Spring 2014 by McMahon Group

Bridging the gap between the hospital and alternate-site care Volume 3 • Number 2 • Spring 2014 • specialtypharmacycontinuum.com

In This Issue Ask the Expert

Elizabeth Whalley Buono offers takeaways from the recent international summit on adherence.

Obamacare May Raise Patient Costs For Specialty Drugs

Ensuring mutual benefit can be tricky

In ACO Dance, Who Leads, Who Follows?

atients who rely on expensive specialty drugs to treat their rare and complex conditions may be forced to pay a steep percentage of the drug’s cost in lieu of a traditional, fixed copay if they are in an Affordable Care Act (ACA) exchange health plan, according to specialty pharmacy experts. Despite the allure of lower monthly premiums with some of the exchange plans, consumers should brace themselves for higher deductibles and unpredictable out-of-pocket (OOP) costs that are increasing underinsurance and forcing some patients to abandon their new

Policy

Specialty distributors are ready in wake of Otezla approval.

Clinical

In this issue’s Disease State Spotlight, Diplomat’s Hetty Lima provides an overview of hemophilia management.

•

see PATIENT COSTS, page 10

Operations & Mgmt

Ensuring temperature integrity of specialty drugs, Part 2 of a Series

Educational Review Medication Errors: A Year in Review See insert after page 28.

Corporate Spotlight Omnicare Specialty Care Group

See page 21.

pecialty pharmacy hasn’t been a big player in accountable care organizations (ACOs) so far, but that could change very soon, said Leigh Ann Bruhn, the director of reimbursement for health care consultancy Avalere Health, during the most recent of a series of webinars on what the growth of ACOs means for specialty pharmacy. There are now more than 500 ACOs in the United States—a number that is steadily increasing, according to a Premier Inc, survey of hospital executives released in December 2013. (The survey estimates that about half of all hospitals will be participating in an ACO by the end of 2014). These networks of doctors, hospitals and health systems, and other health care providers—usually with a primary care physician or practice at the hub—have a “pool” of people for whose health care needs they are jointly accountable. There are financial incentives for keeping patients healthy and out

of the hospital—carrots if you meet certain benchmarks on quality, prevention and costs, sticks if you don’t. During the March 19 webinar, cohosted by Avalere, Armada Healthcare and the Specialty Pharmacy Association of America, expert panelists focused on strategies for integrating specialty pharmacy into ACOs.

Latest Hepatitis C Guidelines Raise Payor Concerns

“ACOs and ACO-like entities are really looking for partners that can help them achieve quality goals, but pharmacy is not necessarily top of mind for them,” Ms. Bruhn noted during the webinar. The managed care organizations—especially the Medicare ACOs—are focused instead on partners they think can help them deal effectively with hot-button issues such as hospital readmission rates, which can result in big penalties when they are higher than expected.

Tampa, Fla.—New guidelines for hepatitis C treatment issued at the end of January—the first to incorporate the antiviral agents sofosbuvir and simeprevir, which were approved by the FDA at the end of 2013—have many payors in need of antianxiety medications of their own. A lack of clear patient selection criteria for the new medications and a projected $600 million bump in annual drug costs for larger plans that agree to cover the costly drugs are among the reasons why the treatment guidelines—by the American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA) and the International Antiviral Society-USA (IAS-USA)—are giving payors the jitters.

see ACO DANCE, page 12

see HEP C GUIDELINES, page 8

Collaborating on Quality

•

Now Available: Brand New Specialty Pharmacy News iPad App

CIDP, PIDD, and ITP In the treatment of CIDP, PIDD, and ITP...

SEIZE THE DATA, SEIZE THE DAY Proven efﬁcacy in 3 FDA-approved indications1 CIDP

PIDD

ITP

Chronic inﬂammatory demyelinating polyneuropathy

Primary immunodeﬁciency disease

Idiopathic thrombocytopenic purpura

All immune globulin (IG) formulations are not the same. Consider your patient’s risk factors when choosing an IG therapy.

Product features1 No sugar

Close to physiologic osmolality

Low infusion volume

Only trace amounts of sodium

Optimal pH

Low IgA content

Important Safety Information GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency disease (PIDD), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting 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 IVIG 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 patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity. Severe hypersensitivity reactions may occur with IVIG products, including GAMUNEX-C. In case of hypersensitivity, discontinue GAMUNEX-C infusion immediately and institute appropriate treatment. Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C. There have been reports of noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]), hemolytic anemia, and aseptic meningitis in patients administered with IVIG, including GAMUNEX-C. 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. Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the CreutzfeldtJakob disease (CJD) agent. Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis. If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient’s serum. 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 PIDD) and infusion-site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PIDD); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP). Please see brief summary of GAMUNEX-C full Prescribing Information on adjacent page. Reference: 1. GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) Prescribing Information. Grifols; 2013.

