Dispensing Excellence

A PUBLICATION OF AVELLA SPECIALTY PHARMACY | AVELLA.COM

VOLUME 1, ISSUE 1 SPRING 2013

04The Medication Non-Adherence Epidemic:

A Billion-Dollar Healthcare Crisis

08Ask the Pharmacist: Hepatitis C

15Pharmacists: Patient-Centric Team

Members and Community Resources

16Accreditation: A Testament to

Transparency, Quality and Safety

19Pharmacy Quality Assurance Checklist

20What Is a Specialty Pharmacy?

23Avella’s History and Strategic Growth

27What’s Behind Food Medication

Warning Labels?

2 | Dispensing Excellence Issue 1: Spring 2013 ©2013, Avella of Deer Valley, Inc.

contents

04

08

15THE MEDICATION NON-ADHERENCE EPIDEMIC: A BILLION-DOLLAR HEALTHCARE CRISIS

16ACCREDITATION: A TESTAMENT TO

TRANSPARENCY, QUALITY AND SAFETY

ASK THE PHARMACIST: HEPATITIS C

PHARMACISTS: PATIENT-CENTRIC TEAM MEMBERS AND COMMUNITY RESOURCES

23AVELLA’S HISTORY AND

STRATEGIC GROWTH20WHAT IS A SPECIALTY PHARMACY? 27

WHAT’S BEHIND FOOD MEDICATION WARNING LABELS?

VOLUME 1, ISSUE 1 SPRING 2013

19PHARMACY QUALITY ASSURANCE CHECKLIST

Connect with Avella: | 3

A publication of Avella Specialty Pharmacy

avella.com

Editors:Julie MystromDirector, Marketing Avella Specialty Pharmacy

Todd Speranzo, MBAVice President, MarketingAvella Specialty Pharmacy

Design:Brian LeachCreative DirectorAvella Specialty Pharmacy

Contributors:Eric Sredzinski, Pharm.D., AAHIVEVice President, Clinical AffairsAvella Specialty Pharmacy Todd Bleak, Pharm.D., MBA, AAHIVERegional Director, Colorado/NevadaAvella Specialty Pharmacy Kelly Kistler, Pharm.D.Director, Clinical ServicesAvella Specialty Pharmacy

Cheryl Weiner, MBACertified Grant WriterThe Writer’s Block

Corporate:John D. Musil, Pharm.D., FACACEO & Founder

Keith L. Cook, R.PhPresident

A. Hamilton Baiden IVExecutive Vice President, Sales

Nathan Downhour, Pharm.D.Executive Vice President, Operations

Gary WilliamsChief Financial Officer

Sign up for Avella eNews: avella.com/enews

Please direct questions, comments or advertising inquiries to: [email protected]

©2013, Avella of Deer Valley, Inc.

Dispensing Excellence is published by Innovative Publishing Ink10629 Henning Way, Suite 8Phone 502.423.7272 • Fax 888.780.2241www.ipipub.com

Whether you are an existing customer or have just heard of Avella for the first time, thank you for taking the time to read Dispensing Excellence. We have developed the original content in this publication to better inform and connect with our healthcare provider customers and patients. Since founding the company in 1996, it has been my goal to provide an outstanding customer experience. We do this by going above and beyond our customer expectations and by maintaining a strong focus on clinical excellence. While we have grown substantially from the first store I opened, we retain that pioneering spirit and continue to look for new and improved ways to support our customers. That focus on clinical excellence is as important today as when we started the business. In a current time of pharmacies not sharing that same attention to detail and patient safety, we are proud to be serving and protecting our patients by exceeding industry safety requirements. We believe that, to deliver clinical excellence, we need to provide our customers with more than just prescription medications. That commitment to clinical excellence

means that we impart knowledge and experience to better serve our customers. The content shared in this premiere issue of Dispensing Excellence aims to do just that. In this issue, you will find topics ranging from the challenge of medication adherence to understanding pharmacy accreditations. Hopefully, we have found a way to both entertain and educate through this publication. Our intent in developing and sharing this content is to foster a conversation around how specialty pharmacies can uniquely support the healthcare provider and better serve patients. As you speak with your account managers or pharmacy staff, we encourage you to further discuss the articles and ask questions you may have. I also welcome your direct feedback. Please feel free to email me with any thoughts, questions or suggestions. I look forward to your input. Thank you for reading and for choosing Avella. Best regards,

John D. Musil, Pharm.D., FACAFounder and Chief Executive [email protected]

4 | Dispensing Excellence Issue 1: Spring 2013

When Dr. Koop made this seemingly simple statement 20 years ago, he could not have predicted the billions of dollars that are now wasted every year by patients’ non-adherence to their medication regimens.

