IP June/July 2014

InsidePharmacyOnline.com June | July 2014 VOL. 2 • NO. 3

8 The Networking

Pharmacist

14 Integrating

Health&

Wellness

Pretravel Health into Daily • Chain Headquarters • Independents • Physician Assistants • Nurse Practitioners Pharmacists Pharmacy Practice

25 Benefits of

Professional Association Involvement

32 HR 4190: A Modest

The Role of Retail Pharmacists in Promoting and Maintaining Patients’ Health PAGE 11

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Transforming Retail Pharmacies into Healthcare Delivery Companies™

Proposal or Healthcare System Paradigm Shift?

38 Eight Prescriptions

to Improve Your Finances

© 2014 The Lynx Group, LLC

Call for submissions

?

Do you have a retail pharmacy best practice to share?

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

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Submit a 750- to 1500-word original article, previously unpublished and submitted exclusively to Inside Pharmacy, that your fellow pharmacy managers will want to read.

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Mission Statement Inside Pharmacy is an independent journal founded on the principle of value-based, patient-centered, evidence-based healthcare. As retail pharmacies transform into healthcare delivery companies, Inside Pharmacy offers a forum for pharmacists, chain headquarters, independent pharmacies, physician assistants, and nurse practitioners to navigate the healthcare system and achieve professional success.

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

Contact information: For subscription information and editorial queries, please contact: fevans@the-lynx-group.com; tel: 732-9921895; fax: 732-992-1881.

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Inside Pharmacy ❚ June | July 2014

3

the Editorial Board

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

“ Page 8

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

A real benefit in today’s dynamic work environment is that networking can extend your reach and introduce you to potential new employment opportunities.”

—Donald J. Dietz, RPh, MS

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

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

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

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

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

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

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

Albert Garcia Executive Vice President Navarro Health Services Medley, FL

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

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

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

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

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

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

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

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

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Inside Pharmacy ❚ June | July 2014

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June | July 2014 Volume 2 Number 3

INSIDE

Wellness

Health&

COLUMNS

Wellness

PAGE

8

THE First Word

14 Integrating Pretravel Health into Daily Pharmacists • Chain Headquarters • Independents • Physician Assistants • Nurse Practitioners Pharmacy Practice Pharmacists have protected patients against influenza, pneumococcal disease, shingles, and other diseases through vaccination.

Donald J. Dietz, RPh, MS

The Networking Pharmacist

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17 Three Components to Natural, Easy, andTransforming Retail Pharmacies into Healthcare Delivery Companies Lasting Weight Loss

PAGE

32

™

HealthCARE Policy

Guiding patients to adopt lifelong, healthy, nutritional habits instead of trying a nutrient-limiting diet is invaluable.

Robert E. Henry HR 4190

Patient Care

22 Five Tips For Sun Protection

Starts

Now that the warm weather is here, it is important for patients to protect their skin.

on page

cover story I wellness

The Pharmacy

25 Benefits of Professional Association Involvement Whether you see membership as a right, responsibility, or both, there are benefits to being involved in a professional pharmacy organization.

28 CMS Call to Action Call Letter 2015

❚

❚

Money

❚

Financial planning is a process that can help you reach your goals and evaluate the whole financial picture.

call for submissions

4

Editorial Board

6

Inside Pharmacy Online

7

letter from the editor

23 RETAIL CLINIC NewS ® 35 S takeholder Perspective

Retail Pharmacists’ Role in Promoting and Maintaining Health and Wellness

It is critical for all stakeholders to actively participate in the dialogue with CMS and shape the plan offering each year.

38 Eight Prescriptions to Improve Your Finances

11

2

36 CHAIN HEADQUARTERS 41 FDA UPDATES

components of health and 8 wellness

44 Drug Update

mbracing your expanding E role in retail pharmacy ervice offerings available S to promote health and wellness

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Inside Pharmacy ❚ June | July 2014

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adquarter • Chain He

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Practitioner

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

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Letter from the Editor Setting the Trend in Healthcare Retail Pharmacies Bridge the Gap in Patient Access to Care

by Frederique H. Evans, MBS, Editorial Director, Inside Pharmacy

The reality about disruptive innovation is that other disruptions come along, I was told recently in an interview. }} }} Healthcare delivery is in a constant state of flux and retail pharmacies are transforming the healthcare landscape to provide affordable, accessible products and services for their customers. This paradigm is shifting away from traditional healthcare venues like hospitals and doctors’ offices into retail clinics and patients’ homes.

Patient access to care is at the core of the issue. The implementation of the Affordable Care Act, private healthcare exchanges, an aging population, and empowered customers have been met with a shortage of primary care providers and gatekeepers to care. Retail pharmacies, and the team inside the pharmacy, have the incredible opportunity to meet these challenges and provide access to care for patients who need it the most.

Chain headquarters have anticipated these gaps of care and have allocated a tremendous amount of resources to transform retail pharmacies into healthcare delivery companies. They are joining accountable care organizations, promoting health and wellness in their stores, and building relationships with patients, primary care physicians, physician assistants, nurse practitioners, and pharmacists.

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Patients are seeing these changes take place and taking full advantage of their local retail pharmacy—getting to know their pharmacists better and visiting retail clinics without making a phone call, dealing with excessive wait times, or taking a day off from work. Since the very beginning, pharmacists have been right there to answer questions and educate patients, and now, retail clinics are available to take care of acute treatment of conditions ranging from the common cold to minor injuries, and to manage chronic conditions.

IP promotes a multistakeholder approach to care.

With that in mind, Inside Pharmacy (IP) broadened its scope to help guide the growing needs of retail pharmacies, including their patients, customers, and shoppers, as they transform into healthcare delivery companies by promoting a multistakeholder approach to care from executives at chain headquarters, pharmacy buyers, and managers to physician assistants and nurse

practitioners in retail clinics and independent pharmacies. Each issue of the journal provides a balanced, high-level overview of value-based health drivers, and the impact of healthcare sector initiatives. The information will focus on how these forces open new opportunities for the business growth of pharmacies.

As a forum for pharmacists, chain headquarters, independent pharmacies, physician assistants, and nurse practitioners, we welcome your feedback and hope that we can generate discussion on the topics covered in this issue. An independent pharmacist reached out to us last month about an article on electronic prior authorization we published in April asking us how to start the process.

We’ll tell you how. The goal of the journal isn’t to add on to the wealth of information you encounter on a daily basis, but get to the heart of the matter and tell you what you need to know about the clinical, business, and policy aspects of retail pharmacy.

Inside Pharmacy is an all-encompassing informational resource to achieve professional success as it relates to prevention and wellness, acute treatment, and monitoring and management of chronic diseases of the patient. ❚

Inside Pharmacy ❚ June | July 2014

7

The First Word The Networking Pharmacist

“

by Donald J. Dietz, RPh, MS, Editor-in-Chief, Inside Pharmacy

A real benefit in today’s dynamic work

environment is that networking can extend your reach and introduce you to potential new employment opportunities as well.”

C

ommunity pharmacists often measure how many prescriptions are dispensed in a given day or week.

We also look at pharmacy sales, profits, labor costs per prescription, dispensing errors, and customer service metrics, among a variety of other measurements, to determine how we are progressing or how we compare with a similar group of pharmacies.

I propose that we add another subjective attribute to our list: networking. Networking is defined as the exchange of information or services among individuals, groups, or institutions, specifically the cultivation of productive relationships for employment or business.

Although networking most likely will not be on an upcoming performance evaluation in your pharmacy, improving in this area could certainly provide benefit to the above metrics, where we are measured.

Networking Is Ongoing There are many benefits to networking, including expanding our network of contacts; deepening our relationships with friends and customers; exposing ourselves to new views, and perhaps, new business opportuni-

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Inside Pharmacy ❚ June | July 2014

5 reasons to network: ❚ Expand your reach ❚ Exchange information with colleagues ❚ Develop business opportunities ❚ Connect with other members inside the pharmacy ❚ Discover new employment opportunities

ties; developing new ways of looking at old problems; and even establishing new employment opportunities.

Networking should be ongoing and continuous. Pharmacists can start with existing customers to learn more about their needs as part of their community, and then expand to network with potential new customers.

There are several articles in this issue of Inside Pharmacy that build upon the networking concept as it relates to our role as community pharmacists.

Garcia and Calixte describe 8 key components of wellness that we can discuss with our patients to cultivate and support our role as community pharmacists (see “Retail Pharmacists’

Role in Promoting and Maintaining Health and Wellness,” on page 11).

In another article, Patricia Lininger, MSEd, details the role of community pharmacists in wellness and weight management (see “3 Components to Natural, Easy, and Lasting Weight Loss,” on page 17).

This can include expanding service offerings at your pharmacy to help differentiate yourself from competition. If your store has a dietitian, this can further enhance your service offerings and provide an additional level of care; it can also open additional doors for networking with other healthcare professionals outside of the usual pharmacist–physician or pharmacist–nurse communication. This level of networking can help you provide a more holistic approach to your patients’ care.

Expanding Your Reach Inside Pharmacy recently expanded its reach to include retail clinics inside stores with pharmacies. Pharmacists in this environment should engage and work closely with the physician assistants and nurse practitioners to provide comprehensive services to meet patients’ needs, perhaps through new or coordinated service offerings.

This also creates another opportunity to exchange information with

InsidePharmacyOnline.com

DISPENSE Albuterol Sulfate HFA as PROAIR HFA Inhalation Aerosol

NO GENERIC ALBUTEROL INHALER CURRENTLY EXISTS

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

The First Word professionals in our work location to cultivate relationships and expand business opportunities.

In this issue, Dennis D. Stanley, BPharm, provides an excellent overview of travel immunizations (see “Integrating Pretravel Health into Daily Pharmacy Practice,” on page 14). Networking within your community could help uncover if this is an unmet business need that your pharmacy could provide for those traveling for business or leisure. Dennis provides a framework for immunizations, as well as other travel-related services, where the community pharmacist provides an invaluable service that can make travel abroad a safer and enjoyable experience.

Networking with business leaders, neighbors, and physicians, as well as your existing patients, could help you assess opportunities to expand immunization services in your pharmacy.

Networking extends to our fellow pharmacists by connecting and expanding relationships within pharmacy groups. In this issue, Melissa S. Krause, PharmD, outlines the benefits of becoming an active member in your local, state, or national pharmacy association (see “Benefits of Professional Association Involvement,” on page 25). Benefits

Networking as a pharmacist should be ongoing and include patients, coworkers, and professionals both inside and outside the pharmacy profession.

and introduce you to potential new employment opportunities as well.

of belonging to an active, motivated group of your peers extend beyond continuous education sessions and presentations at meetings. The networking benefits can help uncover new service offerings and ways for you to become a better pharmacist. While many community retail pharmacists work with the same small group of individuals on a daily basis, joining a local or state pharmacy organization can allow you to expand your circle of pharmacy acquaintances and provides an excellent environment for mingling. A real benefit in today’s dynamic work environment is that networking can extend your reach

Getting Past the Hurdles of Networking Initially, networking may be difficult because it requires you to reach beyond your comfort zone. This can be especially daunting for new pharmacists. However, I find that most people are welcoming and willing to discuss their interests and needs, and conversely, are willing to learn more about you and your interests. With patients, this can involve a deeper understanding of life situations that can be affecting their wellness.

Networking as a pharmacist should be ongoing and include patients, coworkers, and professionals both inside and outside the pharmacy profession. This issue contains 4 articles about specific areas where pharmacists could expand their networking opportunities. I hope you find these articles beneficial and of interest to you. Please feel free to reach out to me and our authors to begin and/or extend your networking opportunities. ❚ Mr Dietz is Editor-in-Chief of the journal, and Vice President of Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.

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INSIDE

PRETRAVEL HEALTH Integrating travel health into pharmacy practice [14]

Wellness

WEIGHT LOSS

Coaching patients to make long-lasting changes [17]

PATIENT CARE Patient tips for sun protection [22]

Cover Story

Retail Pharmacists’ Role in Promoting and Maintaining Health and Wellness

by Albert L. Garcia, RPh, MHL, and Fatima Calixte, PharmD

Pharmacy is no longer considered simply as the science and technique of preparing and dispensing drugs and medicines. }} }} In this modern day, pharmacists are no longer considered “pill counters.” Contemporary pharmacy practice reflects an evolving paradigm from one in which the pharmacist primarily supervises medication distribution and counsels patients, to a more expanded and team-based clinical role providing patient-centered medication therapy management, health improvement, and disease prevention services.1 For decades, in Latin American countries the pharmacist has been seen as “The Doctor” of the community and the patients consult the pharmacist for all of their health and wellness needs, including medication therapy prior to initiating a drug regimen and throughout the course of therapy. We are seeing a familiar shift in the United States as pharmacists are taking on a more clinical versus dispensing role.1

InsidePharmacyOnline.com

Health and wellness, as defined by the World Health Organization, is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.2 Many employer groups have developed health and wellness programs within the workplace in an effort to support a healthy workforce while decreasing overall healthcare costs.

According to a 2008 survey by Hewitt Associates, approximately 93% of US employers have some type of wellness program instilled within their institution.3 Over the past several years, we have seen drastic annual increases in healthcare costs for Americans with a decrease in health benefits and care.4 The skyrocketing healthcare costs have been a major concern for US employers and several organizations, includ-

Key Points ❚ Contemporary pharmacy practice reflects an evolving paradigm ❚ Pharmacists today are capable of supporting key components in health and wellness by providing a broad spectrum of services ❚ Intensive education and ensuring patients are using their medications correctly can contribute to improved patient outcomes and lower total healthcare costs

Inside Pharmacy ❚ June | July 2014

11

Inside Wellness 8 Components

of Health and Wellness:

Wellness 1 Social How you relate to self, others, and community; having supportive relationships and a sense of belonging

Wellness 2 Physical How you care for your body and mind; your health and vitality Wellness 3 Environmental How you create environments around you to support your best self, as well as how you relate to the global environment

Wellness 4 Emotional/Mental Your awareness and acceptance of your feelings; your thoughts, attitudes, and self-talk; your resilience and self-esteem

Wellness 5 Intellectual Having creative and stimulating activities that allow you to continue learning and pursuing your interests

6 Career/Livelihood Having fulfilling and meaningful work in which you nurture your gifts, skills, and talents

Wellness 7 Spiritual Your sense of meaning and purpose in your life; how you integrate your beliefs and values into action

8

Financial Wellness How you understand and handle your money in ways that provide for you now, as well as prepare you for financial changes ing the National Business Group on Health, which is working on reasonable solutions to improve quality and safety while decreasing cost challenges.5 Similarly, it is important to educate policymakers and legislators on how these issues impact employer-sponsored care and today’s workforce.

