IP August/September 2014 by Value-Based Cancer Care

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August | September 2014 VOL. 2 • NO. 4

14 Ensuring

Continuity of Care for Psychiatric Patients

16 Appropriate Use

of Combination Antipsychotics

MENTAL

Health Pharmacist Counseling with Mental Health Patients PAGE 10

27 Upcoming US

Pharmacopeial Convention, Chapter 800

30 Ten Preceptor

Qualities That Create a Great Learning Environment

an afﬁliate of

GE PA LE C P E AB CE/ AIL AV

Transforming Retail Pharmacies into Hea

Pharmacists • Chain Headquarters • Independents • Phy

Call for submissions

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Submit a 750- to 1500-word original article, previously unpublished and submitted exclusively to Inside Pharmacy, that your fellow colleagues will want to read.

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INSIDE PHARMACY ❚ August | September 2014

Transforming Retail Pharmacies into Healthcare Delivery Companies

August | September 2014 Volume 2 Number 4

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

INSIDE

Mental Health

MENTAL

COLUMNS

Health

14 ENSURING CONTINUITY OF CARE FOR PSYCHIATRIC PATIENTS

PAGE

THE FIRST WORD

Donald J. Dietz, RPh, MS

Pharmacists are in an ideal position to provide continuing assistance as patients make the transition into outpatient care.

Informing Patients and Protecting Pharmacies’ Reputation

16 APPROPRIATE USE OF COMBINATION ANTIPSYCHOTICS

PAGE

It is important for community pharmacists to identify patients who may benefit from education or who require an intervention by their care provider.

HEALTHCARE POLICY

Robert E. Henry

Patient Care

STARTS

21 FIVE TIPS FOR A HEALTHY MENTAL STATE

ON PAGE

These tips may help patients reduce and manage their stress, and promote a healthy state of well-being.

The Pharmacy 27 UPCOMING US PHARMACOPEIAL CONVENTION, CHAPTER 800 The USP Convention has released a new chapter with a focus on the handling of hazardous drugs within healthcare settings.

30 TEN PRECEPTOR QUALITIES THAT CREATE A GREAT LEARNING ENVIRONMENT There are a number of best practices that can be universally employed to ensure that both preceptor and student alike benefit from a positive experience during rotations.

COVER STORY I MENTAL HEALTH

Pharmacist Counseling with Mental Health Patients ❚

❚ ❚

Impacting nonadherence in patients

Increased Scope of Care and the Ultimate Paradigm Change: Team-Based Care

2 CALL FOR SUBMISSIONS 6 EDITORIAL BOARD 7 LETTER FROM THE EDITOR 23 PHARMACY RETAIL CLINIC NEWS® 36 CHAIN HEADQUARTERS NEWS® 38 DRUG UPDATE 44 CONTINUING EDUCATION

Providing patient education The next steps in mental healthcare

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

INSIDE PHARMACY ❚ August | September 2014

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Some People Talk About The Future We Invest In It.

Keeping You In The Know About PDMPs A Prescription Drug Monitoring Program (PDMP) is a statewide, electronic database used to collect data on controlled substances dispensed within the state. The PDMPs are specific to the state in which they are enacted. PDMPs are designed to help address prescription drug diversion, addiction and abuse by providing visibility for prescribing history and practices. They provide healthcare professionals with data on controlled substance usage in order to help identify and deter possible abuse or diversion. PDMPs are designed to support legitimate medical use of controlled substances, help prevent abuse, and facilitate identification and treatment of persons addicted to prescription drugs. The programs help prescribers avoid drug interactions and identify drug-seeking behaviors or “doctor shopping.” They are also used to identify clinicians with patterns of inappropriate prescribing and dispensing. Because Mallinckrodt Specialty Generics manufactures and distributes controlled substances, we applaud the efforts to make this data consistently available in real time to pharmacies and prescribers in a way that is easy to use. More information is also available at http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm. Keeping customers educated and well-informed is just one of the many ways that we invest in the future.

www.mallinckrodt.com For more information, scan the QR code with a web-enabled device.

the Editorial Board

The board members and consultants contribute expertise and analysis that help shape the content of Inside Pharmacy

“ PAGE 9

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

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

John O. Beckner, RPh Senior Director Strategic Initiatives National Community Pharmacists Association Richmond, VA

Mitch Betses, RPh Senior Vice President Retail Pharmacy Services CVS Caremark Corporation Woonsocket, RI

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

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

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

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

Albert Garcia Executive Vice President Navarro Health Services Medley, FL

Mark J. Gregory, RPh Senior Vice President of Store Operations Kerr Drug, Inc Raleigh, NC

Kevin James, RPh, MBA Vice President Managed Markets Avella Specialty Pharmacy Phoenix, AZ

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

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

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

Ernie Richardsen, RPh, MBA Group Vice President Pharmaceutical Purchasing and Clinical Services 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

Adoption of legitimate .pharmacy websites will help stop the rampant illegal distribution of unauthorized products.” —Donald J. Dietz, RPh, MS

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

INSIDE PHARMACY ❚ August | September 2014

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

InsidePharmacyOnline.com

Letter from the Editor Retail Healthcare at the Forefront of Disruptive Innovation Integrating Primary Care into the Retail Setting by FREDERIQUE H. EVANS, MBS, Editorial Director, Inside Pharmacy

At the 2nd Annual NACDS Total Store Expo in Boston, Steven C. Anderson, IOM, CAE, President and Chief Executive Officer, talked about the race to “capture the flag” of healthcare innovation in Congress. }} }} RETAIL PHARMACIES are leading the pack in finding innovative ways to provide better access to care for patients. “The retail clinics are disruptive in a sense as they allow patients to become consumers of healthcare,” Tine HansenTurton, Executive Director of the Convenient Care Association, said in a recent interview (see “Retail Clinics Fill the Void in Patient Access to Care,” on page 23). In this issue of Inside Pharmacy, which focuses on mental health, key stakeholders of primary care provide their insight on patient care in the retail setting, resources to achieve professional success, and what you need to know in order to best coordinate care with other colleagues in the pharmacy. Pharmacists share their knowledge and experience on how to best care for mental health patients, including counseling patients, ensuring continuity of care, and the appropriate use of combination antipsychotics

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(see mental health section, starting on page 10). A user-friendly patient tip is also provided to share with your patients how to reduce and manage stress, which you can also download online (see “5 Tips for a Healthy Mental State,” on page 21). In addition to our interview with Tine from the Convenient Care Association, Kevin Letz, one of the original founders of retail clinics, discusses the expanding role of nurse practitioners (NPs) and its impact on immunotherapy (see Retail Pharmacy Clinic News®, on page 25). Ken P. Miller, PhD, RN, President of the American Association of Nurse Practitioners, provides insight on the role of NPs and shares insight on what pharmacists need to know about their counterpart in the retail clinic (see InsidePharmacyOnline.com). Keeping you abreast of the latest immunization recommendation, Jonathan L. Temte, MD, PhD, Chair, US Advisory Community on Immunization Practices (ACIP),

and Professor, Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, discusses the latest ACIP vaccine recommendations and the importance of retail pharmacies in ensuring optimal immunization rates (see InsidePharmacyOnline.com). This issue also includes what you need to know about the latest US Pharmacopeial Convention chapter on handling hazardous drugs, Chapter 800 (see page 27), how to create the best learning environment during rotations (see “10 Preceptor Qualities That Create a Great Learning Environment,” on page 30), as well as continuing education (see page 44). One of the goals of Inside Pharmacy is to provide a forum for pharmacists, chain headquarters, independent pharmacies, physician assistants, and NPs to share their knowledge, experience, and best practices to provide optimal primary care in the retail setting and achieve professional growth and success. ❚

INSIDE PHARMACY ❚ August | September 2014

The First Word Informing Patients and Protecting Pharmacies’ Reputation by DONALD J. DIETZ, RPH, MS, Editor-in-Chief, Inside Pharmacy

“

The .pharmacy domain will provide a low cost option for properly identifying legitimate pharmacy websites.”

harmacists have consistently been ranked near the top of the list of most trusted healthcare professionals. According to a 2013 Gallup poll,1 pharmacists are rated as the second most trusted professionals in terms of honesty and ethics, with 70% of people saying that they would give pharmacists a “high” or “very high” rating. A concern exists that online pharmacy scams and illegal websites may be leading to a decline in these numbers, because some patients may be confused about the legitimacy of a product. Although most consumers have become savvy to these fraudulent practices, others still fall for the scams. Currently, the gold standard for online pharmacy accreditation is the Verified Internet Pharmacy Practice Sites (VIPPS) accreditation from the National Association of Boards of Pharmacy (NABP).

The .Pharmacy Domain VIPPS has accredited 34 online pharmacy websites, which, with chains, encompasses over 12,000 dispensing pharmacies.2 Using 19

5 Reasons to Certify Pharmacy Websites ❚ Secure your website ❚ Legitimize online offerings ❚ Be a trusted online resource ❚ Build patient confidence ❚ Help stop illegal distribution of unauthorized products

criteria for certification, pharmacies with accreditation can be considered safe for consumers.3 However, the costs of becoming VIPPS-certified can be quite onerous and prohibitive for a small independent pharmacy. This may be why free Internet pharmacy verification services, such as LegitScript.com, have emerged. LegitScript is approved by NABP and provides free certification to online pharmacies once they pass an 11-point standards test.4 So far, 216 online pharmacies are listed on LegitScript as being safe for patients.5 For smaller pharmacies that want to

INSIDE PHARMACY ❚ August | September 2014

obtain some sort of certification for their websites, LegitScript can be a worthwhile, free alternative. To further strengthen the legitimacy of online pharmacies, NABP has supported the creation of a .pharmacy domain registration through the Internet Corporation for Assigned Names and Numbers (ICANN). It was only in 2005 that ICANN began considering the introduction of new domains, also known as generic top-level domains (gTLDs), besides the usual .com, .net, .org, and others. There are currently 22 gTLDs, but ICANN expects dozens or even hundreds more in the next few years,6 due to the new gTLD Applicant Guidebook. NABP has been working for over a year to secure the .pharmacy domain and negotiate the terms, and in June 2014, a registry agreement was executed.7 The new domain is scheduled to launch this fall, and should give a sense of confidence to users who visit these pharmacy sites that the visit is secure and trustworthy, and that medications are both safe and authentic. Similar to the VIPPS accreditation, NABP will screen anyone applying for a .pharmacy

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The First Word domain. Eligible registrants must meet a number of criteria, including demonstrating compliance with their laws of jurisdiction and ensuring that they have the proper pharmacy licensure, drug authenticity, and valid prescription requirements.8 The website names chosen must correspond to a trademark, service mark, or business name of the registrant, followed by the .pharmacy domain.9 This will help to reduce confusion related to website authenticity by refusing site names such as “painpills.pharmacy.”

Pharmaceutical Federation, and state boards of pharmacy. Unlike the current VIPPS accreditation, the .pharmacy domain will be available for parties other than pharmacies. Pharmacy benefit managers, wholesalers, manufacturers, drug-related patient advocacy groups, and many others may be eligible to apply for a .pharmacy website. For now, interested parties can go to www.dotpharmacy.net for information about the application process.

Building Patient Confidence So far, the .pharmacy domain has been met with much excitement in the pharmacy community. Eli Lilly, Merck, and Pfizer have all contributed $100,000 or more to support the initiative to have NABP establish the domain.10 A successful adoption of legitimate .pharmacy websites will help to stop the rampant illegal distribution of unauthorized products claiming to be from manufacturers. Other supporters in this global approach include the European Alliance for Access to Safe Medicines, International

This will reduce confusion related to website authenticity. The .pharmacy domain will provide a low-cost option for properly identifying legitimate pharmacy websites. This is another step in the right direction for pharmacies, as it enables patients to have confidence in the pharmacy websites they visit and ultimately helps ensure that

pharmacists remain one of America’s most trusted professionals. ❚

References

1. Gallup poll. Honesty/Ethics in Professions. 2013. www.gallup.com/poll/1654/honesty-ethics-professions. aspx. Accessed August 21, 2014. 2. National Association of Boards of Pharmacy. Recommended Sites. 2014. www.nabp.net/programs/ consumer-protection/buying-medicine-online/recom mended-sites. Accessed August 21, 2014. 3. National Association of Boards of Pharmacy. VIPPS Criteria. 2014. www.nabp.net/programs/accreditation/ vipps/vipps-criteria. Accessed August 21, 2014. 4. National Association of Boards of Pharmacy. Standards. 2014. www.nabp.net/programs/accredita tion/e-advertiser-approval-program/standards. Accessed August 21, 2014. 5. LegitScript. Pharmacies. www.legitscript.com/pharma cies. Accessed August 21, 2014. 6. The Internet Corporation for Assigned Names and Numbers. About the Program. 2014. http://newgtlds. icann.org/en/about/program. Accessed August 21, 2014. 7. The Internet Corporation for Assigned Names and Numbers. gTLD Applicant Guidebook. 2012. 8. National Association of Boards of Pharmacy. NABP Executes Registry Agreement with ICANN for .Pharmacy Domain. 2014. www.nabp.net/news/nabp-ex ecutes-registry-agreement-with-icann-for-pharmacy-do main. Accessed August 21, 2014. 9. LegitScript. Standards. www.legitscript.com/pharma cies/standards. Accessed August 21, 2014. 10. National Association of Boards of Pharmacy. NABP .PHARMACY Governance Document. www.nabp.net/ system/rich/rich_files/rich_files/000/000/290/original/ pharmacy-gtld-governance.pdf. Accessed August 21, 2014.

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

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INSIDE PHARMACY ❚ August | September 2014

INSIDE

TRANSITIONING CARE

Ensuring continuity of care in mental health [14]

Mental Health

ANTIPSYCHOTICS

Appropriate use of combination antipsychotics [16]

PATIENT CARE Patient tips for a healthy mental state [21]

Cover Story

Pharmacist Counseling with Mental Health Patients by SHELBY FREE, PHARMDc

Mental illness has become a significant problem in public health, with almost 25% of the US adult population with a mental disorder.1 }}

KEY POINTS ❚ Rates of nonadherence in patients with mental health issues can exceed 50% ❚ Pharmacists can have an impact on patient adherence by providing education and consultation for patients and their caregivers

}} THE RATES OF MEDICATION adherence in this population have always been a significant challenge for healthcare providers.1 Rates of nonadherence in particular mental disorders, including bipolar disorder and depression, often exceed 50% and contribute to the poor health outcomes and increased healthcare costs associated with these diseases.2

Making an Impact on Adherence Pharmacists can have an impact on patient adherence in any disease state by providing education through consultation with their patients. However, a survey developed by the College of Psychiatric and Neurologic Pharmacists Foundation and the

INSIDE PHARMACY ❚ August | September 2014

National Alliance on Mental Illness in 2012 found that 75% of respondents reported they did not receive effectiveness or safety monitoring assistance from their pharmacists; 43% of the respondents taking mental health medications stated they did not have a strong relationship with their pharmacist.3 The reason for these numbers may be largely due to the numerous barriers associated with educating this population. The primary concern reported in the study was the lack of privacy in the pharmacy to perform these consultations.3 Other barriers to counseling include the inability of pharmacists to communicate because of lack of time, lack of patient-specific information, and

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DISPENSE Albuterol Sulfate HFA as PROAIR HFA Inhalation Aerosol

NO GENERIC ALBUTEROL INHALER CURRENTLY EXISTS

Inside Mental Health inadequate training, as well as patients with complex dosing schedules, drug interactions, and cultural influences.2,4 As a pharmacist, it is important to conquer these barriers by implementing strategies to address these concerns, such as lack of privacy, which can be overcome by designating a private area in the pharmacy for consultation, or scheduling telephone consultations at times convenient for the patient.3 For

Under the appropriate conditions, pharmacists do have the opportunity to play a positive role in the mental health field. complex dosing schedules or patients taking multiple medications, a pillbox or a blister pack could be very beneficial.2 Under the appropriate conditions, pharmacists do have the opportunity to play a positive role in the mental health field.

