important for pharmacists to personally

counsel the patient or caregiver at prescription pickup that the prescription product appearance has changed, but that it is the same item as prescribed.”

he US Food and Drug Administration (FDA) is preparing to survey pharmacists and patients on vari­ations in the physical characteristics of generic drugs and patient perceptions. This is important to retail pharmacy, since approximately 85% of all prescriptions dispensed are generic medications.1 When a generic drug is dispensed as a substitute for a brand medication, it is pharmaceutically equivalent (ie, same active ingredient, strength, dosage form, and route of administration) and bioequivalent.

The FDA Orange Book assigns “A” ratings to products that are pharmaceutically equivalent, bioequivalent, and that can be substituted.2 Although the FDA validates bioequivalence of pharmaceutically equivalent products to determine the A rating, the physical appearance such as color, shape, or size of the tablet or capsule may vary. The concern is that changing the drug product appearance could lead to patient confusion and concern about product safety and efficacy.3

8

4 factors to consider: ❚ The Orange Book ratings ❚ The supporting data on patient adherence ❚ The importance of pill characteristic continuity when feasible ❚ The dispensing pharmacist’s role to counsel patients

Supporting Evidence A recent study has shown that patients are more likely to stop taking a generic medication when the physical appearance of the drug product changes, which can have a negative impact on patients’ health and lead to an increase in overall healthcare costs.4 In the study, which was published in Annals of Internal Medicine, Aaron S. Kesselheim, MD, JD, MPH, Associate Professor of Medicine at Harvard Medical School, Boston, MA, and colleagues followed

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

patients who were discharged after myocardial infarction. The study evaluated patients between 2006 and 2011 treated with a generic ß-blocker, angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or statin, and found that the odds of nonpersistence increased by 34% after a change in pill color, and 66% after a change in pill shape.

The survey of pharmacists and patients on the variations in the physical characteristics of generic drug pills and patients’ perceptions conducted by the FDA may enable them to investigate factors that explain the association between changes in pill appearance and nonadherence, including which factors could be modified to improve the safe and effective use of generic drugs.5

The Pharmacist’s Role What can retail pharmacists do with this information? If you are one of the 2100 pharmacists who receive the survey, taking the time to complete and return it will help provide additional insight into the issue.

There has been an increasing trend of generic product shortages,

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The First Word price changes, and suppliers exiting the market that lead to changes in suppliers at retail pharmacies.

Although the Kesselheim study was conducted from 2006 to 2011, I suspect the challenge of tablet and capsule color, shape, and size variations has increased in the past 3 years. If, as a pharmacist, your role involves choosing the generic drugs purchased at your pharmacy, continuity in pill characteristics may become a more important consideration if you have a choice in suppliers and there is minimal variation in purchase price.

When dispensing pharmacists encounter a change in the generic supplier of a product for a prescription refill, they follow their pharmacy guidelines for documenting the change in the pharmacy dispensing system. They also apply an auxiliary label to the vial, alerting the patient that the shape and/or color of the vial contents have changed, but the product is the same as previously received. This has been the baseline

standard of practice for decades.

Flagging prescriptions with product appearance changes on the outside of the prescription bag is a simple solution to alert the technician or cashier that a pharmacist would like to explain changes in product color/shape to the patient or caregiver. Based on the study findings, it is important for pharmacists to personally counsel the patient or caregiver at prescription pickup that the prescription product appearance has changed, but that it is the same item as prescribed.

Although it will most likely be months before the FDA survey results are released, taking steps in your pharmacy to better communicate to patients when a change in product shape, size, or color occurs is a proactive, positive step that fosters patient engagement and may help increase patients remaining on the prescribed medication.

As always, I am interested in your views, and you can reach me at ddietz@phsirx.com. ❚

References

1. Fischer MA, Choudhry NK, Brill G, et al. Trouble getting started: predictors of primary medication nonadherence. Am J Med. 2011;124:1081. e9-22.

2. US Food and Drug Administration. Orange Book preface. www.fda.gov/Drugs/DevelopmentApprovalProcess/ ucm079068.htm. Updated March 14, 2014. Accessed November 15, 2014.

3. US Department of Health & Human Services, US Food and Drug Administration, US Center for Drug Evaluation and Research. Guidance for industry: size, shape, and other physical attributes of generic tablets and capsules. www.fda.gov/downloads/drugs/guidancecompli anceregulatoryinformation/guidances/ucm377938.pdf.

Published December 2013. Accessed November 15, 2014.

4. Kesselheim A, Katsiaryna B, Jerry A, et al. Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case–control studies. Ann Intern Med. 2014;161:96-103.

5. Federal Register. Agency information collection activities: proposed collection; comment request; survey of pharmacists and patients; variations in the physical characteristics of generic drug pills and patients’ perceptions. www.federalregister.gov/articles/2014/10/15/2014-24365/ agency-information-collection-activities-proposedcollection-comment-request-survey-of-pharmacists.

Published October 15, 2014. Accessed November 15, 2014.

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

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9

Inside Infectious Disease

Facing Concerns About the Ebola Virus in the Community Setting

by JOCELYN HATFIELD, PHARMDc, and BRIAN A. POTOSKI, PHARMD, BCPS

Ever since the first case of Ebola in the United States was confirmed on September 30, 2014, the country has been on heightened alert about the possibility of an outbreak of the virus.1 }} KEY POINTS ❚ Patient education is an important part of containing the Ebola outbreak ❚ Know the signs and symptoms of the disease, and understand how they differ from influenza symptoms ❚ Become familiar with frequently asked questions to effectively communicate the facts to patients

10

}} WEST AFRICA is currently experiencing the largest Ebola outbreak in history.2 Many fear that with confirmed cases here in the United States, we may face the same epidemic. Pharmacists in the community and retail clinicians can play a vital role in containing an outbreak through patient education, effectively recognizing the signs and symptoms of the disease, and answering questions.

Recognition As the most accessible healthcare professional for most patients, pharmacists can play an important role in identifying individuals who may be infected with Ebola.2 Early detection is crucial, and pharmacists in the community can direct patients suspected of having Ebola to proper facilities for management and testing (see page 11

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

for a Clinical Checklist of signs and symptoms).3 It is also important to stress the need for symptom monitoring in patients who feel they may have been exposed to the virus. They should check their temperature daily, and report the detection of any symptoms to public health officials immediately.

Prevention With the fear of an outbreak lingering in the minds of the US population, patients may come to see their community pharmacist with questions about how to prevent contagion. Here are some key points to stress to patients who may express concerns about the disease4:

1/

Practice good hand hygiene. Wash your hands with soap and water or an

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Inside Infectious Disease alcohol-based sanitizer, and avoid contact with the bodily fluids of people who have, or may have, Ebola.

CLINICAL CHECKLIST

2/ Avoid traveling to areas with an

SIGNS AND SYMPTOMS OF EBOLA

3/

❚ Fever (>38.6°C or 101.5°F)

Ebola outbreak. These areas include the West African countries of Liberia, Sierra Leone, and Guinea.

If traveling to one of these areas is necessary, practice extreme caution by not entering hospitals where patients with Ebola may be receiving treatment, avoid coming into contact with individuals who may have the disease, and refrain from touching bats or nonhuman primates as they may carry Ebola. Individuals traveling to these areas should also monitor themselves for signs and symptoms of Ebola for 21 days after their return.

4/

Immediately report any signs or symptoms of Ebola to healthcare officials.

Frequently Asked Questions As individuals in the community begin asking more questions about the disease, it is important to know the facts in order to relay the appropriate information. The following are some questions that pharmacists in the community may be asked.5 How is Ebola transmitted? The Ebola virus is spread through direct contact with blood or bodily fluids (eg, tears, saliva, feces, vomitus, breast milk) of an individual infected with Ebola, objects that may be contaminated by the virus, and infected animals (ie, bats, and nonhuman primates). Ebola is not spread through the air or water, and there is currently no evidence that insects can carry the virus. It is important to note that the virus can only be spread from person to person when the infected individual is actively experiencing symptoms.

I may have been exposed to Ebola— how long should I look out for symptoms? Symptoms may present anywhere

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❚ Severe headache ❚ Diarrhea ❚ Vomiting ❚ Unexplained hemorrhage (bruising or bleeding) ❚ Muscle pain ❚ Weakness ❚ Abdominal pain

from 2 to 21 days after exposure. On average, symptoms appear between 8 to 10 days after exposure. It is important to monitor for symptoms closely, and to alert health officials immediately if any appear.

Is it safe to travel during the outbreak? The Centers for Disease Control and Prevention (CDC) have issued Warning Level 3 travel alerts, which urge avoidance of nonessential travel, for the countries in West Africa with the highest rates of infection.6 If individuals must travel to these areas, they should observe proper precautions.

Are there treatments available for Ebola? Currently, there is no vaccine or treatment available for Ebola.

Supportive care, such as fluid management, is essential for patients infected with the virus. Experimental medica-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

11

Inside Infectious Disease DIFFERENTIAL EBOLA VERSUS INFLUENZA SYMPTOMS Ebola

Influenza

Fever

Fever and chills

Severe headache

Headache

Muscle pain

Muscle and body aches

Diarrhea and vomiting

Diarrhea and vomiting (children > adults)

Weakness

Fatigue

Abdominal pain*

Sore throat*

Bleeding or bruising*

Runny or stuffy nose* Cough*

*Important differentiating symptoms.

tions have been used for the treatment of infected individuals in the United States, but they require permission from the US Food and Drug Administration (FDA) and are in limited supply.

I heard that I can buy medications online to prevent Ebola. Are they safe? The FDA has issued a statement warning consumers of fraudulent products that are being sold on the Internet intended to either prevent or treat the Ebola virus. There are no FDAapproved medications or vaccinations available for Ebola at this time.7

Dr Hatfield is a Student at the University of Pittsburgh School of Pharmacy, Pittsburgh, PA; Dr Potoski is Associate Professor, Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, PA.

12

What is being done in the United States to help prevent an outbreak?

The CDC has sent teams of public health experts to counties that are currently experiencing outbreaks to help control the spread of the virus. In addition, they have trained airport crews to recognize symptoms in individuals who may be infected. Screening procedures have been implemented in certain airports with the hope of isolating infected

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

individuals early, and offering information to travelers arriving from West African countries.

Ebola versus Influenza With flu season in full swing, it is important to be able to differentiate between symptoms associated with the influenza virus from those of Ebola.

There are many similarities between the 2 viruses; it is important to be able to tell them apart (see Differential, which contrasts the symptoms for Ebola and influenza).8 Conclusion Pharmacists can play a significant role in the containment of an Ebola outbreak. It is important for community clinicians to understand their patients’ concerns, and provide education about virus prevention. Although the CDC states that there is a low risk of an outbreak, it is important to take all necessary preventive actions at this time.9 ❚ References

1. Centers for Disease Control and Prevention. CDC and Texas Health Department confirm first Ebola case diagnosed in the US. www.cdc.gov/media/releases/2014/s930ebola-confirmed-case.html. Published September 30, 2014.

Accessed November 3, 2014.

2. American Pharmacists Association. Ebola primer: facts for pharmacists. www.pharmacist.com/Ebola-primerfacts-pharmacists. Published August 5, 2014. Accessed November 3, 2014.

3. Centers for Disease Control and Prevention. Ebola (Ebola virus disease). Signs and symptoms. www.cdc.gov/ vhf/ebola/symptoms/index.html. Accessed November 3, 2014.

4. Centers for Disease Control and Prevention. Ebola (Ebola virus disease). Prevention. www.cdc.gov/vhf/ebola/ prevention/index.html. Accessed November 3, 2014.

5. Centers for Disease Control and Prevention. Ebola (Ebola virus disease). www.cdc.gov/vhf/ebola/index.html.

Updated November 1, 2014. Accessed November 3, 2014.

6. Centers for Disease Control and Prevention. Travel health notices. wwwnc.cdc.gov/travel/notices. Updated October 22, 2014. Accessed November 3, 2014.

7. US Food and Drug Administration. FDA warns consumers about fraudulent Ebola treatment products. www. fda.gov/newsevents/newsroom/pressannouncements/ ucm410086.htm. Published August 14, 2014. Accessed November 3, 2014.

8. Centers for Disease Control and Prevention. Seasonal influenza (flu). Flu symptoms & severity. www.cdc.gov/flu/ about/disease/symptoms.htm. Updated August 13, 2014.

Accessed November 3, 2014.

9. Centers for Disease Control and Prevention. Questions and answers on Ebola. www.cdc.gov/vhf/ebola/outbreaks/ 2014-west-africa/qa.html. Update November 3, 2014.

Accessed November 4, 2014.

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Inside Infectious Disease

The Role of the Pharmacist and Retail Clinicians in Travel Health

by ADELE CHATELLIER, PHARMDc, and ANN JOHNSON, PHARMD

International travel has been increasing exponentially over the years, and it will continue to increase with the number of international tourists expected to reach 1.6 billion by 2020.1 }} }} IN THE UNITED STATES, citizens travel not only for tourism, but also for business, study abroad programs, research, visiting friends and family, and mission work. With travel increasing, there will be a greater demand for travel health services, and pharmacists and retail clinicians are in an excellent position to provide these services.2 Traveling poses a risk for various illnesses and health hazards, especially in certain patient populations such as pregnant women and persons with diabetes.

For healthcare practitioners to administer quality travel healthcare, they need to have specialized knowledge and training, and be up to date on the most recent risks associated with geographic areas.

advice to avoid spreading diseases and minimize environmental risks. They may also provide necessary warnings regarding the destination of travel and travel-related medications (prescription and nonprescription). Travel consultations also address nonbiologic health risks, discuss behavioral risk factors, and identify measures that special populations and those with chronic disease states must undertake.

Practical travel-related information, such as required documents and records, is also given. The Centers for Disease Control and Prevention (CDC) recommends that travelers consult a travel clinic 4 to 6 weeks before traveling to allow ample time for vaccines and/or medications to take effect before departure.

Travel Clinics Defined Travel clinics offer travel health services to minimize the risk of acquiring illnesses while traveling abroad.3 Clinics provide preventive health

Pharmacists’ Roles Pharmacists are in an excellent position to become involved in travel medicine because of their high accessibility and visibility to the public.

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KEY POINTS ❚ Pharmacists are in an excellent position to offer travel health services, because of their visibility and accessibility to the public ❚ Travel health clinics not only provide necessary immunizations for traveling abroad, but they also address nonbiologic health risks, discuss behavioral risk factors, and identify measures that special populations must undertake

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

13

Inside Infectious Disease Community pharmacies that are not equipped to run as travel clinics can still play an active role in travel medicine. Pharmacists can identify patients with travel plans who warrant pretravel medication and confirm that physicians have selected appropriate vaccines.

Pharmacists should update patients on travel vaccinations as well as routine vaccinations, such as the influenza vaccination.