Pharmacists Play a Key Role in Health and Wellness As pharmacists, we play a key role in providing an important piece of the puzzle regarding the health and wellness of our patients. There are 8 key components of wellness6: social wellness, physical wellness, environmental wellness,

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Inside Pharmacy ❚ June | July 2014

emotional/mental wellness, intellectual wellness, career/livelihood, spiritual wellness, and financial wellness.

Pharmacists today are capable of supporting several of these key components by providing a broad spectrum of services, including health and wellness screenings, chronic disease management, immunizations, and medication therapy management.7 Retail pharmacists have solidified their roles within the healthcare team by being one of the most highly accessible healthcare providers in the community and assisting their patients in maintaining continuity of care by educating patients on disease management (ie, Certified Diabetes Educator), chronic therapy management, administering immunizations, and narrowing the communication gap between physicians and patients. In doing so, the retail pharmacist is assisting in the new healthcare reform by improving healthcare outcomes in patients and lowering overall healthcare costs.

Embracing an Expanding Role With managed care organizations and physicians being forced to focus more on patient adherence and overall outcome, pharmacists will continue to play a critical role within the healthcare team––paving the way for pharmacists to spend more clinical time reviewing, managing, and supporting the overall wellness and outcome of patients.

Pharmacists in the retail setting should embrace this opportunity bestowed upon them and prove to any skeptics that they are no longer considered “pill counters.”

Pharmacists are now members of the healthcare team and are a key component between patient and physician in improving the overall health and wellness of the patient.

Numerous community-based initiatives have demonstrated that retail pharmacists providing services, such as intensive education and ensuring patients are using their medications correctly, can contribute to improved

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Inside Wellness patient outcomes and lower total healthcare costs. With the support of a “pharmacist health-coach,” patients can become effective at self-managing a chronic disease.8-10 Several studies have shown the importance of pharmacist-provided patient care services. The Asheville Project began in 1996 as an effort by a self-insured employer to provide education and personal oversight for employees with chronic health problems such as diabetes, asthma, hypertension, and high cholesterol. During a 6-year period, cardiovascular and cerebrovascular (cardiovascular collectively) medication use increased nearly 3-fold, and cardiovascular-related medical costs decreased by 46.5%.9 The Diabetes Ten City Challenge was launched in 2005, involving employers in 10 distinct geographic locations in the United States.10 Using incentives, employers encouraged people to manage their diabetes with the help of pharmacist coaches, physicians, and community health resources.

Results to date indicate that this collaborative approach results in (1) savings of approximately $918 per employee in total healthcare costs for the initial year, with even greater savings in subsequent years; (2) return on investment of at least 4:1 beginning in the second year; (3) a 50% reduction in absenteeism and fewer workers’ compensation claims; (4) high employee satisfaction (95% approval for pharmacist care) and improved quality of life; and (5) employees saving an average of $400 to $600 per year with incentives such as waived copays.10 Overall, the contributions of retail pharmacists have positively contributed to health and wellness as demonstrated by The Asheville Project and the Diabetes Ten City Challenge. These studies exemplify why pharmacist-provided patient-care services are an asset not only to the patient, but to overall healthcare in the United States.9,10 The studies showed that pharmacist inter-

InsidePharmacyOnline.com

vention was associated with increased access to and adherence with prescription drug therapies, reduced medication errors and other harms, improved outcomes, and reduced costs.

Using incentives, employers encouraged people to manage their diabetes with the help of pharmacist coaches, physicians, and community health resources.

Because of the high priority of health and wellness in today’s society, retail pharmacists are capable of providing the broad spectrum of services. In doing so, retail pharmacists are assisting in the healthcare reform by reducing hospital readmissions, improving healthcare outcomes in patients, lowering overall healthcare costs, and increasing prescription counts. ❚

References

1. Hritcko PM. A new paradigm for pharmacy practice and education. Harvard Health Policy Review. 2006;7(1):143-146.

2. World Health Organization. WHO definition of health. www.who.int/about/definition/en/print.html. Accessed June 4, 2014.

3. The Incentive Research Foundation Resource Center.

Energizing Workplace Wellness Programs: The Role of Incentives and Recognition. http://theirf.org/research/ content/6078727/energizing-workplace-wellness-programsthe-role-of-incentives-and-recognition/. Accessed June 4, 2014.

4. America’s Health Insurance Plans. Rising health care costs. www.ahip.org/Issues/Rising-Health-Care-Costs.aspx.

Accessed June 4, 2014.

5. National Business Group on Health. Cost solutions and benefits designs. www.businessgrouphealth.org/resources/ csbd/index.cfm. Accessed June 4, 2014.

6. Substance Abuse and Mental Health Services Admin­ istration. Eight dimensions of wellness: a holistic guide to whole-person wellness. www.promoteacceptance.samhsa. gov/10by10/dimensions.aspx. Accessed June 4, 2014.

7. American Pharmacists Association. Medication therapy management services. www.pharmacist.com/medicationtherapy-management-services. Accessed June 4, 2014.

8. Garrett DG, Bluml BM. Patient self-management program for diabetes: first-year clinical, humanistic, and economic outcomes. J Am Pharm Assoc. 2005;45(2):130-137.

9. Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a communitybased long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc. 2008; 48(1):23-31.

10. Fera T, Bluml BM, Ellis WM. Diabetes Ten City Challenge: final economic and clinical results. J Am Pharm Assoc (2003). 2009;49:383-391.

Mr Garcia is President, and Dr Calixte is Clinical Pharmacist, Navarro Health Services.

Inside Pharmacy ❚ June | July 2014

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Inside Wellness

Integrating Pretravel Health into Daily Pharmacy Practice

“

Offering comprehensive pretravel health services is

professionally rewarding and personally enjoyable. It may differentiate your practice from others in your community.”

by Dennis D. Stanley, BPharm

Key Points ❚ Skills, including vaccination, can be the basis for expanding clinical offerings into the arena of pretravel health and consultations ❚ Educational resources readily available for pharmacists include the travel health continuing education offered by the American Pharmacists Association, certification examination offered by the International Society of Travel Medicine, and state programs

Experiencing sunset in the Kalahari Desert, attending a business meeting in New Delhi, or paddling a canoe in the Amazon, these journeys all present different and often fascinating health challenges for our travelers, but they may also present fascinating opportunities for pharmacists. }} }} Patient-focused clinical activities continue to be an integral and growing part of community pharmacy practice.

For well over a decade, pharmacists have protected patients against influenza, pneumococcal disease, shingles, and other diseases through vaccination.

These skills can be the basis for expanding our clinical offerings into the arena of pretravel health and consultations.

Informing the Patient In 2013, US passengers traveling abroad spent more than $180 billion in travel and fare payments.1 This ranks travel in the top 10 industries in 49 states and the District of Columbia.

Many individuals will journey to destinations that present unique health

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Inside Pharmacy ❚ June | July 2014

challenges, and pharmacists with skills in counseling and drug therapy development are in a position to help protect the health of these travelers. Building on our immunization expertise, our knowledge of disease treatment, and patient counseling, we can educate our patients about appropriate vaccine use, disease avoidance, security precautions, and travel safety.

Developing a plan for any patient’s itinerary may be simple or complicated.

In either event this plan must be created for each individual traveler based on that traveler’s specific itinerary and medical history.2 Online information sources such as Travax, TropiMed, and others are essential resources that provide up-to-the-minute information,

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Inside Wellness allowing pharmacists to appropriately immunize, medicate, and counsel patients.3,4 Accurate information regarding the correct medication to prevent malaria or altitude sickness, antibiotics to treat travelers’ diarrhea, and prevention and treatment of other location-specific diseases is essential.2,5,6 Although routine vaccines make up a large portion of the needs for travelers, pharmacists must also provide travel-specific vaccines for typhoid, yellow fever, and Japanese encephalitis.5 As a travel health expert, the pharmacist must define appropriate patients and appropriate travel situations in which these vaccines should be administered.

Vaccines must be evaluated, dispensed if needed, and fully discussed with the patient.2,6 A complete discussion of disease avoidance, including insect protection, food and water precautions, sun protection, altitude sickness prevention, and other travel-related subjects are essential pieces of this puzzle as well.2,5 Pharmacists may be tempted to become “shot shop” and offer only vaccines without the itinerary-based counseling. The potential problems with this approach are numerous. Many individuals are traveling to areas for which there is no vaccine or preventive medicine (eg, dengue fever, chikungunya).

Consequently, an effective counseling session is imperative to protect these travelers.2,5 If we fail to warn these patients, they may be at an increased risk for acquiring the disease and we may be at risk of liability. A full consultation and patient handouts should be sufficient to educate that patient and limit our liability.

To provide this level of expertise, pharmacists must be educated in travel health. Fortunately, there are plenty of educational resources readily available to pharmacists. The American Pharmacists Association, for example, offers a continuing education program in travel health.7 The International Society of Travel Medicine offers a

InsidePharmacyOnline.com

certificate examination, and the preparation sessions for this exam are very informative.8 In addition, state associations often offer continuing education programs at conventions. The travelrelated information at the Centers for Disease Control and Prevention is extensive and readily available.9 Simply put, there is considerable travel education available, but some effort is required to fully educate yourself and to keep up to date.

Many, if not most, of the phone calls that we receive seeking travel services, start with “my doctor told me to call you.”

Establishing a Business Model Because considerable time and effort are spent on counseling individuals about travel health, the return on your investment is important. Establishing a business model that fits your practice is essential. Obviously providing these services takes time––ample time is required to investigate each traveler’s itinerary and craft any physician requests. Counseling and vaccine administration require time for proper completion and require dedicated blocks of time or time during daily overlap. Each of these tasks adds to the expense for the service; therefore, creating a price schedule for vaccines, administration fees, counseling, or visit fees is needed. Immunizations often provide a higher profit margin than most prescriptions and more opportunities result from providing travel health services. Developing multiple sources for vaccines, administration supplies, patient handouts, and Vaccine Information Statements are also needed. Purchasing vaccines from your wholesaler is easiest but may limit your choices; some travel vaccines may only

Inside Pharmacy ❚ June | July 2014

15

Inside Wellness Key Point ❚ Building partnerships in the community with local and state health departments, medical societies, immunization coalitions, pharmacy associations, and pharmacy schools may offer opportunities to expand your immunization and travel health services

Mr Stanley is Pharmacy Manager at Martin’s Food Markets Pharmacy, Richmond, VA.

16

be available from the manufacturer or a specialty wholesaler.

Developing a marketing program is crucial. Any marketing program must address your end user or patient and as many referral sources as possible. An effective marketing program may be as simple as handouts with every prescription or overhead announcements throughout the day. This is a low-cost option but may be surprisingly effective.

The message must be short, informative, creative, and sufficiently entertaining to interest your patients.

Outdoor signs, whether printed or digital, will inform everyone who passes that you are a travel health provider every hour of every day. Mailers, weekly flyers, print media, radio, and television can all be very effective tools but must be evaluated on a cost–benefit basis. Never underestimate the power of word-of-mouth advertising. Providing efficient, effective, and appropriate services to travelers can rapidly circulate among individuals and local groups. Be aware that poor service will circulate in your community.

Churches, missionary groups, community groups, schools, and humanitarian groups are all potential customers for your pretravel health services.

These organizations often have a large group of people funding the travels of a smaller group and may provide a constant source of patients. Educating these groups about travel health, travel security, or protection from disease may prompt them to seek your services.

Marketing your services to physicians can be very effective. Working with a patient’s physician to protect that patient often builds a partnership between the pharmacist and the physician. As pharmacists, we are working with physicians to protect their patient’s health. A personal visit to the physician’s office is an excellent way to showcase your knowledge and explain your pretravel health service. Many, if not most of the phone calls that we receive seeking travel services, start

Inside Pharmacy ❚ June | July 2014

with “my doctor told me to call you.”

Building partnerships in the community with local and state health departments, medical societies, immunization coalitions, pharmacy associations, and pharmacy schools may offer opportunities to expand your immunization and travel health services. This may be as simple as attending a quarterly webinar with the health department personnel, attending a local or state immunization coalition meeting, or accepting students on rotation from the nearest pharmacy school. Professional collaborations may add to your knowledge or give you an opportunity to share your knowledge and aid other clinicians.

These partnerships may also be an important referral source. As your expertise is shared, the likelihood that referrals may result improves. If your peers know you as “the vaccine expert,” it certainly adds to your good reputation and builds your business. Offering comprehensive pretravel health services is professionally rewarding and personally enjoyable. In addition, it may differentiate your practice from others in your community. ❚

References

1. US Travel Association, US Travel Answer Sheet 03/2014.

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

3. Travax. About Travax. www.travax.nhs.uk/about-travax. aspx. Accessed May 16, 2014.

4. Tropimed. Tropimed: a comprehensive travel medicine database with daily updates. www.tropimed.com/en/index. html#&panel1-1. Accessed May 16, 2014.

5. International Society of Travel Medicine. Guidance towards best practice in travel medicine. www. istm.org/WebForms/Members/MemberActivities/ VolunteerActivities/prof_groups/npg_guidance.aspx.

Accessed May 16, 2014.

6. International Society of Travel Medicine. Pharmacist Professional Group International Society of Travel Medicine. www.istm.org/WebForms/Members/Member Activities/VolunteerActivities/prof_groups/pharmacy.aspx.

Accessed May 16, 2014.

7. American Pharmacists Association. APhA2014 additional education training. www.pharmacist.com/apha2014additional-education-training. Accessed May 19, 2014.

8. International Society of Travel Medicine. Certificate in Travel Health™. www.istm.org/WebForms/Members/ MemberResources/cert_travhlth/Default.aspx. Accessed May 19, 2014.

9. Centers for Disease Control and Prevention. Clinician information center. wwwnc.cdc.gov/travel/page/clinicianinformation-center. Accessed May 19, 2014.

InsidePharmacyOnline.com

Inside Wellness

3 Components to Natural, Easy, and Lasting Weight Loss

“

Your patients will value your coaching and ongoing support on this life-changing issue of weight loss.”

by Patricia Lininger, MSEd

Despite a profitable weight-loss industry, there has been little progress in resolving the dilemma of obesity, and an overweight population in the United States. }}

}} the prevalence of overweight or obese individuals has not diminished, according to data reported in 2003 and 2012, with approximately a third of the population documented as obese.1,2

Confusion About Weight Loss Stems from Contradicting Information One of several reasons for this impasse could be the mass confusion generated by a multitude of contradicting information regarding the most effective methods to achieve and maintain weight loss. Much of the information distributed to the public is based on unsustainable quick fixes and unproven strategies. Even some information based on actual scientific studies is clouded with conflicting advice on how it translates to real-life plans that can result in lasting weight loss. Fortunately, as

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a healthcare professional you have an opportunity to alleviate some of the confusion surrounding weight loss and help many patients recognize valid options.