“Adherence” is defined as the extent patients take their medications as prescribed, such as twice daily, and suggests an effort by the patient. “Compliance” is considered a synonym for adherence but suggests a more passive patient role, e.g., a lack of involvement from the patient and coercion by the provider. Another term often used when discussing adherence is “persistence,” defined as the length of time the therapy has been prescribed, e.g., 30 days. To receive optimal benefit from a medication regimen, a patient must adhere (comply) and persist. The measurement of adherence is typically reported as the medication possession ratio (MPR).

To support patients’ medication adherence, it is critical to understand the scope of barriers patients face. Healthcare providers can only help to solve this national epidemic if they are aware of patients’ challenges to adherence.

BARRIERSResearchers identified more than 200 factors (see Table 1 above, right) that led to the lack of medication adherence in patients participating in clinical trials. However, the three most common factors are:• Forgetfulness• Understanding• Medication Cost

Forgetfulness:In 2009, Kelton Research conducted a poll with results providing a profile of individuals in the U.S. who are 65 years old and older and who use medications: • 51% take at least five different prescription drugs regularly• 25% take between 10 and 19 pills each day

It is not difficult to see why adherence can be so challenging for the elderly when they are required to take so many medications, multiple times a day, and often with very specific instructions. Non-adherence is not limited to the elderly. Research results published in Alimentary Pharmacology

THE MEDICATION NON-ADHERENCE EPIDEMIC:

A BILLION-DOLLAR HEALTHCARE CRISIS“Drugs don’t work in patients who don’t take them.”

C. Everett Koop, M.D.Surgeon General of the United States, 1982-1989


& Therapeutics demonstrated that 61% of patients younger than 40 years old with inflammatory bowel disease, primarily ulcerative colitis and Crohn’s disease, self-reported as non-adherent due to having to take medication, often multiple doses, while at work.

Understanding:To truly ensure adherence, patients must fully comprehend their condition, the short- and long-term effects of their condition, how their prescribed medication will resolve their condition, how to take their medication, their medication’s potential side effects, how to prevent or address side effects, how regularly they need to visit their providers, and how often they should have blood tests to measure their circulating medication level, if appropriate.

Cost:In 2010, there were approximately 29 million documented residents in the U.S. who were considered underinsured. Sadly, individuals with enviable insurance plans find themselves unable to afford their co-pays when they must take specialty medications to treat life-threatening or chronic conditions.

The creation of Medicare Part D for individuals age 65 and older in 2006 dramatically improved patient access to prescription medications. However, patients are exposed to the “doughnut hole,” a gap that results in large out-of-pocket expense for their medications once they’ve exhausted their initial coverage.

Irrespective of insurance status, financial exposure, especially for newer, specialty drugs, such as oral oncology drugs, can cost $8,000-$15,000 per month, resulting in extreme out-of-pocket costs, decreased adherence or leaving prescriptions unfilled.

SOLUTIONSThe causes and factors that contribute to medication non-adherence are multi-faceted. Studies have shown that three distinct categories of factors contribute to adherence. Patients with overlapping categories have the highest probability of adherence. For example, a patient without family or a support network is more likely to be non-adherent. However, there are strategies and tools available that foster adherence.

1. It is incumbent upon providers and their office staff to educate patients throughout their therapy. Education should not begin and end with the first new prescription.

2. The relationship of health outcomes as a result of positive and negative adherence rates must be clearly outlined to patients.

3. Patients must be aware of the risks for adverse events and the tools to minimize them, as well as when the situation is sufficiently urgent to contact their healthcare provider.

4. Never assume a patient understands. Use open-ended questions to confirm patients’ comprehension and to engage and empower them to participate in their care.

5. Encourage patients’ to develop a health goal to improve behaviors and outcomes.

6. Create a multi-disciplinary healthcare team, comprised of the patient’s provider, nurse and dispensing pharmacy, with each member accountable for patient outcomes. Communication should be freely exchanged on the treatment goals and barriers to successful outcomes.

7. Regularly conduct patient outreach using multiple vehicles, such as live scheduled calls, automated calls, letters, email, text messaging, etc.

8. Identify the pharmacy that can best support patients, particularly those on specialty medications.

Continued

Physical/Mental Barriers Social BarriersEmotional stateHealth beliefsVisual deficitsMental disordersPhysical, e.g., unable to open a prescription bottle to take dose

Poor literacyLow literacy Poor relationship with providerCultural/religiousAttitude, e.g., fear

Perceptual Barriers Logistical BarriersLack of education on therapyLack of understanding of therapyLack of belief in benefit of therapy

CostAccess to therapyAdverse effectsComplex administration or instructions

TABLE 1: ADHERENCE BARRIERS


Specialty medications are high-cost injectable, infused, oral or inhaled drugs that generally require special storage or handling and close monitoring of the patient’s drug therapy. It is prudent to direct patients on these medications to specialty pharmacies to maximize patient outcomes.

