Specialty Pharmacy Continuum - Vol 1., Num 1., Winter 2012

Bridging the gap between the hospital and post-discharge care

Volume 1 • Number 1 • Winter 2012 A Supplement to Pharmacy Practice News

In This Issue

Embracing Rather Than Fighting Specialty Pharmacy

Ask the Expert

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nfusion centers and other community practice sites that manage patients post-discharge share a common lament: Why do so many of those patients often struggle with the basics of care after they leave the (usually) safe confines of the hospital?

One glaring contributing factor is a lack of collaboration between hospitals and the community sites of care, according to Dennis Street, RPh, lead pharmacist at Mercy Home Infusion, which is affiliated with Mercy Hospital in St. Louis. “It’s a big enough transition to get patients out of the hospital, much less getting them out of the hospital and starting them on

Tips for partnering with managed care organizations, plus cost-saving strategies.

Q&A

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Stephanie Holliday, PharmD, discusses REMS, self-administered oral chemotherapy and other hot topics in specialty pharmacy.

Opinion

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Aetna Specialty Pharmacy, other providers offer drug adherence strategies.

Educational Review

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Antimicrobial Efficacy

Policy

24

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N. Lois Adams, BPharm, on reining in the high cost of drug therapy.

Operations & Mgmt

Patient assistance programs, plus a projection that specialty pharmacy drug spending will soar by 26.5% in 2012.

Building a Better Care Transition: What Works Now

see CARE TRANSITION, page 8

University of Illinois clinical staff pharmacist Nehrin Khamo, PharmD, educates a patient on self-injection techniques.

Tips for Surviving The TPN Shortage

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lthough many health-system pharmacists bristle at limited distribution networks and other restrictions placed on some specialty medications, more and more of them are deciding to embrace specialty pharmacy rather than fight it, and thus join the ranks of smaller and larger specialty operations providing that segment of care.

To offer insights into this new source of competition, Specialty Pharmacy Continuum profiled three hospitals that are bolstering their presence in the market: The University of Illinois Hospital and Health Sciences System, Chicago; Fairview Pharmacy Services, Minneapolis; and Duke University Hospital, Durham, N.C. The health systems cite revenue loss as one reason for their recent efforts: they simply can’t afford to continue seeing patients siphoned off to specialty pharmacy providers. But finances aren’t the only motivation; another key driver is the need to provide for patients’ total health needs across transitions of care, as the era of accountable care organizations and payments based on quality standards gets under way.

For Kyle Skiermont, PharmD, director of specialty infusion operations at Fairview Pharmacy Services, improving patient care is the No. 1 reason health systems enter or expand into the specialty pharmacy area. His operation, a part of Fairview Health Services, a large regional network of hospitals, already is well established as a

•

see EMBRACE, page 11

FDA Approvals

hings have been heating up on the IV nutrition shortage front. Last fall, Baxter hosted the first-ever nutrition shortage safety summit, and the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), which put together a task force to address the supply shortages, has been issuing frequent updates and guidances to help its members prioritize, substitute and manage the limited supplies they have.

But such regulatory and policy efforts only go so far in mitigating the effects of the shortage on patient care. Here are several practical strategies that home infusion centers are using right now to weather the storm.

•

see TPN SHORTAGE, page 10

The Book Page

Kalydeco approved for cystic fibrosis patients with CFR gene mutation.

MedInfoNow Subscription

See page 26.

See page 27.

The PROOF is everywhere you look GAMUNEX- C has proven efficacy and patient outcomes in CIDP, PI, and ITP*1

Important Safety Information for GAMUNEX-C Gamunex-C, Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gamunex-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer Gamunex-C at the minimum concentration available and the minimum infusion rate practicable.

Gamunex-C is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

Gamunex-C is not approved for subcutaneous use in patients with ITP or CIDP. Due to the potential risk of hematoma formation, Gamunex-C should not be administered subcutaneously in patients with ITP. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization and/or known or suspected hyperviscosity.

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV. The high dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

Gamunex-C is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation.

In clinical studies, the most common adverse reactions with Gamunex-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).

The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP). *CIDP=Chronic inflammatory demyelinating polyneuropathy; PI=Primary immunodeficiency; ITP=Idiopathic thrombocytopenic purpura.

Reference: 1. Data on file, Grifols.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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GAMUNEX®-C

Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified

• Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.

• Aseptic Meningitis Syndrome (AMS) has been reported with GAMUNEX-C and other IGIV treatments, especially with high doses or rapid infusion.

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to • Hemolytic anemia can develop subsequent to IGIV therapy due use GAMUNEX®-C safely and effectively. See full prescribing to enhanced RBC sequestration. Monitor patients for hemolysis information for GAMUNEX-C. and hemolytic anemia.

GAMUNEX-C, [Immune Globulin Injection (Human) 10% • Monitor patients for pulmonary adverse reactions (transfusionCaprylate/Chromatography Purified] related acute lung injury [TRALI]).

Initial U.S. Approval: 2003 • Volume overload WARNING: ACUTE RENAL DYSFUNCTION and FAILURE See full prescribing information for complete boxed warning.

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.

• Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX-C does not contain sucrose.

• For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.

• GAMUNEX-C is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

• Passive transfer of antibodies may confound serologic testing.

----------------------------ADVERSE REACTIONS---------------------------• PI – The most common adverse reactions (ⱖ5%) with intravenous use of GAMUNEX-C were headache, cough, injection site reaction, nausea, pharyngitis and urticaria. The most common adverse reactions (ⱖ5%) with subcutaneous use of GAMUNEX-C were infusion site reactions, headache, fatigue, arthralgia and pyrexia.

• ITP – The most common adverse reactions during clinical trials (reported in ⱖ5% of subjects) were headache, vomiting, fever, -------------------------INDICATIONS AND USAGE------------------------nausea, back pain and rash.

GAMUNEX-C is an immune globulin injection (human) 10% liquid • CIDP – The most common adverse reactions during clinical indicated for treatment of: trials (reported in ⱖ5% of subjects) were headache, fever, chills, hypertension, rash, nausea and asthenia.

• Primary Humoral Immunodeficiency (PI) • Idiopathic Thrombocytopenic Purpura (ITP) • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

To report SUSPECTED ADVERSE REACTIONS, contact Talecris Biotherapeutics, Inc. at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

----------------------------CONTRAINDICATIONS-------------------------------------------------------DRUG INTERACTIONS---------------------------• Anaphylactic or severe systemic reactions to human • The passive transfer of antibodies may transiently interfere with immunoglobulin the response to live viral vaccines, such as measles, mumps • IgA deficient patients with antibodies against IgA and a history and rubella. Passive transfer of antibodies may confound of hypersensitivity serologic testing.

---------------------WARNINGS AND PRECAUTIONS--------------------• IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.

• Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of developing acute renal failure.

• GAMUNEX-C is not approved for subcutaneous use in ITP patients. Due to a potential risk of hematoma formation, do not administer GAMUNEX-C subcutaneously in patients with ITP. • Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy.

--------------------USE IN SPECIFIC POPULATIONS -------------------• Pregnancy: no human or animal data. Use only if clearly needed.

• Geriatric: In patients over 65 years of age do not exceed the recommended dose, and infuse GAMUNEX-C at the minimum infusion rate practicable.

Talecris Biotherapeutics, Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1716

08939771/08939782-BS Revised: October 2010

4

Specialty Pharmacy Continuum • Winter 2012

EDITOR’S NOTE

New Players in Specialty Pharmacy G

iven the rapid growth of the specialty pharmacy market—from 2006 to 2010, the segment grew by nearly 70%, according to the latest industry estimates—it may not be surprising that new players are entering the field. That includes providers, such as the three health systems profiled in our lead cover story, and, well, us— Specialty Pharmacy Continuum debuts with this winter issue.

First, a few thoughts on why hospitals are entering the mix.

“There’s lots of hoops to jump through, but at least five hospitals in my state have decided that it’s worth doing, and I’m not surprised,” said Ernie Anderson Jr, MS, RPh, system vice president of pharmacy at Steward Health Care System in Boston, and a member of the editorial advisory board of Specialty Pharmacy Continuum.

“There are compelling reasons to do this, not the least of which is cost: helping providers and patients comply with REMS programs, educating patients about their medications, doing well-coordinated discharge planning, data collection—all of those efforts are basically unfunded mandates that can siphon off lots of resources if you don’t buy the drug and bill for it as a specialty pharmacy provider.”

Mr. Anderson added a few important caveats to consider before concluding that health systems are poised to storm the gates of this challenging market. “If hospitals are serious about making this move, the ones that have the best shot at pulling it off are those that already have a strong network of perhaps four or five outpatient facilities in their system, with PBM contracts in place, plus strong partnerships with local physician practices. That certainly does not describe a majority of hospitals out there.” Other hurdles exist, he noted, such as bringing on new or enhanced outpatient pharmacy computer systems that will enable hospitals to adjudicate specialty drug claims online.

The potential payoff, Mr. Anderson noted, is not just the economic benefits of holding onto specialty pharmacy patients. “This also is a continuity of care issue— without at least some strategy for connecting with these patients post-discharge, we have little or no role in their ongoing care. And that’s tragic, because hospital

Ask the Expert Jay Bryant-Wimp, RPh, owner and CEO, Accurate Rx Pharmacy, Columbia, Missouri

Q A

: What strategies would work for a small specialty pharmacy looking to partner with a managed care organization (MCO)?

: Any approach to partnering would involve listening to the MCO’s concerns about inefficiencies. Even if the MCO leadership isn’t able to articulate inefficiencies, there are several strategies that most leaders at MCOs would find helpful. For example, you

pharmacists have the clinical skills to help keep patients healthy and at home.”

Which brings us to our raison d’être as a publication. Our editorial mission— bridging the gap between the hospital and home—focuses squarely on continuity of care efforts. Interestingly, every segment of the specialty pharmacy market quoted in this issue, including hospitals, specialty/home infusion providers and managed care groups, claim they provide the best continuity of care. In some cases, they even challenge their competitor’s ability to do so. But our role as a new publication is not to take sides. Our mission instead is to give each market segment the opportunity to make a case for how it brings value to the provision and management of specialty pharmaceuticals.

Do we have a strong link to health systems? Of course—we’ve been publishing Pharmacy Practice News, a sister publication to Specialty Pharmacy Continuum, for more than 30 years. But there is a reason why PPN is perennially ranked No. 1 in readership by independent auditors: our ability to report the news and practice management trends in a fair, hard-hitting, unbiased fashion, without favor to any one segment of our audience.

We look forward to applying that successful formula—with help from you, the reader—in the specialty pharmacy market. Give us a call or drop us an email at spceditor@mcmahonmed.com: We’d love to hear your thoughts on how we can best meet the information needs of this dynamic group of providers.

David Bronstein Editorial Director davidb@mcmahonmed.com

could establish an early patient discharge program to expedite the transfer of patients receiving specialty medications in the hospital setting to a more cost-effective location (e.g., at home or your ambulatory infusion suite).

Another strategy is to track emergency room avoidance based on your clinical interventions and, on a quarterly basis, present the data and cost-savings to key leadership at the MCO. Finally, there are many medications that are dosed based on the patient’s weight. In the case of hemophilia drugs, the standard is to treat patients to within 10% of the calculated prescribed dose. By matching our goal to be within 2% of the calculated dose, you could achieve significant savings and present those savings to MCO leadership. This will give you instant credibility and an opportunity to expand your partnership.

EDITORIAL BOARD

Frank Tagarello, Senior Art Director/Managing Director, MAX Graphics

HOME INFUSION

James O’Neill, Senior Systems Manager

Randy Fasnacht, RPh Director of Pharmacy Advanced Infusion Services Akron, OH

Dan Radebaugh, Director of Production and Technical Operations Marty Barbieri, Production Manager

Jay Bryant-Wimp, RPh Owner/CEO Accurate Rx Pharmacy Columbia, MO

Brandy Wilson, Circulation Coordinator

Volume 1 • Number 1 • Winter 2012

McMAHON PUBLISHING Raymond E. McMahon, Publisher and CEO, Managing Partner

SPECIALTY PHARMACY Cindy Kunzendorf, PharmD General Manager Accredo/CCS Locations Elmhurst, IL N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL

James Prudden, Group Editorial Director

Ernest R. Anderson Jr, MS, RPh System Vice President of Pharmacy Steward Health Care System Boston, MA

Robin B. Weisberg, Manager, Editorial Services

REIMBURSEMENT

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Stephanie Holliday, PharmD Clinical Pharmacy Specialist Prosperity Specialty Pharmacy Falls Church, PA

EDITORIAL STAFF David Bronstein, Editorial Director davidb@mcmahonmed.com

ALTERNATE-SITE PHARMACY

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Michael Sicilian President, Managed Health Care Associates, Inc. Florham Park, NJ

Kevin Horty, Don Pizzi, Adam Marcus, Cynthia Gordon, Kate O’Rourke, Contributing Editors

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Specialty Pharmacy Continuum • Winter 2012

Q & A

Hot Topics in Specialty Pharmacy A major uptick in new approvals for self-administered medications—and the attendant challenge of helping patients comply with their drug regimens and avoid adverse reactions— is just one example of the many practice challenges faced by specialty pharmacy providers, according to Stephanie Holliday, PharmD, clinical pharmacy specialist for Prosperity Specialty Pharmacy group, based in Falls Church, Va. In a wide-ranging interview with Specialty Pharmacy Continuum, Dr. Holliday suggested strategies for meeting these challenges head-on, and offered her views on REMS and other key topics.

Q: What would you say is the biggest issue facing specialty pharmacists today?

A: On the clinical side, probably the biggest challenge is the growing number of novel self-administered agents that are being approved for conditions such as cancer and hepatitis C. For example, in late January, the FDA approved Pfizer’s Inlyta (axitinib) for advanced kidney cancer. This is one of many new oral oncolytics that, while allowing for patient autonomy with administration, are not without issues surrounding drug–drug interactions and side effects. The challenge is that we’ve lost our usual clinical safety net with these drugs: When patients receive care in an infusion suite, there is a doctor and nurse present to address any concerns and side effects immediately, unlike when these drugs are self-administered at home. This trend calls for close collaboration between the provider and specialty pharmacy.

And the focus in not just on cancer: Self-injectable regimens for hepatitis C often require the patient to be instructed on how to manipulate a prefilled syringe and other injectable device. Specialty pharmacies can serve as a source of this instruction, often spending 30 to 60 minutes meeting with patients, versus the 15-minute session patients would receive through their provider’s office. The result of this one-on-one focused session is correct manipulation of the device, and reduced risk for “misfiring” of the injection device and injection site reactions.

This instruction can possibly lower total health care costs by reducing the need for a replacement injection device and avoiding another provider visit for injection site reaction management.

There are a lot of specialty medications that patients can administer subcutaneously. Interferon is the classic example, but now we have injectables for rheumatoid arthritis, Crohn’s disease and psoriasis—and patients need education on how to administer these medications and use the associated devices.

Q: Why is the specialty pharmacist’s role in dispensing these medications so important?

A: Many of these drugs have sideeffect or dosing profiles that are just

slightly different from other medications that target the same type of cancer; axitinib is a good example of this.

As specialty pharmacists, we are the experts—we have in-depth knowledge of these drug classes and are familiar with how multiple drugs within the same class differ in terms of side effects and dosing. Because of our consistent exposure to patients and their medication therapy, we know what is necessary to treat their disease and can talk to them as well as act as consultant experts for the provider. There are more than enough opportunities for providers and pharmacists to collaborate. We need to take advantage of opportunities to create interdisciplinary teams for our patients.

Q: How do recent developments affect the regulatory and technology side of patient care for specialty pharmacists?

A: FDA requires risk evaluation and mitigation strategy (REMS) programs for many of these specialty medications.

These programs require the patient, provider, manufacturer and pharmacy to collaborate in reducing adverse medication-related events. This places important responsibilities on the specialty pharmacist, who along with the provider and the manufacturer play a key role in ensuring that a medication’s side-effect profile is monitored and reported. On the technology side, we are implementing a very comprehensive computerized dispensing system and then adding on a comprehensive clinical module that will allow us to capture data for and manage REMS programs.

We’re also using the new computer system to help us manage our patients with hepatitis C. We certainly need the help, because the hepatitis C landscape has changed drastically in the last eight months or so. In May 2011, the FDA approved two new medications—telaprevir (Incivek, Vertex) and boceprevir (Victrelis, ScheringPlough)—that will shorten the duration of hepatitis C therapy, reducing the cost and time the patient has to be on treatment while dramatically increasing cure rates. But the caveat is this: seeing a patient through to positive therapeutic outcomes requires

response-guided therapy. The provider has to follow the patient response pretty closely for the first three months. Our new computer system will help the provider keep track of that response using laboratory datadriven decision points. Based on these decision points, pharmacists will communicate with the prescriber to establish the patient’s treatment plan based on response to therapy. Implementation of these decision points can proactively prevent unnecessary prescriptions from being filled, for example.

Other components we are working on will offer checkpoints and assess side effects, and help educate patients and warn them of potential interactions with over-the-counter or prescription

medications. We want our system not to just dispense medications but also to help us execute clinical interventions at the point of care.

Q: What are the payers seeking from specialty pharmacists?