Recommendations that every individual should consume only gluten-free and dairy-free foods are rampant. Some self-proclaimed experts advise a vegan diet, while others recommend high-protein diets that include meat. There are testimonials for the Paleo Diet, Atkins Diet, low-glycemic diets, and more, plus nutrient-limiting fads allowing only greens, juices, or smoothies, and others.

Further confusion comes from advertisements and ravings about new-found “magic supplements,” derived from exotic plants that promise effortless weight loss. In addition, conflicting information on the mode, duration, and intensity of exercise that is best for

Key Points ❚ Despite a profitable weight-loss industry, there has been little progress in resolving the dilemma of overweight and obesity in the United States ❚ The majority of information distributed to the public about weight loss is based on unsustainable quick fixes and unproven strategies ❚ Nutrition, exercise, and motivation are equally important to succeed at healthy and lasting weight reduction and improved health

Inside Pharmacy ❚ June | July 2014

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Inside Wellness

3 considerations for Tips health & wellness nutrition A healthy and balanced diet can facilitate increased fat burning and decreased fat storing. Guide patients to adopt lifelong, healthy, nutritional habits instead of trying a nutrient-limiting diet. In a short amount of time, you can provide patients with recommendations that can make a difference and connect with other resources for more in-depth nutritional counseling.

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Exercise Exercise can improve health, prevent hypokinetic disease, and lower risk factors. Counsel your patients to exercise for weight loss and for improved health and wellness. The CDC recommends 150 minutes of moderateintensity exercise or 75 minutes of vigorous activity on a weekly basis. Patients should be advised to add weight or resistance training on alternate days to further enhance fat burning.

More tips on health and wellness can be found at InsidePharmacyOnline.com

weight loss may leave some patients, including those who are overweight, feeling overwhelmed, if not hopeless.

Fortunately, you can reassure patients that losing weight and getting healthier are possible. Furthermore, you can inform them of the best weightloss strategies that can improve health,

Each of the 3 components—nutrition, exercise, and motivation—is equally important for an individual to succeed at healthy and lasting weight reduction and improved health. Unfortunately, at least one of these components is often neglected. Nutrition is usually addressed, but not always correctly.

Much of the information distributed to the public is based on unsustainable quick fixes and unproven strategies.

Balanced Nutrition Equals Greater Fat Burning Guiding patients to adopt lifelong, healthy, nutritional habits as opposed to trying a nutrient-limiting diet plan is invaluable. A healthy and balanced diet can facilitate increased fat burning and decreased fat storing.3 When your body reaches homeostasis, all functions are improved, including the conversion of fat to fuel for energy.3 In addition, when systems spend less time filtering out toxins from unhealthy foods, they can more readily work to convert and transport fuel for energy, versus storing it as fat.3 Also, consuming less sugar and refined grains causes less

alleviate fatigue and inflammation, and even boost moods and energy levels. Armed with an evidence-based, healthy nutrition plan; a strategic, science-based exercise plan; and authentic motivation, most patients can successfully boost their metabolism to lose weight, alleviate many discomforts, and reduce risk factors for disease.

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Motivation Some patients may not be ready to make lasting changes to their daily behaviors. It is not as easy to guide patients to the right mind-set as sharing nutrition and exercise information. Advise patients to explore resources to provide motivational guidance and continual support, including weight-loss coaches and support groups.

Inside Pharmacy â?š June | July 2014

1/

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Inside Wellness insulin spikes cueing less fat storage.

In a short amount of time, you can provide patients with significantly beneficial recommendations and connect them with other resources for more in-depth nutritional counseling.

The first recommendation is to re­ place processed, packaged, and sugarladen foods with whole, raw, or natural foods. I have found that many of my clients consume plenty of processed foods, believing that if foods are labeled low fat, they will aid in weight loss. On the contrary, many low-fat, packaged foods are highly processed, made of refined grains, and contain added sugars and unnatural ingredients––clouding the body with toxins. Furthermore, many of these processed foods are high in calories. By simply steering your patients away from processed foods and toward a diet rich in raw and whole foods, you can help them improve their overall health and lose weight.

In addition, you can suggest a diet rich in complex carbohydrates (eg, vegetables and fruits with a 3- to 4-ounce serving of a lean protein with each meal). The fiber in carbohydrates aids in weight loss and the protein can slow the breakdown of foods into glucose, minimizing insulin spikes.4,5 Proteins can also provide beneficial amino acids, which enhance metabolism, alleviate cravings, and enhance mood.6,7 Finally, many people mistakenly avoid fats, but a small serving of healthy fats (eg, omega-3, polyunsaturated, or monounsaturated) helps to optimize the functions of neurotransmitters for better moods and increased fat burning, promote organ and brain health, and reduce inflammation.8 You can recommend incorporating half an avocado; a tablespoon of whole-natural butter or all-natural almond butter; and an ounce of nuts, seeds, or healthy oils, such as almond oil or flaxseed oil. These can improve overall health and help patients lose weight naturally.

These are just a few simplified examples of how eating healthy translates

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to getting leaner. Detailed information on this is too vast to be listed here, but as a healthcare professional, you can help your patients by guiding them to healthy nutritional habits that facilitate a state of wellness. This state can result in a natural boost in fat burning.

Guiding patients to adopt lifelong, healthy, nutritional habits opposed to trying a nutrient-limiting diet plan is invaluable.

2/

Effective Exercise Takes Little Time The second component for weight loss is exercise. Of course, all patients should be advised to get a physical examination before embarking on an exercise regimen. Our advice should never trump a physician’s specific advice for any individual. That being said, as health professionals we know that exercise can improve health, prevent hypokinetic disease, and lower risk factors. We should recommend exercise for weight loss and for improved health and wellness.

The Centers for Disease Control and Prevention recommends 150 minutes of moderate-intensity exercise or 75 minutes of vigorous activity per week.9 However, studies indicate that brief, high-intensity interval training can equal or surpass the training benefits of a long cardiovascular workout. One study concluded that short bursts of extremely high-intensity intervals alternated with short recovery periods can provide these results in as little as 4 minutes (Tabata Protocol), and the postexercise oxygen consumption, which is the metabolic boost after a workout, can last up to 36 hours.10 However, the intensity used for that protocol is impractical for many patients and the short duration limits calorie burn. Therefore, adaptations have emerged requiring 6 to 10

Inside Pharmacy ❚ June | July 2014

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Inside Wellness revolutions of alternating 20 seconds to It is likely that 60 seconds of high-intensity bouts (less than the Tabata Protocol) your patients will extreme with 1 minute to 2 minutes of lowervalue your coach- intensity bouts, providing impressive results. ing and ongoing The message here is that fat burning can be achieved with a 15-minute support on this to 20-minute workout a few times per week. Because a common reason for life-changing neglecting exercise is time constraints, this is good news. Advise your patients issue of weight to add weight or resistance training on alternate days to further enhance fat loss. Help them burning. Again, providing additional resources for the safest and most effecaddress all tive methods should be provided to 3 components: ensure safety and effectiveness. nutrition, 3/ Motivation and Support Improve Chances for Success exercise, and Even when given the most detailed information about healthy foods conmotivation. sumed in the right proportions and the

Ms Lininger is Health Educator, HealthFitness Inc; and freelance health, wellness, and nutrition coach.

20

evidence-based exercise that burns fat and boosts the basal metabolic rate, many will not achieve their weight-loss goals because their motivation is too weak to change behaviors.

As theorized in Prochaska’s Transtheoretical Model, one must be beyond the contemplating stage and be ready to change in order to permanently alter health behaviors.11 Many individuals are just not ready to make lasting changes in their daily behaviors.

It is true that almost any diet will create some weight reduction if followed very diligently. Yet, with access to numerous plans, millions of people are still overweight. This supports the case that despite a desire to be leaner, motivation is missing for many weight-loss seekers.

Until this is cultivated, success will not likely be achieved.

Unfortunately, guiding patients to the right mind-set is not as easy as sharing nutrition and exercise information. It can take a myriad of behavior-modification strategies and motivational techniques to increase patients’ chances of achieving weight loss and

Inside Pharmacy ❚ June | July 2014

adopting healthy habits. This explains the growing trend of health, nutrition, and weight-loss coaches.

More people are recognizing the value of motivational guidance and continued support, along with the customized eating and exercise plans. Therefore, you might advise them to explore these options. In addition to your coaching and support, provide them with resources and encourage them to seek a weightloss coach or a support group. Many coaches are accessible from anywhere at any time and local groups are plentiful.

Conclusion It is likely that your patients will value your coaching and ongoing support on this life-changing issue of weight loss. Help them address all 3 components: nutrition, exercise, and motivation. Although this short article can only touch on each, many resources are available to you to share with your patients to help them live leaner, healthier, and happier lives. ❚ References

1. Ogden CL, Caroll MD, Flegal KM. Prevalence of childhood and adult obesity in the US, 2011-2012. JAMA. 2014;311:806-814.

2. Centers for Disease Control and Prevention. Vital signs: state specific obesity prevalence among adults US, 2009. www.cdc.gov/mmwr/preview/mmwrhtml/mm5930a4.htm.

Accessed May 8, 2014.

3. Hyman M. Systems biology, toxins, obesity, and functional medicine. Altern Ther Health Med. 2007;13:S134-S139.

4. Higgins JA. Resistant starch and energy balance: impact on weight loss and maintenance. Crit Rev Food Sci Nutr.

2014;54:1158-1166.

5. St Jeor ST, Howard BV, Prewitt TE. Dietary protein and weight reduction: a statement for healthcare professionals from the Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism of the American Heart Association. Circulation. 2001;104:1869-1874.

6. Benon D, Donohoe RT. The effect of nutrients on mood.

Public Health Nutr. 1999;2:403-409.

7. Prasad C. Food, mood and health: a neurobiological outlook. Braz J Med Biol Res. 1998;31:1517-1527.

8. Lorente-Cebrián S, Costa AG, Navas-Carretero S, et al.

Role of omega-3 fatty acids in obesity, metabolic syndrome, and cardiovascular diseases: a review of the evidence. J Physiol Biochem. 2013;69:633-651.

9. Centers for Disease Control and Prevention. Division of Nutrition, Physical Activity and Obesity. How much physical activity do adults need? Updated April 4, 2014. www. cdc.gov/physicalactivity/everyone/guidelines/adults.html.

Accessed May 9, 2014.

10. Tabata I, Nishimura K, Kouzaki M, et al. Effects of moderate-intensity endurance and high-intensity intermittent training on an aerobic capacity and VO2max. Med Sci Sports Exerc. 1996;28:1327-1330.

11. Prochaska J, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997;12:38-48.

InsidePharmacyOnline.com

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

“

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

Donald J. Dietz, RPh, MS

Vice President Pharmacy Healthcare Solutions, Inc. Editor-in-Chief Inside Pharmacy

e.com

InsidePharmacyOnlin

June/July 2014 VOL. 2 • NO. 3

8 The Networking

Pharmacist

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14 Integrating

Pretravel Health

Wellness

rmacists tioners ailianPha Assistants • Nurse Practi of Ret • Physic The Rolendents intaining in Promoting and Ma Patients’ Health

Daily • Chain Headquarters • Indepe intoacists Pharm e Pharmacy Practic

25 Benefits of

Professional Association Involvement

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PAGE 11

Transforming Retail Pharm

acies into Healthcare Deliver

y Companies

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32 HR4190: A

Modest Proposal or Healthcare Paradigm Shift?

36 Eight Solutions

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

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

to Improve Your Finances

© 2014 Engage Healthcare Communications, LLC

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InsidePharmacyOnline.com Transforming Retail Pharmacies into Healthcare Delivery Companies

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Inside Pharmacy is a publication of The Lynx Group. © 2014 All rights reserved.

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Inside

Patient Care 5 TIPS for sun Protection Now that the warm weather is here, it is important for patients to protect their skin. The following tips are meant to help reduce risks associated with spending too much time in the sun and protecting your skin:

1 Apply Sunscreen

2 Reapply Often

3 Stay in the Shade

Use a broad spectrum sunscreen with sun protection factor (SPF) values of 15 or higher regularly and as directed

4 Cover Your Skin

Reapply sunscreen at least every 2 hours, and after swimming, sweating, or toweling off

Seek shade, especially between 10 am and 2 pm, when the rays of the sun are most intense

Wear clothing to cover skin exposed to the sun Wear a hat with a wide brim to shade the face, head, ears, and neck Wear sunglasses that wrap around and block as close to 100% of both ultraviolet (UV) A and UVB rays as possible

5 Check the UV Index

Check the US Environmental Protection Agency’s UV Index before you spend time outdoors and plan your sun protection accordingly

Sources: US Food and Drug Administration and Centers for Disease Control and Prevention.

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Inside Pharmacy â?š June | July 2014

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Inside

Retail Clinic News Retail Pharmacy Community Working with “Traditional” Providers In a recent interview with Inside Pharmacy, Alexandra Jung, Principal, Advisory Services, Ernst & Young, LLP, and former Senior Vice President, Corporate Strategy, Walgreens, discussed trends in healthcare delivery and the multistakeholder approach to patient care.

How are retail pharmacies evolving to accommodate changes in healthcare delivery?

AJ: A lot of the retail pharmacy chains have recognized the fact that they can play a pretty sig­ nificant role in commu­ nity-based care, primary care, and acute care. The reason for that is many of them are sitting on retail footprints, feuding about their geography and their brick and mortar stores that are accessible to over 80% of the US popula­ tion. Leveraging that re­ tail footprint in the com­ munity and playing a role in primary care, for exam­ ple, is an opportunity for them to expand their business into areas that would create new revenue streams for them.

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What is the role of the retail clinics in this capacity?

AJ: Retail clinics have been around for quite a while now. They started out as occupational health clinics on employer work­ sites. They have evolved into more acute care set­ tings, where you can go and get primary care. You can have an office visit, just like you would with your primary care physi­ cian. The role that they are playing is really to ex­ tend access to the com­ munity. There are a lot of people in this country that either do not have access or cannot get to a primary care doctor, whether it is because we have a primary care physi­ cian shortage, or they live in a geography where it is

not easily accessible, or they lack transportation.