January 2014

GX22-0114

GAMUNEXÂŽ-C

C ?6+8685:+/4+3/' =/:. 8+9;2:'4: ).'4-+9 /4 9+8;3 </9)59/:? '4* +2+):852?:+ /3('2'4)+9 3'? 5));8 /4 6':/+4:9 8+)+/</4- # :.+8'6? Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified C !.853(59/9 .'9 5));88+* /4 6':/+4:9 8+)+/</4- # :.+8'6? 54/:58 6':/+4:9 =/:. 145=4 8/91 ,'):589 ,58 :.853(59/9 )549/*+8 HIGHLIGHTS OF PRESCRIBING INFORMATION ('9+2/4+ '99+993+4: 5, (255* </9)59/:? ,58 :.59+ ': 8/91 5, .?6+8 </9)59/:? These highlights do not include all the information needed to use GAMUNEXÂŽ-C safely and effectively. See full prescribing C 9+6:/) +4/4-/:/9 ?4*853+ .'9 (++4 8+658:+* =/:. information for GAMUNEX-C. " $ '4* 5:.+8 # :8+':3+4:9 +96+)/'22? =/:. ./-. *59+9 58 8'6/* /4,;9/54 GAMUNEX-C, [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] C +352?:/) '4+3/' )'4 *+<+256 9;(9+7;+4: :5 # :.+8'6? *;+ :5 +4.'4)+* 9+7;+9:8':/54 54/:58 6':/+4:9 ,58 .+352?9/9 '4* Initial U.S. Approval: 2003 .+352?:/) '4+3/' WARNING: THROMBOSIS, RENAL DYSFUNCTION C 54/:58 6':/+4:9 ,58 6;2354'8? '*<+89+ 8+'):/549 :8'49,;9/54 and ACUTE RENAL FAILURE 8+2':+* ');:+ 2;4- /40;8? %! & See full prescribing information for complete boxed warning. C #52;3+ 5<+825'* E $3=:8-:>4> 8,y occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

E := ;,?409?> at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. E "09,7 /Csfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. E "09,7 /Csfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX-C does not contain sucrose. E := ;,?409?> at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.

C " $ /9 3'*+ ,853 .;3'4 62'93' '4* 3'? )54:'/4 /4,+):/5;9 '-+4:9 + - </8;9+9 '4* :.+58+:/)'22? :.+ 8+;:@,+2*: '15( */9+'9+ '-+4: C " $ /9 45: '6685<+* ,58 9;();:'4+5;9 ;9+ /4 ! 6':/+4:9 ;+ :5 ' 65:+4:/'2 8/91 5, .+3':53' ,583':/54 *5 45: '*3/4/9:+8 " $ 9;();:'4+5;92? /4 6':/+4:9 =/:. ! C '99/<+ :8'49,+8 5, '4:/(5*/+9 3'? )54,5;4* 9+8525-/) :+9:/4- ----------------------------ADVERSE REACTIONS ---------------------------+8/5;9 '*<+89+ 8+'):/549 =./). 5));88+* /4 :.+ )2/4/)'2 :8/'29 =+8+ '4 +>')+8(':/54 5, ';:5/33;4+ 6;8+ 8+* )+22 '62'9/' /4 54+ 9;(0+): '4* 6;2354'8? +3(52/93 /4 54+ 9;(0+): =/:. ' ./9:58? 5, !.+ 359: )53354 '*<+89+ 8+'):/549 5(9+8<+* /4 âą&#x2013; 6':/+4:9 =+8+ PI 4tra<enous +'*').+ )5;-. /40+):/54 9/:+ 8+'):/54 4';9+' 6.'8?4-/:/9 '4* ;8:/)'8/' ;();:'4+5;9 4,;9/54 9/:+ 8+'):/549 .+'*').+ ,':/-;+ '8:.8'2-/' '4* 6?8+>/' ITP +'*').+ <53/:/4- ,+<+8 4';9+' (')1 6'/4 '4* 8'9. CIDP +'*').+ ,+<+8 )./229 .?6+8:+49/54 8'9. 4';9+' '4* '9:.+4/'

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics Inc. at 1-800-520-2807 or FDA at 1-800-FDA-1088 or GAMUNEX-C is an immune globulin injection (human) 10% liquid www.fda.gov/medwatch. indicated for treatment of: ----------------------------DRUG INTERACTIONS ---------------------------C 8/3'8? ;358'2 33;45*+A)/+4)? C !.+ 6'99/<+ :8'49,+8 5, '4:/(5*/+9 3'? :8'49/+4:2? /4:+8,+8+ =/:. C */56':./) !.853(5)?:56+4/) ;86;8' ! :.+ 8+96549+ :5 2/<+ </8'2 <'))/4+9 9;). '9 3+'92+9 3;369 '4* C .854/) 4B'33':58? +3?+2/4':/4- 52?4+;856':.? 8;(+22' --------------------------INDICATIONS AND USAGE -------------------------

----------------------------CONTRAINDICATIONS ----------------------------

---------------------USE IN SPECIFIC POPULATIONS ---------------------

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----------------------WARNINGS AND PRECAUTIONS---------------------C - *+A)/+4: 6':/+4:9 =/:. '4:/(5*/+9 '-'/49: - '8+ ': -8+':+8 8/91 5, *+<+256/4- 9+<+8+ .?6+89+49/:/</:? '4* '4'6.?2'):/) 8+'):/549 '<+ +6/4+6.8/4+ '<'/2'(2+ /33+*/':+2? :5 :8+': '4? ');:+ 9+<+8+ .?6+89+49/:/</:? 8+'):/549 C 54/:58 8+4'2 ,;4):/54 /4)2;*/4- (255* ;8+' 4/:85-+4 9+8;3 8/,529 !.+8'6+;:/)9 4) )8+':/4/4+ '4* ;8/4+ 5;:6;: /4 6':/+4:9 ': 8/91 5, *+<+256/4- ');:+ +9+'8). !8/'4-2+ '81 " 8+4'2 ,'/2;8+ " /)+49+ 5

