Inside Pharmacy October 2013 by Value-Based Cancer Care

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Pharmacy

OCTOBER 2013 • Vol 1 • No 1

Empowering Community Pharmacists as Health Consultants in a Value-Based Healthcare System

INSIDE SEASONAL pharmacy: INFLUENZA What’s New This Flu Season?................... 7

INSIDE PATIENT CARE Engaging Patients: Characteristics and Qualities Patients Seek of Their Pharmacists.............................................. 10

INSIDE PHARMACY MANAGEMENT Emergency Preparedness in the US: What Is the Strategic National Stockpile?................................................. 20

INSIDE CARDIOMETABOLIC: OBESITY The Pharmacist’s Emerging Role in Weight Management: A Look into New Prescription Weight-Loss Medications........................ 30

INSIDE CARDIOMETABOLIC: DIABETES Demystifying the A1C Test for Patients with Diabetes........................................... 40

L A R

From the Publishers of THE PEER-REVIEWED FORUM FOR REAL-WORLD EVIDENCE IN BENEFIT DESIGN™

U G U

FOR PAYERS, PURCHASERS, POLICYMAKERS, AND OTHER HEALTHCARE STAKEHOLDERS

an affiliate of

U S S I

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

Editorial Advisory Board James S. Beaumariage, RPh Chief Operating Officer NuScript Rx Nashville, Tennesse

John O. Beckner, RPh District Manager Giant Food Stores Richmond, Virginia

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

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

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

Rebecca Wheeler Chater, RPh, MPH, FAPhA Ateb Raleigh, North Carolina

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

Albert Garcia Executive Vice President Navarro Discount Pharmacies Medley, Florida

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

Kevin James, RPH, MBA Vice President, Managed Markets Avella Specialty Pharmacy Phoenix, Arizona

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

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

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

Ernie Richardsen, RPh, MBA Group Vice President, Pharmaceutical Purchasing and Clinical Services Senior Vice President, Operations Rite Aide Corporation Camp Hill, Pennsylvania

Debbie Sheppard Vice President, Sales and Marketing Ateb Raleigh, North Carolina

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

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October 2013

Vol 1, No 1

Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com Executive VP/Managing Director Chuck Collins ccollins@engagehc.com Director, Client Services Ron Gordon rgordon@engagehc.com Editorial Director Dalia Buffery dalia@engagehc.com Managing Editor Lisa Neuman lneuman@the-lynx-group.com Strategic Editor Robert E. Henry Editorial Assistant Jennifer Brandt Production Manager Melissa Lawlor The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris

Table of Contents the first word

4 Stepping Out from Behind the Counter…A Pharmacy Business Model for a New Healthcare Era Donald J. Dietz, RPh, MS Inside healthcare

5 Grab Your Life Preservers…Healthcare Delivery Is on a Sea Change Charles E. Collins, Jr, MS, MBA INSIDE SEASONAL PHARMACY: INFLUENZA

7 What’s New This Flu Season? Adam C. Welch INSIDE PATIENT CARE

10 Engaging Patients: Characteristics and Qualities Patients Seek of Their Pharmacists Elliott M. Sogol, BS Pharm, PhD, FAPhA Inside PHARMACY MANAGEMENT

Vice President of Finance Andrea Kelly

13 Drug Donation Repositories: State Programs to Leverage Scarce Health Resources Jon-Michael Rosmann, BA, BBA

Director, Human Resources Blanche Marchitto

INSIDE PHARMACY MANAGEMENT

Associate Director, Content Strategy & Development John Welz

20 Emergency Preparedness in the US: What Is the Strategic National Stockpile? Ann Johnson, PharmD

Associate Editorial Director, Projects Division Terri Moore

INSIDE PHARMACY MANAGEMENT

Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen

Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

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23 Trends in the Dispensing of 90-Day-Supply Prescriptions at Retail Pharmacies: Implications for Improved Convenience and Access Joshua N. Liberman, PhD; Charmaine Girdish, MPH Inside CARDIOMETABOLIC: OBESITY

30 The Pharmacist’s Emerging Role in Weight Management: A Look into New Prescription Weight-Loss Medications Lucas A. Berenbrok, PharmD; and Ben Culpepper, PharmD INSIDE CARDIOMETABOLIC: DIABETES

32 Strategies to Enhance Outcomes for Patients with Type 2 Diabetes Rhonda Greenapple, MSPH INSIDE CARDIOMETABOLIC: DIABETES

40 Demystifying the A1C Test for Patients with Diabetes Shannon Irene Burke, PharmD

Mission Statement Inside Pharmacy ™ educates community pharmacists on wellness-based health principles and advances, equipping them to attract, retain, and engage customers as long-term health coaches who complete the immediate process of care begun by the physician’s prescription, and by answering customer questions on health, wellness, value-based healthcare, evidence- based healthcare, and navigating the healthcare system. An informed pharmacist encouraging customers to make productive health decisions at all stages of their lives and take responsibility for their own health, achieving optimal health and value through the knowledge and application of traditional and nontraditional wellness-based health wisdom is the vision of Inside Pharmacy.

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The first word

Stepping Out from Behind the Counter… A Pharmacy Business Model for a New Healthcare Era Donald J. Dietz, RPh, MS, Editor-in-Chief

e welcome you to the launch issue of Inside Pharmacy®. The goal of this column is to frame your expectations for the issue. This being the launch issue, we want to share our editorial concept, which is as new as the healthcare system environment in which we find ourselves. Our goal is to help you, the pharmacist, adapt to the radical new conditions driving the practice of healthcare. The complex synthesis of conditions in healthcare’s 3 fundamental sectors―clinical, business, and government―present today’s pharmacists with an opportunity to engage the beneficiary of healthcare’s changes: the patient. Simply put, Inside Pharmacy will help prepare you to reach out to those you now call your customers and make them your patients. By working in tandem with physicians, pharmacists can be the patients’ healthcare “coach” and help them navigate through the confusing information confronting today’s healthcare consumer/patient. The shape of healthcare is being stretched and patients are receiving a mystifying set of signals: become master of your health, choose and evaluate the courses of treatment rather than take orders from physicians, make up your own mind about taking prescribed medications, choose a health plan that “fits your lifestyle”…whatever that means. While patients may feel liberated from the tyranny of being told what to do by their physician, they could also be isolated from the security that reliance on doctors offered them. Pharmacists can help patients bridge this transition. The ranks of physicians are dwindling while aging baby boomers swell healthcare consumption, straining healthcare’s ability to reimburse physicians. There is no room for error in an overburdened system, yet physicians no longer have the time to coach their patients. The result is patients who are unsure of how to make sense out of the conflicting agendas of multiple stakeholders and lack an understanding of how to attain the elusive goal of wellness. These conditions place the pharmacist in a unique position, where it is possible to step forward from “behind the counter” and engage the patient in dialogue concerning the challenges to value-based healthcare. Now more than ever, your advice is welcome and needed. Patients need your knowledge on product safety and the role of formularies and deductibles. They can also benefit from individualized care and wellness-based healthcare interactions. In short, Inside Pharmacy is filling a pent-up need for

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you, and through you, for your patients. With fewer doctors to treat the increasing number of patients, time spent with physicians is dwindling, and more patients arrive at the pharmacy with prescriptions in hand and questions involving their healthcare. You need information at your fingertips to engage patrons thoughtfully and helpfully. If you do, you will transform a customer into a patient and yourself from a commodity into a valued resource that will ensure return business. Providing this personal touch can be possible by increasing your awareness of clinical, business, and government issues. While patients are often in a hurry for their prescription, opportunities exist for you to engage them. It might be a matter of handing the prescription to the patient with a comment on the importance of compliance with the regimen and the consequences of failure to do so. It could include a question about how the patient has responded to the regimen in the past or what caused the lapse between scripts. You may find that it was cost, quality, or access (the 3 components of value) that delayed continuation of their regimen. This is just the beginning of what Inside Pharmacy plans to bring you. Inside Pharmacy can assist you in reinventing yourself as a valued healthcare consultant and not just a supplier of medications. It means expanding your focus from medications to the patients taking them—a patient population hungry for knowledge. They need a guide, and you are uniquely positioned for the role. Our remarkable editorial board represents a brain trust of experts from multiple facets of the pharmacy world. We will keep you abreast of the issues at hand so that you can be the pharmacist your patients want and need. The scope of editorials will follow the aforementioned categories: clinical, business, and government developments relevant to the issues patients face. In conclusion, the time is now for you to “step out from behind the counter” and engage your patients. We will do our part to identify the issues that can help you engage your customers in a running dialogue on health, complementing their physician’s treatment regimens. Working within your time constraints, you can become the valued health consultant your patients seek. Inside Pharmacy will help you every step of the way. The ultimate result of an informed patient is a healthcare system that does not overspend, overpromise, or undertreat. We need your help to convert this knowledge into action.

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Vol 1, No 1

inside healthcare

Grab Your Life Preservers…Healthcare Delivery Is on a Sea Change By Charles E. Collins, Jr, MS, MBA

s the Wall Street Journal reported last month, Walgreens, the nation’s largest drugstore chain, in a drastic effort to curb the escalating costs of providing healthcare, plans to move more than 180,000 of its workers—and their families—into an online private insurance exchange. Charles E. Collins, Jr. Think this is a passing fad until the next cost-saving venue is created? You may want to think again. Since the mid-1940s, many employees’ compensation packages have included healthcare benefits for them and, more importantly, their families. Although offering limited flexibility, employers have typically provided several health insurance options for their employees to choose from but, in doing so, employers also incurred most of the costs. Over the past few decades, employers have been slowly shifting larger and larger portions of the rising healthcare costs to the employee in the form of higher premiums and/or deductibles. Most employers have tried to keep these increases to a reasonable level to retain their employees. But now, we are faced with the proverbial “tipping point” of healthcare delivery. The idea of private insurance exchanges is not entirely new, as it has worked well in smaller, more localized geographic pockets across the country. However, not only is the trend of shifting larger and larger portions of the spiraling costs to more workers gaining traction, but shifting the risk of being a self-insured to a fully insured employer is also becoming more common. This fully insured approach reduces a company’s healthcare exposure by taking the risk of unpredictable expenses and moving them to the insurer. By making a lump sum payment to the employee, the employer can now create an environment of predictability and stability with Charles E. Collins, Jr, MS, MBA, is the Executive Vice President of Engage Managed Markets, a division of The Lynx Group, and Inside Pharmacy.

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October 2013

respect to healthcare expenses. But what about the employee in this equation? Walgreens and the other companies that are making this shift in healthcare options maintain that this will create greater employee engagement and offers a choice of options that “best” fit employees’ personal and family needs. For example, this year Walgreens employees have 2 high-deductible plans to choose from. In 2014, the new options will include 5 insurance carriers with up to 5 options each, thus creating up to 25 new venues for healthcare delivery. (As a side note, we can only hope that Walgreens employees will be given a road map to navigate their future healthcare delivery frontier!) In any case, the idea is to create competition in the marketplace to reduce the overall healthcare costs for the employees and their families. Will this actually happen? It is too early to predict because many insurers are trying to keep the initial costs low during this “honeymoon” period. However, costs continue to rise and if employers do not adjust the lump sum payment to purchase healthcare, then the employee will be forced to pay the difference by way of higher premiums, deductibles, and coinsurance.

Walgreens and the other companies that are making this shift in healthcare options maintain that this action creates greater employee engagement and offers a choice of options that “best” fit employees’ personal and family needs. One trend that is here to stay will be the ever-increasing environment of “defined contribution.” As in the case of Walgreens and other companies such as Darden Restaurants, Inc., which is the parent company of such eateries as Red Lobster and Olive Garden, and Sears Holdings Corporation, which has almost 2500 retail and specialty stores across the United States, more and more employers are providing a defined financial benefit to purchase healthcare or to offset healthcare expenses

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through a health savings account (HSA). The basic premise of an HSA is to allow employees to have more control over managing their healthcare expenses. Over time, empowered employees will not need their employers to assist them in their healthcare choices—but they will still need the employer funding. Defined contribution could very well change the retention strategies of many employers as the conversation changes from “what healthcare options do you provide,” to “what is my lump sum payment going to be to provide healthcare for me and my family?” So get ready, because other options not “in the norm”

are hitting like a tidal wave and you don’t want to be caught at sea without a life preserver. Imagine, as a retiree, your former employer has now thrown you into the private exchange for your retiree health benefits. You will now deal with an insurer, not your former company. Imagine, as an employee, you will continue to be offered health insurance but your spouse now has to get his or her own health insurance through their employers—if it’s offered—or the private exchanges. Imagine, if the 25 healthcare options work through the private exchange for Walgreens, who will be the next retail pharmacy chain to jump ship? n

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Pharmacy

VOl 1 • NO 1 OCTOBER 2013 •

inside

Empowering Community Pharmacists as Health Consultants in a Value-Based Healthcare System

as munity Pharmacists Empowering Com Healthcare System in a Value-Based Health Consultants INSIDE SEASONAL INFLUENZA What’s New This Flu

phArmAcy:

Season? .........................7

INSIDE pATIENT cArE

ristics and Qualities Engaging Patients: Characte ists ...............10 Pharmac Patients Seek of Their

INSIDE phArmAcy mANAGEmENT

Is ness in the US: What Emergency Prepared ...20 l Stockpile? .............. the Strategic Nationa

TABOLIc:

INSIDE cArDIOmE OBESITy

g Role in Weight The Pharmacist’s Emergin into New Prescription Management: A Look ..30 ions ............................ Weight-Loss Medicat

TABOLIc:

INSIDE cArDIOmE DIABETES

Test for Patients with Demystifying the A1C .............................40 Diabetes ............................

From the Publishers of THE PEER-REVIEWED

FORUM FOR REAL-WORLD

EVIDENCE IN BENEFIT

L RA

an affiliate of

re Communications,

LLC

™

DESIGN

STAKEHOLDERS OTHER HEALTHCARE POLICYMAKERS, AND FOR PAYERS, PURCHASERS,

Inside Pharmacy™ educates community pharmacists on wellness-based health principles and advances, equipping them to attract, retain, and engage customers as long-term health coaches who complete the immediate process of care begun by the physician’s prescription, and by answering customer questions on health, wellness, value-based healthcare, evidence-based healthcare, and navigating the healthcare system. An informed pharmacist encouraging customers to make productive health decisions at all stages of their lives and take responsibility for their own health, achieving optimal health and value through the knowledge and application of traditional and nontraditional wellness-based health wisdom is the vision of Inside Pharmacy.

Inside Pharmacy

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October 2013

Vol 1, No 1

Inside seasonal pharmacy: Influenza

What’s New This Flu Season? By Adam C. Welch, PharmD, MBA, BCACP

y now, most healthcare providers should understand the importance of the flu vaccine in preventing influenza disease. Influenza, a contagious respiratory viral infection, is characterized by symptoms of cough, sore throat, runny or stuffy nose, headache, muscle aches, and fatigue.1 The flu is Adam C. Welch often more severe than a cold and can lead to pneumonia and bacterial infections.2 In addition, most healthcare providers should also realize by now that since 2010, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices has recommended universal influenza vaccination for all children and adults 6 months of age and older.3 What healthcare providers may not realize is how much advancement there has been recently in influenza vaccine manufacturing and the options now available for use. Four years ago, there were 6 influenza vaccines available on the US market.4 Today, there are more than a dozen vaccines available.5 It is important to understand how these vaccine options will affect patients individually as well as public health as a whole.

Three to Four Strains One of the most significant changes this year is the development of quadrivalent influenza vaccines. Historically, the influenza vaccine was formulated to contain 3 strains of virus: 2 strains of Type A influenza and 1 strain of Type B. Type A influenza is spread between humans and certain animals. It affects all age groups and is typically responsible for moderate to severe disease. Type B is transmitted only by humans, usually occurs in children, and leads to milder disease.6 There is a Type C influenza, but it is typically of not much concern to humans. Surveillance data over the past few years suggest that 2 strains of Type B influenza have been cocirculating in the United States.7 Because the trivalent influenza Dr. Welch is Acting Dean for Academic Affairs and Assessment and Associate Professor at Wilkes University School of Pharmacy in Wilkes-Barre, Pennsylvania.

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KEY POINTS Manufacturing processes for influenza vaccines have evolved, creating a wider distribution of vaccines available on the market.

➤

Pharmacists may be called upon to aid in the decision-making process on which influenza vaccine is preferred for a given patient.

➤

The CDC generally prioritizes receiving any influenza vaccine over receiving a particular brand of vaccine, taking into consideration various age and medical indications.

➤

One of the most significant changes this year is the development of quadrivalent influenza vaccines.

➤

Surveillance data over the past few years suggest that 2 strains of Type B influenza have been cocirculating in the United States.

➤

The current vaccine manufacturing process becomes inadequate when the threat of pandemic occurs.