Patient Education Is Key The importance of counseling patients cannot be stressed enough, especially in a population that uses mental health medications. The side effects and strict regimens associated with these medications can often deter patients from their use. However, it is our job as pharmacists to inform these patients of what to expect while taking these medications. One important counseling point regarding mental health medications includes their delayed onset of action. Many of these medications, including antidepressants, require at least 2 weeks before any antidepressant activity is noted. It is important to inform patients that they should not expect to feel better right away and that they need to give time for the medication to take effect.5 Failure to notify patients of this fact can often lead to early discontinu-

INSIDE PHARMACY â?&#x161; August | September 2014

ation of their medications because they do not believe the medicine is working appropriately. Side effects associated with medications can have a significant impact on patient adherence, and should also be explained during patient consultation. Patients should be informed of what to expect when taking a medication and the importance of following the entire prescribed regimen. Often, patients begin to feel better and decide that the medication is no longer needed to help them. What they may not comprehend is that this is a result of their medication, and that by stopping the medication prematurely, they will revert back to their usual behavior. This is why it is extremely important that patients are informed to continue taking the medication even if they do start to feel better.5 The abrupt discontinuation of certain medications that require dose tapering could also have a negative impact on patients. Patients should also be aware that stopping these medications â&#x20AC;&#x153;cold turkeyâ&#x20AC;? could produce unwanted side effects.6 Our goal as pharmacists is to improve patient health and quality of life, so counseling patients on these important side effects is an example of how we can achieve that goal.

Third-Party Consultations If the patient is not directly available for counseling, it is still important to make sure that the counseling points are discussed. Third parties can play an important role in taking care of the patient; therefore, it is equally important to inform them of any pertinent drug information. Although the Health Insurance Portability and Accountability Act prevents a pharmacist from discussing personal information with these third parties,7 it is still appropriate to discuss important points about the medication. Informing third parties of how medication should be taken (eg, daily, multiple times per day, with or without food),

InsidePharmacyOnline.com

Inside Mental Health

3 Considerations in TIPS Mental Health ADHERENCE Pharmacists can have an impact on patient adherence in any disease state by providing education through consultation with their patients.

+ MORE ONLINE

EDUCATION Educate patients about their medication, side effects, and other relevant factors such as delayed-onset action.

More tips on mental health can be found at InsidePharmacyOnline.com

along with the notable side effects associated with the medication, are impor tant for the patients’ overall health. Third parties should be informed of the appropriate situations in which a physician should be called and should encourage them to have the patient call you if any additional questions arise.

Taking a Step Forward in Mental Health Care To show the impact pharmacists can have on antipsychotic medication adherence, a controlled trial involving patients with schizophrenia, schizoaffective disorder, and bipolar disorder was conducted.2 Using pharmacist-based intervention versus no pharmacist involvement, the study found that during a 12-month period, adherence rates had a statistically significant improvement from a medication possession ratio of 0.54 at baseline to 0.86 in the pharmacist-controlled group compared with no pharmacist involvement.2 This study helps to show that pharmacists can make a difference with medication adherence by becoming actively involved with their patients’ overall care. More than ever, the impact that pharmacists have on a patient’s med-

InsidePharmacyOnline.com

COMMUNICATE Discussing relevant information with other healthcare providers, such as dosage, is crucial when coordinating the care of mental health patients.

ication-related outcomes is extremely important. Counseling patients on appropriate side effects and additional medication-specific information plays an important role in improving adherence. As pharmacists, it is our duty to take a step forward and overcome certain barriers and ensure our patients are receiving the best healthcare that we can provide. We are given the opportunity to have a positive impact on our patients’ lives, and it is up to us to make sure that we are doing so every chance we get. ❚

References

1. Centers for Disease Control and Prevention. CDC Report: Mental Illness Surveillance Among Adults in the United States. www.cdc.gov/mentalhealthsurveillance/ fact_sheet.html. Accessed June 27, 2014. 2. American Pharmacists Association. Improving medication adherence in patients with severe mental illness. Pharmacy Today. 2013;19:69-80. 3. Tanzi MG. Improve counseling of patients with mental health conditions. American Pharmacists Association. www.pharmacist.com/improve-counseling-patients-men tal-health-conditions. Accessed June 27, 2014. 4. Bostwick JR, Diez HL. Optimizing care for patients with depression in the community pharmacy setting. US Pharm. 2008;33:24-28. 5. Teter CJ. Counseling patients being treated with antidepressants. 2004. www.pharmacytimes.com/publications/ issue/2004/2004-02/2004-02-7660. Accessed June 27, 2014. 6. National Institute of Mental Health. Mental Health Medications. www.nimh.nih.gov/health/publications/men tal-health-medications/index.shtml. Accessed June 27, 2014. 7. Figge HL. HIPAA: privacy, security, and pharmacy information technology. US Pharm. 2011;36:79-81.

Ms Free is a PharmD Candidate 2015, Ohio Northern University College of Pharmacy, Ada.

INSIDE PHARMACY ❚ August | September 2014

Inside Mental Health

Ensuring Continuity of Care for Psychiatric Patients Community pharmacists’ intervention during outpatient care by SCOTT PRICE, PHARMD; and EFE JOHNSON, PHARMD

The transition from inpatient to outpatient care can be a challenging time in any healthcare setting. }} KEY POINTS ❚ Mental health patients may be hesitant to communicate openly with healthcare professionals regarding their care ❚ Community pharmacists are in an ideal position to provide continuing assistance and reinforcement as patients make the transition into outpatient care ❚ Tobacco cessation and medication adherence are other intervention opportunities for community pharmacists

}} IN THE PSYCHIATRIC SETTING, however, this period represents a crucial time that can make the difference between successful outpatient clinical outcome and a relapse and rehospitalization. Continuity of pharmaceutical care is vital to the success of this transition. Having an understanding of this process can allow community pharmacists to better assist patients as they move into the outpatient care setting.

A Word on Communication The importance of communicating with empathy in a nonjudgmental manner is critical. Because of the stigma that inherently surrounds mental illness, patients may be hesitant to communicate openly with healthcare professionals regarding their care. A patient’s medication regimen may change dramatically and he or she may be confused, uncertain, or even fearful of managing his or her medications after being discharged from the hospital or

INSIDE PHARMACY ❚ August | September 2014

inpatient facility. As healthcare professionals, we are well aware of the importance of effective communication with all patients, and mental health patients are no exception to this.

The Discharge Process Pharmacists in the community setting can play an integral role in addressing issues that may occur as patients make the transition to outpatient care. After an inpatient admission, patients are discharged into a multitude of settings ranging from self-managed home care to intensive outpatient or partial hospitalization programs. Understanding to what setting a patient has been discharged will help identify and address barriers to care and open channels of communication. Upon discharge from the Barnabas Health Behavioral Health Center (BHBHC), patients are provided with prescriptions for a short-term supply of their current medications that will

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Inside Mental Health last approximately 30 days along with instructions for follow-up with aftercare services. Information regarding their medications, including instructions for how and when to take each medication, is also provided. This short-term supply should be sufficient to allow time for the patient to follow up with his or her aftercare provider. Inpatient facilities, such as BHBHC, cannot refill prescriptions once patients are discharged; these requests should instead be directed to their current outpatient provider.

Reinforcing Patient Education Even with this information, patients often feel overwhelmed and confused about the changes made during their inpatient stay. It is important to determine what medications they were taking prior to their admission and what changes have been made during their admission to help them understand what their new regimen will be following discharge. Community pharmacists are in an ideal position to provide continuing assistance and reinforcement as patients make the transition into outpatient care, in addition to the patient education provided in the inpatient setting. Because several medication changes must be made slowly, patients may be discharged before such a change is completed. In these cases, every effort is made to provide both the patient and his or her outpatient provider with clear instructions for the steps needed for completion. This is another opportunity for community pharmacists to assist patients understand and properly adhere to prescriber instructions. Other Opportunities for Community Pharmacists During inpatient hospitalization, arrangements are made for continuing psychiatric care after discharge. It is imperative that community pharmacists stress the importance of longterm adherence to prescribed therapy.

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Similar to other fields of medicine, medication nonadherence is an all too common occurrence among psychiatric patients. As would be expected, nonadherence with treatment has been associated with illness recurrence and rehospitalization among patients with bipolar disorder.1 It has also been shown that patients with psychosis often underestimate the risk of recurrence due to nonadherence or may not even be aware that nonadherence can lead to illness recurrence.2 We have seen, however, that pharmacists can play an important role in improving medication adherence. For example, pharmacist intervention has been shown to improve adherence in patients taking antidepressant medication.3 Tobacco cessation is another area in which community pharmacists can provide intervention in mental health patients. Tobacco use is prevalent among patients with mental illness. In addition to the known risks associated with tobacco, smoking can substantially affect the metabolism of a number of psychiatric medications, which, in turn, may impact efficacy of treatment. In the inpatient setting, we consistently encourage tobacco cessation but patients are only with us for a short time. Community pharmacists can provide continued encouragement and facilitation such as education regarding nicotine replacement products. Transitioning into outpatient care after psychiatric hospitalization can be a challenging time for patients. Community pharmacists are able to play a vital role in easing this transition. â?&#x161;

References

1. Li C, Chen C, Qiu B, Yang G. A 2-year follow-up study of discharged psychiatric patients with bipolar disorder. Psychiatry Res. 2014;218:75-78. 2. Chan KW, Wong MH, Hui CL, et al. Perceived risk of relapse and role of medication: comparison between patients with psychosis and their caregivers. Soc Psychiatry Psychiatr Epidemiol. 2014 Jul 24. Epub ahead of print. 3. Al-Jumah KA, Qureshi NA. Impact of pharmacist interventions on patientsâ&#x20AC;&#x2122; adherence to antidepressants and patient-reported outcomes: a systematic review. Patient Prefer Adherence. 2012;6:87-100.

Efe Johnson, PharmD

Dr Price is a Pharmacist, Barnabas Health Behavioral Health Center in Toms River, NJ, and Clinical Psychiatric Pharmacist at Clara Mass Medical Center, Belleville, NJ; and Dr Johnson is a Pharmacy Practice Resident, Barnabas Health Behavioral Health Center, Toms River, NJ.

INSIDE PHARMACY â?&#x161; August | September 2014

Inside Mental Health

Appropriate Use of Combination Antipsychotics

“

When a patient presents...with prescriptions for more than 1 antipsychotic...it is prudent to discuss the treatment plan with the patient.” by SANDRA GIRGIS, PHARMD; MEI T. LIU, PHARMD, BCPP; and MEGAN E. MARONEY, PHARMD, BCPP

Antipsychotic medications are used in the treatment of patients with various psychiatric conditions, including schizophrenia, bipolar disorder, and in some cases, major depressive disorder. They are categorized into first and second generation. }} KEY POINTS ❚ Combination antipsychotics may be beneficial for some patients when monotherapy is not effective ❚ It is important to identify patients who may benefit from education or who require an intervention by their care provider ❚ Patients should be counseled on the risks involved and the importance of adhering to their drug regimen as prescribed

}} MEDICATIONS from each category are listed in Table 1. The first-generation antipsychotics (FGAs), also known as typical antipsychotics, work primarily through the blockade of centrally located dopamine (D2) receptors.1 Secondgeneration antipsychotics (SGAs), or atypical antipsychotics, exert their mechanism of action through antagonism of both D2 receptors and serotonin 5-HT2A receptors in the central nervous system.1 An antipsychotic from either class can be used alone or in combination with other psychotropic medications, such as mood stabilizers or antidepressants. In some patients, particularly those with schizophrenia, the combination of more than 1 antipsychotic medication may be warranted to help control symptoms; however, this may present additional risks to the patient, which must be taken into account.2

INSIDE PHARMACY ❚ August | September 2014

Indications for Combination Antipsychotics The American Psychiatric Association (APA) practice guidelines for the treatment of patients with schizophrenia briefly discuss potential indications for antipsychotic polypharmacy.2 One indication is if the patient is switched from 1 agent to another using cross-titration. During this process, the dose of the patient’s current antipsychotic is slowly tapered while the new antipsychotic is titrated up to a therapeutic dose. Psychiatrists may use this approach to help prevent an acute exacerbation while switching medications. Some patients may also be taking multiple long-term antipsychotics because of ineffective response to monotherapy treatment. The APA specifically notes the use of an antipsychotic to augment clozapine.

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Inside Mental Health This may be appropriate for patients who have more resistant schizophrenia, as clozapine is usually reserved for patients who did not respond to at least 2 trials of antipsychotic medications. The Texas Medication Algorithm Project (algorithm for the treatment of patients with schizophrenia developed by the Texas Department of Mental Health and Mental Retardation) also recommends augmentation of clozapine when a patient does not respond to 3 trials of antipsychotic monotherapy.3 Although a limited amount of data supports the use of antipsychotic polypharmacy, much of these data focus on clozapine combinations. Several case reports have shown a benefit with the addition of risperidone.4-6 In 1 randomized controlled trial, investigators evaluated the safety and efficacy of augmenting clozapine with risperidone versus clozapine with placebo in patients with treatment-resistant schizophrenia. Although patients in both groups showed improvement in symptoms during the 12-week period, those in the treatment group who were taking risperidone had a greater reduction in symptoms without a significant difference in adverse events, including parkinsonism, agranulocytosis, weight gain, and seizures.7 In another study, Anil Yagcioglu and colleagues conducted a double-blind study comparing adjunctive risperidone with placebo in patients taking clozaÂ pine, and found no significant difference in efficacy or safety end points between the 2 groups.8 Although there is conflicting data from randomized trials, augmentation of clozapine remains the most widely studied antipsychotic combination and is a generally accepted treatment option for select patients.2 The APA recognizes that other combinations of antipsychotics may be beneficial to some patients who did not adequately respond to monotherapy.2 These patients should have documentation of a suboptimal response to either medication when used alone

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Table 1. First- and Second-Generation Antipsychotics Generic name

Brand name

First-generation antipsychotics Chlorpromazine

Thorazine

Fluphenazine

Prolixin

Haloperidol

Haldol

Loxapine

Loxitane

Perphenazine

Trilafon, Etrafon

Pimozide

Orap

Thioridazine

Mellaril

Thiothixene

Navane

Trifluoperazine

Stelazine

Second-generation antipsychotics Aripiprazole

Abilify

Asenapine

Saphris

Clozapine

Clozaril, FazaClo, Versacloz

Iloperidone

Fanapt

Lurasidone

Latuda

Olanzapine

Zyprexa

Paliperidone

Invega

Quetiapine

Seroquel

Risperidone

Risperdal

Ziprasidone

Geodon

before initiating the combination. The Texas Medication Algorithm Project algorithm for schizophrenia lists the combination of 2 antipsychotics (SGA + FGA, or 2 SGAs) as a possible option following the failure of several monotherapy trials and a trial of a combination therapy with clozapine.3 Some antipsychotic combinations that do not include clozapine have been studied, including aripiprazole with risperidone. This combination is of particular interest because risperidone is known to be associated with hyperprolactinemia and aripiprazole has been found to decrease prolactin levels.9 Kane and colleagues compared aripiprazole adjunctive therapy in patients taking either risperidone or quetiapine with placebo and found no significant difference in efficacy end points between the groups.10 However,

INSIDE PHARMACY â?&#x161; August | September 2014

Inside Mental Health Table 2. Criteria for Combination Antipsychotics Per HBIPS Measures13 First-generation antipsychotics History of a minimum of 3 failed monotherapy trials Plan to taper to monotherapy, cross-tapering antipsychotics Augmentation of clozapine HBIPS indicates Hospital-Based Inpatient Psychiatric Services

patients taking risperidone with adjunctive aripiprazole had significantly lower prolactin levels compared with patients in the adjunctive placebo group. In another study, Chen and colleagues found that the addition of aripiprazole to risperidone in patients with symptomatic hyperprolactinemia effectively reduced serum prolactin to

Combination antipsychotics may be beneficial for some patients when monotherapy is not effective. normal levels in the majority of the risperidone patients.9 In 1 meta-analysis, investigators examined studies with various combinations of antipsychotics, including the use of 2 SGAs, 2 FGAs, or 1 of each.11 Combination antipsychotics were found to be more efficacious in producing a clinically significant response than monotherapy, especially when combining an FGA and an SGA, when adding a second antipsychotic to clozapine, and in trials lasting at least 10 weeks. However, this meta-analysis did not have sufficient data to report on adverse event rates.11 Overall, it appears combination antipsychotics may be beneficial for some patients when monotherapy is not effective.