3036427/3036428-BS Revised: 9/2013

Specialty Pharmacy Continuum • Spring 2014

ASK THE EXPERT

Elizabeth Whalley Buono, RN, MBA, JD, of MWV Healthcare

Summit Joins Health Sectors To Foster Adherence C

ollaboration was the watchword at the Second Annual World Congress Summit to Improve Adherence and Enhance Patient Engagement, held in March in Philadelphia. Elizabeth Whalley Buono, RN, MBA, JD, a vice president at MWV Healthcare, the packaging solutions firm that sponsored the event, has focused on adherence issues for nearly a decade. She spoke with Specialty Pharmacy Continuum about the summit, and the need for representatives of the different health sectors to work together more closely to help patients take their medications correctly.

SPC: What was the significance of the World Congress? Ms. Whalley Buono: There’s currently a public, private and academic discussion all around adherence. This type of meeting is important because it brings together the different market segments for discussion. It was interesting to me to see the real disconnect that often exists between payors, providers and others. The different market segments

don’t always seem to know much about what the others are doing. They don’t seem to understand their challenges. SPC: Were there any “Ah, ha!” moments? Ms. Whalley Buono: Yes, it became clear that it’s not fair to demonize one market segment for this lack of mutual insight. We each get myopic in the business we’re involved in, and we don’t always understand the handoff that

needs to occur for patients to get the proper treatment. What also resonated through the panels was a recognition that we have to become more innovative. We have to demand that the benefits of our programs be substantiated, so we’re not simply investing in things because we’ve done so the past 25 years. SPC: Can you give an example of how to make innovation work for the different health sectors? Ms. Whalley Buono: Regarding electronic health records, there’s a need for whatever system goes into place to work and be interoperable for all the different segments and uses. To be valuable to providers, they have to be able to access the records, to input data. If patients have different physicians, that can be complicated. From the payor perspective, how are they going to measure performance, evaluate formulary access issues and administer reimbursement?

From the hospital perspective, they ideally need to understand what the physician is doing, and what payors are doing to run the business profitably. From the patients’ perspective, it’s nice to be able to view records and make sure they’re accurate. So you’ve got to get input from all the users in order for it to be designed optimally. SPC: Can you elaborate on the panel you moderated on measuring adherence? Ms. Whalley Buono: There are many tools used to measure patient medication adherence, but they’re meant to evaluate different things. For example, the pharmacy claims–based measures evaluate how efficiently prescriptions are being dispensed. But they don’t tell you a lot about how people are taking their medications. There were discussions on how to harness pharmacy claims data so you

•

see WHALLEY BUONO, page 9

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Volume 3 • Number 2 • Spring 2014

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RightSource Specialty Pharmacy

Managing a complex condition can be hard We help make it easier Our pharmacists, registered nurses and financial assistance specialists work together to give patients and physicians the support they need. • Support for numerous complex therapies, 24 hours a day, seven days a week • Guidance on side effects and sticking to your medication plan • Convenient mail delivery • Reﬁll reminders to make it easy to stay on track

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GCHHT98EN 0414

URAC accredited specialty pharmacy

Specialty Pharmacy Continuum • Spring 2014

POLICY

Specialty Pharmacy Accreditation: A Tool To Facilitate Achievement Champ Burgess, PharmD, MBA, BCPS

Molly Schneider, PharmD

Scott W. Savage, PharmD, MS

Pharmacy Clinical Manager UNC Medical Center UNC Shared Services Center Assistant Professor of Clinical Education UNC Eshelman School of Pharmacy Chapel Hill, North Carolina

Lead Pharmacist UNC Medical Center UNC Shared Services Center Chapel Hill, North Carolina

Associate Director of Pharmacy UNC Medical Center UNC Shared Services Center Assistant Professor of Clinical Education UNC Eshelman School of Pharmacy Chapel Hill, North Carolina

lue Cross Blue Shield of North Carolina (BCBSNC) is the largest commercial pharmacy insurance payor in the state. In July 2011, BCBSNC notified its members that beginning on Aug. 15, 2011, all self-administered specialty medications must be filled by a pharmacy within a preferred specialty pharmacy network that could help its members optimally manage their complex and chronic medical conditions, while addressing the rising costs of these specialty medications. Membership in the preferred network was contingent on several criteria, including specialty pharmacy accreditation by URAC,1 an independent, nonprofit organization that is nationally known as a leader in promoting health care quality through accreditation.2 The first preferred network was a combination of traditional retail pharmacy and large mail-order providers. At the time of the BCBSNC announcement, UNC Medical Center (UNCMC) had a retail pharmacy operation serving a predominantly (75%) low-income, uninsured population in North Carolina. Each year, within this safety-net pharmacy network, more than 3,000 patients using a UNCMC pharmacy are enrolled in an assistance program that provides in excess of $12 million in charity medications annually. To continue to provide specialty pharmacy services to insured patients and generate revenue to support its extensive pharmacy assistance programs, UNCMC sought to obtain URAC accreditation and join the BCBSNC preferred specialty network. URAC’s specialty pharmacy accredi-