A: Even payers are focusing on the clinical side. They want to know, “If I send my patients to your specialty pharmacy, are they going to be well taken care of?” They want satisfaction. Same with the manufacturers.

They want to know that their drugs are going to be utilized appropriately. It’s important that we as specialty pharmacists create programs to allow us to report that information back to manufacturers and payers.

—Reported by Gina Shaw

Editor’s note: Dr. Holliday also serves as a clinical consultant for the Center for Minority Studies, Inc., a pharmacist-run nonprofit organization dedicated to increasing health literacy and health awareness among people living with HIV/AIDS in the Washington, DC.

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6

Specialty Pharmacy Continuum • Winter 2012

OPINION

Specialty pharmacy and the high cost of care:

Being Part of the Solution N. Lois Adams, MBA, RPh President/CEO HHCS Health Group of Companies Orlando, Florida

As I enter my 50th year as a practicing pharmacist, I am reflecting on the tremendous changes that have occurred and are occurring in the field as well as in the number of players, many who enter this market for the wrong reasons.

As more players become involved in pharmaceutical care, the more costly it has become. There are myriad layers in the distribution channel, each making a profit. This results in a tremendous cost to the ultimate payer, the patient.

My colleagues and I feel we entered the field for the right reason—to improve patient care. We opened our second pharmacy, Cystic Fibrosis Pharmacy, Inc., in 1984, because a little girl with cystic fibrosis was dropped from her insurance and needed extraordinary amounts of a special vitamin product, which her parents could not afford. Because the manufacturer refused to reduce the cost, I decided to use my talents and education to compound the product for her.

As word got around about this, physicians from major medical centers called me to ask if I could compound the product for their patients, many of whose

families were financially and emotionally devastated by this disease. Word spread to other states and countries, and soon we became the “go to” pharmacy for cost-effective health care for cystic fibrosis and other complicated disease states. Were we a “specialty pharmacy” with “specialty drugs”? No; we were just professionals working with other professionals who cared enough about these patients to lend a helping hand.

Over the past decades, we have been able to help patients who have faced challenges paying for their treatments by providing compounded alternatives to expensive marketed drugs. These include patients with AIDS-related pneumonia, who, in the 1980s, needed a compounded version of aerosol pentamidine, cystic fibrosis patients who needed compounded versions of aerosolized tobramycin and other antibiotics, as well as bio-identical hormone products to assist in normalizing hormone levels in the body.

We’ve had to be versatile because one size, strength and route of a medication does not fit all. We have had to compound various liquid products and emulsions with different amounts of active ingredient to help patients cope with their individual diseases, as well as products with various routes of administration.

As I consider these approaches we have taken as a pharmacy that tried to reduce the cost of medications for patients and society, I can’t help but think about other factors that contribute to the high cost of drugs. One practice that increases the overall costs of medications is the mailing

of 90-day supplies of medications, including very expensive specialty medications. The Drug Enforcement Administration (DEA) and its law enforcement and community partners have sponsored three national “drug take-back” days over the past year or so. Patients were asked to search their medicine cabinets for prescription medication that was not taken for various reasons. These reasons include discontinuation by the physician, death of the patient or failure to be adherent or compliant with the medication regimen. I participated in two of those days and witnessed the tremendous waste. According to the DEA, these three “take-back” dates yielded more than 498 tons of medications. Pictures of these returned drugs can be found on the the DEA Web site (http://www.justice.gov/dea/pubs/pressrel/pr110311_photo.html) and the National Community Pharmacists Association Web site (http://www.ncpanet.org/pdf/ leg/sep11/mail_order_waste.pdf ). If we reduced dispensing to a 30- to 34-day supply, we would be less likely to accumulate 498 tons of costly unused medicines.

What is the market value or cost of 498 tons of the medications so freely dispensed to patients who did not need them? Some of these were high-cost medications and specialty medicines—for which Medicare, Medicaid and private insurance programs paid the bill. And who really pays for all of these medications? Ultimately, you and I, in the

form of increased insurance premiums, co-pays, etc. There also are some additional consequences of overdispensing. These medication can get into the hands of young people who can become harmed or addicted.

Also, because some patients flush their unused drugs down the toilet or pour them down the drain, these drugs can contaminate our drinking water supply and the water supply for our wildlife.

Surely, a purported slight savings in dispensing fees cannot compensate for the actual drug costs as well as the costs of these unintended effects.

We have seen the cost of health care escalate to an almost unaffordable level, due in part to drug waste and price escalation. Pharmacists must look for ways they can help to reduce these costs by being innovative and creative with the knowledge that they have, while at the same time enhance the health outcomes of their patients.

Patients should have the option to obtain their prescription medications from a pharmacist whom they know and trust—one who knows the variables that come into play in getting the particular patient well and who understands why a “high-touch” approach is so important in the care of patients with chronic, complex illnesses.

Ms. Adams, a member of Specialty Pharmacy Continuum’s editorial advisory board, welcomes your feedback at nloisadams@hhcs.com.

Focus on the Patient at All Care Points Cindy Kunzendorf, RPh, MBA General Manager Accredo/CCS Locations Elmhurst, Illinois

The past 35 years have shaped my experience and knowledge of the expanding pharmacy profession.

I have been lucky enough to provide pharmacy services in a wide range of practice settings: a small community retail pharmacy, a national chain pharmacy, hospitals and clinics, home infusion clinics, as well as consulting and specialty pharmacies. All of

these practice sites always focused on patient care goals.

Focusing on the patient is crucial in today’s health care environment. The world continues to move at a faster pace with increasingly more patient care needs, more medications available and more medical complexity than ever before. We are dealing with patients who live longer, have more chronic disease states and have multiple comorbidities that influence outcomes. Additionally, they are receiving medications via an ever-increasing number of different dispensing sites—hospitals, outpatient clinics, retail and mail order pharmacies and specialty pharmacies.

The challenges that come with each of these settings are many, but one that is particularly difficult is maintaining continuity with the patient as he or she

navigates this complex path of care.

Each professional who interacts with a patient must be committed to the patient’s treatment plan. The professional must have a complete medical history and medication profile on each patient so that when a new drug is added, the patient’s information can be completely evaluated. The professional also must educate the patient on the medication’s wide range of effects, to ensure adherence and optimal outcomes.

One question that remains to be answered is whether there are enough pharmacists to meet these complex patient needs. There were more than 269,000 pharmacists in 2008, with an expected growth rate of 17% per year.

Based on those numbers, it is projected that there will be at least 315,000

pharmacists by 2018. Unfortunately, it’s possible that those numbers may still not be enough to meet patient requirements. And the shortfall may hit some sectors of pharmacy more than others: It is expected that retail will use 65% of available pharmacists, and 22% of pharmacists will work in hospitals, leaving only 13% of pharmacists working in specialty pharmacy sectors. Will that be enough to ensure the safe use of specialty medications?

Even today, our industry goal of 100% accuracy and safety in the delivery of medications has not been met, and when one looks at the number of errors that could result even with an error rate as low as 1%, there’s major cause for concern. For example, a fill rate of 3 billion prescriptions per year in the United States translates to about

7

Specialty Pharmacy Continuum • Winter 2012

OPINION

3 million prescription errors each year. Put another way, there could be approximately one prescription error committed every week in every pharmacy in the United States. That’s just not an acceptable metric when one considers our profession’s primary goal: to help ensure the safe and effective delivery of medication therapy to all of our patients.

Technology certainly offers a partial solution. Many pharmacies, for example, have used bar coding, clinical decision support and computerized prescriber order entry to prevent mistakes, but there are still many pharmacies without these expensive technologies.

their attention on the cost of their care and don’t always recognize the long-term value to their health when complying with a treatment plan and the consultation provided by health care professionals. Their attention also is distracted by the daily errors that can occur in processing prescriptions and their lack of benefit coverage.

The reality is that many patients cannot afford the medication they need.

There are large numbers of uninsured patients in this country. It is a huge challenge to find more efficiencies

How does all of this relate to the continuum of care that, at least in my view, is so important in today’s health care environment? For one thing, the supply of pharmacists going forward will be a crucial determinant of whether pharmacists or clinical staff can extend themselves beyond the confines of their practice settings to ensure that patients receive help at home to continue their treatment plan. And do we even have a common language to discuss these issues? What are the definitions related to pharmacy industry standards when it relates to continuum of care? Where do we connect? And how do we document successful care transitions? We really don’t have measurements or benchmarks across all pharmacy service lines.

There are many initiatives to improve pharmacy outcomes within specialty pharmacy, but these quality outcomes require professional resources. There continues to be attrition in payments in the health care industry that has led much of the pricing to be related solely to a single National Drug Code number or the purchase price of a drug instead of the cost of supplies and services required to manage that patient’s care comprehensively. That silo mentality is yet another aspect of practice change that has to occur for us to move forward as a profession.

Cost is a huge concern for the patient as well. Indeed, many patients focus

?20<::2;1

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and cost savings to make pharmacy business operations sustainable when the American public has one of the highest rates of uninsured populations in history.

Ms. Kunzendorf, a member of Specialty Pharmacy Continuum’s editorial advisory board, welcomes your feedback at ckunzendor@aol.com.

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8

Specialty Pharmacy Continuum • Winter 2012

OPERATIONS & MANAGEMENT

CARE TRANSITION

‘Underinsured people with conditions like diabetes, congestive heart failure and chronic obstructive pulmonary disease … receive education, prescription management and monitoring to reduce their risk of readmission to the hospital.’

continued from page 1

home infusion therapy,” Mr. Street said.

“A poorly coordinated transition to home care can result in missed [medication] doses and lack of compliance”—a recipe for hospital readmission, he stressed.

For Mr. Street, the drug regimens primarily affected are not specialty medications; rather, they are the usual staples of home infusion centers, such as IV antibiotics. But on occasion when specialty medications are involved, he noted, helping patients understand their regimens via stronger outreach and transition-of-care efforts can be critical, given the high-risk nature of the drugs.

Regardless of the type of drug or disease state involved, before a patient is discharged, one of Mr. Street’s staff members visits the patient in his or her room to discuss what to expect from home infusion services and what’s expected of the patient post-discharge, as well as to emphasize the importance of completing the entire infusion schedule. “Once patients understand the process, it’s easier for them to follow through at home.

We want them to feel comfortable and not get scared off or [have to go] back into the hospital because they’re not involved enough in the process,” Mr. Street added.

The staff also coordinates the logistics and bureaucratic tasks—an equally important aspect of continuity of care.

They verify insurance, consult with social workers and discharge coordinators, schedule home visits, prepare prescribed drugs and deliver them to patients’ homes or to providers when needed.

Medco Focus on Care Transitions Medco’s Rare and Specialty Therapeutics section is particularly involved in transitions of care for patients with pulmonary arterial hypertension (PAH), according to Richard Faris, PhD, RPh, vice president and national practice leader for the section. The specialty pharmacy provider has an outreach program that helps patients with PAH transition to infused therapy such as epoprostenol sodium prior to discharge.

“We have specialty-trained nurses and pharmacists with extensive PAH experience, and usually they will go into the hospital and work directly with the staff to help train the patient to administer their medication at home,” he said. “Being able to transition the patient home quicker enables the hospital to save money and the patient to be more comfortable.”

But patient comfort and cost-savings aren’t the only goals of these efforts, Dr. Faris stressed: education is also key.

“Self-administering infused PAH therapy requires extensive training in using the pumps and mixing the therapies,” he said.

“If the patient doesn’t take the treatment, or if something happens with the

—Stephanie Holliday, PharmD pump, the consequences can be very dire and very quick, so we have to make sure the patient is well trained and is getting a continuous infusion. We don’t want any mistakes. After they’ve transitioned home, we’ll maintain the contact and ongoing training to make sure they can live as normal a life as possible.”

IV immune globulin therapy for patients with primary immune deficiency is another area in which Medco has an active care transitions program. “Our nurses don’t do as much training in the hospital as they do with PAH, but we work with prescribers on the different brands of IVIG, and educate the patients about IV infusion,” Dr. Faris said.

Patients who go home with IVIG typically receive an infusion of six or more hours, once every four weeks. “We go into the home and help infuse that therapy continuously,” he explained. “It’s a less expensive site of care and is equally efficacious, and limits these immune-compromised patients’ exposure to hospitalacquired infection risk. Adverse events can be troublesome with IVIG and could limit the infusion, but our adverse event rates in supervised home infusion are typically lower than what’s been seen in the literature. The care model and what our nurses do in the home helps to achieve the optimal outcome.”

Another Outreach Approach Stephanie Holliday, PharmD, a clinical pharmacy specialist with Prosperity Specialty Pharmacy, in northern Virginia, agreed that continuity of care issues are “a huge concern” for her practice. Prosperity recently began a chronic care management program aimed at reducing hospital readmission rates that is coordinated by the Inova Healthcare System. “They’re using facilities that are part of [an HIVfocused initiative] called Inova Juniper to execute this chronic care,” Dr. Holliday said. “Underinsured people with conditions like diabetes, congestive heart failure and chronic obstructive pulmonary disease will be admitted into the program and receive education, prescription management and monitoring to reduce their risk of readmission to the hospital.”

Dr. Holliday and a pharmacy resident from Prosperity spend one day a week at the Juniper program, meeting with and advising patients on managing their medications. “They’re followed at Inova Juniper for 60 to 90 days, or until they are

able to connect with a primary care provider, whichever comes first,” she said.

What Hospitals Are Doing Hospitals have their own set of challenges when it comes to preparing patients for their transition home. Poor medication reconciliation, inadequate discharge planning and a lack of patient outreach post-discharge are just a few of the roadblocks that can lead to poor outcomes (Ann Intern Med 2003;138:161167). Fortunately, these transition challenges are being addressed by innovative hospitals. Pharmacists at Geisinger Health System, Danville, Pa., for example, established a system in which clinical pharmacists participate in team rounds.

Each morning before clinical rounds, the head nurse, inpatient physician, social worker or care manager and clinical pharmacist convene to review the status of every patient on the floor. The physician leads the meeting and updates target discharge dates for each patient.

That information is key to facilitating successful pre-discharge activities such as patient education about their medications and arranging post-discharge care, noted Angela Slampak-Cindric, PharmD, a clinical pharmacist at Geisinger. “Knowing when a patient will go home turned out to be very important,” she said “because it provides a baseline from which nurses and pharmacists can prepare patients prior to their departure.”

If, for example, the pharmacist identifies a patient who will require IV antibiotics after discharge, the pharmacist will contact a home infusion center and request that the appropriate medications be prepared and that home visits be scheduled. The pharmacist also can coordinate orders to switch from IV to oral dosing. For patients who require anticoagulants, the pharmacist will alert the anticoagulation clinic of needed followup appointments; patients new to anticoagulant therapy receive pre-discharge bedside education. The same level of follow-up occurs for patients starting antiplatelet agents and for those prescribed five or more post-discharge drugs. The program, which began in June 2009 on one inpatient unit, has since expanded to include eight units.

Pharmacy Concierge Service Regardless of how well prepared patients are before they leave the hospi-

tal, they still must fill their home-going prescriptions. That simple task can be an objectionable chore when reaching the comfort of home trumps all else. To help avoid treatment gaps, pharmacists at Summa Western Reserve Hospital in Cuyahoga Falls, Ohio, initiated a pharmacy concierge service in which prescriptions are filled and delivered to patients’ rooms before they leave the hospital.

“After physically leaving the hospital, it is often challenging to go to a community pharmacy to fill newly written prescriptions. There are often long wait times, unavailable products and transportation barriers,” said Tom Bauer, RPh, the hospital’s director of pharmacy. “Any initiative that relieves patients of this inconvenience was identified as a high priority.” Once all the discharge prescriptions have been written, a pharmacy technician explains the service to the patient. For those who opt in, the prescriptions are filled at the on-site pharmacy and delivered to the patient’s room, and a clinical pharmacist counsels the patient about his or her drug regimen.

Copayments also are collected in the room. Patients transferring to nursing homes or extended care facilities are not eligible for the service.

The service was offered to 773 patients from January 2011 through October 2011. The 663 patients (86%) who participated filled 1,504 prescriptions. The main reasons patients gave for declining the service were not having money on hand and the desire to go to their own retail pharmacy.

“Patients tell us they like the convenience; residents like it because they know prescriptions are getting filled; and nurses say they appreciate the availability of a pharmacist’s expertise,” Mr. Bauer said. He has also observed that the program potentially reduces the risk for medication errors because inpatient clinicians are familiar with the patient and patient profiles are easily accessible. In one case, a prescription was written for prednisone, 40 mg, three times daily, but it should have said once per day. A hospital pharmacist discovered the error and phoned the resident. “That mistake may not have been caught at a community pharmacy,” he said, “because the patient records aren’t accessible.”

—Steve Frandzel, Gina Shaw

9

Specialty Pharmacy Continuum • Winter 2012

OPERATIONS & MANAGEMENT

Strategies can help avoid disruptions in care

High-Touch Tips for Specialty Drug Adherence Patient nonadherence to prescription regimens remains a vexing problem in medication management, according to a pair of recent studies, but specialty pharmacists can implement strategies to help minimize it.

One recent investigation found that 24% of nearly 425,000 new retail prescriptions went unfilled (Am J Med 2011;124:1081.e9-1081.e22) and a second study concluded that 3.3% of more than 10.3 million prescriptions were abandoned at the pharmacy (Ann Intern Med 2010;153:633-640). In the latter study, prescriptions for initial therapy, expensive drugs and drugs that required high copayments or were transmitted electronically were significantly more likely to be abandoned.