Retail clinics are filling that void by creating a place where, as a destina­ tion, people can go and get the kind of care that they would get in a prima­ ry care physician’s office.

How are changes in retail pharmacy impacting the consumer?

AJ: The retail pharmacy has been around a really long time. It has tradi­ tionally been seen as a destination for you to just go pick up your medica­ tions. We have underleveraged the profession for a long time. Pharma­ cists were relegated to sit­ ting behind the counter and counting out pills into a vile.

It is part of our ecosys­

®

tem from a provider’s standpoint that is very underutilized. The role of the pharmacist is one that we ought to value, and, frankly, elevate to the highest level of their li­ cense and give them an opportunity to share in the delivery of care for patients. They are very well educated. They have face-to-face relationships with the patient and can have a meaningful impact on a patient’s outcomes.

The fact that we are finally repurposing that profession and respecting it and giving pharmacists a role where they cannot only be an advocate, but potentially a provider of care, I think extends the profession, and also gives us the capacity that we need in healthcare to give people access to pro­ viders where there may not be one.

What patient group have you seen take advantage the most of retail clinics?

AJ: Interestingly enough, there is a misconception out there that retail clin­ ics are frequented by moms and young kids.

Typically, you might think there might be a mom who has a little kid with an upper respiratory infection or is going in for some medications that

Inside Pharmacy ❚ June | July 2014

23

Inside

Retail Clinic News are low-end prescription needs.

What we have actual­ ly seen in the studies is that it is mostly the peo­ ple who are on Medicare that are accessing the re­ tail clinics. Again, it is convenience. They also like the ability to go in without an appointment, and they like the ability to be able to get their medications convenient­ ly with a pharmacist who they already have a rela­ tionship with that might be sitting 20 feet away from that clinic.

The population, as it gets more comfortable with retail clinics and sees them as a valid and legitimate place of ser­ vice; the volume is going to grow and you are going to see much more diversi­ ty of users.

There are statistics, however, that indicate that the majority of those users are still women. I still think there is a per­ ception that it may not be a safe environment for people who want to have a more private conversa­ tion, and, of course, there are limitations on the scope of practice of a nurse practitioner.

The guideline basically is we can only diagnose things from the waist up.

They can’t do a full diag­ nosis of anything more serious than an acute epi­ sode, if you will.

24

This is an exciting area, because we are seeing for the first time much more collaboration.

How is the healthcare team inside and outside the pharmacy coordinating patient care?

AJ: This is an exciting area, because we are see­ ing for the first time much more collaboration and alliances being formed be­ tween the retail pharmacy community and what we consider the traditional provider community.

If you think about the expansion of retail phar­ macies in hospital foot­ prints, for example, 340B is one of the reasons that a lot of the pharmacies are entering the hospital space. It is typically an entry point for them to help with the supply chain and the cost of drugs.

What it ends up becoming is a relationship where they can then manage pa­ tient care, do clinical in­ terventions, and help with adherence and outcomes.

We are starting to see formal alliances and part­ nerships being created be­ tween hospitals, provider systems, physician sys­ tems, and pharmacies for

Inside Pharmacy ❚ June | July 2014

®

the first time in a long time. It is actually the foundation of accountable care organizations, and whether or not they con­ tinue to mature remains to be seen. What is prom­ ising is the fact that they are sharing data.

For example, they are starting to share informa­ tion on pharmacy dis­ pensing platforms that typically were not found in the electronic medical records in the past. There is much more openness now to sharing that data bilaterally and using it to intervene for clinical out­ come improvement.

What key opportunities and challenges lie ahead for retail clinics?

AJ: I think the biggest opportunity for retail clinics is to continue to prove their model and to demonstrate that they are going to be partners in the value chain and not just threats to the provider community.

That they can be there as physician extenders, as excess capacity that can be utilized by the physi­ cian, and as individuals, pharmacists in particular, who have face-to-face re­ lationships with patients that can be leveraged for better results.

I think some of the challenges they face, quite frankly, are in regulatory restrictions and the fact

that we are continuing to operate in an environ­ ment that has not caught up with the evolution of the business models. We still work against restric­ tions around licensing, cross border, state-to-state transfer of goods and ser­ vices and the disparity of regulatory requirements that we have to comply with from state to state, not to mention the feder­ al level.

The complexity of the regulations is, in many ways, stifling this innova­ tion. If we could get our elected officials to recog­ nize what efficiency could look like, we could strip a lot of waste out of the system and, frankly, deliv­ er some savings. ❚ “If you haven’t been in a retail clinic lately, and if you haven’t talked to a pharmacist that counsels patients, I would tell you to go experience it for yourself, because I think you’d walk away very surprised at how far they’ve come,” Ms Jung stated in her concluding remarks.

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To watch the entire interview with Alexandra Jung, visit our Media Library at InsidePharmacyOnline.com insidepharmacyonline.com/ media-library

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INSIDE

cms call Letter Participate in the dialogue and shape 2015 [28]

The Retail Pharmacy Benefits of Professional Association Involvement

“

Education, advocacy, and networking are some of the benefits of being a member of a professional association.”

by MELISSA S. KRAUSE, PharmD

When I was in pharmacy school, I came across a quote that changed my life: “Every man owes a part of his time and money to the business or industry in which he is engaged.

No man has a moral right to withhold his support from an organization that is striving to improve conditions within his sphere.”

—Theodore Roosevelt. }}

}} up until that point, I had joined clubs and organizations that I thought would help me in my journey: first, to get into a good college; then, to learn more about pharmacy; and later, to increase my chances of getting an internship. But this quote—along with some sage advice—made me realize that joining and contributing to an organiza­ tion is part of being a professional. It is a duty of all members of the pharmacy profession. Luckily, membership comes

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with benefits, some of which include education, advocacy, and networking.

Education Pharmacists in every state must complete continuing education (CE) requirements to maintain competency and licensure. Pharmacy associations provide CE in various formats, includ­ ing live programs, online programs, and sometimes in print media. Even if your employer provides you with enough

Key Points ❚ It is a duty of all members of the pharmacy profession to join and contribute to a professional pharmacy organization ❚ Pharmacy associations’ advocacy work can benefit individual pharmacists, regardless of employer or practice setting ❚ On a national and state level, pharmacy associations are extending efforts to transform the pharmacy practice

Inside Pharmacy ❚ June | July 2014

25

Inside the Retail Pharmacy TOP ASSOCIATIONS

FOR RETAIL PHARMACISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTItiONERS ❚ American Academy of Managed Care Pharmacy ❚ American Academy of Physician Assistants ❚ American Association for Nurse Practitioners ❚ American Nurses Association ❚ American Pharmacists Association ❚ National Community Pharmacists Association

CE to renew your license, it is helpful to have other options for CE programs that pertain to your personal areas of interest and in your preferred format.

Pharmacy associations have been at the forefront of pharmacists’ clinical services, including medication therapy management, immunizations, and dia­ betes education. In addition, pharmacy

It is helpful to have options for CE programs that pertain to your personal areas of interest and in your preferred format. associations provide opportunities for pharmacists to gain credentials, such as the Board of Pharmacy Specialties.1 These specialties, offered as a way to distinguish pharmacists who have spe­ cialized experience and skills, include

26

Inside Pharmacy ❚ June | July 2014

certifications in Ambulatory Care Pharmacy, Nutrition Support Pharmacy, and Pharmacotherapy, as well as Added Qualifications in Cardiology and Infectious Disease.2,3 Board certification helps establish a pharmacist as an expert in the certification area, and may confer financial benefits.4

Advocacy One of the most important aspects of being a member of a professional phar­ macy organization is that the associa­ tion’s staff and volunteers advocate for your rights as a pharmacist and impor­ tant pharmacy-related issues. Employee pharmacists may contend that they get all the information they need from their company’s corporate headquarters.

Although this may be true for some pharmacists, pharmacy associations’ advocacy efforts can benefit individual pharmacists, regardless of employer or practice setting.

In a recent podcast from ReachMD, Donald Palmisano, MD, JD, past president of the American Medical Association, said, “it does no good to have the knowledge and the skill to treat a patient if you are not permitted to be able to treat the patient in the patient’s best interest.”5 He was speaking about the need for physician leadership, but this quote could be equally applied to pharmacists. Currently, pharmacy associations are advocating for provider status for pharmacists through organi­ zations such as the Patient Access to Pharmacists’ Care Coalition. This coa­ lition comprises a variety of pharmacy organizations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, the Food Marketing Institute, the International Academy of Compounding Pharmacists, the National Alliance of State Pharmacy Associations, the National Association of Chain Drug Stores, and the National Community Pharmacists Association.

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Inside the Retail Pharmacy Other pharmacy companies including CVS Caremark, Fred’s Pharmacy, Rite Aid, Safeway Inc, SuperValu Pharmacies, and Walgreens. Wholesalers, includ­ ing AmerisourceBergen and, Cardinal Health, are also involved.6 The coa­ lition is actively working to “advance patient access to, and payment for, Medicare Part B services by state-li­ censed pharmacists in medically under­ served communities.”7 Other recent advocacy efforts at the national level include proposed expan­ sion of medication therapy manage­ ment services to more Medicare Part D beneficiaries, improvement in care coordination through accountable care organizations, enactment of essential health benefits, and new models for healthcare, such as integrated care and transitional care.8 On a state level, pharmacy associations around the country are extending grassroots efforts to transform the pharmacy practice.9

Making Connections: Leadership and Communication Think back to when you were in college. Chances are you were involved in some club or organization. Perhaps you led a committee or held an office in a student group. Those same types of opportunities for connecting with peers and gaining leadership experi­ ences exist today in professional phar­ macy organizations. Join to reconnect with former classmates and colleagues, meet other pharmacy professionals in your area, and/or explore future career opportunities.

Whether you see professional organi­ zation membership as a right, a respon­

sibility, or both, there are definitely benefits to being involved in profession­ al pharmacy organizations. ❚

Pharmacy associations are advocating for provider status for pharmacists through organizations such as the Patient Access to Pharmacists’ Care Coalition.

Acknowledgment: The author would like to acknowledge Mallory Mitchell, PharmD Candidate 2014 from Duquesne University Mylan School of Pharmacy, for her assistance with this article.

References

1. Board of Pharmacy Specialties. About BPS. www. bpsweb.org/about/vision.cfm. Accessed May 14, 2014.

2. Board of Pharmacy Specialties. www.bpsweb.org/special ties/qualification.cfm. Accessed May 14, 2014.

3. Board of Pharmacy Specialties. Specialties. www.bpsweb. org/about/vision.cfm. Accessed May 14, 2014.

4. Board of Pharmacy Specialties. Rewards of certification. www.bpsweb.org/certification/rewards.cfm. Accessed May 14, 2014.

5. Palmisano DJ. Teaching Physicians to Lead [Podcast]. www.reachmd.com. Accessed May 14, 2014.

6. Yap O. New coalition working on federal provider status legislation. American Pharmacists Association. www.phar­ macist.com/new-coalition-working-federal-provider-statuslegislation-1. Accessed May 14, 2014.

7. Ventimiglia VJ. Patient Access to Pharmacists’ Care Coalition. RE: Health Care Workshop Project No. P131207 [Letter to the Federal Trade Commission]. National Association of Chain Drug Stores. www.nacds.org/ ceo/2014/0508/papcc.pdf. Sent April 30, 2014. Accessed May 14, 2014.

8. American Pharmacists Association. Health care reformimplementation of the Affordable Care Act. www.phar macist.com/health-care-reform-implementation-afford­ able-care-act. Accessed May 14, 2014.

9. Smart Retailing Rx. Grassroots efforts advance the phar­ macy profession. http://smartretailingrx.com/regulatorypublic-affairs/grassroots-efforts-advance-pharmacy-profes sion/. Accessed May 14, 2014.

Dr Krause is Consultant, Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.

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Inside Pharmacy ❚ June | July 2014

27

Inside the Retail Pharmacy

CMS Call to Action Call Letter 2015

“

All stakeholders should actively participate

in a dialogue with the Centers for Medicare & Medicaid Services.”

by Mark J. Gregory, RPh

Key Points ❚ Early each year, the CMS releases their Call Letter for Part C and Part D programs ❚ CMS will continue to review the retail networks of plans offering cost-sharing for the 2014 and 2015 plan years ❚ CMS continues to encourage standards for Health Information Technology for MTM service documentation

28

E

arly each year, the Centers for Medicare & Medicaid Services (CMS) releases their Call Letter contain­ ing information on Part C and Part D programs that Medicare Advantage organizations and Part D sponsors need to take into consideration when prepar­ ing their 2015 bids.

According to CMS, policies in the 2015 Call Letter have been designed to improve the overall management of the Medicare Advantage and Prescription Drug Programs using 4 major outcomes: (1) vibrancy and stability, (2) value for the beneficiaries and taxpayers, (3) quality improvement, and (4) compli­ ance improvement.1 “This year, to achieve these overlap­ ping outcomes, CMS’ Call Letter activ­ ities follow 4 major themes: improving bid review, decreasing costs, promoting creative benefit designs, and improving beneficiary protections,” according to

Inside Pharmacy ❚ June | July 2014

the Call Letter.1 The process used to create the Call Letter consists of a culmination of feed­ back from payers, providers, and bene­ ficiaries. Although some suggested that changes from year to year may place plans, providers, and/or beneficiaries in direct conflict, it does provide a channel for comment and change.

It is critical for all stakeholders to actively participate in the dialogue with CMS, which will shape the plan offer­ ing each year. Adoption of a final Call Letter is a transparent process whereby all comments are read and taken into consideration. I believe that failure to participate as a stakeholder may lead to policies and rules unfriendly to your environment.

Preferred Cost-Sharing In their draft letter, CMS proposed requiring Part D plan sponsors to offer terms and conditions for every level of cost-sharing, including preferred cost-sharing, to any willing pharmacy that will accept the terms. This propos­

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Inside the Retail Pharmacy al would benefit seniors by giving them more choice among pharmacies in their drug plan and lead to increased compe­ tition in the marketplace.

In particular, CMS has awarded a contract to study beneficiary access to preferred cost-sharing and assess ben­ eficiaries’ geographic access to phar­ macies offering preferred cost-sharing plans’ networks. The results of the study would allow them to decide whether standards should be set for network adequacy for pharmacies offering pre­ ferred cost-sharing, similar to current standards for retail network adequacy.