➤

vaccine contained only 1 Type B strain, it essentially became ineffective against half of the circulating strains. This led to the inclusion of a second B strain to create a quadrivalent influenza vaccine. For this flu season, 4 manufacturers received US Food and Drug Administration (FDA) approval to license a quadrivalent influenza vaccine.8

The Need for Speed The influenza virus continuously mutates through processes defined as antigenic drift (minor change) and antigenic shift (major change). This requires a new vaccine each year to better match the current circulating viruses—and this process takes time. Typically, in January and February, public health groups such as the FDA and the CDC, in conjunction with the World Health Organization, will make an educated prediction on the circulating viruses for the following flu season.7 Once the strains have been identified, vaccine manufacturers use chicken eggs to grow the virus and make enough copies to manufacture a supply of vaccine for the country. Purification and testing phases commence, and the entire process takes about 6 months. This is why

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Table Licensed Influenza Vaccines, 2013-2014, United States5,14 Abbreviation IIV3

Brand

Manufacturer

Afluria

CSL Limited

Availability

NDC

Medicare Reimbursement Code Age Indication

0.5-mL single-dose prefilled syringes

33332- Q2035 0013-02

5.0-mL multidose vial

333320113-11

Route

≥9 years (per ACIP)

IIV3

Fluarix

GlaxoSmithKline

0.5-mL single-dose prefilled syringes

581600880-41

≥3 years

IIV3

FluLaval

ID Biomedical Corporation of Quebec (distributed by GlaxoSmithKline)

5.0-mL multidose vial

19515- Q2036 0890-02

≥3 years

IIV3

Fluvirin

Novartis Vaccines

0.5-mL single-dose prefilled syringes

66521- Q2037 0116-12

≥4 years

5.0-mL multidose vial

665210116-11

0.25-mL single-dose prefilled syringes

49281- 90655 0113-25

6-35 months

0.5-mL single-dose prefilled syringes

42981- Q2038 0013-50

≥36 months

0.5-mL single-dose vial

429810013-10

≥36 months

5.0-mL multidose vial

429810392-15

≥6 months

IIV3

Fluzone

Sanofi Pasteur

IIV3

Fluzone Intradermal

Sanofi Pasteur

49281- 90654 0707-55

18-64 years

IIV3, high dose

Fluzone High Dose

Sanofi Pasteur

492810393-65

≥65 years

ccIIV3

Flucelvax

Novartis Vaccines

0.5-mL single-dose prefilled syringes

638510612-11

≥18 years

IIV4

Fluarix Quadrivalent

GlaxoSmithKline

0.5-mL single-dose prefilled syringes

581600900-52

≥3 years

IIV4

FluLaval Quadrivalent

ID Biomedical Corporation of Quebec (distributed by GlaxoSmithKline)

195150895-11

≥3 years

IIV4

Fluzone Quadrivalent

Sanofi Pasteur

0.25-mL single-dose prefilled syringes

492810513-25

6-35 months

0.5-mL single-dose prefilled syringes

492810413-50

≥36 months

0.5-mL single-dose vials

92810413-10

≥36 months

RIV3

Flublok

Protein Sciences

0.5-mL single-dose vials

428740012-01

18-49 years

LAIV4

FluMist Quadrivalent

MedImmune

0.2-mL prefilled intranasal sprayer

66019- 90660 0300-10

2-49 years (healthy, nonpregnant)

ACIP indicates Advisory Committee on Immunization Practices; ID, intradermal injection; IIV3, inactivated influenza vaccine in trivalent form; IIV4, inactivated influenza vaccine in quadrivalent form; IM, intramuscular injection; IN, intranasal spray; LAIV4, live, attenuated influenza vaccine in quadrivalent form; NDC, National Drug Code; RIV3, recombinant influenza vaccine in trivalent form.

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October 2013

Vol 1, No 1

vaccines are not typically available until late summer.9 Because flu season does not typically peak until several months later, this time frame for manufacturing has been adequate for decades.6 The current vaccine manufacturing process becomes inadequate when the threat of pandemic occurs. A 6-month manufacturing timeline is too long when the containment of a rapidly spreading strain is of primary concern. Likewise, the reliance on eggs introduces a potential uncertainty in the supply chain and a small risk for allergic reactions (although some patients with egg allergies can still receive the vaccine).10 Enter 2 new vaccines with novel manufacturing processes for influenza. The first is a recombinant influenza vaccine in trivalent form (RIV3). It contains recombinant hemagglutinin proteins produced from an armyworm source.11 Because eggs are not used in this process, the RIV3 vaccine may be used in patients who are 18 to 49 years of age with a severe egg allergy. The second vaccine is a cell-cultured inactivated influenza vaccine (ccIIV3) in trivalent form.12 The benefits of cell culture manufacturing are a reduction in production time and an enhancement in the volume that can be produced.13 The ccIIV3 can be used in patients 18 years of age and older.

Abbreviations and Billing With more than a dozen influenza vaccines available, the traditional trivalent inactivated influenza vaccine will no longer appropriately describe the type of vaccine being administered. (The acceptable abbreviations used in identifying the influenza vaccines are listed in the Table.5,14) In addition, similar to last year’s flu season, Medicare reimbursement is dependent on the brand of vaccine being administered. Providers who have received Medicare Part B billing authorization specific for vaccines (separate from other Part B numbers) may bill using these codes. (The Table lists the appropriate vaccine abbreviations and billing codes.) It is important to note that the administration of the influenza virus vaccine should be billed using code G0008. Not every vaccine has a specific code. Flu vaccines not otherwise specified should use the code Q2039 for the vaccine product.15 It is likely that as new vaccines come to market, codes will be developed to accommodate their availability. Product Selection When selecting an influenza vaccine for your patient, it is important to consider the positions of the FDA and the CDC. The CDC says, “Within approved indications and recommendations, no preferential recommendation is made for any type or brand of licensed

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The current vaccine manufacturing process becomes inadequate when the threat of pandemic occurs. A 6-month manufacturing timeline is too long when the containment of a rapidly spreading strain is of primary concern. influenza vaccine over another.”5 The FDA has age indications for each of the influenza vaccines. (A summary of the age indications is found in the Table.) Pharmacists should consider this information when providing vaccination services. n

Author Disclosure Dr. Welch has previously served as a paid consultant to Pfizer. References

1. Centers for Disease Control and Prevention. Key facts about influenza (flu) and flu vaccine. 2013. http://www.cdc.gov/flu/keyfacts.htm. Accessed October 12, 2013. 2. Centers for Disease Control and Prevention. Cold versus flu. 2011. http://www.cdc. gov/flu/about/qa/coldflu.htm. Accessed October 12, 2013. 3. Centers for Disease Control and Prevention. CDC’s Advisory Committee on Immunization Practices (ACIP) recommends universal annual influenza vaccination [press release]. 2010. http://www.cdc.gov/media/pressrel/2010/r100224.htm. Accessed October 12, 2013. 4. Fiore AE, Shay DK, Broder K, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Morb Mortal Wkly Rep. 2009;58(RR08):1-52. http:// www.cdc.gov/mmwr/preview/mmwrhtml/rr5808a1.htm. Accessed October 12, 2013. 5. Centers for Disease Control and Prevention (CDC). Summary Recommendations: prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices—(ACIP)—United States, 2013–14. 2013. http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm. Accessed October 12, 2013. 6. Centers for Disease Control and Prevention. In: Atkinson W, Wolfe S, Hamborsky J, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th ed, 2nd printing. Washington, DC: Public Health Foundation; 2012. http://www.cdc.gov/vaccines/ pubs/pinkbook/flu.html. Accessed October 14, 2013. 7. US Food and Drug Administration. Advisory committees: vaccines and related biological products advisory committee meeting summary minutes. February 27, 2013. http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/blood vaccinesandotherbiologics/vaccinesandrelatedbiologicalproductsadvisorycommittee/ ucm343796.htm. Accessed October 19, 2013. 8. US Food and Drug Administration. Vaccines, blood & biologics: influenza virus vaccine, quadrivalent, types A and types B. August 2013. http://www.fda. gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm295057.htm. Accessed October 14, 2013. 9. US Food and Drug Administration. For consumers: The evolution, and revolution, of flu vaccines. September 2013. http://www.fda.gov/ForConsumers/ ConsumerUpdates/ucm336267.htm. Accessed October 14, 2013. 10. Centers for Disease Control and Prevention. Prevention and control of influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP)–United States, 2012–13 influenza season. MMWR Morb Mortal Wkly Rep. 2012;61:613-618. http://www.cdc.gov/mmwr/pdf/wk/mm6132.pdf. Accessed October 16, 2013. 11. Flublok [package insert]. Meriden, CT: Protein Sciences Corp; 2012. 12. Flucelvax [package insert]. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc; 2013. 13. Osterholm MT, Kelley NS, Manske JM, et al. The compelling need for game-changing influenza vaccines: An analysis of the influenza vaccine enterprise and recommendations for the future. Center for Infectious Disease Research and Policy, University of Minnesota. 2012. http://www.cidrap.umn.edu. Accessed October 16, 2013. 14. Novitas Solutions. 2013 flu, pneumococcal and hepatitis B vaccine reimbursement and administration. https://www.novitas-solutions.com/partb/reimbursement/ flu-pnu-hep-13.html. Accessed October 18, 2013.

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Engaging Patients: Characteristics and Qualities Patients Seek of Their Pharmacists By Elliott M. Sogol, BS Pharm, PhD, FAPhA

hroughout history, people have looked upon others to be “good”— good neighbors, good coworkers, good teachers, good friends, and, in general, good people. To link the term “good” to pharmacy, we must be aware that past and present remedies (medications) can do good or cause harm. Of Elliott M. Sogol course, this depends on whose hands the remedy (medication) is in—a knowledgeable person who wants to do good, or someone who means to do harm. Evidence-based quality and outcomes were not a key component of medication use even a few decades ago. This has changed with the continued growth of healthcare and the pharmacy profession. Today when we look at healthcare, we see scorecards for process management, research, outcomes, fund-

Understanding this patient need can help us move the profession toward a visible patient-centered model where the patient is fully engaged in all aspects of medication-related care. ing, success rates for procedures, STAR ratings, and numerous other areas that are evaluated, assessed, and reviewed. However, it seems that 2 areas have been left out—the specific needs of the individual patient, and the quality and attributes of a “good” healthcare provider. “He is a good pharmacist” or “she is a good pharmacist” is a commonly heard phrase. Those compliments lift that pharmacist above other pharmacists. However, a quesDr. Sogol is a consultant and an adjunct faculty member at University of Florida, University of North Carolina, University of Minnesota, and Campbell University.

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tion arises as to what this actually means. Historically, the qualities and characteristics of a “good pharmacist” have remained obscure, especially when looking at this from the patient perspective. Knowing what patients are looking for in a “good pharmacist” can help practicing pharmacists become better practitioners. Understanding this patient need can help us move the profession toward a visible patient-centered model where the patient (or caregiver) is fully engaged in all aspects of medication-related care, including prescriptions, over-the-counter medications, vitamins, herbals, and preventive care such as vaccinations.

Patient-Centered Care Patient-centered care ensures that the transitions of care are coordinated, efficient, respectful, and also take into consideration the patient’s personal preferences and values.1 The Institute of Medicine (IOM) made visible patient-centered care 1 of 6 domains of quality. According to the IOM, “research shows that orienting the health system around the preferences and needs of patients has the potential to improve patients’ satisfaction with care as well as their clinical outcomes.”2 The key question is how we apply this model in a community setting. A few years ago, a community pharmacy study asked patients what they expected of their pharmacist.3 The result was disappointing—most patients did not have an answer. After providing the patients with a list of possibilities, the top patient expectations of pharmacists were to: (1) fill the prescription correctly; (2) uphold confidentiality; (3) check for correct dosage; (4) check for drug interactions; and (5) check for drug allergies (most items that are now done with technology). Of the patients who responded, 94% said that it was important or very important that pharmacists showed that they cared about them. However, only 40% of the patients and 50% of the pharmacists queried felt that they had a close relationship with each other. In the past few years, we have seen great progress in the expansion of our pharmaceutical care role in the

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community setting. Clinical services such as medication therapy management, vaccinations, healthcare screening, and disease-based programs are becoming more common. However, for this to become more of a standard of practice, the profession will require that each pharmacist assume even greater responsibility for their patients’ outcomes and to establish a meaningful communication exchange to help their patients make informed decisions and adhere to the appropriate therapy.

Characteristics of a Good Pharmacist In a more recent study, in 2011, patients, physicians, nurses, and pharmacists were asked a series of open-ended questions about what qualities make a “good pharmacist.”4 The information gathered began to form a baseline of characteristics, virtues, and qualities that patients and others seek to find in a good pharmacist. The remainder of this article will discuss the highlights of this study, focusing on the patients’ thoughts and comments regarding important qualities and characteristics that allow a pharmacist to have the greatest impact on the lives of their patients. Table 1 lists the top 5 characteristics that patients said are personally important to them. Being knowledgeable is, of course, central to our profession. Our education and continued learning are part of the covenant that we have with our patients. However, knowledge alone is not the key. Being knowledgeable but not having any of the other characteristics would not provide the basis for the sound relationship that patients are seeking to have with a good pharmacist. Patients described “caring” as an essential ingredient in building an effective therapeutic alliance with them. However, one question that needs to be asked is whether we even consider measuring caring as a component of quality clinical services? If one looks at the list in Table 1 and pulls out the behavioral-related areas of “caring,” “attentive,” and “being friendly,” we can begin to see what a patient is looking for to be more engaged with us in their own healthcare. While we still have issues of patients who want their medication fast and are in a hurry, we need to consider that these patients do not understand the services that we provide, nor have they been exposed to or provided the characteristics they are seeking. The characteristics identified are central to our moving forward with hiring, training, and professional development of future community-based “good pharmacists.” Qualities of a Good Pharmacist While the characteristics help us to understand some aspects of what patients are looking for in an individual pharmacist, there are broader qualities that patients seek. Table 2 provides the qualities that all groups (patients,

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KEY POINTS Visible patient-centered care is 1 of the Institute of Medicine’s 6 domains of quality. ➤ Patients describe “caring” as an essential ingredient for pharmacists in building effective therapeutic alliances with them. ➤ 94% of patients say that it is important or very important that pharmacists show they care about them. ➤ Patient-centered care ensures that the transitions of care are coordinated, efficient, respectful, and also take into consideration the patient’s personal preferences and values. ➤ Only 40% of the patients and 50% of the pharmacists queried felt that they had a close relationship with each other. ➤ Clinical services such as medication therapy management, vaccinations, healthcare screening, and diseased-based programs are becoming more common. ➤ Patients are looking for an expert to communicate information in a way they can understand and apply to their medication and how this will impact their health. ➤

physicians, nurses, and pharmacists) indicate are critical to engaging patients in a patient-centered care process. Patients provided information across a wide variety of terms that they listed in the open-ended questions. From Table 1 Characteristics of a Good Pharmacist— Patient Perspectives • Knowledgeable • Caring/compassionate • Attentive • Precise/accurate • Friendly

Table 2 Qualities of a Good Pharmacist— All Perspectives • Expert • Professional • Solid work ethic • Strong moral character • Patient-oriented

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a qualitative perspective, the list in Table 2 is a compilation of the terms that were used related to a pharmacist who they categorized as a good pharmacist. For example, an Expert is someone who is knowledgeable, smart, clinically competent, and provides evidence-based care. Patients were not looking for a walking medical dictionary, nor were they looking for someone who can just read directions on a bottle or the medication guide. Patients are looking for an expert to communicate information in a way they can understand and apply to their medication and how this will impact their health.

Being knowledgeable is, of course, central to our profession. Our education and continued learning are part of the covenant that we have with our patients. However, knowledge alone is not the key. A Professional is someone who collaborates with others, takes a leadership role in patient advocacy, and has high integrity. Of interest is the additional emphasis that the “patient comes first.” It also makes sense that patients look for someone with a solid work ethic—someone who is hard-working, detail-oriented, accurate, and results-oriented (clinical outcomes). The good pharmacist has a strong moral character and displays honesty, takes responsibility for the patient’s medication/pharmacy care, is mature, and is supportive of questions through the information-giving process to meet the patient’s needs and preferences. Finally, a pharmacist who practices with a patient-oriented (ie, being patient centric) focus is approachable, responsive, and readily available to come out from behind the counter and counsel not only when the patient asks but also proactively to determine how the patient’s pharmaceutical care is progressing. The pharmacist needs to provide this not only on the first fill but also on refills of chronic medications and concerns when acute medications are added.

Visible Patient-Centered Care A pharmacist who is practicing in an environment that supports visible patient-centered care makes the patient the central focus. Pharmacists can provide this

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visible care by being friendly and attentive, showing that he or she cares, takes patient diversity into account, and considers the patient’s perspective by placing emphasis on patient participation and decision options. Being patient-centric is putting the patient first—being 100% focused on the patient during the counseling process or when they call for follow-up questions.