Although these studies were in the retail setting, the findings are likely applicable to the specialty pharmacy arena. Nonadherence has not been thoroughly measured in a specialty setting, but practitioners report that it still can disrupt care, compromising outcomes and leading to life-threatening complications, hospitalization or emergency room visits. In fact, although the number of patients who rely on specialty pharmacy represent a small (albeit quickly growing) proportion of the overall pharmaceutical market, the stakes for specialty prescriptions often are higher because they tend to be expensive, require special handling and storage, and are administered via complex dosing schedules.

“Nonadherence can be a real problem, usually if a patient gets tired of the grind and having to take all these medicines day after day,” said N. Lois Adams, BPharm, MBA, president and CEO of HHCS Health Group, in Orlando, Fla. Many of the patients she works with have cystic fibrosis, and some spend two hours preparing and taking medications before they can leave home each day.

“You’ve got to really keep up with them.

This is a very high-touch business, or it should be—it doesn’t cut it to just mail out medicine.”

Poor adherence can even stem from a patient’s sense of lost control, added Dennis Street, RPh, lead pharmacist with Mercy Home Infusion in St. Louis.

“Some of these people have so little control over what they’re doing, so their noncompliance is a way of asserting themselves and regaining that sense of control,” he said, even if it’s ultimately harmful. Ideally, one of his staff members meets patients before they leave the hospital—or soon after they’re released at the latest —to discuss drug regimens.

“The key to patient compliance is mak-

ing sure that they understand what they’re being treated for and that we want to keep them out of the hospital,” Mr. Street said.

“Keeping in touch really does make a

tions or they say they still have plenty on hand, that triggers us to talk to their physicians about why they have so much.”

Dr. Pezalla also noted that adherence improves when patients are motivated to take their medications. Aetna’s specialty pharmacy staff (which includes nurses, pharmacists and pharmacy technicians) is trained in motivational interviewing that is designed to tap into a patient’s internal incen-

‘If you’re not looking at factors such as hospitalization based on nonadherence, you don’t have a complete picture.’

—Jay Bryant-Wimp, RPh

‘Instead of telling patients that they ought to take their medications, we try to help them understand why they would want to take them. … The hard part is that the motivation has to come from within.’

—Edmund Pezalla, MD

difference,” according to Edmund Pezalla, MD, chief clinical officer at Aetna Pharmacy Management, which oversees the Aetna Specialty Pharmacy Care Management program. Aetna uses both personal and automated phone calls, as well as occasional letters, to remind patients to take their medications on time. “If patients aren’t refilling their prescrip-

tive. “Instead of telling patients that they ought to take their medications, we try to help them understand why they would want to take them—to see their children graduate from college or to play with their grandchildren, for example,” said Dr. Pezalla. “We’re asking them to make an investment today against something that’s pretty far in

the future. The hard part is that the motivation has to come from within.”

Aetna reports adherence rates ranging from 93.4% to 97.4% for eight different disease states that it tracks in its specialty division. Aetna does not routinely track hospitalizations related to nonadherence, but it does periodically conduct studies to examine the impact of nonadherence on patient care and the causes of hospital readmissions.

Jay Bryant-Wimp, RPh, co-owner and CEO of Accurate Rx Pharmacy, in Columbia, Mo., chafes at the practice of using the amount of medication dispensed over a given time period as a proxy for adherence, as Aetna and other large pharmacy benefits managers do. “It’s great to recognize that there’s medicine going out from the pharmacy, but collecting data on how well patients are getting refills isn’t enough,” he said. “If you’re not looking at factors such as hospitalization based on nonadherence, you don’t have a complete picture.” Mr. Bryant-Wimp’s company maintains a scoreboard to keep track of events, such as hospitalizations and emergency room visits related to a patient’s diagnosis.

Keeping up with patients by phone is essential to maximize adherence and optimize care, he added. However, he said, calls are best suited for screening for underlying problems that can be followed by a home visit for additional assessment or teaching. Additionally, problems such as inappropriate use of a drug or unexpected side effects are more likely to be caught during a personal visit.

Mr. Bryant-Wimp expressed concern that “as an industry, specialty pharmacy is more and more about getting medications out to the home, regardless of whether or not there is a real connection with the patient.”

He emphasized that continued adherence and optimal outcomes hinge on “establishing relationships and visiting patients in their homes, especially if it’s only the first or second time they receive their medications.” Ms. Adams agreed. “It’s about more than just the patients getting medicine; it’s about the relationships you have with the patients. We have to get to know these people and encourage them.”

—Steve Frandzel Ms. Adams, Mr. Street and Mr. Bryant-Wimp reported no relevant conflicts of interest. Dr. Pezalla has a financial relationship with Aetna.

10

Specialty Pharmacy Continuum • Winter 2012

OPERATIONS & MANAGEMENT

TPN SHORTAGE continued from page 1

Stock up on macronutrients. Buying higher concentrations of some macronutrients, such as amino acids, can help take the sting out of some shortage situations, according to Michael Fadeyi, PharmD, director of pharmacy for Fort Worth, Texas-based American Outcomes Management. “We try to get the higher percentage concentrations and then dilute it down to what we want,” Dr. Fadeyi explained. “That’s helped somewhat.” When an oral equivalent exists, substitute that, in a milled form through the gastric feeding tube. “For many nutrients, you can get the oral drug, grind it up and deliver it to the patient that way,” he said. “It’s not an ideal solution, but in some cases it’s the only option.”

Increase the frequency of blood draws and clinical re-evaluations.

“When we are short on a particular nutrient, we occasionally have to have patients get blood drawn every week instead of every other week in order to be sure that their levels are adequate,” said Randy Fasnacht, PharmD, director of pharmacy for Ohio-based Advanced Infusion Services. “You have to make a lot of adjustments to keep all the balls in the air. More blood draws are an inconvenience for the patient, but they’re necessary. So far, we’ve had no adverse outcomes and no hospitalizations have been needed, because we’re staying on top of things.”

Establish trading relationships.

“We’re part of a hospital system, so occasionally we could dip into their supply, but not always, so we’ve traded with other pharmacies close by,” Dr. Fasnacht said. “We’re constantly talk-

Stay informed. Infusion pharmacists agree that keeping up with the shortage has become almost a full-time job. “At times, we’ve been changing formulas almost daily because that’s how often supplies change,” Dr. Fasnacht said.

“The wholesaler won’t let you know supplies are short until they’re out. You have to stay on top of supplies with everyone every day.”

Dr. Fasnacht urges home infusion pharmacists to sign up for the FDA’s drug shortage emails (www.fda. gov/drug/drugsafety/drugshortages/ default.html) and monitor on a daily basis the National Home Infusion Association’s member-only message boards (www.nhia.org), where they can also download the mp3 of a recent membership forum call on managing the impact of the drug shortage crisis.

The Root of the Problem In the meantime, it may help to understand the underpinnings of the shortage and how the factors that contribute to it may play out in the future.

“It really started in spring 2010, beginning with fat emulsions and then progressing to every component of IV nutrition,” said Jay Mirtallo, MS, RPh, associate professor of clinical pharmacy at the Ohio State University College of Pharmacy, Columbus, and executive director of A.S.P.E.N. The factors behind the shortage are similar to those that have led to the ongoing supply crisis involving chemotherapy drugs: consolidation of industry, a limited number of suppliers, low supplies of raw materials and low profit margins on many of the products involved.

The shortage has left hospitals and

‘Yes, generic manufacturers are now ramping up production and beginning to make sure inventories are adequate. But that will take years. What about patients who need to get adequate nutrition now?’

—Jay Mirtallo, MS, RPh

ing with vendors and keeping pressure on wholesalers, but we’re a small company and we don’t have the leverage of someone larger. But fortunately, there are enough small people around that if somebody has more of one item than another, we can balance it out. We try to keep a week’s supply of nutrients on hand, and if we have more than that, we’re willing to trade [with] someone who has less.”

home providers facing impossible choices. “We’re having to ration our nutritional components, diluting product and putting people on oral therapies when they really should be on IV,” Mr. Mirtallo said.

In a hospital setting, for example, neonates receive top priority for IV nutrition because they have no reserves.

“But what if there’s a baby with a cardiac problem who is not doing well and

needs calcium?” Mr. Mirtallo asked. “If the hospital has a limited supply of the product, they may need to take the calcium from one baby’s nutritional IV because in the short term the damage is not as drastic as not getting calcium for the heart.

But a baby needs calcium for bone growth and stability, so this really isn’t an acceptable alternative.”

Suppliers Scrambling To Respond Dr. Fadeyi said that he and his colleagues are now frequently buying higher concentrations of macronutrients like amino acids, and then diluting them to maximize supply. But even then, that’s often not enough. “We had a patient, a young man with complications from leukemia treatment, who was severely dehydrated,” Dr. Fadeyi said. “He was on IV nutrition but we were about to run out of potassium phosphate. We informed the physician a week before we ran out, and he discontinued the drug after the end of that week and placed the patient on oral therapy. He then transferred the young man from his home in the Dallas area to MD Anderson Cancer Center in Houston for a continuation of his therapy, because we couldn’t get what he needed anywhere that allowed him to stay home.”

PN suppliers and patient advocates, like the Oley Foundation, are urging support for U.S. Senate Bill 296 (SB 296), the Preserving Access to LifeSaving Medications Act, introduced by Sens. Amy Klobuchar (D-Minn.) and Robert Casey (D-Pa). SB 296 directs the FDA to address drug shortages by requiring manufacturers to notify the FDA about manufacturing problems or when a drug is to be discontinued. The bill also requires that the FDA maintain an online list of drugs in shortage situations, and revises the agency’s definition of “medically necessary.”

Time is of the essence, Mr. Mirtallo stressed. “Yes, generic manufacturers are now ramping up production and beginning to make sure inventories are adequate,” he said. “But that will take years. What about patients who need to get adequate nutrition now?”

One possible source of products: Europe, where no apparent shortage exists. “I’ve traveled there and none of those professionals have any drug shortage issues,” Mr. Mirtallo said.

“They are quizzical, asking why we have this problem when they have more

‘We try to keep a week’s supply of nutrients on hand, and if we have more than that, we’re willing to trade [with] someone who has less.”

—Randy Fasnacht, RPh

than adequate supplies.” But since the Europeans’ products use different components that are not generically equivalent to U.S. products, current regulations would require the drawnout process of filing a New Drug Application (NDA) with the FDA before such importation could occur. Mr. Mirtallo said that A.S.P.E.N. is trying to work with the American Society of HealthSystem Pharmacists to advocate a change in the Klobuchar–Casey bill that would allow the FDA to permit importation of products from Europe that are not generically equivalent, but “therapeutically equivalent,” without an NDA. Until such efforts bring significant relief to the PN shortage, cautious conservation is the name of the game, Mr. Mirtallo noted. “If you have to lower dosages, dilute or substitute, you need to monitor for the deficiency symptoms that are likely to occur,” he said.

“If you don’t normally monitor certain lab parameters, like trace elements or vitamin levels, you need to start doing that in patients who aren’t getting adequate dosages.”

—Gina Shaw

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Specialty Pharmacy Continuum • Winter 2012

OPERATIONS & MANAGEMENT

EMBRACE continued from page 1

specialty pharmaceutical provider, with more than a decade of experience and an output of about 1,000 prescriptions a day. “We really offer everything the big guys offer,” Dr. Skiermont said. “We just do it on a much smaller scale.” (For more details, see sidebar, “Fairview Pharmacy Expands Reach.”)

No national data are available to document health-system pharmacies’ push to claim a larger slice of the rapidly expanding specialty pharmaceutical market, but pharmacists who have networked with colleagues at other institutions say the trend is clear.

“Many institutions are moving forward with plans either to outfit their existing pharmacies to accommodate specialty pharmaceuticals or to build out new facilities where they can provide these services,” said Michael DeCoske, PharmD, BCPS, associate chief pharmacy officer, ambulatory services, at Duke University Hospital, Durham, N.C. Duke is an example of a health system that is “building out” to fulfill its commitment to deliver more specialty pharmaceuticals to its patients. A newly designed specialty pharmacy facility is scheduled to open Feb. 27 as part of the Duke Cancer Institute on the university’s campus. “It’s going to focus primarily on oncology and transplant

University of Illinois clinical staff pharmacists Kyle Mork, PharmD and Phyllis Lin, PharmD, prepare a medication order for temperature-sensitive shipping.

‘We really want to make customer service paramount, so we’ll try to adjust the staffing to a level where we can really see to the special needs of our patients.’

—Colin Sheffield, PharmD patients initially,” Dr. DeCoske said, but it may eventually expand to other chronic diseases requiring specialty

drugs, he added.

When Duke University’s new specialty pharmacy opens, it will consolidate

and expand many of the services now scattered around the large academic medical center. Located within Duke’s new state-of-the-art cancer center, the pharmacy will initially concentrate on providing medications ordered by the university’s oncology faculty as well as bolstering the specialty services already being given to organ transplant patients. Down the road, the pharmacy’s coordinator, Colin Sheffield, PharmD, anticipates expanding the specialty services to other specialty disease states.

“Initially, the [program] will consist of a small staff,” said Dr. Sheffield, “but in the near future, we’re looking to build a concierge type of service. We really want to make customer service paramount, so we’ll try to adjust the staffing to a level where we can really see to the special needs of our patients.”

The specialty services will include working with providers to obtain prior authorizations for many of the costly specialty medications and helping to connect patients who need financial support to medication assistance programs. Patient follow-up will also be priority, Dr. Sheffield said, with calls made to select patients 48 to 72 hours after discharge or initiation of new therapies to see if they’re having any medication-related issues. Complimentary drug delivery service will also be

•

see EMBRACE, page 12

Fairview Pharmacy Expands Reach

A

lthough more health systems are taking steps to beef up their specialty pharmaceutical capacity, few match the full service lines offered by national specialty pharmacy providers like Accredo, CVS Caremark and CuraScript.

Fairview Pharmacy Services in Minneapolis is one of them.

Launched more than a decade ago as a convenience to Fairview Health Services’ patients and providers, Fairview’s specialty pharmacy has since extended its offerings to a far larger population, with deliveries that reach patients in all 50 states.

Kyle Skiermont, PharmD, director of specialty infusion operations at Fairview Health Services, said the specialty pharmacy has had success in gaining insurer contracts by emphasizing its connection to the large network of hospitals, clinics and physician group practices maintained by its parent, Fairview Health Services, which was recently named one of 32 organizations to participate in Centers for Medicare & Medicaid Services’ Pioneer Accountable Care Organization program.

‘It’s been a key piece for us to be able to go to insurers and say, ‘If we’re responsible for the total cost of care, you can’t shut us out on pharmaceuticals because they are 20% of the cost.’

—Kyle Skiermont, PharmD

“It’s been a key piece for us to be able to go to insurers and say, ‘If we’re responsible for the total cost of care, you can’t shut us out on pharmaceuticals because they are 20% of the cost,’” Dr. Skiermont said.

Still, one of the biggest challenges to winning contracts is trying to meet insurers’ rate demands. Dr. Skiermont said that although margins are thin, “we look at it more from a continuity-of-care perspective” rather than as a moneymaking opportunity.

Fairview Pharmacy Services operates out of a 62,000-square-foot building in an

industrial complex near the University of Minnesota. The building houses a number of pharmacies as well as Fairview Pharmacy’s corporate offices. The specialty pharmacy itself, including its call center, occupies about 15,000 square feet.

Between the specialty pharmacy and the mail service operation, some 40 to 50 staff members, including about 10 pharmacists, are at work on any given day.

Specialty prescriptions arrive from a variety of sources, including physicians’ offices, patients themselves or often from a pharmaceutical company using a hub connection to transmit orders.

“When we receive a prescription,” Dr. Skiermont explained, “we reach out to the patient to gather demographic information and figure out when and where they need the medication delivered. Do they want it sent to them? Is it going to a clinic or a work address? All the logistics of delivery.”

The pharmacy has a team of financial experts that work with patients on prior authorizations and help find financial assistance for those unable to meet the costs of therapy, which can run to thousands of dollars per month. “That’s really a key step,” Dr. Skiermont said.

Every patient also is counseled by a pharmacist before a prescription is dispensed, he said. Follow-up calls vary in complexity, depending on where patients are in their course of treatment. For example, he said, a multiple sclerosis (MS) patient with a lot of experience using a self-injectable specialty drug requires less time than a newly diagnosed MS patient. “But our standard is that every patient gets a call from our pharmacy at least once a month,” he said.

Dr. Skiermont said Fairview also is weighing applying for accreditation from an organization like the Utilization Review Accreditation Commission (URAC).

“Historically, we haven’t needed it,” he said, but now “we’re starting to feel that even though there are still not a lot of times that it’s needed, we may want it anyway just to be able to say, ‘Yes, we’re accredited,’ when the question is asked.”

For health systems considering entry into the specialty pharmacy business, Dr. Skiermont’s advice is that patient care improvement should be foremost in the decision-making process. But financial considerations also should be part of the equation, he said. “If you’re not controlling the medication side of things, there is a huge chunk of cost of care that is really being dictated by someone else.”