CMS plans to continue to review retail networks for the 2014 and 2015 plan years, and states it will take “appro­ priate action regarding any plan whose network of pharmacies offering pre­ ferred cost sharing appears to offer too little meaningful access to the preferred cost sharing.”1 Prior to release of the final Call Letter, CMS withdrew parallel rules being pro­ posed, which would also address pre­ ferred cost-sharing. In the final Call Letter, the CMS indicated that they will continue to review the retail networks of plans offering cost-sharing for the 2014 and 2015 plan years.2

Medication Therapy Management Medication therapy management (MTM) services are critical to patients’ understanding and adherence to their medication regimens and provided by pharmacists. Here, the agency expands access to these critical services and posi­ tions MTM service as a critical compo­ nent of the Prescription Drug Benefit.

Monitoring and Compliance CMS has been assessing Part D spon­ sors’ ability to implement their CMSapproved MTM programs in accor­ dance with statutory requirements and related CMS guidance. Performance has been below standard for MTM targeting, comprehensive medication review (CMR) offers and providing

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patient written summaries, and meet­ ing standards for targeted medication reviews.

In the future, sponsors identified as noncompliant with MTM program requirements may be subject to com­ pliance actions, according to the draft letter. In addition, CMS is exploring new audit performance elements for MTM programs, which may be pilot­ ed in 2014 and fully implemented in 2015. Findings from the audits may also impact sponsors’ Part D Star Ratings for MTM.

CMS continues to encourage standards for Health Information Technology for MTM service documentation.

In the final Call Letter, findings from the MTM monitoring project suggest that sponsors identified as noncompli­ ant with MTM program requirements may be subject to compliance actions.

In addition, CMS plans to develop new audit performance elements for MTM programs. Findings from the audits may also impact sponsors’ Part D Star Ratings for MTM for 2016 or beyond.

Prior to piloting this audit area, CMS will publicly release the audit protocols.

CMS may pilot MTM program audits as early as the 2014 or 2015 audit season.2

Health Information Technology Standards CMS continues to encourage standards for Health Information Technology (HIT) for MTM service documentation. It also encourages con­ sensus on more robust definitions for MTM, CMRs, and drug therapy recom­ mendations and resolutions for service delivery and performance measurement.

The Call Letter mentions that the CMS will work with the industry to convene technical expert panels and

Inside Pharmacy ❚ June | July 2014

29

Inside the Retail Pharmacy develop additional standards and defini­ tions, which will be proposed in future rulemaking for adoption by all Part D sponsors.1 In the final letter, the CMS encour­ ages industry to develop and use stan­ dards for HIT for MTM service doc­ umentation, including more robust definitions for MTM, CMRs, and drug therapy recommendations, as well as resolutions for service delivery and per­ formance measurement.

It is critical for all stakeholders to actively participate in the dialogue with CMS, which will shape the plan offering each year.

In addition, the CMS suggests that it will coordinate with the Office of the National Coordinator for Health Information Technology (ONC), and work with the industry to develop additional standards and definitions.

The latter will be proposed in future rulemaking for adoption by all Part D sponsors.

“Commenters overwhelmingly sup­ ported the development and use of HIT standards for MTM and work­ ing towards reaching consensus on service-level definitions to streamline delivery, documentation, and report­ ing,” according to the final Call Letter.2

Administrative Costs in Bids In its draft letter, the CMS stated that it considers MTM program services provided to targeted beneficiaries as an administrative cost to be included in the plan bid, incident to appropriate drug therapy, and not an additional benefit. In addition, an MTM program is based on the contract year. The plan’s bid should take into account MTM costs for the applicable contract year, as MTM programs can change from year to year. These proposals were all con­

30

Inside Pharmacy ❚ June | July 2014

firmed in the final Call Letter.

CMS also stated in their draft let­ ter that eligibility targeting require­ ments are established as the minimum threshold and believes that as part of their broader efforts with respect to drug utilization management and qual­ ity assurance, sponsors may also elect to offer MTM services to an expanded population of beneficiaries who do not meet the statutory eligibility and may incorporate these additional costs of providing MTM services to an expand­ ed population in the administrative costs in their bids.

However, the final Call Letter indi­ cates that the CMS eligibility target­ ing requirements are established as the minimum threshold. Therefore, they believe that as part of broader efforts with respect to drug utilization manage­ ment and quality assurance, sponsors may also elect to offer MTM services to an expanded population of beneficiaries who do not meet the eligibility criteria under section 423.153(d). Sponsors may incorporate these additional costs of providing MTM services to an expand­ ed population in the administrative costs in their bids.2

Opioids CMS is encouraging sponsors to also offer MTM services to beneficiaries who meet the sponsors’ internal criteria for retrospective identification of opioid overutilization, but do not otherwise qualify for MTM. These beneficia­ ries may benefit from MTM services, including CMR, targeted medication reviews, and interventions with their prescribers.

In the final Call Letter, the CMS states that offering MTM to this popula­ tion could complement the current drug utilization management requirements to reduce overutilization of opioids, assist in coordination of care, and improve pain management. “Commenters were mixed with regard to their support for this pro­ posal,” they added. “Sponsors who were opposed generally agreed with the goals,

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Inside the Retail Pharmacy but questioned the benefit and effec­ tiveness of providing MTM services to engage this patient population to address overutilization of opioids.”

Conclusion Most recently, the CMS finalized 1 provision opposed by the Academy of Managed Care Pharmacy (AMCP).3 Plans will have to provide advance notice to pharmacies regarding chang­ es in maximum allowable prices start­ ing in 2016. Several provisions listed as important by AMCP include pre­ ferred networks and any willing pro­ vider terms and conditions, integration of the noninterference clause of the Medicare Modernization Act, expan­ sion of MTM, as well as requirements for mail-order pharmacies to require ful­ fillment within 3 to 5 days after receipt of a prescription.

Because adoption of the final Call

Letter is a transparent process, I encour­ age all stakeholders to actively par­ ticipate in a dialogue with the CMS. Failure to do so may lead to policies and rules counter to your needs. From year to year, the Call Letter has been a vehi­ cle to apply innovation to plan benefits and provider services. It is important to understand the process—how com­ ments are viewed by CMS. ❚

References

1. CMS, Advance Notice of Methodological Changes for Calendar Year (CY) 2015 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2015 Call Letter, February 21, 2014.

2. CMS, Advance Notice of Methodological Changes for Calendar Year (CY) 2015 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2015 Final Call Letter, April 7, 2014.

3. Academy of Managed Care Pharmacy. CMS’ Final Medicare Part D Rule: CMS’ Final Medicare Part D Rule delays many provisions opposed by AMCP and others, but implements MAC Pricing Standards in 2016. www. magnetmail.net/actions/email_web_version.cfm?recip ient_id=1030745711&message_id=4497191&user_ id=AMCP&group_id=872545. Accessed May 22, 2014.

Mr Gregory is Senior Vice President of Store Operations, Kerr Drug, Inc, Raleigh, NC.

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

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31

Inside

Healthcare Policy HR 4190: A Modest Proposal or Healthcare System Paradigm Shift?

The bill, its provisions, and the issues it raises

by Robert E. Henry

HR 4190 is a short legislative pharmacy bill that deserves a long look by retail pharmacists. Its significance rests not in its immediate provisions, but in what it is related to and what it suggests.

This interesting bill provides a portal that facilitates entrance into vitally important topics, in particular, the expansion of the scope of practice of pharmacists and other nonphysicians, its impact (if any) on the declining physician workforce, the future division of labor of providers, and the feasibility of interstakeholder collaboration, to name but a few.

Pharmacy associations everywhere are applauding HR 4190 as a progressive healthcare system measure that would help the process of expanding pharmacists’ scope of practice of primary care patient treatment. On the face of it, this is peculiar, as the bill makes no

32

change in pharmacists’ scope of practice. But that does send a signal to look closely at the bill and think about its context.

Upon closer examination, it becomes apparent that HR 4190 in itself is a paradox: “a modest proposal” that pertains to matters anything but modest. The bill may not make provisions for expanding pharmacists’ scope of practice, but pharmacy association leaders use it to raise the issue, which has a long history and bright future.

And although this bill goes no further than to correct an obvious flaw in the pharmacist reimbursement process for Medicare beneficiaries in underserved areas, it provides a portal into the matter of reorganization of healthcare providers’ responsibilities.

From here, the factors extend to several issues of significance: projected physician shortages; ex-

Inside Pharmacy ❚ June | July 2014

The bill may not make provisions for expanding pharmacists’ scope of practice, but pharmacy association leaders use it to raise the issue. pansion of the scope of practice of nonphysicians; the vision of a new model for an integrated, interprovider team; new technology and research discoveries that make this team model possible and necessary; government legislative initiatives; and, finally, the challenge to make strategic changes to so many healthcare constants.

All signs ultimately point to a cohesive provider system, even if it will take considerable work to get there. This is what makes the examination of HR 4190 worthwhile. It provides realworld interplay of issues: those that are gaining traction, those being opposed, and those being ignored or put on hold while stakeholders try to sort them out.

The goal that HR 4190 is pursuing through government legislation has its counterparts in physician legislation proposals, medical association position papers, and other initiatives.

The Facts of HR 4190 This pharmacy-related legislation is titled “HR 4190: To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services.” Congressman Brett Guthrie (R-

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

“

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

Donald J. Dietz, RPh, MS

Vice President Pharmacy Healthcare Solutions, Inc. Editor-in-Chief Inside Pharmacy

e.com

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June/July 2014 VOL. 2 • NO. 3

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Pharmacist

HEALLTTH&

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Pretravel Health

Wellness

rmacists tioners ailianPha Assistants • Nurse Practi of Ret • Physic The Rolendents intaining in Promoting and Ma Patients’ Health

Daily • Chain Headquarters • Indepe intoacists Pharm e Pharmacy Practic

25 Benefits of

Professional Association Involvement

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32 HR4190: A

Modest Proposal or Healthcare Paradigm Shift?

36 Eight Solutions

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

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Inside

Healthcare Policy HR 4190: The Questions the Bill Raises Q: Does this bill reflect the professional interests of pharmacists?

Q: Is a new collaborative model involving pharmacists, physicians, PAs, and NPs needed?

Q: Why is the bill being delayed?

Q: What is the long-term impact of the bill?

Q: Has the time come to reinvent the healthcare system?

Q: What is the division of labor?

Q: Is this in the best interest of the patient?

Q: How will it impact cost and access to care?

Q: Is this a path to new efficiencies?

Q: What is being done to protect primary care providers?

Q: Will this be the solution to the physician workforce shortage?

KY) introduced HR 4190 in the House of Representatives on March 11, 2014, where it quickly gained bipartisan support and the applause of pharmacy associations.

The bill proposes to extend access to care to Medicare beneficiaries in areas underserved by primary care physicians, by establishing codes enabling pharmacists to re-

34

ceive payment for services they are already allowed to perform according to their state’s laws, but for which no reimbursement mechanism exists. Thus, the bill is an exercise in simple, Lincolnesque honesty and directness—a mere 300 words of legislation with no hidden traps or ambiguities. It does not expand pharmacists’ scope

Inside Pharmacy ❚ June | July 2014

of practice, but that does not prevent its advocates from labeling it as a first step in that direction.

The bill was met with enthusiasm, optimism, declarations of commitment, and then lack of movement. Currently it is stalled in Congress, which must approve it before it adjourns at the end of 2014 to be adopted in its present form.

What Is Preventing Passage of HR 4190?

The first premise of understanding “Inside the Beltway” thinking is to appreciate that a bill entering the policy portal will be approached in cir­ cumspect, systematic, political, and pragmatic ways.

Parsing this out a bit, a bill may be expedited if it does not offend any important group, if it is clear

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Inside

Healthcare Policy and unambiguous, and if it matters to a large constituency or otherwise has a major impact on society. Two major reasons suggest themselves: opposition, or more likely, the time and effort involved in passing a bill.

Congress’s overburdened agenda produces a constant backlog of bills.

A second possible cause for the delay is opposition from one or more stakeholder groups that stand to lose from expanded pharmacist scope of practice—although this is less likely than in past years.

The only parties who may want its delay are physician organizations.

However, the American College of Physicians and the Institute of Medicine both have a history of supporting the expansion of pharmacists’ scope of practice. Until recently, however, the American Medical Association regarded pharmacists as competitors for physician business and had taken steps to oppose it.

First Conclusions The introduction of HR 4190 is akin to throwing a small pebble into a pond and watching the ripple effect. In healthcare and healthcare legislation, as in most of life, everything relates to everything else, making even the simplest

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+ MORE ONLINE Stakeholder Perspective Factors Affecting the Passage of HR 4190 Policy expert Kip Piper, MA, FACHE, provides insight on congressional processes HR 4190 is one of thousands of bills introduced in each session of Congress. As legislation goes, the 300-word bill is quite straightforward. However, to get to the President’s desk for his signature or veto, it will need to navigate the unique, rule-driven, and inherently political process of the US Congress.

The House and Senate have different processes, but, in general, a bill must be approved by the relevant House and Senate committees, with any differences in language resolved, and the identical language passed by votes of the full House and Senate. The bill is then sent to the President for his signature or veto. Bills can make it through this gauntlet as stand-alone legislation or similar language can be incorporated in a larger, faster-track piece of legislation—the latter being more likely for short Medicare-related bills like HR 4190.

Once the language is drafted, any Repre­ sentative or Senator may introduce the bill in their respective chamber. The bill is then referred to the relevant standing committees for consideration.

House committees often have subcommittees, so the appropriate subcommittee(s) considers the bill first.

HR 4190, with a bipartisan mix of 69 cosponsors, was referred by the House Speaker to the Ways and Means Committee and Energy and Commerce Committee, which share jurisdiction in the House for Medicare Part B. The bill was further referred to the Energy and Commerce Committee’s Health Subcommittee.

Prospects for passage of HR 4190 this year are low. In terms of the legislative process, sev-

bill subject either to intense scrutiny or strategic indifference.

In the case of HR 4190, there are some potent reasons why some stakeholders may regard it as crowding in on their turf, and other reasons why this might not hold any long­ er. Supposition is deadly if it is used in place of the facts. But as a spur to

eral factors weigh in the bill’s favor. The policy has merit, the language is tightly focused, the bill has support from a mix of Republicans and Democrats, sponsors include members of key committees, outside support from pharmacists and pharmacies is strong, and the Medicare budget impact is likely modest.

However, only about 10% of all bills make it through committee in some fashion and only about 3% become law. The odds are lower for stand-alone Medicare bills, bills not essential to keeping programs and agencies running, bills introduced in only 1 chamber, and any legislation in an election year. Calendars are tight, gridlock is in high gear, and Congress faces a backlog of must-pass legislation, including appropriations. If HR 4190 is scored by the Congressional Budget Office as increasing Medicare spending, offsetting savings or revenues must be identified, further complicating passage. The bill also may be opposed by other provider groups.