AVELLA, FOR EXAMPLE, OFFERS EVERY PATIENT THE FOLLOWING SERVICES:

SUMMARYPoor adherence to medication is common, and it does not discriminate based on the severity of disease, age, race or socioeconomic status. Suboptimal adherence rates to medications contribute to poor outcomes, worsening of disease, death and increased healthcare costs. Numerous reasons contribute to a patient’s poor adherence rate, with forgetfulness, lack of knowledge and costs being the most common. Engaging patients with open-ended questions to determine where potential barriers lie and using a multi-disciplinary approach with a specialty pharmacy to present innovative techniques to educate, empower, engage and remind patients of the importance of adherence is critical in managing chronic disease states.

REFERENCES1. Medco Health Solutions, Inc., December 29, 2009. 2. Choudhry NK, et al. Measuring Concurrent Adherence to Multiple Related

Medications. Am J Managed Care. 2009;15:457-464. 3. Leslie RS. Using Arrays to Calculate Medication Utilization. SAS Paper 043-2007.

Available at: http://www2.sas.com/proceedings/forum2007/043-2007.pdf.4. Steiner JF, Earnest MA. The Language of Medication-Taking. Ann Intern Med

2000;132:926-30.5. Cramer J., Rosenheck R., Kirk G., Krol W., Krystal J. Medication Compliance

Feedback and Monitoring in a Clinical Trial: Predictors and Outcomes. Value Health 2003; 6:566-73.

6. Haynes RB, McDonald HP, Garg AX. Helping Patients Follow Prescribed Treatment: Clinical Applications. JAMA 2002; 288:2880-3.

7. Benner JS, Balkrishnan, R. 2005. The Importance of Medication Adherence in Improving Chronic Disease Related Outcomes.

8. Med Care 43:517-520; Cramer J.A., Roy A., Burrell A., et al. Medication Compliance and Persistence: Terminology and Definitions. Value Health. 2008; 11:44–47.

9. Affordable Care Act Reforms Could Reduce the Number of Underinsured U.S. Adults by 70 Percent, September 8, 2011. Authors: Cathy Schoen, M.S., Michelle M. Doty, Ph.D., Ruth H. Robertson, M.Sc., and Sara R. Collins, Ph.D. Journal: Health Affairs, Sept. 2011 30(9): 1762–71.

10. Risk Factors for Non-Adherence to Medication in Inflammatory Bowel Disease Patients. R. D’Incà, P. Bertomoro, K. Mazzocco, M.G. Vettorato, R. Rumiati, G.C. Sturniolo Disclosures. Aliment Pharmacol Therapy, 2008; 27(2):166-172.

A financial assistance team that has extensive training in assisting underinsured patients to minimize their financial risk. Avella team members have strong working relationships with several nonprofit organizations and manufacturers that offer financial assistance. (Cost)

Each patient works with members of a trained team, each of which are subject-matter experts in the patient’s condition. This specialty care coordinator reaches out to patients every month to personally inquire about their health, to conduct a screening to assess patients’ understanding of their conditions, to evaluate compliance and to see if a medication refill is in order. (Forgetfulness and Understanding)

A clinical pharmacist contacts patients with new prescriptions to counsel them about their specialty medication. (Understanding)

Free monthly medication shipments, based on medication. (Cost)

Avella is able to offer patients on certain medications an innovative electronic medication reminder, GlowCap®. The GlowCap is placed on the prescription bottle, and a wireless reminder light plugs into a kitchen or bathroom outlet and pulses and glows orange at a predetermined time. It is a subtle reminder for a patient to take one’s medication. (Forgetfulness)

In addition to the services noted, Avella clinical pharmacists have developed written educational tools that are shipped with patients’ medication. These easily read one- to two-page fliers reinforce the topics covered during patient counseling calls. (Education and Understanding)

Hepatitis 101:“Hepatitis” means inflammation of the liver. Toxins, certain drugs, some diseases, heavy alcohol use, and bacterial and viral infections can all cause hepatitis. The most common types are hepatitis A, hepatitis B and hepatitis C.

Hepatitis A appears only as an acute or newly occurring infection and does not become chronic. People with hepatitis A usually improve without treatment. Hepatitis B and hepatitis C can also begin as acute infections, but, in some people, the virus remains in the body, resulting in chronic disease and long-term liver problems. Source: Centers for Disease Control and Prevention.


THE PHARMACIST

A schedule is the most effective way to maximize health outcomes when a patient undergoes treatment for hepatitis C. The duration of treatment for hepatitis C varies among patients but is usually 24-48 weeks.

Schedule Medications. A common reason for hepatitis C treatment failure is missing medication doses or stopping treatment prematurely. The key to success is medication adherence. Avella pharmacists can help patients develop a schedule to fit medication administration requirements into their lifestyle and ensure their refills are processed on time.

Schedule Lab Tests. The nurses or medical assistants in the providers’ practices should work with patients to have their blood drawn on a regular schedule. These tests are essential for healthcare providers to monitor the amount of virus in patients’ blood and monitor for certain side effects.