Conclusion Patients who experience care from a good pharmacist are more inclined to be a patient engaged in the relationship who seeks out the pharmacist to provide more than just the medication. These “good pharmacists” are practicing at the top of their license, not only providing the most up-to-date knowledge, but providing this knowledge in a genuine patient-centered care process that is attentive to the patient’s needs. They are caring and friendly, and they proactively take responsibility for their patients. The patients who receive patient-centered care perceive the value of the care they receive and are not concerned if they have to wait a few extra minutes because they know that the pharmacist will be completely focused on them at the time they provide counseling. They understand that the pharmacist is looking out for them even at times when they are not getting a prescription. Future “good pharmacists” are what the profession needs to become a true clinical profession, to be recognized as a true healthcare provider, and to receive reimbursement for making a difference in patient care, quality services, and positive evidence-based, clinical-based outcomes. n References

1. Institute for Healthcare Improvement. Across the Chasm Aim #3: Health Care Must Be Patient-Centered. www.ihi.org/knowledge/Pages/ImprovementStories/ AcrosstheChasmAim3HealthCareMustBePatientCentered.aspx. Accessed June 25, 2013. 2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. www.iom.edu/~/media/Files/Report%20Files/2001/Crossing-theQuality-Chasm/Quality%20Chasm%202001%20%20report%20brief.pdf. Accessed June 25, 2013. 3. Smith LL, Kramer SV, Kelly WN. Are pharmacists’ and patients’ expectations of each other the same? Georgia Pharmacy J. 2004:20-22. 4. Kelly WK, Sogol EM, eds. The Good Pharmacist: Characteristics, Virtues, and Habits. Oldsmar, FL: William N. Kelly Consulting Inc; 2011.

Author’s Note For more detailed information on how patients, physicians, nurses, and pharmacists commented to the survey regarding a good pharmacist, please visit www. thegoodpharmacist.com/.

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inside Pharmacy management

Drug Donation Repositories: State Programs to Leverage Scarce Health Resources By Jon-Michael Rosmann, BA, BBA

cross the country and beyond, drug donation programs are quietly emerging as a practical channel to connect patients in need of assistance with unused prescription medications. The World Health Organization has developed international guidelines for humanitarian relief as a basis for Jon-Michael Rosmann national and institutional guidelines. In the United States, 44 states have legislatively created drug donation programs, although many are nonoperational or underutilized.1 In states where drug donation programs have demonstrated success, the benefits of the program are enjoyed by a variety of stakeholders, generating significant cost savings to program donors, healthcare providers, and patients seeking assistance. For instance, a young, uninsured patient was being treated at a critical access hospital for methicillin-resistant Staphylococcus aureus, a bacterial infection that is highly resistant to some antibiotics. The patient had been hospitalized for 3 days and was receiving intravenous (IV) antibiotic treatment, and he was scheduled to receive an additional 10 days of IV treatment. As an alternative, the hospital received a donation of 24 linezolid (Zyvox) tablets from the stateâ&#x20AC;&#x2122;s centralized drug donation repository. The young man received the oral antibiotic and was able to return home to treat his infection without further hospitalization. The donated linezolid saved the patient more than $41,000 in medication and hospitalization costs. The additional 10-day IV antibiotic treatment was estimated at $5956. The cost of 10 additional days in the hospital (excluding physician fees) was estimated at $35,980.2

Sources of Medication Drug donation regulations are governed at the state Mr. Rosmann is executive director of the Iowa Prescription Drug Corporation.

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level and contrast greatly from state to state. However, virtually all laws include restrictions designed to ensure the purity, integrity, and safety of the medications donated.3 Most drug donation programs only accept medications that have been in the possession of a licensed healthcare professional, manufacturer, pharmacy, or healthcare institution.1 However, some states also accept unused medications from individuals if the donor can certify that the medications were stored as recommended by the manufacturer and have not been tampered with. In general, donated medications must have an expiration date greater than 6 months from the date of donation; must be contained in the original sealed, or unit-dose tamper-evident packaging; must not require refrigeration or temperature requirements different from room temperature; and must not be a compounded or controlled substance. Contributed medications that do not meet the donation criteria must be incinerated or destroyed. Because of the donation criteria, any medications dispensed in an amber vial or dispensed in a manner that does not use sealed, tamper-evident packaging is strictly prohibited. As a result, many operational programs rely on dispensing pharmacies for long-term care as the primary source for donated medications. The 31-day or less blister packs that are used in long-term care settings allow for easy visual inspection for drug identification and tampering. Dispensing pharmacies for long-term care have welcomed drug donation repository programs as an economical option to dispose of previously dispensed but unused medications.

Patients Served Drug donation programs are designed to provide short-term assistance to low-income and under- or uninsured patients. These programs are not intended to provide medication assistance in lieu of state or federal programs, but they do serve patients who need shortterm assistance, such as an insured, low-income patient who cannot afford a drug copay, an individual waiting to receive Medicaid benefits, or a senior who has reached

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the Medicare coverage gap. Assistance is often provided in the form of 30-, 60-, or 90-day supplies of medication. Although some states allow the drug donation program to dispense directly to the patient in need, many programs are licensed in their state as a wholesale distributor. As distributors, the drug donation programs supply medical facilities, such as free medical clinics or federally qualified health centers, with donated medications that will be dispensed to patients in need. Once the donated medications are received by the medical facility, the

In general, donated medications must have an expiration date greater than 6 months from the date of donation; must be contained in the original sealed, or unit-dose tamper-evident packaging; must not require refrigeration or temperature requirements different from room temperature; and must not be a compounded or controlled substance. medications are dispensed to the patient in its donated format; however, some states also allow the dispensing medical facility to repackage the donated items in a format that is consistent with retail pharmacies. Drug donation programs with a history of success often use state assistance to underwrite operating costs. As a result, almost all state regulations for drug donation programs stipulate that only state residents are eligible to accept the donated drugs. Most states also specify that the donated drugs must be dispensed to low-income patients lacking prescription insurance. The term â&#x20AC;&#x153;safety-net patientâ&#x20AC;? is often used to identify individuals who are eligible for assistance, and are loosely defined as a patient with a household income less than 200% of the federal poverty level, who is also uninsured or underinsured.

The Role of the Pharmacist Licensed pharmacists must be engaged in the drug donation process to ensure the safety and effectiveness of the donated medications. All state regulations require a state-licensed pharmacist or pharmacy to be part of the drug inspection and distribution processes.3 Most often, donated medications are collected at a centralized repository or pharmacy where the donated items are inspected by a licensed pharmacist and verified as safe for redistribution. Common medication elements inspected by a pharmacist include the condition of the original

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or tamper-evident sealed packaging; evidence of medication damage; accurate drug labeling and dosage; drug expiration; and presence of identification markers. Any questionable product is destroyed without hesitation. Pharmacists who regularly handle prescription drugs often excel in the drug inspection process. Online drug identification resources can be helpful during the inspection process. In addition, many states also require a pharmacist to document and return or destroy any controlled substances obtained through the drug donation program. The operating status, scope, and structure of drug donation programs across the country vary drastically. Most state programs are only a few years old or are still in the development and testing stages. These programs often operate on a limited budget and may rely on parttime or volunteer pharmacists and program staff to manage the drug donation repository. A small number of states have invested in the drug donation repository model and use full-time administrators, pharmacists, and program staff. In these programs, pharmacists and staff are compensated at rates competitive with the local retail pharmacy market. In states where drug donation programs continue to grow and evolve, professional opportunities with these programs will increase.

Whatâ&#x20AC;&#x2122;s Ahead Drug donation programs are emerging as practical models to effectively improve access to affordable medications, decrease costs, eliminate waste, and reduce pollution. However, these programs are relatively new models in the healthcare delivery system. Additional detailed analysis is needed to identify program factors that contribute to long-term sustainability, maximize patient safety, and increase utilization. Drug donation programs must also effectively embrace industry changes to address the increasingly complex global supply chain and minimize consumer exposure to substandard drugs. These are changes that could effectively end drug donation programs as they are currently structured. However, 10 years ago, drug donation programs were distant concepts. At this time, states turned to leadership at their boards of pharmacy, state pharmacy associations, and colleges of pharmacy to develop practical and safe regulations for drug donation programs. These same strong, earned partnerships can also lead us through the next 10 years. n References

1. Zhang Y, Sorofman B, Rosmann J. Policy analysis of drug donation regulations in America. J Am Pharm Assoc. 2013;53:(2):e43. 2. Data on file. The Iowa Hospital Association; February 2011. 3. National Conference of State Legislatures Staff. State Prescription Drug Return, Reuse and Recycling Laws. National Conference of State Legislatures. September 2012. http://www.ncsl.org/issues-research/health/state-prescription-drug-return-re use-and-recycling.aspx. Accessed August 6, 2013.

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IN THE TREATMENT OF ACUTE CORONARY SYNDROME

DECISIONS TODAY CAN IMPACT A LIFE

IN THE TREATMENT OF ACUTE CORONARY SYNDROME

HELP MAKE AN IMPACT WITH BRILINTA BEYOND 30 DAYS, BEYOND THE HOSPITAL, BETTER EFFICACY THAN CLOPIDOGREL

AT 30 DAYS, BRILINTA plus aspirin reduced the primary composite end point of cardiovascular (CV) death, myocardial infarction (MI),* or stroke by 12% RRR† (ARR‡ 0.6%) vs clopidogrel plus aspirin.§1,2

AT 12 MONTHS, BRILINTA plus aspirin signiﬁcantly reduced the primary composite end point by 16% RRR (ARR 1.9%) vs clopidogrel plus aspirin. The difference between treatments was driven by CV death and MI with no difference in stroke.§1

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA WARNING: BLEEDING RISK • BRILINTA, like other antiplatelet agents, can cause signiﬁcant, sometimes fatal, bleeding • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage • Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg–100 mg per day CONTRAINDICATIONS BRILINTA is contraindicated in patients with: • History of intracranial hemorrhage • Active pathological bleeding such as peptic ulcer or intracranial hemorrhage • Severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins • Hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product

PROVEN SUPERIOR TO CLOPIDOGREL IN REDUCING CV DEATH AT 12 MONTHS CV death secondary end point: RRR with BRILINTA plus aspirin was 21% (ARR 1.1%) vs clopidogrel plus aspirin.§1 INDICATIONS BRILINTA is indicated to reduce the rate of thrombotic CV events in patients with acute coronary syndrome (ACS) (unstable angina [UA], non–ST-elevation MI [NSTEMI], or ST-elevation MI [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis. BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin >100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin >100 mg daily.

BLEEDING AT 12 MONTHS, there was no signiﬁcant difference in Total Major Bleeding (which includes Fatal and Life-threatening bleeding) for BRILINTA plus aspirin vs clopidogrel plus aspirin (11.6% vs 11.2%). There was a somewhat greater risk of Non–CABG-related Major plus Minor Bleeding for BRILINTA plus aspirin vs clopidogrel plus aspirin (8.7% vs 7.0%) and Non–CABGrelated Major Bleeding (4.5% vs 3.8%), respectively. PLATO trial did not show an advantage for BRILINTA compared with clopidogrel for CABG-related Bleeding (Total Major 85.8% vs 86.9% and Fatal/Life-threatening 48.1% vs 47.9%, respectively). 1

*Excluding silent MI. †RRR=relative risk reduction. ‡ARR=absolute risk reduction. § The PLATO study compared BRILINTA (180-mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter) for the prevention of CV events in 18,624 patients with ACS (UA, NSTEMI, STEMI). Patients were treated for at least 6 months and up to 12 months. BRILINTA and clopidogrel were studied with aspirin and other standard therapies.

WARNINGS AND PRECAUTIONS • Moderate Hepatic Impairment: Consider the risks and beneﬁts of treatment, noting the probable increase in exposure to ticagrelor • Premature discontinuation increases the risk of MI, stent thrombosis, and death • Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes • BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers. Avoid simvastatin and lovastatin doses >40 mg • Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy

ADVERSE REACTIONS • The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were Total Major Bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%) • In clinical studies, BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias. PLATO excluded patients at increased risk of bradycardic events. Consider the risks and beneﬁts of treatment

PLATO used the following bleeding severity categorization: Major Bleed–Fatal/ Life threatening. Any one of the following: fatal; intracranial; intrapericardial bleed with cardiac tamponade; hypovolemic shock or severe hypotension due to bleeding and requiring pressors or surgery; clinically overt or apparent bleeding associated with a decrease in hemoglobin (Hb) of more than 5 g/dL; transfusion of 4 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding. Major Bleed–Other. Any one of the following: signiﬁcantly disabling (eg, intraocular with permanent vision loss); clinically overt or apparent bleeding associated with a decrease in Hb of 3 g/dL; transfusion of 2 to 3 units (whole blood or PRBCs) for bleeding. Minor Bleed. Requires medical intervention to stop or treat bleeding (eg, epistaxis requiring visit to medical facility for packing).

Please see Brief Summary of Prescribing Information, including Boxed WARNINGS, on the adjacent pages. References: 1. Data on ﬁle, 1755503, AstraZeneca. 2. BRILINTA Prescribing Information, AstraZeneca.

BRILINTA® (ticagrelor) Tablets WARNING: BLEEDING RISK • BRILINTA, like other antiplatelet agents, can cause signiﬁcant, sometimes fatal bleeding [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage [see CONTRAINDICATIONS]. • Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery [see WARNINGS AND PRECAUTIONS]. • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA [see WARNINGS AND PRECAUTIONS]. • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events [see WARNINGS AND PRECAUTIONS]. WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75-100 mg per day [see WARNINGS AND PRECAUTIONS and CLINICAL STUDIES (14) in full Prescribing Information].

BRIEF SUMMARY of PRESCRIBING INFORMATION: For full Prescribing Information, see package insert.

INDICATIONS AND USAGE Acute Coronary Syndromes BRILINTA is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction). BRILINTA has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis [see Clinical Studies (14) in full Prescribing Information]. BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily [see Warnings and Precautions and Clinical Studies (14) in full Prescribing Information].

DOSAGE AND ADMINISTRATION Initiate BRILINTA treatment with a 180 mg (two 90 mg tablets) loading dose and continue treatment with 90 mg twice daily. After the initial loading dose of aspirin (usually 325 mg), use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg. ACS patients who have received a loading dose of clopidogrel may be started on BRILINTA. BRILINTA can be administered with or without food. A patient who misses a dose of BRILINTA should take one 90 mg tablet (their next dose) at its scheduled time.

CONTRAINDICATIONS History of Intracranial Hemorrhage BRILINTA is contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical Studies (14) in full Prescribing Information]. Active Bleeding BRILINTA is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) in full Prescribing Information]. Severe Hepatic Impairment BRILINTA is contraindicated in patients with severe hepatic impairment because of a probable increase in exposure, and it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins [see Clinical Pharmacology (12.3) in full Prescribing Information]. Hypersensitivity BRILINTA is contraindicated in patients with hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product [see Adverse Reactions (6.1) in full Prescribing Information].

WARNINGS AND PRECAUTIONS General Risk of Bleeding Drugs that inhibit platelet function including BRILINTA increase the risk of bleeding. BRILINTA increased the overall risk of bleeding (Major + Minor) to a somewhat greater extent than did clopidogrel. The increase was seen for non-CABG-related bleeding, but not for CABG-related bleeding. Fatal and life-threatening bleeding rates were not increased [see Adverse Reactions (6.1) in full Prescribing Information]. In general, risk factors for bleeding include older age, a history of bleeding disorders, performance of percutaneous invasive procedures and concomitant use of medications that increase the risk of bleeding (e.g., anticoagulant and fibrinolytic therapy, higher doses of aspirin, and chronic nonsteroidal anti-inflammatory drugs [NSAIDS]). When possible, discontinue BRILINTA five days prior to surgery. Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or other surgical procedures, even if the patient does not have any signs of bleeding. If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) in full Prescribing Information]. Concomitant Aspirin Maintenance Dose In PLATO, use of BRILINTA with maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Therefore, after the initial loading dose of aspirin (usually 325 mg), use BRILINTA with a maintenance dose of aspirin of 75-100 mg [see Dosage and Administration and Clinical Studies (14) in full Prescribing Information]. Moderate Hepatic Impairment BRILINTA has not been studied in patients with moderate hepatic impairment. Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.

Dyspnea In PLATO, dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea was usually mild to moderate in intensity and often resolved during continued treatment, but occasionally required discontinuation (0.9% of patients taking BRILINTA versus 0.1% of patients taking clopidogrel). If a patient develops new, prolonged, or worsened dyspnea during treatment with BRILINTA, exclude underlying diseases that may require treatment. If dyspnea is determined to be related to BRILINTA, no specific treatment is required; continue BRILINTA without interruption. In the case of intolerable dyspnea requiring discontinuation of BRILINTA, consider prescribing another antiplatelet agent. In a substudy, 199 patients from PLATO underwent pulmonary function testing irrespective of whether they reported dyspnea. There was no significant difference between treatment groups for FEV1. There was no indication of an adverse effect on pulmonary function assessed after one month or after at least 6 months of chronic treatment. Discontinuation of BRILINTA Avoid interruption of BRILINTA treatment. If BRILINTA must be temporarily discontinued (e.g., to treat bleeding or for elective surgery), restart it as soon as possible. Discontinuation of BRILINTA will increase the risk of myocardial infarction, stent thrombosis, and death. Strong Inhibitors of Cytochrome CYP3A Ticagrelor is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. Cytochrome CYP3A Potent Inducers Avoid use with potent CYP3A inducers, such as rifampin, dexamethasone, phenytoin, carbamazepine, and phenobarbital [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) in full Prescribing Information].