Disadvantages of Combination Antipsychotics Several arguments exist, however, against the long-term use of combina-

INSIDE PHARMACY â?&#x161; August | September 2014

tion antipsychotics.12 There are limited clinical studies demonstrating the benefits of this treatment approach. It is reasonable to believe that the addition of a second antipsychotic may increase the risk of adverse events.12 This includes an increased risk for extrapyramidal symptoms (EPS), metabolic disturbances, or other adverse events associated with antipsychotics. Because most antipsychotics are extensively metabolized in the liver and are substrates of cytochrome P450 enzymes, combination therapy could increase the risk of drug interactions.1 The addition of another medication also raises the cost of treatment and may decrease adherence as the drug regimen becomes more complicated.12 Finally, when more than 1 antipsychotic is used, it is more difficult for clinicians to identify which agent is responsible for any changes in symptoms or adverse effects the patient experiences, thus complicating the psychiatristâ&#x20AC;&#x2122;s ability to develop the ideal treatment plan for the patient. Overall, due to the lack of available data on combination therapy, it is difficult to effectively weigh the risks and benefits of antipsychotic polypharmacy.

Criteria for Using Combination Antipsychotics In 2008, The Joint Commission implemented core measures for the care of psychiatric patients known as the Hospital-Based Inpatient Psychiatric Services (HBIPS) measures.13 These standards address various aspects of psychiatric care, including admission criteria, use of physical restraints, seclusion hours, and care plan development and communication. One of the 7 core measures outlines 3 appropriate justifications for discharging patients on multiple antipsychotics (Table 2). One appropriate justification is documentation that the patient has had at least 3 adequate trials of monotherapy with antipsychotics without a sufficient improvement in symptoms.

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Inside Mental Health The second appropriate justification is that there should be a documented plan to describe tapering off the dose of 1 antipsychotic while titrating up the dose of the other. The final justification listed in the HBIPS core measures for the use of combination antipsychotics is the augmentation of clozapine. These criteria align closely with the situations discussed in the APA guidelines for the treatment of patients with schizophrenia and should be used to assess patients seen as outpatients who are on combination antipsychotic therapy. Patients not meeting these criteria may be on inappropriate therapy and could present an opportunity for intervention.

Role for Community Pharmacists For community pharmacists and other healthcare professionals, it is important to identify patients who may benefit from education or who require an intervention by their care provider. When a patient presents to the pharmacy with prescriptions for more than 1 antipsychotic or with a new prescription for an additional antipsychotic, it is prudent to discuss the treatment plan with the patient. It may identify patients who are being cross-titrated from 1 antipsychotic to another as well as patients who will continue taking combination therapy. If the patient seems unsure or confused about the plan, a discussion with the prescribing physician or psychiatrist is necessary to clarify whether both antipsychotics are to be dispensed. If the patient is maintained on a combination of antipsychotics, whether temporarily or long-term, it is impor tant for community pharmacists to counsel him or her about the potential adverse events of his or her medication. Adverse events vary depending on the antipsychotics prescribed; however, general class adverse effects are a good starting point for counseling. FGAs are known to cause EPS, such as acute dystonia, akathisia, pseudoparkinsonism, and tardive dyskinesia.1 Patients should

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be aware of how these adverse effects present and should notify their doctor if they occur. These effects are not fatal and patients should be counseled to continue their medication even if they experience EPS until they are seen by their physician. Certain types of EPS, such as dystonia and pseudoparkinsonism, may alleviate with the use of overthe-counter diphenhydramine.3 SGAs as a class tend to have less EPS associat-

Patients on multiple antipsychotics should also be counseled on the importance of compliance and adherence. ed with them than FGAs; however, the risk still exists. SGAs have more metabolic side effects, including increases in weight or cholesterol. Patients’ SGAs are at risk of developing glucose intolerance or diabetes.1 In addition, many antipsychotics have effects on histamine, cholinergic, and alpha-1a adrenergic receptors. They can cause sedation, dry mouth, dizziness, lethargy, or orthostatic hypotension. Patients should always notify their physician or psychiatrist if bothersome or severe adverse events occur. Patients on multiple antipsychotics should also be counseled on the importance of compliance and adherence with their treatment regimen. Lack of adherence can lead to relapses or acute exacerbations of their symptoms, which may lead to self-harm or hospitalization. Overall, there are many patients who may be managed with multiple antipsychotics. According to APA guidelines and the standard measures listed in the HBIPS criteria, appropriate reasons for combinations include cross-titration of antipsychotics, resistant schizophrenia after failing multiple trials of monotherapy, and augmentation of clozapine. It is important to identify the justification

Sandra Girgis, PharmD

Dr Girgis is a PGY2 Neuropsychiatric Pharmacy Resident at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey; Dr Liu is a Psychiatry Clinical Pharmacist at Princeton House Behavioral Health, and Clinical Assistant Professor at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey; Dr Maroney is a Psychiatry Clinical Pharmacist at Monmouth Medical Center, and Clinical Assistant Professor at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey.

INSIDE PHARMACY ❚ August | September 2014

Inside Mental Health for combination therapy in all patients with antipsychotic polypharmacy. If the treatment is appropriate, patients should be counseled on the risks involved and the importance of adhering to their drug regimen as prescribed. ❚

References

1. Ferrando S, Owen J, Levenson J. Psychopharmacology. In: Hales RE, Yudofsky SC, Roberts LW, eds. The American Psychiatric Publishing Textbook of Psychiatry. 6th ed. Arlington, VA: American Psychiatric Publishing; 2014. 2. Lehman AF, Lieberman JA, Dixon, LB, et al. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004;161:1-56. 3. Moore TA, Buchanan RW, Buckley PF, et al. The Texas Medication Algorithm project antipsychotic algorithm for schizophrenia: 2006 update. J Clin Psychiatry. 2007;68:17511762. 4. Kontaxakis VP, Ferentinos PP, Havaki-Kontaxaki BJ, et al. Risperidone augmentation of clozapine: a critical review. Eur Arch Psychiatry Clin Neurosci. 2006;256:350-355. 5. Raskin S, Katz G, Zislin Z, et al. Clozapine and risperidone: combination/augmentation treatment of refractory schizophrenia: a preliminary observation. Acta Psychiatr Scand. 2000;101:334-336. 6. Raju GVL, Kumar R, Khanna S. Clozapine-risperidone

combination in treatment-resistant schizophrenia. Aust N Z J Psychiatry. 2001;35:543. 7. Josiassen RC, Joseph A, Kohegyi E, et al. Clozapine augmented with risperidone in the treatment of schizophrenia: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry. 2005;162:130-136. 8. Anil Yagcioglu AE, Kivircik Akdede BB, Turgut TI, et al. A double-blind controlled study of adjunctive treatment with risperidone in schizophrenic patients partially responsive to clozapine: efficacy and safety. J Clin Psychiatry. 2005;66:63-72. 9. Chen CK, Huang YS, Ree SC, Hsiao CC. Differential add-on effects of aripiprazole in resolving hyperprolactinemia induced by risperidone in comparison to benzamide antipsychotics. Prog Neuropsychopharmacol Biol Psychiatry. 2010;34:1495-1499. 10. Kane JM, Correll CU, Goff DC, et al. A multicenter, randomized, double-blind, placebo-controlled, 16-week study of adjunctive aripiprazole for schizophrenia or schizoaffective disorder inadequately treated with quetiapine or risperidone monotherapy. J Clin Psychiatry. 2009;70:1348-1357. 11. Correll CU, Rummel-Kluge C, Corves C, et al. Antipsychotic combinations vs monotherapy in schizophrenia: a meta-analysis of randomized controlled trials. Schizophr Bull. 2009;35:443-457. 12. Miller AL, Craig CS. Combination antipsychotics: pros, cons, and questions. Schizophr Bull. 2002;28:105-109. 13. The Joint Commission. Hospital-based inpatient psychiatric services. www.jointcommission.org/hospital-based_ inpatient_psychiatric_services/. Updated May 5, 2014. Accessed July 15, 2014.

NEW at InsidePharmacyOnline.com Why Inside Pharmacy ?

Donald Dietz, RPh, MS, Editor-in-Chief of the journal, discusses the role of Inside Pharmacy in today’s ever-changing healthcare environment.

• Integrate the team inside the pharmacy — pharmacy managers, physician assistants, and nurse practitioners • An overarching information source for helping retail pharmacies transform into healthcare delivery companies • Capitalize on the healthcare system transformation to empower pharmacists to achieve professional success as it relates to prevention and wellness, acute treatment, and monitoring and management of chronic diseases of the customer • Influence buyers and C-level executives at chain headquarters

Transforming Retail Pharmacies into Healthcare Delive

Pharmacists • Chain Headquarters • Independents • Physician Assistants • N

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Inside

Patient Care 5 TIPS FOR A HEALTHY MENTAL STATE Stress is a routine part of our lives and affects everyone differently. The following tips are ways to reduce and manage stress, and promote a healthy state of well-being.

1 Identify the Source of Your Stress

2 Reach Out to Friends, Family

3 Lead a Balanced Lifestyle

Dealing with a stressful person or environment is different from facing a traumatic event; knowing the source(s) of your stress can help you better cope with it Spend time with your family and friends; they are there to support you in a time of need

Having an active lifestyle and balancing work, home, and making some time for yourself can help reduce stress

4 Be Active, Stay Healthy

5 Seek Help

Exercising on a regular basis can help you cope with stress and help you maintain a healthy lifestyle; getting an average of 7-9 hours of sleep is also recommended It is difficult to know when to seek help. If you continue to feel stressed, despite your efforts to cope with it, seek help from a professional

+ MORE ONLINE

More patient tips can be found at InsidePharmacyOnline.com

Source: Centers for Disease Control and Prevention.

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g Retail Ph Transformin

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ependents

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Pharmacy Retail Clinic News Retail Clinics Fill the Void in Patient Access to Care A conversation with Tine Hansen-Turton, Executive Director of the Convenient Care Association

In a recent interview with Inside Pharmacy, Tine Hansen-Turton, Executive Director, Convenient Care Association, discussed trends in healthcare delivery and the multistakeholder approach to patient care. In addition, Tine talked about the challenges and opportunities that lie ahead for pharmacists, physician assistants, and nurse practitioners, including restricting legislation.

How are retail clinics evolving to meet the trends in healthcare delivery? THT: January 1, 2014, marked the beginning of an evolution in how the United States deals with access to healthcare. As more people become insured, they are looking for convenient options for healthcare. However, because of the physician shortage, those newly insured will quickly join the ranks of those who—even though they have healthcare—still do not have timely access to a provider for simple healthcare needs. Retail clinics are part of the evolution and are growing, 600 more nationally this year alone, to meet the need for preven-

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tive and primary care that we face. How is the role of pharmacists evolving to accommodate these changes? THT: The biggest issue with healthcare delivery is implementation of the Affordable Care Act and providing Americans with access to care and access to information. To be successful, healthcare reform needs to focus on preventive and primary care. The role of the pharmacist in that spectrum is so critical. Whether it is drug information, drug interactions, or patient education and chronic disease management, pharmacists play an important part in the inter-

disciplinary care team. I think that is something that pharmacists do very well. They are such an integral part of the primary care network, and I think that perhaps we don’t use them to the fullest extent and integrate them in the overall primary care chain. Retail pharmacy is changing the trends and highlighting the overall value that the pharmacy brings to healthcare. In other parts of the world, such as Europe, pharmacies are where people go for healthcare advice. The pharmacists are interacting with patients, providing advice, and educating them about the different drugs in the aisles, their healthcare is-

sues, and what they need to do to take care of their health. How do you think these trends will impact the team inside the pharmacy? THT: It will only get better as pharmacists, physician assistants (PAs), and nurse practitioners (NPs) are so complementary to each other. I think it is a very strong team and they work very well together. The pharmacist has more knowledge on the pharmacological side compared with other providers who really think more holistically on issues that are impacting people’s health. That’s what we see in the retail clinic—the symbiotic relationship between the practitioner, the clinic, and the pharmacy. It’s a win–win relationship. How are the roles of PAs and NPs expanding to meet the demands in the retail space? THT: Every legislative year we see changes in the laws expanding legal authority in the states to allow NPs and PAs to practice closer to the full scope of their abilities under their respective training and licensure. This allows clinics to operate in more

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Inside

Pharmacy Retail Clinic News states. The retail clinic industry believes in the interdisciplinary nature of healthcare—all providers are needed and all have their role in the total care of each patient. Continuing to allow providers to practice to the full extent of their license will only make care more available for those who need it, and that will naturally increase availability of healthcare in retail settings. What key challenges are pharmacists facing in this changing healthcare environment? THT: We find that the regulatory scheme is not necessarily always supportive for them and there can be issues with the state laws that prohibit them to practice to the full extent of their training. However, the larger challenge is getting the payers, including Medicaid, to recognize their contributions and pay for all the vital services that pharmacists provide. How are changes in retail pharmacy impacting the patient? THT: The patient trusts the pharmacist because he or she is readily accessible when the pharmacy is open. Pharmacists are there in the community, which enables many people to develop a trusting relationship with that

pharmacist. That relationship is critical for patient– provider engagement. Who have you seen take the most advantage of retail clinics? THT: Recent patient growth trends are marked by families. We are seeing a growth in both pediatrics and adults. In addition, while treating minor acute illnesses and injuries continues to be a core focus, we are also seeing growth in broader services such as vaccines, wellness services, and chronic care monitoring. How is the healthcare team inside and outside the pharmacy coordinating care? THT: The retail clinic healthcare team coordinates patient care by using electronic healthcare records, sending rec ords to primary care physicians (PCPs), and connecting people to PCPs who don’t have one. Every patient at a retail clinic is asked if they have a PCP, and that is added to their rec ord, to ensure continuity and excellence in care and treatment. How are retail clinics contributing to “disruptive healthcare innovation”? THT: The retail clinics are disruptive in a sense as

INSIDE PHARMACY ❚ August | September 2014

they have allowed patients to become consumers of healthcare. Retail clinics are really shaped by the consumer, and the clinic listens to patients and creates solution centers for their healthcare. This is an industry that examines and sets trends, provides better access to healthcare, and addresses patient needs. Ultimately, it is about providing accessible, affordable, and high-quality healthcare services in the most efficient, patient-friendly, and lowest-cost way. From the different iterations of telehealth to using healthcare devices more strategically, those are the kinds of things you will see in the future in retail clinics. What are the drivers of growth in the retail clinic space? THT: Certainly, the partnership with the pharmacist as well as with the pharmacy is one driver. However, it is really making sure you are providing high-quality care in the healthcare clinic. I would say that there are many

things that work well in the community, but what drives the success is that people still need access to quality primary care. Since many people who come into the clinics don’t have access to primary care, the clinics really fill a void assuring that people get access to care. What key opportunities lie ahead for retail clinics? THT: The influx in the need for care due to the Affordable Care Act is an incredible opportunity for retail clinics. As an industry that is patient-driven with a focus on accessible, affordable, high-quality care, you will continue to see growth and expansion of the clinic model as well as service expansion and overall service delivery. Retail clinics will also play a role in reducing healthcare costs as they are an appropriate site for healthcare after hours, which may help alleviate the demand on emergency departments and divert nonemergent patients out of the costly emergency departments. ❚

In her concluding remarks, Tine emphasized that the future is bright for the retail clinic industry. “Consumers have made it clear that they want access to affordable, convenient, high quality healthcare and that retail clinics fit the bill,” she said. “This is further evidenced by the recent and projected growth in the number of clinics and the acquisition of RediClinic by Rite Aid. All major pharmacy chains are now in the retail clinic space.”

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Pharmacy Retail Clinic News

The Expanding Role of Nurse Practitioners and Its Impact on Immunotherapy

“

I am taking part in a positive shift in healthcare— a shift in which NPs are becoming empowered to provide patient care and specialized services more than ever before.” by KEVIN LETZ, DNP, MBA, MSN, RN, CNE, CEN, FNP-C, ANP-BC, PNP-BC

TODAY, the US healthcare system faces a mounting shortage of general practitioners, rising costs of running a primary care practice, and growing patient demand for healthcare services. This trifecta has created a conundrum for providers: how can physicians’ practices reduce costs without negatively impacting quality of care? With an influx of 30 to 33 million newly insured patients anticipated by 2016 as a result of Affordable Care Act legislation, according to an estimate from the Congressional Budget Office,1 healthcare demand and cost pressures are only anticipated to climb. A key resource to

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address physician shortages, improving efficiency in primary care, and ultimately increasing access to healthcare for many more patients lies with the nurse practitioner (NP). As an NP, I am taking part in a positive shift in healthcare—a shift in which NPs are becoming empowered to provide patient care and specialized services more than ever before. An empowered NP staff can provide medical practices with desperately needed flexibility and cost-savings in a time of increased economic pressure.