By understanding the patient’s drug history, pharmacists can identify any drug–drug interactions before initiating preventive care or treatment. They can also better counsel patients on the efficacy of medications and discuss other nonpharmacologic ways to prevent malaria and other communicable diseases. Not only can every pharmacist assist with pretravel health needs, but they can also identify signs and symptoms of diseases when patients return.

Multidisciplinary teams that include pharmacists run many travel clinics, some of which are incorporated into community pharmacies. Many independent and community pharmacies are developing travel-related health services to attract business and increase profits.

Currently, a leading pharmacy chain advertises that they offer travel services at select locations. In addition to retail chain pharmacists, independent pharmacists and others can become integral members of the interprofessional teams at more traditional travel clinics.

Pharmacies offering travel health services are expanding because of a growing need. They are open longer hours than primary healthcare providers, in more accessible locations, and have many travel supplies available on-site, making it more convenient for patients to get the required pretravel care. Thorough risk assessments require patients to provide their medical history, immuniza-

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

tion history, and medication records, which are easily accessible at the traveler’s local pharmacy.

The travel risk assessment also requires identification of drug–drug and drug–disease interactions for therapy recommendations. Pharmacists are the healthcare professionals with the most medication knowledge, and they are specifically trained to correctly identify these interactions.

Conducting a pretravel consultation requires background knowledge of epidemiology, disease transmission, and preventive measures. Elements that pharmacists should address during a pretravel consultation include patients’ overall health, travel itinerary, and duration, season, and manner of travel. Pharmacists should address unmet vaccination needs, and provide education on preventive measures and health maintenance.4 From there, pharmacists can select appropriate prescription, over-the-counter, and ancillary prophylactic and therapeutic products related to other travel health needs.

Some common topics of discussion include ways for patients to protect themselves against foodborne, bloodborne, and respiratory infections during travel. Pharmacists should update patients on travel vaccinations as well as routine vaccinations, such as the influenza vaccination.

Pharmacists may also want to discuss ways to prevent travelers’ diarrhea, including dietary restrictions, use of self-treatment methods for prophylaxis, and the risks and benefits of prophylactic antibiotics. Currently, the CDC does not recommend the use of prophylactic antibiotics to prevent travelers’ diarrhea for most people. However, people who are on short trips and/or a part of high-risk special populations with immunosuppression may benefit from prophylactic therapy.

Malaria prevention is necessary for people departing to malaria-endemic regions, which encompass approximately half of the world’s population.5 The

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Inside Infectious Disease CDC estimates that about 1500 cases of malaria occur in the United States each year from patients becoming infected while traveling abroad.6 Malaria is estimated to cause 627,000 deaths worldwide each year.7 An infected person can also contaminate local mosquito populations, further spreading the disease. To choose the appropriate drug regimen, it is necessary to know the species of malaria that is common in the area, whether that species is resistant to antimalarial medications, current medications that could interact with prophylactic agents, and medical conditions that are contraindicated for travel to the area altogether. The duration of the trip is also important, since it can affect which antimalarial agent is chosen.

Some medications, such as mefloquine, require treatment for up to 4 weeks after an individual’s return home. This would be prohibitory for individuals planning

a short trip, in which case Malarone would be a better option. Prophylactic agents are not 100% effective, so pharmacist-provided counseling on personal protective measures is also necessary.

Packing Lists for Travelers Pretravel counseling should also address the practical matters of traveling. The CDC recommends that travelers pack certain health-related items to ensure safety (ie, they strongly recommend that travelers pack copies of prescriptions for all of their medications). Some countries prohibit certain medications (eg, narcotics), even if the patient has a valid medical need and prescription.8 Travel clinics can assist patients in identifying these forbidden medications.

If patients with diabetes require needles and syringes, they should pack these supplies along with a letter from their

TRANSFORMING RETAIL PHARMACIES INTO HEALTHCARE DELIVERY COMPANIES TM

PANIES TM

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NICS

December 2014 VOL. 2 • NO. 6

are.com

INFECTIOUS

18 Five Tips to

Prevent the Flu This Season

19 Questions

Disease

Answered: Immunization in the Community Setting

38 The Specialty

Pharmacy Conundrum: 5 Steps to Consider Before Changing Your Business Model

Facing Concerns About the Ebola Virus in the Community Setting PAGE 10

44 Ten Tips

to Cut Your 2014 Taxes

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e © 2014 Novellus Healthcar Communications, LLC an affiliate of

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, 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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Inside Infectious Disease physician and a copy of the prescription.8 All health insurance documents, claim forms, and a list of all current medications—including the drug, route of administration, formulation, strength, and frequency—should be carried with travelers at all times.

Patients should wear medical alert bracelets when appropriate. Pharmacies

Pharmacists can recommend products specific to patients’ needs depending on their destination and mode of travel. can help patients create a medication list if necessary, and they can also provide, first aid, preventive illness and injury supplies, and over-the-counter medications recommended for travel.

At a minimum, patients should pack medications for mild pain or fever, stomach upset, diarrhea, and upper respiratory irritations.8 Pharmacists can recommend products specific to patients’ needs depending on their destination and mode of travel. Finally, pharmacists should remind patients to check with their health insurance provider to determine if they have international coverage when appropriate.

Ann Johnson Ms Chatellier is a 2015 PharmD candidate from Duquesne University, Pittsburgh, PA; Dr Johnson is a consultant, Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.

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Pharmacist Resources Retail pharmacists may be unsure where to get started when implementing a travel health clinic. One of the premier resources for travel health education is the CDC’s biennially published book, CDC Health Information for International Travel, commonly referred to as The Yellow Book.

The Yellow Book is a guide to the practice of travel medicine, as well as the authoritative source of US government recommendations for immunizations and prophylaxis for foreign travel.9 Although the book can be used by travelers themselves, its main purpose

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

is to serve as a reference for healthcare workers.

From counseling tips to disease state references, The Yellow Book is indispensable for any healthcare worker advising patients on travel overseas. The book is an excellent resource not only for pharmacists who wish to open a travel health clinic, but also for those who just need a reference for the occasional travel-related patient question, such as retail clinicians.

Call to Action For pharmacists wishing to expand their business, they may want to consider specialized training that would enable them to offer travel health services in their pharmacy. The lack of knowledge about the risks of traveling and the limited availability of travel health clinics are barriers preventing patients from seeking travel health services. Pharmacists are in an excellent position to identify and educate travelers requiring travel health services. Ultimately, providing these extra clinical services will contribute to expanding the role of the pharmacist while potentially increasing pharmacy profits. ❚ References

1. World Tourism Organization. Tourism 2020 Vision. www.unwto.org/facts/eng/vision.htm. Accessed November 10, 2014.

2. Hamer DH, Connor BA. Travel health knowledge, attitudes and practices among United States travelers. J Travel Med. 2004;11:23-26.

3. Centers for Disease Control and Prevention. See a doctor before you travel. wwwnc.cdc.gov/travel/page/see-doctor.

Updated January 13, 2011. Accessed November 10, 2014.

4. Hill DR, Ericsson CD, Pearson RD, et al. The practice of travel medicine: guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006;43:1499-1539.

5. Hartjes LB. Preventing and detecting malaria infections.

Nurse Pract. 2011;36:45-53.

6. Centers for Disease Control and Prevention. CDC and malaria. www.cdc.gov/malaria/resources/pdf/fsp/cdc_malar ia_program.pdf. Published April 2014. Accessed November 10, 2014.

7. World Health Organization. 10 facts on malaria. www. who.int/features/factfiles/malaria/en/. Published March 2014. Accessed November 10, 2014.

8. Amanda Whatley Lee; Centers for Disease Control and Prevention. Travel health kits. wwwnc.cdc.gov/travel/yel lowbook/2014/chapter-2-the-pre-travel-consultation/travelhealth-kits. Updated August 1, 2013. Accessed November 10, 2014.

9. Centers for Disease Control and Prevention. CDC Health Information for International Travel 2014: The Yellow Book.

New York, NY: Oxford University Press; 2013.

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Inside

Patient Care 5 TIPS TO PREVENT THE FLU With influenza activity peaking between December and February, it is important for patients to be aware of the following tips to reduce their risk for catching the flu: 1 Get Vaccinated

2 Wash Your Hands

3 Cover Your Mouth, Nose

Patients 6 months and older should be vaccinated against the flu annually. This season, the vaccine protects against influenza A (H1N1, H3N2) viruses, as well as 1 or 2 influenza B viruses, depending on the vaccine.

Using soap and water, or alcohol-based hand sanitizer, wash your hands often to prevent the spread of germs.

Use the following simple steps: wet, lather, scrub, rinse, and dry.

4 Avoid Close Contact

5 Stay Home

Try to avoid close contact with people who are sick and, if you are sick, try to keep your distance from others to protect them from getting sick, too.

If you experience flu-like symptoms, stay home for at least 24 hours after your fever is gone, and limit contact with others to avoid infecting them.

When coughing or sneezing, make sure to cover your mouth and nose with a tissue, because it may help prevent people around you from getting sick.

In addition, patients should avoid touching their eyes, nose, â DOWNLOAD RESOURCES or mouth, as germs can often More patient tips are available online at spread this way.

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Sources: (1) Centers for Disease Control and Prevention. Seasonal influenza: flu basics. www.cdc.gov/flu/about/disease/index.htm. Accessed November 15, 2014; (2) Centers for Disease Control and Prevention. Preventing the flu: good health habits can help stop germs. www.cdc.gov/flu/protect/habits.htm. Accessed November 15, 2014.

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INSIDE PATIENT CARE: PHARMACY & CLINICS â?š December 2014

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Patient Care Questions Answered: Immunization in the Community Setting In a recent interview with Inside Patient Care: Pharmacy & Clinics, Jonathan L. Temte, MD, PhD, Chair of the US Advisory Committee on Immunization Practices, discusses the role of the committee and the importance of pharmacists and retail clinicians in immunization.

What is the role of the committee?

A: The US Advisory Committee on Immunization Practices (ACIP) evaluates vaccines and other closely related biologic products (eg, immune globulin preparations and/or antimicrobial agents) for the best deployment or best use in the civilian population of the United States.

In doing so, we primarily look at vaccines—either existing vaccines or newly licensed vaccines—licensed through the US Food and Drug Administration, and consider their safety, efficacy, and disease burden.

We also consider the cost-effectiveness of a vaccine program, as well as the practicality of implementing a recommendation. We are also concerned about equity, feasibility, and acceptability. By and large, we are the people who make the recommendations for patients across the United States in terms of use of standard immunizations.

How did you become the Committee Chair?

A: It began when I was asked to represent the American Academy of Family Physicians in March 2000 during a meeting at the Centers

Do you have any questions regarding ACIP and the latest immunization recommendations? Send them to info@inside patientcare.com.

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for Disease Control and Prevention (CDC) that dealt with the elimination of measles in the United States.

We were impaneled to review all the evidence available for the transmission of measles in the United States and had to reach a consensus on whether it met the criteria for pathogen elimination in our country. We were able to conclude that it was.

That was my very first activity dealing specifically with vaccines. I had initial training within family medicine in terms of infectious disease and immunology. From there, it just blossomed. I was also involved in the rubella elimination meeting in 2004. Also that year, I was asked to be the liai-

son between the American Academy of Family Physicians and the Advisory Committee on Immunization Practices. That’s a role that I held for approximately 4 years.

At that point, I was nominated to serve on the ACIP and was approved as a voting member. As it turned out, that is an appointment by the US Secretary of Health & Human Services. I was appointed to a 4-year term in 2008 and reappointed for a second term in 2012, as the incoming Chair.

I became the chair of ACIP in 2012. My term goes through next summer, at which point I will be rotating off ACIP. How are recommendations made?

A: The 15 voting members of the committee hold a vote and a recommendation requires a majority of votes. Most of the time, we do so with a fairly high level of consensus. It is most common that we have a unanimous decision. The most recent recommendation we made was for the use of live attenuated influenza vaccine for children 2 to 8 years of age, in preference to the inactivated form of the vaccine, if the live attenuated vaccine is imme-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

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Inside

Patient Care diately available. If it’s not, then we recommend the use of whichever vaccine is available. That was not a new vaccine and it was for a limited group of people, but it maximized the benefit of a vaccine policy.

Keep in mind that we review and update the routinely recommended immunization schedules for 2 population groups on an annual basis: children and adolescents, 0 through 18 years of age; then we have a second recommendation or several recommendations for adults 19 years and older. Each year, ACIP and the CDC cojointly review and approve any modifications to the 2 immunization schedules; it is also harmonized with a number of professional organizations.

For example, the child and adolescent schedule is a product not only of ACIP and the CDC but also the American Academy of Pediatrics and the American Academy of Family Physicians.

The adult schedule is cosponsored and co-approved by the CDC, the American Academy of Family Physicians, the American College of Physicians, the American College of Obstetricians and Gynecologists, and the American College of Nurse-Midwives.

The recommendations

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are the standard of practice in medicine and are a product of ACIP, but also approved and endorsed by our stakeholder organizations as well.

Why are these recommendations important in the community setting?

A: The recommendations that we make and the schedules we produce provide a blueprint of good medical practice in terms of the preventive services associated with vaccinations. ACIP does not express any strong opinion as to who should vaccinate and who should provide the vaccines.

Rather, it is a road map to achieve good coverage.

Traditionally, we do an excellent job of providing immunization in children, especially the routine vaccines from birth through age 6 years. Those are largely done in the offices of pediatricians and family physicians. As we get into older age groups, however, I think we see much more opportunity for retail pharmacies to be involved. The coverage that we have with some of the adolescent vaccines, particularly the human papillomavirus vaccine, really has a lot of room for improvement.

We just are not at our target in terms of good coverage. The situation is

even more critical for adults. For example, Tdap—tetanus, diphtheria, and acellular pertussis vaccine—and the pneumococcal vaccine for high-risk individuals are far from meeting our goals in terms of appropriate coverage.

We find that retail pharmacies oftentimes have much more generous hours than clinical practices. Most clinical practices require an appointment for vaccinations, whereas many pharmacies allow walk-in visits and are able to administer immunizations relatively easily. I think it certainly is a method to fill in the gap.

The ability for retail pharmacies to provide vaccinations to children is highly variable from state to state. No real generic comment can be made about child vaccinations— especially through age 6 years— other than that it has always been a very important component of routine clinical care.

There is a need for an expanding role of retail pharmacies in providing vaccination. Every year, we have the need to immunize several million individuals for influenza, and, oftentimes, there is no capacity within clinical practice to do so. We rely and benefit from our colleagues in the pharmacies.

From my point of

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

view, there is also a need for very good communication between pharmacies and the medical homes so we know what immunizations are being provided. Vaccine administration needs to be documented appropriately, and reported in an immunization registry.

One of the things we have for any retail pharmacy, in a statement, is immunization registry— that registry should be used with every vaccine. ❚

Jonathan L. Temte “As a primary care physician, I can say that we have a very long and beneficial mutual relationship with our colleagues providing pharmacy care and that is just very important for people within the medical profession and the pharmacy profession to work together to improve communication and improve dialogue,” Dr Temte concluded.