ADVERSE REACTIONS Clinical Trials Experience The following adverse reactions are also discussed elsewhere in the labeling: • Dyspnea [see Warnings and Precautions (5.4) in full Prescribing Information] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. BRILINTA has been evaluated for safety in more than 10000 patients, including more than 3000 patients treated for more than 1 year. Bleeding PLATO used the following bleeding severity categorization: • Major bleed – fatal/life-threatening. Any one of the following: fatal; intracranial; intrapericardial bleed with cardiac tamponade; hypovolemic shock or severe hypotension due to bleeding and requiring pressors or surgery; clinically overt or apparent bleeding associated with a decrease in hemoglobin (Hb) of more than 5 g/dL; transfusion of 4 or more units (whole blood or packed red blood cells (PRBCs)) for bleeding. • Major bleed – other. Any one of the following: significantly disabling (e.g., intraocular with permanent vision loss); clinically overt or apparent bleeding associated with a decrease in Hb of 3 g/dL; transfusion of 2-3 units (whole blood or PRBCs) for bleeding. • Minor bleed. Requires medical intervention to stop or treat bleeding (e.g., epistaxis requiring visit to medical facility for packing). • Minimal bleed. All others (e.g., bruising, bleeding gums, oozing from injection sites, etc.) not requiring intervention or treatment. Figure 1 shows major bleeding events over time. Many events are early, at a time of coronary angiography, PCI, CABG, and other procedures, but the risk persists during later use of antiplatelet therapy. Figure 1 Kaplan-Meier estimate of time to first PLATO-defined ‘Total Major’ bleeding event

Annualized rates of bleeding are summarized in Table 1 below. About half of the bleeding events were in the first 30 days. Table 1 Non-CABG related bleeds (KM%) BRILINTA Clopidogrel N=9235 N=9186 Total (Major + Minor) 8.7 7.0 Major 4.5 3.8 Fatal/Life-threatening 2.1 1.9 Fatal 0.2 0.2 Intracranial (Fatal/Life-threatening) 0.3 0.2 As shown in Table 1, BRILINTA was associated with a somewhat greater risk of non-CABG bleeding than was clopidogrel. No baseline demographic factor altered the relative risk of bleeding with BRILINTA compared to clopidogrel. In PLATO, 1584 patients underwent CABG surgery. The percentages of those patients who bled are shown in Table 2. Rates were very high but similar for BRILINTA and clopidogrel.

BRILINTA® (ticagrelor) Tablets Table 2 CABG bleeds (KM%) Patients with CABG BRILINTA Clopidogrel N=770 N=814 Total Major 85.8 86.9 Fatal/Life-threatening 48.1 47.9 Fatal 0.9 1.1 Although the platelet inhibition effect of BRILINTA has a faster offset than clopidogrel in in vitro tests and BRILINTA is a reversibly binding P2Y12 inhibitor, PLATO did not show an advantage of BRILINTA compared to clopidogrel for CABG-related bleeding. When antiplatelet therapy was stopped 5 days before CABG, major bleeding occurred in 75% of BRILINTA treated patients and 79% on clopidogrel. No data exist with BRILINTA regarding a hemostatic beneﬁt of platelet transfusions. Drug Discontinuation In PLATO, the rate of study drug discontinuation attributed to adverse reactions was 7.4% for BRILINTA and 5.4% for clopidogrel. Bleeding caused permanent discontinuation of study drug in 2.3% of BRILINTA patients and 1.0% of clopidogrel patients. Dyspnea led to study drug discontinuation in 0.9% of BRILINTA and 0.1% of clopidogrel patients. Common Adverse Events A variety of non-hemorrhagic adverse events occurred in PLATO at rates of 3% or more. These are shown in Table 3. In the absence of a placebo control, whether these are drug related cannot be determined in most cases, except where they are more common on BRILINTA or clearly related to the drug’s pharmacologic effect (dyspnea). Table 3 Percentage of patients reporting non-hemorrhagic adverse events at least 3% or more in either group BRILINTA Clopidogrel N=9235 N=9186 Dyspnea1 13.8 7.8 Headache 6.5 5.8 Cough 4.9 4.6 Dizziness 4.5 3.9 Nausea 4.3 3.8 Atrial fibrillation 4.2 4.6 Hypertension 3.8 4.0 Non-cardiac chest pain 3.7 3.3 Diarrhea 3.7 3.3 Back pain 3.6 3.3 Hypotension 3.2 3.3 Fatigue 3.2 3.2 Chest pain 3.1 3.5 1 Includes: dyspnea, dyspnea exertional, dyspnea at rest, nocturnal dyspnea, dyspnea paroxysmal nocturnal

Bradycardia In clinical studies BRILINTA has been shown to increase the occurrence of Holterdetected bradyarrhythmias (including ventricular pauses). PLATO excluded patients at increased risk of bradycardic events (e.g., patients who have sick sinus syndrome, 2nd or 3rd degree AV block, or bradycardic-related syncope and not protected with a pacemaker). In PLATO, syncope, pre-syncope and loss of consciousness were reported by 1.7% and 1.5% of BRILINTA and clopidogrel patients, respectively. In a Holter substudy of about 3000 patients in PLATO, more patients had ventricular pauses with BRILINTA (6.0%) than with clopidogrel (3.5%) in the acute phase; rates were 2.2% and 1.6% respectively after 1 month. Gynecomastia In PLATO, gynecomastia was reported by 0.23% of men on BRILINTA and 0.05% on clopidogrel. Other sex-hormonal adverse reactions, including sex organ malignancies, did not differ between the two treatment groups in PLATO. Lab abnormalities Serum Uric Acid: Serum uric acid levels increased approximately 0.6 mg/dL from baseline on BRILINTA and approximately 0.2 mg/dL on clopidogrel in PLATO. The difference disappeared within 30 days of discontinuing treatment. Reports of gout did not differ between treatment groups in PLATO (0.6% in each group). Serum Creatinine: In PLATO, a >50% increase in serum creatinine levels was observed in 7.4% of patients receiving BRILINTA compared to 5.9% of patients receiving clopidogrel. The increases typically did not progress with ongoing treatment and often decreased with continued therapy. Evidence of reversibility upon discontinuation was observed even in those with the greatest on treatment increases. Treatment groups in PLATO did not differ for renal-related serious adverse events such as acute renal failure, chronic renal failure, toxic nephropathy, or oliguria. Postmarketing Experience The following adverse reactions have been identified during post-approval use of BRILINTA. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders – Hypersensitivity reactions including angioedema [see Contraindications (4.4) in full Prescribing Information].

DRUG INTERACTIONS Effects of other drugs Ticagrelor is predominantly metabolized by CYP3A4 and to a lesser extent by CYP3A5. CYP3A inhibitors [see Warnings and Precautions and Clinical Pharmacology (12.3) in full Prescribing Information]. CYP3A inducers [see Warnings and Precautions and Clinical Pharmacology (12.3) in full Prescribing Information].

Aspirin Use of BRILINTA with aspirin maintenance doses above 100 mg reduced the effectiveness of BRILINTA [see Warnings and Precautions and Clinical Studies (14) in full Prescribing Information]. Effect of BRILINTA on other drugs Ticagrelor is an inhibitor of CYP3A4/5 and the P-glycoprotein transporter. Simvastatin, lovastatin BRILINTA will result in higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4. Avoid simvastatin and lovastatin doses greater than 40 mg [see Clinical Pharmacology (12.3) in full Prescribing Information]. Digoxin Digoxin: Because of inhibition of the P-glycoprotein transporter, monitor digoxin levels with initiation of or any change in BRILINTA therapy [see Clinical Pharmacology (12.3) in full Prescribing Information]. Other Concomitant Therapy BRILINTA can be administered with unfractionated or low-molecularweight heparin, GPIIb/IIIa inhibitors, proton pump inhibitors, beta-blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies of BRILINTA use in pregnant women. In animal studies, ticagrelor caused structural abnormalities at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area. BRILINTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. The lowest dose was approximately the same as the MRHD of 90 mg twice daily for a 60 kg human on a mg/m2 basis. Adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the MRHD on a mg/m2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae. When pregnant rabbits received ticagrelor during organogenesis at doses from 21 to 63 mg/kg/day, fetuses exposed to the highest maternal dose of 63 mg/kg/day (6.8 times the MRHD on a mg/m2 basis) had delayed gall bladder development and incomplete ossification of the hyoid, pubis and sternebrae occurred. In a prenatal/postnatal study, pregnant rats received ticagrelor at doses of 10 to 180 mg/kg/day during late gestation and lactation. Pup death and effects on pup growth were observed at 180 mg/kg/day (approximately 10 times the MRHD on a mg/m2 basis). Relatively minor effects such as delays in pinna unfolding and eye opening occurred at doses of 10 and 60 mg/kg (approximately one-half and 3.2 times the MRHD on a mg/m2 basis). Nursing Mothers It is not known whether ticagrelor or its active metabolites are excreted in human milk. Ticagrelor is excreted in rat milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from BRILINTA, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of BRILINTA in pediatric patients have not been established. Geriatric Use In PLATO, 43% of patients were ≥65 years of age and 15% were ≥75 years of age. The relative risk of bleeding was similar in both treatment and age groups. No overall differences in safety or effectiveness were observed between these patients and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment BRILINTA has not been studied in the patients with moderate or severe hepatic impairment. Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Hence, BRILINTA is contraindicated for use in patients with severe hepatic impairment and its use should be considered carefully in patients with moderate hepatic impairment. No dosage adjustment is needed in patients with mild hepatic impairment [see Contraindications, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information]. Renal Impairment No dosage adjustment is needed in patients with renal impairment. Patients receiving dialysis have not been studied [see Clinical Pharmacology (12.3) in full Prescribing Information].

OVERDOSAGE There is currently no known treatment to reverse the effects of BRILINTA, and ticagrelor is not expected to be dialyzable. Treatment of overdose should follow local standard medical practice. Bleeding is the expected pharmacologic effect of overdosing. If bleeding occurs, appropriate supportive measures should be taken. Other effects of overdose may include gastrointestinal effects (nausea, vomiting, diarrhea) or ventricular pauses. Monitor the ECG.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility [see section (13.1) in full Prescribing Information] PATIENT COUNSELING INFORMATION [see section (17) in full Prescribing Information]

Issued: March 29, 2013 BRILINTA® is a trademark of the AstraZeneca group of companies. Distributed by: AstraZeneca LP, Wilmington, DE 19850 © AstraZeneca 2011, 2013 Rev. 3/13 2574902 4/13

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Emergency Preparedness in the US: What Is the Strategic National Stockpile? By Ann Johnson, PharmD Pharmacy Healthcare Solutions, Inc

f there were to be a major earthquake, flu outbreak, or terrorist attack in one or more of the nation’s largest cities tomorrow, gaining access to life-saving medications may seem impossible. Thankfully, the strategic national stockpile (SNS) is in place in case of an emergency. The mission of the Ann Johnson SNS program is to “deliver critical medical assets to the site of a national emergency.”1 Despite the fact that the national stockpile contains more than $1 billion worth of medications, most pharmacists are unaware of the stockpile and do not know what would happen during an emergency. The Centers for Disease Control and Prevention (CDC), a division of the US Department of Health and Human Services, manages the SNS in coordination with the US Department of Homeland Security. An individual retail pharmacy cannot request medications

Despite the fact that the national stockpile contains more than $1 billion worth of medications, most pharmacists are unaware of the stockpile and do not know what would happen during an emergency. from the SNS, however. Requests for products from the SNS must come from a state’s department of health, usually in coordination with the governor’s office, or from a national agency, such as the Federal Emergency Management Agency. Any local requests for SNS Ms. Johnson is a pharmacist consultant at Pharmacy Healthcare Solutions, Inc, in Pittsburgh, PA.

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medications must first be approved at the state level. Although the government has classified SNS locations for security reasons, once they make the decision to deploy drugs, medications can be delivered to any area of the country within 12 hours. Healthcare workers can then dispense and administer the SNS medications to qualifying individuals free of charge. Although the public does not have access to the exact SNS formulary, many of the medications included in the SNS are known, and others can likely be guessed based on the stockpile’s purpose. Category A threat agents include those used to treat smallpox, botulism, anthrax, plague, tularemia, and others. To combat these diseases, as well as to prepare for a nuclear attack or natural disaster, the inventory in the SNS contains an array of medications. The CDC is constantly evaluating current biological and chemical threats and determining the medical vulnerability of the US population in order to keep the SNS adequately stocked. The CDC also performs quality assurance and quality control checks quarterly, and they complete a 100% inventory inspection annually. Because the SNS inventory encompasses approximately 500,000 square feet of warehouse space, this can be a large task. The SNS inventory is also divided between multiple locations, and consists of both 12-hour “push packages” and managed inventory. When the exact nature of the disaster is unknown, prepackaged 12-hour push packages can be sent to the disaster site. The push packages contain oral and intravenous (IV) antibiotics, emergency medications, IV fluids and administration sets, airway equipment, and bandages, and are stored in different, nondescript locations across the country near major transportation hubs. For security reasons, armed guards protect the facilities. Push packages serve as a first-line medical response measure and constitute approximately 5% of the SNS inventory. When the exact nature of the disaster or threat is known, managed inventory also can be sent

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within 24 to 36 hours to treat specific health conditions. Managed inventory would likely include vaccines, antitoxins, ventilators, surgical supplies, painkillers, epinephrine, and other drugs and supplies. Although tragic, after Hurricane Katrina hit the Gulf Coast, the United States was better prepared to deal with emergency public health responses. One of the major lessons learned from the hurricane response involved the need for medications to treat chronic health conditions. The original intent of the SNS was to respond to the immediate, critical needs of patients. However, as seen with Hurricane Katrina, people affected by natural disasters may be without chronic medications for days or even weeks. While we may not think of medications like insulin and beta-blockers as emergency preparedness medications, the experiences of those in Katrina have caused the CDC to reevaluate the expansion of the SNS formulary to include medications to treat chronic conditions. One positive outcome from Hurricane Katrina was the creation of KatrinaHealth, a web portal that combined prescription data from a number of sources including Medicaid, Veterans Affairs, commercial payers, and retail pharmacies. This enabled evacuees to have their prescription and medical information accessed out of state by any authorized physician or pharmacist providing them care. Should another disaster strike, this portal will likely serve as a model for others. Likewise, when the H1N1 flu pandemic struck in 2009, the SNS was used to supply approximately 11 million doses of oseltamivir (Tamiflu) and zanamivir (Relenza) across all 50 states. The SNS currently has approximately 80 million courses of oseltamivir and zanamivir therapy stockpiled. This would be enough to treat approximately 25% of the US population if another pandemic occurred. While it may seem strange that only 25% of the population could receive the antivirals, it is important to remember that even in the severe 1918 influenza pandemic, only 30% of the nation contracted the disease. Thus, a supply of 80 million courses of antiviral therapy is most likely sufficient. While it is great to have an SNS in place, if those who need the medications are unable to get them, the drugs are of little value. This raises the question of how emergency medications will be delivered, distributed, and administered to the patients who need them most during a disaster. Once federal authorities approve the deployment of SNS medications, unmarked trucks and/ or airplanes will deliver the drug products to their state destination. After that, each state has its own plan in place for receiving and distributing the medications locally. States will have certain predetermined dispensing locations, such as local hospitals or clinics, where they will deliver the medications. As made apparent by

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KEY POINTS The strategic national stockpile (SNS) is in place in case of an emergency, and it contains more than $1 billion worth of medications. ➤ The SNS is managed by the Centers for Disease Control and Prevention (CDC) in coordination with the Department of Homeland Security. The CDC constantly evaluates current biological and chemical threats and determines the medical vulnerability of the US population to keep the SNS adequately stocked. ➤ SNS locations are classified for security reasons, but once a decision is made to deploy drugs, medications can be delivered to any area of the country within 12 hours. ➤ When the exact nature of a disaster is unknown, prepackaged 12-hour “push packages” containing oral and intravenous (IV) antibiotics, emergency medications, IV fluids and administration sets, airway equipment, and bandages can be sent to the disaster site. ➤ Managed inventory would likely include vaccines, antitoxins, ventilators, surgical supplies, painkillers, epinephrine, and other drugs and supplies, and can be deployed within 24 to 36 hours to treat specific health conditions. ➤

the H1N1 vaccine distribution in 2009, communication between federal, state, and local health departments is extremely important. The H1N1 experience has led to an increase in strategic planning to strengthen weak communication channels. While state officials may provide technical support, it is the responsibility of local jurisdiction personnel to actually dispense and administer the medications. Local methods for administering vaccines and other medications vary. Traditional methods of administering vaccines include publicizing set administration times at local hospitals and health clinics. Many areas of the country have also developed nontraditional plans. Some local governments have created partnerships with schools, nursing homes, jails, or businesses, whereby these facilities would administer the vaccines to their own residents in case of an emergency. Other local governments in Florida and Kentucky have planned to operate drive-through dispensing clinics, which would function much like fast-food restaurant drive-through windows. To receive information about procuring the SNS medications, the public should watch television, listen to the radio, or check community websites or newspapers for public service instruc-

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tions during a disaster. While it may sound like a smooth and well-thoughtout process, without trained staff, reacting to an emergency can be difficult. US Public Health Service workers and the states’ Department of Health workers are all trained to serve in these types of situations. These departments will probably be the first to provide staffing support in case of an emergency. However, during large disasters, additional staff may be needed to help sort, dispense, and administer medications. Much of this additional help comes in the form of volunteers. Most states have an online registry for medical and nonmedical emergency disaster responders. Anyone can register, and those who do register are not obligated to participate in emergency response initiatives. The registry simply makes it easier for the state to reach out for help, should a disaster strike. Volunteer positions that may be crucial in case of an emergency include triage greeters, pharmacy unit leaders, pharmacy technicians, and dispensing personnel. If you are interested in becoming an emergency disaster responder, visit your state’s Department of Health website for more information.