Schedule Doctor Visits. Regularly scheduled visits allow providers to assess how patients’ treatments are working, how much longer they should continue, how well patients are tolerating the medications, and how side effects are being or should be managed.

Schedule Meals. Some hepatitis medications must be taken with food and spaced out eight hours apart. A schedule to take medication with meals is easy for patients to remember.

Schedule Exercise and Rest. One of the most common side effects of hepatitis C treatment is fatigue. Patients should be encouraged to maintain their exercise regimen or to start one. Modest exercise, like 30 minutes of walking, can combat treatment-related fatigue.

Schedule Learning. Utilize your healthcare professionals to educate you on your disease and your medications. Your therapy may cause side effects, and your ability to recognize these side effects and notify your healthcare team may determine your success on therapy.

Most patients manage their hepatitis C treatments well. If they prepare a schedule and adhere to it, they are more apt to achieve success.

A:

When diagnosed with hepatitis C, how can my treatment outcomes be improved? Q:





The pharmacy profession has greatly evolved over the years. In the past, pharmacists’ main function was to dispense medication. Today, however, pharmacists are experts in medication therapy management and are integral members of patients’ treatment teams. Pharmacists’ extensive education prepares them for their role in patient care.

Most pharmacists now earn a doctor of pharmacy (Pharm.D.) degree, which demands at least six years of intensive education in pharmacokinetics, therapeutics, medicinal chemistry, over-the-counter medications and supplements, and pharmacy law. Pharmacists can earn an undergraduate degree and then attend four years of graduate school or can directly enter a Pharm.D. program that is usually six years in duration. Upon graduation, additional training is common with residency programs for one or two years. Residencies allow pharmacists to further specialize in their area of interest and expertise.

Pharmacists lead patients’ medication therapy management teams by counseling patients on critical factors that include: dosage, duration, conditions, adverse events, drug interactions and monitoring parameters.

This drug therapy knowledge helps to drive patients’ persistence and

adherence to maximize clinical outcomes. Pharmacists also review a patient’s complete medication profile prior to dispensing medication as part of medical therapy management.

Pharmacists who work in specialty disease states, such as oncology, transplant, inflammatory conditions or infectious disease, are trained to be experts on complex drug therapy regimens that usually require closer involvement with patient and providers.

Specialty pharmacists may use tools to monitor and improve adherence, may offer more extensive and recurring educational and counseling sessions to improve patients’ understanding and adherence of their therapy regimens, and may provide resources for additional financial and emotional support. Pharmacists must effectively communicate with prescribers and patients to ensure optimum care.

Pharmacists offer many services outside of dispensing medications. They are active members in their communities and can be certified to administer immunizations, such as flu shots and travel vaccines. Pharmacists help manage chronic disease states, such as diabetes, high blood pressure and high cholesterol, by providing screenings to evaluate patient risk factors, make suggestions for medication therapy, and provide education on diet and lifestyle improvements.

A career in pharmacy offers many rewards. The field of pharmacy offers professionals a variety of opportunities as responsibilities within the field continue to advance.

PHARMACISTS:Patient-Centric Team Members and Community Resources

Give us your feedback. Take our online provider survey at avella.com.


A TESTAMENT TO TRANSPARENCY, QUALITY AND SAFETY.Our daily lives are filled with symbols, labels, ratings and acronyms that translate to a product or service provider’s quality and safety. Manufacturers, farmers, hospitals, etc., invite outside accrediting agencies to inspect and test their products and to review their policies and procedures. Accreditation signifies to consumers and patients that they can be confident in a product’s or service’s safety and quality. Accredited companies distinguish themselves from their non-accredited competitors.

Avella is a pioneer in voluntarily seeking accreditation by independent agencies that are experts in specialty pharmacy. In 2006, Avella of Scottsdale became the first specialty pharmacy in the nation to receive accreditation by the Pharmacy Compounding Accreditation Board (PCAB®). PCAB is a voluntary quality accreditation designation for the compounding industry that was founded by eight of the nation’s leading pharmacy organizations. PCAB’s founders set high expectations for compounding pharmacies seeking accreditation. Compounding pharmacies invest substantial time and money to prepare for and maintain PCAB accreditation. PCAB-accredited pharmacies are the gold standard for compounding pharmacies.

In order to merit accreditation, a compounding pharmacy must have current, detailed procedures for every step in the process of compounding a medication. Additionally, the compounding pharmacy must have training procedures, personnel requirements for compounding pharmacists and HIPAA policies to ensure patient confidentiality.

Avella’s national distribution facility and its eight community-based specialty pharmacies that compound medications are PCAB-accredited. A team of PCAB professionals performs on-site inspections prior to accreditation and every three years following accreditation. In addition, PCAB has the authority to conduct unannounced on-site inspections at any point during a pharmacy’s accreditation cycle.