“At the end of the day, we have a much better ability to provide appropriate treatments, be they preventive or therapeutic, to our patients—this is a wonderful area for collaboration and cooperation.”

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Inside

Patient Care Personalized Medicine: Are We There Yet?

by DAVID B. NASH, MD, MBA

I AM PRIVILEGED to still be seeing patients in our primary care practice within the Division of Internal Medicine at Sidney Kimmel Medical College (formerly Jefferson Medical College). Parenthetically, I am also the oldest physician in the group.

Like many primary care physicians, I have recently seen an increase in the number of patients who bring results of proprietary genetic testing to the office. These results, often from companies such as 23andMe, a DNA analysis service, represent a sea change in at least one aspect of the doctor– patient relationship. In what some have called the “democratization” of information (see Eric Topol’s wonderful book, The Creative Destruction of Medicine),1 genetic typing is potentially the first step toward our realization of personalized medicine.

As of now, however, I do not believe we are

quite there yet. In other words, I am unable to thoroughly interpret the results of testing from companies such as 23andMe, and the opportunities to modify a medication regimen, make solid evidentiary-based recommendations for changes in behavior, or for future clinical testing for patients are limited.

Let us first examine the public’s view of personalized medicine, and then review some examples of where we currently are, and where we may be in the future.

According to a March 2014 survey of public opinion conducted on behalf of the Personalized Medicine Coalition by KRC Research, a reputable public opinion research consultancy based in Washington, DC, a large majority (62%) of the 1024 American adults polled on the topic had not heard of personalized medicine, but they react-

Reprinted with permission from Nash DB. Personalized Medicine: Are We There Yet? Am Health Drug Benefits.

2014;7:371-372. All rights reserved.

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ed positively when it was described to them.2 Among the surveyed adults who had heard the term (38%), only 2 in 10 believed they were very informed about personalized medicine. Furthermore, only 11% said that their doctor had discussed or had recommended any aspect of personalized medicine to them.2 First, let us define our terms. The investigators at KRC Research used the following description of personalized medicine when conducting the survey: “Personalized medicine is an emerging field that uses diagnostic tools to identify specific biologic markers, often genetic, to help determine which medical treatments and procedures will be best for each patient. By combining this information with an individual’s medical records and circumstances, personalized medicine allows doctors and patients to develop targeted prevention and treatment plans. The goal is to provide the right treatment in the right

dose to the right patient at the right time.”2 The KRC Research investigators further noted that the majority of the survey participants were “excited about the potential benefits of personalized medicine, including choosing a treatment that is most likely to work for them and the potential to prevent illness.”2 A large majority of those surveyed “also recognize the value of these technologies and that they should be covered by insurance.”2 Finally, “the idea that personalized medicine can provide useful prevention and treatment information, help avoid or reduce side effects, avoid trial-anderror medicine, and give more control to prevent or treat illness are very compelling benefits.”2 One could quibble slightly with KRC Research’s definition of personalized medicine, but my hunch is that the results truly reflect the positions of the survey responders. Who could

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

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Patient Care argue with treatment that avoids trial and error, is more focused on the individual, and that has long-term benefits when done correctly? So, yes, parts of these results are dependent on how we ask the question; however, although the public is not currently well informed, this situation will very likely change in the very near term.

Where are we now regarding the implementation of personalized medicine? Clearly, this is a complex issue. I have written about this complexity elsewhere,3 but it is fair to say that personalized medicine has not yet delivered on its “hype.”

I certainly expected that by late 2014 we would be doing a buccal smear on our primary care patients, assessing their genotype quickly in the office, and making very specific, evidence-based recommendations for their future health and well-being.

We have not yet realized this dream.

For example, findings from a recent meta-analysis by Stergiopoulos and Brown show that a “genotype-guided dosing strategy [for warfarin] did not result in a greater percentage of time that the INR [international normalized ratio] was within the therapeutic range, fewer patients with

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an INR greater than 4, or a reduction in major bleeding or thromboembolic events compared with clinical dosing algorithms.”4 In other words, despite the availability of pharmacogenomic testing to determine who may benefit from therapy with warfarin and appropriate dosing, this meta-analysis of randomized clinical trials revealed no difference between our current standard of care and care complemented by genetic testing. In an editorial accompanying the meta-analysis, Kazi and Hlatky state that the “routine use of genetic testing to guide warfarin management cannot be recommended.”5 Warfarin is just one example. There are now a score of drugs that have been assessed in the literature based on genetic testing, and the take-home message is very mixed. Kazi and Hlatky conclude that “evidence of improved clinical outcomes, not biological causability or hype, should drive the adoption of genetic tests into practice.”5 Although the example of warfarin is not compelling, evidence in psychiatric care (and other clinical areas, such as cancer care) may present a different story. In an article on pharmacoge­ nomic testing, Winner

I AM CONFIDENT THAT WITH NEW TECHNOLOGY, WE WILL OVERCOME ANY CURRENT LIMITATIONS, AND MY DREAM OF PRACTICING PERSONALIZED MEDICINE WILL BE REALIZED IN MY OWN PRACTICE LIFETIME. states that “given that the current strengths of pharmacogenomics testing align directly with the common pharmacologic challenges in the elderly and the need for better outcomes with lower costs, the aging population may be the first large group of individuals to benefit from a paradigm shift in treatment with integrated pharmacoge­ nomic testing.”6 Winner further suggests that within the burgeoning arena of geriatric psychiatry, pharmacogenomic testing will identify individual genetic differences as they relate to response to therapy, and that this can be used to personalize medication treatment for the

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

large number of elderly patients with depression.

What about the future? In August, I had the opportunity to participate in a leadership panel program sponsored

by Pennsylvania Bio (www.pabio.org), a large membership organization headquartered in suburban Philadelphia that represents more than 600 companies in the life sciences. At this leadership program entitled “From Personalized Medicine to Precision Prevention— What Will It Mean for You?,” the group of participating experts were very enthusiastic about the future of personalized medicine. Despite the regulatory and scientific challenges, these experts from across the state were very upbeat in their assessment of the future of personalized medicine. They also cited an increase in Wall Street’s interest in companies working in this arena.

With that in mind, I am personally intrigued by the work of companies such as Genelex Corporation and their YouScript system, a personalized prescribing system that uses genetic screening to reduce adverse drug events.7 For example, a description of YouScript’s services notes that “more than 75% of patients have detectable

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Patient Care variations in their DNA that may increase their risk of unwanted side effects and adverse drug events.”8 YouScript brochures suggest that its testing is recommended for patients who take multiple medications, complain that their medications are not working or who are wary of standard dosing based on negative experiences, and are using complex drug treatment plans.

This description applies to the vast majority of my own patients. So perhaps companies and services such as YouScript, 23andMe, and others are going to enjoy a very successful future.

We are certainly on

the right road, but we’re not there yet. Although common therapeutic regimens involving drugs such as warfarin and tricyclic antidepressants are reporting variable outcomes within the personalized medicine arena, I am confident that with new technology, we will overcome any current limitations, and my dream of practicing personalized medicine will be realized in my own practice lifetime. Let us get past the hype and improve the science so we can make real advances in this field. For me, time is of the essence.

As always, I am interested in your views, and you can reach me at david. nash@jefferson.edu. ❚

References

1. Topol E. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York, NY: Basic Books; 2012.

2. Personalized Medicine Coalition, KRC Research. US public opinion about personalized medicine: survey shows public optimism about personalized medicine. March 5-16, 2014. www.personalizedmedicinecoalition. org/Userfiles/PMC-Corporate/file/us_ public_opinion_about_personalized_ medicine.pdf. Accessed September 4, 2014.

3. Nash DB. The challenge of personalizing health care. Manag Care.

2013;22:49-53.

4. Stergiopoulos K, Brown DL. Genotype-guided vs clinical dosing of warfarin and its analogues: meta-analysis of randomized clinical trials. JAMA Intern Med. 2014;174:1330-1338.

5. Kazi DS, Hlatky MA. Warfarin, genes, and the (health care) environment. JAMA Intern Med. 2014;174: 1338-1339.

6. Winner J. Pharmacogenomic treatment support advances mental wellness. Todays Geriatr Med. 2014;7:20.

7. Genelex Corporation. YouScript. http://youscript.com. Accessed September 3, 2014.

8. Allscripts. https://store.allscripts. com/applications/id-13027/youscript.

Accessed September 4, 2014.

Dr Nash is Editorin-Chief, American Health & Drug Benefits; Founding Dean, Jefferson School of Population Health, Philadelphia, PA.

Want to reach retail pharmacy managers?

Place your classified ad here.

Let your message resonate with the decision makers in the retail pharmacy setting.

For more information, please contact fevans@the-lynx-group.com

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Continuing Education Release date: December 9, 2014 Expiration date: December 31, 2015 Estimated time to complete activity: 0.75 hour Jointly provided by Postgraduate Institute for Medicine and Center of Excellence Media, LLC.

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

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

EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Explain the role of community pharmacists in ensuring safe and effective medication use • Review factors that can impact clinical outcomes, including patient, disease, and medication • Utilize strategies to improve patient care, including patient education and medication adherence counseling • Describe the ways that community pharmacists can help their patients achieve optimal health and value through the knowledge and application of traditional and nontraditional care • Provide accurate and appropriate counsel as part of the treatment team FACULTY Darrell Hulisz, RPh, PharmD Associate Professor Case Western Reserve University School of Medicine Clinical Pharmacy Specialist Department of Family Medicine University Hospitals, Case Medical Center Cleveland, OH Pharmacist Continuing Education Accreditation Statement Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Credit Designation Postgraduate Institute for Medicine designates this continuing education activity for 0.75 contact hour(s) (0.075 CEUs) of the Accreditation Council for Pharmacy Education.

(Universal Activity Number - 0809-999914-225-H01-P) Type of Activity: Knowledge

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Empowering Community Pharmacists as Health Consultants: Hypertension

by DARRELL HULISZ, RPH, PHARMD

H

ypertension, defined as blood pressure (BP) that exceeds 140/90 mm Hg, affects nearly 77 million US adults aged 20 years and older, representing just over 33% of this population group.1-3 Hypertension typically does not cause symptoms; thus, the disorder remains undetected in individuals who do not schedule regular physician visits or other appropriate health screenings. Hypertension is clearly one 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 CE activity: Name of Faculty or Presenter Darrell Hulisz, RPh, PharmD

Reported Financial Relationship Honorarium from WebMD, AMN Healthcare

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

of most important, potentially modifiable, independent risk factors for cardiovascular disease, such as heart attacks, heart failure, and stroke, as well as chronic kidney disease.4 Clinical trials have demonstrated that aggressive lowering of BP, on average, is associated with a 35% to 40% decrease in stroke, a 20% to 25% decrease in myocardial infarction, and a >50% decrease in rates of heart failThe planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity: The following PIM planners and managers—Laura Excell, ND, NP, MS, MA, LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP; and Jan Schultz, RN, MSN, CCMEP—hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

Center of Excellence Media, LLC: Susan Berry hereby states that she or her spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

Instructions for Credit There is no fee for this activity. To receive credit after

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Continuing Education ure.4,5 Hypertension is classified as essential hypertension when the exact cause is unknown, and represents the majority of cases.3 In secondary hypertension, a potential cause can be identified, such as medications, sleep apnea, hyperthyroidism, kidney disease, or tumor of the adrenal glands.4 Several risk factors for hypertension exist, including poor diet (inadequate intake of fruits, vegetables, and potassium; excessive intake of sodium), sedentary lifestyle, obesity, smoking, excessive alcohol intake, and certain genetic factors.4 Since most patients are asymptomatic, but can potentially suffer life-threatening complications, hypertension is aptly referred to as the “silent killer.”

Community pharmacists are ideally positioned and well suited to enhance the detection of hypertension through BP screening, to improve hypertension management, and to provide assistance in addressing risk factors. Pharmacists should inform patients of the consequences of untreated hypertension, as well as the benefits of effective BP control and medication adherence.

This article will equip community 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/COE176-2. Upon completion of the evaluation and scoring 75% or better on the posttest, you will immediately receive your certificate online. If you do not achieve a score of 75% or better on the posttest, you will be asked to take it again. Please retain a copy of the certificate for your records.

If you have any questions regarding the CE certification for this activity, please contact Postgraduate Institute for Medicine at: information@pimed.com or 303-799-1930.

Pharmacists: Upon successfully completing the posttest with a score of 75% or better and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Media: Printed report Disclosure of Unlabeled Use This educational activity may contain discussion of pub-

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pharmacists with the tools necessary to better understand hypertension in terms of the disease process and its management, practice-based screening, patient education, and improvements in medication adherence.

Pathogenesis Although the cause of essential hypertension is unknown, several pathophysiologic mechanisms are observed in the disease. These include activation of the sympathetic nervous system and the renin-angiotensinaldosterone system (RAAS), increases in vascular resistance, and changes in arterial and aortic baroreceptors.6 Elevations in angiotensin II also appear to contribute to exaggerated sympathetic stimulation. Over time, sustained sympathetic stimulation often results in left ventricular hypertrophy and vascular remodeling, putting patients at increased risk for heart failure. Thus, a major basis for treating hypertension includes targeting the RAAS and the adrenergic system, as well as the use of drugs that act on the vasculature and sodium homeostasis. lished and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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Continuing Education Community pharmacists play an integral role in the screening of patients for hypertension, and thereby have the potential to improve clinical outcomes.

The Role of Community Pharmacists in Hypertension Screening Community pharmacists play an integral role in the screening of patients for hypertension, and thereby have the potential to improve clinical outcomes.

Pharmacists are able to provide prescribers with feedback on medication adherence, are knowledgeable about drug interactions and the ideal timing of medication administration, and have practical knowledge in organizing drug treatment plans and dosing schedules. They can often simplify drug regimens by recommending combination therapy or once-daily dosage forms.

Increasingly, they also have access to electronic health records and patient prescription profiles.

A number of studies in medical and pharmacy literature document the ef­ fectiveness and accuracy of BP screen­ing performed by pharmacists in the community.7-10 Assessing Blood Pressure Assessing BP can be conducted by a properly trained pharmacist using a manual, traditional Mercury sphygmomanometer, or an automated digital device. Patients should be advised to refrain from using nicotine or consuming caffeine for at least 30 minutes prior to BP testing. They should take 5 minutes or longer to relax themselves prior to testing and should speak to the pharmacist during the BP reading. The ideal positioning for patients is seated with legs uncrossed and arm at heart level. Furthermore, 2 readings should be taken at intervals of at least 1 minute apart, and then averaged, especially if BP is elevated.

If BP is elevated, patients should be asked the following questions: Are you currently diagnosed with hypertension?

What medications do you take for BP?

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How often do you take your medications? Did you remember to take your medications today? Do you take your BP at home? What does your BP normally run? Did you recently smoke a cigarette, or drink any caffeinated beverages, including energy drinks?