—Bruce Buckley

12

Specialty Pharmacy Continuum • Winter 2012

OPERATIONS & MANAGEMENT

EMBRACE continued from page 11

provided for patients who live across North Carolina or in neighboring states.

“Right now, I’m maintaining the transplant patients we already have,” Dr. Sheffield said, “so I’m bouncing back and forth between pharmacies and trying to set up the brand new pharmacy. Once we get that pharmacy up and running, it’s just a matter of rolling those services over and providing a lot more clinical counseling.”

A Precedent Already Set The preparation and dispensing of specialty pharmaceuticals may be expanding in some health-systems, but it is not a completely new trend, according to JoAnn Stubbings, BSPharm, MHCA, clinical associate professor at University of Illinois Hospital and Health Sciences System. Cit-

University of Illinois Hospital and Health Sciences System clinical staff pharmacist Nehrin Khamo, PharmD, consults with gastroenterologist Vijay Khiani, MD.

ing the provision of costly and complex oncology and transplant drugs as an example, Ms. Stubbings said that “most

health systems do some level of specialty pharmacy already.”

Most of those specialty pharmacy

drugs, however, have typically been provided on an inpatient or discharge basis. “The challenge is that a lot of people get diagnosed with other conditions, such as multiple sclerosis and hepatitis C, as outpatients,” she said.

“We started paying attention to those prescriptions and tried to find ways that we could offer similar services, so that we could dispense them from our own outpatient pharmacy.”

As a result of those efforts, University of Illinois has taken several steps in recent years to expand its outpatient specialty pharmacy services. In fact, the health system already has amassed data that underscore the financial benefits that can accrue from such a strategy (see sidebar, “University of Illinois Reaps Benefits of Getting Into the Game”). Based on those initial successes, the University is formalizing its specialty pharmacy structure into University of Illinois Specialty Pharmacy

University of Illinois Reaps Benefits of Getting into the Game

A

‘The face-to-face contact between the clinical pharmacists and patients is very important to making this type of program work.’

—JoAnn Stubbings, PharmD

4

Revenue, $ (millions)

t the University of Illinois Hospital and Health Sciences System, getting into the specialty/outpatient pharmacy arena has turned a lost opportunity for revenue into a financial gain for the hospital—and a boon to patient care.

Ten years ago, “the majority of specialty prescriptions from our clinics were being diverted from our outpatient pharmacy to for-profit specialty pharmacies,” said JoAnn Stubbings, BSPharm, MHCA, clinical associate professor at University of Illinois. “In general, it wouldn’t be unusual for 10 specialty prescriptions to be generated by a clinic in an institution, but having only one dispensed from the on-site pharmacy.”

3,665,546

3 2 1 203,909

0

2002

2011

Year of Operation Among the reasons for that loss to outside pharmacies are restrictive payer contracts, limited access to specialty medications by an outpatient pharmacy, as well as inadequate specialty pharmacy capabilities.

At the 2011 American Society of Health-System Pharmacists Midyear Clinical Meeting, Ms. Stubbings and colleague Juliana Chan, PharmD, described how their 491-bed hospital overcame many of these challenges, improved coordination of care and increased revenue from specialty pharmaceuticals through an outpatient specialty pharmacy clinical practice model that is now being formalized and expanded into an even larger effort.

In the first phase of the practice mode, the hospital assigned two full-timeequivalent clinical pharmacists to four outpatient specialty clinics, starting with the liver clinic in 2003 (followed by gastroenterology in 2007, rheumatology in 2008, and multiple sclerosis in 2010). Their responsibilities included reviewing the therapeutic appropriateness of prescribed specialty medications for the medical condition in question; completing the prior-authorization process; providing patient education about adverse drug effects and drug self-administration of injectable agents; and monitoring for laboratory abnormalities and adverse effects. If applicable, the pharmacist also managed the risk evaluation and mitigation strategies (REMS) program for a specialty medication.

The pharmacist also provided patients with a list of pharmacies where they could fill their prescriptions. If a patient chose the on-site pharmacy, the prescription was referred to the outpatient specialty pharmacy staff. The drug could be picked up by the patient or the clinical pharmacist, who then delivered it to the clinic during the patient’s appointment. Refills were picked up by the patient or mailed to the patient’s home.

Figure. Financial impact of adding specialty pharmacy services at University of Illinois. pharmacy dispensed 191 specialty prescriptions from the four specialty clinics, representing $203,909 in revenue. In 2011, the pharmacy dispensed 1,656 specialty prescriptions, representing annualized revenue of $3,665,546.

Every time the model was implemented for a particular clinic, related prescriptions dispensed by the on-site pharmacy increased. For example, in the year subsequent to the program’s initiation in the liver clinic, the number of related prescriptions dispensed increased to 383, compared with 35 the previous year. In the multiple sclerosis clinic, the number of prescriptions dispensed increased from 84 to 207 in a comparable time period. Similarly impressive gains were reported for biological agents prescribed in the gastroenterology and rheumatology clinics: from 155 to 360 in 2008, then to 670 in 2009.

“The process is complex and time-consuming,” Ms. Stubbings said, “but the face-to-face contact between the clinical pharmacists and patients is very important to making this type of program work. Pharmacy presence and collaboration with health care providers in the specialty clinics is the key to success.”

This type of program reaps benefits beyond the economic gains, noted Ms. Stubbings. Hospital-based specialty programs can address some of the problems inherent in specialty pharmacy—patients getting fragmented care that is difficult to coordinate and getting medications from multiple pharmacies that don’t have access to their medical records. She said that wanting to improve this aspect of patient care is what drove University of Illinois to get into the specialty arena.

Impressive Results In 2002, before the new practice model took effect, the hospital’s outpatient

—Steve Frandzel

13

Specialty Pharmacy Continuum • Winter 2012

OPERATIONS & MANAGEMENT

Services. The practice will initially focus on gastrointestinal disease, rheumatology, multiple sclerosis, hepatitis C and pulmonary disease.

“We will use what we call a ‘capture model,’” Ms. Stubbings said, “where the specialty pharmacist reviews the specialty prescription and performs initial functions, such as prior authorization, medication assistance assessment and insurance benefit verification. If we are able to fill the prescription, we will speak with the patient and offer the choice of having it filled at University of Illinois. If the patient agrees, then we have ‘captured’ the prescription and we continue to manage the coordination of the patient’s care, including the prescription and all refills.”

The Bigger Players

A

lthough the push by health systems to get a share of the specialty pharmacy market is a significant trend, they are up against stiff competition. National scale, rigorous quality controls, cost-saving efficiencies and a focus on patient care are some of the attributes that large commercial specialty pharmaceutical providers like CVS Caremark and Medco’s Accredo say have allowed them to gain a large share of the specialty pharmacy market.

Years of experience in the business have also helped, they say. CVS Caremark, for example, was “one of the pioneers in the specialty space” some 30 years ago when the company’s Caremark division—at that time a separate corporate entity—began to manage the distribution of hemophilia clotting-factor products, said Randy Falkenrath, the company’s senior vice president of specialty pharmacy.

Richard Faris, PhD, vice president at Accredo, Medco Health Solutions, Inc.’s specialty subsidiary, said that Medco has been involved in the specialty business ever since “these types of medications were introduced,” adding that “management and service levels were taken to new levels in 2004 when [Medco] began a strategic partnership with Accredo Health.”

Medco acquired Accredo in 2005.

‘Our internal controls and management processes ensure that any drug we acquire is coming from a reliable source.’

—Randy Falkenrath, CVS Caremark

Pushback From Other Channels That focus on patient care comes as a surprise to N. Lois Adams, BPharm, MBA, RPh, president and CEO of HHCS Health Group, in Orlando, Fla., which manages patients with cystic fibrosis and other chronic disorders that often require specialty medications. Asked to comment on the effort of some hospitals to expand their specialty pharmacy offerings, she replied, “There is no way that large health systems can adequately take care of these patients or give them the ‘high touch’ that they require.”

Ms. Stubbings countered by reiterating that many of the core components of the University of Illinois approach to providing specialty pharmacy care are in fact focused on the patient. The progam’s call center, for example, is staffed by a mix of pharmacists and technicians, and it’s where the bulk of case management is done. “Pharmacists at the call center can actually go into the clinic on certain days when patients are there and work directly with the health care team in providing patient education,” Ms. Stubbings said. “Simpler tasks, such as prior authorizations, are typically done by a technician, but if it’s more complex like a prior authorization that requires a lot of clinical information or maybe an appeal to the insurance company, that may also be done by the pharmacist.” Clinical questions from doctors and patients are also handled by pharmacists, she added.

Other core components—many patientfocused—include the following: Hands-on help. A lot of the patients are on medications that they have to selfinject either once a day or once a week.

“Pharmacists will take patients’ initial prescriptions directly to them in the clinic and show them how to do the injection and then give them their prescriptions,” Ms. Stubbings said.

Flexible dispensing. “We also mail prescriptions to patients, but if they want to come in and pick them up they can do that as well. For the hepatitis C model that we described in the [2011 ASHP

Both companies have built their market share success around national networks of mail-service facilities and local specialty pharmacies that enable them to efficiently dispense millions of specialty pharmaceuticals annually to patients.

“The one thing that we think is a differentiator for us is patient access,” Mr. Falkenrath said. “We have a sizeable specialty business that gives patients access by mail, if they choose that; through community specialty pharmacies where that makes sense; or for certain medications, through a CVS retail store. They’re not locked into a single mechanism.”

Dr. Faris noted that while most of Accredo’s specialty medications are shipped to patients’ homes for self-administration, “we also have certain infused therapies, where our nursing staff will go into the home to administer the therapy—intravenous immunoglobulin, for example.” Accredo, he added, also works with clinics and physicians’ offices for therapies that require administration in those settings.

As part of its service, CVS Caremark will also arrange for nursing services to educate patients who elect to self-inject medications at home, Mr. Falkenrath said. “In our business model,” he said, “we can also refer patients to one of our MinuteClinic locations, where they can get injection training from one of our nurse affiliates.”

A Focus in Patient Care Both companies say their business models insist on a focus on patient care from initial intake to long-term follow-up.

“Accredo is a premier specialty pharmacy because of its philosophy surrounding patient care,” said Dr. Faris, adding that the company serves patients “with chronic and complex conditions requiring advanced treatment with extensive clinical expertise and hands-on care and support from nurses and pharmacists in the patient’s home, which is widely considered the preferable place for treatment.”

Dr. Faris said that Accredo schedules regular follow-ups for patients, where “critical information is gathered and teachable opportunities are identified. This total-care approach helps ensure adherence to these costly medication regimens, and helps comfort and care for people managing rare and complex conditions.”

Mr. Falkenrath stressed the close attention paid to clinical protocols for all of the different therapies that patients are receiving. “Depending on whether it’s a patient on an existing therapy or one who is new to therapy, we determine how our relationship starts off with them,” he said. Typically, patients are assessed before the first prescription is dispensed, he added, and then depending on the medication, a follow-up call goes out, often soon after the patient begins therapy, to find out if any side effects have developed or if dosing adjustments might be needed.

“There are other checks that we’ll do,” Mr. Falkenrath said. “With pulmonary hypertension products, for example—which are all about breathing capacity—you can do a six-minute walking test,” he said, “and based on their test results, we can get a good sense of whether or not the medication is helping and whether or not the disease is progressing. We’ll also use our patient assessment information to inform the physician of changes in the patient’s status.”

Both companies also stressed the care with which they ensure product integrity, only buying directly from manufacturers or reliable wholesale distributors. They also make sure that stringent handling and shipping requirements are followed, including for products that require cold-chain management.“That’s where our quality certification comes in and where our internal controls and management processes ensure that any drug we acquire is coming from a reliable source,” said Mr. Falkenrath. “We also address any issues in terms of managing the cold chain. We’ll take a product out of inventory in the event we see any issues.”

—Bruce Buckley

Midyear Clinical] meeting, those patients typically come to the clinic once a month to get their lab work done and visit with the clinical pharmacist. We coordinate that visit so they also get their prescriptions and any education that needs to be done. So it’s a pretty integrated model.”

Access to the electronic medical record. “Another plus of our approach,” Ms. Stubbings said, is that “before we fill a prescription, we can review the medical record to find out if the dose or anything else in the patient’s record has

changed. You can do a lot of background work before you fill that prescription.”

Does Size Really Matter?

Many of the special distribution requirements and case management services provided by health-system specialty pharmacies are similar to those offered by large national companies, but health-system pharmacists say their smaller size, access to patients’ electronic medical records and ability to call on physician experts within their sys-

tems help to set them apart. At Fairview, for example, Dr. Skiermont said smaller size means that patients are “more likely to talk to the same person on a regular basis and have a team of people taking care of them, versus being the next name in the queue” at a large call center.

“We have access to their medical records, which is huge,” he added, “because if we need to look up lab values or see how a clinic visit went, we can do those things pretty readily.”

•

see EMBRACE, page 14

14

Specialty Pharmacy Continuum • Winter 2012

OPERATIONS & MANAGEMENT

continued from page 13

Access to experts within Fairview Health Services—recently named one of 32 participants in the Center for Medicare & Medicaid Services’ Pioneer Accountable Care Organization (ACO) program—is another important feature that their health-system specialty pharmacy has, Dr. Skiermont said. “We have countless pharmacists, physicians, mid-level practitioners and nurses who we can tap into,” he said. “So, if we have a cystic fibrosis patient, for example, [Fairview has] one of the best cystic fibrosis centers in the country that we can reach out to.”

CVS Caremark Makes its Case Large national specialty pharmacy companies say that the ability to access patient health records and tap medical experts for guidance isn’t limited to health-system pharmacies; they also offer such access. Randy Falkenrath, CVS Caremark’s senior vice president of specialty pharmacy, noted that “we have medical directors who we rely on” for guidance and support, “whether it’s the internal medical director consulting with clinical pharmacists or doing a consultation with the patient’s physician.” Mr. Falkenrath added that when CVS Caremark contracts with a health plan for specialty services, “we will also coordinate with their medical directors. So we do have the connectivity in place.”

The blanket national coverage offered by the CVS Caremark specialty pharmacy, along with the company’s huge network of retail pharmacies and in-store medical clinics—features also shared by Walgreens Specialty Pharmacy—often make it an attractive option to large health insurers and employers demanding uniform quality care delivery and lower costs for patient populations that often cross multiple state lines.

Other large pharmacy benefit management companies with specialty pharmacies, like Medco’s Accredo and Express Scripts’ CuraScript, offer similar advantages of scale. Accredo, for example, has three specialty mail-service facilities and 74 branch specialty pharmacies located nationally. Its 2010 net revenues totaled $11.3 billion. CVS Caremark operates 12 specialty pharmacy mail facilities and 32 community specialty pharmacies while also providing access to select specialty medications at their 7,400 CVS retail stores.

The company expects to fill more than 4 million specialty prescriptions in 2012.

(For more details on this segment of the specialty pharmacy market, see sidebar, “The Bigger Players,” page 13.)

Smaller specialty pharmacy operators also say they are well-positioned

to serve the needs of these challenging patients. In fact, Ms. Adams argues that “there’s no difference between the services that the larger specialty and smaller specialty pharmacies can provide.”

A Market On the Rise Specialty pharmaceuticals are among the fastest growing U.S. market segments. Growth data are hard to pin down because of varying definitions of what constitutes the specialty market. Last year, however, IMS Health reported that in 2010, specialty drug wholesale acquisition costs increased 6.3% to $67.8 billion.

(For more in-depth data on this growth, see sidebar, “Specialty Pharmacy Trending Up,” at right.)

Category growth also is expected to remain vigorous as drug manufacturers focus on the discovery and development of high-cost products targeting cancer, HIV infection, inflammatory diseases, hepatitis C, multiple sclerosis and other chronic conditions that primarily affect the country’s growing elderly population.

But no amount of growth will guarantee success in the specialty pharmacy market: Providers, whether they are health-systems or more established players, have to prove they can meet the complex requirements of handling specialty medications. For example, specialty pharmaceuticals often call for strict preparation and handling measures as well as rigorous adherence to risk evaluation and mitigation strategies (REMS) that the FDA requires manufacturers to develop for certain high-risk drugs.

Health-system pharmacies count REMS management practices among their strengths. “Health systems are uniquely qualified to effectively manage REMS due to their direct access to electronic records, to the patients themselves and to the health care providers on the team,” Ms. Stubbings said. For example, she said University of Illinois is certified to “dispense and thereby manage the very complex REMS requirements for Revlimid [lenalidomide] as well as for Thalomid [thalidomide].”

And then there’s the question of accreditation. Creating a specialty pharmacy service that qualifies for accreditation by the Utilization Review Accreditation Commission (more commonly referred to as URAC) or the Joint Commission requires a facility that can safely deliver complex, high-cost medications along with comprehensive patient services, while also meeting cost reductions demanded by stringent insurer contracts.

Services range from cold-chain management of medications requiring refrigeration throughout the delivery process— a capability that University of Illinois handles well (photo, page 11), Ms. Stubbings stressed—to case management, financial assistance programs and claims adjudication for products that can cost

$100,000 or more per year.

Still, “cost and expertise are two of the big barriers” to entering the specialty pharmacy arena, Dr. Skiermont said.