NPs’ Reach Extends to Retail Clinics NPs are well-equipped with sufficient medical

education and training to function as primary and specialty care providers for many patients. Meanwhile, this role typically requires less compensation than a physician. Because NPs are able to write prescriptions, diagnose many conditions, and offer a flexible approach to treating the whole patient, they are a valuable asset to many practices, even helping some to increase profit margins. As NPs become more empowered, their role has started to expand its reach. Although the core responsibilities of NPs have remained relatively constant for decades, the profession is navigating away from traditional

primary care roles to a variety of other settings, including inpatient and retail medicine.

NP Specialization A growing number of NPs, including myself, are also choosing to be more specialized in their work. For example, NPs provide allergy testing and immunotherapy directly to patients. This specialization helps to improve access to therapy for more patients and increases healthcare efficiency. Immunotherapy is a specialty service that can benefit a far greater number of patients than those who currently have access to it. Unlike overthe-counter treatments, which are short-term

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Pharmacy Retail Clinic News PHYSICIANS, MEDICAL PRACTICE ADMINISTRATORS, AND PATIENTS ALIKE STAND TO BENEFIT FROM THIS GROWTH WITH OPPORTUNITIES.

Dr Letz is Chairman/ Founder of Advanced Practice Provider Executives (appexecutives.org).

remedies and typically do little more than mask patients’ allergy symptoms, immunotherapy, also known as allergen-specific subcutaneous immunotherapy, is the only long-term relief from allergies and can even prevent the progression of the condition. Yet, the significant patient need for allergy care—allergies are one of the single most common chronic conditions in the United States2—combined with the insufficient number of board-certified allergists to meet patient demand, creates a healthcare challenge. According to the Centers for Medicare & Medicaid Services, only approximately 50% of patients who receive allergy shots are currently being treated by an allergist,3 mostly because of the lack of supply. The

INSIDE PHARMACY ❚ August | September 2014

rest of the patients are treated by ear, nose, and throat physicians and primary care physicians. More NPs providing allergy and asthma care could free up these physicians to focus on other areas of patient care, including acute allergy cases that require a specialized allergist. An NP workforce that is skilled and empowered with the ability to deliver specialty services, such as immunotherapy, provides an opportunity to bridge this gap and improve access for a majority of patients needing allergy care.

The Time Is Now for NPs NPs are a welcomed asset in today’s healthcare landscape. Primary care has already been taking on more of the straightforward allergy cases and, with more NPs joining primary care offices or working in retail clinics, these practices have the opportunity to fulfill a common patient need. By increasing specialty service offerings, medical practices cannot only boost patient satisfaction, but also attract new patients and gain revenue opportunities. Now is a good time to be an NP. A key benefit of the NP role is the flexibility that it offers. We are able to pur-

sue different specialties in healthcare, expand our skills and experience in new ways, and, ultimately, devote our time to the most pressing patient needs and our own career interests. The demand for NPs has always existed, but today, it is growing. Not surprisingly, more of us entering the healthcare field are opting for careers as NPs—in fact, the number of NPs has been forecasted to double by 2025, according to a study in Medical Care.4 Physicians, medical practice administrators, and patients alike stand to benefit from this growth with opportunities to improve the efficiency and accessibility of patient care. ❚

References

1. Congressional Budget Office. Updated Estimates for the Insurance Coverage Provisions of the Affordable Care Act. March 2012. www.cbo. gov/sites/default/files/cbofiles/attach ments/43472-07-24-2012-Coverage Estimates.pdf. Accessed August 20, 2014. 2. Centers for Disease Control and Prevention. Allergies. Updated February 2, 2011. www.cdc.gov/health communication/ToolsTemplates/ EntertainmentEd/Tips/Allergies.html. Accessed August 20, 2014. 3. Academy of Allergy & Asthma in Primary Care. Academy of Allergy & Asthma in Primary Care Provides a Voice for PCPs for Allergy and Asthma Care and Prevention. February 2013. www.aaapc.us/academy-of-allergyasthma-in-primary-care-provides-avoice-for-pcps-for-allergy-and-asth ma-care-and-prevention/. Accessed August 20, 2014. 4. Auerbach DI. Will the NP workforce grow in the future? New forecasts and implications for healthcare delivery. Med Care. 2012;50:606-610.

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The Retail Pharmacy Upcoming US Pharmacopeial Convention, Chapter 800

“

These changes are necessary to ensure the safety of personnel, patients, and the environment when handling HDs.”

by MEGAN PETERSEN, BS, PHARMDc

US Pharmacopeial (USP) Convention has released a new proposed chapter with a focus on the handling of hazardous drugs (HDs) within healthcare settings: USP Chapter 800. }}

}} THIS CHAPTER IS AVAILABLE to the public on the USP website, and the organization accepted comments until July 31, 2014.1 Although Chapter 800 focuses on compounding, it also addresses other situations in which healthcare personnel come in contact with HDs, including receiving, storing, administering, and disposing of HDs. It also discusses dealing with HD spills and contamination. This chapter applies to all entities and personnel who deal with HDs in an attempt to greatly diminish HD exposure and has come about because there is no level of personnel exposure to HDs that is deemed acceptable.2

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Chapter Details Chapter 800 explains in depth the storage requirements for HDs. All HDs should be stored at or below eye level away from non-HDs and should not be stored on the floor. They should be stored in a negative-pressure room that has at least 12 air changes per hour (ACPH). The only exception to this is nonantineoplastic HDs that are in a final coated dosage form. These HDs may be stored with non-HDs as long as they are labeled as HDs and the entity has developed safety strategies in its standard operating procedures to handle such exceptions. These storage require-

KEY POINTS ❚ Chapter 800 focuses on compounding, as well as receiving, storing, administering, and disposing of hazardous drugs ❚ Any personal protective equipment used should be considered contaminated after being worn ❚ This new chapter will help people who handle hazardous drugs with completing their daily tasks effectively while keeping exposure to these drugs to a minimum

INSIDE PHARMACY ❚ August | September 2014

Inside the Retail Pharmacy Table. USP Chapter 800 Requirements2 Negative pressure room

ACPH

C-PEC

ISO Class 7

BUD

Storage

Yes

≥12

None

Manufacturer expiration date

Nonsterile compounding

Yes

≥12

Class I/II BSC or CACI

see Chapter 795

Configuration 1

Yes

≥30

BSC or CACI

Yes

see Chapter 797

Configuration 2

Yes

≥12

CACI

See Chapter 797

Configuration 3

Yes

≥12

BSC

≤12 hours

Sterile compounding

ACPH indicates air changes per hour; BSC, biological safety cabinet; BUD, beyond use date; C-PEC, containment primary engineering control; CACI, compounding aseptic containment isolator; ISO, International Organization for Standardization.

ments apply to all the items included on the National Institute for Occupational Safety and Health (NIOSH) list, as well as any other items the entity chooses to add to its own list.2 Some examples of HDs on the NIOSH list include antineoplastic agents, such as cyclophosphamide and methotrexate, and immunosuppressants, such as azathioprine and tacrolimus.3 If nonsterile compounding is to be performed using HDs, this should occur in a separate negative pressure room with at least 12 ACPH. This room does not need to meet International Organization for Standardization (ISO) 7 criteria or have high-efficiency particulate air (HEPA)-filtered supply air. Personnel do need to use a containment primary engineering control (C-PEC) that provides protection to both personnel and the environment. This includes Class I biological safety cabinets (BSCs) or Class II BSCs, or compounding aseptic containment isolators (CACIs) dedicated to nonsterile compounding.2 As for sterile compounding, there are 3 main configurations deemed acceptable by Chapter 800. Each configuration includes a separate negative-pressure room along with the use of some type of C-PEC in which an ISO Class 5 critical area is provided. The first configuration is a C-PEC within an ISO Class 7 cleanroom with a minimum of

INSIDE PHARMACY ❚ August | September 2014

30 ACPH. The second configuration is a CACI that meets Chapter 797 requirements but is located in a room that does not meet ISO 7 criteria. With these 2 configurations, the beyond use date (BUD) listed in Chapter 797 can be used for the compounded products that are made. The third configuration cannot be used when compounding high-risk sterile HDs. This configuration involves the use of a BSC or CACI that does not meet Chapter 797 requirements in a room that does not meet ISO 7 criteria. Due to these shortcomings, the sterilely compounded products made in this configuration cannot have a BUD exceeding 12 hours. A summary of these requirements can be found in the Table.2

Changes Needed to Assure Safety Chapter 800 also goes into great detail about the personal protective equipment (PPE) that must be worn when dealing with HDs in different situations. The chapter discusses gloves, gowns, hair and shoe covers, as well as eye, face, and respiratory protection. Any PPE that is worn when handling HDs should be considered to be contaminated with at least trace amounts of HDs. Because of this, PPE should be destroyed accordingly at a regulated incinerator for medical waste.2

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Inside the Retail Pharmacy Entities will also need to develop their own Hazard Communication Program and medical surveillance program. The Hazard Communication Program is required by the Occupational Safety and Health Administration. This program will encompass personnel training, hazardous chemical labeling, and Safety Data Sheets. A medical surveillance program will include a baseline assessment of employees’ health and HD exposure, routine monitoring for exposure and health changes, record keeping of what HDs are being handled and how long they are being handled each week, as well as an exit exam of employees’ health and HD exposure. This program will help identify reversible effects from HD exposure that can be diminished or eliminated before permanent damage occurs. The program’s findings will help personnel identify system failures within the entity’s policies and protocols that need to be changed in order to help employees to avoid exposure.2 Although much of this information is touched upon in USP Chapter 797, Chapter 800 goes much more in depth and makes a few changes. The first major change is the requirements for those entities that only do a low volume of HD preparations. Chapter 797 allowed those entities to do their HD preparations in a nonnegative pressure room as long as 2 tiers of containment were used.4 Chapter 800 now mandates that all HD preparations and compounding be done within a separate negative-pressure area.2 The second major change addresses the section in Chapter

797 stating that if a BSC is used, it must be used in a separate ISO Class 7 area.4 Chapter 800 allows the use of a BSC in a separate area that does not meet ISO Class 7 criteria, but it cannot be used to

Chapter 800 now mandates that all HD preparations and compounding be done within a separate negative-pressure area. compound high-risk HDs and cannot have a BUD longer than 12 hours.2 These changes, and this chapter, will help those involved in handling HDs with completing their daily tasks effectively while keeping exposure to HDs to a minimum. Although this chapter will cause changes in policies and procedures, these changes are necessary to ensure the safety of personnel, patients, and the environment when handling HDs. ❚

References

1. US Pharmacopeial Convention. General chapter <800> hazardous drugs—handling in healthcare settings. www.usp. org/usp-nf/notices/compounding-notice. Accessed July 9, 2014. 2. US Pharmacopeial Convention. <800> hazardous drugs—handling in healthcare settings. www.usp.org/ sites/default/files/usp_pdf/EN/m7808.pdf. Published 2014. Accessed July 9, 2014. 3. Centers for Disease Control and Prevention. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2012. Published June 2012. www.cdc.gov/niosh/ docs/2012-150/pdfs/2012-150.pdf. Accessed July 9, 2014. 4. Society of Nuclear Medicine and Molecular Imaging. USP-NF General Chapter <797>. www.snmmi.org/files/ docs/USP%20797.pdf. Accessed July 9, 2014.

Ms Petersen has a BS in Pharmaceutical Sciences, and is a PharmD Candidate 2015, at University of Pittsburgh School of Pharmacy, Pittsburgh, PA.

GET YOUR RETAIL CLINIC PROFILED IN INSIDE PHARMACY! 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 the Retail Pharmacy

10 Preceptor Qualities That Create a Great Learning Environment

“

Open communication is one of the most essential components of any rotation.”

by JANET K. ASTLE, BS PHARM, EDD, RPH

he richness of experiential education derives from the diversity and uniqueness of each practice setting. This same diversity presents challenges in de livery of the educational experience. Added to the complexity are differences in student content knowledge and skill set, readiness for practice, attitude, and motivation. Nonetheless, there are a number of best practices that can be universally employed to ensure that both preceptor and student alike benefit from a positive experience. The following is a list of the top 10 approaches that can be used by community pharmacy preceptors to increase the odds of providing a rotation experience that is worthwhile and satisfying. This list was composed from more than 20 years of personal experience in the field as well as an analysis of more than 3500 comments derived from students engaged in both introductory and advanced pharmacy practice experiences.

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1/ Be a Role Model

One of the most important contributions that a preceptor can make toward the professional development of the student is to serve as an exemplary role model. Although students gain substantive content knowledge and practice skills through didactic courses, it is within the practice setting that students acquire professional behaviors. Students learn how to interact with patients, other healthcare professionals, and staff by observing how their preceptors perform. A positive disposition toward the profession on the part of the preceptor is critical as students ready themselves to enter practice. Disgruntled pharmacists who have a negative attitude toward their employer or the profession should think twice about serving as a preceptor. Students need to be encouraged, not discouraged, as they prepare to enter their chosen profession.

Perform a Prerotation Assessment Each student comes to the practice site with varying levels of content knowledge, previous experience, and career

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Inside the Retail Pharmacy goals. Although each practice setting has its own standard offerings that are inherent to the site with pharmacy schools contributing a set of learning goals and objectives, it is nonetheless important to provide some flexibility within these constructs to meet the needs of the individual student. Preceptors should make it a habit to sit down with students to conduct an assessment of their content knowledge, past pharmacy experiences, and learning gaps at the beginning of the rotation. Students should be asked to share any self-assessment instruments as well as learning portfolios that are required by their schools. In addition, preceptors should determine any specific goals that the student has for the rotation. In preparation for the practice experience, preceptors need to be familiar with expectations of the school regarding assignments and activities.

3/ Provide Structure

Although it is important for students to assume responsibility for their learning, it is difficult for them to know what they ought to be pursuing, particularly when confronted with a new practice environment. As one student commented, “I wish there was a set schedule of things to do each day. I am not one to ‘slack’ so it made me feel as though I should be busy/working on something, but I literally could not do anything. This was my first…experience, so there wasn’t anything I know how to do to self-start.” Preceptors should not assume that students know how to insert themselves into the workflow, until evidence proves otherwise. The challenge is to provide structure with sufficient flexibility to accommodate the individual needs of the student.

4/ Give Meaningful Work

Students are adept at recognizing when the preceptor assigns “busy work.” Having students on rotation should not be burdensome, but rather should result in a “win-win” situation. The most effective preceptors identify work

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for students that offers a meaningful educational experience while making a positive contribution to the practice site. Students are most discouraged with practice settings that simply place them in an observation role. Students are most satisfied when they feel that they have provided a positive benefit to the site. Students need to be involved in the real work of the practice setting.

Share Your Knowledge and Expertise Students should benefit from the knowledge and expertise of their preceptors over the course of the rotation. This can be accomplished by traditional methods such as conveying key concepts, offering explanations, and demonstrating skills and techniques. Employing questioning and quizzing techniques that keep the student engaged can also be quite effective. Sharing the preceptor’s own reasoning skills and the problem-solving thought process in the midst of resolving an issue can be particularly illuminating for the student. Finally, encouraging students to ask questions motivates students to remain actively involved.

6/ Be a Coach

A good preceptor does not simply provide students with all of the answers. Rather, an effective preceptor also functions as a coach. The preceptor can accomplish this by prompting students to identify problems, seek the necessary information to resolve the given situation, and propose solutions. The ability of students to accomplish these activities varies greatly. Some students will need more direction, while others can perform the majority of these tasks independently. It may be helpful to break down a complicated task into smaller units for those students who need a bit more direction along the way. Preceptors can also assist students in meeting their goals and objectives by identifying opportunities for engagement such as patient counseling, medication therapy manage-

INSIDE PHARMACY ❚ August | September 2014

Inside the Retail Pharmacy ment, interaction with other healthcare professionals, identification of medication-related problems, self-care interventions, and drug information questions.

Dr Astle is Assistant Dean for Student Services having previously served in the position of Director of Experiential Education, Duquesne University Mylan School of Pharmacy, Pittsburgh, PA.