tation process requires a comprehensive evaluation process that considers standards in 5 categories: core organizational quality, customer service, specialty drug management, pharmacy operations, and patient management. Accreditation takes approximately 9 to 12 months from initial application fee submission through scheduling of the final onsite visit; however, the individual site’s infrastructure lays the framework for the “building of the application” and making the rest of the accreditation process as successful as possible.3 A brief overview of URAC’s specialty pharmacy accreditation process is presented in Table 1. The process at UNCMC started with the BCBSNC announcement, at which point the medical center’s specialty pharmacy leadership team conducted financial modeling for the patients who would potentially opt to receive these services. The team assigned a fourth-year pharmacy student within its established intern program to work alongside pharmacy leadership to assess feasibility of moving forward with URAC accreditation. The UNCMC approach consisted of 3 phases (developmental, organizational, and submission) to ensure that the accreditation process was successful. Successful movement through each phase prepared UNCMC for URAC’s required onsite visit. During the developmental phase, the team developed a detailed gap analysis tool using Microsoft Excel, populating it with the 41 core pharmacy standards as well as the 55 specialty pharmacy standards with their respective weights per the URAC

tions and initiate the “organizational” phase of the URAC accreditation process. A task force consisting of pharmacy assistant directors, clinical managers, and pharmacy staff conducted weekly meetings to address each standard graded as “partial” or “none.” The task force developed ongoing action plans for each of these items and assigned responsibility to specific individuals to maintain accountability. Throughout the process, the task force created more than a dozen new policy and procedure documents

Figure. URAC gap analysis tool created to facilitate the accreditation process. Specialty Pharmacy Accreditation Guide, Version 2.0. Compliance at the time of the gap analysis was graded as “full,” “partial,” or “none.” An example of the gap analysis tool is shown in the Figure and a description of the grading system is presented in Table 2. Each quality standard was comprised of up to 12 individually weighted criteria. The standards were all measured for compliance and given a numerical score that contributes to the overall accreditation rating. In total, there were more than 400 weighted criteria included in the gap analysis tool, with only 42 (11%) graded as being in “full” compliance by UNCMC at the start of the accreditation process. Pharmacy leaders then created a team to specifically target day-to-day opera-

Table 1. The URAC Specialty Pharmacy Accreditation Process Phase

Description

Time Period

Building the application

• Completion of application forms and supplying supporting documentation.

Site-specific

Desktop review

• Analysis of applicant documentation for compliance with the intent of URAC standards. • Review summary provided with potential for multiple clarifications as needed pending issues defined.

3-6 mo

Onsite review

• Onsite review to verify compliance with the standards. • Reviewers conduct audits, analyze personnel and credentialing files, review education and quality management programs.

Committee review

• URAC’s accreditation and executive committee reviews written summary documenting the findings of the Desktop and Onsite reviews.

and formed partnerships with ancillary medical center departments, including telecommunications, marketing, and information security. The URAC gap analysis and its required 96 standards and 400 criteria appeared overwhelming when viewed in their entirety. To better manage this assignment, the task force split the 5 URAC standard categories among its members and assigned timelines for completion. The group met at least weekly to ensure that members responsible for each assignment were on track. Once they completed the gap analysis spreadsheet and all standards were coded as “green” for full compliance, citations were added to notate which policy or procedure document was used to fulfill the standard. One task force member was responsible for uploading all the required documents and citations to the URAC accreditation portal. This individual also was responsible for being the main point of contact for URAC reviewers if there were any questions or if clarifications were needed regarding any submitted information. Once all the submitted documentation was accepted by URAC, the UNCMC task force began preparing for the required onsite visit, during which 2 accreditation reviewers from URAC spend an entire day interviewing staff, monitoring workflow, and verifying that UNCMC was abiding by its submitted

Specialty Pharmacy Continuum • Spring 2014

POLICY

policy and procedure documents according to the URAC standards. To facilitate this process, the task force prepared organized and indexed binders with every policy and procedure document submitted to URAC. These binders were used throughout the day of the onsite visit to easily reference policies or procedures when questions arose. The URAC reviewers appreciated this level of organization, and at the end of the onsite visit recommended that UNCMC receive full URAC specialty pharmacy accreditation. With this recommendation, UNCMC

entered the final phase of accreditation, receiving “full accreditation” effective Jan. 1, 2014.

Table 2. URAC Gap Analysis Grading System Grade

Color

Criteria

Full

Green

Current medical center policy/procedure existed and completely satisfied the standard.

Partial

Yellow

Current medical center policy/procedure existed but did not completely satisfy the standard.

None

Red

No current policy/procedure existed to satisfy the standard.

References 1. BCBSNC establishes network of accredited specialty pharmacies. http://mediacenter. bcbsnc.com/news/bcbsnc-establishes-networkof-209717. Published July 1, 2011. Accessed January 23, 2014. 2. About URAC. https://www.urac.org/abouturac/about-urac. Accessed January 23, 2014. 3. Accreditation programs. http://www.urac.org/ accreditation-and-measurement/accreditationprograms. Accessed January 23, 2014.

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HEP C GUIDELINES continued from page 1

In a panel at the Academy of Managed Care Pharmacy’s Specialty Pharmacy Conference, in April, representatives from Premera BlueCross, Aetna and MedImpact expressed concerns about several aspects of the new guidelines, but particularly their recommendation of a costly sofosbuvir (Sovaldi, Gilead) plus simeprevir (Olysio, Janssen) combination as an option for HCV genotype 1 patients who cannot take interferon (IFN).