The outbreak of fungal meningitis in the fall of 2012 from contaminated vials of compounded steroids illustrates the risk and fatal consequences to patients who received compounded medication from a non-accredited compounding pharmacy. A PCAB-accredited pharmacy must adhere to stringent procedures to maintain sterility and must regulate internal temperatures to prevent an environment that promotes bacterial and fungal growth.

As the demand for compounding medication grows in response to the medical community’s move toward personalized medicine, it is even more important for healthcare providers to entrust their patients’ safety to Avella, a compounding specialty pharmacy whose mission is “To optimize patient health through a relentless devotion to clinical excellence.” Avella strives for perfection in every aspect of its services, and accreditation is evidence of that commitment.

Avella Wholesale earned accreditation from the National Association Boards of Pharmacy (NABP) in 2011 as a Verified-Accredited Wholesale Distributor (VAWD). Avella proudly joined the ranks of wholesale distributors such as Cardinal Health, Eli Lilly and


Company, McKesson Corporation and Schering Corporation that have successfully undergone a criteria-compliance review, including a rigorous review of operating policies and procedures, licensure verification, survey of facility and operations, background checks and screening through the NABP Clearinghouse. This professional accreditation is awarded to pharmaceutical wholesale distributors that are in compliance with state and federal laws in preventing counterfeit drugs from entering the U.S. drug supply and protecting the public from drugs that have been contaminated, diverted or counterfeited.

To qualify for VAWD accreditation status, Avella Wholesale was required to meet stringent criteria regarding its licensure, facilities, personnel, records-keeping practices, policies and procedures, and authentication and verification activities. Further qualification for this accreditation requires the safe handling policies and procedures for returned, damaged and outdated drugs.

Avella is currently in the process of securing Utilization Review Accreditation Commission (URAC) accreditation. URAC accreditation is one of healthcare’s most prestigious accreditations, with more than 600 organizations and companies accredited worldwide. URAC is, in fact, healthcare’s largest accrediting body. Committees of experts

Continued

The outbreak of fungal meningitis in the fall of 2012 from contaminated vials of compounded steroids illustrates the risk and fatal consequences to patients who received compounded medication from a non-accredited compounding pharmacy, New England Compounding Center (NECC). As of December 1, 2012, 37 patients had died from fungal meningitis, and 590 patients had suffered a fungal infection, 368 of which were fungal meningitis. NECC, located in Massachusetts, distributed three lots of compounded steroid syringes to 17 medical facilities in 23 states to be used primarily for outpatient epidural injections to alleviate back pain, a relatively common and historically uneventful procedure. Sadly, this was not the case for more than 500 patients.

The FDA cited aberrant conditions in NECC’s compounding laboratory. Inspectors found residue on sterilization equipment, surfaces coated with levels of mold and bacteria that exceeded the company’s own environmental limits, and an air conditioner that was shut off nightly despite the importance of controlling temperature and humidity. It is virtually impossible to find unsanitary conditions such as described at NECC in a PCAB-accredited compounding pharmacy. A PCAB-accredited pharmacy must adhere to stringent procedures to maintain sterility and must regulate internal temperatures to prevent an environment that promotes bacterial and fungal growth. Several NECC customers stated that NECC’s prices led them to purchase their compounded medications. What price do we put on a patient’s safety and life?

When Lack of Outside Oversight Turns Deadly


representing diverse interests in the healthcare community develop URAC standards.

For Avella, URAC accreditation is not limited to operations directly related to the dispensing of medications. Indeed, in addition to policies and procedures commonly associated with a specialty pharmacy, Avella must meet URAC standards for customer service, call-center operations, HIPAA privacy and security, claims processing, drug therapy management, quality assurance, governance, facility security, and scores of other policies and procedures. Avella is confident that it will receive full URAC accreditation in 2013.

The demand for specialty and compounded medications is growing rapidly due to the medical community’s move toward personalized medicine as well as advances in pharmaceutical technology. Protect your patients, and research your options for a specialty pharmacy provider as thoroughly as you would research any other component of their care. Avella’s accreditations by unbiased, independent experts communicate Avella’s commitment to quality and safety.

Find your nearest Avella location using our interactive tool at avella.com.


Other Compounding

Pharmacy

Have you earned the Pharmacy Compounding Accreditation Board’s (PCAB) Seal of Accreditation showing the pharmacy meets the highest quality and safety standards in the profession?

Are you committed to compliance with the USP 797 guidelines for sterile compounding?

Do you have independent labs test your air and laminar flow hoods in the sterile lab and do surface sampling?

Do you have a dedicated Quality Assurance department and safety programs, including safety administrator and safety officer?

Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates and reduce potential contamination?

Are your laboratory pharmacists and technicians dedicated exclusively to compounding?

Is your staff trained and validated in proper hand hygiene and guarding techniques, aseptic techniques, cleanroom regulations and USP guidelines?

Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers?