Conclusion Although the thought of a natural disaster, terrorist attack, or disease epidemic makes everyone nervous, there is some solace in the fact that a SNS is in place with plans to distribute and administer drugs to the public should they be needed. Because of their frequent patient interactions and connections with many healthcare providers, pharmacists are uniquely situated to play a key role during these situations. Whether you will be working as an emergency disaster responder, collaborating with public health workers, or simply answering questions for patients and their families during an emergency, being informed about the SNS is vital during a disaster. Being able to disseminate information and explain the government’s plan of action can go a long way toward calming the fears of others during an emergency. Besides, when a disaster strikes, if you have failed to plan, you plan to fail. n Reference

1. Centers for Disease Control and Prevention. Office of Public Health Preparedness and Response. Strategic National Stockpile fact sheet. http://www.cdc.gov/phpr/ stockpile/stockpile.htm. Accessed June 24, 2013.

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Trends in the Dispensing of 90-Day-Supply Prescriptions at Retail Pharmacies: Implications for Improved

Convenience and Access Joshua N. Liberman, PhD; Charmaine Girdish, MPH

Background: Mail-service pharmacies offer consumers the convenience of prescriptions filled with a 90-day supply of medication. Unlike mail-service pharmacies, retail pharmacies traditionally dispensed maintenance medication prescriptions with a 30-day supply. However, the retail landscape changed in May 2008 with Walmartâ&#x20AC;&#x2122;s announcement of an extension of its $4 Prescription Program to include 90-day-supply prescriptions. Objective: To evaluate recent changes in access to and use of 90-day-supply maintenance medications dispensed via retail pharmacy. Summary: As of the first quarter of 2007, the proportion of retail-dispensed maintenance medications with a 90-day supply (compared with all maintenance prescriptions dispensed) among Medicare Part D plans, self-insured employers, and private health plans was 5.1%, 5.1%, and 5.0%, respectively. As of December 2009, this ratio had risen to 8.0% for Medicare plans and 8.1% for commercial health plans; the ratio among employers had risen more modestly to 6.1%. Of particular interest and importance, the proportion increased similarly for brand and for generic medications. Conclusion: There has been substantial growth in 90-day prescriptions dispensed via retail pharmacy, a trend that is likely to continue as more insurance providers adopt compatible benefit designs. It is important to continue monitoring these trends and to identify opportunities to rigorously evaluate their impact on medication adherence and healthcare costs.

Joshua N. Liberman

early 96% of all employers allow employees and covered beneficiaries to fill medication prescriptions from either retail or mail-service pharmacy.1 In 2009, mail-service pharmacies dispensed approximately 238 million prescriptions, representing 6.6% of the 3.6 billion prescriptions dispensed that year.2 Mail-service pharmacies have enjoyed high levels of consumer satisfaction.3 Mail-service pharmacies offer consumers the convenience of home delivery, online ordering and renewal processes, and prescriptions filled with a 90-day supply of medication. Unlike mail-service pharmacies, retail pharmacies traditionally dispensed maintenance medication prescriptions with a 30-day supply. However, the

For individuals with a pharmacy insurance benefit, access to a 90-day supply of maintenance medications, either through mail or retail pharmacy, expanded as payers and pharmacy benefits managers began enhancing their retail pharmacy networks and pharmacy benefit designs.

Dr. Liberman was Vice President, Strategic Research, CVS Caremark, Hunt Valley, MD, at the time of this research, and Ms. Girdish is Senior Analyst, Strategic Research, CVS Caremark, Scottsdale, AZ.

select maintenance medications for $10.4 Although positioned primarily as a program to lower drug costs for the uninsured for a limited number of chronic medications, the program was available to virtually all

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retail landscape changed in May 2008 with Walmartâ&#x20AC;&#x2122;s announcement of an extension of the $4 Prescription Program to include 90-day-supply prescriptions of

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KEY POINTS Traditionally, retail pharmacies predominantly dispensed prescription medications for the treatment of chronic disease with a 30-day-supply limit. ➤ However, in 2008 Walmart fundamentally changed access to retail pharmacy–dispensed 90-day-supply prescriptions by launching a program to dispense select maintenance medications in 90-day supplies for $10 via its retail pharmacy. ➤ This current study measured changes in paid pharmacy claims between January 2007 and December 2009, using 467 million claims purchased at retail pharmacies and adjudicated by CVS Caremark. ➤ Results showed that in that 3-year period, the ratio of 90-day prescription dispensing increased from 5.1% to 8.0% and from 5.0% to 8.1% among beneficiaries of select Medicare Part D and commercial health plans, respectively. ➤ Recent studies have shown increased medication adherence with expanded drug supply with mailservice pharmacies compared with retail pharmacies. It is therefore reasonable to assume that extended access to medications in retail pharmacy is similarly likely to improve adherence, which may have important implications on overall healthcare costs and utilization. ➤

Studies are needed to investigate the impact of 90-day prescription supply at retail pharmacies on medication adherence.

➤

consumers. Many retail pharmacy chains followed this lead, instituting similar low-cost, 90-day-supply drug programs. For individuals with a pharmacy insurance benefit, access to a 90-day supply of maintenance medications, either through mail or retail pharmacy, expanded as payers and pharmacy benefits managers (PBMs) began enhancing their retail pharmacy networks and pharmacy benefit designs. As a response to these initiatives, CVS Caremark, Rite Aid Health Solutions, and Walgreens Health Initiatives now offer programs that allow consumers to receive 90-day-supply prescriptions via mail or retail pharmacy. Today, even stand-alone PBMs, such as Express Scripts and Medco Health Solutions, have retail pharmacy networks that accommodate 90-day prescriptions. According to the 2010-2011 Prescription Drug Benefit Cost and Plan Design report, 96.3% of employers offer access to mail-service pharmacy for maintenance

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medications (routinely dispensed with 90-day supplies) but 58.3% also use retail pharmacies to dispense maintenance supplies of medications.1 The availability of prescriptions with an expanded-day supply in retail pharmacies may have important implications for medication adherence. Recent evaluations of mail-service pharmacy have documented improved medication adherence compared with prescriptions dispensed with 30-day supplies via retail pharmacy, in large part because of the availability of extended-day supply dispensed with each prescription.5,6 Yet despite the recent expansion of 90-day prescription drug access at retail pharmacies, little has been documented in peer-reviewed literature about the use of these programs by consumers. Understanding this trend has important implications for payers and patients.

Methods To document recent medication trends, we measured changes in paid pharmacy claims purchased at retail pharmacies and adjudicated by CVS Caremark during the 3-year period from 2007 through 2009. To be eligible, a payer had to fulfill the following criteria: • Provide covered beneficiaries with pharmacy insurance benefits administered by CVS Caremark continuously from January 1, 2007, through December 31, 2009 • Not mandate maintenance medications to be dispensed by a mail-service pharmacy • Have no more than ±15% change in average membership between calendar years 2008 and 2009. During the study period (2007-2009), the use of 90-day-supply prescriptions among Medicaid beneficiaries was negligible and thus excluded. Eligible paid pharmacy claims were (1) submitted by a retail pharmacy, (2) designated as a maintenance medication by either Medi-Span or First DataBank, and (3) adjudicated and paid during the 3-year study period. In January 2009, CVS Caremark launched Main tenance Choice—a pharmacy benefit design which, in general, provides members with the choice of receiving their 90-day prescriptions through CVS Caremark mail-service pharmacy or at a CVS/pharmacy retail location for the same out-of-pocket (ie, copayment) cost as a mail prescription. Because the CVS Caremark PBM data overrepresents this Maintenance Choice pharmacy benefit, we stratified the results by retail pharmacy— CVS/pharmacy versus all other retail pharmacies. The overall trend in dispensing 90-day prescriptions was tested for statistical significance using the Cochran- Armitage test for trend, testing the frequency of 90-day-supply prescriptions monthly over the study period.

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Figure 1 P ercent of Maintenance Prescriptions Filled as 90-Day Supply in Retail Pharmacies by Market Segment and Pharmacy Employer CVS/pharmacy Employer other retail Health plan all pharmacies Medicare all pharmacies

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Results In total, we included 467 million claims adjudicated for 27 million members covered by 1115 insurers. Figure 1 (page 20) displays the percent of maintenance prescriptions dispensed with a 90-day supply (thereafter, 90-day ratio) from January 2007 through December 2009. As of the first quarter of 2007, the 90-day ratio was 5.1%, 5.1%, and 5.0% for Medicare Part D plans, self-insured employers, and private health plans, respectively. As of December 2009, the 90-day ratio had risen to 8.0% for Medicare and 8.1% for health plans; the ratio among employers had risen more modestly to 6.1%. Among the network of CVS/pharmacy retail stores, the 90-day ratio increased by 13.4 percentage points among employers, with substantial increases subsequent to the launch of Maintenance Choice. Of particular interest, the 90-day ratio increased similarly for brand and generic medications, with the ratio increasing by 3.3 percentage points for brand-name and

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for generic drugs. Comparable increases were noted for generic drugs that were included on and omitted from the $10/90 generic drug program lists (Figure 2, page 21). The increase in dispensed 90-day prescriptions at retail pharmacies during this period was significant (P <.001).

Recent evaluations of mail-service pharmacy have documented improved medication adherence compared with prescriptions dispensed with 30-day supplies via retail pharmacy, in large part because of the availability of extended-day supply dispensed with each prescription. Discussion The growth in the 90-day ratio reveals a preference by consumers and further supports the growing body

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Figure 2 Percent of Retail Prescriptions Filled as 90-Day Supply by Brand and Generic Status

9.0 $10/90-day-supply generics All maintenance brands Nonâ&#x20AC;&#x201C;$10/90-day-supply generics 8.0

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of evidence in support of offering consumers access to extended-day supplies of prescriptions at mail and retail pharmacies. Consumers cite high levels of overall satisfaction with retail and mail pharmacy services3,7,8 and value choice in pharmacy and prescription drug access.9 According to recent market research conducted by Walgreens, nearly 4 of 5 patients stated a preference for receiving their 90-day prescription at a retail pharmacy rather than by mail.10 Furthermore, in a recent study of consumer pharmacy preference, Liberman and colleagues showed that among commercially insured patients who transitioned from mandatory mail benefit to the Maintenance Choice benefit, 66.3% of those initiating therapy without a recent mail pharmacy prescription and 23.7% of current mail-service pharmacy users selected a retail pharmacy for subsequent 90-day-supply prescriptions.11 This benefit design, however, in general charges the consumer with the same copayment, regardless of the pharmacy channel selected. Not all pharmacy programs apply identical copayments for mail or retail pharmacy

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dispensed as 90-day prescriptions, and this will likely alter consumer preference and program uptake. The growth in 90-day prescriptions at retail pharmacies has implications for medication adherence. In a recent study of 13,922 patients from the Kaiser Permanente Northern California diabetes registry, Duru and colleagues reported that mail-order pharmacy users had better adherence to antiglycemic, antihypertensive, and dyslipidemic medications.6 In a study of oral antiÂ diabetic medication use, Devine and colleagues used propensity scores to match 14,600 cases to 43,800 controls selected from the MarketScan database.5 After adjustment, mail-service pharmacy users realized significantly higher adherence rates. In addition, the improved adherence was associated with lower total and diabetes-related medical costs over time. Although we are unaware of any research that demonstrates improved adherence with 90-day medication access at retail pharmacy, it is reasonable to assume that access to a 90-day supply of medication, regardless of point of access (retail or mail), would

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be associated with an improvement in adherence and improved control of many chronic conditions. If so, the recent studies of mail-service pharmacy by Devine and colleagues and Duru and colleagues provide compelling, supporting evidence for that likely improvement in adherence.5,6

Limitations This analysis was limited to prescriptions managed through insurance benefits of a major PBM. As such, it is potentially not representative of the consumer behavior related to prescriptions purchased without the use of such insurance (ie, cash purchases) nor those related to some government programs that provide beneficiaries copay assistance (ie, Medicaid). Furthermore, because of the increasing availability of cash-only programs, it is possible that the actual access to, and use of, 90-day prescription supplies are higher than our estimates. Conclusion Optimizing access to essential medications while managing pharmacy expenditures is a key function of PBMs.12 Benefit managers must weigh the potential value of increased convenience against the potential costs of providing access through different distribution channels. Nonetheless, the growth in 90-day prescriptions at retail pharmacy is likely to continue as more insurance providers adopt compatible benefit designs. Preliminary research indicates the potential benefits to the consumer by providing greater convenience and satisfaction, and overall health benefits resulting from improved medication adherence. It is important to continue monitoring these trends and to identify oppor-

tunities to rigorously evaluate their impact on healthcare costs and utilization. n

Editorâ&#x20AC;&#x2122;s Note This article originally appeared in American Health & Drug Benefits, March/April 2011, Volume 4, No 2. Used with permission. Author Disclosure Statement Dr. Liberman has reported no conflicts of interest. Ms. Girdish owns stock in CVS Caremark. CVS Caremark provided support for this study.

References

1. Pharmacy Benefits Management Institute. Prescription Drug Benefit Cost and Plan Design Online Report, 2010-2011 Edition. www.pbmi.com/BenefitDesign.asp. Accessed December 9, 2010. 2. National Association of Chain Drug Stores. Industry facts-at-a-glance. www.nacds. org/wmspage.cfm?parm1=6536#pharmpricing. Accessed September 9, 2010. 3. Birtcher KK, Shepherd MD. Usersâ&#x20AC;&#x2122; perceptions of mail-service pharmacy. Am Pharm. 1992;NS31:35-41. 4. Walmart. Walmart launches phase three of $4 Prescription Program. May 5, 2008. http://walmartstores.com/pressroom/news/8248.aspx. Accessed September 9, 2010. 5. Devine S, Vlahiotis A, Sundar H. A comparison of diabetes medication adherence and healthcare costs in patients using mail order pharmacy and retail pharmacy. J Med Econ. 2010;13:203-211. 6. Duru OK, Schmittdiel JA, Dyer WT, et al. Mail-order pharmacy use and adherence to diabetes-related medications. Am J Manag Care. 2010;16:33-40. 7. J.D. Power and Associates. 2009 National Pharmacy Study. www.jdpower.com/ healthcare/articles/2009-National-Pharmacy-Study/. Accessed February 25, 2011. 8. 90-day Rx solution. More health plans implement mandatory mail-order pharmacy programs, yielding greater savings and adherence rates. Drug Benefit News. 2010;11:1-2. www.silverlink.com/assets/pdfs/silverlinknews/dbn030510.pdf. Accessed March 11, 2011. 9. Desselle SP. Determinants of satisfaction with prescription drug plans. Am J Health Syst Pharm. 2001;58:1110-1119. 10. Business Wire. Walgreens to promote 90-day prescriptions at community pharmacies in Minneapolis. August 3, 2010. www.businesswire.com/news/home/ 20100803006228/en/Walgreens-Promote-90-Day-Prescriptions-CommunityPharmacies-Minneapolis. Accessed August 26, 2010. 11. Liberman JN, Wang Y, Hutchins DS, et al. Revealed preference for retail and mail-service pharmacy. J Am Pharm Assoc. 2011;51:50-57. 12. Shrank WH, Porter ME, Jain SH, Choudhry NK. A blueprint for pharmacy benefit managers to increase value. Am J Manag Care. 2009;15:87-93.

Stakeholder Perspective When More Is Almost Always Better POLICYMAKERS/PAYERS: The current relationship between mail order versus retail dispensing and 30-day versus 90-day prescriptions seems artificial. That 90-day prescriptions come by mail and 30-day prescriptions come from retail pharmacies is likely to be a side effect of the marketplace and of competition among pharmacy benefit managers (PBMs), insurers, and pharmacies rather than a rational, patient-centered approach to offering prescriptions.