In November, findings from the COSMOS (Combination Of SiMeprevir and sOfosbuvir in HCV genotype 1 infected patientS) trial presented at the Liver Meeting indicated that a 12-week all-oral combination of sofosbuvir plus simeprevir led to sustained virologic response in 93% of genotype 1, null-responder patients with mild to moderate liver fibrosis, working as well as a longer course of treatment or triple therapy with ribavirin. But the FDA has not yet approved the regimen, and many argue that the cohort was too small—about 25 people in each

arm—to influence clinical practice. “We don’t have a problem with Sovaldi or Olysio,” said Steven Avey, RPh, MS, the vice president of specialty pharmacy for MedImpact. “We believe the evidence shows that these are effective treatments, and that the efficacy is higher than with [telaprevir (Incivek Vertex)] and [boceprevir (Victrelis, Merck)]. But with drugs that cost $1,000 a pill, the COSMOS data had insufficient numbers of patients in each study arm to make a good recommendation for the combination of the two protease inhibitors together.”

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A report from the California Technology Assessment Forum (CTAF), finalized in early April, estimates the average yearly increase in treatment costs for patients moved to the newer agents to be approximately $70,000. CTAF further estimates that in an employer-sponsored group health plan with 1 million members and an assumed underlying infection rate of 1.7%, 17,000 patients would be infected with hepatitis C. “If even 50% of this population comes forward for treatment, the immediate one-year budget impact for the plan would be estimated to be nearly $600 million.” Treating 50% of the infected patients throughout California with newer regimens, CTAF estimated, would cost more than $50 billion. CTAF ultimately rated the new regimens a “low” value for the health care system from the perspective of a Medicaid program, which has led many California plans to refuse to cover the sofosbuvir-simeprevir combination, said panelist Steven D. Pearson, MD, MSc, the President of the Institute for Clinical and Economic Review. Indeed, according to Mr. Avey, some Medicaid plans have decided that they will not pay for either of the newer agents except under very rare circumstances, such as hepatocellular carcinoma. “Then on the other end, there are some groups with generous benefits that don’t want to disrupt their members, so they will pretty much pay for anything that has evidence to show it’s effective,” he said. “And in the middle, you have a lot of people like us who are concerned about the guidelines but have elected to pretty much mirror their recommendations in our policies. For interferon-ineligible type 1 patients, we probably would have indicated [sofosbuvir] for 24 weeks with ribavirin and skip interferon, but because of the guidelines, we’re allowing [sofosbuvir] plus [simeprevir] for now.” Aetna’s current Pharmacy Clinical Policy Bulletin for HCV also allows the sofosbuvir-simeprevir combination for IFNineligible patients. Premera Blue Cross does as well, said John Watkins, PharmD, MPH, the pharmacy manager for formulary development but only for patients who cannot wait to be treated until subsequent regimens are available, such as those with advanced-stage fibrosis. Many plans are taking a very careful look at which patients are being presented as IFN-ineligible. “That number

Specialty Pharmacy Continuum • Spring 2014

POLICY

is higher than we anticipated,” Mr. Avey said. “I’m not saying doctors are being inaccurate in their assessment, but to qualify as interferon-ineligible, we’re looking for someone with comorbidities like clinical depression that would rule out interferon, or someone who has tried and failed interferon previously due to serious side effects. We rely on physician reporting for that information, but, given the numbers we’re having, we’re considering whether or not to require some kind of documentation in the patient’s chart that they were previ-

ously tried on interferon.” The panelists also noted that the AASLD guidelines do not take into consideration cost, or which patients need to be treated. “The [AASLD-IDSA] committee was asked only, ‘What is the best clinical approach today with the new agents?’” Mr. Avey said. “But what we’re after is in the real world where you only have so much money to spend, where do these agents line up? We know that around 20% of HCV patients never develop any chronic disease or have any significant

problem from having the virus on board, so before initiating any of these treatments, we would want to see evidence that they are, indeed, having some damage done to the liver.” An amendment to the AASLD guidelines, incorporating considerations such as cost and who needs to be treated, is expected in six months. “We’re all waiting eagerly for that, and for continued follow-up data from the clinical trials,” Mr. Avey said. And of course, the hepatitis C treatment landscape is due for more seis-

mic change in 2015, with multiple new agents expected, including Bristol-Myers Squibb’s daclatasvir, and Gilead’s coformulation of sofosbuvir with the investigational NS5A replication complex inhibitor ledipasvir, which made headlines with a greater than 90% response rate in data presented in early April at the European Association for the Study of the Liver meeting, in London. So, whatever decisions payors make now about the new agents, they’ll be due for revisiting before the ink is dry. —Gina Shaw

ASK THE EXPERT

WHALLEY BUONO continued from page 4

can monitor trends. But that’s not giving you the type of information you need to understand how to address an individual patient’s needs. For example, although you can monitor dispensing trends, there has also got to be a faceto-face dialogue between providers and patients to design adherence programs that move the needle. At the heart of this is one human being not taking their medications correctly. There isn’t one simple fix to address nonadherence. SPC: What was the most important takeaway for pharmacists? Ms. Whalley Buono: Just over the last couple of years, there has been a real transformation in how the industry considers the practice of pharmacy to be an important part of the total equation. The adherence programs proving to be the most effective involve pharmacists in a critical role in design and implementation. The pharmacist has the best opportunity to engage with patients on a recurring basis, and to assist patients in taking their medications correctly. There are frustrations about how pharmacists don’t have as much time as they need to do that, but now the tables are turning. Walgreens, CVS and other large pharmacies are recognizing the importance of providing pharmacists with the time, appropriate atmosphere and tools they need. Two physicians on the panel were talking about the accountable care organization model, saying the greatest success they have had is integrating clinical pharmacists into their medical practice. When patients leave their office and are able to immediately speak with a pharmacist to answer their questions, it’s very helpful. It’s a clear example of how when the different parties work together, it benefits patients. —Dana Hawkins-Simons