The policy change in HR 4190 has a better chance of passage if it is bundled within a large Medicare bill, such as the next round of legislation on Medicare physician rates, which is expected

by March 2015. If HR 4190 is not enacted before the 114th Congress takes office in January 2015, the bill can be reintroduced. Even the most meritorious policies can take years to gain sufficient support and find the right legislative vehicle.

Kip Piper, MA, FACHE, is Senior Consultant with Sellers Dorsey, and CEO, Medonomics, Washington, DC.

thought and inquiry, it serves useful purposes.

Change is afoot, and healthcare mavens inside and outside of Congress know it. That is making some stakeholders very happy and others very nervous. Stalling HR 4190 is either opposition or, more likely, the time and effort involved in passing a bill. ❚

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

Inside Pharmacy ❚ June | July 2014

35

Inside Business

Chain Headquarters Dress Code and Related Employee Appearance Issues

by Robert D. Orzechowski, MBA, SPHR

One of the challenges for human resources is how best to align policies regarding appearance, grooming, and hygiene with business necessity, safety, legal compliance, and reasonable accommodation. This includes retail pharmacies as well as retail headquarters operations. The following are substantive aspects of dress and appearance policies that should be considered when employers communicate their expectations to employees.

Policies should be clearly written, and each policy should include a purpose, summary, and scope (eg, who is covered by it, specific departments, and eligibility), as well as relevant definitions and the actual policy narrative. This last part should include the basic course of action or general approach designed to achieve the results desired. Finally, these policies should direct employees to seek

36

management’s guidance or approval if the appropriateness of any specific course of action or employee decision may be in question. In many cases, if a compromise cannot be easily agreed upon, management should reserve the right to send an employee home to correct a policy violation before returning to work.

Policies covering these issues are generally accepted as the province of the employer, such as chain headquarters or independent pharmacy owners, who develop the policies in compliance with state and federal regulations.

Exceptions may exist within public sector entities or when employees are covered by a collective bargaining agreement.

Business necessity should be the driving force when developing policies on dress code guidelines, to maintain a professional appearance for patients who consult with pharmacists

Inside Pharmacy â?š June | July 2014

for example, and behind the counter, for the safety of the employees. This standard can range from safety (no open-toed shoes) to comfort (shorts for delivery personnel in hot weather) and company branding (ie, uniforms or formal business attire and a clean, professional image).

Dress codes may also be set to help patients easily identify pharmacists, physician assistants, and/or nurse practitioners from other employees. For example, retail pharmacists and pharmacy managers may wear a white jacket or lab coat, while pharmacy technicians and clerks may wear a burgundy or light blue jacket.

This distinction can help patients better identify pharmacists behind the counter, or healthcare providers in the retail clinic.

Other settings, such as retail chain headquarters, may not require a uniform and have more flexible dress code, such as dress-

ing for the day ahead,1 which is based on your schedule for the next day, from business attire such as a suit or a dress, or dressy jeans and a blazer on more casual days. Dress code policies reinforce company culture and values, and each job description should include clear and valid requirements for a particular dress and grooming standard.

Closely related issues include responding to employee requests for accommodation for health or religious reasons, or for reasons related to other factors that place the employee in a protected class. One large supermarket pharmacy chain has their grooming and dress code guidelines readily available online.2 Standards provided may include headwear, jewelry, hair placement or length, and allergic reactions to certain materials.

Policies must also strive for fair treatment of

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Inside Business

Chain Headquarters all races, both sexes, and any employee in a protected class; policies cannot be unnecessarily burdensome for one sex or group. A more contemporary dimension includes the topics of sexual orientation and transgender employees. As with any accommodation, employers should make good faith efforts to identify and implement them.

The exception, of course, is if the accommodation creates an undue hardship for the employer.

Personal grooming and hygiene are topics usually addressed in related policies. Topics should in-

clude standards of cleanliness, naturally occurring hair colors, hair length, absence of unpleasant body odor, use (or prohibition) of personal fragrances and other grooming products, visible body piercings, and body art.

Human resources, as well as managers, such as pharmacy managers, must have the communication skills necessary to address real or potential violations with employees in a professional manner.

Many of today’s workforces are widely diverse, and companies may want to reexamine their appearance and grooming

policies to accommodate this diversity. Employers should strive for a culture of respect, open communication, fair and reasonable treatment, and a genuine concern for employee safety and productivity.

This is simply good business and sound management. Finally, all human resource policies should receive legal review on a regular basis. â?š

References

1. Target headquarters team members dress for their day. Target. https:// corporate.target.com/discover/article/ headquarters-Target-team-membersdress-for-their-d. Accessed July 7, 2014.

2. Dress code and uniform policies.

Safeway Inc. www.safewayemployeestore.com/dress_code.aspx. Accessed July 6, 2014.

Mr Orzechowski is Chief Operating Officer, Lancaster Cancer Center, PA.

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Inside Pharmacy â?š June | July 2014

37

INSIDE

Money 8 Prescriptions to Improve Your Finances

by Andrew D. Schwartz, CPA, and Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF

Key Points ❚ A financial plan can help you balance competing financial priorities ❚ Make sure that your plan is up to date ❚ You will need to modify your plan due to changes in your personal circumstances or the economy

Financial planning is a process that can help you reach your goals by evaluating the whole financial picture, then outlining strategies that are tailored to your individual needs and available resources. }} }} Why Is Financial Planning important? The term financial planning can be used to illustrate many things. It can be a comprehensive plan, focusing on several needs or goals simultaneously, or limited to specific areas such as establishing a budget, or saving for a home, a child’s education, or retirement. A comprehensive financial plan serves as a framework for organizing your financial life. One of the main benefits of a financial plan is that it can help you balance competing financial priorities by clearly showing you how your financial goals are related, and how decisions made in one area subsequently affect the others.

What Steps Can You Take?

Here are some prudent steps you can take to keep personal finances heading in the right direction:

38

Inside Pharmacy ❚ June | July 2014

1/

Reset your retirement savings.

Most people find it easier to maximize their retirement plans by depositing a fixed dollar amount each month or a percentage of their salary. Instruct your employer to withhold enough each month for your 401(k) or 403(b) plan to ensure reaching the maximum contribution of $17,500 in 2014. Are you self-employed? If so, you can contribute up to $52,000 annually into a Simplified Employee Pension (SEP), Keogh, or Solo 401(k) plan for 2014.

In addition, if you are aged 50 years or older by December 31, 2014, the maximum contribution increases to $23,000 for 401(k) and 403(b) salary deferrals, and $57,500 for Solo 401(k) plans.

2/ Refinance your home. You’ve heard

about the record-low interest rates. You may want to lower your monthly mort-

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Inside Money gage payment by refinancing to a lower interest rate or to a shorter loan term (eg, from a 30-year mortgage to a 15-year mortgage), allowing you to own your home in a shorter period of time. You may want to refinance your adjustable rate mortgage (ARM) to a fixed-rate mortgage or a new ARM with better terms. Finally, another option would be to refinance in order to take cash out of your home or simply use your home equity for home improvements, to pay for college, or to reduce or consolidate existing debt.

3/

Reduce your student loan debt.

Unfortunately, many healthcare professionals who could be eligible to refinance student loan debt are not aware that the option exists. Most borrowers tend to “set and forget” student loans, choosing a repayment plan after graduation and never taking a second look. The problem with this approach is that their rate remains the same throughout the life of the loan, even as their financial situation improves and they potentially become eligible for a lower rate. As its name suggests, consolidating implies combining multiple student loans into 1 loan.

However, the word can have different implications depending on whether it refers to federal or private student loans.

Federal student loan consolidation is offered by the government and is available for most types of federal loans (no private loans allowed). After the loans are combined, the resulting interest rate is a weighted average of the original loan rates, which means the borrower does not effectively save any money.

Similar to federal consolidation, a private consolidation loan allows a borrower to combine multiple loans into 1.

However, the resulting interest rate is not a weighted average of the original loan rates. Instead, a private lender will typically use the borrower’s credit score and other relevant financial information to give him a new interest rate and loan, then use that loan to pay off the original loans. Essentially, consolidating

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loans with a private lender is the same thing as refinancing those loans. Not all student loan refinance lenders are alike. When comparing private lenders to determine where to refinance, borrowers should consider the interest rates, flexibility, and additional benefits available. Social Finance, Inc and Darien Rowayton Bank are examples of private lenders. Important disclosure and repayment information for SoFi refinance loans can be viewed on their website at www.SoFi.com.

4/

Revise your savings and debt reduction goals. Take a few minutes to set new savings goals. Ideally, pharmacists, physician assistants, and nurse practitioners should save 15% to 20% of their gross income toward retirement.

While it is true that if you start early you can save less, saving 15% to 20% provides flexibility for years where you might not be able to save as much, to allow for poor investment returns, or for a personal or financial catastrophe such as divorce or disability. If all goes well and none of these scenarios materialize, then you will be left with a wonderful choice: retire earlier or retire wealthier.

5/ Rebalance your investment portfo-

lio. Warren Buffett said it best by stating, “A simple rule dictates my buying: Be fearful when others are greedy, and be greedy when others are fearful.” During 2013, the stock market posted substantial gains. By rebalancing your portfolio to its original or updated asset allocation, you lock in gains from the sectors that performed the best and move money into sectors that underperformed and soon enough should be poised to catch up.

6/ Recalculate how much your retire-

ment savings will be worth when you retire. Take a look at how much buying power you can expect to have at retirement. Be sure to download the online retirement calculator (www.mdtaxes. com) to find out what your savings will really be worth when you retire.

The 8 R’s of

FINANCIAL SECURITY

1.

Reset your retirement savings

2.

Refinance your home

3.

Reduce your student loan debt

4.

Revise your savings and debt reduction goals

5.

Rebalance your investment portfolio

6.

Recalculate how much your retirement

savings will be

worth when

you retire

7.

Revisit your disability, life, and property and casualty insurance needs

8.

Resolve errors on your credit report

Inside Pharmacy ❚ June | July 2014

39

Inside Money 7/

Revisit your disability and life insurance needs. Throughout your career and life, disability and life insurance needs change. Give some thought to how much of these insurances you need versus how much you currently receive through your employer.

As a healthcare professional, the ability to earn an income is your most valuable asset.

Lawrence B. Keller

Mr Schwartz, CPA, is a partner in the Boston CPA firm Schwartz & Schwartz, P.C. Mr Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services.

40

As a healthcare professional, the ability to earn an income is your most valuable asset. For this reason, you should purchase an individual noncancelable, guaranteed renewable “own-occupation” disability insurance policy with benefits payable to the age of 65 years or longer, a residual disability rider, a cost-of-living adjustment rider, and a future increase option rider. This type of policy will provide you with income if you are disabled and cannot perform your duties as a pharmacist, physician assistant, or nurse practitioner—even if you choose to work in another occupation. Be sure to look for a policy with a “multilife” or association discount. While this can provide men with a savings of 10% to 15% off of their policies, women can save as much as 60% off of their polices if a gender neutral or “unisex” rate is available.

Term life insurance is for the most part a commodity, so the pricing is very competitive and comparison shopping is easy. Websites such as www.term4 sale.com can compare the premium rates of several insurance companies and various death benefit amounts and guarantee periods. You should employ the services of an experienced insurance agent who represents several companies to help you get the best rates, especially if your health is less than perfect.

The agent will know which carriers are likely to provide a better underwriting

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classification based on your height and weight, immediate family history, and/ or other medical issues to allow you to secure a lower premium rate. For example, if you have an immediate family (mother, father, brother, sister) history of cancer, certain companies will allow you to qualify for their best underwriting classification while others will not.

As your financial situation changes, you can reevaluate the amount and type of insurance you own. A good general rule of thumb is to insure yourself for 7 to 10 times your gross income.

Purchase automobile, homeowner’s/ renter’s, and umbrella (“excess liability”) policies. These policies will protect you and/or your assets, and future earnings. Make sure your deductible is at least $1000 and that the liability limits of your automobile and homeowner’s insurance match. In addition, if they are all with the same company, substantial discounts may be available.

8/

Resolve errors on your credit report. Each year, you are entitled to 3 free credit reports, so there is no excuse not to look at this important financial report annually, especially since errors are common. If you find information that is outdated, incorrect, or misleading upon review, you should contact the credit reporting agency as soon as possible. If the disputed data are found to be incorrect, the lender or information provider must notify all credit reporting agencies nationwide to correct the information in your file. If the negative information proves to be correct, you still have the right to insert a brief commentary (100 words) about the entry on your credit report. Order your free report at www.annualcreditreport.com.

Conclusion Make sure that your plan is up to date. It is also possible that you will need to modify your plan due to changes in your personal circumstances or the economy. These 8 steps are a great place to start. ❚

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FDA Updates The following updates include new approved drugs by the US Food and Drug Administration (FDA). For the full list, please visit fda.gov.

Afrezza Inhalation Powder Approved for Diabetes Afrezza (insulin hu­ man) Inhalation Powder, a rapid-acting inhaled in­ sulin to improve glycemic control in adults with dia­ betes mellitus, has been approved by the US Food and Drug Administration (FDA), according to a press release. The inhaled insulin powder is adminis­ tered at the beginning of each meal.

The safety and effec­ tiveness of the drug were evaluated in a study con­ sisting of 3017 partici­ pants, including 1026 patients with type 1 dia­ betes and 1991 patients with type 2 diabetes. The efficacy of mealtime treatment with the drug in adult patients with type 1 diabetes was com­ pared with mealtime in­ sulin aspart (fast-acting insulin), both in combi­ nation with basal insulin (long-acting insulin) in a 24-week study. At week 24, treatment with basal insulin and mealtime treatment with the insu­ lin inhalation powder provided a mean reduc­ tion in glycated hemoglo­

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bin (HbA1c) that met the prespecified noninferiori­ ty margin of 0.4%.

The insulin inhalation powder provided less HbA1c reduction than in­ sulin aspart, and the dif­ ference was statistically significant. The drug was also evaluated in adults with type 2 diabetes in combination with oral antidiabetic drugs; the ef­ ficacy of mealtime insulin inhalation powder in type 2 diabetes patients was compared with placebo inhalation in a 24-week study. At week 24, treat­ ment with the insulin in­ halation powder plus oral antidiabetic drugs provid­ ed a greater statistically significant mean reduc­ tion in HbA1c compared with the HbA1c reduction seen in patients in the placebo group.