An alternative is seen in the Veterans Affairs (VA) Healthcare System, where I practice. At the VA system, the 90-day prescriptions for chronic medications (ie, noncontrolled substances) is the standard, and these typically come by mail, but some patients elect to receive a partial fill at the window during the visit. The 30-day prescriptions that are set to be dispensed at the window but are never picked up are subsequently mailed directly to the patient. This synergy between Continued

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Stakeholder Perspective (Continued) retail and mail-order prescriptions creates rates of abandonment of prescriptions of almost zero, unlike outside the VA system.1 In the private sector, more options for where to fill a prescription (and thus more competition) would likely lower costs. Each of the players in the equation, however, faces financial risks if costs are lowered. Pharmacies that fill 90-day prescriptions are likely to receive fewer dispensing fees and lowered foot traffic through their pharmacies. These pharmacies could also, however, increase their market share if patients buy prescriptions at retail pharmacies instead of by mail. The mail-order operations run by PBMs face risks of dropping market share if patients can obtain 90-day prescription fills at retail pharmacies, although centralized mail-order pharmacies can achieve economies of scale and drive generic dispensing, making it difficult for retail pharmacies to compete. Employers are likely to benefit on several levels, from a more satisfied and potentially more adherent (and thus healthier) workforce, to more choice in pharmacy benefits. PATIENTS: From the patient’s perspective, it is difficult to argue against the availability of 90-day supplies of prescriptions at retail pharmacies. The proposition of offering more choices to patients for where and how to fill their prescriptions seems, on the surface, easily justified. As the present article by Dr Liberman and Ms Girdish describes, there is some evidence of

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greater satisfaction and improved adherence with 90-day versus 30-day supplies. Although the evidence is by no means definitive, the conclusions make intuitive sense—I have yet to meet a patient using ongoing, stable medications in my own practice who complains about having to come back in 3 months for a prescription rather than in 1 month. I do hear, however, patients who complain about having to coordinate receiving their prescriptions from multiple sources, whether they get their generics from low-cost retail pharmacies, their chronic disease medications in the mail, and their acute-need medication for their child (eg, antibiotic) from the pharmacy nearest to their workplace. The availability of 90-day supplies of medications from retail pharmacies may offer patients the option of receiving their long-term medications at the same location (and from the same pharmacists) where they pick up their short-term medications or over-thecounter products—more choice, better adherence, lower costs. 1. Shrank WH, Choudhry NK, Fischer MA, et al. The epidemiology of prescriptions abandoned at the pharmacy. Ann Intern Med. 2010;153:633-640.

Walid F. Gellad, MD, MPH Staff Physician, VA Pittsburgh Healthcare System Assistant Professor of Medicine, University of Pittsburgh Adjunct Scientist, RAND Health

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Pharmacy Empowering Community Pharmacists as Health Consultants in a Value-Based Healthcare System

Call for submissions

Do you have a retail pharmacy best practice to share?

In your background as a retail pharmacy manager, it’s likely there’s one business experience – and maybe more – that pharmacy managers across the nation would want to read about.

High-interest topics include the solution you found to a pharmacy management challenge, reimbursement, patient counseling across different therapeutic areas, clinical advances, regulatory changes, and business impacts on retail pharmacy.

Step out from “behind the counter” and send us your ideas!

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

Submit to: Lisa Neuman, Managing Editor E-Mail: lneuman@the-lynx-group.com

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Inside cardiometabolic: obesity

The Pharmacist’s Emerging Role in Weight Management: A Look into New Prescription Weight-Loss Medications By Lucas A. Berenbrok, PharmD; and Ben Culpepper, PharmD

pproximately 69% of adult Americans aged 20 years and older are overweight or obese, according to data collected by the Centers for Disease Control and Prevention in 2009-2010.1 Even more staggering is that nearly one third of adults in the United States are considLucas A. Berenbrok ered obese, causing an estimated $147 billion in US medical costs in 2008.2 To help increase the health and wellness of patients who are considered overweight or obese, pharmacists can encourage healthy lifestyles while providing patient care services such as medication therapy management. Pharmacists can also expand their role in helping patients lose weight through lifelong learning and staying current with new prescription medications that have been approved for weight reduction. In this discussion of newly approved therapies for chronic weight reduction, lorcaserin hydrochloride (Belviq) and phentermine/topiramate extended release (ER) (Qsymia) will be reviewed together using the 4 unique pillars of the pharmacy profession: indication, effectiveness, safety, and compliance.3 As the first US Food and Drug Administration (FDA)-approved medications for chronic weight management in more than a decade,4,5 lorcaserin and phentermine/topiramate ER are indicated adjuncts to diet and exercise for chronic weight management. Patients who can safely use these medications for weight reduction include adults with a body mass index (BMI) >30 kg/m2 with no weight-related comorbidities, or a BMI >27 kg/m2 with at least 1 weight-related comorbidity, Dr. Berenbrok is a PGY-1 community pharmacy practice resident at the University of North Carolina Eshelman School of Pharmacy in Chapel Hill, North Carolina; Dr. Culpepper is a PGY-2 pharmacy resident at the University of North Carolina Eshelman School of Pharmacy in Chapel Hill, North Carolina.

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KEY POINTS According to the CDC, 69% of adult Americans aged 20 years and older are overweight or obese, and one third of these adults are considered obese.

➤

In 2008, obesity cost the United States an estimated $147 billion in medical costs.

➤

The first FDA-approved medications for chronic weight management in over a decade are lorcaserin and phentermine/topiramate ER.

➤

Patients who can safely use these medications for weight reduction include adults with a BMI >30 kg/m2 alone or >27 kg/m2 if they have at least 1 weight-related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia.

➤

Pharmacists should counsel patients who are using lorcaserin and experiencing signs and symptoms of valvular heart disease, such as shortness of breath, edema, congestive heart failure, or a new cardiac murmur, to see their physician for immediate evaluation.

➤

Patient progress should be evaluated after 12 weeks with each medication to assess effectiveness and to consider continuation of therapy.

➤

such as hypertension, type 2 diabetes, or dyslipidemia. Although these novel therapies are not options for everyone, they may provide clinically meaningful weight reduction in the patient populations mentioned above in as little as 12 weeks.6,7

Dosages In addition to its specific indications for use, phentermine/topiramate ER is accompanied by a detailed dose titration. After an initial 2 weeks at 3.75 mg/23 mg once daily, therapy should be increased to 7.5 mg/46 mg once daily. Following 12 weeks of therapy at the 7.5-mg/ 46-mg dose, effectiveness should be evaluated using the patient’s weight-loss percentage from baseline. If >3%

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weight reduction is achieved, the dose can be continued. If >3% weight reduction is not achieved, the dose can be further titrated to the maximum dose of 15 mg/92 mg, or discontinued. After an additional 12 weeks at the maximum dose, effectiveness should again be evaluated using a 5% weight reduction from baseline to determine whether to continue or discontinue the therapy. In contrast, lorcaserin does not require a dose titration, eliminating the need for dose escalation, which may be an advantage in some patient populations. To correctly dose lorcaserin, patients should be initiated at the approved dose of 10 mg twice daily, and effectiveness should be evaluated after 12 weeks of therapy using a 5% decrease in body weight from baseline. Unfortunately, for both therapies it is unlikely that patients will achieve and sustain a clinically meaningful weight reduction if these markers from baseline are not attained.6,7

Safety and Compliance Several key points must be kept in mind to maximize patient outcomes through safety and compliance while minimizing the associated risks without limiting access to appropriate patients. An FDA-required Risk Evaluation and Mitigation Strategy (REMS) for phentermine/topiramate ER has been established to inform healthcare providers of the increased risk of teratogenicity, which includes a cleft lip with or without a cleft palate in infants exposed to topiramate in the first trimester. As such, phentermine/topiramate ER is only available through a network of certified pharmacies, which requires pharmacies to enroll and pharmacists to complete a training program and knowledge assessment. Pharmacists must ensure that the associated medication guide and patient brochure outlining the risk of birth defects is provided to the patient with every fill. Lorcaserin, a serotonin 2C receptor agonist, is not associated with a REMS program. However, many prescribers and patients may have questions regarding valvular heart disease, a complication of fenfluramine, a component of Fen-Phen and a serotonin 2B receptor agonist, which was previously used for weight loss until it was withdrawn from the market in 1997.8 Encouragingly, in the Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) trial, lorcaserin was not associated with an

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increased risk of valvulopathy when compared with placebo.9 Regardless, pharmacists should still counsel patients who are using lorcaserin and experiencing the signs and symptoms of valvular heart disease, which include shortness of breath, edema, congestive heart failure, or a new cardiac murmur, to see their physician for immediate evaluation.7

Pharmacists can also expand their role in helping patients lose weight through lifelong learning and staying current with new prescription medications that have been approved for weight reduction. Conclusion As prescribers, pharmacists, and patients become more comfortable prescribing, dispensing, and using prescription medications for chronic weight management, additional opportunities for pharmacists to make direct and meaningful interventions with patients will arise. Because both lorcaserin and phentermine/topir amate ER necessitate specific indicated uses, adequate trials for clinical effectiveness, safety requirements, and encouraged compliance, pharmacists can help patients achieve the health, wellness, and confidence that accompany weight loss by understanding the medications’ limitations and their adjunct role in chronic weight management. n References

1. Centers for Disease Control and Prevention. Obesity and Overweight. http://www. cdc.gov/nchs/fastats/overwt.htm. Accessed October 17, 2013. 2. Centers for Disease Control and Prevention. Adult Obesity Facts. http://www.cdc. gov/obesity/data/adult.html. Accessed October 17, 2013. 3. Cipolle RJ, Strand LM, Morley PC. Pharmaceutical Care Practice: The Clinician’s Guide. 2nd ed. New York, NY: McGraw-Hill; 2004. 4. US Department of Health and Human Services. US Food and Drug Administration. FDA approves Belviq to treat some overweight or obese adults [press release]. http:// www.fda.gov/newsevents/newsroom/pressannouncements/ucm309993.htm. Accessed October 17, 2013. 5. US Department of Health and Human Services. US Food and Drug Administration. FDA approves weight-management drug Qsymia [press release]. http://www.fda.gov/ newsevents/newsroom/pressannouncements/ucm312468.htm. Accessed October 17, 2013. 6. Belviq [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2012. 7. Qsymia [package insert]. Mountain View, CA: VIVUS, Inc; 2013. 8. US Department of Health and Human Services. US Food and Drug Administra tion. FDA announces withdrawal fenfluramine and dexfenfluramine (Fen-Phen) [press release]. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm179871.htm. Accessed October 17, 2013. 9. Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010;363:245-256.

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inside cardiometabolic: diabetes

Strategies to Enhance Outcomes for Patients with Type 2 Diabetes By Rhonda Greenapple, MSPH

iabetes is an important disease state causing sig nificant morbidity and mortality throughout the United States and worldwide. The cur rent obesity epidemic, together with the US aging population, is fueling the rapid increase in diabetes prevalence. A model ing study suggests that by 2020, Rhonda Greenapple 15% of adults will have dia betes, and 37% will have prediabetes compared with 12% and 28%, respectively, today.1 By 2050, approx imately 15 new diabetes cases per 1000 people are expected annually. This will result in a diabetes prev alence of between 1 in 5 diagnosed adults and 1 in 3 undiagnosed adults.1 Estimates from the Centers for Disease Control and Prevention (CDC) suggest that as of 2007, 23.6 million adults and children in the United States had diabetes; this represented nearly 8% of the US population.2 In addition, 5.7 million individuals who have diabe tes remain undiagnosed.2 Currently, type 2 diabetes accounts for at least 95% of diabetes cases.3 Prediabetic patients with elevated blood glucose levels represent 57 million individuals who are at high risk for progressing to diabetes within 10 years.3

Diabetes Comorbidities Patients with type 2 diabetes are at increased risk for the development of cardiovascular disorders, including coronary artery disease (CAD) and stroke. The constel lation of symptoms that includes insulin resistance and central obesity greatly increases the likelihood of emer gence of additional comorbidities.4 Common comor bidities associated with diabetes include hypertension (Figure 1), hyperglycemia, and dyslipidemia. Overall, interventions to improve these comorbidi ties individually result in concurrent improvements in other related clinical parameters. For example, when Ms. Greenapple is the Chief Executive Officer of Reimbursement Intelligence, LLC, Madison, New Jersey.

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obese individuals lose weight, insulin resistance is typi cally diminished, improving blood glucose levels, blood pressure (BP) typically decreases, and lipid parameters are improved.

Clinical Consequences Patients with diabetes are at great risk for serious and life-threatening complications.5 Adults with diabetes have cardiovascular disease (CVD)-related death rates approximately 2 to 4 times higher than adults without diabetes. And the risk for stroke is 2 to 4 times greater in patients with diabetes compared with those without diabetes. Macrovascular complications of diabetes include CAD, stroke, and peripheral vascular disease, which can result in ulcers, gangrene, and lower-extremity amputa tions. Diabetes macrovascular complications associated with larger blood vessels include CVD and stroke, which are responsible for 65% of all deaths in diabetes.5 Macrovascular complications representing small vascu lar injuries include diabetic retinopathy and peripheral nerve damage. Neuropathy, renal disease, and ocular damage are among the microvascular complications of diabetes. Diabetes is currently the leading cause of endstage renal disease.5 The complications of diabetes can be prevented or delayed with appropriate glycemic control and ongo ing disease management and monitoring. The benefits of good glycemic control have a long-term impact on outcomes. For example, a reduction in hemoglobin (Hb) A1c of 1% diminishes the risk for microvascular complications of eye, kidney, and nerve damage by 40%.1 Each 10-mm Hg reduction in systolic BP reduces diabetes-related complications by 12%, and correction of dyslipidemia may reduce the risk for cardiovascular complications by up to 50%.1 Economic Impact The costs associated with diabetes are staggering. Data released by the CDC in 2007 showed that the total cost of diagnosed diabetes in the United States was $174 billion, which included $116 billion of direct medical costs and $58 billion of indirect costs (ie, disability,

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work loss, and premature death).2 An analysis by UnitedHealth Group indicated that the majority of patients with diabetes are covered by private insurance, but the prevalence of diabetes and prediabetes in Medicare and Medicaid populations is higher than among the privately insured; consequently, these programs carry a disproportionate responsibility for healthcare costs attributed to these conditions.1 This analysis included data from a sample of 10 million commercial health plan members, showing that the average annual costs incurred by a patient with diabetes in 2009 was $11,700 compared with annual costs of $4400 for a patient without diabetes.1 Furthermore, the average annual costs incurred by a diabetic patient with complications was $20,700, which is nearly 3 times that of a diabetic patient with out complications ($7800).1 Another analysis demonstrated that even when controlling for specific comorbidities, including hyper tension, congestive heart failure, and CAD, patients with diabetes require greater expenditures compared with nondiabetic patients with those conditions.6 Estimates from the Agency for Healthcare Research and Quality indicate that nearly 25% of hospital spending results from patients with diabetes.7 In addi tion, hospital admissions for persons with diabetes cost more than comparable admissions for patients without diabetes.1 The optimal management of diabetes requires con trol of the patient’s glucose levels, BP, and lipid levels. However, a relatively low proportion of patients with diabetes actually achieve the treatment goals. Less than 50% of adults with diabetes aged <65 years demonstrate target HbA1c levels of <7%, as illustrated in Table 1.8 Adherence to antihyperglycemic drug therapy is relatively poor, which is an important reason for limited treatment success.6 A meta-analysis of adherence stud ies demonstrated a range of adherence between 36% and 93% in retrospective studies, and between 67% and 85% in prospective monitoring studies.9 Multiple studies have confirmed that poor adher ence to drug therapy is associated with poor glycemic control; similarly, a strong correlation exists between good compliance and adherence to antihyperglycemic medication regimens and glycemic control. One issue that contributes to poor medication adherence is the burden of copayments.10 With increasing copayments for antihyperglycemic drugs, adherence to prescribed regimens decreases.