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continued from page 1

prescriptions, according to presentations at the National Association of Specialty Pharmacy (NASP) 2014 Specialty Pharmacy Expo, in Tampa, and studies by Avalere Health and Prime Therapeutics. Although the cost structures vary between the exchange plans, patients may face this issue whether they are enrolled in bronze, silver, gold or platinum exchange plans, according to the Avalere study (although the high coinsurance is less frequent in higher-premium platinum plans; Figure). Avalere examined 603 unique plan designs offered by 60 different carriers in 19 states to assess whether specialty medications are being put in a higher tier with a larger percentage of coinsurance, said Jenna Stento, a senior manager at Avalere. The analysis found that 59% of silver plans on exchanges across the country use coinsurance on the specialty tier instead of a fixed copay. It also found that 23% of silver plans charged coinsurance rates of at least 30% more than the cost of the drugs on the highest formulary tier, and 60% of lower-premium bronze plans apply specialty tier coinsurance greater than 30% of the drug price. “This examination highlights the

fact that patients relying on specialty medications are going to have to lay down significant finances up front until they hit the out-of-pocket cap, which is $6,350 for most people and $2,250 if that person is 200% below the federal poverty rate,” said Ms. Stento. “The fact that patients will be paying an unknown percentage will make it harder for some to plan financially, and will raise questions about access and availability.” These concerns were emphasized by a Prime Therapeutics study that found pharmacy plan members are more likely to abandon their new prescriptions as costs rise. It showed that abandonment rates became significantly higher for both multiple sclerosis (MS) and biologic anti-inflammatory (BAI) drugs when OOP costs reached $250. Further, members whose OOP costs reached $2,000 or more were 24 times more likely to abandon new MS prescriptions and 19 times more likely to abandon new BAI prescriptions than members whose OOP costs were less than $100. “This analysis indicates [that] costs may be impacting members’ ability to initiate these important treatments,” said Patrick Gleason, PharmD, BCPS, FCCP, the director of health outcomes for Prime. “Health insurers should consider these findings when designing pharmacy

■ Copayment ■ Coinsurance 0%-29% ■ Coinsurance 30%-49% ■ Coinsurance 50% or higher

Frequency of Cost-Sharing Type, %

PATIENT COSTS

100 90

16 25

7 15

7 3 28

70 60

50 40 30

20 10 0

62 41

Silver

Gold

Bronze

Platinum

Figure. Plan cost-sharing for specialty tier in exchange plan formularies. Source: Avalere PlanScape analysis of 603 plan designs in 19 states, updated Nov. 1, 2013.

benefits, and keep in mind the members’ maximum OOP cost per claim for preferred formulary specialty drugs.” There aren’t high coinsurance rates across the board for all drugs, but it’s clear that patients in the specialty tier are likely to feel the costs more acutely, said Pamela Morris, the director of syndicated research at Zitter Health

Insights. In tier 2, about 2,500 plans used copays, whereas around 800 of them used coinsurance, according to data from Zitter’s Health Insurance Exchange Monitor. However, in tier 4, the most common specialty tier, only about 650 plans are using copays and about 2,100 are using coinsurance. The heavy use of coinsurance in tier 4 indicates a

Otezla Distributors Focus on Patient Care

atient care, communication and coordination take center stage as Diplomat Specialty Pharmacy, Avella Specialty Pharmacy, Amber Pharmacy and 32 other select companies begin distributing apremilast, the first FDAapproved oral therapy for psoriatic arthritis. With the endorsement earned in March, apremilast (Otezla, Celgene) opens up a new, simplified treatment option for sufferers of this form of chronic inflammatory arthritis, which affects up to 30% of the approximately 7.5 million people in the United States with psoriasis. Apremilast controls the characteristic symptoms of psoriatic arthritis, such as joint pain, stiffness and swelling, by inhibiting phosphodiesterase 4 (PDE4), and, thereby, modulating inflammation. Three clinical trials involving 1,493 patients with active psoriatic arthritis, on which the FDA approval was based, showed that the effectiveness of apremilast was on par with available injectable and infusible biologics. In most cases, it also resulted in fewer side effects. In one of the trials, 38% of patients taking apremilast experienced at least a 20% improvement in signs and symptoms of psoriatic arthritis compared with 19% of patients on placebo ((P=0.0001).

“For those beginning therapy who may not want to be on an injectable or an infusible, they now have a third option,” said Gary Rice, RPh, MS, MBA, CSP, the vice president of clinical services at Diplomat Specialty Pharmacy. Eric Sredzinski, PharmD, AAHIP, the executive vice president of clinical affairs and quality assurance and pharmacy program director at Avella Specialty Pharmacy, also highlighted the less stringent Risk Evaluation and Mitigation Strategies program requirements for apremilast compared with other specialty drugs. He said that apremilast “is a little easier to manage for everybody as an oral agent.” Still, specialty pharmacies pledge to take steps—above and beyond the requirements of the limited distribution contract—to maximize the treatment benefits, while minimizing the potential physical and financial costs of the drug for patients.