“When you look at all things it takes to start a specialty pharmacy, a lot of health systems think, ‘There are enough irons in the fire right now. This isn’t one that we’re going to tackle at this time.’”

For others, like University of Illinois,

the time is now to embrace specialty pharmacy or get left out of too many lucrative prescription dispensing opportunities and also lose contact with too many patients. As Ms. Stubbings noted, “this really isn’t the time for hospitals to stay completely on the sidelines when it comes to specialty pharmacy.”

—Bruce and Joan Buckley

Specialty Pharmacy Trending Up

T

he U.S. specialty pharmaceutical market is poised for significant growth over the next few years, with rates likely to double those of traditional pharmaceuticals, according to the Center for Healthcare Supply Chain Research, a not-for-profit arm of the Healthcare Distribution Management Association (HDMA).

The center has been keeping an eye on the specialty market since 2009, when it produced the first edition of “Specialty Pharmaceutical Facts, Figures and Trends,” according to Karen Ribler, executive vice president and chief operating officer of HDMA’s Research and Education Foundation.

The newest report, released in 2011, is chock full of data on the specialty segment, ranging from market characteristics to dispensing and administration information to anticipated growth rates in specific therapeutic categories.

100

Percent of Sales (%)

EMBRACE

80 64 60 40 20 0

Independent physician-owned or operated clinics

10

8

8

Hospitals

Specialty pharmaciesa

Clinics/specialty clinicsb

Figure. Specialty pharmacy product sales by selected customer groups.c a

Regardless of parent company affiliation; b Owned or operated by hospitals; Excluded: direct to patients, retail pharmacies, government organizations, other healthcare distributors, home health care, etc.: 10%

c

Among the highlights: • The U.S. specialty pharmaceutical market grew 6.3% in 2010, the latest year for which information is available, nearly double the 3.3% growth rate for traditional pharmaceuticals. From 2006 to 2010, the growth rate was 69%.

• By 2016, eight of the top 10 branded drugs in the United States are expected to be specialty pharmaceuticals, as established manufacturers shift into that segment to replace diminishing revenues from drugs that have lost patent protection.

• Sixty-four percent of specialty product sales by distributors will be generated by shipments to independent physician-owned or -operated clinics, followed by shipment sales to hospitals (10%), specialty pharmacies (regardless of parent company affiliation; 8%), hospital clinics and specialty clinics (8%), direct to patients (2%) and retail pharmacies (1%) (Figure).

• Oncology products led the way in distributors’ 2011 specialty sales with 46% of the total, followed by supportive care (e.g., anemia and blood modifiers) at 14%, anti-inflammatory products (including those for rheumatoid arthritis) at 13%; hematology (blood disease/disorders) at 8%; orphan drugs not included in other categories at 4%; central nervous system (including multiple sclerosis) at 3%; ophthalmology at 3%; and autoimmune diseases (including HIV/AIDS) at 2%.

• Specialty pharmaceutical dispensing is evenly divided among the clinical setting (35%), patients’ homes (33%) and the pharmacy setting (32%).

However, administration takes place predominantly in the clinical setting (55%); this is followed by self-administration in the home setting (32%) and clinician administration in the home setting (13%).

—Bruce Buckley

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Specialty Pharmacy Continuum • Winter 2012

PATIENT EDUCATION

Hopes About New HCV Drugs Often Unrealistic Careful patient selection, preparation and education is key to successful treatment San Francisco—Soon after the FDA approved two direct-acting antiviral agents (DAAs) last spring for treating infection with hepatitis C virus (HCV), a 57-year-old black man came to see gastroenterologist Andrew Muir, MD. The man had been diagnosed with hepatitis C in 2001. A liver biopsy one year later revealed he had stage II fibrosis. At that time, the patient declined treatment, saying the duration was too long and offered too few benefits.

But recently, he came back to Dr. Muir, wanting to try one of the new protease inhibitors. Based on information he had read, the man believed he could avoid interferon (IFN) and ribavirin (RBV), take a protease inhibitor as monotherapy for 24 weeks and expect a 75% chance of achieving a sustained viralogic response (SVR).

Unfortunately, the patient’s expectations were unrealistic on all counts.

The new protease inhibitors can only

be given in conjunction with IFN and RBV, and the treatment duration varies.

For black patients, therapy usually lasts a full 48 weeks, and in clinical trials, only 30% of black patients achieved an SVR with 28 weeks of therapy. Moreover, among black patients in the Phase III trials, SVR rates fell short of the 75% that the patient expected, and in treatment-naive blacks, only 62% of those taking telaprevir (Incivek, Vertex) and 53% of those taking boceprevir (Victrelis, Schering-Plough) achieved an SVR.

Educate To Encourage Adherence Unrealistic expectations are com-

mon among patients with HCV infection who, after years of waiting for better therapies, are eager to try treatment with the new DAAs, said Dr. Muir, clinical director of hepatology at Duke University Medical Center, Durham, N.C. But, the DAAs on the market today are complex, with varied stoppage rules, monitoring points and some serious adverse events and drug–drug interactions.

In a presentation at the 2011 annual meeting of the American Association for the Study of Liver Diseases, Dr. Muir stressed that for patients to achieve optimal benefits from DAA therapy, they need to be prepared through clear, detailed discussions prior to and throughout treatment. “The major challenges are preparing patients for the rigors of therapy, checking in frequently to make decisions about the duration of treatment and managing any issues as the patient goes along,” he said.

Comparative Effectiveness Guides Hepatitis C Therapy Steve Burman, RPh President, CEO Burman’s Specialty Pharmacy Brookhaven, Pennsylvania

C

onfusion and inappropriate expectations about new therapies are common among patients with hepatitis C, as reported above. The available regimens differ with respect to efficacy, side effects, etc. Comparative effective research (CER)—a method of gathering and comparing evidence on the efficacy, benefits and hazards of diagnostic methods and treatment options—is an important tool for health care providers as they seek to provide optimal therapy for their patients with hepatitis C. Based on the premises of the American Recovery and Reinvestment Act, the U.S. Department of Health and Human Services approved and allocated $1.1 billion to the Federal Coordinating Council for CER, the efforts of which guide research investments. Clinicians, patients, policymakers, health insurance companies and other payers also use the results of CER to make health care decisions. Furthermore, CER data must accompany arguments by pharmaceutical companies for FDA approval of treatments in addition to safety and efficacy data from clinical trials.

The emerging emphasis on CER impacts the management of hepatitis C on many levels. Hepatitis C is a complex disease state that demands complex therapeutic regimens and extensive monitoring to facilitate successful outcomes.

Laboratory values that need to be monitored and measured as hepatitis C virus (HCV) intermediate outcome criteria using the CER method include early viral response, sustained viral response, histologic changes, biochemical response, alanine transaminase and drug resistance. Other essential data to consider include static patient characteristics, such as age, gender, ethnicity and HCV genotype; historical patient data, such as whether the patient is treatment-naive or being retreated, previous and/or failed treatment regimens, and possible reasons for treatment failure or relapse; and “real-world” patient situation factors, such as education level, comorbidities, drug interactions, presence of mental illness and a variety of other adherence deterrents. Additionally, the following final outcomes should be measured: morbidity, mortality, quality of life, transmission of HCV, liver transplantation, development of cirrhosis, disease relapse and development of hepatocellular carcinoma.1 Specialty pharmacy is an ideal support resource for educational programs that are required to manage the increasingly complex HCV treatment regimens as well as patients’ expectations about those regimens. The specialty pharmacy can provide the necessary staff to assess and comment on patient laboratory values and to send out provider and patient reminders to promote medication adherence and appropriate laboratory visits. Some specialty pharmacies use software that can store relevant clinical data and provide reports for patient clinical management and outcome and trend analysis purposes. Specialty pharmacists also can help manage drug interactions and adverse effects.

Innovative thinking is still necessary to address the current and future challenges posed by drug treatment of hepatitis C. Clinical, service and cost outcomes of specialty pharmacy products will become increasingly important in health care, and there is an emerging need to evaluate outcomes as more and more high-cost specialty pharmaceuticals are used for the treatment of hepatitis C.2

References 1. Agency for Healthcare Research and Quality AHRQ Effective Health Care Program. Comparative effectiveness of hepatitis C treatment adherence interventions. http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction= displayproduct&productid=839. Accessed January 18, 2012.

2. Stern D, Reissman D. Specialty pharmacy cost management strategies of private health care payers. J Manag Care Pharm.

2006;12(9):736-744. http://www.amcp.org/data/jmcp/736-744.pdf.

To clarify a patient’s expectations, Dr. Muir outlines the complex prescribing rules, contraindications, life style changes and duration of treatment related to DAA therapy.

He cautions patients that the lifestyle changes can be significant.

Both telaprevir and boceprevir must be taken three times a day, and always with a meal.

It is very challenging, agreed Raymond Chung, MD, chief of hepatology and vice-chief of gastroenterology at Massachusetts General Hospital, in Boston. “Patients must adhere to that regimen because lapses in the concentration of telaprevir and boceprevir have historically been the risk period for breakthrough variants on therapy,” said. He noted that many of his patients limit or reschedule their work hours while on DAA therapy to help with adherence.

The key to getting patients through DAA treatment successfully is to select patients carefully and prepare them assiduously, said Gary L. Davis, MD, director of general and transplant hepatology at Baylor University Medical Center, Dallas. “This means that any issues that might impact compliance, tolerance and drug access should be dealt with before treatment starts. Educating the patient is essential,” he said, adding that patients and others involved in their care “need to clearly understand the importance of dosing compliance, lab monitoring and treatment stopping rules/end points.”

Follow Through: Monitor For Response, Resistance, Reactions, Interactions Once treatment begins and throughout treatment, the entire treatment care team, including physicians, pharmacists, and nurse practitioners, needs to remain in close contact with the patient to reinforce adherence and offer feedback on the process. Careful follow-up, with monitoring for any viral breakthroughs is essential to prevent unwarranted continuation of treatment in patients when a breakthrough has occurred. A breakthrough “would signal the emergence of resistant variants.

Upon discovery, it would be paramount to discontinue the entire regimen to

17

Specialty Pharmacy Continuum • Winter 2012

PATIENT EDUCATION

prevent selection of additional resistance mutations,” stressed Dr. Chung.

Equally important is the need to monitor patients closely for adverse reactions and drug–drug interactions. Because IFN and RBV remain the backbone of this HCV regimen, the same contraindications exist as with standard dual therapy: decompensated cirrhosis, renal insufficiency, advanced cardiac/pulmonary disease, active depression, severe mental illness, anemia/neutropenia/thrombocytopenia and noncompliance.

Additionally, there are important drug–drug interactions with boceprevir and telaprevir. Both DAAs inhibit the CYP3A4/5 enzyme. Patients may have increased exposure to drugs metabolized

by CYP3A4/5 while taking boceprevir or telaprevir. The DAAs themselves are metabolized by this cytochrome. As a result, other drugs that induce or inhibit CYP3A4/5 could affect HCV levels.

“Planning is key to deal with drug– drug interactions,” said Dr. Muir. It’s very important to do a risk–benefit analysis of treatment with boceprevir and telaprevir, taking into account patients’ comorbidities, he added. It is important to review all drugs that the patient is taking, including overthe-counter and herbal medications.

Check with the patient’s primary care provider, cardiologist and psychiatrist about medication use, Dr. Muir said.

“It’s a good time to revisit the need for all medications. Ask if the antidepressant can be changed, the blood pressure medicines. Can the patient hold their statin for 12 weeks?” he said.

Women taking oral contraceptives should be advised to try alternative methods of contraception, such as an intrauterine device or barrier methods. Additionally, pregnant women should not take either drug, as both are considered pregnancy category X, meaning the risks “clearly outweigh potential benefits,” according to the FDA. Anemia and rashes are the two most common adverse events associated with the new therapies. Before a patient starts therapy, a pretreatment evaluation for anemia should be done, considering the impact on comorbidities, such as cardiac and pulmonary disorders.

The benefits of reducing the dose versus increasing or starting erythropoietin should be weighed.

For rashes, patients should be proactive by moisturizing twice a day, limiting sun exposure and wearing loose-fitting clothing. Dr. Chung recommends including a dermatologist on the treatment team.

One other important element that needs to be taken into account when considering patients for DAA therapy is whether patients should wait for something else to be approved, said Dr. Chung. Recent results from Phase II studies of second-generation DAAs sug-

gest that some combination of these could be approved in the next three years. These therapies may allow the omission of IFN from the treatment regimen and can generally be taken orally once a day, with or without food.

“That’s something critical to consider.

With all the complexities of therapy— the issues of tolerability, adherence, drug–drug interactions, quality of life— there’s another equally important set of events going on, and that’s the emerging data on all-oral, interferon-free treatments,” said Dr. Chung. “It’s clear that

the promise of interferon-sparing therapy is very real.”

Dr. Chung recommends that all patients with HCV infection who have advanced-stage disease, regardless of whether they are treatment-naive or experienced, should be considered for boceprevir or telaprevir, provided the benefits outweigh the risks. Patients who can reasonably defer treatment because of early-stage disease or who cannot tolerate IFN may be able to wait for investigational therapies to be approved. These patients also may

be eligible for investigational studies, which are ongoing.

—Christina Frangou Dr. Muir disclosed that he has relationships with Abbott, Anadys, Bristol-Myers Squibb, Gilead, Medtronic, Merck, Pfizer, Roche, Santaris, Scynexis and Vertex. Dr. Chung receives grant/research support from Gilead, Merck, Pfizer and Romark. Dr. Davis is a consultant for Vertex and receives grant/research support from Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, Novartis, Pharmassett, Tibotec and Vertex.

18

Specialty Pharmacy Continuum • Winter 2012

EDUCATIONAL REVIEW

Antimicrobial Efficacy JARED L. CRANDON, PHARMD, BCPS Associate Director

JOSEPH SEPH L. KUTI, PHARMD Associate Director

DAVID P. NICOLAU, PHARMD, DSA FCCP, FIDSA Director ctor Center for Anti-Infective Research and Development nt Hartford Hospital al Hartford, Connecticutt

T

his review is intended to be a reference

to describe the potential in vivo activity e identity of various antimicrobial agents when the

of the infecting organism is known. Because the en noted early initiation of appropriate therapy has been ctions, empiric to improve clinical outcomes for serious infections, therapy frequently demands broad-spectrum antimicrobial agent(s) until the specific infecting bacterium has been identified.

Given the continuing concerns of increasing antimicrobial resistance among grampositive and gram-negative bacteria and the lack of new antibiotics coming to market, knowledge of microbiologic activity and clinical treatment guidelines increases the likelihood of providing appropriate antimicrobial therapy to patients and minimizes the use of unnecessary agents. Importantly, antimicrobial susceptibilities can be highly variable based on institution-specific and geographic factors (including various institutional sites—eg, outpatient vs inpatient, intensive care unit vs ward). Therefore, an awareness of local susceptibility data is essential to ensure the highest probability of successful clinical outcomes. While the use of various dosing techniques, especially for β-lactams, may potentiate in vivo activity, the information contained herein pertains only to standard dosing regimens. This review reflects the opinions of the authors and is intended to be a general guide to antimicrobial applications, with the appreciation that host factors (eg, site of infection, clinical picture, comorbid conditions) can greatly impact antimicrobial selection.

Key to Table

1

First-line agent based on clinical efficacy, susceptibility patterns, and consideration of antimicrobial stewardship and the cost of care.

2

Indicates an alternative drug based on clinical efficacy and susceptibility patterns.

3

Indicates a drug with a low level of activity against this organism, and/or limited clinical efficacy.

Either there is insufficient clinical data or this drug should not be used for this organism.

19

Specialty Pharmacy Continuum â&#x20AC;˘ Winter 2012

Cocci

Neisseria meningitidis

1

2

2

2

2

2

2

1

1

3

3

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

Ertapenem

Others

Ampicillin-Sulbactam

Nafcillin/Oxacillin

Amoxicillin-Clavulanate

Cloxacillin/Dicloxacillin

Doripenem

Meropenem

Imipenem-Cilastatin

Piperacillin-Tazobactam

Aztreonam

Piperacillin

Moraxella catarrhalis Neisseria gonorrhoeaea

Antistaphylococcal

Antipseudomonal

Ticarcillin-Clavulanate

Ticarcillin

Penicillin V

Penicillin G

Ampicillin

Nonantipseudomonal

& Related Antimicrobials

Amoxicillin

Table 1. Penicillins

2

2

Chlamydia pneumoniae (TWAR)

Chlamydia

Chlamydia psittaci Chlamydia trachomatis Bordetella pertussis

3

3

3

3

Brucella spp.b Campylobacter jejuni

3

3

Coccobacilli

Helicobacter pyloric

Hemophilus influenzaed

2 3

3

2

2

2

2

2

1

1

3

3

3

2

Citrobacter spp.e

2

2

2

2

2

2

1

1

1

1

Enterobacter spp.e,f

1

1

1

2

2

2

1

1

1

1

2

3

Legionella pneumophila

Escherichia colif,g

3

3

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

Proteus vulgaris

2

2

2

2

2

2

2

2

Providencia stuartii

2

2

2

2

2

2

2

2

3

2

2

2

2

2

2

2

3

3

2

2

2

2

2

2

2

2

2

2

2

3

3

3

2

3

2

2

2

2

2

2

1

2

Klebsiella pneumoniaef,g

2

Morganella morganii

2 2

Proteus mirabilis

Other Bacilli (nonenterobacteriaceae)

1

Hemophilus ducreyi

Enterobacteriaceae

Gram-Negative Aerobes

Francisella tularensis

1

Salmonella spp.