Do you perform pH testing on injections, ophthalmic preparations and other compounds?

Do certified outside laboratories perform potency validation on selected formulations?

Is every step of the compounding process reviewed and authorized by a licensed pharmacist?

Do you maintain both master formulas and lot-specific worksheets for all compounds?

Can you trace a prescription back to the original formula log sheet and the source of ingredients?

Does the pharmacy have comprehensive liability insurance?

Do you test your staff on a regular basis to ensure competency?

WHEN SELECTING A PHARMACY, BE SURE TO ASK THE QUESTIONS BELOW


What is a

The simple answer is no; pharmacies are not always interchangeable. Just as oncologists treat patients with cancer, neurologists treat patients with multiple sclerosis and gastroenterologists treat patients with Crohn’s disease and hepatitis C, specialty pharmacies dispense the unique medications to treat these diseases and offer services that promote adherence and improve patient outcomes. Not only do traditional drugstores not offer extensive adherence services, but they oftentimes don’t have access to the medications prescribed for complex and chronic conditions like the ones mentioned above. Additionally, their pharmacists may not have specialized training in these disease states and the medications prescribed to treat them.Medications typically fall into the specialty drug category because of their cost, their storage requirements and the need for close patient monitoring. As reported in 2012 by the Pharmacy Benefit Management Institute, a research organization in Arizona, the average monthly cost of a specialty drug is $2,000. In addition to oral specialty drugs, many specialty drugs are infused, injected and inhaled. Many must be refrigerated at all times, including transportation.

Lastly, patients prescribed specialty medications must follow the directions exactly as prescribed, or the consequences may be life-threatening.

Exactly what is “special” about a specialty pharmacy? 1. Access to Specialty Medications Drug manufacturers often restrict the number of pharmacies that have access to specialty medications. Many specialty drugs are biologics, i.e., made from living organisms, and the manufacturing process is complex and time-consuming. It is critical for manufacturers to control inventory levels of their products. These particular specialty medications are vigorously controlled by the manufacturer and the FDA, which allow only specialty pharmacies with a sophisticated and established infrastructure, personnel and management to dispense these medications.

Are all pharmacies the same? Do they offer the same services and medications?

SpecialtyPharmacy


2. Extensively Trained Clinical PharmacistsSpecialty pharmacies employ pharmacists who have completed clinical residencies after graduating from pharmacy school. Most pharmacists enter the workforce directly from pharmacy school. Clinical pharmacists supplement their educations with residencies in a variety of specialties, including but not limited to infectious diseases, HIV/AIDS, rheumatology, solid organ and cell transplantation, and oncology. They work side by side with physicians who are themselves specialists in these disciplines in order to become subject-matter experts in their field of specialty pharmacy. This allows them to become valuable members of patients’ treatment teams.

3. 24-Hour Clinic SupportA clinical pharmacist is only a phone call away for patients and practitioners, 24 hours a day, 365 days a year. A specialty pharmacy may not be filling prescriptions, but its clinical pharmacists are always available to respond to questions or concerns from patients and their doctors. As a member of the patient’s clinical team, the pharmacist may elect to contact a patient’s doctor to relay information or a concern about the patient’s condition.

4. Specialty Medication Treatment Management Adherence and persistence with specialty medications is particularly essential. Adherence is taking the medication as

Continued

THE SPECIALTY PHARMACY MODEL:

Working as an integral aspect of the healthcare system, Avella collaborates with both providers and patients to offer unique solutions to their challenges.

Prior Authorization

Support

Patient Education

Financial Assistance

Novel Adherence

Tools

Access to Limited

Distribution Medications


prescribed, e.g., once a day on an empty stomach. Persistence is taking the medication for the length of time prescribed, e.g., three months, a year, etc. Patients must not have lapses in taking their specialty drugs, so it is imperative that their refills arrive prior to running out of their medication. Some specialty medications can, at times, have uncomfortable side effects, such as swelling around the eyes or ankles, nausea, and tender palms and soles. Some patients may suffer from depression.

To address adherence, persistence, refills and side effects, specialty pharmacies offer specialty medication treatment management, which includes:

A. Patient CounselingPatients must be educated about their diseases and their specialty medications. Specialty pharmacies’ clinical pharmacists counsel every patient about how his or her medication will treat his or her condition, possible side effects and how to manage those side effects. Clinical pharmacists will review with the patient the proper way to take his or her medication to ensure that the patient receives optimal outcomes. An educated patient is an empowered patient. And a clinical pharmacist is available 24 hours a day should the patient have a question about his or her medication.

B. Specialty Care CoordinatorsEvery specialty pharmacy patient and provider has a specialty care coordinator who is his or her primary contact. Specialty care coordinators are extensively trained call-center staff members, usually certified pharmacy technicians, who have received comprehensive training in their specialty area. Specialty

care coordinators work in conjunction with clinical pharmacists to respond to every patient and provider question. Specialty care coordinators proactively contact patients to guarantee that refills arrive in time to eliminate any possibility of disruption of treatment. Specialty care coordinators cultivate relationships with their patients and are sensitive to changes in demeanor that might be indicators of depression or other conditions/situations that may lead to non-adherence.