Insurance Verification The wholesale price tag for apremilast therapy, according to Celgene, is about $22,500 per year, so it also is important to verify insurance and access any copay assistance for patients. Jo Ann Hyres, the vice president of client services and marketing at Amber

Pharmacy, noted that her company “verifies insurance and conducts a comprehensive benefits investigation within two hours of receiving an [apremilast] referral.” Amber will also facilitate the process of obtaining prior authorization or financial assistance as needed, she said. At Avella, Dr. Sredzinski said, “we do a lot of work on the back end so that once the drug is prescribed and found to be clinically appropriate, we can get the patient access to that drug.” Depending on the patient’s insurance and financial situation, Avella may help him or her obtain a copay card, use assistance from a 501c(3) foundation or obtain free medication from the manufacturer. Mr. Rice noted that Diplomat, too, would coordinate with their service hub (Covance) for patient financial assistance or medication support based on eligibility requirements or restrictions. Upon patient initiation of therapy, Diplomat would again coordinate with the patient and either a physician or Covance on the dosing titration, Mr. Rice noted. This includes a “welcome” call to the patient from Diplomat, covering education on the disease, the medication and the titration regimen. Patient support continues throughout the course of treatment and includes monitoring for safety and efficacy of the drug.

Avella not only will provide a patient with information on possible side effects but also will take inventory of other drugs that patient may be taking as well as his or her concomitant disease status, noted Dr. Sredzinski. This helps zero in on the most likely potential concerns during treatment. “With [apremilast], weight loss, diarrhea, nausea and headaches are possibilities,” he said. “But we also want to be careful not to list all side effects [for] patients. We don’t want to flood them with information.” Should a patient report losing a number of pounds over time or suffering another side effect, he said that Avella would provide an assessment on the patient and notify the provider to follow up. All adverse drug events also are reported to Celgene and, if necessary, to the FDA. Amber Pharmacy uses a proprietary, customizable platform called Excipio Therapy Management System to collect and report contract-required data and information, Ms. Hyres said. Still, the human component, according to company representatives, remains most crucial. “Patients will be continually counseled on adherence and monitored and assessed for side effects, the need for additional education and/or intervention and progress toward treatment goals.” —Lynne Peeples

Hizentra 20%

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More than 10,000 patients and providers put their conﬁdence in Hizentra 20%1

Safe, effective SCIg therapy for pediatric to geriatric riatric patients

t Weekly or biweekly (every 2 weeks) dosing t Stable steady-state IgG levels t Low infusion volume t Demonstrated safety and tolerability* t Room-temperature storage

*US Phase 3 trial results with Hizentra weeklyy dosing. g Reference: 1. Data on File. Available from CSL Behring as DOF HIZ-003.

Important Safety Information Hizentra is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI), age 2 and older. This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. WARNING: THROMBOSIS Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. For patients at risk of thrombosis, administer Hizentra at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. See full prescribing information for complete boxed warning. Please see additional Important Safety Information on reverse side and brief summary of full prescribing information for Hizentra, including boxed warning, on adjacent page.

Hizentra—

the ﬁrst and only 20% SCIg therapy t Approved for weekly or biwe weekly dosing t Stable steady-state IgG le evels week to week t Demonstrated efﬁcacy and safety in patients 2–65 years of age and older* t Low infusion volume— —delivers the same Ig dose in half the volume of 10% solutions† t No refrigeration nee eded—freedom to infuse anytime, anywhere *US Phase 3 trial results with weekly Hizentra dosing. † Based on an equivalent dosee in grams.

Learn about the MyHizentra™ Infusion Manager App at Hizentra.com! Important Safety Information (continued) Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or components of Hizentra, such as polysorbate 80. Because it contains the stabilizer L-proline, Hizentra is contraindicated in patients with hyperprolinemia. Hizentra is also contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity. Hizentra should be administered subcutaneously only. y Do not administer intravenously. IgA-deficient patients with anti-IgA antibodies may be at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of Hizentra. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration immediately and treat as medically appropriate. Monitor patients for aseptic meningitis syndrome (AMS), which has been reported with SCIg. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. Also monitor patients for clinical signs of hemolysis or transfusion-related acute lung injury (TRALI). Hizentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. The most common adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritus, vomiting, upper abdominal pain, migraine and pain. Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing. Please see additional Important Safety Information on reverse side and brief summary of full prescribing information for Hizentra, including boxed warning, on adjacent page.

Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC. Hizentra® is a registered trademark of CSL Behring AG. MyHizentra™ is a trademark of CSL Behring LLC. ©2014 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring-us.com www.Hizentra.com HIZ14-02-0007 3/2014

Specialty Pharmacy Continuum • Spring 2014

POLICY

higher cost burden to the patient for expensive specialty therapies. “We also took a look at the combined medical and pharmacy deductibles for 842 bronze plans, and the average deductible was over $5,000,” said Ms. Morris. “If you think about a patient who’s taking an oral MS product on a bronze plan, they have to pay that deductible out of pocket and then have to pay an average tier 4 coinsurance of 34%. The cost-sharing for that person is so high that some people may think twice about what they need.”