Community pharmacists should also screen patients for drug-induced hypertension. Agents responsible for this condition may include high-dose aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS; eg, ibuprofen), corticosteroids (eg, prednisone), high-dose estrogens, amphetamines and related central nervous system stimulants, tacrolimus, cyclosporine, and ginseng.11

Treatment: Lifestyle Modification Community pharmacists are health professionals with extensive knowledge and training, who afford easy access to patients with hypertension. Therefore, they are in an ideal position to encourage these individuals to adopt appropriate lifestyle modifications. Examples include reducing the intake of sodium (salt), saturated fats, sugars, red meat, alcohol, caffeine, and nicotine. It is recommended that 2.3 g of sodium daily be the upper limit, and that potassium intake be increased in most patients to 4.7 g daily.4,12 Practically speaking, most patients would benefit more from specific examples of how to limit sodium intake.

These may include using a salt substitute or avoiding consumption of foods high in sodium, such as canned soups, frozen dinners, sausage, bacon, hot dogs, bologna, and pickles. Increased intake of potassium-rich fruits and vegetables, along with consuming more fiber and fish, are generally recommended.

Moderation of alcohol intake down to 1 or 2 alcoholic drinks per day is recommended, where 1 drink is considered 12 oz of beer, 5 oz of wine, or 1.5 oz of

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Continuing Education 80-proof liquor.4 Community pharmacists should also screen patients for tobacco dependence and offer assistance with smoking-cessation products, counseling, and selfhelp referral programs. Weight loss and increases in physical activity and exercise should be highly encouraged whenever appropriate. Regular aerobic exercise is recommended for 30 minutes a day on most days of the week. However, patients with serious comorbid medical conditions, such as coronary artery disease, should obtain medical clearance before engaging in strenuous exercise.

Community pharmacists can also offer patients body mass index (BMI) screenings. The BMI is a ratio of weight in kilograms, over height in meters squared. Maintaining a BMI of less than 25 is considered ideal for preventing and treating hypertension.4

Treatment: Medication Management Overview Lifestyle changes are not only difficult to implement and adhere to, they are also ineffective in many patients when used alone to control BP. Although these changes should be continued, drug therapy is often necessary for most patients with hypertension. In fact, greater than 50% of patients require 2 or more medications to achieve BP goals.13 Numerous categories of medications are available (Table),2 including several subclasses of diuretics; aldosterone antagonists (eg, eplerenone); angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril); angiotensin II receptor antagonists (eg, losartan); direct renin inhibitors (eg, aliskiren); beta blockers (eg, metoprolol); calcium channel blockers (eg, amlodipine); alpha-adrenergic antagonists (eg, clonidine); and direct vasodilators (eg, hydralazine). The drug of choice for initial therapy has been the topic of

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considerable debate; however, it is the amount of BP reduction that is the major determinant of reduction in cardiovascular risk, rather than the initial drug prescribed.1,13-15 The Eighth Joint National Committee (JNC 8) guidelines should be applied in the initial approach to managing patients with hypertension.1 However, subsequent monitoring and titration of medications must be individualized. Whereas thiazide diuretics are still generally considered first-line drugs, they may not be optimally effective as monotherapy in certain patients.1 Some patients may respond better to a calcium channel blocker, ACE inhibitor, or an angiotensin receptor blocker. In many cases, other considerations should be taken into account, such as concurrent diseases, potential for drug interactions, adverse effect profiles, warnings, precautions, contraindications, history of response, and affordability.

According to the JNC 8, in the general population aged <60 years, pharmacotherapy is recommended to lower BP at a threshold diastolic BP of â&#x2030;Ľ90 mm Hg, with a general goal of keeping BP <140/90 mm Hg. In the general population aged 60 years or older, medications are initiated to decrease systolic BP to <150 mm Hg, and diastolic BP to <90 mm Hg. Additionally, systolic BP should be decreased to <140 mm Hg in most patients with chronic kidney disease or diabetes.1 Patients with suboptimal BP control on a single drug may be started on combination therapy. Many agents are commercially available in a fixed-dose combination as a single daily dosage unit, which may also result in improved adherence.

The definitions of hypertension and prehypertension are not addressed in the JNC 8 guidelines; however, thresholds for pharmacologic intervention are defined as above.1 The Seventh Joint

Some patients may respond better to a calcium channel blocker, angiotensinconverting enzyme inhibitor, or an angiotensin receptor blocker.

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Continuing Education Table. Common Antihypertensive Drugs with Select Adverse Effects2 Drug Class and Specific Agents

Adverse Effects

Pregnancy Category

Aldosterone antagonists Eplerenone

Dizziness, hyperkalemia, hypertriglyceridemia

B

Fatigue, gynecomastia, hyperkalemia, menstrual changes

C

Spironolactone Alpha-adrenergic antagonists Clonidine

Constipation, dizziness, drowsiness, xerostomia

C

Doxazosin

Dizziness, fatigue, headache, orthostatic hypotension

C

Methyldopa

Drowsiness, dry mouth, peripheral edema

B

Prazosin

Dizziness, drowsiness, headache, orthostatic hypotension, palpitation

C

Terazosin

Dizziness, edema, muscle weakness, orthostatic hypotension

C

Angiotensin-converting enzyme inhibitors Benazepril

Angioedema, cough, headache, hyperkalemia

D

Enalapril

Angioedema, cough, dizziness, hyperkalemia

C (1st trimester); D (2nd/3rd trimester)

Lisinopril

Angioedema, cough, dizziness, hyperkalemia

C (1st trimester); D (2nd/3rd trimester)

Ramipril

Angioedema, cough, hyperkalemia, hypotension

C (1st trimester); D (2nd/3rd trimester)

Dizziness, hyperkalemia, hypotension, increased serum creatinine

C (1st trimester); D (2nd/3rd trimester)

Irbesartan

Dizziness, hyperkalemia, orthostatic hypotension, upper respiratory infection

C (1st trimester); D (2nd/3rd trimester)

Losartan

Angioedema (rare), chest pain, fatigue, hyperkalemia, hypotension

C (1st trimester); D (2nd/3rd trimester)

Valsartan

Dizziness, hyperkalemia, hypotension, increased BUN

D

AV block, bradycardia, dizziness, fatigue, hypotension

D

Bisoprolol

Chest pain, dyspnea, fatigue, GI effects

C

Carvedilol

AV block, bradycardia, dizziness, edema, fatigue, hypotension C

Labetalol

Dizziness, fatigue, nausea, postural hypotension

C

Metoprolol tartrate; Metoprolol succinate

AV block, bradycardia, dizziness, fatigue, hypotension

C

Angiotensin II receptor antagonists Candesartan

Beta blockers Atenolol

Calcium channel blockers Amlodipine

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Dizziness, fatigue, flushing, peripheral edema

C

Diltiazem

AV block, bradycardia, edema, headache, hypotension

C

Felodipine

Flushing, headache, peripheral edema, tachycardia

C

Nifedipine

Dizziness, flushing, headache, heartburn, peripheral edema

C

Verapamil

AV block, constipation, edema, headache, gingival hyperplasia, hypotension

C

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Continuing Education Table. Common Antihypertensive Drugs with Select Adverse Effects2 continued Direct renin inhibitors Aliskiren

Diarrhea, hyperkalemia, increased creatinine, orthostatic hypotension, rash

C (1st trimester); D (2nd/3rd trimester)

Epigastric distress, hypokalemia, orthostatic hypotension, photosensitivity

B

Epigastric distress, hypokalemia, photosensitivity

B

Hyperuricemia, hypokalemia, orthostatic hypotension, photosensitivity

B

Electrolyte depletion, hyperuricemia, ototoxicity, nephrotoxicity

C

Furosemide

Electrolyte depletion, ototoxicity, photosensitivity, nephrotoxicity

C

Torsemide

Electrolyte depletion, GI effects, ototoxicity, nephrotoxicity

B

(Potassium-sparing diuretic) Spironolactone

Fatigue, gynecomastia, hyperkalemia, menstrual changes

C

Dizziness, fluid/sodium retention, orthostatic hypotension, peripheral edema, tachycardia

C

ECG changes, fluid/sodium retention, hypertrichosis, peripheral edema

C

Diuretics (Thiazide) Hydrochlorothiazide (Thiazide-like diuretics) Chlorthalidone Metolazone (Loop diuretics) Bumetanide

Vasodilators Hydralazine Minoxidil

AV indicates atrioventricular block; BUN, blood urea nitrogen; ECG, electrocardiogram; GI, gastrointestinal.

National Committee had introduced the term “prehypertension” to include those with BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic.4

Community Pharmacists: Collaboration, Patient Education, and Adherence Several studies have documented the positive impact pharmacists can have by collaborating with physicians to improve BP control in a variety of practice settings.16-18 Medication therapy management and collaborative practice agreements with medical providers is an emerging field for community pharmacists, but beyond the scope of

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this article.

With respect to patient education, individuals should be counseled about the consequences of uncontrolled or untreated hypertension. Likewise, an explanation of the benefits of optimal BP control should be provided, while avoiding the use of medical verbiage and technical jargon. However, patients should be made aware of the most likely side effects of drug therapy, especially those that require medical attention, such as angioedema associated with an ACE inhibitor.

Community pharmacists should encourage self-monitoring of BP at home by recommending a digital BP monitoring device. They should con-

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Continuing Education

30

The pharmacist should frequently remind patients that hypertension is asymptomatic and that they may not “feel” any better during drug treatment.

tinuously monitor the refill history of all patients with hypertension and contact them and their providers when concerns arise. Pharmacists should assist individuals with identifying routine activities that may help them remember to take their medications on schedule, such as brushing one’s teeth or other daily rituals.

When counseling on antihypertensive drugs, it is helpful to ask patients to repeat the advice given; this is known as the teach-back method. Patients should routinely be asked about their level of physical activity and dietary factors, such as sodium and alcohol intake. In addition, the pharmacist should frequently remind patients that hypertension is asymptomatic and that they may not “feel” any better during drug treatment. However, it should still be emphasized that regular medication use offers protection against stroke, coronary heart disease and heart attacks, heart failure, and progression of kidney disease.

Pharmacists can improve patient care by identifying iatrogenic (drug-induced) causes of hypertension, such as the excessive use of commercially available NSAIDs. Assistance for individuals with nicotine dependence should also be a top priority, and represents an excellent opportunity for pharmacists to directly impact clinical outcomes.

Finally, community pharmacists can play a pivotal role in referring patients who screen positive for elevated BP to seek appropriate medical care. ❚

Dr Hulisz is Associate Professor, Case Western Reserve University, School of Medicine, and Clinical Pharmacy Specialist, Department of Family Medicine, University Hospitals Case Medical Center, Cleveland, OH.

References

1. James PA, Oparil S, Carter BL, et al. 2014 Evidencebased guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311:507-520.

2. Saseen JJ, MacLaughlin EJ. Hypertension. In: DiPiro JT, Talbert RL, Yee GC, et al, eds. Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, NY: McGrawHill; 2014:49-84.

3. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart dis-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

ease and stroke statistics—2012 update: a report from the American Heart Association. Circulation. 2012:125:e2-e220.

4. National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication No. 04-5230. Bethesda, MD: US Department of Health & Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute, October 2007.

5. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288:29812997.

6. Oparil S, Zaman MA, Calhoun DA. Pathogenesis of hypertension. Ann Intern Med. 2003;139:761-776.

7. Chambers LW, Kaczorowski J, O’Rielly S, Ignagni S, Hearps SJ. Comparison of blood pressure measurements using an automated blood pressure device in community pharmacies and family physicians’ offices: a randomized controlled trial. CMAJ Open. 2013;1:E37-E42.

8. Palombi LC, Bastianelli K, Stratton T. Point-of-care screenings at the University of Minnesota: mechanism for civic engagement. J Am Pharm Assoc (2003). 2014;54:56-62.

9. Snella KA, Canales AE, Irons BK, et al. Pharmacy- and community-based screenings for diabetes and cardiovascular conditions in high-risk individuals. J Am Pharm Assoc 2003.

2006;46:370-377.

10. Mangum SA, Kraenow KR, Narducci WA. Identifying at-risk patients through community pharmacy-based hypertension and stroke prevention screening projects. J Am Pharm Assoc 2003. 2003;43:50-55.

11. Hulisz D, Lagzdins M. Drug-induced hypertension. US Pharmacist. 2008;33:HS11-HS20.

12. Appel LJ, Brands MW, Daniels SR, et al. Dietary approaches to prevent and treat hypertension: a scientific statement from the American Heart Association.

Hypertension. 2006;47:296-308.

13. Turnbull, F, Neal, B, Ninomiya, T, et al; Blood Pressure Lowering Treatment Trialists’ Collaboration. Effects of different regimens to lower blood pressure on major cardiovascular events in older and younger adults: meta-analysis of randomised trials. BMJ. 2008;336:1121-1123.

14. Rosendorff C, Black HR, Cannon CP, et al. Treatment of hypertension in the prevention and management of ischemic heart disease: a scientific statement from the American Heart Association Council for High Blood Pressure Research and the Councils on Clinical Cardiology and Epidemiology and Prevention. Circulation. 2007;115:2761-2788.

15. Mancia G, De Backer G, Dominiczak A, et al. 2007 Guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2007;28:1462-1536.

16. Weber CA, Ernst ME, Sezate GS, Zheng S, Carter BL. Pharmacist-physician comanagement of hypertension and reduction in 24-hour ambulatory blood pressures. Arch Intern Med. 2010;170:1634-1639.

17. Vivian EM. Improving blood pressure control in a pharmacist-managed hypertension clinic. Pharmacotherapy.

2002;22:1533-1540.

18. Morgado M, Rolo S, Castelo-Branco M. Pharmacist intervention program to enhance hypertension control: a randomised controlled trial. Int J Clin Pharm. 2011;33:132140.

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CMS STAR RATING Hypertension Medicare Part D Star Ratings [34]

SPECIALTY PHARMACY Five steps to consider before changing your business model [38]

The Retail Pharmacy The Shift to Value-Based Care Payers are recognizing that pharmacists can be an integral part of the solution to meet their quality needs

by DANIELLE MAYER, PHARMDc; MARIA V. SCARLATOS, PHARMD, CPHQ; and SAMUEL STOLPE, PHARMD

In recent years, the US healthcare system has been shifting from a fee-for-service system to a value-driven system. }} }} PURCHASING FOR VALUE, which is led by the federal government inside programs such as the Medicare star rating system and considers cost and quality, is becoming a significant driver of healthcare reimbursement.

Medication use quality is becoming increasingly important as both federal and commercial healthcare dollars are strained in the chronic disease management of America’s aging population.

Pharmacists can contribute meaningfully to the quality goals of payers. Their unique position in the community setting grants enhanced patient access and excellent opportunities for medication management.