5. Financial Assistance SupportThe cost of specialty medications is often prohibitive even for patients with health insurance. With monthly co-pays in the hundreds of dollars, many patients cannot afford their specialty medication. Several pharmaceutical companies offer co-pay assistance, as do several nonprofit agencies. The applications, however, can be daunting, especially for a patient just diagnosed with cancer. Specialty pharmacies recognize that patients need expert advice and support in their attempt to secure financial assistance for the specialty medication. Specialty pharmacies have teams of knowledgeable financial assistance coordinators who help patients navigate through applications, guide patients to the most appropriate source of financial support and provide patients with moral support during these stressful times.

Patients won’t find candy, groceries, magazines and Band-Aids at a specialty pharmacy. What they will find are caring, knowledgeable specialty pharmacy professionals who will support them throughout their treatment.

Watch our video to learn more about what a specialty pharmacy is at avella.com.

AVELLA SPECIALTY PHARMACY TIMELINE:


Avella’s History and Strategic GrowthJohn Musil, Pharm.D., FACA, attended the University of Arizona College of Pharmacy with dreams of becoming a pharmacist who took care of his patients. To Dr. Musil, pharmacy begins with excellence in delivery and dispensing drugs. However, he believes that a pharmacist’s role does not begin and end there. To Dr. Musil, truly taking care of patients involves taking as much time as needed to counsel patients about their medication, to be available to patients day or night to answer their questions and concerns, and to partner with physicians in their patients’ care. The culture and time constraints of a typical or traditional pharmacy do not give pharmacists the opportunity to be the pharmacist that Dr. Musil was dedicated to becoming.

Dr. Musil decided to open his own pharmacy, The Apothecary Shops, and to focus its services and his expertise on patients who most desperately need personal care — patients who had undergone transplants, patients with cancer, and those with lifelong, often debilitating diseases such as multiple sclerosis, HIV/AIDS, hepatitis and rheumatoid arthritis. In addition, Dr. Musil offered superior compounding services for patients who needed customized dosages of medications or liquids instead of capsules. The Apothecary Shops allowed Dr. Musil to dispense specialty medications, give patients one-on-one care, and partner with physicians as a member of a patient’s treatment team. The Apothecary Shops’ reputation as a specialty pharmacy with high-touch patient care spread throughout the community and the nation.

To reflect its growth from a strong regional specialty pharmacy to a national provider of specialty pharmacy services, The Apothecary Shops launched its new corporate identity, Avella, in August 2012. The letters within Avella are

1998Just two years in, the demand for Avella services warrants the opening of six new locations in metropolitan Phoenix.

2001Responding to demand for a local pharmacy offering expert clinical care in fertility, Avella expands to Tucson.

2005The demand for expertise in the clinical area of infectious diseases, particularly HIV/AIDS, encourages Avella leadership to expand into Nevada. The first of two Las Vegas community-based specialty pharmacies opens.

2006Avella is the first pharmacy in the nation to achieve the coveted PCAB–accredited compounding pharmacy designation. With a focus in clinical excellence and quality, Avella pharmacies achieve recognition and accreditation as leaders in the practice of compounding patient medication.

Continued

1996Avella opens its first pharmacy in Scottsdale, Arizona, under its former company name, The Apothecary Shops.


2009Avella opens its new corporate headquarters, expanding its call-center operations and national distribution facility to more than 25,000 sq. ft., allowing Avella to keep up with its growing base of patients.

2010Avella acquires Greater Sacramento Pharmacy, which offers Avella additional clinical expertise in the key focus area of oncology and facilitates expanded services to patients.

2010Avella broadens its patient coverage with the addition of a community-based location in St. Louis, Missouri.

2006Expanding the physical locations farther east, the new Columbus, Ohio, location establishes Avella’s presence as a national pharmacy.

selected from key words “health,” “devotion” and “excellence” in the company’s mission statement, “To optimize patient health through a relentless devotion to clinical excellence.”

As the number of specialty medications skyrocketed, the complexity of their processing with health plans also increased. This placed quite a burden on physician practices to complete volumes of paperwork as well as keep current on all of the specialty medication options for their patients. Avella leadership recognized the need for a new and expanded approach to support physicians. Avella, therefore, created an account management team of experts in each of Avella’s specialty areas. Now dozens of members strong, Avella’s account management team partners with physicians throughout the U.S., visiting them and supporting them, their staff members and their patients. Avella is one of the few specialty pharmacies in the country that offers on-the-ground account managers to support physician practices.