The FDA emphasized that this drug is not a sub­ stitute for long-acting in­ sulin. It must be used in combination with longacting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of patients with diabetic ketoacidosis, or in patients who smoke.

Zykadia Approved for Metastatic, ALKPositive Lung Cancer The FDA approved Zykadia (ceritinib) for the treatment of patients

The insulin inhalation powder provided less HbA1c reduction than insulin aspart. with metastatic, anaplas­ tic lymphoma kinase (ALK)-positive non– small-cell lung cancer (NSCLC). Ceritinib is an ALK tyrosine kinase inhibitor that blocks pro­ teins that promote cancer cell growth. The drug is approved for the treat­ ment of patients with late-stage NSCLC who were previously treated with crizotinib, the first and only other ALK tyro­ sine kinase inhibitor ap­ proved by the FDA. The safety and efficacy of ceritinib were estab­ lished in a clinical trial with 163 patients with metastatic, ALK-positive NSCLC. All patients re­ ceived ceritinib: approxi­ mately 50% of the pa­ tients had their tumor shrink with this therapy, and this result lasted an average of approximately 7 months.

Reported side effects were mainly gastrointesti­ nal, such as diarrhea, nau­ sea, vomiting, and ab­

dominal pain. Laboratory abnormalities included increased liver enzymes and pancreatic enzymes, as well as increased glu­ cose levels.

FDA Approves First Generic Celecoxib The first generic ver­ sions of Celebrex (celecox­ ib) capsules, a treatment for patients with rheuma­ toid arthritis, osteoarthri­ tis, acute pain, and other conditions, have been ap­ proved by the FDA, ac­ cording to a press release by the agency.

Teva Pharmaceutical Industries received ap­ proval to market celecox­ ib capsules in 50-mg, 100-mg, 200-mg, and 400-mg strengths, and has 180-day exclusivity on the 100-mg, 200-mg, and 400-mg products.

Mylan Pharmaceuticals Inc received approval to market 50-mg celecoxib capsules.

Celecoxib is a nonste­ roidal anti-inflammatory drug (NSAID). All NSAIDs have a boxed warning in their prescrib­ ing information to alert healthcare professionals and patients about the risk of heart attack or stroke that can lead to death. This chance in­ creases for people with heart disease or risk fac­ tors for heart disease,

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41

Inside

FDA Updates such as high blood pres­ sure, or taking NSAIDs for long periods of time.

The boxed warning also highlights the risk of seri­ ous, potential life-threat­ ening gastrointestinal bleeding that has been associated with the use of NSAIDs. In the clinical trials for celecoxib, the most com­ monly reported adverse reactions in patients tak­ ing the drug for arthritis were abdominal pain, di­ arrhea, dyspepsia, flatu­ lence, peripheral edema, accidental injury, dizzi­ ness, pharyngitis, rhinitis, swollen nasal passages, si­ nusitis, upper respiratory tract infection, and rash.

Information about the availability of generic ce­ lecoxib can be obtained from the companies.

First Drug Combination Approved for Unresectable or Metastatic Melanoma The FDA approved the use of Tafinlar (dab­ rafenib; GlaxoSmith­ Kline) plus Mekinist (trametinib; GlaxoSmith­ Kline) as a new combina­ tion therapy for the treat­ ment of patients with advanced melanoma that is unresectable or meta­ static. The 2 drugs were individually approved by the FDA in 2013 for mel­ anoma. Dabrafenib was initially approved for pa­

42

The FDA approved the use of dabrafenib plus trametinib as a new combination therapy for the treatment of patients with advanced melanoma. tients with melanoma whose tumors express the BRAF V600E mutation.

The dabrafenib-trame­ tinib combination is indi­ cated for patients with melanoma who also have the BRAF V600E or BRAF V600K mutation.

Approximately 50% of skin melanomas have a BRAF mutation.

The FDA approval was based on results of a clinical trial of 162 pa­ tients with unresectable or metastatic melanoma with the BRAF V600E or BRAF V600K mutation; the majority of the pa­ tients were treatmentnaïve. They received dabrafenib as a single agent until their disease progressed or their side effects became intolera­ ble, at which point they began using the combina­

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tion. Overall, 76% of pa­ tients receiving the com­ bination had an objective response for an average of 10.5 months compared with 54% of patients re­ ceiving dabrafenib alone who had an objective response lasting 5.6 months. Clinical trials are ongoing to determine whether this combina­ tion will also result in improved survival.

Sivextro Approved for Skin Infections The FDA approved Sivextro (tedizolid phos­ phate), a new antibacteri­ al drug, for the treatment of patients with acute bac­ terial skin and skin struc­ ture infections (ABSSSI) associated with certain susceptible bacteria, in­ cluding Staphylococcus aureus such as methicil­ lin-resistant strains and methicillin-susceptible strains, as well as various Streptococcus species, and Enterococcus faecalis. The drug is available for intra­ venous and oral use.

The application for te­ dizolid phosphate, which is intended to treat serious or life-threatening infec­ tions, was designated as a qualified infectious dis­ ease product. It received an expedited review.

The safety and efficacy of tedizolid phosphate were evaluated in 2 clini­ cal trials, including 1315 adults with ABSSSI. Par­

ticipants were randomly assigned to receive te­ dizolid phosphate or linezolid, another anti­ bacterial drug approved to treat patients with ABSSSI. Tedizolid phos­ phate was as effective as linezolid for the treat­ ment of patients with ABSSSI, according to study results.

Common side effects associated with the drug identified in the clinical trials were nausea, head­ ache, diarrhea, vomiting, and dizziness. The safety and efficacy of tedizolid phosphate have not been evaluated in patients with decreased levels of white blood cells (neutropenia); therefore, alternative therapies should be con­ sidered, the FDA noted.

Apremilast Approved for Psoriatic Arthritis The FDA approved the use of Otezla (apremi­ last), a phosphodiester­ ase-4 inhibitor, on March 21, 2014, for the treat­ ment of adults with ac­ tive psoriatic arthritis.

Most people develop psoriasis first and are later diagnosed with psoriatic arthritis. Joint pain, stiff­ ness, and swelling are the main signs and symptoms of psoriatic arthritis.

Three clinical trials (N = 1493) evaluated the safety and effectiveness of apremilast in this patient population. Patients treat­

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FDA Updates ed with the drug showed improvements in signs and symptoms of psoriatic arthritis, including tender and swollen joints as well as physical function com­ pared with placebo.

The FDA noted that patients treated with apremilast should have their weight monitored regularly by a healthcare professional. If unex­ plained or clinically sig­ nificant weight loss oc­ curs, the weight loss should be evaluated and discontinuation of treat­ ment should be consid­ ered. Apremilast was also associated with an in­ crease in depression com­ pared with placebo.

Common side effects ob­ served in patients taking the drug were diarrhea, nausea, and headache.

In addition, the FDA is requiring a pregnancy exposure registry as a postmarketing require­ ment to assess the risks to pregnant women related to apremilast exposure.

First Antihemophilic Factor Approved for Hemophilia A The FDA approved Eloctate, antihemophilic factor (recombinant), Fc fusion protein, for adults and children who have hemophilia A. It is the first hemophilia A treat­ ment designed to require less frequent injections when used to prevent or

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reduce the frequency of bleeding, according to a press release published by the agency.

The drug is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes. It con­ sists of the coagulation factor VIII molecule linked to a protein frag­ ment (Fc), which makes the product last longer in the patient’s blood.

The safety and efficacy of the antihemophilic factor recombinant were evaluated in a clinical trial of 164 patients that compared the prophylac­ tic treatment regimen to on-demand therapy. The trial demonstrated that therapy with this drug was effective in the treat­ ment of bleeding epi­ sodes, in preventing or reducing bleeding, and in the control of bleeding during and after surgical procedures. No safety concerns were identified in the trial.

The recombinant re­ ceived orphan drug desig­ nation for this use by the FDA because it is intend­ ed for the treatment of a rare disease or condition.

Ofatumumab Approved for Chronic Lymphocytic Leukemia The FDA approved

The approval of ofatumumab was based on the results of a multicenter, randomized, open-label trial.

Arzerra Injection (ofatu­ mumab; GlaxoSmith­ Kline) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leu­ kemia, for whom flu­ darabine-based therapy is considered inappropriate.

The approval was based on the results of a multicenter, randomized, open-label trial compar­ ing ofatumumab in com­ bination with chloram­ bucil with chlorambucil alone. The 447 patients included in the study were deemed ineligible for fludarabine-based therapy because of ad­ vanced age or comorbid­ ities. Overall, 72% of pa­ tients had ≥2 co­morbid­ ities, and 48% had a creatinine clearance of <70 mL/min.

Infusion of intravenous ofatumumab was adminis­ tered as 300 mg in cycle 1 on day 1, followed by 1000

mg on day 8 (first arm), or 1000 mg administered on day 1 of all subsequent 28day cycles (second arm).

In both arms, chlorambu­ cil was administered at a dose of 10 mg/m2 orally on days 1 to 7 every 28 days.

Before each infusion of ofatumumab, patients received premedication with acetaminophen, an antihistamine, and a glucocorticoid.

The primary end point of the trial was pro­gressionfree survival as assessed by a blinded in­dependent re­ view committee. The me­ dian progression-free sur­ vival was 22.4 months (95% confidence interval [CI], 19-25.2) in patients receiving ofatumumab plus chlorambucil com­ pared with 13.1 months (95% CI, 10.6-13.8) in pa­ tients receiving chlor­ ambucil alone (hazard ratio, 0.57; 95% CI, 0.450.72; P <.001).

The most common ad­ verse reactions (≥5%) re­ ported with ofatumumab plus chlorambucil were infusion reactions, neu­ tropenia, asthenia, head­ ache, leukopenia, herpes simplex, lower respiratory tract infection, arthral­ gia, and upper abdominal pain. Overall, 67% of the patients who received ofatumumab had ≥1 symptoms of infusion re­ action. In addition, 10% of patients had a grade ≥3 infusion reaction. ❚

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43

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Drug Update Aveed (Testosterone Undecanoate): A Novel Dosing Schedule Approved for Testosterone Replacement in Men with Hypogonadism

by Lisa A. Raedler, PhD, RPh, Medical Writer

The diagnosis of hypogonadism should be made in men who have consistent signs and symptoms, as well as low total testosterone levels.

In men, hypogonadism (or testosterone deficiency) occurs when the testes fail to produce physiological levels of testosterone and the normal number of spermatozoa.1 This condition is caused by disruption at 1 or more levels of the hypothalamic-pituitary-gonadal axis.1 Primary hypogonadism can result from testicular injury, autoimmune disorders, and genetic disorders (ie, Klinefelter syndrome), infection, liver disease, kidney disease, radiation, or surgery.2,3 In contrast, a faulty hypothalamus or pi-

tuitary gland causes central hypogonadism.2 Certain medications (ie, steroids, long-term opiate use), genetic disorders, bleeding disorders, nutritional deficiencies, radiation, surgery, and pituitary tumors can result in central hypogonadism.2 Affecting approximately 39% of men aged ≥45 years in the United States, hypogonadism is diagnosed more often as men grow older.3,4 The signs and symptoms of hypogonadism include decreased body hair, enlarged breasts, muscle weakness, sexual

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

44

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dysfunction, fatigue, and depression.3 The loss of libido, impotence, infer­ tility, and osteoporosis are also characteristic of this condition.3 According to the Endocrine Society, the diagnosis of hypogonadism should be made in men who have consistent signs and symptoms, as well as low total testosterone levels.1 A serum total testosterone level of 300 ng/dL is considered the lower limit of normal.1 Identification of the condition is important, in part because hypogonadism is often associated with 1 of several diseases and medical conditions, including

obesity, diabetes, hypertension, hyperlipidemia, osteoporosis, and asthma or chronic obstructive pulmonary disease.2,4 Pharmacologic treatments for hypogonadism are designed to replace deficient testosterone and to improve symptoma­ tology. Testosterone replacement therapy has been shown to restore sexual function and muscle strength, prevent osteoporosis, increase energy, and enhance sex drive.5,6 Testosterone replacement products are available in multiple formulations, such as a skin patch, topical gel, depot injection, buccal tablet, and subcu-

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DISPENSE Albuterol Sulfate HFA as PROAIR HFA Inhalation Aerosol

NO GENERIC ALBUTEROL INHALER CURRENTLY EXISTS

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

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Drug Update Hypogonadism and its related comorbidities result in a significant cost burden for the US healthcare system. taneous pellet implant.1,2 Despite the variety of route of administration options, however, today’s testosterone replacement therapies have many shortcomings; some require twice-daily application, some men cannot tolerate the buccal tablet on their gums, transdermal patches can cause local skin irritation, and gel formulations can potentially transfer testosterone to women or to children.7 Hypogonadism and its related comorbidities result in a significant cost burden for the US healthcare system.8 Retrospective analysis of an administrative claims database of 55 large, self-insured US companies has documented that compared with controls, male employees with hypogonadism were significantly more likely to have co-

46

morbidities, including hyperlipidemia, hypertension, back or neck pain, mental disorders, and HIV/AIDS.8 Men with hypogonadism also had significantly higher rates of hospitalization, emergency department visits, outpatient physician visits, and prescription medication use.8 In that analysis, the direct and indirect healthcare costs were higher for men with hypogonadism compared with the controls.

These costs were primarily related to the management of comorbid conditions associated with hypogonadism.8

New Treatment Option for Hypogonadism: Testosterone Undecanoate On March 6, 2014, the US Food and Drug Administration (FDA) approved testosterone un­ decanoate (Aveed; Endo Pharmaceuticals) for testosterone replacement ther­ apy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (con­ genital or acquired) and hypogonadotropic hypo­gonadism (congenital or acquired).9 Testosterone undecanoate is a long-acting depot formulation of tes-

Inside Pharmacy ❚ June | July 2014

tosterone formulated in refined castor oil and benzyl benzoate.10 The new drug has a novel dosing schedule: a single intramuscular (IM) injection is given initially, followed by a second injection 4 weeks later.