Performance Measures A key feature of value-driven payment systems is the use of performance measures to evaluate the quality of provider services. The basis of performance measurement is the regular collection of data to assess whether the processes performed are leading to desired patient outcomes. There are several types of performance measures used in our health-

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care system. The widely used framework for measuring quality of care includes metrics to analyze structure, process, and outcome. Structure measures focus on the physical attributes of a setting where patient care is delivered, whereas process measures assess how care is delivered in these settings. Outcome measures gauge the impact of the care provided on health status.

With the advent of new quality incentive structures put in place through federal government programs, health plans and pharmacy benefit managers (PBMs) are shifting focus to quality-of-care measurement goals. The Centers for Medicare & Medicaid Services (CMS) has done this through the implementation of a program called the star rating system. This program rates contracted health plans and PBMs that provide coverage to individuals who enroll in Medicare Advantage (Medicare Part C) and Medicare prescription drug plans (Medicare Part D).

The 2015 star rating system for Medicare Part D includes 13 quality metrics, 8 that assess member expe-

KEY POINTS ❚ A key feature of valuedriven payment systems is the use of performance measures ❚ The unique position of pharmacists in the community setting provides excellent opportunities to improve medication adherence and medication use safety

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Inside the Retail Pharmacy rience, and 5 that are directly tied to clinical quality, specifically medication safety and adherence.1 These 5 measures account for approximately 50% of the given Part D plan’s star rating and represent a potential area for pharmacist intervention and impact. The medication safety measures include the use of

Star ratings have been shown to influence patients’ plan selection. high-risk medications in elderly patients and the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) in patients with diabetes. The additional 3 measures determine adherence to oral diabetes medications, ACE inhibitors/ ARBs, and statins. The 2015 star rating system for Medicare Advantage plans contains 33 measures of quality in addition to the Part D measures.

Star ratings that health plans or PBMs obtain are public facing, and published in multiple plan listing services, such as Medicare’s online enrollment tool on Medicare.gov. Star ratings have been shown to influence patients’ plan selection and are tied to other benefits and penalties.2 Medicare Part D plans that receive a 5-star rating have open enrollment throughout the year, enabling beneficiaries to switch to a 5-star plan at any time. Medicare Advantage plans receive quality bonus payments based on their overall star rating. These quality bonus payments have resulted in almost $200 million per year in revenue for 5-star plans. Plans that receive fewer than 3 stars for 3 consecutive years risk termination of their CMS contracts.3

Incentives to Improve Ratings In response to these measures, Medicare plans have developed strategies to improve their ratings. There are many levers available to health plans and PBMs to improve their star rating perfor-

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

mance. Some plans have restructured their formularies and others are implementing clinical services to improve disease state management. Some health plans and PBMs are moving forward with incentive and penalty programs for pharmacies based on improvements to the plan’s star measures. The unique position of pharmacists in the community setting provides excellent opportunities to improve medication adherence and medication use safety, the 2 areas of most gravity inside the CMS Part D measure set. Payers are recognizing that pharmacists can be an integral part of the solution to meet their quality needs.

Some incentive programs emerging in the marketplace include bonus payments for pharmacies based on star measure performance. In October 2013, Inland Empire Health Plan, based out of Southern California, created a pay-for-performance program to motivate community pharmacies to collaborate with the health plan and improve medication use quality for their beneficiaries.4 In-network pharmacies are measured based on metrics that are included in the Medicare star rating system, including adherence and medication use safety. Pharmacies that perform well on the metrics receive a monetary incentive every 6 months.5

How to Perform Well One of the most important initial steps for a pharmacy to perform well inside of a pay-for-performance model is to learn exactly how they are performing on the measures that matter to health plans.

Pharmacy Quality Solutions has developed a performance information management platform, called EQuIPP, which currently includes more than 53,000 pharmacies.6 EQuIPP provides health plans and community pharmacy organizations unbiased, benchmarked performance information. This platform allows pharmacies and health plans to engage in strategic relationships to improve medication use quality. For example, EQuIPP provides information

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Inside the Retail Pharmacy to plans and pharmacies about medication adherence metrics, a group of measures that comprise 3 of the 5 medication-related measures in the Medicare Part D star rating system.

Adherence is measured using the proportion of days covered methodology that is based on the fill dates and days supply for each fill of a prescription.

This type of adherence calculation is able to account for early fills and overlapping prescriptions, and provides a conservative adherence estimate. Based on numerous studies of the relationship between adherence and health outcomes, 80% was set as the threshold above which patients can be considered highly adherent to most chronic medications.7 Medication adherence and medication use safety constitute common goals for patients, health plans, and pharmacies to collaborate on to achieve positive health outcomes.

An increasing number of health plans and PBMs are partnering with their network pharmacies, using EQuIPP as a common platform to target medication use goals. For example, Healthfirst of New York announced a partnership with Pharmacy Quality Solutions in May to improve its CMS star ratings for the 120,000 individuals covered by their Medicare Advantage Plan using EQuIPP.6 This partnership will enable Healthfirst to use a pay-for-performance model to collaborate more efficiently with in-network community pharmacies on medication use quality for Healthfirst beneficiaries. Pharmacies included in these types of incentive and disincentive programs incorporate a variety of solutions to target high performance on Pharmacy Quality Alliance (PQA)’s medication use measure set. Pharmacists have employed programs such as medication synchronization, medication therapy management, and patient-centered behavioral counseling interventions.

Pharmacists seeking to further understand their role in this value-driven system can access a program recently launched by PQA called EPIQ

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(Educating Pharmacists In Quality).

This complimentary online continuing education program is designed to train practicing pharmacists, health professionals, and pharmacy students in measuring, improving, and reporting quality of care in pharmacy practice.

Pharmacists must transition their approach from a mind-set of quality measurement resistance to quality measurement engagement.

Managing the quality of medication use is now a recognized component to ensure optimal patient care, and pharmacists are an integral part of the solution to meet payers’ quality needs.

Leveraging pharmacy services to help health plans impact quality metrics is an opportunity for pharmacists to serve as a critical member of an integrated healthcare team. To take advantage of this opportunity, however, pharmacists must transition their approach from a mindset of quality measurement resistance to quality measurement engagement. ❚

References

1. Centers for Medicare & Medicaid Services. Part C and D performance data: 2015 Part C and D Medicare star rating data. www.cms.gov/Medicare/Prescription-Drug-Coverage/ PrescriptionDrugCovGenIn/PerformanceData.html. Updated November 18, 2014. Accessed November 24, 2014.

2. Reid RO, Deb P, Howell BL, Shrank WH. Association between Medicare Advantage plan star ratings and enrollment. JAMA. 2013;309:267-274.

3. Nau DP. Intersection of quality metrics and Medicare policy. Ann Pharmacother. 2011;45:1582-1584.

4. Inland Empire Health Plan. IEHP rolls out early payments to providers eligible for ACA Medicare increases. https://ww3.iehp.org/en/our-communities/newsroom/2013/ october/aca-physician-payments. Published October 2013.

Accessed November 17, 2014.

5. Inland Empire Health Plan. Pay for performance (P4P) program. https://ww3.iehp.org/en/providers/pharmaceuticalservices/pharmacy-p4p-program/. Accessed October 14, 2014.

6. Pharmacy Quality Solutions. Healthfirst selects EQuIPP to support improvement of Medicare star ratings. www. pharmacyquality.com/Documents/Healthfirst_PQS_ release_05212014.pdf. Published May 22, 2014. Accessed October 13, 2014.

7. Nau D. Proportion of days covered (PDC) as a preferred method of measuring medication adherence. www.pqaalliance. org/images/uploads/files/PQA%20PDC%20vs%20%20 MPR.pdf. Accessed October 10, 2014.

Samuel Stolpe Ms Mayer is a Doctor of Pharmacy Candidate at the University of Pittsburgh School of Pharmacy, PA; Dr Scarlatos is Executive Fellow, Pharmacy Quality Alliance, Springfield, VA; and Dr Stolpe is Director, Quality Strategies, Pharmacy Quality Alliance, Springfield, VA.

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Inside the Retail Pharmacy

What Happens When Healthcare Measurements Don’t Keep Up with Guidelines?

The Appropriate Treatment of Hypertension in Diabetes Medicare Part D Star Rating

by EMILY HANSON, PHARMD; and TRIPP LOGAN, PHARMD

KEY POINTS ❚ One of the CMS Medicare Part D Star Ratings is Appropriate Treatment of Hypertension in Diabetes, which measures the percentage of patients with diabetes and hypertension who are on appropriate treatment ❚ JNC 8 guidelines include thiazide-type diuretics and CCBs, along with ACEIs and ARBs as appropriate options for patients with diabetes and hypertension ❚ When current guidelines are updated, changes to population health measures must follow

W

hen working in healthcare, quality is always being measured. There are many acronyms, measures, and surveys that are used in everyday conversations in pharmacy. You may hear “HCAHPS,” “Star Rating,” “PDC,” adherence rates, readmission rates—the list goes on and on—and you find yourself asking: “What do these measurements mean? What are they based on?”

We would like to think that the measurements are based on evidence, whether that evidence comes from expert opinion, best practice, or current guidelines. Often the measurements are also based on guidelines or other evidence-based medicine. But what happens when guidelines change? How do these measurements keep up?

The CMS 5-Star Rating A good example of an existing quality measure that is not supported by new clinical guidelines is the Appropriate

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

Treatment of Hypertension in Diabetes.

This quality measure, as well as 4 other pharmacy-driven quality measures, is included in the Centers for Medicare & Medicaid Services (CMS) Star Rating formula, and account for a large percentage of a Medicare Part D Plan’s overall rating.

CMS uses this 1-5 Star Rating system to assess the quality of Medicare Part D Plans. The more stars a Medicare Part D Plan has, the better perceived quality, and the more incentives it can receive. There are 5 heavily weighted measures in the CMS Star Rating formula that pharmacies can directly influence. Three of these pharmacy measures assess medication adherence in diabetes, hypertension, and cholesterol medication.

Another pharmacy measure evaluates the percentage of a Medicare plan’s population that is 65 years of age or older and taking medications with a high risk for adverse events. The fifth measure, and the focus of this article, looks at Medicare Part D Plan participants with diabetes and hypertension, and mea-

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DISPENSE Albuterol Sulfate HFA as PROAIR HFA Inhalation Aerosol

NO GENERIC ALBUTEROL INHALER CURRENTLY EXISTS

ProAir® is a registered trademark of Teva Respiratory, LLC. ©2014 Teva Respiratory, LLC PRA-40585

Inside the Retail Pharmacy sures the percentage of patients taking recommended hypertension medication.

Measuring Diabetes and Hypertension When the Star Rating quality measure for hypertension treatment in diabetes was created, it was based on current clinical guidelines. At the time, recommendations from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) served as the basis for the quality measure.

The ADA guidelines have not been updated since JNC 8 was released.

According to the JNC 7 Express guidelines, patients with diabetes and hypertension often need two or more drugs to achieve goal blood pressure.

Thiazide-type diuretics should be used as initial therapy for most patients, either alone or in combination with another class of medications. Angiotensionconverting enzyme inhibitor (ACEI) or angiotension receptor blocker (ARB)based treatments favorable affect the progression of diabetic nephropathy and reduce albuminuria and ARBs have been shown to reduce the progression to macroalbuminuria.1 With JNC 7 recommending ACEI or ARB-based treatments because of their positive effects on the kidneys the current American Diabetes Association (ADA) guidelines also use JNC 7 to make their recommendations for patients with hypertension and diabetes. They recommend that patients with diabetes and hypertension receive an ACEI or an ARB as initial treatment, if tolerated by the patient.2 The Appropriate Treatment of Hypertension in Diabetes Star Rating measure evaluates whether patients with diabetes and hypertension fill their prescription for the recommended hyper-

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INSIDE PATIENT CARE: PHARMACY & CLINICS â?&#x161; December 2014

tension medication in the renin-angiotensin system antagonist class. Based on the JNC 7 guidelines, the Appropriate Treatment of Hypertension in Diabetes performance measure, used by CMS and others, is sound, evidence-based, and rooted in nationally accepted clinical recommendations.

JNC 8 Guidelines In February 2014, the JNC on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure released their eighth report (JNC 8), and, in many ways, it changed the way hypertension is treated.

There were a number of controversial changes between JNC 7 and JNC 8, and the recommendations for the treatment of patients with hypertension in diabetes were among them. One of the changes that sparked controversy applies here.

Recommendation 6 of the report states that in the general nonblack population, including those with diabetes, initial antihypertensive treatment should include a thiazide-type diuretic, calcium channel blocker (CCB), ACEI, or ARB.3 Recommendation 7 of the report states that in the general black population, including those with diabetes, initial antihypertensive treatment should include a thiazide-type diuretic or CCB. With these new recommendations, thiazide-type diuretics and CCBs are appropriate treatment options along with ACEIs or ARBs for the treatment of patients with hypertension and diabetes. The ADA guidelines have not been updated since JNC 8 was released, and, as of today, the guidelines still are limited to an ACEI or an ARB as initial treatment for hypertension in diabetes.

However, according to these new JNC 8 guidelines for hypertension treatment in diabetes, the current CMS Star Rating performance measure is outdated.

Local, National Implications of Data Currently, health plans are being evaluated based on whether patients with

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Inside the Retail Pharmacy diabetes are taking an ACEI or an ARB. What happens if they are on a CCB or thiazide-type diuretic? According to current guidelines, these would also be appropriate choices for managing hypertension in patients with diabetes.

At one of our pharmacies, we decided to look at these numbers and assess how many patients with diabetes received treatment for hypertension that reflected current clinical guidelines, but are not reflected in the current Star Rating performance measurement. Of 284 patients who have diabetes and hypertension, 249 were on an ACE/ARB/ direct renin inhibitor (DRI) (87.7%).

Moreover, in 35 patients (12.3%) who were not on an ACE/ARB/DRI, 26 were taking CCB or thiazide (9.1%).

These data indicate that 35 patients represent a “gap in care” based on the current Star Rating performance measurement, and only 9 patients (3.2%) were actually not on current appropriate therapy based on JNC 8 guidelines.

At our pharmacy, according to the most current clinical guidelines, only 3.2% of patients with diabetes and hypertension are not being treated with the appropriate hypertension medications. However, according to the most current Star Rating performance measurement, 12.3% of patients with diabetes and hypertension in our pharmacy are not being treated according to the newest JCN 8 guidelines. That is a difference of almost 10%, and this is for only one pharmacy in rural Missouri.

What does this mean for all pharmacies and for all health plans?

Updated Star System Rating Needed With so many moving parts in the healthcare system, sometimes change is slow. How long will it take CMS to modify their Star Rating performance measurements to reflect the new JNC 8 recommendations? This is actually being analyzed right now. Testing is under way within the Pharmacy Quality Alliance (PQA) to assess the validity of

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this measure with the addition of CCBs and thiazide-type diuretics.