Salmonella typhi

1

3 3

3

Shigella spp. 2

2

2

Serratia spp.

FermentNegative

Acinetobacter spp.h

2

2

2

2

Burkholderia (Pseudomonas) cepaciah

3

3

3

3

Pseudomonas aeruginosah

3

1

2

3

3

2

1

1

2

2

Stenotrophomonas (Xanthomonas) maltophilia

Ferment-Positive

2

2

2 2 2

2

2

3

2

1

1

1

1

1

1

2

2

2

2

1

2

3

Pasteurella multocida

2

2

Vibrio cholerae

3

3

2

Enterococcus faecalis

1

1

1

2

2

2

3

3

3

2

2

3

3

3

3

3

3

3

3

3

3

3

2

2

2

2

2

1

1

2

2

2

2

2

2

2

2

2

2

2

2

2

Vancomycin-resistant Enterococcus faecalis Enterococcus Enterococcus faecium Vancomycin-resistant Enterococcus faecium Methicillin-susceptible Staphylococcus aureus Methicillin-resistant Staphylococcus aureus

Methicillin-susceptible Staphylococcus epidermidis Methicillin-resistant Staphylococcus epidermidis Streptococcus Group A (S. pyogenes)

1

1

1

1

2

2

2

2

2

2

2

3

3

2

2

2

Streptococcus Group B (S. agalactiae)

1

1

1

1

2

2

2

2

2

2

2

3

3

2

2

2

Streptococcus Group D (eg, S. bovis)

1

1

1

1

2

2

2

2

2

2

2

3

3

2

2

1

1

1

1

2

2

2

2

2

2

2

3

3

2

2

2

2

2

2

2k

2

2

2

2

Streptococcus pneumoniaei Cocci

Gram-Positive Aerobes

Glycopeptide-intermediate susceptible Staphylococcus aureus

Penicillin-resistant Streptococcus pneumoniaej,k

2k

Viridans streptococci

3

3

3

3

Actinomyces israelii

1

1

1

2

2

2

2

2

2

3

3

2

2

2

3

3

2

Actinomycetes Nocardia spp.

Bacillus anthracisl

3 2

2

Corynebacterium diphtheriaem

GramBacilli Negative

2

Gardnerella vaginalisn

2 1

1

2

Bacteroides fragilis Fusobacterium spp. 2 Prevotella melaninogenica

3

2

2

2

2

3

3

3

2

3

3

2

1

1

1

1

2

1

1

2

2

2

3

2

3

2

2

2

2

2

2

2

3

3

3

3

2

2

2

2

2

2

2

2

Clostridium difficilep

GramPositive

Anaerobes

2

2

Corynebacterium jeikeium

Listeria monocytogeneso

3

Mycoplasma

Clostridium perfringens

2

2

1

1

2

2

2

2

2

2

2

2

2

Clostridium tetani

2

2

2

2

2

2

2

2

2

2

2

2

2

Peptostreptococcus spp. 2

2

1

1

2

2

2

2

2

2

2

2

2

2

Mycoplasma pneumoniae Ureaplasma urealyticum Borrelia burgdorferi (Lyme disease)q

Spiral Organisms

2

1

Borrelia recurrenis Leptospira spp. 2 Treponema pallidum

2 1

1

2

1 Continues on page 20

20

Specialty Pharmacy Continuum â&#x20AC;˘ Winter 2012 Continued from page 19 Generations

Cocci

Moraxella catarrhalis 3 Neisseria gonorrhoeaea Neisseria meningitidis Chlamydia pneumoniae (TWAR)

Enterobacteriaceae Cocci GramNegative GramPositive

Anaerobes

Bacilli

Gram-Positive Aerobes

Other Bacilli (Nonenterobacteriaceae)

Gram-Negative Aerobes

Coccobacilli

Chlamydia

Mycoplasma

Spiral Organisms

3

3

3

2

AntiMRSA

Ceftaroline

Ceftriaxone

Ceftizoxime

Ceftibuten

4th

Ceftazidime

Cefpodoxime

Cefotaxime

Cefditoren

Cefdinir

Cefuroxime

3rd

Cefprozil

Cefoxitin

Cefotetan

Cefaclor

2nd

Cephalexin

Cefazolin

Cefadroxil

1st

Cefepime

Table 2. Cephalosporins

2

2

3

2

2

2

2

3

2

2

2

2

3

3 3

3 3

3

3 3

2 2

2

3 3

2

2 2

1 2

2 2

2

2

2

3

2

2

2

2

2 2

2 2

2

2

2 2

2 1

1 1

2

2

2 2

3 3 2 2 3 2

2 2 2 2

2 2 1 1 1 1

2 2 1 1 1 1

1 1 2 2 1 1

2 2 2 2 2 2

Chlamydia psittaci Chlamydia trachomatis Bordetella pertussis Brucella spp.b Campylobacter jejuni Francisella tularensis Helicobacter pyloric Hemophilus ducreyi Hemophilus influenzaed Legionella pneumophila Citrobacter spp.e Enterobacter spp.e,f Escherichia colif,g 1 Klebsiella spp.,g 2 Morganella morganii Proteus mirabilis 2

3

2

3 3 2 2 3 2

2 2 3 2

Proteus vulgaris

3

3

Providencia stuartii Salmonella spp.

Salmonella typhi Serratia spp.

Shigella spp. h Acinetobacter spp. h Burkholderia (Pseudomonas) cepacia Fermenth Negative Pseudomonas aeruginosa Stenotrophomonas (Xanthomonas) maltophilia Pasteurella multocida FermentPositive Vibrio cholerae Enterococcus faecalis Vancomycin-resistant Enterococcus faecalis Enterococcus Enterococcus faecium Vancomycin-resistant Enterococcus faecium Methicillin-susceptible Staphylococcus aureus Methicillin-resistant Staphylococcus aureus Glycopeptide-intermediate susceptible Staphylococcus aureus Methicillin-susceptible Staphylococcus epidermidis Methicillin-resistant Staphylococcus epidermidis Streptococcus Group A (S. pyogenes) Streptococcus Group B (S. agalactiae) Streptococcus Group D (eg, S. bovis) Streptococcus pneumoniaei Penicillin-resistant Streptococcus pneumoniaej,k Viridans streptococci Actinomyces israelii Actinomycetes Nocardia spp.

Bacillus anthracis l Corynebacterium diphtheriae m Corynebacterium jeikeium Gardnerella vaginalis n Listeria monocytogenes o

3 3

3 3

2 3

3 3

1 2

1 2

2 3

2

2

2

2

1

1

2 1

2

1

3 2

2 2 1 1 1 1

2

2 2 2 2 2 2

3

1

3

2

2

1

1

1

2

3 3

2 1

3

2 2

3

2

2 2 3

3

2 2 2 3 1

3

2 1 1 2 2 3

1 2

3

2 1 1 2 2 3

1 2 3 3 1

2

2

2

2

3 2

2

2

2

2

2

2

2

3

2

2

2

3

3

3

3

3

2 2 2

1

1

1

3

3

3

3

2

2

2

2

3

3

3

2

2

2 2 2 2

2 2 2 2

2 2 2 2

2 2

3 3

3 3

2 2

2 2

2 3

2

2 2

2 2

2 3

3 3

2 2

2 2

2 2

2

3

3

2

2

2

2

2

3

3

2

2

2

2

2

3

3

2

2

2

2 2x 2 3 3

1 2x 2 2 3

2 2 2

3

2

2 2

2 3

Bacteroides fragilis

2

2

3

Fusobacterium spp.

2

2

2

3

2

2

Prevotella melaninogenica

2

2

2

3

2

2

2 3 2

2 3 2

3

2 3 2

2 3 2

Clostridium difficile p Clostridium perfringens Clostridium tetani Peptostreptococcus spp. 2 Mycoplasma pneumoniae

3 2

3 2

3

3

3

3

2

2

2 3 2

1

2

2

2

2

3

Ureaplasma urealyticum Borrelia burgdorferi (Lyme disease)q Borrelia recurrentis Leptospira spp.

Treponema pallidum

2 2

2 2 1 2 2 2 2 2 2

21

Specialty Pharmacy Continuum â&#x20AC;˘ Winter 2012

Cocci Coccobacilli

1 1

Bordetella pertussis

1 2

Campylobacter jejuni Francisella tularensis

1

2

1

2

2

3

2

2

1

1

2

3

3

3

3

3

3

2

2

2

2

1

Hemophilus ducreyi

Legionella pneumophila Citrobacter spp.e 2

2

2

1

3

3

2

2

2

2

1

1

2

1

1

2

1

1

Other Bacilli (Nonenterobacteriaceae) Cocci

Gram-Positive Aerobes

2

1

1

2

3

3

Norfloxacin

Nitrofurantoin

Fosfomycin

3

Suggested Reading

2

2

2 1

3

2

2 3

1

2

2

2

1

1

2

2

2

3

2

2

1

1

2

2

2

3

2

Morganella morganii 2

1

1

2

2

2

2

2

2

2

1

2

2

2

2

2

2

2

3 2

2

2 3

3

2

3

3

3

3

3

2

2

3

2

2

2

2

2

3

3

2

3

3

2

Proteus mirabilis

2

1

1

2

2

2

3

3

2

3

2

Proteus vulgaris

2

1

1

2

2

2

3

3

2

3

3

2

Providencia stuartii 2

2

2

2

2

3

2

Salmonella spp.

2

2

2

2

2

3 2

1

2

2

2

2

2

2

2

Serratia spp.

2

1

2

2

2

3

3

3

2

2

Shigella spp.

3

3

3

2

2

2

3

3

2

2

Acinetobacter spp.g 3

1

1

2

2

3

Burkholderia (Pseudomonas) cepaciag

2

Pseudomonas 1 aeruginosag

1

1

Pasteurella multocida

2

Vibrio cholerae

2

Enterococcus faecalis

2

3

Vancomycin-resistant Enterococcus faecalis

3

3

Enterococcus faecium

3

3

Vancomycin-resistant Enterococcus faecium

3

3

Glycopeptide-intermediate susceptible Staphylococcus aureus

2

2

3

3

2

2

2

3

2

3

3

2

3

3

3

2

3

3

3

3

2 3

3

3

2

2

3

1

1

2

2

1

2

2

1

1

1

3

2

2

2

2

2

2

2

3

3

1

1

2

1

1

3

2

2

3

2

2

3

3

3

2

2

2

3

3

Methicillin-resistant 3 Staphylococcus epidermidis

3

3

3

Streptococcus Group A (S. pyogenes)

2

2

Streptococcus Group B (S. agalactiae)

2

2

3

2

3

3

2

3

3

3 2

2

3

2

3

2

2

2

3

1

2

2

3

1

2

2

2

2

1

1

1

3

3

3

3

3

2

2

3

3

3

3

3

3

2

2

2

2

2

3

2

2

2

2

2

2

3

2

3

1

2

2

2

3

2

3

2

2

2

2

2

2

3

2

3

2

2

2

2

2

3

2

2

3

2

1

2

2

2

3

2 3

3

2

3

2

1

3

3

Listeria monocytogenes o 3

3 3

3

3

3

3

2

2

3

2

3

Gordon KA, Biedenbach DJ, Jones RN. Comparison of Streptococcus pneumoniae and Haemophilus influenzae susceptibilities from community-acquired respiratory tract infections and hospitalized patients with pneumonia: fiveyear results for the SENTRY Antimicrobial Surveillance Program. Diagn Microbiol Infect Dis. 2003;46(4):285-289.

Hansen GT, Blondeau JM. Comparison of the minimum inhibitory, mutant prevention and minimum bactericidal concentrations of ciprofloxacin, levofloxacin and garenoxacin against enteric gram-negative urinary tract infection pathogens. J Chemother. 2005;17(5):484-492.

Kuti JL, Florea NR, Nightingale CH, Nicolau DP. Pharmacodynamics of meropenem and imipenem against Enterobacteriaceae, Acinetobacter baumannii, and Pseudomonas aeruginosa. Pharmacotherapy.

2004;24(1):8-15.

Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of North America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children.

Clin Infect Dis. 2011;52:e18-e55.

3

Martin SI, Kaye KM. Beta-lactam antibiotics: newer formulations and newer agents. Infect Dis Clin North Am. 2004;18(3):603-619.

3

Paterson DL, Bonomo RA. Extended-spectrum beta-lactamases: a clinical update. Clin Microb Rev. 2005;18(4):657-686.

Petersen PJ, Bradford PA, Weiss WJ, Murphy TM, Sum PE, Projan SJ. In vitro and in vivo activities of tigecycline (GAR-936), daptomycin, and comparative antimicrobial agents against glycopeptide-intermediate Staphylococcus aureus and other resistant gram-positive pathogens.

Antimicrob Agents Chemother. 2002;46(4):2595-2601.

Rhomberg PR, Fritsche TR, Sader HS, Jones RN. Comparative antimicrobial potency of meropenem tested against gram-negative bacilli: report from the MYSTIC surveillance program in the United States (2004). J Chemother. 2005;17(8):459-469.

2

Rice LB. Antimicrobial resistance in gram-positive bacteria. Am J Med. 2006;119(6 suppl 1):S11-S19; discussion S62-S70.

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1 3

2 1

1

3

Ferrara AM. Potentially multidrug-resistant nonfermentative gram-negative pathogens causing nosocomial pneumonia. Int J Antimicrob Agents.

2006;27(3):183-195.

Nordmann P, Cuzon G, Naas T. The real threat of Klebsiella pneumoniae carbapenemase producing bacteria. Lancet Infect Dis. 2009;9(4):228-236.

2

3

1 3

2

2

2

Gardnerella vaginalis n

2

2

Corynebacterium diphtheriae m Corynebacterium jeikeium

2

Curran M, Simpson D, Perry C. Ertapenem: a review of its use in the management of bacterial infections. Drugs.

2003;63(17):1855-1878.

Pfaller MA, Segreti J. Overview of the epidemiological profile and laboratory detection of extended-spectrum beta-lactamases. Clin Infect Dis. 2006;42(suppl 4):S153-S163.

3 3

Bacillus anthracisl

2

Critchley IA, Blosser-Middleton RS, Jones ME, Thornsberry C, Sahm DF, Karlowsky JA. Baseline study to determine in vitro activities of daptomycin against gram-positive pathogens isolated in the United States in 2000-2001. Antimicrob Agents Chemother.

2003(5);47:1689-1693.

Nguyen M, Chung EP. Telithromycin: the first ketolide antimicrobial. Clin Ther. 2005;27(8):1144-1163.

2

2

Chow JW, Satishchandran V, Snyder TA, Harvey CM, Friedland IR, Dinubile MJ. In vitro susceptibilities of aerobic and facultative gram-negative bacilli isolated from patients with intra-abdominal infections worldwide: the 2002 Study for Monitoring Antimicrobial Resistance Trends (SMART). Surg Infect (Larchmt).

2005(4);6:439-448.

Nicolau DP. Spotlight on Clostridium difficile infection: an educational resource for pharmacists. Pharmacy Times.

2009;2:91-99.

1

2

3

2

1

2

2

2

3

2

3

2

1

2

3

2

Brook I. Management of anaerobic infection. Expert Rev Anti Infect Ther. 2004;2(1):153-158.

Livermore DM. Linezolid in vitro: mechanism and antibacterial spectrum. J Antimicrob Chemother.

2003;S1(suppl 2):ii9-ii16.

2

1

2

3

2

3

3

3

2

2

2

2

3

2

3

2

3

2

2

2

2

2

2

2

3

3

1

2

2

2

1

2

3

1

2

3

2

Actinomyces israelii

1

1

2

Penicillin-resistant Streptococcus pneumoniae j,k

3 2

2

2

Streptococcus pneumoniaei

Nocardia spp.

2

2

Viridans streptococci

3

1

3

Staphylococcus epidermidis 2

2

2

3

3

3

1

3

2

2

2

3

2

2

3

Streptococcus Group D (eg, S. bovis)

Actinomycetes

3

1

3

Vancomycin

2

2

Staphylococcus aureus 2

Cocci

3

2

Community-associated methicillin-resistant Staphylococcus aureusv

Bacilli

2

2

Hospital-associated methicillin3 resistant Staphylococcus aureusw

Gram-Positive Aerobes

3

2

Stenotrophomonas (Xanthomonas) maltophilia

Enterococcus

2

2

2

1

Salmonella typhi

FermentPositive

2

3

2

2

Klebsiella pneumoniaef

3

2

1

Escherichia coli f

2

1

1

e

Enterobacter spp.