It is frustrating for students to discover for the first time that they did not meet the expectations of the preceptor at the end of the rotation. Students need to understand areas of improvement early in the rotation and be given the opportunity to address any deficiencies.

Give Context to Future Practice It is important for students to understand how their experience will contribute toward their future practice. This may be particularly challenging when the student has no interest in pursuing a career in community practice. For example, students who will be applying for a postgraduate residency may view the community pharmacy rotation as simply a school requirement that must be met. In these instances, it is critical for the preceptor to assist students in understanding how the community pharmacy plays a role in the transition and continuum of care. Students need to recognize that community pharmacies are also responsible for assisting patients with the long-term management of chronic conditions, disease management, and prevention. Equally challenging are students who have spent a preponderance of their time as community pharmacy employees. In this situation, it is especially important for the preceptor to ascertain student needs and learning gaps to prevent redundancies.

Spend Time with Your Students Time spent with the preceptor is held in high regard by students. Its value is expressed by the following comment, “I would have liked to spend more time with [my preceptor] because I learned so much when I was around her.” Students are eager to learn from their preceptors. Yet, there are times when spending significant time with students is just not possible. In those instances, preceptors should schedule a dedicated meeting time with students on a regular basis to provide feedback and ensure that learning goals and objectives are being met. Having the ability to adjust activities and learning opportunities in response to student needs is most appreciated and beneficial. In situations where responsibility for students needs to be delegated to other pharmacy staff members, preceptors should ensure that the responsible parties are aware of student learning needs and expectations.

8/ Provide Feedback

10/ Communicate

Students need to understand how they are performing. Schools of pharmacy provide mechanisms for formal assessment, most typically at the midpoint and conclusion of the rotation. However, it is also important for students to receive regular and consistent formative feedback regarding their performance both from a pharmacy practice and behavioral perspective. Feedback should be targeted, specific, and, when applicable, offer recommendations for improvement. As one student commented, “I would have liked to have known if I was doing anything wrong or if more was expected from me and I needed to work harder, or if I was performing tasks efficiently.”

INSIDE PHARMACY ❚ August | September 2014

Open communication is one of the most essential components of any rotation. Students consistently cite the support, willingness to help, and caring attitude of their preceptors as some of the most important attributes that made the learning experience valuable. Demonstrating respect for students, concern for student progress, and providing positive reinforcement enhances student motivation and engagement. Sharing the preceptor’s story regarding his or her own professional journey can open the door for further discussion. Effective communication can head off many problems and cure a multitude of misunderstandings. ❚

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Healthcare Policy Increased Scope of Care and the Ultimate Paradigm Change: Team-Based Care Beneath the Surface of Healthcare Bill HR 4190 by ROBERT E. HENRY

HR 4190 is awaiting passage in Congress with importance to pharmacists, but not for its provisions, which would have little effect on most pharmacists. This segment addresses the strategic factors underlying the rhetoric about HR 4190. For it has been positioned by the American Pharmacists Association (APhA) and the Patient Access to Pharmacists’ Care Coalition (PAPCC), as part of an agenda of expanding pharmacists’ scope of practice, which merits keen understanding. The bill does virtually nothing to expand pharmacists’ scope of practice; its provisions touch on it only peripherally. The APhA and PAPCC are using HR 4190 as a point of reference to raise support for expanding pharmacists’ scope of practice, based on the premise that current strictures on pharmacists’ involvement in treating patients fail to

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tap into the full measure of pharmacists’ capabilities and do not address the shrinking physician workforce levels and societal needs. Clearly, the strident tone of a current post in the Pharmacists Provide Care section of the APhA website merits examination, for the message is delivered with the unmistakable firmness of pursuit of a mandate for change to the system, not support of an isolated bill: “Pharmacists are not currently recognized as healthcare providers under federal law, despite having more medication education and training than any other health care professional. Beyond being unfair to our profession, this lack of federal recognition restricts the contributions pharmacists can make to improving patient care. That’s why APhA has embarked on a campaign to achieve ‘provider status,’ which will recognize

pharmacists as valued members of the healthcare team, and allow us to use our unique skills and extensive education to enhance patient health. Join Pharmacists Provide Care, and demand to be recognized!

Rather than berate the APhA and PAPCC for reading too much into this modest bill, it turns out that, upon examination, the substance of the matter does lie in the rhetoric surrounding the bill rather than the bill itself.

Current Status: On March 11, 2014, HR 4190 was introduced in the House of Representatives by Congressmen Brett Guthrie (R-KY), G.K. Butterfield (D-NC), and Todd Young (R-IN). HR 4190 amends Title XVIII of the Social Security Act to enable patient access to, and coverage for, Medicare Part B services by state-licensed pharmacists in medically underserved communities. Translation: A bill that would recognize pharmacists as healthcare providers! Contact your member of Congress today and ask him or her to support and cosponsor this bill!”1

At Issue: The Healthcare Provider Paradigm in Transition Turning our attention accordingly, there is ample evidence that the healthcare provider paradigm is indeed undergoing changes both remarkable and necessary to the roles, responsibilities, and contributions of pharmacists to the process of care. What is more, expanding pharmacists’ scope of practice to provide many primary care functions previously performed only by physicians is not an isolated agenda, but one tied to several other ambitious changes in the healthcare paradigm:

INSIDE PHARMACY ❚ August | September 2014

Inside

Healthcare Policy team-based care, the transformation of the retail pharmacies into healthcare delivery companies, the explosion of knowledge concerning wellness, personalized medicine, drug optimization, and the ominous condition of multimorbidity that is experienced by aging patients.2 These factors combine to form a new dynamic in healthcare that inevitably calls for expanding the scope of practice of pharmacists, while also changing the provider model from the solo practitioner to teambased care as patient conditions warrant. The significance of this multidisciplinary teambased provider model— outlined in the 2012 Discussion Paper by the Institute of Medicine (IOM)3—cannot be overstated. Team-based care entails assigning a multidisciplinary team to care for patients requiring special care according to their unique needs, which may range from multimorbidity to drug optimization with advanced biologics to counseling needs. These clinical provider teams are extraordinarily heterogeneous in their makeup, leadership, and outcome strategies. One common thread, however, is the increasing demand for participation of and often the team leadership by clinical

pharmacists to manage patients with multimorbidities requiring complicated drug regimens. An immediate consequence of team-based care is elimination of turf wars between pharmacists and physicians competing for solo treatment of the same patient. This model also fits the type of medical care required for many of today’s aging baby boomers suffering from multiple, not single, chronic disease states—exceeding the ability of a single physician to manage the patient alone. For a hard fact of medical progress is that most medications manage symptoms without curing the disease state, which can impact other chronic diseases and requires attention. The joint attention/ expertise of a multidisciplinary provider team is suited to the patient’s personalized needs. This scenario demands drawing together the specialized skill sets of multiple healthcare providers, and the IOM Discussion Paper’s overview reveals a picture of extraordinary diversity in the makeup of clinical-based teams.

The Road to Team-Based Care The expanded scope of practice is warranted for not only pharmacists, but nurse practitioners,

INSIDE PHARMACY ❚ August | September 2014

physician assistants, and other healthcare specialists where team-based care is needed. As realization of the necessity and effectiveness of teambased care expands, bar riers between provider groups are dissolving spontaneously—just as the site of care is expanding from always being treated in a physician’s office to the alternative location of the pharmacy retail clinic, which is fast becoming recognized as individual healthcare companies that likewise employ diverse providers.

sources and body of biologic and pharmacologic knowledge, increased scope of practice of nonphysicians, team-based care, the epidemiologic situation of multimorbidity and its demand for multidisciplinary team-based provider care, and the growing transformation of retail pharmacies into healthcare delivery companies. One thing is for certain: this is not your father’s drugstore anymore, nor is it being run by your father’s pharmacist. ❚

Making the Change from Tradition: A Daunting Tactical Restructuring This segment of our healthcare policy column provides a schematic of the gap between the provisions of HR 4190 and the agenda it really signifies without stating it literally. The fact being that indeed the innermost factor in play here is not only increased scope of practice, but teambased care that requires pharmacists to have increased scope of practice as a means to that end. Of particular interest remains the specific tactical details of these issues that are intersecting to forge a new healthcare system paradigm, such as making optimal use of re-

1. Pharmacists Provide Care. Provider Status. American Pharmacists Associa tion. www.pharmacist.com/providerstat usrecognition. Accessed August 8, 2014. 2. Tinetti ME, Fried TR, Boyd CM. Designing health care for the most common chronic condition—multimorbidity. JAMA. 2012;307:2493-2494. 3. Mitchell P, Wynia M, Golden R, et al. 2012. Core Principles & Values of Effective Team-Based Health Care. Discussion Paper. Institute of Medicine, Washington, DC. www.iom. edu/tbc. Accessed August 24, 2014.

References

Mr Henry is President of Glendalough Productions Inc, Founding Editor-inChief of American Health & Drug Benefits, and Strategic Editor of Inside Pharmacy.

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

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

Diabetes Detection and Control of Hypertension: Role of the Community Pharmacist Improving Women’s Health with Pharmacist-Led Osteoporosis Screening and Medication Closing the Loop: Pharmacist-Assisted Management of Asthma Pharmacist’s Perspective on the Management of Irritable Bowel Syndrome Pharmacist Involvement in the Management of Chemotherapy-Induced Nausea and Vomiting Community Pharmacist Intervention in Noncancer Pain Management Common Dermatologic Conditions: Pharmacists’ Perspectives Spectrum of Rheumatologic Diseases: Pharmacists’ Perspectives Community Pharmacists’ Role in Medical Management: Case-Based Illustration of Polypharmacy in the Geriatric Population Empowering Community_IP A-SIZE_90414

View the complete series online at:

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Inside Business

Chain Headquarters News

2014: The Year of the Healthcare Consumer by DAVID B. NASH, MD, MBA

UNDOUBTEDLY, 2014 will be characterized by the ascendency of a new type of healthcare consumer. “Consumers are no longer passive patients, but rather engaged—and more discerning—customers wielding new tools and better information to comparison shop. The year ahead will be marked by how well the healthcare industry responds to this shift. Organizations that fail to adapt will risk declining revenues as consumers turn elsewhere to have their health needs met.”1 Now that we are at the midpoint of 2014, it is interesting to take a look at how expert predictions are playing out in the marketplace. With a little help from my friends at PricewaterhouseCoopers (PwC) and their report from the Health Research Institute entitled “Top Health Industry Issues

of 2014: A New Health Economy Takes Shape,”1 let us take a look at the scorecard of predictions for 2014 as they relate to healthcare consumerism: the rise of the retail marketplace, the new role for employer private exchanges, price transparency, and how new technology may help put all of this together. I am no stranger to the retail healthcare marketplace, having been a board member of the iTrax Corporation, which was eventually sold to Walgreens. And Walgreens combined iTrax with other resources to develop what is now known as Take Care Health Systems—the pharmacy giant’s retail healthcare arm. According to our colleagues at PwC and their detailed consumer survey, nearly 1 in 4 persons indicated that either

INSIDE PHARMACY ❚ August | September 2014

they or someone in their household had sought healthcare treatment in a retail clinic in 2013.1 Of those who sought care, a whopping 73% said they would go back to a retail clinic again in the future.1 Clearly, the predicted “retailization” of healthcare is progressing, as Walgreens and CVS Caremark continue to expand their product and service offerings inside their stores to deliver medical management of chronic conditions. “Walgreens, the country’s largest drugstore chain, announced last week that its 330-plus Take Care Clinics, will be the first retail store clinics to both diagnose and manage chronic conditions like asthma, diabetes, high blood pressure, and high cholesterol.”2 Not to be outdone, CVS Caremark is now accepting Medicaid in its 28 South Carolina retail clinics. The company reportedly has more

than 800 clinic locations across the United States,3 and continues to rapidly expand this aspect of its business. Consumers want care when they want it—and it better be convenient, and at an appropriate price point. After a rocky rollout of the exchanges, there are many more insured Americans now that the federal and state exchanges have completed their initial open enrollment. The implementation of the Affordable Care Act (ACA) has led to corresponding changes in the insurance market. As PwC predicted, there has been rapid growth in private exchanges, which are “reshaping the employer benefits landscape, drawing high profile converts, such as IBM and Sears.”1 These private exchanges offer a similar platform as those created by the ACA. Because more than 156 million Americans receive health insurance

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Chain Headquarters News through the workplace, private exchanges have a bright future. “At its core, a private exchange is an online marketplace for employers to send active or retired employees who shop for medical and other benefits with an employer contribution.”1 Think of these private exchanges as very narrow networks, with high-quality providers linked via digital communication and personalized information for the employee. “While employers are pushing private exchanges, a large number of diverse organizations, including brokerage firms, consulting companies, managed care insurers and high technology companies are also in the mix.”1 While the move to ward retail clinics and private exchanges is certainly important, none of this would be possible without price transparency. I completely agree with PwC that this time it’s a different story. “As families pay more for their care, the demand for transparency—and lower costs—has risen.”1 There are key implications of greater price transparency. As employers look to reduce costs, they will play “hardball” with provider organizations. Businesses will make price transparency a primary factor in negotiating with

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insurers and provider organizations. Perhaps the private exchanges will fuel this push toward price transparency. Citing a report from the Los Angeles Times, the PwC report discusses a very interesting development in California. “When the health benefits plan for California’s retirees [CalPERS] said it would pay no more than $30,000 for hip or knee replacements, its members changed how they selected providers and medical treatment…. Providers responded by dropping their prices to compete. CalPERS saved $5.5 million in the program’s first two years and the price of the procedure dropped 26% or about $9,000.”4 Price transparency drove providers to change in a dramatic way. Can we put retail clinics, private exchanges, and price transparency together on our mobile devices? As we move through 2014, I envision a future in which providers integrate patient data visible in their electronic health records with the information that patients share with them via social media. I also see patients having complete and unfettered access to their own medical records online. “Social mobile analytics and cloud technologies are the under-

pinnings for completing new business models in which organizations will be paid based on value rather than volume.”1 It only makes sense that providers, who will be under increasing pressure to keep costs down, would promote technology that helps patients manage health outside of the hospital setting. In other words, “today just 27% of physicians encourage patients to use mobile health applications, even though 59% of physicians and insurers believe that the widespread adoption of mobile health is inevitable in the near future.”1 Finally, as consumers assume more financial risks for their own healthcare, especially via high-deductible health plans, they may be more willing to pay for those social mobile analytics and cloud technologies that will enable them to manage their own health. This is the best example of a digital marketplace coming to healthcare, fueled by price transparency and consumer engagement. So far, 2014 is most certainly playing out to be the year of the healthcare consumer. What are your predictions for the year ahead? I am confident and excited that as we move forward, our work, and all the articles

published in American Health & Drug Benefits, will continue to reflect new developments in our nearly $3-trillion-a-year healthcare economy. As always, I am interested in your views, and you can reach me at david. nash@jefferson.edu. ❚

References

1. PricewaterhouseCoopers Health Research Institute. Top health industry issues of 2014: a new health economy takes shape. December 2013. http://pwchealth.com/cgi-local/hregis ter.cgi/reg/pwc-hri-top-healthcare-is sues.pdf. Accessed May 1, 2014. 2. Ganguli I. Chronic care at Walgreens? Why not? Boston Globe. April 22, 2013. www.bostonglobe.com/ lifestyle/health-wellness/2013/04/21/ chronic-care-walgreens-why-not/ WVB3YqhyDIPqvI5APVuodM/story. html?event=event12. Accessed May 1, 2014. 3. CVS Caremark. MinuteClinic. 2014. http://info.cvscaremark.com/ better-health-care/minuteclinic. Accessed May 23, 2014. 4. Terhune C. Hospitals cut some surgery prices after CalPERS caps reimbursements. Los Angeles Times. June 23, 2013. 5. http://articles.latimes.com/2013/ jun/23/business/la-fi-mo-calpers-hospi tal-surgery-prices-20130623. Accessed May 1, 2014.