According to Julie Kuhle, RPh, Senior Director of Performance Measurement at PQA, “Testing results for the revised measures are expected by the end of the year.” PQA creates, tests,

Clinical guidelines are regularly assessed and improvements are made based on clinical data and outcomes. and maintains many of the quality measures used today, and the Appropriate Treatment of Hypertension in Diabetes is one of them. We will see what happens, but as of today it appears that the JNC 7-based measure will be included in the 2015 Medicare Part D Star Rating calculations. This is just one example of our healthcare system’s evolution.

Clinical guidelines are regularly assessed and improvements are made based on clinical data and outcomes.

Changes to population health measurements, such as those included in the CMS Medicare Part D Star Ratings are also evolving to keep up with current clinical recommendations.

When we, as clinicians, strive to improve quality and outcomes, we also have to recognize that change does not always come quickly. However, as our practice models and guidelines evolve, this example shows us that the measurement systems also evolve along with them. ❚

References

1. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Express: the JCN 7 report. JAMA. 2003;289:2560-2572.

2. American Diabetes Association. Standards of medical care in diabetes-2014. Diabetes Care. 2014;37:S14-S80.

3. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311:507-520.

Emily Hanson

Dr Hanson is PGY1 Community Pharmacy Resident, St. Louis College of Pharmacy and L&S Pharmacy; and Dr Logan is Senior Consultant, MedHere Today, Vice President, Logan & Seiler, Inc, L&S Pharmacy, Medical Arts Pharmacy, New Madrid Pharmacy.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

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Inside the Retail Pharmacy

The Specialty Pharmacy Conundrum Five Steps to Consider Before Changing Your Business Model

by KEVIN JAMES, RPH, MBA

KEY POINTS ❚ Many successful specialty pharmacies began by focusing on 1 therapeutic category ❚ It is crucial to create a comprehensive clinical program around a specific disease state ❚ Differentiating your service is the key to success in specialty pharmacy

38

O

ne of the most talked about topics in our industry right now is the growth of specialty pharmacy. The cost of many specialty medications has employers and health plans scrambling for answers on how to best manage their growing specialty drug expenditure.

The price tags associated with recent hepatitis C drug launches have been all over the media, and debate rages on over how to pay for such costly medications. By 2019 or 2020, specialty drugs are expected to account for 50% of overall drug costs,1 and the new drug pipeline is full of these large molecule drugs as manufacturers turn their focus to specialty therapies and orphan drugs.2 This begs the question of what a retail pharmacy should do to avoid being left behind as the pharmacy industry shifts its focus to the high costs of long-term

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

therapy for chronic diseases such as rheumatoid arthritis, multiple sclerosis, and cancer.

Retail pharmacies noticed that specialty pharmacy has the fastest growth in our industry; independent and chain pharmacies alike have shown interest in changing their business models to capitalize on this new trend.

There are, however, many challenges associated with being recognized as a specialty pharmacy provider, and we are seeing a wide variety of business models emerge. Some pharmacies are building a specialty pharmacy from the ground up, whereas others have participated in acquisitions or joint ventures to capitalize on the expertise of other specialty pharmacies already established in the industry.

There are also retail pharmacies that have elected loose partnerships with specialty pharmacies whereby the specialty pharmacy fills any prescriptions that the retail pharmacy either cannot access or chooses not to fill for other reasons. A recent report from the Office of Inspector General at the

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Inside the Retail Pharmacy US Department of Health & Human Services has called into question the viability of this model, and suggested that specialty pharmacies cannot make payments to another pharmacy where a referral is involved without risk of violating the anti-kickback statute.3 What can retail pharmacies do to change their business models and participate in the ever-growing specialty pharmacy space? Although there is no 1 simple step to changing a business model overnight, there are several key points that should be taken into consideration.

It is important to recognize that there is no standard definition for what constitutes a specialty medication. They are generally defined as expensive medications requiring special handling and administration, typically have an extensive adverse effect profile, and are often indicated for conditions for which there have been no other recent drug approvals. As a result, specialty drug lists vary from payer to payer so that pharmacies can typically fill the same drug for some payers and not for others because of network exclusion.

1/ Pick a Therapeutic Category

Many successful specialty pharmacies began by focusing on 1 therapy category and became recognized as experts in that space before branching out into other therapies.

One of the first considerations for retail pharmacies is choosing the therapy category or categories of focus. This will likely depend partly on the prescribers in the area. Who are the top prescribers in close proximity to your pharmacy and what therapies do they practice? Which prescribers do you have the best relationships with? Are there specialists in the area who you have not called on in the past?

Specialists are more likely to refer patients to your pharmacy for care if they understand the clinical expertise and level of service you can offer their patients.

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2/ Create a Clinical Program

Once the therapeutic area has been established, it is crucial to create a comprehensive clinical program around that disease state.

Clinical assessments will be needed to record data that can be reported back to providers and payers. Oftentimes this necessitates special pharmacy software that can accommodate recording clinical information that cannot normally

It is important to recognize that there is no standard definition for what constitutes a specialty medication. be maintained in a typical pharmacy management system.

Having a defined program to drive compliance and record outcomes can be a key differentiator for your pharmacy and is critical to competing in the specialty pharmacy space. You will need to consider special education, training, and credentialing for your staff to confirm the required clinical expertise.

Pharmacy accreditation is also becoming a standard requirement for payer and pharmaceutical access.

3/

Provide Access to Medications Even pharmacies with the best clinical programs still have challenges accessing limited distribution specialty pharmaceuticals. Manufacturers are increasingly using limited networks for specialty medications as part of their marketing strategies. Manufacturers limit access to control costs and help ensure clinical expertise and data reporting.

Most specialty pharmacies have staff dedicated to new business development and manufacturing relationships.

Being involved with manufacturers very early on in the new product development process is important, as network decisions are made well before

INSIDE PATIENT CARE: PHARMACY & CLINICS â?&#x161; December 2014

39

Inside the Retail Pharmacy the product receives US Food and Drug Administration approval.

Manufacturers are typically interested in pharmacies that have a history of clinical excellence, good relationships with providers and payers, and the ability to record and report clinical data points.

Recognize that transitioning into a specialty provider role will be more of a marathon than a sprint.

4/

Mr James is Vice President, Payer Strategy, AmerisourceBergen, US Bioservices.

Get Access to Payer Agreements Perhaps the biggest challenge associated with specialty pharmacy is how to get into payer networks. Even if you have access to limited distribution medication, great provider relationships, and a robust clinical program, there is no guarantee that you will be able to fill the prescription.

Pharmacy benefit managers are increasingly using narrow networks and often go to great efforts to funnel business to their own specialty pharmacy.

Independent specialty pharmacies must dedicate resources to meeting with payers and negotiating access to networks.

Payers that use open or preferred net-

works are interested in how you can help lower costs and enhance outcomes.

Although aggressive pricing is generally at the top of the priority list, keep in mind that you will need to meet reporting requirements and other performance guarantees to qualify for participation in most specialty networks.

5/ Differentiate Your Business

Differentiating your service is the key to success in specialty pharmacy. It is important to determine what services you can provide that are not currently available to patients and providers in your area. Find a therapeutic category that you are passionate about, and where you can identify an unmet need.

Lastly, recognize that transitioning into a specialty provider role will be more of a marathon than a sprint. It takes time to create and implement new clinical programs, and the sellcycle for manufacturers and payers is lengthy. ❚

References

1. The Express Scripts Lab. The 2013 Drug Trend Report. http://lab.express-scripts.com/~/media/7f14884da6ef434dbf30abd82dd7e655.ashx. Published April 2014. Accessed November 4, 2014.

2. Pharmacy Benefit Management Institute. 2014 PBMI Specialty Drug Report. http://reports.pbmi.com/report. php?id=5. Published February, 2014. Accessed November 4, 2014.

3. Office of Inspector General, Department of Health & Human Services. re: OIG Advisory Opinion No. 14-06. https://oig.hhs.gov/fraud/docs/advisoryopinions/2014/ AdvOpn14-06.pdf. Published August 15, 2014. Accessed November 4, 2014.

GET YOUR RETAIL CLINIC PROFILED IN INSIDE PATIENT CARE: PHARMACY & CLINICS! We want to interview PAs, NPs, and Medical Directors from around the country.

The process is easy – just a short phone interview and some photos.

Contact: fevans@the-lynx-group.com for information

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

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INSIDE

Money Ten Tips to Cut Your 2014 Taxes

by ANDREW D. SCHWARTZ, CPA, and LAWRENCE B. KELLER, CFP, CLU, CHFC, RHU, LUTCF

Most people are familiar with the old adage about life’s 2 certainties: taxes, like death, are inevitable. But why pay more in taxes than you have to? }} }} THIS ARTICLE provides 10 potential tax-saving opportunities for 2014. The key is to take the time to evaluate which of these concepts, if any, may work in your situation. There is still time to take advantage of these 10 tax-saving opportunities before December 31, 2014.

1/ If you have not been contributing

to your 401(k) and 403(b) plans at the maximum rate all year, increase your contributions. This year, you can put up to $17,500 into your 401(k) or 403(b) plan. Anyone aged ≥50 years

by December 31, 2014, can put away an additional $5500 (for a total of $23,000). Contributing to a 401(k) or 403(b) plan at work is one of the best tax shelters available to you during your working years.

2/

If you are self-employed, consider setting up a Solo 401(k) by December 31, 2014. A Solo 401(k) plan allows a self-employed person to reach the

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$52,000 retirement plan maximum with less income than a SEP-IRA. It also allows people aged ≥50 years to put away an additional $5500 (for a total of $57,500) into a retirement plan for 2014.

3/

To avoid an underpayment penalty, review your withholdings and instruct your employer to withhold additional taxes if you have not had enough taxes withheld during the year. The IRS Withholding Calculator for 2015 is available at www.irs.gov/Individuals/ IRS-Withholding-Calculator.

KEY POINTS ❚ Increase your 401(k) and 403(b) contributions ❚ Consider selling investments ❚ Send your January 2015 mortgage payment early ❚ Donate

4/ Consider selling your investments

held in nonretirement accounts that have depreciated. Since your capital losses can offset other capital gains realized during the year (including those from your mutual funds), excess losses can then be used to offset up to $3000 of wages and other income.

However, wait at least 31 days before

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

41

Inside Money buying back security sold at a loss, or the IRS will not allow the loss under “wash sale” rules.

5/ If you are in the lowest tax brack-

et, consider selling your investments that have increased in value. Since the capital gains rate will be 0%, those securities can be bought back, and the “cost-basis” will be the higher amount.

This strategy will save you taxes when you sell these securities in the future.

Ensure that the capital gains realized don’t push you out of the 15% tax bracket, or you will be taxed on gains that fall outside that range.

6/ Send in your January 2015 mortLawrence B. Keller Mr Schwartz, CPA, is a partner in the Boston CPA firm Schwartz & Schwartz, PC, and is also the founder of the MDTAXES Network (www.mdtaxes.com).

Mr Keller, CFP, CLU, ChFC, RHU, LUTCF, is the founder of Physician Financial Services.

gage payment early enough for processing before December 31, 2014.

You can deduct the interest portion of that payment a year earlier by sending in your payment a few weeks early.

7/

Clean out your closets; donate your clothing and household items to a charitable organization, since itemized “noncash” contributions are tax deductible. Remember to get a receipt.

Make an itemized list that includes condition of the donated items, and take a few pictures of the items as well. Only donations of clothing and household

items in “good condition or better” qualify for a deduction.

8/

Making monetary donations by credit card before December 31, 2014, allows you to deduct the donation on this year’s return, even if you don’t pay your credit card bill until 2015.

You always have the option of donating to charities any investments that have appreciated. You can claim your donation based on the value of the donated assets without paying capital gains taxes on the appreciation.

9/

Prepay your projected state tax shortfall if you will be itemizing your deductions and you will not be subject to the alternative minimum tax.

10/

Prepay and pay off your medical bills if your total medical expenses exceed 10% of your income and you itemize. The threshold increased from 7.5% to 10% in 2013, except for people aged >65 years, for whom the threshold remains at 7.5%.

This month, evaluate whether you will save taxes by postponing 2014 income or deductions into 2015 or by accelerating 2015 income or deductions into 2014. ❚

GET YOUR QUESTIONS ANSWERED IN INSIDE PATIENT CARE: PHARMACY & CLINICS Do you have questions regarding best practices in the pharmacy or clinic? We want to hear from pharmacists, NPs, PAs, and Medical Directors from around the country about the key issues they are facing in the field today.

Contact: fevans@the-lynx-group.com with your questions

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

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Drug Update Eliquis (Apixaban) Received New Indications for DVT Prophylaxis After Hip/Knee Replacement Surgery and Risk Reduction for Recurrent DVT and PE

by LISA A. RAEDLER, PHD, RPH, Medical Writer

Approximately 900,000 Americans are affected by venous thromboembolism (VTE) annually.1 }} }} VTE INCLUDES deepvein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot that partially or totally blocks the blood flow through a vein, typically in the lower leg or thigh.