Enterobacteriaceae

Gram-Negative Aerobes

3

1

1

2 3

2

3

3

1

Hemophilus influenzaed 3

3

2

3

2

3

Helicobacter pylori c

2

2

2

2

2

Trimethoprim-Sulfamethoxazole

1

Chlamydia psittaci Chlamydia trachomatis

Tigecycline

2

2

Tetracyclines (eg, Doxycycline)t

2

2

2

Telithromycin

2

3

Telavancin

2

2

Rifampin

2

Quinupristin-Dalfopristin

2

Metronidazole

Chloramphenicol

Chlamydia pneumoniae (TWAR)

Linezolid

Moxifloxacin 2

Fidaxomicin

Levofloxacin 2

2

Daptomycins

Gemifloxacin

2

1

Colistin/Polymixin B

Ciprofloxacin

3

1

Erythromycin

2

Dirithromycin

Neisseria meningitidis

Clarithromycin

3

2

3

Azithromycin

2

2

Tobramycin

2

Streptomycin

2

Gentamicin

2 2

Amikacin

2 3

3

UTI Agentsu

Other Antibiotics

2

Brucella spp.b

FermentNegative

Quinolonesr

Neisseria gonorrhoeaea

Moraxella catarrhalis 3

Chlamydia

Macrolides

Clindamycin

Aminoglycosides

Table 3. Aminoglycosides, Macrolides, Quinolones, & Other Antibiotics

1

3

Roberts S, Chambers S. Diagnosis and management of Staphylococcus aureus infections of the skin and soft tissue. Intern Med J. 2005;35 (suppl 2):S97-S105.

Torres-Viera C, Dembry LM. Approaches to vancomycin-resistant enterococci. Curr Opin Infect Dis. 2004;17(6):541-547.

Continues on page 22

22

Specialty Pharmacy Continuum • Winter 2012 Continued from page 21

3

2

2

GramPositive

Mycoplasma

Spiral Organisms

3

3

3

Clostridium tetani

2

2

3

3

3

Peptostreptococcus spp.

3

3

3

3

Mycoplasma pneumoniae

1

1

1

1

1

Ureaplasma urealyticum

2

2

3

3

Borrelia burgdorferi q

2

2

3

Borrelia recurrentis (Lyme disease)

3

3 2

2

2

2

2

2

2

2

2

2

3

2

3

2

3

2

3

2

2

2

2

2

2

3

3

3

b Use a combination: for example, doxycycline with gentamicin or rifampin or doxycycline with trimethoprim-sulfamethoxazole and chloramphenicol. c Combination therapy with high eradication rates includes omeprazole + clarithromycin + amoxicillin; or bismuth subsalicylate + metronidazole + tetracycline. However, metronidazole resistance has risen significantly. d Up to 30% of Haemophilus influenzae strains are capable of producing β-lactamases.

2

high-level penicillin resistance (MIC [minimum inhibitory concentration] >1 mcg/mL). The Centers for Disease Control and Prevention Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group recommends MIC ≥4 mcg/mL for high-level resistance. The clinical significance of penicillin resistance in nonbacteremic patients is still uncertain when parenteral treatments are used.

a Resistance to penicillin, tetracycline, and ciprofloxacin may be as high as 21.5%, 29.2%, and 47.7%, respectively, according to a 2006 report; 50% of patients have Chlamydia trachomatis. j

PRSP (penicillin-resistant Streptococcus pneumoniae) being defined as nonsusceptible to penicillin (PCN [penicillin] MIC ≥2 mcg/mL).

k Amoxicillin doses of 80 mg/kg/d may be effective against nonmeningeal RSP infections. l

For updates, see www.fda.gov/oc/opacom/hottopics/ bioterrorism.html.

e Citrobacter spp. and Enterobacter spp. may differ in susceptibility patterns. Consult individual test results for appropriate choice.

m Membranous pharyngitis treated with antitoxin and IV erythromycin (antimicrobials used to decrease toxin production and bacterial spread).

f

n New classification: bacteria are gram-variable.

Carbapenemase-producing Enterobacteriaceae are increasing, and are endemic in certain geographic regions. Viable treatment options are limited and should be based on susceptibilities. Generally, colistin/polymixin B and tigecycline offer in vitro susceptibility, although clinical data are limited. Combination therapy is encouraged.

g A significant number of strains are capable of producing extendedspectrum β-lactamases (ESBL). Consider this possibility according to antibiogram, patient’s history, and local resistance patterns. In suspected or proven cases, use carbapenems or proper non–β-lactam antibiotics based on susceptibility studies. h Combination therapy is suggested.

In 2005, the penicillin resistance rate in the United States was reported to be approximately 34%; 10% to 15% of isolates displayed

o Aminoglycosides (gentamicin) may be synergistic with β-lactams. p Gastroenteritis is treated with only oral formulations of vancomycin.

Vancomycin is recommended as first-line therapy for patients with severe illness, whereas metronidazole is recommended for patients with mild to moderate disease. Fidaxomicin was non-inferior to oral vancomycin in treating CDI, but it was superior in preventing recurrences of non-NAP1/BI/027 strains. q Stage of disease determines choice of treatment. Consult specific references. r

Van Bambeke F, Michot JM, Van Eldere J, Tulkens PM. Quinolones in 2005: an update. Clin Microbiol Infect.

2005;11(4):256-280. Erratum in: Clin Microbiol Infect.

2005;11(6):513.

Yamaguchi T, Hashikita G, Takahashi S, Itabashi A, Yamazaki T, Maesaki S. In vitro activity of beta-lactams, macrolides, telithromycin, and fluoroquinolones against clinical isolates of Streptococcus pneumoniae: correlation between drug resistance and genetic characteristics.

J Infect Chemother. 2005;11(5):262-264.

Zhanel GG, Hisanaga TL, Laing NM, et al; NAUTICA Group. Antibiotic resistance in outpatient urinary isolates: final results from the North American Urinary Tract Infection Collaborative Alliance (NAUTICA).

Int J Antimicrob Agents. 2005;26(5):380-388.

Dr. Crandon reports no relevant conflicts of interest.

Dr. Kuti has received research funding from and/or is on the speaker’s bureau and/or advisory board for Astellas, BioMerieux USA, Forest, Merck, Ortho-McNeil, and Pfizer.

Dr. Nicolau has received research funding from and/or is on the speaker’s bureau and/or advisory board for AstraZeneca, Cerexa, Cubist, Forest, Johnson & Johnson, Merck, Ortho-McNeil, Pfizer, Rib-X, Tetraphase, and Vertex.

2 3

Trampuz A, Zimmerli W. Antimicrobial agents in orthopaedic surgery: prophylaxis and treatment. Drugs.

2006;66(8):1089-1105.

3 1 2

Notes to Chart

i

1

Norfloxacin

2

2

Nitrofurantoin

2

3

3

Fosfomycin

3

Vancomycin

2

1

Leptospira spp.

Treponema pallidum

2

3

2

2

2

3

Trimethoprim-Sulfamethoxazole

Telithromycin

Rifampin

1 1

3

Telavancin

Quinupristin-Dalfopristin

Linezolid

Fidaxomicin

Metronidazole

3 2

Daptomycins

2

Clostridium difficile p Clostridium perfringens

Colistin/Polymixin B

3

Tigecycline

2

3

2

3

Tetracyclines (eg, Doxycycline)t

2

2

1

3

Fusobacterium spp.

Prevotella melaninogenica

1

2

Clindamycin

Levofloxacin

Gemifloxacin

3

UTI Agentsu

Other Antibiotics

Chloramphenicol

Bacteroides fragilis

Quinolonesr

Ciprofloxacin

Erythromycin

Dirithromycin

Clarithromycin

Azithromycin

Tobramycin

Streptomycin

Macrolides

Moxifloxacin

GramNegative

Anaerobes

Gentamicin

Aminoglycosides

Amikacin

Table 3. Aminoglycosides, Macrolides, Quinolones, & Other Antibiotics

Resistance rates can vary greatly against P. aeruginosa, Acinetobacter spp., and the Enterobacteriaceae. Use as empiric therapy against these organisms should be based on local susceptibilities.

s

Despite its potent in vitro activity against Streptococcus pneumoniae, daptomycin is not indicated for the treatment of pneumonia because it extensively binds to pulmonary surfactant resulting in clinical failure.

t

The specific tetracycline recommended varies. For methicillin-resistant Staphylococcus aureus, minocycline is most active among class.

Consult specific references.

u These agents are generally recommended for urinary tract infections (UTIs) only. Use of the “1” to “3” scale refers to activity for treatment of UTI. v Vancomycin is considered first-line when IV therapy is required.

However, ceftaroline, daptomycin, linezolid, telavancin, and tigecycline may be suitable alternatives in specified patients. Tetracyclines, clindamycin, trimethoprim-sulfamethoxazole, macrolides, and linezolid are viable alternatives when oral therapy can be used. In the face of erythromycin resistance, clindamycin should be considered only if the isolate is D-test–negative. w Vancomycin is considered first-line when IV therapy is required.

Notably, in recent years vancomycin MICs have gradually increased for S. aureus and have included an increased occurrence of heteroresistance. Clinical reports have associated this loss of in vitro potency with vancomycin clinical failures in a number of patients. Alternative therapies—such as ceftaroline, daptomycin, linezolid, telavancin, and tigecycline—should be considered in the appropriate clinical setting.

Consult specific references. x Effective choice for meningeal infections if the ceftriaxone/cefotaxime MIC <0.5 mcg/mL.

Commentary

Antimicrobial Efficacy From a Home Infusion Perspective Randy Fasnacht, RPh, BSPharm, CGP, FASCP Director of Pharmacy Services Advanced Infusion Services, LTD Akron, Ohio

O

ver the past several decades, outpatient parenteral antimicrobial therapy (OPAT) in the home setting has become a standard treatment method for patients requiring long-term IV antibiotic therapy.

OPAT offers many advantages, including reduced hospital length of stay, reduced treatment expense, and improved patient outcomes. Many factors need to be considered when determining the appropriateness of this type of therapy, including whether a patient is suitable for outpatient care, the availability of reimbursement, and the infection being treated. Once it is determined that OPAT is appropriate, deciding on the specific antibiotic to use is of utmost importance.

The home infusion pharmacist should work closely

with the primary care provider or infectious disease physician treating the patient. It is important to obtain a diagnosis with identification of the bacteria involved. Knowledge of local susceptibility patterns and geographic factors will help ensure the correct antibiotic selection. Using tables such as those provided by Crandon, Kuti, and Nicolau will help ensure that the correct antibiotic is chosen when a particular bacterium has been identified or is suspected.

Once antibiotic agents are identified as being clinically efficacious, other factors can be evaluated to determine the final treatment. In the case of OPAT, a number of other factors need to be considered.

1. Does the patient have the correct type of IV access for this medication (peripherally inserted central catheter vs midline catheter vs peripheral venous access catheter)?

2. Is the frequency of dosing something the patient

can manage (once-daily treatments are preferred over more frequent administrations)?

3. Is the drug stable enough that it can be used in the outpatient setting?

4. How will the medication be delivered (gravity, elastomeric device, or electronic pump)?

5. How much training or nursing time will be needed and how many visits are required for this specific patient/treatment combination?

There are many other questions beyond the 5 listed here.

In summary, it is critical to the success of OPAT that the antibiotic chosen is the most efficacious against the particular bacteria identified. The reference chart provided in the educational review can be a vital tool for selecting the correct antibiotic for a given patient.

23

Specialty Pharmacy Continuum • Winter 2012

POLICY

USP Standard Aims for Supply Chain Integrity Threats to pharmaceutical supply chain integrity abound, from counterfeit and adulterated medicines to illegal diversion of drugs. A new U.S. Pharmacopeia (USP) standard, the proposed USP General Chapter <1083> Good Distribution Practices— Supply Chain Integrity, offers recommendations on how to minimize supply chain risks.

Although not mandatory, the new standard is meant to be a central guidance document outlining core elements of an effective strategy. According to Michael N. Eakins, PhD, principal consultant, Eakins & Associates, East Windsor, NJ, and vice-chair, Packaging, Storage, and Distribution Expert Committee, USP, the new standard differs from other guidance documents. “While there are numerous articles and guidelines available to help to promote the integrity of individual steps in the pharmaceutical supply chain,” he wrote, the new standard “is intended to provide best practices to protect the integrity of the whole supply chain in a single document.”

Desmond Hunt, PhD, senior scientific liaison, USP, Rockville, Md., wrote in an email: “The USP standard will provide one, central place that all parties can refer to regarding best practices— and as new issues arise, and technology

advances, USP will update the standard to reflect current realities.”

The standard covers four main areas: importation; counterfeit drugs and medical devices; best practices to combat counterfeit drugs and medical devices; and diversion and theft. Details include the connection of counterfeit drugs to drug shortages—counterfeiters are “opportunistic” in supplying drugs during shortages—as well as innovative solutions such as product track-and-trace technology.

USP expects the standard will be useful to all organizations and individuals in the global supply chain, from manufacturers and distributors to hospital and other pharmacies. Particularly important, in the view of Dr. Eakins, are “recommendations on good importation practices, technologies to establish drug pedigrees, approaches to combat illegal Internet pharmacies, and advice on how to reduce the risk of theft.”

Dr. Hunt wrote, “It is difficult to pull out any one recommendation, which speaks to the real bottom line: every link in the supply chain is important. It only takes one misstep to lead to a substandard product, or a product diversion.”

Available at www.usp.org/USPNF/ notices/generalChapter1083.html, the draft general chapter will be published as a formal proposal open for public comment in the March-April Pharmacopeial Forum. The chapter and comments will be discussed at a Supply Chain Integrity Workshop to be convened by USP May 22-23, 2012, in Rockville, Md. “Input from the workshop and from written public comments will assist in determining whether the chapter has got the correct balance between the areas covered and the depth of guidance provided for each area,” wrote Dr. Eakins.

Dr. Hunt expects many comments and changes. “There may be topics we did

not think about that should be included in the chapter, or there may be items that people don’t find helpful or relevant.” He added, “USP’s goal is to provide something meaningful, which is why we really are asking for extensive input, and providing multiple forums for people to provide this to us.”

Specialty Pharmacy’s Response The specialty pharmacy market is no stranger to counterfeit medications; several initiatives in recent years have been aimed at thwarting bogus versions of these costly medications from reaching patients. In 2009, for example, Armada Healthcare partnered with XStream Technologies to provide preferred pricing for XStream’s anti-counterfeiting system, which authenticates and verifies drug products while they are still inside sealed containers as they move through various stages of the supply chain.

—George Ochoa Dr. Eakins reported no relevant financial disclosures

Class-Wide TIRF REMS Approved

T

he FDA has approved a single shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products.

According to the agency, the new shared REMS will replace the individual REMS for the drugs in this class.

All of the drugs affected (Abstral, Actiq, Fentora, Lazanda and Onsolis) are opioid analgesics indicated for breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy for underlying persistent cancer pain. Called the TIRF REMS Access Program, the new shared system will begin in March.

Pharmacy experts applauded the class-wide TIRF REMS. “The new proposal for a single REMS for TIRF products will provide consistency and easier administration of the REMS program for this class of medications,” Joan O’Rourke, vice president of specialty pharmacy operations at CVS Caremark, in Northbrook, IL, told Specialty Pharmacy Continuum. Doug Lawrence, vice president of REMS at McKesson Specialty Health, in Scottsdale, Ariz., concurred that “this is an important first step towards easing the burden on the heath care system.”

According to the FDA, the goals of the TIRF REMS Access Program are to ensure patient access while mitigating risks by including the prescribing and dispensing of TIRF medications only to appropriate patients; preventing inappropriate conversion between fentanyl formulations; and educating clinicians and patients on the potential for misuse, abuse, addiction, and overdose, among other measures.

“The main changes we expect are an easier sign-up process as pharmacies ... will not have to re-enroll as new TIRF products are added to the class,” Ms. O’Rourke noted. There also will be “more streamlined staff training as there is only one program, versus having to do training on each individual TIRF product REMS.” Until TIRF REMS is launched, prescribers, pharmacies and patients should continue to enroll in the individual REMS programs, according to the FDA. Prescribers and pharmacies already participating in an individual REMS program for at least one TIRF medication will automatically be transitioned to the new program. Clinicians who prescribe TIRF medications for use in an inpatient setting, and patients who receive them there, will not be required to enroll.

—George Ochoa

Corp Co rpor oral al Gre eg Ca Caro ro on McMa Maho hon Publishi hiing, the publisher off thi h s news wspaper,, ws is spo p nsoring a fu fund n ra rais ise er for Cpl. Greg g Ca Caro ron.

Cpl. Caron is an Ellingt gton on, Conn. Marine. He was injured ed in November in the lin ne of duty after stepp ppin ing g on an IE I D in Afg fgha hani nist ni stan an. He los ostt bo oth of his iss leg egss an nd a fing nger er, and also o broke his col olla larbone. We are ar e ra rais isin ing g fu funds to help Greg and d hi hiss fa fami mily mi ly as th they ey y fac ace ea very lon ong reco ove v ry.

If you would like to help, please visit www.gr g eg gr egca ca aro ronf nfou f nd dat atio tio ion n.co n. com.

If you wou ould like to donate, ple lea ase ma ail che heck ck cks ks to: Greg Caron on Foundation P.O P. O. Box 262 Ellingto to on, CT 06029 Checks can be made de e payable to: Greg Caron Family Fu Fund n Please indicate McMahon Publishing on the sub bjec je t line of your check ch che heck so the family knows where the donation cam am me from.

P ase Ple se note, contr ntribu ibuti tio ons n to this fund are not tax-deduc uc ctib ti le.