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

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Drug Update Farxiga (Dapagliflozin), an Oral SGLT-2 Inhibitor, a New FDA-Approved Treatment Option for Type 2 Diabetes by LORETTA FALA, Medical Writer

Improvements in glycemic control have been shown to reduce the morbidity and mortality associated with type 2 diabetes by decreasing chronic complications. }} }} AN ESTIMATED 25.8 million people—more than 8% of the US population—are affected by diabetes.1 Moreover, approximately 35% of US adults aged ≥20 years have prediabetes; the rate of prediabetes increases to 50% for adults aged ≥65 years.1 More concerning is the projection that the prevalence of diabetes will increase dramatically, from 1 in 10 adults today to 1 in 3 adults by 2050— a trend that coincides with the aging of the US population over the next few decades.2 Diabetes is a chronic illness associated with multiple comorbidities

and health complications.1 Aside from being a major cause of heart disease and stroke, diabetes is the leading cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness in US adults. In fact, diabetes is the seventh leading cause of mortality in the United States.1 In 2012, US healthcare costs attributable to diabetes totaled $245 billion, including $176 billion in direct medical costs, and $69 billion in indirect costs (ie, increased absenteeism, reduced productivity, lost productivity because of early mortality, and in-

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ability to work resulting from disability).3 Overall, medical expenses for patients with diabetes are approximately 2.3 times higher than expenses for people without diabetes.3 Type 2 diabetes accounts for 90% to 95% of all cases of diabetes, whereas type 1 diabetes accounts for approximately 5% of all cases.1 Type 2 diabetes requires ongoing management and support to prevent acute long-term complications.4 According to the American Diabetes Association (ADA), diabetes management is complex and generally requires multiple risk-reduction strategies, including glycemic control.4 Improvements in gly-

cemic control have been shown to reduce the morbidity and mortality associated with type 2 diabetes by decreasing chronic complications.5 In fact, a 1% reduction in glycated hemoglobin (HbA1c) is associated with a 35% reduction in diabetes-related microvascular complications, including diabetic neuropathy, nephropathy, and retinopathy.5 In a 2013 position statement, the ADA recommended a general target HbA1c level of <7% for adults with diabetes; however, the stringency of this goal may need to be adapted, based on the patient’s duration of diabetes, comorbidities, age, known cardiovascular or advanced microvascular

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Drug Update complications, and other relevant patient factors.4 The American Association of Clinical Endocrinologists recommends an HbA1c target level of <6.5% in the majority of patients with type 2 diabetes, with the caveat that this goal may be too aggressive for some patients and not aggressive enough for others (ie, younger patients for whom a lower target may prevent later complications).6 According to the American Association of Clinical Endocrinologists 2013 consensus statement, the goals of lifestyle modification and antihyperglycemic pharmacotherapy are “(1) to achieve clinical and biochemical glucose targets; (2) to avoid hypoglycemia; (3) to avoid weight gain in persons who are obese and to assist with weight loss; and (4) to reduce or avoid increasing CVD [cardiovascular disease] risk.”6 Despite strides made in the number of people in the United States who achieve the target HbA1c level of <7%, there is still a substantial need for strategies to improve the achievement of glycemiccontrol targets and outcomes for individuals with diabetes and prediabetes.7 Over the past 2 decades, accumulating evidence has shown that the kidney plays an important

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role in regulating glucose.8 In patients with type 2 diabetes, there is an increased reabsorption and release of renal glucose.9 In hyperglycemia, excess glucose is reabsorbed by the kidney. This reabsorption process increases the renal glucose threshold and perpetuates a cycle of hyperglycemia, along with its associated microvascular complications.9 The sodium-glucose cotransporter (SGLT)-2, a cotransporter expressed in the proximal renal tubules, is responsible for reabsorbing 90% of the glucose filtered at the glomerulus.9,10 By reducing the reabsorption of filtered glucose and lowering the renal threshold for glucose, the SGLT-2 inhibitors increase urinary glucose excretion and lower blood glucose levels.11

Dapagliflozin: A New Oral SGLT-2 Option On January 8, 2014, dapagliflozin (Farxiga; Bristol-Myers Squibb/ AstraZeneca), an oral SGLT-2 inhibitor, was approved by the US Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.12 Dapagliflozin is not indicated for the treatment of type 1 diabetes mellitus or for diabetic ketoacidosis.13

According to the FDA, the safety and efficacy of dapagliflozin were evaluated in 16 clinical trials that involved more than 9400 patients with type 2 diabetes.12 Curtis Rosebraugh, MD, MPH, Director of the Office of Drug Evaluation II at the FDA Center for Drug Evaluation and Research, commented, “Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes.”12 The FDA is requiring the manufacturer to conduct 6 postmarketing studies for dapagliflozin, including a cardiovascular outcomes trial in patients with a high baseline risk for cardiovascular disease; a double-blind, randomized, controlled evaluation of bladder cancer risk in patients enrolled in the cardiovascular outcomes study; an animal study to assess dapagliflozin-induced urinary flow, rate, and composition changes on bladder tumor promotion; 2 clinical studies on the pharmacokinetics, efficacy, and safety of dapagliflozin in pediatric patients; and an enhanced pharmacovigilance program to monitor any reports of liver abnormalities and pregnancy outcomes.12

Mechanism of Action Dapagliflozin is an inhibitor of SGLT-2, a protein expressed in the proximal renal tubules that is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. By inhibiting SGLT-2, dapagliflozin reduces the reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.13 Dosing and Administration Dapagliflozin is available as a 5-mg and a 10-mg tablet for oral use. The recommended starting dose is 5 mg once daily, taken in the morning. The dose can be increased to 10 mg once daily in patients who can tolerate dapagliflozin and who require additional glycemic control. Dap agliflozin can be administered with or without food.13 Before initiating treatment with dapagliflozin, renal function should be assessed. Treatment with dapagliflozin should not be initiated if the patient’s estimated glomerular filtration rate (eGFR) is <60 mL/min/1.73 m2. If the eGFR falls persistently below 60 mL/min/1.73 m2, dapagliflozin should be discontinued.13

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Drug Update Table 1. Comparing 24-Week Dapagliflozin Monotherapy versus Placebo in Patients with Type 2 Diabetes Dapagliflozin 10 mg (N = 70)

Dapagliflozin 5 mg (N = 64)

Placebo (N = 75)

Baseline, mean, %

8.0

7.8

Change from baseline, adjusted mean,a %

–0.9

–0.8

–0.2

–0.7b (95% CI, –1.0 to –0.4)

–0.5 (95% CI, –0.8 to –0.2)

––

50.8

44.2

31.6

Baseline, mean, mg/dL

166.6

157.2

159.9

Change from baseline, adjusted mean,a mg/dL

–28.8

–24.1

–4.1

–24.7b (95% CI, –35.7 to –13.6)

–19.9 (95% CI, –31.3 to –8.5)

––

Efficacy parameter HbA1c

Difference from placebo, adjusted mean,a % Patients achieving HbA1c <7% adjusted for baseline, % Fasting plasma glucose

Difference from placebo, adjusted mean,a mg/dL

Least squares mean adjusted for baseline value. P <.001 versus placebo; sensitivity analyses yielded smaller differences with placebo. CI indicates confidence interval; HbA1c, glycated hemoglobin. Source: Farxiga (dapagliflozin) tablets prescribing information; 2014. a

Clinical Trials Dapagliflozin was studied as monotherapy and in combination with metformin, pioglitazone, glimepiride, sitagliptin (with or without metformin), or insulin (with or without other oral antidiabetes therapy). The efficacy of dapagliflozin was compared with a sulfonyl urea (glipizide) added on to metformin. Dapagliflozin was also studied in patients with type 2 diabetes and moderate renal impairment.13 Treatment with dap agliflozin as monotherapy

and in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin produced significant improvements in the mean change of HbA1c levels from baseline at week 24 compared with the control HbA1c levels. These reductions in HbA1c levels were seen across a number of subgroups, including gender, age, race, duration of disease, and the baseline body mass index.14,15

Monotherapy Studies Two placebo-controlled clinical trials eval-

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uated the safety and efficacy of dapagliflozin monotherapy in 840 treatment-naïve patients with inadequately controlled type 2 diabetes.13,14 One of the monotherapy trials was a 24-week study that included 558 treatment-naïve patients with inadequately controlled diabetes.14 Following a 2-week diet and exercise placebo lead-in period, 485 patients with HbA1c levels of ≥7% and ≤10% were randomized to dapagliflozin 5 mg or 10 mg once daily in the morning (main cohort) or in the

evening, or to placebo. At week 24, patients receiving dapagliflozin 10 mg once daily in the morning showed significant improvements in HbA1c and fasting plasma glucose (FPG) levels compared with patients receiving placebo (Table 1).13,14

Combination Therapy Studies with Metformin Two active-controlled, 24-week studies evaluated the safety and efficacy of initial therapy with dap agliflozin 5 mg or 10 mg in combination with metformin extended-release (XR) formulation. A total of 1241 treatment-naïve patients with inadequately controlled type 2 diabetes (HbA1c ≥7.5% and ≤12%) participated in these 2 studies.15 Study 1. Dapagliflozin 10 mg plus metformin XR. A total of 638 patients were randomized to 1 of 3 treatment arms after a 1-week lead-in period: dapagliflozin 10 mg plus metformin XR (up to 2000 mg daily), dapagliflozin 10 mg plus placebo, or metformin XR (up to 2000 mg daily) plus placebo. The metformin XR dose was uptitrated weekly in 500-mg increments, as tolerated, with a median dose of 2000 mg.15 The combination treat ment of dapagliflozin 10 mg plus metformin XR demonstrated significant

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Drug Update improvements in HbA1c and FPG levels compared with either of the monotherapy treatments, as well as a significant reduction in body weight compared with metformin XR alone (Table 2). Moreover, dapagliflozin 10-mg monotherapy provided significant improvements in FPG levels and a significant reduction in body weight versus metformin alone; in addition, it was noninferior to metformin XR monotherapy in lowering HbA1c levels.15 Study 2. Dapagliflozin 5 mg plus metformin XR. In this study of 603 patients, the combination treatment of dapagliflozin 5 mg plus metformin XR showed significant improvements in HbA1c and FPG levels compared with either of the monotherapy treatments; in addition, there was a significant reduction in body weight compared with metformin XR alone.15

Safety The safety data for dap agliflozin were derived from 12 placebo-controlled clinical trials that ranged from 12 to 24 weeks, in which 2338 patients were exposed to dapagliflozin for a mean duration of 21 weeks. In these studies, the most common (≥5% incidence) adverse reactions associated with dapaglifloz-

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Table 2. Dapagliflozin Initial Combination with Metformin XR versus Dapagliflozin or Metformin Alone at 24 Weeks

Efficacy parameters

Dapagliflozin 10 mg + metformin XR (N = 211)

Dapagliflozin 10 mg (N = 219)

Metformin XR (N = 208)

HbA1c Baseline, mean, %

9.1

9.0

Change from baseline, adjusted mean,a %

–2.0

–1.5

–1.4

Difference from dapagliflozin, adjusted mean,a %

–0.5b (95% CI, –0.7 to –0.3)

––

Difference from metformin XR, adjusted meanb, %

–0.5b (95% CI, –0.8 to –0.3)

0.0c (95% CI, –0.2 to 0.2)

––

Patients achieving HbA1c <7%, adjusted for baseline, %

46.6d

31.7

35.2

Baseline, mean, mg/dL

189.6

197.5

189.9

Change from baseline, adjusted mean,a mg/dL

–60.4

–46.4

–34.8

Difference from dapagliflozin, adjusted mean,a mg/dL

–13.9b (95% CI, –20.9 to –7.0)

––

Difference from metformin XR, adjusted mean,a mg/dL

–25.5b (95% CI, –32.6 to –18.5)

–11.6d (95% CI, –18.6 to –4.6)

––

Baseline, mean, kg

88.6

88.5

87.2

Change from baseline, adjusted mean,a kg

–3.3

–2.7

–1.4

Difference from metformin XR, adjusted mean,a kg

–2.0b (95% CI, –2.6 to –1.3)

–1.4b (95% CI, –2.0 to –0.7)

––

Fasting plasma glucose

Body weight

Least squares mean adjusted for baseline value. P <.001. c Noninferior versus metformin XR. d P <.05. CI indicates confidence interval; HbA1c, glycated hemoglobin; XR, extended release. Source: Farxiga (dapagliflozin) tablets prescribing information; 2014. a

in were female genital mycotic infections, nasopharyngitis, and urinary tract infections (Table 3).13

Warnings and Precautions Contraindications. Dapagliflozin is contrain-

dicated in patients with a history of serious hypersensitivity reaction to dap agliflozin and in pa-

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Drug Update Table 3. Adverse Reactions Reported in ≥2% of Patients Receiving Dapagliflozin 5 mg or 10 mg in 12 Placebo-Controlled Clinical Trials Dapagliflozin 5 mg, % (N = 1145)

Dapagliflozin 10 mg, % (N = 1193)

Placebo, % (N = 1393)

Female genital mycotic infections

8.4

6.9

1.5

Nasopharyngitis

6.6

6.3

6.2

Urinary tract infections

5.7

4.3

3.7

Back pain

3.1

4.2

3.2

Increased urination

2.9

3.8

1.7

Male genital mycotic infections

2.8

2.7

0.3

Nausea

2.8

2.5

2.4

Influenza

2.7

2.3

Constipation

2.2

1.9

1.5

Dyslipidemia

2.1

2.5

1.5

Discomfort with urination

1.6

2.1

0.7

Pain in extremity

2.0

1.7

1.4

Adverse reaction

Source: Farxiga (dapagliflozin) tablets prescribing information; 2014.

tients with severe renal impairment or end-stage renal disease, or those on dialysis.13 Hypotension. Dapagliflozin may cause osmotic diuresis, which may lead to reductions in intravascular volume. Adverse reactions related to volume depletion include reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension. Before initiating dapagliflo zin therapy, volume status should be assessed and hypovolemia should be corrected in elderly patients, in patients with renal impairment or low systolic blood pressure, and in patients taking diuretics. Patients should

also be monitored for signs and symptoms of volume depletion during therapy.13 Impairment in renal function. Because dapagliflozin increases serum creatinine levels and decreases the eGFR, renal function should be monitored before and after therapy with dapagliflozin.13 Hypoglycemia. To reduce the risk for hypoglycemia, a lower dose of insulin or insulin secre tagogue should be considered in patients taking dapagliflozin with insulin or with an insulin secretagogue.13 Genital mycotic infections. Dapagliflozin is associated with an increased

INSIDE PHARMACY ❚ August | September 2014

risk for genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop these infections. Patients should be monitored and managed appropriately.13 Increased low-density lipoprotein cholesterol (LDL-C). Increases in LDL-C levels often occur with dapagliflozin. Elevated LDL-C levels should be treated according to standard of care after dapagliflozin therapy.13 Bladder cancer. In clinical trials, dapagliflo zin was associated with an increased risk for bladder cancers compared with placebo or the comparator drug. Dapagliflozin should

not be used in patients with active bladder cancer and should be used with caution in patients with a history of bladder cancer.13 Macrovascular outcomes. Clinical studies have not established conclusive evidence of macrovascular risk reduction with dapagliflozin or with any other antidiabetic drug.13

Drug Interactions In in vitro studies, dap agliflozin and dapagliflozin 3-0-glucuronide neither inhibited cytochrome (CY)P1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4, nor induced CYP1A2, CYP2B6, or CYP3A4. Overall, dap agliflozin is unlikely to affect the pharmacokinetics of concurrently administered medications that are P-glycoproteins, OCT2, OAT1, or OAT3 substrates.13 Use in Specific Populations Pregnancy. There are no adequate and well-controlled studies of dapagliflozin in pregnant women. Dapagliflozin should only be used in pregnant women if the potential benefit justifies the potential risk.13 Nursing mothers. Because many drugs are excreted in human milk, a decision should be made

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Drug Update whether to discontinue nursing or to discontinue dapagliflozin.13 Geriatric use. More patients aged ≥65 years receiving dapagliflozin had adverse reactions related to volume depletion and renal impairment or failure compared with patients receiving placebo.13 Renal impairment. Dapagliflozin is associated with an increased incidence of adverse reactions related to reduced intravascular volume and renal function.13

Conclusion The FDA approval of dapagliflozin marked the availability of a new oral SGLT-2 option for patients with type 2 diabetes, as an adjunct to diet

and exercise. Dapagliflo zin blocks renal glucose reabsorption, increases urinary glucose excretion, and lowers blood glucose levels. In 16 clinical trials with more than 9400 patients with type 2 diabetes, dapagliflozin significantly improved HbA1c levels. This approval provides the millions of patients with diabetes an additional option in controlling their blood glucose levels. The most common adverse reactions associated with dapagliflozin were female genital mycotic infections, nasopharyngitis, and urinary tract infections. ❚

References

1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general

information on diabetes and prediabetes in the United States, 2011. 2011. www.cdc.gov/diabetes/pubs/pdf/ ndfs_2011.pdf. Accessed March 7, 2014. 2. Boyle JP, Thompson TJ, Gregg EW, et al. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010;8:29. 3. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36:10331046. 4. American Diabetes Association. Standards of medical care in diabetes—2013. Diabetes Care. 2013;36 (suppl 1):S11-S66. 5. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853. 6. Garber AJ, Abrahamson MJ, Barzilay JI, et al. American Association of Clinical Endocrinologists’ comprehensive diabetes management algorithm 2013 consensus statement. Endocr Pract. 2013;19(suppl 2):1-48. 7. Cheung BM, Ong KL, Cherny SS, et al. Diabetes prevalence and therapeutic target achievement in the United States, 1999 to 2006. Am J Med. 2009;122:443-453. 8. Gerich JE. Role of the kidney in normal glucose homeostasis and in the hyperglycaemia of diabetes mellitus:

therapeutic implications. Diabet Med. 2010;27:136-142. 9. Triplitt CL. Understanding the kidneys’ role in blood glucose regulation. Am J Manag Care. 2012;18(1 suppl): S11-S16. 10. Marsenic O. Glucose control by the kidney: an emerging target in diabetes. Am J Kidney Dis. 2009;53:875883. 11. List JF, Whaley JM. Glucose dynamics and mechanistic implications of SGLT2 inhibitors in animals and humans. Kidney Int Suppl. 2011; 79(suppl 120):S20-S27. 12. US Food and Drug Administration. FDA approves Farxiga to treat type 2 diabetes. Press release. January 8, 2014. Updated January 9, 2014. www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm380829. htm. Accessed February 26, 2014. 13. Farxiga (dapagliflozin) tablets [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company, and Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2014. 14. Ferrannini E, Ramos SJ, Salsali A, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010;33:2217-2224. 15. Henry RR, Murray AV, Marmolejo MH, et al. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66:446-456.