The symptoms of DVT include discomfort, pain, edema, redness, and distended veins. DVT can progress to PE—a thrombus in the lungs—and can result in sudden death.2 The adverse consequences of VTE are significant, including approximately 300,000 fatalities and hundreds of thousands of hospitalizations annually.1

In addition to advancing patient age, the risk factors for VTE include a history of VTE, surgery or trauma within 3 to 6 months, hospitalization or nursing home confınement, active cancer, paralysis of the leg, obesity, venous catheterization, pregnancy and the postpartum period, estrogen use, and various medical conditions (eg, myocardial infarction, stroke, systemic lupus erythematosus, inflammatory bowel disease, and hematologic conditions).3,4 Patients who undergo joint replacement proce-

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

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dures, including total hip replacement surgery and total knee replacement surgery, are at a high risk for VTE and require effective thromboprophylaxis.5 The American College of Chest Physicians has estimated that the baseline risk for symptomatic VTE and bleeding in the absence of prophylaxis is 4.3% for the first 35 days after major orthopedic surgery.5 The prevalence of total hip replacement surgery or total knee replacement surgery is increasing in the United States. Between 1990 and 2002, the rate of primary total hip replacement procedures per 100,000 persons increased

by approximately 50%, and the corresponding rate of total knee replacement procedures nearly tripled.6 The current projections indicate that between 2005 and 2030, the total number of hip replacement procedures will reach nearly 600,000 annually.7 Strategies to reduce the risk for VTE in patients who are undergoing joint replacement surgery include low-molecularweight heparin (LMWH), such as enoxaparin or dalteparin; fondaparinux; oral antithrombotic drugs, such as dabigatran or rivaroxaban; aspirin; vitamin K antagonists; and mechanical methods (eg, intermittent pneumatic

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Drug Update Table 1. Timing and Duration of Drug Therapy in the ADVANCE Clinical Trials Patients randomized, N

Timing of first apixaban dose postsurgery, hrs

Timing of first enoxaparin dose postsurgery, hrs

Treatment duration, days

ADVANCE-1 (knee replacement)

3195

12-24

12-24

10-14

ADVANCE-2 (knee replacement)

3057

12-24

9-15

10-14

ADVANCE-3 (hip replacement)

5407

12-24

9-15

32-38

Clinical trial

Source: Eliquis (apixaban) tablets prescribing information; August 2014.

compression device).8 The administration of prophylactic medications must be balanced against the hazard of symptomatic bleeding events, as well as their practical limitations.8 For example, LMWH and fondaparinux require subcutaneous injections; warfarin has a delayed onset of action, making it relatively ineffective in the immediate postsurgical time period. Furthermore, compression devices can be cumbersome and are relatively ineffective after hip replacement surgery.8 Novel oral antithrombotic agents combine the convenience of administration with efficacy and safety profiles that are comparable or superior to other methods.8 Rivaroxaban, a factor Xa inhibitor, was approved on July 1, 2011, by the US Food and Drug Administration (FDA) to reduce the risk for blood clots, DVT, and PE after knee or hip replacement surgery.9,10

44

Dabigatran, a direct thrombin inhibitor, is not approved by the FDA for use in patients undergoing joint replacement surgery,11 but it has been evaluated in several phase 3 clinical trials for the prevention of VTE in patients who undergo these procedures.12-14 Because VTE is associated with several potentially serious complications, its economic burden on the US healthcare system is significant. Using a large, geographically diverse US managed care database, a 2009 study estimated the annualized total healthcare costs across the entire continuum of care for patients who presented with DVT and/or PE.15 The study showed that during and after DVT, PE, and DVT/ PE events, the annualized median costs increased to $17,512, $18,901, and $25,554, respectively, com­pared with a median cost of $680 in the control

group. The investigators concluded that clinical and economic benefits are likely to result from early detection and the appropriate treatment of DVT.15

Apixaban Receives New Indications in 2014 In 2014, apixaban (Eliquis; Bristol-Myers Squibb and Pfizer) received 2 new indications. On March 13, 2014, the FDA approved apixaban for the prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery.16,17 On August 21, 2014, apixaban received supplemental approval for the treatment of DVT and PE, and for risk reduction of recurrent DVT and PE after initial therapy.18,19 Apixaban was first approved by the FDA on December 28, 2012, to reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

fibrillation (NVAF).19,20 This approval was contingent on the manufacturer’s provision of a Risk Evaluation and Mitigation Strategies program to inform healthcare professionals about the increased risk for thrombotic events, including stroke, when apixaban is prematurely discontinuing without an adequate alternative anticoagulant use.19 The FDA approved apixaban for DVT prophylaxis and for the prevention of PE, in patients who have undergone hip or knee replacement surgery, after reviewing data from studies conducted as a part of the ADVANCE trial program.8,17,19,21 The pooled data from 2 of the ADVANCE trials showed that apixaban was more effective than enoxaparin for the prevention of VTE in patients undergoing hip or knee replacement surgery.21 The approval of apixaban for the treatment of DVT and PE, and for risk reduction for recurrent DVT and PE after initial therapy, was based on data from 2 global studies— AMPLIFY and AMPLIFY-EXT.18,22,23 In AMPLIFY, apixaban demonstrated efficacy comparable with standard of care using a composite efficacy end point of recurrent symptomatic VTE or VTErelated death.19,22 In addi-

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Drug Update Table 2. Key Efficacy Results from ADVANCE-1 and ADVANCE-2 in Patients Undergoing Elective Knee Replacement Surgerya ADVANCE-1 Events during 12-day treatment Patients, N Total VTE /all-cause death, N (%) (95% CI) b

Relative risk P value Patients, N

ADVANCE-2

Apixaban 2.5 mg oral twice daily

Enoxaparin 30 mg subcutaneous every 12 hrs

Apixaban 2.5 mg oral twice daily

Enoxaparin 40 mg subcutaneous daily

1157

1130

976

997

104 (8.99) (7.47-10.79)

100 (8.85) (7.33-10.66)

147 (15.06) (12.95-17.46)

243 (24.37) (21.81-27.14)

1.02 (95% CI, 0.78-1.32) Not significant

0.62 (95% CI, 0.51-0.74) <.001

1599

1596

1528

1529

All-cause death, N (%) (95% CI)

3 (0.19) (0.04-0.59)

3 (0.19) (0.04-0.59)

2 (0.13) (0.01-0.52)

0 (0.00-0.31)

Pulmonary embolism, N (%) (95% CI)

16 (1.00) (0.61-1.64)

7 (0.44) (0.20-0.93)

4 (0.26) (0.08-0.70)

0 (0.00-0.31)

Symptomatic DVT, N (%) (95% CI)

3 (0.19) (0.04-0.59)

7 (0.44) (0.20-0.93)

3 (0.20) (0.04-0.61)

7 (0.46) (0.20-0.97)

Patients, N Proximal DVT,c N (%) (95% CI) Patients, N Distal DVT,c N (%) (95% CI)

1254

1207

1192

1199

9 (0.72) (0.36-1.39)

11 (0.91) (0.49-1.65)

9 (0.76) (0.38-1.46)

26 (2.17) (1.47-3.18)

1146

1133

978

1000

83 (7.24) (5.88-8.91)

91 (8.03) (6.58-9.78)

142 (14.52) (12.45-16.88)

239 (23.90) (21.36-26.65)

Events associated with each end point were counted once per patient, but patients may have contributed events to multiple end points.

Total VTE includes symptomatic and asymptomatic DVT and pulmonary embolism. c Includes symptomatic and asymptomatic DVT. CI indicates confidence interval; DVT, deep-vein thrombosis; VTE, venous thromboembolism.

Source: Eliquis (apixaban) tablets prescribing information; August 2014. a

b

tion, apixaban demonstrated superiority in the primary safety end point of major bleeding, as well as fewer clinically rele­­ vant nonmajor bleeding events.19,22 In the AMPLIFY-EXT clinical trial, patients who had completed 6 to 12 months of anticoagulant therapy without having a recurrent event were randomized to receive apixaban or placebo for 12 months.19,23 Both doses of

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apixaban (ie, 5 mg and 2.5 mg) were superior to placebo in the primary end point of symptomatic recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death.19,23

Mechanism of Action Apixaban is an oral selective factor Xa in­ hibitor. By inhibiting this key blood clotting protein, apixaban decreases thrombin generation and blood clot formation.19

Apixaban decreases thrombin generation and thrombus development by selectively inhibiting free and clot-bound factor Xa. Apixaban does not require antithrombin III for antithrombotic activity, and it has no direct effect on platelet aggregation.19

Dosing and Administration For the prophylaxis of DVT after hip or knee replacement surgery, the

recommended dose of apixaban is 2.5 mg orally twice daily, with or without food. The first dose should be administered 12 to 24 hours after surgery.

Patients who undergo hip replacement surgery should take apixaban for a total of 35 days, and patients who undergo knee replacement surgery should take apixaban for 12 days (Table 1).19 For the treatment of DVT and PE, apixaban

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Drug Update Table 3. Key Efficacy Results from the ADVANCE-3 Clinical Trial in Patients Undergoing Elective Hip Replacement Surgerya Events during 35-day treatment Patients, N Total VTEb/all-cause death, N (%)

Apixaban 2.5 mg oral twice daily

Enoxaparin 40 mg subcutaneous daily

1949

1917

27 (1.39) (95% CI, 0.95-2.02)

74 (3.86) (95% CI, 3.08-4.83)

Relative risk P value

0.36 (95% CI, 0.22-0.54) <.001

Patients, N

2708

2699

All-cause death, N (%)

3 (0.11) (95% CI, 0.02-0.35)

1 (0.04) (95% CI, 0.00-0.24)

Pulmonary embolism, N (%)

3 (0.11) (95% CI, 0.02-0.35)

5 (0.19) (95% CI, 0.07-0.45)

Symptomatic DVT, N (%)

1 (0.04) (95% CI, 0.00-0.24)

5 (0.19) (95% CI, 0.07-0.45)

2196

2190

7 (0.32) (95% CI, 0.14-0.68)

20 (0.91) (95% CI, 0.59-1.42)

1951

1908

20 (1.03) (95% CI, 0.66-1.59)

57 (2.99) (95% CI, 2.31-3.86)

Patients, N Proximal DVT, N (%) c

Patients, N Distal DVT, N (%) c

Events associated with each end point were counted once per patient, but patients may have contributed events to multiple end points.

Total VTE includes symptomatic and asymptomatic DVT and pulmonary embolism.

Includes symptomatic and asymptomatic DVT. CI indicates confidence interval; DVT, deep-vein thrombosis; VTE, venous thromboembolism.

Source: Eliquis (apixaban) tablets prescribing information; August 2014.

a

b c

should be dosed at 10 mg orally twice daily for 7 days, followed by 5 mg orally twice daily.19 To reduce the risks for recurrence after at least 6 months of treatment for DVT or PE, the recommended dose of apixaban is 2.5 mg orally twice daily.19 For patients who are unable to swallow tablets, the 5-mg and 2.5-mg apixaban tablets may be crushed and suspended in a dextrose solution and immediately delivered through a nasogastric tube.19

46

The ADVANCE Clinical Trials: Prophylaxis of DVT After Hip or Knee Replacement Surgery Overall, 3 doubleblind, multinational studies documented the clinical efficacy of apixaban in adults who underwent orthopedic procedures: ADVANCE-1 (knee replacement surgery), ADVANCE-2 (knee replacement surgery), and ADVANCE-3 (hip replacement surgery).8,19,21 A total of 11,659 patients were

randomized in these 3 clinical trials to apixaban (N = 5770) or to enoxaparin (N = 5755); overall, the studies included 1866 patients aged ≥75 years, 1161 patients with low body weight (≤60 kg), 2528 patients with a body mass index of ≥33 kg/m2, and 625 patients with severe or moderate renal impairment.19 Each clinical trial compared oral apixaban with subcutaneously administered enoxaparin, and the primary efficacy end point

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

was a composite of adjudicated asymptomatic and symptomatic DVT, nonfatal PE, and all-cause death at the end of the intended treatment period. In the ADVANCE-1 trial, the primary end point was tested for noninferiority of apixaban to enoxaparin. In the ADVANCE-2 and the ADVANCE-3 trials, the primary end point was tested for noninferiority, then superiority, of apixaban to enoxaparin.8,19,21 The ADVANCE clinical trials randomized more

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Drug Update Table 4. Bleeding During Treatment in Patients Undergoing Elective Hip or Knee Replacement Surgery ADVANCE-1 knee replacement surgery

ADVANCE-2 knee replacement surgery

ADVANCE-3 hip replacement surgery

Apixaban 2.5 mg oral twice daily 12 ± 2 days

Enoxaparin 30 mg subcutaneous every 12 hrs 12 ± 2 days

Apixaban 2.5 mg oral twice daily 12 ± 2 days

Enoxaparin 40 mg subcutaneous daily 12 ± 2 days

Apixaban 2.5 mg oral twice daily 35 ± 3 days

Enoxaparin 40 mg subcutaneous daily 35 ± 3 days

First dose 12-24 hrs postsurgery

First dose 12-24 hrs postsurgery

First dose 12-24 hrs postsurgery

First dose 9-15 hrs postsurgery

First dose 12-24 hrs postsurgery

First dose 9-15 hrs postsurgery

All treated patients, N

1596

1588

1501

2659

Major bleeding, including surgical site, N (%)

11 (0.7)

Major and CRNM bleeding, N (%) All bleeding, N (%)

Bleeding end pointa

1508

2673

22 (1.4)

b

9 (0.6)

14 (0.9)

22 (0.8)

18 (0.7)

46 (2.9)

68 (4.3)

53 (3.5)

72 (4.8)

129 (4.8)

134 (5.0)

85 (5.3)

108 (6.8)

104 (6.9)

126 (8.4)

313 (11.7)

334 (12.6)

c

All bleeding criteria included surgical-site bleeding.

Includes 5 patients with major bleeding events that occurred before the first dose of apixaban.

Includes 13 patients with major bleeding events that occurred before the first dose of apixaban.

CRNM indicates clinically relevant nonmajor.

Source: Eliquis (apixaban) tablets prescribing information; August 2014.

a

b c

than 11,000 patients to assess the safety and efficacy of apixaban in preventing DVT in patients who have undergone hip or knee replacement surgery.8,17,21

Efficacy The phase 3 studies demonstrated that apixaban was more effective than enoxaparin for the prevention of VTE in patients undergoing hip or knee replacement surgery.17,19 The efficacy data for apixaban and enoxaparin from the ADVANCE-1 and the ADVANCE-2 trials (ie, patients undergoing knee replacement surgery) are summarized in Table 2.19

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Efficacy data for apixaban and enoxaparin from the ADVANCE-3 trial (ie, patients undergoing hip replacement surgery) are summarized in Table 3.19 The efficacy of apixaban was generally consistent across patient subgroups, including age, sex, race, body weight, and renal impairment.19

Safety Apixaban 2.5 mg twice daily for up to 38 days was evaluated in 4 clinical trials (1 phase 2 study and 3 phase 3 studies) with a total of 5924 patients undergoing elective hip or knee replacement surgery.19 Adverse reactions were observed in 11% of

the patients who received apixaban 2.5 mg twice daily.19 Table 4 summarizes the bleeding results during the treatment period in the phase 3 studies. In each study, bleeding was assessed starting with the first dose of the doubleblind study drug.19 Other adverse reactions that occurred in ≥1% of patients undergoing hip or knee replacement surgery included nausea (2.6% for apixaban and 2.7% for enoxaparin); anemia (including postoperative and hemorrhagic anemia), and respective laboratory parameters (2.6% vs 3.0%, respectively); contusion (1.4% vs

1.9%, respectively); hemorrhage, including hematoma, and vaginal and urethral hemorrhage (1.1% vs 1.4%, respectively); postprocedural hemorrhage, including postprocedural hematoma, wound hemorrhage, vessel puncture–site hematoma, and catheter-site hemorrhage (0.9% vs 1.0%, respectively); increased transaminases, including increased alanine aminotransferase and abnormal alanine aminotransferase (0.8% vs 1.2%, respectively); increased aspartate aminotransferase (0.8% vs 1.2%, respectively); and increased gamma-glutamyltransferase (0.6% vs 1.1%, respectively).19

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Inside

Drug Update Table 5. Key Efficacy Results from the AMPLIFY Clinical Trial Event

Apixaban (N = 2609)

VTE or VTE-related death,a N (%) DVT,b N (%) Pulmonary embolism,b N (%) VTE-related death,b N (%)

59 22 27 12

Relative risk VTE or all-cause death, N (%)

71 35 25 16

(2.7) (1.3) (0.9) (0.6)

0.84 (95% CI, 0.60-1.18) 84 (3.2)

Relative risk VTE or CV-cause death, N (%)

Enoxaparin plus warfarin (N = 2635)

(2.3) (0.8) (1.0) (0.4)

104 (4.0) 0.82 (95% CI, 0.61-1.08)

61 (2.3)

Relative risk

77 (2.9) 0.80 (95% CI, 0.57-1.11)

Noninferior compared with enoxaparin/warfarin (P <.001).