Specialty medications are inherently expensive due to their manufacturing process. Many are biologics, meaning they are derived from human or animal proteins, specifically recombinant DNA and various cell-therapy techniques. Due to their expense, patients’ co-pays may reach hundreds or thousands of dollars per month. To this day, Avella operates under Dr. Musil’s philosophy of patient care. Assisting patients to access specialty medications is an integral part of that philosophy. Avella strategically built strong relationships with many nonprofit organizations that offer financial aid to patients who cannot afford their specialty medications. Avella’s team of financial assistance experts works with the nonprofit agencies, as well as specialty medication manufacturers, to secure funding for patients when their co-pays would be a barrier to treatment.

As the complexity of specialty medications has evolved, so have their distribution channels. Avella again responded to the ever-changing landscape of specialty drugs and now has ongoing communication with manufacturers to ensure

that Avella patients will have access to specialty drugs that manufacturers determine will have limited distribution channels. The relationship between Avella and manufacturers also allows for open communication regarding patient adherence rates, side effects and other data that is helpful to manufacturers and, in the long term, beneficial to patients.

AVELLA SPECIALTY PHARMACY TIMELINE:

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2011Avella continues strategic expansion with opening of regional hub pharmacy in Austin, Texas. With a prime retail location and capacity for distribution, this location serves patients across the state of Texas.

2012Avella Wholesale receives designation as a Verified-Accredited Wholesale Distributor (VAWD). Avella’s wholesale division achieves this prestigious accreditation that validates the close attention to detail in all processes.

2012Avella acquires Colorado Pharmacy in Denver. Primarily focused on infectious diseases, such as HIV/AIDS, Avella now offers new and existing customers specialty pharmacy services with Avella’s corporate mission and values.

2012With the opening of its first community-based specialty pharmacy in Orlando, Florida, Avella now has a brick-and-mortar presence on the East Coast. The Orlando location complements existing national distribution capabilities.

Discover more about Avella. View our interactive timeline at avella.com.

The cost of healthcare accounts for a larger percentage of the nation’s budget every year. Payors must consider how best to contain their costs while ensuring the best possible outcomes from specialty medication therapy. Avella’s account management team works closely with payors to identify services, such as adherence programs, that will support patients on specialty medications.

Avella’s primary focus has been and will always be its patients. Avella will respond as needed and develop and implement best practices and new services to address specialty pharmacy demands as they pertain to patient care.

AVELLA: A COMPANY OVERVIEW

...who work in retail locations in 8 states and serve all 50.

We are clinical experts: 15% of our full-time workforce

are trained pharmacists...

#1

We have been in business since

From 2009-2012we experienced1996

2010 2012 2013

100

200

300

400

500

700

600

Revenue, $Millions

Date

103

170

330

501

200820062004200220001998

We were the fastest-growing privately held company in

Arizona in 2012.

500%revenue growth.

And we’re lowering the cost of medication for our patients:

We work closely with our managed care partners:

* Financial assistance secured through manufacturer co-pay cards and 501c(3) foundations

In financial assistance we secured for our patients in 2012*

$7,210,228Over 3,000,000 limited and exclusively

contracted lives.

We are accredited with these organizations:



Examples of drug interactions with food and beverages include:

• Grapefruit juice: Grapefruit juice shouldn’t be taken with certain blood-pressure-lowering drugs or cyclosporine for the prevention of organ-transplant rejection.

• Licorice: Licorice could possibly reduce the effects of blood-pressure drugs.

• Chocolate: Someone eating an excessive amount of chocolate after taking some monoamine (MAO) inhibitors may experience a sharp rise in blood pressure.

Take with Food, Take on an Empty Stomach, Do Not Take with Dairy. What’s Behind Food Medication Warning Labels? Adherence is more than just taking the correct daily dosage. The presence or absence of food in a patient’s stomach often affects the rate of the medication’s absorption. How fast the medication is metabolized by the body can have beneficial outcomes or detrimental consequences.

• Food can block the body’s ability to absorb certain medications, effectively reducing the dose a person receives. In this instance, the drug has a decreased effectiveness.

• Foods can sometimes enhance the absorption of drugs, which can lead to a possible overdose and other times increase the absorption, which is critical.

• Some medications must not be taken with dairy products, such as milk, cheese and yogurt. Dairy products contain large amounts of calcium, which can react with some medications and prevent them from being absorbed into the body.

• Grapefruit/grapefruit products and citrus fruits contain certain chemicals that can interfere with the enzymes that break down various medications. This may lead to potentially dangerous levels of medication, causing serious side effects.

With technological advances in automated prescription labels, the use of separate, brightly colored warning labels on medication vials has decreased. Information about food intake and other warnings has been incorporated into the primary prescription label and is now less obvious to many patients, particularly elderly patients.

Always advise your patients to follow all of their medication instructions and to consult with their physician and their Avella pharmacist about taking their medication(s) correctly to receive its maximum benefit.

Subscribe to our enewsletter to get the latest in health news: avella.com/enews.

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