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Continuing Education Release date: September 15, 2014 Expiration date: September 30, 2015 Estimated time to complete activity: 1.0 hours Jointly provided by Postgraduate Institute for Medicine and Medtelligence, LLC.

Medtelligence

This activity is supported by an independent educational grant from Amarin Pharma Inc. TARGET AUDIENCE This activity has been designed to meet the educational needs of pharmacists, physicians, and other healthcare professionals involved in the care of patients with hyperglyceridemia. EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Identify the significance of elevated triglycerides as a risk factor in cardiovascular disease and other health conditions; • Review recommended methods for monitoring triglyceride levels, including how to determine elevations in triglycerides in relation to other lipid levels; • Describe the pharmacist's role in managing patients with dyslipidemia; • Expand the pharmacist's patient counseling skills to improve outcomes in lipid management; • Assess available clinical trial data on agents used to modify triglyceride levels and describe appropriate use of these agents in patients with elevated triglycerides; • Provide accurate and appropriate counsel as part of the treatment team FACULTY Michael B. Bottorff, PharmD, FCCP, FNLA, CLS, Professor and Chair, Department of Pharmacy Practice, School of Pharmacy, South College, Knoxville TN Gregory S. Pokrywka, MD, FACP, FNLA, NCMP, Assistant Professor of Medicine, The Johns Hopkins University School of Medicine, Director, Baltimore Lipid Center, Balrimore MD. Diplomate of the American Board of Clinical Lipidology Physician Continuing Medical Education Accreditation Statement This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine and Medtelligence, LLC The Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Significance of Hypertriglyceridemia: Implications for the Pharmacist

ypertriglyceridemia (HTG; elevated blood triglyceride levels of >150 mg/dL) is prevalent among Americans. According to the latest data, 31% of the adult American population has HTG.1 HTG increases risks for cardiovascular disease (CVD). Reasons for the increased prevalence are poorly understood; however, lifestyle management is the preferred mode to initially treat the condition.2 Primary causes of HTG include genetics, such as familial combined hyperlipidemia and familial HTG. These are fairly common and are associated with an increased risk for CVD.3 Secondary causes, which are much more common than primary causes, include excess calorie ingestion, high carbohydrate intake, type 2 diabetes, untreated or uncontrolled hypothyroidism, recreational drug use, and some medications.3 Credit Designation The Postgraduate Institute for Medicine designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Pharmacist Continuing Education Accreditation Statement Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Credit Designation Postgraduate Institute for Medicine designates this continuing education activity for 1.0 contact hour(s) (0.10 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0809-9999-14-203-H01-P) Type of Activity: Application 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 activities and related mate-

INSIDE PHARMACY ❚ August | September 2014

HTG and CVD HTG often accompanies excess body weight. Obesity, particularly when accompanied by increased abdominal adiposity, often coexists with CVD risk factors such as hypertension, glucose intolerance, and atherosclerosis.4 Indeed, adipose tissue is not merely a fat repository, but a dynamic endocrine organ, with the capability to produce inflammatory mediators contributing to CVD.4 Moreover, obesity contributes to insulin resistance and type 2 diabetes. These conditions can lead to dyslipidemia, hypertension, increased production of thrombotic and antifibrinolytic factors, and hypercoagulability.5 The presence of metabolic syndrome puts patients at greatly increased risks for type 2 diabetes and CVD.6 The major risk factors for metabolic syndrome are abdominal obesity and insurials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity: Name of Faculty or Presenter

Reported Financial Relationship

Michael B. Bottorff

Consulting Fees: Boeringer-Ingelheim Fees for Non-CME/CE Services: AstraZeneca; Boehringer Ingelheim; Pfizer; Bristol-Myers Squibb

Gregory S. Pokrywka

Consulting Fees: Aegerion; Amarin; Novartis Fees for Non-CME/CE Services: Aegerion; Amarin; AstraZeneca; Kowa; Sanofi/Genzyme

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME 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, MSN, RN, CCMEP, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

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Continuing Education lin resistance.6 However, it should be noted that metabolic syndrome (that includes elevated TG levels) insulin resistance, and CVD can occur in normoweight individuals, although the adipose distribution may contribute to the development of the syndrome.6 The relationship between metabolic syndrome and CVD, and the use of statins to mitigate risk for CVD, were evaluated in the MIRACL study.7 More than 3000 patients were enrolled and 38% met the defined criteria for metabolic syndrome. The reduction in relative risk was assessed among patients who received atorvastatin 80 mg daily compared with patients who received placebo.7 Compared with patients without a metabolic syndrome, the cumulative hazard of the primary end point for patients in the study with metabolic syndrome was 1.49 (95% confidence interval [CI], 1.24-1.79).7 Early intervention with atorvastatin 80 mg daily reduced the absolute risk in patients with metabolic syndrome by 2.6%, compared with patients who received placebo.7 Metabolic syndrome also increases long-term outcomes for patients who undergo interventions, Medtelligence, LLC: Ben Caref, PhD; Pamela Clark 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.

such as percutaneous coronary intervention; in a study of patients who underwent percutaneous coronary intervention over 12 years, those with metabolic syndrome were more likely to suffer cardiac events than those without the syndrome (25.5% vs 15.6%; hazard ratio [HR], 2.23; P <.001).8 To quantify the risk for increased CVD posed by triglyceride levels, investigators conducted a meta-analysis of 29 prospective studies in Western populations.9 The overall adjusted odds ratio was 1.72 (95% CI, 1.56-1.90) for risk of CVD in the top third versus the bottom third of triglyceride levels.9 Large trials using statins showed that their use reduced the risk of CVD; in particular, in a trial of 20,536 high-risk patients, simvastatin use reduced the percentage of patients who experienced major CVD events (myocardial infarction or death) from 11.8% (placebo) to 8.7% (simvastatin).10 Recent genetic evidence has pointed to a clear causal role of TG on CAD development and subsequent CV events.11-13

Methods to Monitor Triglycerides Standard lipid panels quantify total For Pharmacists: Upon successfully completing the post-test with a score of 75% or better and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service. Media: printed report

Method of Participation and Request for Credit There are no fees for participating and receiving CME credit for this activity. During the period September 15, 2014 through September 30, 2015, participants must read the learning objectives and faculty disclosures and study the educational activity. Once the activity is complete, please go online to CME University at: www. cmeuniversity.com, and register or login. Once logged in, follow these steps: 1. Click on the “Find Post-Test/Evaluation by Course:” at the top of the page. 2. Type in “10316” and hit enter. 3. Click on the activity title when it appears. 4. Choose your profession/type of credit you are seeking. 5. Complete the online Posttest and Evaluation Form. Upon successful completion of the online Posttest, with a score of 75% or better, and the online Evaluation form, you will have immediate access to a certificate of attendance to print or save for your files. If you have any questions regarding the CME/CE certification for this activity, please contact Postgraduate Institute for Medicine at: information@ pimed.com or (303) 799-1930.

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Disclosure of Unlabeled Use This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Disclaimer Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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Continuing Education cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.14 In the blood, these lipids are carried inside specialized lipoprotein particles. The particles range in size, density, composition, and function.14 Assays exist to quantify the lipid subfractions; these assays subfractionate by size, density, or charge.14 It has been proposed that analyzing lipid subfractions may play a role for assessing the risk of CVD and for guiding which lipid-lowering modality to choose.14 How to use data derived from lipid subfraction assays is still under debate. Several methods are used to analyze in a standard panel. Gradient gel electrophoresis determines the distribution of lipoprotein particle size and, to some extent, charge.14 Density gradient ultracentrifugation measures how cholesterol is distributed among various lipoprotein subfractions.14 Nuclear magnetic resonance spectroscopy works by determining the resonance of methyl groups on lipoproteins.14 Finally, ion-mobility analysis assesses both the size and Table 1. ATP III Treatment Recommendations for Elevated Triglycerides18 ATP III classification

Primary target of therapy

150-199

Borderline high

LDL-C goal

• dec weight • inc physical activity

200-499

High

LDL-C goal

• dec weight • inc physical activity • Consider non–HDL-C goal: o dec LDL-C with statin o dec VLDL-C with niacin or fibrate

≥500

Very high

lower TG to prevent acute pancreatitis

• very low fat diet (fat ≤15% total calories) • dec weight • inc physical activity • add niacin or fibrates

TG, mg/dL

Treatment recommendations

ATP indicates Adult Treatment Panel III; dec, decrease; HDL-C, high-density lipoprotein cholesterol; inc, increase; LDL-C, low-density lipoprotein cholesterol; TG, triglycerides; VLDL-C, very low-density lipoprotein cholesterol.

INSIDE PHARMACY ❚ August | September 2014

concentrations of lipoprotein particles based on differential mobility in the gaseous phase.14 Based on a large body of research, there is a consensus that elevated LDL-C is a risk factor for CVD.15 Further studies showed that the converse is true: lowering LDL-C in those with multiple CVD risk factors or with type 2 diabetes lowers their risk of CVD.15 However, there are limitations to this approach. For example, the current method for determining LDL-C underestimates LDL-C as serum triglyceride levels increase.15 Moreover, the cholesterol content of LDL particles varies among individuals and is subject to metabolically induced fluctuations from causes such as insulin resistance and hyperglycemia.15 A more accurate determination would be to quantify LDL particles through NMR, rather than assessing LDL-C.15 Major limitations to this technique are limited availability, relative expense, and predictive power for CVD risk.15 The surrogate marker used for triglyceride quantification is fasting very low-density lipoprotein (VLDL).15 Triglycerides are not robust predictors of CVD in multivariate studies, perhaps because they are connected to abnormalities in HDL and LDL, and perhaps due to variances in individual biology and laboratory standardization.15 HDL-C is a strong inverse predictor for CVD; this is true in diabetic and nondiabetic patients.15 The value of raising HDL-C to lower CVD risk is difficult to assess unequivocally, because raising HDL-C necessarily affects all serum lipoproteins.15 Triglyceride-rich lipoproteins are particularly atherogenic.1 Thus, the atherogenic potential of plasma should be evaluated when high levels of triglycerides are found.1 Non–HDL-C can serve for part of the measurement, as can determination of apolipoprotein B100

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Continuing Education (ApoB).1 Non–HDL-C does not require fasting.1 Non–HDL-C includes all atherogenic lipoprotein classes: VLDL, and intermediate-density lipoprotein. Since ApoB is contained within all potentially atherogenic particles,1,15 quantifying these particles provides a direct number of circulating atherogenic particles.1 Non-HDL-C and LDL-C have become a key clinical measurement for assessing atherogenicity.16 This is important in light of the fact that the most accurate cholesterol determination does not reveal the number of atherogenic particles, and also because cholesterol and triglyceride contents vary within particles, even in the individual.17 The ratio of triglycerides to HDL-C discloses elevated triglycerides, low HDL-C, or both, and is linked to insulin resistance in Caucasians, but not other populations.1 When lipid panels are done, the consensus guidelines suggest it be done at least once every 5 years in patients >20 years of age who are considered to be low risk.18 More frequent monitoring should be done for those with risk factors, or those whose risk factors rise. LDL-C is estimated from measurements of total cholesterol, total triglycerides, and HDL-C. The equation used to calculate LDL-C is: LDL-C = TC – HDL-C – TG/5 (all units are mg/dL), where TC is total cholesterol, TG is triglycerides, and TG is divided by 5 to estimate VLDL (when TG <400 mg/dL; when this is not the case, the determination is necessarily less accurate, and then ultracentrifugation as described above is generally used)18; the equation to calculate non-HDL-C is: TC - HDL - C. Which cholesterol subfraction predicts CVD risk is an important question to address. The Framingham Heart Study examined this topic and concluded that non–HDL-C is superior to LDL-C for predicting CVD risk.19 Furthermore, the study showed that in

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Table 2. Target Levels for Therapy in Patients with TG >200 mg/dL21 LDL-C target, mg/dL

Non–HDL-C target, mg/dL

No CVD, <2 RFs

<160

<190

No CVD, 2+ RFs

<130

<160

CVD or CVD risk equivalent

<100

<130

Patient category

CVD indicates cardiovascular disease; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; RF, risk factor; TG, triglycerides.

Table 3. Improved Lipid Levels Following Diet and Lifestyle Changes23,24 Diet/lifestyle change

Lipid profile change

Stop smoking

inc HDL-C by 4 mg/dL

Weight loss (5%-10%)

dec TG 20%; dec LDL-C15%; inc HDL-C10%

Dietary: inc fruits, vegetables, low-fat dairy and dec sugar dec total carb; dec total fat (to 33%-50% of caloric intake)

dec LDL-C; inc HDL-C

Brisk walking, 30 min, 3 times/week

dec LDL-C, inc HDL-C 5%-10%

dec TG by 9 mg/dL

Dec indicates decrease; HDL-C, high-density lipoprotein cholesterol; inc, increase; LDLC, low-density lipoprotein cholesterol; TG, triglycerides.

HTG, at a given level of non–HDL-C, there is little or no association between LDL-C and CVD. In contrast, non– HDL-C predicted CVD independently of LDL-C levels. Quantification of lipid subfractions remains an important tool for preventing CVD. It is a major means to evaluate risk, and determine whether targeted goals are being met through current treatment.

The Pharmacist’s Role in Managing Patients with Dyslipidemia The Adult Treatment Panel III (ATP III) treatment recommendations for elevated triglyceride levels are summarized in Table 1.18 In addition to the ATP III guidelines, some practitioners recommend limiting sugars and complex carbohydrates for those with high triglyceride

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Continuing Education Table 4. Effect of Drugs by Class on Triglyceride Reduction1 Drug class

% Reduction

Fibrates

30-50

Immediate-release niacin

20-50

Extended-release niacin

10-30

Omega-3 fish oils

20-50

Statins

10-30

Ezetimibe

5-10

levels, and adding omega-3 fatty acids.18 Omega-3 fatty acids may be underutilized and show mixed results in reducing CVD events.20 Clinicians and pharmacists should work with patients to achieve target goals through lifestyle and pharmacologic approaches, as needed. The vast majority of patients use statins to achieve their blood lipid goals; however, those with type 2 diabetes may still experience persistent HTG.21 These patients may require additional medications to achieve their lipid goals. Target levels for therapy after the LDL-C goal is reached for patients with triglycerides >200 mg/dL are shown in Table 2.22 Recent data from the NEPTUNE II trial of HTG patients revealed that gaps for achieving targeted goals still remain, particularly for very high-risk patients who would be candidates for aggressive treatment.23 In addition, a proportion of HTG patients with CVD risks did not achieve combined LDL-C and nonâ&#x20AC;&#x201C;HDL-C goals; the proportion varied among patients with and without diabetes, and among those having CVD risk factors or no risk factors. The best recommendations for long-term strategies include lifestyle modifications in addition to statins and other medications.24,25 A summary of how lifestyle changes affect lipid levels is given in Table 3.