Subsequent injections are given every 10 weeks thereafter.10 The FDA approved testosterone undecanoate after reviewing data from an 84-week phase 3 clinical trial of men with hypogonadism in the United States.7 This trial showed that testosterone undecanoate increased and maintained mean serum testosterone levels within the adult male reference range at all of the time points that were measured.7 The FDA approval of testosterone undecanoate includes a boxed warning regarding anaphylaxis and serious pulmonary oil microemulsion (POME) reactions.10 The FDA approval also requires the manufacturer to provide a Risk Evaluation and Mit­ igation Strategy (REMS) program that includes pre­scriber education and certification, as well as restricted product distribution.9 Testosterone undecanoate is a Schedule III controlled substance in the Controlled Substances Act.10

Mechanism of Action Testosterone undecanoate injection is an ester of testosterone.10 Testosterone and other endogenous androgens are responsible for the growth and development of male sex organs and the maintenance of secondary sex characteristics.10 Dosing and Administration A dose of 3 mL (750 mg) of testosterone undecanoate is injected intramuscularly at initiation, then at 4 weeks, and at every 10 weeks thereafter.

Dosage titration is not necessary.10 The drug is injected into the gluteus medius muscle, which is located in the upper outer quadrant of the buttock. To minimize the risk of in­ travascular injection, testosterone undecanoate should be injected deeply into the gluteal muscle based on the recommended procedures for IM drug administration.10 After each injection, patients should be observed for 30 minutes in a certified healthcare setting to monitor for, and to potentially treat, serious POME or anaphylaxis reactions.10 Clinical Trials In the single-arm, open-label, 84-week multicenter phase 3 clinical

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Drug Update trial of testosterone un­ decanoate, 130 men with hypogonadism received 3-mL (750-mg) IM injections at weeks 0 and 4, and every 10 weeks thereafter.7,10 A total of 9 injections were administered over 84 weeks.7 The primary efficacy end point of the trial was the percentage of men with average serum total testosterone concentration (Cavg) within the normal range (300-1000 ng/dL) after the third injection, or steady state.10 The secondary end point was the percentage of men with maximum total testosterone concentration (Cmax) above 3 predetermined limits: >1500 ng/dL, between 1800 and 2499 ng/dL, and >2500 ng/dL.10 The average serum prostate-specific antigen (PSA) increased from 1.0 ± 0.8 ng/mL at study baseline to 1.5 ± 1.3 ng/ mL at the conclusion of the 84-week phase 3 study.10 During the 84week treatment period, 10.9% of patients whose baseline PSA was <4 ng/ mL had a postbaseline serum PSA of >4 ng/ mL.10 In total, 725 men with hypogonadism received IM testosterone undecanoate in 7 controlled clinical trials.10 The doses of IM testosterone undec­ anoate varied from 750

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mg to 1000 mg, and the dose frequency ranged from every 9 weeks to every 14 weeks.10 In several of these trials, the loading doses of testosterone undec­ anoate were administered at therapy initiation.

The 84-Week Phase 3 Trial In the 84-week trial, eligible patients included men with primary or secondary hypogonadism who were aged ≥18 years.10 All had a morning screening testosterone concentration of <300 ng/dL.10 Patients with an American Urological Association International Prostate Symptom Score of ≥15, or those with significant prostatic symptoms, were ineligible for this study.7 Patients with serious psychiatric disease or uncontrolled medical illness, and those who used any sex hormones or steroidal anabolic drug supplements within 28 days before enrollment screening or at any time during the course of the study were not included in the study.7 Among the 130 study participants, mean screen­ ing testosterone concentration was 215 ng/dL and mean body mass index was 32 kg/m2.10 Their mean age was 54 years.10 The majority (75%) of patients were white and

Table 1. Mean Serum Total Testosterone Concentrations at Steady State for Testosterone Undecanoate 750 mg Concentration level

Mean (SD) serum total testosterone concentration, ng/dL (N = 117)

Cavg (0-10 wks)

495 (142)

Cmax

891 (345)

Cmin

324 (99)

Cavg indicates average concentration; Cmax, maximum concentration; Cmin, minimum concentration; SD, showed deviation.

Source: Aveed (testosterone undecanoate) injection prescribing information; March 2014.

were diagnosed with primary hypogonadism (approximately 70%).7,10 Of the 130 patients, 38% were naïve to testosterone replacement therapy.7 The phase 3 study demonstrated that testosterone undecanoate injection was efficacious in treating hypogonadism in adult men.10 Of the 130 patients, 117 completed 24 weeks of the study and were included in the pharmacokinetics evaluation. The majority (94%) of patients maintained a Cavg within the normal range (300-1000 ng/dL).10 Of the 117 patients who completed 24 weeks, 6 (5.1%) had a Cavg below the normal range (<300 ng/dL) and 1 (0.9%) patient was above the normal range (>1000 ng/ dL).10 The percentage of patients with a Cmax of

>1500 ng/dL was 7.7%.

None of the patients had a Cmax of >1800 ng/dL.10 The mean serum total testosterone pharmacokinetic parameters at steady state for the 117 patients who completed 24 weeks of the study are summarized in Table 1.

Adverse Events In the 84-week study of testosterone undecanoate, the most frequently reported adverse events were acne, injection site pain, an increase in serum PSA to >4 ng/mL, hypogonadism, and increased estradiol (Table 2).10 A total of 7 (4.6%) patients who participated in the 84-week clinical trial of testosterone undecanoate discontinued the trial because of adverse reactions, which included increased hematocrit, increased estradiol, increased

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47

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Drug Update Table 2. The 84-Week Clinical Study of Testosterone Undecanoate: Adverse Events Reported in ≥1% of Patients Patients using testosterone undecanoate 750 mg, N (%) (N = 153)

Adverse eventsa Acne

8 (5.2)

Injection site pain

7 (4.6)

PSA increased

7 (4.6)

Estradiol increased

4 (2.6)

Hypogonadism

4 (2.6)

a

Fatigue

3 (2)

Irritability

3 (2)

Hemoglobin increased

3 (2)

Insomnia

3 (2)

Mood swings

3 (2)

Aggression

2 (1.3)

Ejaculation disorder

2 (1.3)

Injection site erythema

2 (1.3)

Hematocrit increased

2 (1.3)

Hyperhidrosis

2 (1.3)

Prostate cancer

2 (1.3)

Prostate induration

2 (1.3)

Weight increased

2 (1.3)

NOTE: A total of 7 (4.6%) patients discontinued the trial because of adverse reactions. a Defined as a serum PSA concentration >4 ng/mL. PSA indicates prostate-specific antigen.

Source: Aveed (testosterone undecanoate) injection prescribing information; March 2014.

PSA, prostate cancer, mood swings, prostatic dysplasia, acne, and deep vein thrombosis.10 Adverse events that were reported by ≥3% of patients in the 7 clinical trials, irrespective of the investigator’s assessment of their relationship to the study medication, includ-

48

ed sinusitis, prostatitis, arthralgia, nasopharyngitis, upper respiratory tract infection, bronchitis, back pain, hypertension, diarrhea, and headache.10 In controlled clinical trials of IM testosterone undec­anoate, adverse events attributable to POME and anaphylaxis

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were reported. In the 84week clinical trial of testosterone undecanoate, 1 patient experienced a mild coughing fit that lasted 10 minutes after his third injection. This event was retrospectively attributed to POME. In another clinical trial of IM testosterone undecanoate dosed at 1000 mg, a male patient experienced the urge to cough and respiratory distress at 1 minute after his tenth injection, which was also retrospectively attributed to POME.10 A total of 9 POME events in 8 patients and 2 anaphylaxis events among 3556 patients treated with IM testosterone undecanoate in 18 clinical trials were judged to have occurred during a review that involved adjudication of all cases meeting specific criteria.10

Contraindications Men with breast cancer or with known or suspected prostate cancer should not use testosterone un­decanoate.10 Women who are or may become pregnant or who are breastfeeding should not take testosterone undecanoate. Testosterone can cause fetal harm when administered to a pregnant woman and may also cause serious adverse reactions in nursing infants.10 Androgen ex-

posure to a fetus or a nursing infant may result in varying degrees of virilization.10 Men with known hypersensitivity to testosterone undecanoate or any of its ingredients (ie, testosterone undecanoate, refined castor oil, or benzyl benzoate) should not use testosterone undecanoate.10

Warnings and Precautions Boxed warning regarding serious POME reactions, anaphylaxis.

Testosterone undecanoate carries a boxed warning regarding anaphylaxis and serious POME re­actions, such as cough, urge to cough, dyspnea, hyper­hidrosis, throat tightening, chest pain, dizziness, and syncope.10 POME reactions can occur during or immediately after the IM injection of testosterone un­ decanoate 1000 mg (4 mL).10 Most of these events were of a few minutes in duration and resolved with supportive measures. In other cases, symptoms lasted up to several hours and emergency care and/or hospitalization was required.10 Episodes of anaphylaxis, including life-threatening reactions, have also been reported after IM injection of testosterone undecanoate.10 Anaphylaxis and/or

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Drug Update serious POME reactions can occur after any injection of testosterone un­ decanoate, including after the initial dose. Patients with suspected hypersensitivity reactions to testosterone undecanoate should not be treated again with it.10 After each injection of testosterone undecanoate, patients should be observed in the healthcare setting for 30 minutes to provide appropriate medical treatment should any serious POME and anaphylaxis events occur.10 REMS program. Because of the risk for serious POME and anaphylaxis, testosterone un­ decanoate is distributed through a restricted program, the Aveed REMS Program. Healthcare providers who prescribe testosterone undecanoate must be certified with the REMS program before ordering or dispensing testosterone undecanoate.10 Healthcare settings must be certified with the REMS program and must have certified healthcare providers before ordering and dispensing testosterone undecanoate. Healthcare settings must also have onsite access to equipment and trained personnel to manage serious POME and anaphylaxis.10 (Additional information is available at

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www.AveedREMS.com and via 855-755-0494.10) Worsening of benign prostatic hyperplasia/ risk for prostate cancer.

Patients with benign prostatic hyperplasia (BPH) who use androgens, including testosterone undecanoate, are at an increased risk for, and should be monitored for, worsening of the signs and symptoms of BPH. Patients receiving androgens, including testosterone undecanoate, also have an increased risk for prostate cancer and should be evaluated before starting and during testosterone undecanoate therapy.10 Polycythemia.

Increases in hematocrit may require the discontinuation of testosterone undec­anoate, because increases in red blood cell mass can affect thromboembolic event risk.10 Hematocrit should be checked before starting testosterone undecanoate treatment, every 3 to 6 months while receiving treatment, and then annually. If hematocrit becomes elevated, therapy should be stopped until it decreases to an acceptable level.10 Use in women. Testosterone undecanoate is not indicated for use in women because of a lack of controlled evaluations in women and potential

virilizing effects.10 Effects on spermatogenesis. Spermatogenesis may be suppressed with large doses of exogenous androgens, including testosterone undecanoate.

This can adversely affect sperm count.10 Hepatic events. The continued use of high doses of orally active 17-alpha-alkyl androgens (eg, methyltestosterone) has been associated with serious hepatic adverse events, including peliosis hepatis (which can be fatal), hepatic neoplasms, cholestatic hepatitis, and jaundice.

Long-term therapy with IM testosterone enanthate, which elevates blood testosterone levels for long time periods, has led to multiple hepatic adenomas.

Although testosterone undecanoate is not known to produce these effects, patients should be advised to report any signs or symptoms of hepatic dysfunction (eg, jaundice). If these occur, the cause should be evaluated and testosterone undecanoate should be discontinued.10 Edema. Androgens, including testosterone undecanoate, can increase sodium and water retention. In patients with preexisting cardiac, renal, or hepatic disease, edema can be a serious complication. Diuretic therapy

may be required and testosterone undecanoate should be discontinued.10 Gynecomastia. Gynecomastia may occur and persist in men receiving testosterone replacement therapy for hypogonadism.10 Sleep apnea. Hypo­ gonadal men receiving testosterone replacement therapy may develop sleep apnea, particularly obese men and those with chronic lung disease.10 Lipids. Dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy may be required if changes in serum lipid profile are observed.10 Hypercalcemia. Patients with cancer who are at risk of hypercalcemia and associated hypercalciuria should only use androgens, including testosterone undecanoate, with caution. Serum calcium concentrations should be regularly monitored in these patients.10 Decreased thyroxinebinding globulin. Thyroxine-binding globulin concentrations may be lower in patients using androgens, including testosterone undec­anoate. Because free thyroid hormone concentrations remain unchanged, thyroid dysfunction has not been observed.10

Specific Populations The safety and effec-

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49

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Drug Update tiveness of testosterone undecanoate have not been established in males aged <18 years. The use of testosterone undecanoate in these patients may result in acceleration of bone age and premature closure of epiphyses.10 Whether the efficacy or safety of testosterone un­dec­anoate in men aged >65 years differs from younger patients cannot be determined, because the number of geriatric patients participating in controlled clinical studies was insufficient. Data in geriatric patients are insufficient to assess the risks

for cardiovascular disease or prostate cancer.10

Conclusion The March 2014 FDA approval of a new dosing schedule for testosterone undecanoate provides patients with hypogonadism a novel and convenient administration alternative compared with the currently available testosterone replacement prep­ arations. For men with this condition, testosterone undecanoate offers a long-acting formulation as an effective and convenient treatment option.

Participating in the

REMS program associated with this therapy is important to ensure that it is only used in men for whom the benefits outweigh the risks. ❚

References

1. Bhasin S, Cunningham GR, Hayes FJ, et al; for the Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab.

2010;95:2536-2559.

2. MedlinePlus. Hypogonadism. Up­­ dated December 22, 2012. www.nlm. nih.gov/medlineplus/ency/article/ 001195.htm. Accessed March 14, 2014.

3. Dandona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract. 2010;64:682-696.

4. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006;60:762-769.

5. Arver S, Dobs AS, Meikle AW, et al. Long-term efficacy and safety of a permeation-enhanced testosterone transdermal system in hypogonadal men. Clin Endocrinol. 1997;47:727-737.

6. McNicholas TA, Dean JD, Mulder H, et al. A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function. BJU Int. 2003;91:69-74.

7. Wang C, Harnett M, Dobs AS, Swerdloff RS. Pharmacokinetics and safety of long-acting testosterone undecanoate injections in hypogonadal men: an 84-week phase III clinical trial. J Androl. 2010;31:457-465.

8. Kaltenboeck A, Foster S, Ivanova J, et al. The direct and indirect costs among U.S. privately insured employees with hypogonadism. J Sex Med. 2012;9:2438-2447.

9. US Center for Drug Evaluation and Research. Aveed approval letter.

March 5, 2014. www.accessdata.fda. gov/drugsatfda_docs/appletter/2014/ 022219Orig1s000ltr.pdf. Accessed March 15, 2014.

10. Aveed (testosterone undecanoate) injection [prescribing information].

Malvern, PA: Endo Pharmaceuticals Solutions Inc; March 2014.

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