Overview of the Approach to Treatment Major medical associations have adopted treat ment algorithms and guidelines for the management of

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KEY POINTS Patients with type 2 diabetes are at increased risk for cardiovascular disorders, including coronary artery disease, stroke, and peripheral vascular disease. ➤ The costs for diabetic patients with complications are nearly 3-fold greater than for diabetic patients without complications. ➤ The complications of diabetes can be prevented or delayed with appropriate glycemic control, disease management, and ongoing monitoring. ➤ An approach that uses a combination of strategies across a variety of care and payer modalities may provide substantial improvements in patient outcomes and curb the excess costs. ➤ Payers may need to reexamine how they approach the management of care for patients with diabetes. ➤

patients with diabetes, including the American Diabetes Association, the European Association for the Study of Diabetes, American College of Endocrinology, and the American Association of Clinical Endocrinologists.11 Although there are differences and distinctions in their recommendations, overall treatment approaches include lifestyle modifications to improve diet, increased physi cal activity, and smoking cessation. Virtually all patients with diabetes require phar macologic therapy, however. In addition to achieving glycemic control with target HbA1c levels >7%, medical interventions aim to control BP, correct dyslipidemia, and facilitate weight reduction for patients who are obese or overweight.1 Metformin, a biguanide, is generally the first oral anti diabetic medication administered. Metformin is titrated to maximal effect over 1 to 2 months, with the goal of achieving a significant reduction in HbA1c. If metformin monotherapy does not achieve an HbA1c control level at or near 7%, additional drugs may be added. Some oral drugs are formulated as combinations (typically with metformin) to enhance compliance with multiple-drug combinations. Frequent monitoring is necessary, and clinicians should aggressively modify medication regimens to achieve treatment goals. Appropriate medication selection requires that phy sicians be cognizant of all of the potential effects of antidiabetic medications, beyond their effects on hyper glycemia. For example, the vast majority of patients with type 2 diabetes are overweight or obese, yet the use of many antihyperglycemic medications (ie, insulin, sulfonylureas) results in weight gain. Selection of agents

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Figure 1 P revalence of Comorbidities: Diabetes and Cardiovascular Disease in Adults Aged 20-69 Years 20

Hypertension CAD CHF

16.7%

Prevalence, %

15 12% 10 7.4% 5.6%

4.7%

5 2.4%

1.5%

Type 1 diabetes

Type 2 diabetes

0.8%

0.1%

Nondiabetic patients

Patient population

CAD indicates coronary artery disease; CHF, chronic heart failure. Reprinted with permission from Fitch K, et al. Value-based insur ance designs for diabetes drug therapy: actuarial and implementa tion considerations. Milliman Client Report. December 1, 2008.

that are weight neutral, or promote weight loss, can offer additional advantages to patients. Other factors to consider include the effects of different medications on dyslipidemia and BP.5 The choice of agents may also depend on their effects on beta-cell function. It is estimated that by the time of diagnosis, patients with type 2 diabetes have lost at least 50% of their beta-cells.12 Preservation of remain ing beta-cell function should be a therapeutic priority; weight loss is an important route to this goal. Different antihyperglycemic medications have variable effects on beta-cell function, which should figure in the clinical decision-making.12 For example, the thiazolidinediones promote weight gain, but the thiazolidinedione pioglitazone delays betacell decline. Agents that promote the release of insulin, including sulfonylureas and the glinides, appear to in crease the rate of beta-cell failure. Agents that work via the incretin pathway, glucagon-like peptide (GLP)-1 analogs and dipeptidyl peptidase (DPP)-4 inhibitors, appear to preserve beta-cell function.12

Unmet Needs Current treatment approaches remain far from solv ing the problem of diabetes. This enormous unmet need

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has driven the development of many novel agents that incorporate innovative technologies and address differ ent metabolic pathways. At least 3 different classes of agents to stimulate the incretin pathway are being investigated12: • Small-molecule glucose-dependent insulinotropic receptor agonists (GPR119) are in clinical develop ment by at least 3 different companies • Compounds to stimulate TGR5, which is expressed in enteroendocrine cells of the gut and augments GLP-1 release, are being investigated • Activators of fatty acid–binding receptors, which potentiate insulin secretion by the pancreas in response to fatty acids, are particularly interesting, because they do not seem to promote beta-cell decline. Glucokinase activators increase pancreatic beta-cell sensitivity to glucose, thereby promoting insulin secre tion and enhancing hepatic handling of glucose; they also promote beta-cell function and survival.12 At least 8 companies have glucokinase activators in preclinical or clinical development. Another class of agents under investigation, sodium-glucose cotrans porter inhibitors (SGLT2), promotes urinary excretion of glucose; at least 8 of these agents are the subjects of clinical investigation. Recently, the US Food and Drug Administration approved the first SGLT2. Several for mulations of oral insulin are in development.12

Pharmacist-Led Intervention Approximately 15 years ago, the Asheville Diabetes Care Project was begun.13,14 This innovative, commu nity-wide disease management program utilized phar macists to provide critical information and support to enhance outcomes in patients with diabetes in the Asheville, NC, area. The North Carolina Center for Pharmaceutical Care coordinated the project, which included pharmaceutical companies, universities, and hospital-based resources, physicians, and communi ty-based pharmacists. The city of Asheville was the employer and payer; patients included active and retired employees and their families.13,14 Once patients were identified, their physicians were notified, and a participating pharmacist was assigned to each patient. Pharmacists met with their designated patients for initial 60-minute counseling sessions and offered guidance and advice to help patients achieve their therapeutic goals: patients understood that their progress would be monitored, their physicians would be informed of their progress, and monthly follow-up visits with the pharmacist were planned. Pharmacists documented patient interactions according to a specified protocol and communicated regularly with referring physicians.15 This pharmacist-implemented disease management

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program offered financial benefits for all stakeholders as well as the potential for improved clinical results.15 Copays were waived if patients participated in the program with a trained pharmacist. Pharmacists were paid for their interactions with these patients, and the employer incurred lower overall healthcare costs as a result of improved clinical benefits resulting from enhanced diabetes management.15 The first clinical outcomes of the Asheville Project were reported after 14 months.16 At baseline, 33% of patients had HbA1c levels between 4.4% and 6.4%; after 14 months, 67% of patients enrolled demon strated HbA1c levels within this range. The mean HbA1c of the group improved by 1.4 percentage points. Significant improvements from baseline were observed for high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.16 The economic impact of the Asheville Project was evaluated by comparing insurance claims and prescrip tion drug claims for the 12 months before and after the program initiation date. The total cost of inpatient and outpatient services declined by $20,246 during 12 months of this program.16 Although the number of patient–provider interactions increased, inpatient ser vices decreased as outpatient services were increasingly used, leading to decreased costs. This improvement in expenditure includes fees paid to the pharmacists for their intervention, the initial cost of supplying patients with glucose monitors, and charges for the educational program to train participating pharmacists. The Asheville Project utilized an innovative commu nity-based disease management approach that included pharmacist–patient interactions to provide education and support. With more than 5 years of follow-up, clin ical and economic improvements were clear.17 At each follow-up visit, increasing numbers of patients achieved HbA1c levels <7%, and more than 50% demonstrated improvements in dyslipidemia at every measurement. Multivariate analyses revealed that the patients who benefited the most were the ones with the highest base line HbA1c levels and the highest costs at baseline. Expenditures, which had initially been concen trated on inpatient and outpatient physician services, were increasingly dedicated to prescription medications. Total mean direct medical costs decreased by between $1200 and $1872 per patient annually. One employer group noted that employees lost fewer days to sick time annually, resulting in annual increases in productivity of approximately $18,000. Individuals enrolled in the Asheville Project were committed to participating in the program. The risk manager for Asheville reported that when individuals did not comply with their disease management program,

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ontrol Rates of Blood Glucose, Blood Pressure, and Table 1 C Cholesterol in Patients with Diabetes Control rate for patients aged <65 years

Control rate for patients aged ≥65 years

Blood glucose target HbA1c <7%

49%

62%

Systolic BP target <130 mm Hg

60%

33%

HDL-C target >40 mg/dL men, >50 mg/dL women

49%

56%

LDL-C target <100 mg/dL

39%

48%

BP indicates blood pressure; HbA1c, glycated hemoglobin; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol. Reprinted with permission from Fitch K, et al. Improved man agement can help reduce the economic burden of type 2 diabe tes: a 20-year actuarial projection. Milliman Client Report. April 28, 2010.

they were notified that they would no longer receive free medications and healthcare services; that knowledge became “the greatest adherence tool we ever saw.”18 The program was subsequently expanded to cover other disease areas, including hypertension, dyslipid emia, and asthma; favorable clinical and economic results emerged for all of these conditions.19 The dia betes program was successfully expanded in 2009 to cover 30 employers in 10 cities. Economic analyses confirmed the benefits of the program: employers saved $1100 annually on patient healthcare costs on average, and employees typically saved $600.20 Another North Carolina company instituted a similar program, which covered about 150 individuals with diabetes. In 3 years, the program resulted in savings of approximately $5115 per patient.21

Value-Based Pricing/Risk-Sharing Value-based pricing, or risk-sharing, represents a novel approach to reimbursement based on patient outcomes.22 In the most common type of risk-sharing agreement, the manufacturer assumes the risk of the drug providing benefit to patients. Either the cost of the ineffective drug is refunded to the payer, or an equiva lent amount of drug is provided to another patient at no cost. The net effect is that the payer is responsible to pay only for agents that result in improved health outcomes. Several modifications of this approach have been

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ost and Adherence Impact of 3 Benefit Designs for Table 2 C Patients with Type 2 Diabetes Plan Copay structure Generic/preferred brand/nonpreferred brand, $

Standard VBID1

VBID2

VBID3

10/25/40 0/12.5/30

0/0/0

10/10/10

Net copayment Per patient per month, $

102

PMPM, $

2.16

2.82

3.65

2.85

PMPM increment to base, $

0.67

1.49

0.69

Patients adherent, %

Increment to base, %

Virtual adherence

Copays are listed by tier 1/tier 2/tier 3. Model uses data on the actuarial impact of copays. Virtual population is based on a typical employee population. NA indicates not applicable; PMPM, per member per month; VBID, value-based insurance design. Reprinted with permission from Fitch K, et al. Value-based insurance designs for diabetes drug therapy: actuarial and implementation considerations. Milliman Client Report. December 1, 2008.

devised, although details in the literature are few. An antiobesity drug, rimonabant, was marketed in Sweden according to a finding that it could be cost-effective for patients whose body mass index (BMI) exceeded 35 kg/ m2 or for those with a BMI >28 kg/m2 plus dyslipidemia or type 2 diabetes. A value-based pricing scheme was developed, but it was in effect only through the end of 2008, and no follow-up details are found in the literature. Merck and CIGNA developed a novel agreement regarding the use of sitagliptin and a metformin and sitagliptin combination.22 Merck discounts the cost of these agents to CIGNA with documentation of improved blood glucose control, regardless of whether the improvement results from the use of sitagliptin, the metformin–sitagliptin combination, or other drugs. With this arrangement, Merck actually makes less money per drug used as health outcomes improve, but by placing these products favorably among CIGNA’s options for diabetes treatment, increased use of these agents is expected. An important limitation in understanding the impact of this type of risk-sharing is that, unlike results of con

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trolled clinical trials that are generally widely published, reports of postmarketing outcomes-based approaches, typically based on private agreements between manufac turer and payers, are not often published or disseminated.

Value-Based Insurance Design Value-based insurance design (VBID) is an innova tive approach to benefit planning to reduce long-term healthcare costs while improving health quality.5,10,23 It involves changing the cost structure for plan partici pants to promote the use of services or treatments that result in relatively high health benefits and to discourage use of interventions with no or limited health benefits.6 Briefly, VBID uses a so-called “clinically sensitive copay structure.”10 Patients with diabetes represent a potentially valuable population within which to study this approach, because previous work has demonstrated relatively poor adherence with antidiabetic drug therapy, and a consistent relationship showing diminished med ication adherence with increasing copays.10 Poor adher ence is associated with poor glycemic control. VBID for patients with diabetes aims to increase adherence and treatment compliance by decreasing drug copays.10 The Milliman Group performed a modeling exper iment to assess 3 different VBID copay tier structures, comparing them with a standard structure in which the copay is $10 for generic drugs, $25 for preferred brands, and $40 for nonpreferred brands (Table 2).6 The options modeled included a plan with no copay for any medication ($0/0/0), one in which there was the same copay regardless of preferred status ($10/10/10), and one that reflects the usual copay structure, although at markedly lower copays ($0/12.5/30).6 The analysis demonstrated that all these VBID plans increased medication adherence as well as costs to the payer. Increased payer costs result from lower copays required from patients with diabetes, as well as from filling of prescriptions by patients who previously were not obtaining their medications.6 The Milliman report did not further analyze models to predict the cost-sav ings that might result from improved glycemic control achieved with increased medication adherence after reduction of copays. Results of such modeling exercis es would be very informative and could further guide rational program development to enhance outcomes and control costs. Pitney Bowes implemented a limited VBID program for employees and beneficiaries with diabetes or vascular disease.23 Copays were eliminated for cholesterol-low ering statins, and copays were reduced for patients who were prescribed the antiplatelet agent clopidogrel for blood-clotting prevention. Results on drug adherence from the Pitney Bowes group were evaluated together

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Future Directions in Diabetes Interdisciplinary Cooperation, Engagement As healthcare-related costs in the United States have

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Figure 2 Medication Adherence and Emergency Care Utilization Nonadherent Adherent

0.25

0.23

0.20

Mean visits PMPY, N

with data from comparable patients covered by another plan without VBID.23 Eliminating copays for statins promoted stabiliza tion of statin use and encouraged adherence; statin use continued the typical decline in use in the con trol group. Adherence to statins was 2.8% higher by patients in the Pitney Bowes group than in the con trol group. Adherence to clopidogrel was stabilized with copay reduction, with 4% higher adherence for Pitney Bowes patients compared with controls. Implementation of this VBID plan for statins and a clot-inhibiting drug resulted in modest improvements in medication adherence.23 Nair and colleagues reported on utilization and expenditures in a population of patients with diabetes from a healthcare industry employer.24 Expenditures and drug prescriptions filled were tracked for a 9-month baseline period and 2 full years after initiation of the program. A total 225 patients with diabetes were con tinuously enrolled (mean age, 49 years); 52% had dys lipidemia, and 68% had hypertension.24 The VBID plan introduced for this study had all dia betes drugs and testing supplies at tier 1; retail copay was $10 and mail-order copay was $20. Investigators found a mean increase of 9% for any diabetes-related prescrip tion in year 1, with a smaller increase of 5.5% in year 2. Medication adherence increased between 7% and 8% during year 1, but decreased slightly during the second year of the study. Pharmacy expenditures increased by nearly 50% in both years. Total medical expenditures for diabetes-related services increased 16% in year 1 and 32% in year 2 from baseline, although these changes were not significant.24 Of note, emergency department visits decreased in year 1, although expenditures for office visits increased in both years. As shown in Figure 2, patients who adhered to drug therapy required far fewer emergency department visits overall.24 This analysis indicates that although implementa tion of VBID by reducing drug copays increases pre scription medication adherence, other measures may be necessary to effect the changes that result in meaningful improvements in clinical outcomes. For example, these approaches may include patient and provider educa tion and techniques to aid compliance with treatment, potential components to an integrated disease manage ment program. Furthermore, economic gains resulting in improved adherence to diabetes treatment, with resultant benefits to clinical outcomes, may require a longer-term view.

0.15 0.11 0.10 0.06 0.05 0

0.05 0.03

Preperiod

Year 1

0.04

Year 2

Observation period

PMPY indicates per member per year. Adapted with permission from Nair KV, et al. Am Health Drug Benefits. 2009;2:14-24.

spiraled in an explosive fashion, many stakeholders have actively been seeking creative approaches to maximize the value of healthcare. A diverse array of strategies have been proposed, including consumer-driven health plans, wellness and prevention programs, pay-for-perfor mance initiatives, and use of health information tech nology to collect, measure, and analyze data. Although economic incentives to patients, such as VBID, may increase adherence, such programs alone seem to pro vide only modest gains. An approach that uses a combination of strategies designed to impact patients’ health-related behaviors across a variety of modalities may provide a route to substantial improvements both in health outcomes and, ultimately, in health-related expenditures. The Diabetes Ten Cities Challenge used an integrated disease manage ment approach together with elimination of drug copays, educational initiatives, acceptance of evidence-based guidelines, and community-based pharmacist coaching.25 In a cohort of 573 patients with diabetes, this program demonstrated an average reduction of $1079 in annual total healthcare costs per patient, and mean HbA1c lev els decreased from 7.5% to 7.1% (P = .002).25

Payers’ Key Role in Improving Outcomes The diabetes population is a medically complex population that requires more aggressive case man agement and medical intervention. Many payers have implemented innovative approaches to improve health

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outcomes and per member per month costs for diabetes and at-risk populations. At the same time, payers are limited in how they can effectively engage noncompli ant patients with diabetes to change their lifestyle and improve their overall medical care. With the advent of electronic medical records and accountable care organizations, payers, physicians, and patients will likely have greater coordination of care, adherence to guidelines, and aligned incentives. Patients and their families will need ongoing case management and monitoring to prevent further progression of the disease and its associated complications. Physicians need the tools and incentives to continue to educate and monitor ongoing treatment planning. Future models must take the successes of prior initiatives and ensure that current and future high-risk patients are engaged into the healthcare system. Payers in particular may need to reexamine how they approach care of patients with diabetes.26 The Diabetes Prevention and Control Alliance is a part nership between the CDC, the YMCA, UnitedHealth Group, and Walgreens that aims to reduce the risk of developing diabetes by encouraging lifestyle modifica tions. Their goals include identification of prediabetic individuals, contacting and screening them, and enroll ing them in a program designed to support lifestyle changes. In addition, pharmacists are trained to provide support with regard to diabetes education, medication management, behavioral interventions, and monitoring for complications.

Conclusion To effect meaningful change, improve health out comes, and maximize cost-effectiveness, novel programs to engage patients with diabetes should seek to combine educational initiatives; support for lifestyle modifica tions, including smoking cessation; encouragement of exercise programs; nutritional counseling; health aware ness reminders to promote foot and eye examinations; and regular HbA1c, lipid, and BP monitoring, together with financial incentives to support patients behavior ally and economically. These wide-ranging interdisci plinary cooperative initiatives may result in improved glycemic control and a reduced risk of the long-term complications of diabetes with their attendant effects on morbidity and mortality. n Editor’s Note This article originally appeared in American Health & Drug Benefits, Volume 4, Number 6, September/ October 2011. Used with permission.