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The Mediterranean diet is purported to lower the risk for CVD. Both observational and cohort studies suggest this association.26 In this diet, fats are supplied mainly by olive oil and nuts, and fish and poultry intake is moderate, while red meat and processed foods are limited. Fruit, vegetable, and cereal intake is higher than in a normal Western diet. In this trial, patients further supplemented their daily intake with extra virgin olive oil or nuts, otherwise their food intake was unrestricted with regard to calories. Results showed that such a diet reduced the incidence of major cardiovascular events (HR, 0.70 for the group assigned oil, 95% CI, 0.54-0.92; HR, 0.72, 95% CI 0.54-0.96 for the group assigned nuts).26 When diet plus lifestyle changes are not sufficient to lower CVD risk, pharmacologic approaches are used. A summary from the American Heart Association regarding the effect on triglyceride level by drug class is summarized in Table 4. Adverse events from the use of these drugs include dyspepsia, upper gastrointestinal side effects, gallstones, and myopathy from fibrates; flushing, pruritus, diarrhea, vomiting, hyperglycemia, and hepatotoxicity from extendedrelease niacin; flatulence, dyspepsia, and altered taste from omega-3 fatty acids (arthralgia from purified eicosaÂ pentaenoic acid); myalgia, myopathy (rare), rhabdomyolysis (very rare), and cognitive impairment from statins.1,27 A meta-analysis of 14 randomized trials to determine the effect of cholesterol-lowering drugs on CVD events in diabetic patients revealed that statins are effective as first-line therapy in patients with fasting triglyceride levels >500 mg/dL; that fibrates and omega3 fatty acids are reasonable drugs for patients with fasting triglyceride levels <500 mg/dL and can be used to lower

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Continuing Education cholesterol levels while lowering risk for pancreatitis (statins or niacins may also be used for this latter indication); combination therapy may be necessary to achieve LDL and non-HDL goals.28 Subgroup analysis by statin is summarized in Table 5. The median follow-up was at least 5 years. Fibrate therapy has been used to reduce CVD risk, as they can markedly lower triglyceride levels and, additionally, raise HDL-C levels modestly (Table 4).29 From the results of several clinical trials, fibrate therapy was shown to reduce the risk of CVD from 37% to 78% in patients with dyslipidemia28,30-32; however, a meta-analysis of randomized clinical trials revealed that in some of these trials, primary end points were not met and that fibrate therapy failed to decrease overall mortality.29,33 However, fibrates may reduce total cardiovascular events. The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial enrolled almost 10,000 patients with type 2 diabetes who had not previously taken statins. They were given fenofibrate or placebo to determine the effect on CVD events. Those on fenofibrate had a significant reduction of non fatal myocardial events (24% reduction; HR, 0.76; P = .010), although the risk of primary outcome was not reduced.34 As patients progressed to statin treatment over the 5 years of the study, some benefits derived from fenofibrate may have been masked.34 Combining a statin, simvastatin, with fenofibrate in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial did not benefit patients compared with simvastatin treatment alone. The rate of fatal cardiovascular events, nonfatal myocardial infarction, and stroke was not decreased when the combination was given.35 Although the results of ACCORD do

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Table 5. Statins Reduce CVD Events in HTG Drug

Risk difference vs placebo

WOSCOPS (inc TG)

Pravastatin

–31% (–32%)

<.001 (.003)

CARE (inc TG)

Pravastatin

–24% (–15%)

.003 (.07)

PPP Project (highest TG tertile)

Pravastatin

–23% (–15%)

<.001 (.029)

4S (dyslipidemia)

Simvastatin

–34% (–52%)

<.001 (<.001)

JUPITER (older subjects with inc TG)

Rosuvastatin

–44% (–21%)

<.001 NS

CTT (highest TG tertile)

Various statins

–21% (–24%)

<.001 (.001)

–21% (–24%)

P value

CVD indicates cardiovascular disease; HTG, hypertriglyceridemia; inc, increased; NS, not significant; TG, triglyceride.

not provide evidence for adding fenofibrate to statin therapy, it did show the benefit of fibrate monotherapy in subgroups of patients.30 These subgroups include those with type 2 diabetes and dyslipidemias (optimal LDL-C levels but persistent HTG, and those with low LDL-C).30 Niacin, either in extended-release or immediate-release formulations, has been used in HTG. A meta-analysis of 10 trials revealed that niacin significantly reduced total CVD events.36 However, it should be noted that many of the trials included in the meta-analysis were not niacin monotherapy trials; therefore, the true effect of niacin may have been masked. The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/ High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial compared niacin monotherapy with combination therapy plus statin. Overall, no difference was noted in the 2 groups.37 However, subgroup analysis showed that patients with HTG (triglycerides >200 mg/dL; HDL-C <32 mg/dL) benefited

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Continuing Education from extended-release niacin therapy.37 Niacin added to a statin did not decrease the incidence of primary end points (death, stroke, hospitalization, revascularization) compared with placebo plus statin.37 The Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) study, conducted on more than 25,000 volunteers, also showed that adding extended-release niacin to simvastatin or to ezetimibe/ simvastatin did not reduce the risk of myocardial infarction, stroke, or revascularization but increased the risk of serious adverse events.27 Omega-3 fatty acids contain 2 main cardioprotective n-3 polyunsaturated acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA); a third, docosapentaenoic acid (DPA), is present in smaller amounts.38 These fatty acids have recognized effects for lowering cardiovascular parameters, such as heart rate, blood pressure, thrombotic risk.38,39 Beyond fish, they are found in other foods in smaller concentrations: eggs, chicken breast, beef, and pork contain very small to trace amounts of EPA, DHA, and DPA.38 Among edible fish species, the amounts of these fatty acids vary greatly. For example, the greatest amount may be found in farmed Atlantic salmon (EPA+DHA = 2150 mg per 100 g consumed), whereas white fish species such as Alaskan pollock or Atlantic cod have 120 to 160 mg per 100 g consumed.40 Wild Atlantic salmon, in contrast to farmed, has 1840 mg per 100 g consumed.40 This great variation in concentration from dietary sources is an important consideration for counseling patients to use prescribed omega-3 fatty acids, rather than relying on diet. Besides consistency of dosing over timed intervals, one can be certain about the exact composition with regard to individual fatty acid components, EPA, DPA, and DHA.

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Several studies, notably the Japan EPA Lipid Intervention Study (JELIS) and GISSI-Prevenzione trial, demonstrated the value of omega-3 fatty acids in treating dyslipidemia.32,41,42 That was not the case however, with the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial, which despite a 14.5 mg/dL lowering of TG with 1 gm of omega-3 fatty acids, failed to reduce the rate of cardiovascular events.43 Combining prescription omega-3 fatty acids with statins further reduces triglyceride levels, non– HDL-C, and VLDL-C, while increasing LDL-C and ApoB.20 The MARINE and ANCHOR trials examined the benefits of pure EPA compared with placebo in both trials.44,45 Both studies found that purified EPA had beneficial effects on lipid levels, including significant reductions in non-HDL-C. It should be noted that the FDA does not approve EPA for triglyceride levels <500 mg/dL. Among areas of research for new cholesterol-lowering drugs are diacylglycerol acyltransferase 1 inhibitors, which will inhibit the first committed step in triglyceride synthesis; peroxisome proliferator-activated receptor agonists, which may treat symptoms of metabolic syndrome; and gene therapy approaches. The pharmacist can reassure patients that statins reduce the risk of CVD, that omega-3 fatty acids are a valid approach to treat HTG, and that prescription forms of omega-3 fatty acids have advantages over dietary approaches. ❚

References

1. Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123:2292-2333. 2. Ford ES, Li C, Zhao G, Pearson WS, Mokdad AH. Hypertriglyceridemia and its pharmacologic treatment among US adults. Arch Intern Med. 2009;169:572-578. 3. Bays HE. Fish oils in the treatment of dyslipidemia and cardiovascular disease. In: Kwiterovich PO, ed. The Johns Hopkins Textbook of Dyslipidemia. Philadelphia, PA; Wolters Kluwer Health/Lippincott Williams & Wilkins; 2010:245-257. 4. Gelfand EV, Cannon CP. Rimonabant: a cannabinoid receptor

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Continuing Education type 1 blocker for management of multiple cardiometabolic risk factors. J Am Coll Cardiol. 2006;47:1919-1926. 5. Vasudevan AR, Garber AJ. Insulin resistance syndrome. A review. Minerva Endocrinol. 2005;30:101-119. 6. Grundy SM, Cleeman JI, Daniels SR, et al. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005;112:2735-2752. 7. Schwartz GG, Olsson AG, Szarek M, Sasiela WJ. Relation of characteristics of metabolic syndrome to short-term prognosis and effects of intensive statin therapy after acute coronary syndrome: an analysis of the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial. Diabetes Care. 2005;28:2508-2513. 8. Kasai T, Miyauchi K, Kurata T, et al. Prognostic value of the metabolic syndrome for long-term outcomes in patients undergoing percutaneous coronary intervention. Circ J. 2006;70:15311537. 9. Sarwar N, Danesh J, Eiriksdottir G, et al. Triglycerides and the risk of coronary heart disease: 10,158 incident cases among 262,525 participants in 29 Western prospective studies. Circulation. 2007;115:450-458. 10. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002;360:7-22. 11. Do R, Willer CJ, Schmidt EM, et al. Common variants associated with plasma triglycerides and risk for coronary artery disease. Nat Genet. 2013;45:1345-1352. 12. Holmes MV, Asselbergs FW, Palmer TM, et al. Mendelian randomization of blood lipids for coronary heart disease. Eur Heart J. 2014 Jan 27. [Epub ahead of print] 13. Triglyceride Coronary Disease Genetics Consortium and Emerging Risk Factors Collaboration, Sarwar N, Sandhu MS, Ricketts SL, et al. Triglyceride-mediated pathways and coronary disease: collaborative analysis of 101 studies. Lancet. 2010;375:1634-1639. 14. Mora S. Advanced lipoprotein testing and subfractionation are not (yet) ready for routine clinical use. Circulation. 2009;119:2396-2404. 15. Brunzell JD, Davidson M, Furberg CD, et al. Lipoprotein management in patients with cardiometabolic risk: consensus conference report from the American Diabetes Association and the American College of Cardiology Foundation. J Am Coll Cardiol. 2008;51:1512-1524. 16. International Atherosclerosis Society. An International Atherosclerosis Society Position Paper: Global recommendations for the management of dyslipidemia. www.athero.org/ IASPositionPaper.asp. Accessed September 9, 2014. 17. Otvos JD, Jeyarajah EJ, Cromwell WC. Measurement issues related to lipoprotein heterogeneity. Am J Cardiol. 2002;90: 22i-29i. 18. National Cholesterol Education Program Expert Program. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143-3421. 19. Liu J, Sempos CT, Donahue RP, et al. Non-high-density lipoprotein and very-low-density lipoprotein cholesterol and their risk predictive values in coronary heart disease. Am J Cardiol. 2006;98:1363-1368. 20. Davidson MH, Stein EA, Bays HE, et al. Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2007;29:1354-1367. 21. Feher M, Greener M, Munro N. Persistent hypertriglyceridemia in statin-treated patients with type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2013;6:11-15. 22. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (ATP III). JAMA. 2001;285:2486-2497. 23. Davidson MH, Maki KC, Pearson TA, et al. Results of the National Cholesterol Education (NCEP) Program Evaluation ProjecT Utilizing Novel E-Technology (NEPTUNE) II survey

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and implications for treatment under the recent NCEP Writing Group recommendations. Am J Cardiol. 2005;96:556-563. 24. Miller M, Cannon CP, Murphy SA, et al. Impact of triglyceride levels beyond low-density lipoprotein cholesterol after acute coronary syndrome in the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2008;51:724-730. 25. Sampson UK, Fazio S, Linton MF. Residual cardiovascular risk despite optimal LDL cholesterol reduction with statins: the evidence, etiology, and therapeutic challenges. Curr Atheroscler Rep. 2012;14:1-10. 26. Estruch R, Ros E, Salas-Salvado J, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368:1279-1290. 27. HPS2-THRIVE Collaborative Group; Landray MJ, Haynes R, Hopewell JC, et al. Effects of extended-release niacin with laropiprant in high-risk patients. N Engl J Med. 2014;371:203-212. 28. Maki KC, Bays HE, Dicklin MR. Treatment options for the management of hypertriglyceridemia: strategies based on the best-available evidence. J Clin Lipidol. 2012;6:413-426. 29. Oh RC, Lanier JB. Management of hypertriglyceridemia. Am Fam Physician. 2007;75:1365-1371. 30. Elam M, Lovato LC, Ginsberg H. Role of fibrates in cardiovascular disease prevention, the ACCORD-Lipid perspective. Curr Opin Lipidol. 2011;22:55-61. 31. Rosenblit PD. Do persons with diabetes benefit from combination statin and fibrate therapy? Curr Cardiol Rep. 2012;14:112124. 32. Saito Y, Yokoyama M, Origasa H, et al. Effects of EPA on coronary artery disease in hypercholesterolemic patients with multiple risk factors: sub-analysis of primary prevention cases from the Japan EPA Lipid Intervention Study (JELIS). Atherosclerosis. 2008;200:135-140. 33. Sacks FM, Carey VJ, Fruchart JC. Combination lipid therapy in type 2 diabetes. N Engl J Med. 2010;363:692-694; author reply 694-695. 34. Keech A, Simes RJ, Barter P, et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366:1849-1861. 35. Ginsberg HN, Elam MB, Lovato LC, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010;362:1563-1574. 36. Bruckert E, Labreuche J, Amarenco P. Meta-analysis of the effect of nicotinic acid alone or in combination on cardiovascular events and atherosclerosis. Atherosclerosis. 2010;210:353-361. 37. Boden WE, Probstfield JL, Anderson T, et al. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med. 2011;365:2255-2267. 38. Mozaffarian D, Wu JH. Omega-3 fatty acids and cardiovascular disease: effects on risk factors, molecular pathways, and clinical events. J Am Col Cardiol. 2011;58:2047-2067. 39. Pownall HJ, Brauchi D, Kilinc C, et al. Correlation of serum triglyceride and its reduction by omega-3 fatty acids with lipid transfer activity and the neutral lipid compositions of high-density and low-density lipoproteins. Atherosclerosis. 1999;143:285-297. 40. Bays HE. Rationale for prescription omega-3-acid ethyl ester therapy for hypertriglyceridemia: a primer for clinicians. Drugs Today (Barc). 2008;44:205-246. 41. Yokoyama M, Origasa H, Matsuzaki M, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet. 2007;369:1090-1098. 42. Investigators of the GISSI-Prevenzione. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet. 1999;354:447-455. 43. ORIGIN Trial Investigators, Bosch J, Gerstein HC, et al. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012;367:309-318. 44. Ballantyne CM, Bays HE, Kastelein JJ, et al. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012;110:984-992. 45. Bays HE, Ballantyne CM, Braeckman RA, Stirtan WG, Soni PN. Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies. Am J Cardiovasc Drugs. 2013;13:37-46.

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Inside Pharmacy is tailored to meet the growing needs of retail pharmacies, including their patients, customers, and shoppers, as they transform into healthcare delivery companies by promoting a multistakeholder approach to care from executives at chain headquarters, pharmacy buyers and managers, to physician assistants and nurse practitioners in retail clinics and independent pharmacies.”

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Inside Pharmacy is an independent journal founded on the principle of value-based, patient-centered, evidence-based healthcare. Each issue of the journal includes resources to support the entire healthcare team inside the pharmacy, including how to attract, retain, and engage customers; answer patient questions on prevention and wellness, acute treatment, and monitoring and management of chronic conditions; and empower retail clinicians in a value-based healthcare system.