24

Specialty Pharmacy Continuum • Winter 2012

POLICY

Focusing on high-cost oncology drugs can be huge cost-saver

A Primer on Patient Assistance Programs Jeff Klaus, PharmD

Ali McBride, PharmD, MS, BCPS

Clinical Pharmacy Specialist Hematologic Malignancies/Stem Cell Transplant Barnes-Jewish Hospital St. Louis, Missouri

Clinical Pharmacy Specialist Barnes-Jewish Hospital St. Louis, Missouri

I

requiring high-cost drug therapies.

Pharmaceutical companies are shifting the focus of new drug research.

Historically, these organizations have relied on blockbuster therapies to treat many people for common chronic disease states, such as cardiovascular disease and diabetes mellitus. While research is continuing in these areas, pharmaceutical companies are increasingly shifting their focus to highly sophisticated, targeted therapies that serve smaller groups of patients. The field of targeted oncology

n an era of changing economic times and health care uncertainty, patients are increasingly facing the challenge of how to pay for the rising costs of their medications. In 2009, it was estimated that more than 43 million people were living in poverty and 50 million did not have health insurance.1 The high cost of pharmaceutical care, coupled with an uninsured patient population, has created a large group of patients who cannot afford optimal health care; this portends a particularly worrisome outlook for patients 10

Brand

Generic

Total

drugs is growing exponentially compared with other classes of drugs.2,3 Although it is absolutely necessary to develop these new drugs if we are to advance the treatment of cancer, this advancement comes at an enormous price: In 2009, the average cost of brand-name drugs increased by 8% to 9%, with generic drugs showing a smaller increase in price (Figure).3-5 The patient’s share of costs associated with health care and medications has been increasing at a disproportionate rate to most patients’ incomes.

This increased cost is being passed on to patients in the form of increased cost or copayments.1 In some cases, these costs can be exorbitant. For example, one course of sipuleucel-T (Provenge, Dendreon) used for meta-

CPI-U

Number of brand-name drug products that had extraordinary price increases

9.2

Inflation, %

9 7

8.3 6.7

7.4

6.9

6.3 5.2

Patient Assistance Programs 5.5

5.3

4.9

4.9

4.7

5 3 0.5

0.4

0.2

2004

2005

2006

51

39

47

1 -1

static prostate cancer treatment can cost $93,000, with a resulting life extension averaging 4 months. Malignant melanoma treatment employing ipilimumab (Yervoy, Bristol-Myers Squibb) costs as much as $120,000 for an estimated benefit of 3.5 months. Dasatinib (Sprycel, Bristol-Myers Squibb/Otsuka) is an oral chemotherapy medication taken daily for the treatment of chronic myelogenous leukemia; one month of treatment can cost over $10,000, and therapy is usually continued until disease progression or the development of unacceptable toxicity. Depending on the specific insurance plan, patient copayments may be derived from tiered drug levels or percentages of the total drug cost. While some patients have access to affordable insurance coverage, in many cases, the end result of copayments seems to have changed from one that prevents inappropriate medication use to one that prohibits the continuation of optimal patient care.

0.5

0.3

0.3

2007

2008

2009

74

71

N/A

Figure. Increasing cost of brand-name and generic drugs.

Average sales price of the 219 most widely prescribed brand-name and generic drugs increased on average by 9.3%; this was the fastest growth rate in costs for brand-name drugs since 2002.

CPI-U, Consumer Price Index for All Urban Consumers; NA, not available Based on references 3-5.

To continue the treatment of patients on high-cost medications, including chemotherapy, health care professionals are increasingly turning to the aid of pharmaceutical manufacturer patient assistance programs (PAPs).

PAPs provide brand-name medications at no cost or reduced cost to patients who meet specific program criteria, including income, prescription coverage, and residence. Oral, injectable, and infused medications are available through PAPs. For intravenous medications, there are programs that supply medications for use in an outpatient infusion clinic; there also are limited PAPs that replace medications used by uninsured patients during an inpatient admission (Table).

ASHP annual projection:

2012 Drug Costs Will Rise as Much as 7%

B

ETHESDA,

MD.—Costs for medications will continue to rise in 2012 by as much as 7%, according to a report in the American Journal of Health-System Pharmacy (AJHP). In the case of specialty pharmacy drugs, a nearly fourfold higher spending increase is projected in the report, which was published online last month.

For 2012, the report forecasts a 3% to 5% increase in drug expenditures across all settings, a 5% to 7% increase in expenditures for clinic-administered drugs and a 0% to 2% increase in hospital drug spending, according to lead author James M. Hoffman, PharmD, MS, BCPS, associate member, pharmaceutical sciences, medication outcomes and safety officer, Pharmaceutical Services, St. Jude Children’s Research Hospital, Memphis, Tenn.

The increases are influenced by a variety of factors, including drugs in development, the introduction of new drugs in the marketplace, the growing availability of generic drugs, the continuing problem of drug shortages and the complex issues surrounding the use of biosimilars, Dr. Hoffman and his colleagues reported (DOI 10.2146/ajhp110697).

The authors identified two distinct patterns of drug expenditures:

1. A dominant trend of substantial moderation in expenditure growth for widely used drugs, primarily due to the ongoing introduction and wide use of generic medications, which accounted for 78% of all retail prescriptions dispensed at the end of 2010.

2. A second pattern of significant increases in expenditures for specialized medications, particularly in the outpatient setting as growth in prescription drug expenditures for clinic-administered drugs (such as cancer treatments) consistently outpaces growth in total expenditures.

Data from Express Scripts show the largest projected increase in specialty drug spending, according to the report. The pharmaceutical benefits management company projects that 2012 versus 2011 spending on specialty drugs will increase by 26.5%.

The AJHP report also analyzed drug spending based on practice sites. Growth in drug expenditures in clinics grew by 6% from 2009 to 2010, according to the report. Hospital drug expenditures increased 1.5% from 2009 to 2010; through the first nine months of 2011, hospital drug expenditures increased by 0.3% compared with the same period in 2010, noted Dr. Hoffman, who is also associate professor of clinical pharmacy, College of Pharmacy, University of Tennessee Health Science Center, Memphis.

—Based on a press release from ASHP

25

Specialty Pharmacy Continuum • Winter 2012

POLICY

Until there is an efficient method for providing complete health care coverage for all patients, it will be important for members of the health care team to be aware of patient access to medications through these programs.

The first step to providing uninsured patients with the optimal therapy is to match the PAP with the patient’s current financial and insurance situation. Enrolling patients in these programs can be time-consuming because of wide variations in eligibility require-

ments. Depending on the source of funding for the PAP, eligibility criteria for specific medications are established by either the manufacturer or charitable organizations.

The process of enrolling patients may include the completion of application forms, reporting of a patient’s health insurance coverage, assets, salary, liabilities, Social Security benefits, and proof of income such as federal tax returns or W-2 forms. Once the enrollment paperwork is completed and submitted to the

PAPs, the turnaround time will vary.

In some cases, it can be as quick as the same day, but most programs take from 5 business days to 6 weeks to process and receive medications. The downside of many of these programs is that the application process can be rather nebulous. Furthermore, as health care costs rise and these programs increase in number, it is likely that navigation of program loopholes will become more difficult, especially because a uniform application process does not exist.

Table. Selected Industry-Sponsored Patient Assistance Programs Patient Assistance Program(s)

Sponsoring Organization

Examples of Covered Drugs

AZ&Me Prescription Savings Program

AstraZeneca www.astrazeneca-us.com/ help-affording-your-medicines

Arimidex, Faslodex, Zoladex

ASAP Program Allos Support for Assisting Patients

Allos www.getasapinfo.com

Folotyn

The Safety Net Foundation

Amgen www.amgenassistonline.com

Aranesp, Epogen, Neulasta, Neupogen, Vectibix, Xgeva

NexCCAP

Bayer http://nexavar-us.com/scripts/pages/en/rcc/ patient-assistance-and-support/nexccap/

Nexavar

Destination Access

Bristol-Myers Squibb http://www.destinationaccess.com/index.aspx

Erbitux, Ixempra, Sprycel, Yervoy

Celgene Patient Support

Celgene www.celgenepatientsupport.com

Abraxane, Istodax, Revlimid, Thalomid, Vidaza

CORE: Cephalon Oncology Reimbursement Expertise

Cephalon www.cephalononcologycore.com

Treanda, Trisenox

The Eisai Reimbursement Resources

Eisai www.eisaireimbursement.com

Aloxi, Dacogen, Fragmin, Gliadel, Halaven, Ontak

Lilly Patient One

Eli Lilly www.lillytruassist.com

Alimta, Gemzar

Genentech Access Solutions

Genentech, Inc. www.genentechaccesssolutions.com

Avastin, Herceptin, Rituxan, Pegasys, Pulmozyme, Tarceva, Xeloda

Genzyme Patient Assistance

Genzyme Corporation www.genzymeoncology.com http://www.genzyme.com/healthcare/ services_reimbursement.asp

Aldurazyme, Cerezyme, Fabrazyme, Hectoral, Renagel/Renvela, Campath, Clolar, Fludara, Leukine, Mozobil, Thyrogen

Commitment to Access, CARES by GSK

GlaxoSmithKline http://www.commitmenttoaccess.com/ index.html http://www.caresbygsk.com/hcp.html

Arranon, Arzerra, Bexxar, Hycamtin, Promacta, Tykerb, Votrient

The ACT Program

Merck & Co. www.merck.com/merckhelps

Emend, Intron A, Gardasil, Noxafil, Pegintron, Sylatron, Temodar, Zolinza

Velcade Reimbursement Assistance Program

Millennium Pharmaceuticals, Inc www.velcade.com/payingfortreatment.aspx

Velcade

Novartis Patient Assistance NOW, EPASS Prescription and Reimbursement

Novartis Pharmaceuticals http://www.patientassistancenow.com/ index.jsp

Affinitor, Exjade, Gleevec, Sandostatin LAR Depot, Tasigna, Zometa

First Resource, Pfizer Pfriends

Pfizer www.pfizerhelpfulanswers.com

Aromasin, Camptosar, Ellence, Emcyt, Idamycin, Neumega, Sutent, Torisel, Xalkori, Zinecard

In some cases, application to a PAP can be initiated by the patient; however, action by the prescribing physician or the health care team is required to complete the application. While oncology practices would undoubtedly jump at the chance to provide the necessary therapy to their patients at a reduced and affordable cost, most have not yet created a systematic, organized approach to identifying the PAP that will provide the most assistance to each patient. Some oncology practices that have taken this step have identified a point person in the pharmacy department or have outsourced this role to a PAP manager to streamline the process.

In many community oncology offices, a nurse has been assigned the responsibility of assisting patients with PAPs. In other cases, PAPs may be delegated to companies, such as McKesson and Cardinal, that run the program for a percentage of the reimbursed amount.

Whatever the approach, heightened awareness of such programs is crucial for the optimal provision of treatment in the face of ever-rising health costs.

Conclusion As drug development increasingly shifts to targeted therapies, response rates will continue to improve; but at the same time, health care costs will rise.

The effect of current health care reform on the individual patient remains to be seen. It seems reasonable to assume that widespread and affordable access to vital drugs will not be secured by government agencies in the near future.

It will remain the responsibility of the health care team to ensure that patients have access to the drugs they need for optimal treatment. PAPs can be a valuable tool to facilitate that access.

References

PACT+Provider Portal

Sanofi Patient Assistance Programs www.pactplusonline.com

Eligard, Elitek, Eloxatin, Taxotere

1. Kaiser Family Foundation. Family health premiums rise 3 percent to $13,770 in 2010, but workers’ share jumps 14 percent as firms shift cost burden. http://www.kff.org/ insurance/090210nr.cfm. Accessed November 15, 2011.

2. The costly war on cancer. New cancer drugs are technically impressive. But must they cost so much? The Economist. http://www.economist.com/node/18743951?story_id=18743951.

Accessed November 15, 2011.

3. Medco R&D Directions. 2010 Drug Trend Report. http://www.drugtrend.com/art/drug_ trend/pdf/DT_Report_2010.pdf. Accessed November 28, 2011.

4. US Government Accountability Office.

Report to Congressional Requesters.

Brand-name prescription drug pricing.

Lack of therapeutically equivalent drugs and limited competition may contribute to extraordinary price increases. http:// www.gao.gov/new.items/d10201.pdf.

Accessed November 28, 2011.

5. US Department of Labor. Bureau of Labor Statistics. Consumer Price Index All Urban Consumers U.S. City Average, All Items 198284=100. ftp://ftp.bls.gov/pub/special.requests/ cpi/cpiai.txt. Accessed November 28, 2011.

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Specialty Pharmacy Continuum • Winter 2012

POLICY

FDA Approves Updated Indication for Gleevec New labeling extends treatment to 36 months for certain GIST patients after surgery

O

n Jan. 31, the FDA approved a new indication for Gleevec (imatinib mesylate, Novartis) for use in certain adult patients following surgical removal of KIT (CD117)-positive gastrointestinal stromal tumors (GIST).

The new labeling recommends 36 months of treatment with Gleevec after surgery in adult patients with KIT-positive GIST who meet the risk for recurrence inclusion criteria of the pivotal trial. The 36-month treatment regimen was shown to improve recurrence-free survival (RFS) and overall survival (OS) in patients with KIT-positive GIST compared with 12 months of treatment.

The new approval is based on data

from an international, multicenter, open-label Phase III clinical trial (SSG XVIII) conducted by the Scandinavian Sarcoma Group and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie. The primary end point of the study was to compare, within the first five years, RFS in patients with a greater than 50% estimated risk for GIST recurrence following diagnosis and treatment with adjuvant Gleevec for either 12 or 36 months. Results of the study revealed that RFS was longer for patients assigned to receive 36 months of Gleevec after surgery compared with those who received 12 months of treatment, for a 54% reduction in risk for GIST recurrence (hazard ratio [HR],

0.46; 95% confidence interval [CI], 0.32-0.65; P<0.0001). Additionally, OS was longer in the 36-month treatment group, which resulted in a 55% reduction in the risk for death (HR, 0.45; 95% CI, 0.22-0.89; P=0.0187). Gleevec manufacturer Novartis provided funding for the study.

Gleevec was originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002.

In 2008, Gleevec was granted accelerated approval for adjuvant use for the treatment of patients with GIST who had had potentially curative resection (surgical removal) of GIST, but who had an increased risk for recurrence.

Approval for the metastatic GIST indi-

cation also was granted in 2008.

“The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Although originally approved in the metastatic disease setting, this subsequent trial has demonstrated that longer use of Gleevec can prolong patients’ lives in earlier disease settings.”

First Drug To Target Defective Cystic Fibrosis Protein Okayed

T

he FDA has approved ivacaftor (Kalydeco, Vertex Pharmaceuticals Inc.) for the treatment of people with cystic fibrosis (CF) aged 6 years and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane regulator (CFTR) gene. Approximately 1,200 people in the United States, or 4% of those with CF, are believed to have this mutation.

The approval of ivacaftor was based on data from two, 48-week, placebocontrolled, Phase III studies involving 213 patients who had CF and at least one copy of the G551D mutation. One study, of patients aged 12 years and older, showed that improvement in lung

function from baseline through week 24 (primary end point) was 10.6 percentage points higher among those treated with ivacaftor compared with those given placebo. In the second study, which evaluated that same primary end point among children aged 6 to 11 years, those treated with ivacaftor had an improvement in lung function that was 12.5 percentage points higher than that of the placebo group.

Patients treated with ivacaftor in these studies showed improvements in other disease measures, including weight gain and certain quality-of-life measurements. Patients who received ivacaftor underwent significantly fewer

pulmonary exacerbations and discontinued treatment less frequently because of adverse events than did patients in the placebo groups. Common adverse events in the treatment groups included headache, upper respiratory tract infection, stomach pain and diarrhea.

Kalydeco will be available via “a limited distribution network that ships directly to specialty pharmacies that focus on servicing CF patients,” a spokeswoman for Vertex told Specialty Pharmacy Continuum. “We will also be [using] a second model where wholesalers will distrubute [the drug] to certain pharmacies outside this network; however, we expect the majority of pre-

scriptions to flow through the specialty pharmacies.”

Axitinib Approved for Advanced Renal Cancer

T

he FDA has approved the oral kinase inhibitor axitinib (Inlyta, Pfizer) for treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy, according to press releases from the FDA and Pfizer.

The approval is based on data from a randomized, open-label, multicenter clinical trial of 723 patients whose disease had progressed on or after treatment with a prior systemic therapy.

Axitinib significantly extended progression-free survival (PFS; P<0.0001), resulting in a median PFS of 6.7 months

compared with 4.7 months ths with a standard treatment, t, sorafenib (Nexavar, Bayer// Onyx Pharmaceuticals).

The most common adverse events observed in greater than 20% of patientss receiving axitinib were diarrrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia, weight loss, vomiting, asthenia and constipation. Cases of arterial and venous thrombosis,

hemorrhage, gastrointestinal hemo perforation and fistula, some per fatal, have been reported. fa Axitinib should be used A with caution in patients who are at increased risk for or who have a history of these events.

Axitinib also should not be used in patients with evidence of untreated brain metastasis or rrecent active gastrointestinal bleeding. Additionally, tin blood pressure should be well bloo

controlled prior to initiating axitinib.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., commented in a statement. “Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”

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Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care

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The APhA Complete Review for Pharmacy

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