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Author Disclosure Statement Ms Greenapple reported no conflicts of interest. References

1. UnitedHealth Center for Health Reform & Modernization. The United States of diabetes: challenges and opportunities in the decade ahead. Working paper 5, November 2010. www.unitedhealthgroup.com/hrm/UNH_WorkingPaper5.pdf. Accessed September 1, 2011. 2. Centers for Disease Control and Prevention. National Diabetes Fact Sheet. 2007. www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. Accessed August 2, 2010. 3. National Diabetes Information Clearinghouse. Diabetes Prevention Program. http://diabetes.niddk.nih.gov/dm/pubs/preventionprogram/DPP.pdf. Accessed August 31, 2011. 4. Long AN, Dagogo-Jack S. Comorbidities of diabetes and hypertension: mech anism and approach to target organ protection. J Clin Hypertens (Greenwich). 2011;13:344-351. 5. American Diabetes Association. Complications of diabetes in the United States. http://schoolwalk.diabetes.org/swfd/swfd_mshs_attach.pdf. Accessed April 7, 2009. 6. Fitch K, Iwasaki K, Pyenson B. Value-based insurance designs for diabetes drug ther apy: actuarial and implementation considerations. Milliman Client Report. December 1, 2008. www.sph.umich.edu/vbidcenter/publications/pdfs/vbid-diabetesdrug-therapyRR12-01-08.pdf. Accessed September 7, 2011. 7. Fraze T, Jiang J, Burgess J. Agency for Healthcare Research and Quality. Hospital stays for patients with diabetes, 2008. Statistical brief #93. August 2010. www.hcup-us. ahrq.gov/reports/statbriefs/sb93.pdf. Accessed September 7, 2011. 8. Koro CE, Bowlin SJ, Bourgeois N, Fedder DO. Glycemic control from 1988 to 2000 among US adults diagnosed with type 2 diabetes: a preliminary report. Diabetes Care. 2004;27:17-20. 9. Cramer JA. A systemic review of adherence with medications for diabetes. Diabetes Care. 2004;27:1218-1224. 10. Arevalo JD. Perspectives in value-based insurance design for patients with diabe tes: assessment and application. Am Health Drug Benefits. 2011;4:27-33. 11. Nguyen Q, Nguyen L, Felicetta J. Evaluation and management of diabetes melli tus. Am Health Drug Benefits. 2008;1:39-48. 12. Aicher TD, Boyd SA, McVean M, Celeste A. Novel therapeutics and targets for the treatment of diabetes. Expert Rev Clin Pharmacol. 2010;3:209-229. 13. Kent S. The Asheville Project: walking the tightrope to better health. Pharmacy Times. 1998;suppl:9-10. 14. Spillers C. The Asheville Project: using existing resources to prepare pharmacists for an expanded role. Pharmacy Times. 1998;suppl:30-31. 15. Bunting B, Horton B. The Asheville Project: taking a fresh look at the pharmacy practice model. Pharmacy Times. 1998;suppl:11-18. 16. Cranor CW. Outcomes of the Asheville Diabetes Care Project. Pharmacy Times. 1998;suppl:19-25. 17. Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc (Wash). 2003;43:173-184. 18. Kertsz L. Copay waiver programs cut health costs, improve productivity. Business Insurance. May 10, 2009. www.businessinsurance.com/article/20090510/ISSUE01/ 100027603#crit=kertesz. Accessed September 7, 2011. 19. Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and eco nomic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003). 2008;48:23-31. 20. Esola L. Asheville, NC, spawns a movement while improving the health of residents. Business Insurance. March 14, 2010. www.businessinsurance.com/article/ 20100314/ISSUE07/303149993&template=preprint. Accessed September 7, 2011. 21. Wojcik J. Employer sees clear results. Business Insurance. April 22, 2007. www. businessinsurance.com/article/20070422/ISSUE01/100021708&template=printart. Accessed September 7, 2011. 22. Hunter CA, Glasspool J, Cohen RS, Keskinaslan. A literature review of risskshar ing agreements. J Korean Acad Managed Care. 2010;2:1-9. 23. Choudhry NK, Fischer MA, Avorn J, et al. At Pitney Bowes, value-based insur ance design cut copayments and increased drug adherence. Health Aff (Millwood). 2010;29:1995-2001. 24. Nair KV, Miller K, Saseen J, et al. Prescription copay reduction program for diabetic employees: impact on medication compliance and healthcare costs and utili zation. Am Health Drug Benefits. 2009;2:14-24. 25. Fera T, Bluml BM, Ellis WM. Diabetes Ten City Challenge: final economic and clinical results. J Am Pharm Assoc (2003). 2009;49:383-391. 26. Kuznar W. Payers lead healthcare reform toward prevention of chronic disease. Am Health Drug Benefits. 2010;3(suppl 5):S10. www.ahdbonline.com/sites/default/ files/AHDB0410_0.pdf. Accessed September 1, 2011.

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Stakeholder Perspective We Must All Engage in the Diabetes Challenge: A Lifelong Journey, with No Silver Bullet In her article, Ms Greenapple provided an extensive list of successful strategies to go into full battle with the ever-growing type 2 diabetes giant in an effort to produce better outcomes for patients with this disease. So, why is the rate of diabetes continuing to skyrocket? The medical literature is filled with many articles and volumes indicating that good glycemic control is key to diabetes management. Recommendations from health plans regarding dia betes management start with suggesting to members to change their diet, increase their exercise, and, for those who smoke, quit smoking. For the majority of individuals, however, these 3 functions likely represent the most difficult goals to accomplish successfully longterm, with or without diabetes. After members unsuccessfully attempt these behav ioral modifications, the next payer answer is to provide a plethora of pharmacotherapy options for providers to choose from for their patients. These, however, remain just that—a list of options. Payers must become more active in engaging providers to implement more structured diabetes management initiatives. Gone are the days of simply making antidiabetes drugs available at the preferred lowest branded copayment, thereby relieving the payer of any further involvement. Payer reimbursement for a diabetes office visit and the cost differential of the prescribed drug is just a “paper exercise.” Have we become mere transac tions? Our healthcare delivery system deserves more: it hinges on the payer environment. If we are in this diabetes fight together, then we should demand payers to provide the structured framework necessary to effec tively manage diabetes. In this article, Ms Greenapple

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discusses many examples of innovative payers who took the initiative and developed novel diabetes management programs that led to better outcomes by decreasing hemoglobin (Hb) A1c, blood pressure, and lipid levels, as well as weight. There is no silver bullet to diabetes management, and the onus does not fall entirely on the payer’s shoulders. An integrated approach is absolutely nec essary: all stakeholders must step up and get engaged for successful management to become sustainable. Perhaps the introduction of accountable care organiza tions (ACOs) and ACO-like groups will motivate the healthcare community to implement more aggressive diabetes management interventions. Aggressive inter vention in the prediabetes population puts a stake in the ground toward reversing the ever-increasing trend of diabetes prevalence in this country. Of course, the ultimate elements of successful diabetes management are patient commitment and accountability. For health plans not already engaged, this is a grand opportunity to motivate their members, providers, and retail pharmacists to take charge and make a difference. We need a healthier nation, and it starts with aligning all stakeholders. To paraphrase an old saying, the success of diabetes management in reducing weight, HbA1c levels, blood pressure, and cholesterol is a lifelong journey, not a destination. Charles E. Collins, Jr, MS, MBA Executive Vice President Engage Managed Markets, a division of The Lynx Group, and Inside Pharmacy

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Inside cardiometabolic: Diabetes

Demystifying the A1C Test for Patients with Diabetes By Shannon Irene Burke, PharmD

e are living in an era where the prevalence of diabetes continues to be on the rise. This disease affects nearly 25.8 million, or 1 in 12, Americans.1 While the number of diagnosed cases is steadily increasing, the time that doctors have to spend with their patients is becoming very limShannon Irene Burke ited, especially at a time where there is a dearth of primary care physicians.2 Many patients are turning instead to a pharmacist who they know and trust to provide a more in-depth explanation of their disease states and medications. This unique situation provides pharmacists with the opportunity to showcase our skills and the value that we add to healthcare through patient education, motivational support, and follow-up counseling.3 Pharmacists can also go a step further and become a Certified Diabetes Educator specializing in diabetes management, prediabetes, and diabetes prevention. While many patients understand the importance of monitoring their blood glucose levels, they lack the connection that an A1C reading has to diabetes. Most patients recognize the name of the test, but less than 50% of patients with diabetes know their A1C level or

As pharmacists, we can reinforce that medication adherence and changes in lifestyle, such as dietary modifications and increased physical activity, can significantly impact a patient’s A1C levels. what their target level is.4 It is vital that patients with diabetes understand what the A1C test means, why this test is important to them, and how to manage their Ms. Burke is a clinical pharmacist for RxAlly in Leesburg, Virginia.

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lifestyle and medications to work toward a lower A1C level. Conveying these key concepts to patients at a level that they will understand can be tricky. However, when patients understand the concepts involving their disease states and how it impacts them, they can be more proactive in their care.5 In simple terms, the A1C test conveys to the healthcare provider what percentage of hemoglobin, an iron-containing and oxygen-carrying protein found in red blood cells, is attached to a glucose molecule. When a patient’s blood sugar is high, this allows for more glucose molecules to attach to the blood’s hemoglobin. Red blood cells have an average life cycle of 120 days, and new cells are constantly being created. It is key to point out to the patient that the continuous generation of new blood cells allows for them to achieve different A1C results every few months. This shows them that their diabetic medications and lifestyle choices can make a difference. In patients with dia betes, a higher percentage of coated hemoglobin results in an increase in the patient’s A1C level, which has a strong predictive value for increased complications such as cardiovascular disease, nephropathy, retinopathy, and is indicative of poor control of blood glucose levels. Therefore, maintaining the patient’s A1C close to normal levels should allow for less risks and lower costs of care in the long run.6 The A1C test requires routine blood draws that will occur based on how well the patient’s blood sugar levels are controlled. Patients should expect that their doctor may request to see them quarterly to monitor their progress if they have had a change in therapy or their blood sugar is not well controlled. Taking measurements every 3 months provides a clearer picture to the doctor about whether glycemic goals have been maintained. Once the patient is meeting treatment goals and has stable glycemic control, the A1C test may only need to be performed twice a year. When consulting your patient, make sure that they have a follow-up appointment scheduled with their physician. As pharmacists, we can make sure that the patient understands why this examination is important to them so that they follow through with their care. A typical

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patient with diabetes will test their blood sugar at certain points of the day, which provides their physician with a very limited picture. The A1C test allows the physician to see an average of a patient’s blood glucose over a 3-month period. The American Diabetes Association describes an A1C reading as being similar to a baseball player’s seasonal batting average. This measurement displays the overall success of the patient in controlling their glycemic levels, not a single game’s batting record or a single day’s blood glucose readings.6 Next, it is vital that the patient understands what their A1C number represents. Not knowing your A1C is like driving a car at night with no headlights on a dimly lit road. Clearly, your chances of crashing are high. The normal level for A1C in a patient that does not have diabetes is between 4% and 6%. An A1C of 6% corresponds to an estimated average glucose of 126 mg/ dL.6,7 The goals for glycemic control will vary between patients and are at the physician’s discretion. The A1C target is dynamic and can change for a patient based on their age, comorbid conditions, duration of diabetes, risk for hypoglycemia, and life expectancy. Patients need to understand that once their goal is decided, it will take time to achieve it and should not be rushed. An A1C target of less than 6.5% is still considered optimal according to the “2013 AACE Comprehensive Diabetes Management Algorithm” released by the American Association of Clinical Endocrinologists, but only if that goal can be achieved in a safe manner that avoids hypoglycemia.7,8 Lastly, as pharmacists, we can reinforce that medication adherence and changes in lifestyle, such as dietary modifications and increased physical activity, can significantly impact a patient’s A1C levels. Controlling a patient’s A1C requires a lot of skill. The medication regimen needs to be balanced with their diet choices, physical activity, weight, and daily stress levels. Diabetics do not possess enough insulin to push the excess sugar molecules toward their cells and so it builds up in the blood. When a patient indulges in excessive carbohydrates, this can cause their A1C levels to rise because carbohydrates are broken down into sugar. Stress also can cause an accumulation in the blood by sending a message to the liver to produce more sugar. Excess weight requires more insulin to provide sugar to the muscles and the brain and can result in insulin resistance.5 To counteract their diabetes, it is recommended that patients participate in moderate exercise starting at least 3 times a week for 30 minutes and then building up to 5 days a week. This may include a brisk walk, cycling, or swimming.7 Controlling their diet using the “Plate Method” is a great start toward glycemic con-

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KEY POINTS Diabetes affects almost 26 million people. ➤ B ecause of the increasing shortage of primary care physicians and the increasing demands on their time, patients are increasingly turning to their pharmacists for a more in-depth explanation of their disease states and medications. ➤ P harmacists can become a Certified Diabetes Educator specializing in diabetes management, prediabetes, and diabetes prevention. ➤ W hile many patients understand the importance of monitoring their blood glucose levels, they lack the connection that an A1C reading has to diabetes. ➤ W hen a patient’s blood sugar is high, this allows for more glucose molecules to attach to the blood’s hemoglobin. ➤ L ess than 50% of patients with diabetes know their A1C level or what their target level is. ➤ T he A1C test allows the physician to see an average of a patient’s blood glucose over a 3-month period. ➤

In simple terms, the A1C test conveys to the healthcare provider what percentage of hemoglobin, an iron-containing and oxygencarrying protein found in red blood cells, is attached to a glucose molecule

➤

The normal level for A1C in a patient that does not have diabetes is between 4% and 6%.

➤

The medication regimen needs to be balanced with their diet choices, physical activity, weight, and daily stress levels.

➤

trol.9 The Plate Method involves using a 9-inch plate and reserving half of the plate for vegetables (they can keep this empty for breakfast), 1 quarter of the plate for lean meat or proteins, and the last quarter of the plate for starches or grains. They can also indulge in 8 ounces of low-fat milk and a half cup of fruit with each meal. Meat and proteins may include beef, chicken, salmon, eggs, and cottage cheese. Starches or carbohydrates may include oatmeal, dry cereals, whole grains, and whole wheat pasta. Lastly, nonstarchy vegetables such as broccoli, lettuce, carrots, artichokes, cucumbers, celery, and salsa are recommended. Following the Plate Method for 3 meals a day and adding up to 2 nutritious snacks will help put the patient on the right track to reaching their glycemic goals.9 Over-the-counter supplements such as cinnamon, chromium, and zinc may have value in lowering glucose levels as well. Patients should always

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discuss using these supplements with their doctor first though before beginning use. Avoiding alcohol consumption should also be addressed as well as the use of medications that can cause an increase in blood glucose levels, such as steroids and atypical antipsychotics.

Conclusion Patients with diabetes can face potentially serious health concerns. As pharmacists, we can have a positive impact at the patient level through our regular contact with this population. Before you end your A1C conversation with a patient, always be sure to have them recap what you discussed. This will allow you to judge their level of understanding. This also provides the patient with the opportunity to voice any concerns that they may have. In the end, improving patients’ understanding of diabetes management is the key to establishing better health outcomes. n

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. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2011. 2. Dugdale DC, Epstein R, Pantilat SZ. Time and the patient–physician relationship. J Gen Intern Med. 1999;14(Suppl 1):S34-S40. 3. Fera T, Bluml BM, Ellis WM. Diabetes Ten City Challenge: final economic and clinical results. J Am Pharm Assoc. 2009;49(3):383-391. 4. Harwell TS, Dettori N, McDowall JM, et al. Do persons with diabetes know their (A1C) number? Diabetes Educ. 2002;28(1):99-105. 5. Utah Department of Health. Utah Diabetes Practice Recommendations–Patient Advisory. Utah Department of Health. Salt Lake City, UT: Utah Department of Health; 2006. http://health.utah.gov/diabetes/pdf/udpr/udpr_a1cpatientadvisory_ nov06.pdf. Accessed September 10, 2013. 6. American Diabetes Association. Living with Diabetes: A1C and eAG. Published July 30, 2013. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glu cose-control/a1c/. Accessed September 10, 2013. 7. American Diabetes Association. Standards of Medical Care in Diabetes—2013. Diabetes Care. 2013;36:S11-S66. 8. Garber A, Abrahamson M, Barzilay J, et al. AACE Comprehensive Diabetes Management Algorithm 2013. Endocr Pract. 2013;19:328-335. https://www.aace.com/ files/aace_algorithm.pdf. Accessed September 10, 2013. 9. McCulloch M. Plate Method Meal Ideas. Diabetic Living. 2013. http://www. diabeticlivingonline.com/food-to-eat/nutrition/plate-method-meal-ideas. Accessed September 10, 2013.

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