Events associated with each end point were counted once per patient, but patients may have contributed events to multiple end points.

CI indicates confidence interval; CV, cardiovascular; DVT, deep-vein thrombosis; VTE, venous thromboembolism.

Source: Eliquis (apixaban) tablets prescribing information; August 2014. a

b

AMPLIFY and AMPLIFY-EXT Trials: Treatment of DVT and PE, and Reduction in Risk for Recurrent DVT and PE After Initial Therapy The 2 double-blind, randomized clinical trials, AMPLIFY and AMPLIFY-EXT, supported the approval of apixaban for the treatment of DVT and PE, and for risk reduction of recurrent DVT and PE after initial therapy. In these studies, 2676 patients received apixaban 10 mg twice daily, 3359 patients received apixaban 5 mg twice daily, and 840 patients received apixaban 2.5 mg twice daily.19,22,23 AMPLIFY was a randomized, double-blind clinical trial that investigated the efficacy and safety of apixaban for the treatment of patients with

48

confirmed symptomatic DVT or PE. In AMPLIFY, apixaban was compared with the standard of care (ie, initial enoxaparin treat­ ment for at least 5 days), followed by warfar­ in therapy (international normalized ratio range, 2.0-3.0) for 6 months in patients with confirmed symptomatic DVT and/ or PE.19,22 The primary efficacy end point was a composite of recurrent symptomatic VTE, or VTE-related death. The primary safety end point was major bleeding.19,22 Of the 5244 patients who were evaluable for efficacy in the AMPLIFY trial, the mean age was 57 years.19 Overall, 59% of these patients were male and 83% were Caucasian.

Approximately 90% of the patients had an unprovoked DVT or PE at baseline. The balance of

patients with a provoked DVT or PE were required to have an additional ongoing risk factor, such as a previous episode of DVT or PE, immobilization, history of cancer, active cancer, and a known prothrombotic genotype.19 In the AMPLIFY-EXT trial, 2 doses of apixaban (2.5 mg and 5 mg orally twice daily) were compared with placebo in patients who had been treated for DVT and/or PE for 6 to 12 months with anticoagulant therapy without having a recurrent event.19,23 A total of 2486 patients were enrolled in the AMPLIFY-EXT trial, which involved 328 sites in 28 countries.23 The primary efficacy end point was symptomatic recurrent VTE or all-cause death, and the primary safety end point was major bleeding.19,23 Recurrent

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VTE included nonfatal PE and nonfatal DVT.19 Death was classified as VTE-related, cardiovascu­ lar disease–related, bleeding-related, or as a result of other causes.23 Of the 2482 patients who were enrolled in the AMPLIFY-EXT trial, the mean age was 57 years; the majority of these patients were male (57%) and Caucasian (85%).19 In addition, approximately 33% of the patients had participated in the AMPLIFY trial before enrollment in the AMPLIFYEXT trial.19

Efficacy The AMPLIFY trial showed that apixaban was noninferior to enoxaparin plus warfarin for the primary end point of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death

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Drug Update Table 6. Summary of Key Efficacy Results from the AMPLIFY-EXT Clinical Trial Apixaban 2.5 mg (N = 840)

Apixaban 5 mg (N = 813)

Placebo (N = 829)

Recurrent VTE or all-cause death, N (%)

32 (3.8)

34 (4.2)

96 (11.6)

DVT, N (%)

19 (2.3)

28 (3.4)

72 (8.7)

Pulmonary embolism,a N (%)

23 (2.7)

25 (3.1)

37 (4.5)

All-cause death, N (%)

22 (2.6)

25 (3.1)

33 (4.0)

Event a

Relative risk: apixaban 2.5 mg vs placebo

0.33 (95% CI, 0.22-0.48; P <.001)

Relative risk: apixaban 5 mg vs placebo

0.36 (95% CI, 0.25-0.53; P <.001)

Patients with more than 1 event are counted in multiple rows.

CI indicates confidence interval; DVT, deep-vein thrombosis; VTE, venous thromboembolism.

Source: Eliquis (apixaban) tablets prescribing information; August 2014. a

during 6 months of therapy.19,22 The efficacy data for apixaban and enoxaparin plus warfarin are summarized in Table 5.19 Patients in the AMPLIFY trial were stratified according to their index event of PE (with or without DVT) or DVT (without PE), and the efficacy of apixaban in the initial treatment of VTE was consistent between these subgroups.19,22 In the AMPLIFY-EXT trial, both doses of apixaban were superior to placebo in the composite end point of symptomatic recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death.19,23 These data are summarized in Table 6.19

Safety In the AMPLIFY trial, adverse reactions related to bleeding occurred in 15.6% of patients who received apixaban com-

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pared with 24.6% of patients who received enoxaparin plus warfar­ in.19 The rates of discontinuation as a result of bleeding events were 0.7% in the apixaban group and 1.7% in the enoxaparin plus warfarin group.19 The AMPLIFY trial showed that apixaban was significantly superior to enoxaparin plus warfarin in the primary safety end point of major bleeding.19,22 The relative risk for major bleeding was 0.31 (95% confidence interval, 0.170.55; P <.001).19 The adverse reactions that occurred in ≥1% of patients in the AMPLIFY trial included epistaxis, contusion, hematuria, menorrhagia, hematoma, hemoptysis, rectal hemorrhage, and gingival bleeding.19 Adverse reactions that were related to bleeding occurred in 13.3% of pa-

tients who received apixaban compared with 8.7% of patients who received placebo in the AMPLIFY-EXT trial.19 The rates of major bleeding were 0.2% in the apixaban 2.5mg group, 0.1% in the apixaban 5-mg group, and 0.5% in the placebo group.19 The rates of discontinuation as a result of bleeding events were approximately 1% in the apixaban group and 0.4% in the placebo group.19 The adverse reactions that occurred in ≥1% of patients in the AMPLIFY-EXT study included epistaxis, hematuria, hematoma, contusion, and gingival bleeding.19,23

Contraindications Apixaban is contraindicated in patients with active pathologic bleeding and in patients who have had severe hypersensitivity reactions, including anaphylaxis, to apixaban.19

Warnings and Precautions Boxed warning. The prescribing information for apixaban includes a boxed warning about several risks that are associated with this medication, including increased risk for stroke that is associated with the premature discontinuation of apixaban in patients with NVAF who do not maintain adequate anticoagulation.19 In addition, the boxed warning cautions about the risk for epidural or spinal hematoma. Patients who are receiving neuroaxial anesthesia or who are undergoing spinal puncture and are treated with antithrombotic agents for the prevention of VTE may develop hematomas (spinal or epidural) that can cause long-term or permanent paralysis. The postoperative use of indwelling epidural catheters or the con-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ December 2014

49

Inside

Drug Update comitant use of other drugs that affect hemostasis may increase the risk for these events. Indwelling epidural or intrathecal catheters should not be removed until 24 hours after the last apixaban dose, and the next apixaban dose should be administered at least 5 hours after catheter removal.19 Furthermore, the discontinuation of apixaban in the absence of adequate alternative anticoagulation increases the risk for thrombotic events.19 In clinical trials that involved patients with atrial fibrillation, an increased rate of stroke was observed during the transition from apixaban to warfarin. If apixaban must be discontinued for a reason other than pathologic bleeding or the completion of a course of therapy, coverage with another anticoagulant should be considered.19 Bleeding. Apixaban can cause serious, potentially fatal bleeding.19 The concomitant use of drugs that affect hemostasis increases the risk for bleeding; these drugs include antiplatelet agents (eg, aspirin), anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs. Patients should be counseled about

50

the signs and symptoms of blood loss and should be instructed to report them immediately or to visit an emergency department.19 Patients with active pathologic hemorrhaging should discontinue the use of apixaban.19 The anticoagulant effects of apixaban, which can be expected to persist for at least 24 hours after the last dose, cannot be reversed by any established method, and no specific antidote is available. Hemodialysis does not appear to have a substantial effect on apixaban exposure.19 Traumatic or repeated epidural or spinal puncture can increase the risk for hematoma.19 If traumatic puncture occurs, the administration of apixaban should be delayed for 48 hours. Patients should be frequently monitored for the signs and symptoms of neurologic impairment (eg, numbness or weakness of the legs, bowel, or bladder dysfunction).19 Furthermore, urgent diagnosis and treatment are necessary if neurologic compromise is observed.

For patients who take anticoagulants and for patients who plan to take anticoagulants for thromboprophylaxis, the potential benefit of epidural or spinal intervention should be weighed against the risk.19

Prosthetic heart valves.

Because the safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves, the use of apixaban is not recommended in these patients.19 Acute PE in hemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy should not receive initial treatment with apixaban as an alternative to unfractionated heparin.19

Use in Specific Populations Pediatric use. The safety and effectiveness of apixaban have not been established in pediatric patients.19 Geriatric use. In the ADVANCE-1, ADVANCE-2, and ADVANCE-3 clinical trials, 50% of the patients were aged ≥65 years and 16% of the patients were aged ≥75 years.19 In the AMPLIFY and AMPLIFYEXT trials, more than 32% of patients were aged ≥65 years, and more than 13% of patients were aged ≥75 years.16 Comparisons of patients in various agegroups showed no significant differences in the drug’s safety or efficacy.19

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Pregnancy. Adequate and well-controlled studies of apixaban in pregnant women have not been conducted. Because treatment is likely to increase the risk for hemorrhage during pregnancy and delivery, apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk for the mother and the fetus.19 Labor and delivery.

The safety and efficacy of apixaban during labor and delivery have not been studied in clinical trials.

The risks for bleeding and for stroke with apixaban use should be considered in this setting.19 Nursing mothers. It is not known whether apixaban or its metabolites are excreted in human milk.

Based on the importance of the drug to the mother, women should either discontinue breastfeeding or discontinue the use of apixaban, taking into account the importance of the drug to the mother.19 End-stage renal disease (ESRD). Patients with ESRD with or without hemodialysis were not included in the clinical efficacy and safety studies of apixaban.16 For patients with ESRD that is maintained with hemodialysis, the recommended dose of apixaban is 5 mg orally twice daily. For patients with ESRD that is main-

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Drug Update tained with hemodialysis and are either aged ≥80 years or have a body weight of ≤60 kg, the dose of apixaban should be reduced to 2.5 mg twice daily.19

Conclusion Apixaban is an antithrombotic agent that selectively inhibits factor Xa to decrease thrombin generation and blood clot formation. Apixaban offers a safe, effective, and convenient oral alternative for patients undergoing total hip replacement surgery or total knee replacement surgery, patients who require treatment for VTE, and patients in whom prophylaxis is needed to reduce the risk for recurrent VTE after initial therapy. In addition, apixaban does not require routine coagulation testing and monitoring, which adds to its convenience. In clinical trials, apixaban had significantly lower rates of major bleeding events compared with enoxapa-

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rin plus warfarin, a serious concern in patients undergoing surgery, such as hip or knee replacement surgery. ❚

References

1. Heit J. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Bio. 2008;28:370.

2. American Academy of Orthopaedic Surgeons; American Association of Hip and Knee Surgeons. Deep vein thrombosis. Reviewed January 2009. http://orthoinfo.aaos.org/topic.cfm? topic=A00219. Accessed September 30, 2014.

3. Raskob GE, Silverstein R, Bratzler DW, et al. Surveillance for deep vein thrombosis and pulmonary embolism: recommendations from a national workshop. Am J Prev Med. 2010;38(4 suppl):S502-S509.

4. Geerts WH, Bergqvist D, Pineo GF, et al; for the American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians EvidenceBased Clinical Practice Guidelines (8th edition). Chest. 2008;133 (6 suppl):381S-453S. 5. Falck-Ytter Y, Francis CW, Johanson NA, et al; for the American College of Chest Physicians. Pre­ vention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Pre­ vention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl): e278S-e325S. 6. Kurtz S, Mowat F, Ong K, et al.

Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002.

J Bone Joint Surg Am. 2005;87:14871497.

7. Kurtz S, Ong K, Lau E, et al.

Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint

Surg Am. 2007;89:780-785.

8. Lassen MR, Gallus A, Raskob GE, et al; for the ADVANCE-3 Investigators.

Apixaban versus enoxaparin for thromboprophylaxis after hip replacement.

N Engl J Med. 2010;363:2487-2498.

9. US Food and Drug Administration.

FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements. Press release. July 5, 2011. www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm261839. htm. Accessed September 30, 2014.

10. Xarelto (rivaroxaban) tablets [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; September 2014.

11. Pradaxa (dabigatran etexilate mesylate) capsules [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; September 2014.

12. Eriksson BI, Dahl OE, Rosencher N, et al; for the RE-MODEL Study Group. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost. 2007;5:2178-2185.

13. Eriksson BI, Dahl OE, Rosencher N, et al; for the RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet.

2007;370:949-956. Erratum in: Lancet.

2007;370:2004.

14. Ginsberg JS, Davidson BL, Comp PC, et al; for the RE-MOBILIZE Writing Committee. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.

J Arthroplasty. 2009;24:1-9.

15. Dobesh PP. Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy.

2009;29:943-953.

16. US Center for Drug Evaluation and Research. Eliquis sNDA approval letter. March 13, 2014. www.access data.fda.gov/drugsatfda_docs/applet ter/2014/202155Orig1s003ltr.pdf.

Accessed October 1, 2014.

17. Bristol-Myers Squibb. U.S. FDA approves Eliquis (apixaban) to reduce the risk of blood clots following hip or knee replacement surgery. Press release. March 14, 2014. http://news. bms.com/press-release/us-fda-ap proves-eliquis-apixaban-reduce-riskblood-clots-following-hip-or-kneereplace&t=635304028057992662.

Accessed October 1, 2014.

18. Bristol-Myers Squibb. U.S. FDA approves Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy. Press release. August 21, 2014. http://news.bms.com/press-release/ rd-news/us-fda-approves-eliquis-apix aban-treatment-deep-vein-thrombosisdvt-and-pulmon. Accessed October 1, 2014.

19. Eliquis (apixaban) tablets [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; August 2014.

20. US Food and Drug Administration.

FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation.

Press release. December 28, 2012. www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm333634. htm. Accessed November 24, 2014.

21. Raskob GE, Gallus AS, Pineo GF, et al. Apixaban versus enoxaparin for thromboprophylaxis after hip or knee replacement: pooled analysis of major venous thromboembolism and bleeding in 8464 patients from the ADVANCE-2 and ADVANCE-3 trials. J Bone Joint Surg Br. 2012;94:257264.

22. Agnelli G, Buller HR, Cohen A, et al; for the AMPLIFY Investigators.

Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369:799-808.

23. Agnelli G, Buller HR, Cohen A, et al; for the AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368:699-708.

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