Speaking during a keynote presentation at the NASP Expo, Sandy Robinson, a vice president at Avalere, said that although the ACA is resulting in fewer underinsured patients, the payment trends associated with the exchange plans are resulting in increases in underinsurance, especially with specialty drugs. Ms. Robinson said, even with the copay programs, “there are going to be gaps.” Patrick McKercher, the president of the Patient Access Network Foundation, a nonprofit organization that provides underinsured patients with copayment

assistance, underscored the implications of this growing population of underinsured patients. “It’s a powerful dynamic that’s influencing treatment choices,” he told NASP attendees, noting that approximately 35 million patients are underinsured, and this population is “growing and significant.” With the number of these underinsured and strained patients continuously growing, the best thing for them to do is to find out what the deductible is on their plan and find out what the copay or coinsurance is for their drug, according

to Ms. Morris. “A lot of times, if someone has coinsurance their first exposure to OOP [costs] is at the pharmacy, where they may be unsure if they’ve met their deductible or if the costs are purely coinsurance,” she said. “As a patient, I would want to have an open conversation with my doctor about the plan that I have, what my plan’s cost-sharing looks like, what drug options are available and see if there are any alternatives.” —Paul Bufano, with additional reporting by Sarah Tilyou

HIZENTRA®, Immune Globulin Subcutaneous (Human), 20% Liquid Initial U.S. Approval: 2010

--------------------------------DOSAGE FORMS AND STRENGTHS-------------------------0.2 g per mL (20%) protein solution for subcutaneous injection

BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HIZENTRA safely and effectively. See full prescribing information for HIZENTRA.

-------------------------------------CONTRAINDICATIONS------------------------------------• Anaphylactic or severe systemic reaction to human immune globulin or components of Hizentra, such as polysorbate 80 • Hyperprolinemia (type I or II) (Hizentra contains the stabilizer L-proline) • IgA-deﬁcient patients with antibodies against IgA and a history of hypersensitivity

WARNING: THROMBOSIS See full prescribing information for complete boxed warning. • Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. • For patients at risk of thrombosis, administer Hizentra at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. -----------------------------------INDICATIONS AND USAGE---------------------------------Hizentra is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of primary immunodeﬁciency (PI) in adults and pediatric patients 2 years of age and older. -----------------------------DOSAGE AND ADMINISTRATION-------------------------------For subcutaneous infusion only. Do not inject into a blood vessel. Administer weekly or biweekly (every two weeks). Dosage Before switching to Hizentra, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments. Weekly: Start Hizentra 1 week after last IGIV infusion Previous IGIV dose ((in ggrams)) x 1.53 Initial weekly dose = No. of weeks between IGIV doses • Biweekly: Start Hizentra 1 or 2 weeks after the last IGIV infusion or 1 week after the last weekly Hizentra infusion. Administer twice the calculated weekly dose. • Adjust the dose based on clinical response and serum IgG trough levels (see Dose Adjustment). Administration • Infusion sites – 1 to 4 injection sites simultaneously, with at least 2 inches between sites. • Infusion volume – First infusion, up to 15 mL per site. Fifth infusion, up to 20 mL per site, then to 25 mL per site as tolerated. • Infusion rate – Up to 15 mL per hr per site. Increase to 25 mL per hr per site as tolerated.

-------------------------------WARNINGS AND PRECAUTIONS------------------------------• IgA-deﬁcient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. • Thrombosis may occur following treatment with immune globulin products, including Hizentra. • Aseptic meningitis syndrome has been reported with IGIV or IGSC treatment. • Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. • Monitor for clinical signs and symptoms of hemolysis. • Monitor for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). • May carry a risk of transmitting infectious agents, e.g., viruses, the variant CreutzfeldtJakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ------------------------------------ADVERSE REACTIONS--------------------------------------The most common adverse reactions observed in *5% of study subjects were local reactions (i.e., swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, rash, pruritus, vomiting, abdominal pain (upper), migraine, and pain. To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch. ---------------------------------------DRUG INTERACTIONS-----------------------------------The passive transfer of antibodies may interfere with the response to live virus vaccines, and lead to misinterpretation of the results of serological testing. ----------------------------------USE IN SPECIFIC POPULATIONS---------------------------• Pregnancy: No human or animal data. Use only if clearly needed. • Pediatric: No speciﬁc dose requirements are necessary to achieve the desired serum IgG levels. Based on September 2013 version

Specialty Pharmacy Continuum • Spring 2014

POLICY

ACO DANCE continued from page 1

Of course, specialty pharmacy has a big role to play in keeping readmission rates down—it’s all a matter of making the case to the ACO that your specialty pharmacy can help them achieve such goals, Ms. Bruhn noted. Specialty pharmacy is stronger—or at least perceives itself to be—in some key ACO domains than others, according to an online survey of participants taken during the webinar. Most of the respondents indicated that they saw specialty pharmacy being very prepared to partner with ACOs in the area of medication adherence, but less so in outcomes, data sharing, care coordination, integration and especially whole patient health (Figure). “We know that specialty pharmacy providers do set up great care protocols and collect data,” Ms. Bruhn said. “But to what extent is this data being analyzed, to connect the dots between our strength in medication adherence, and the actual quality of care outcomes? There’s an opportunity there.”

Documentation Still Lacking Specialty pharmacists may already be doing more “whole patient health” than they may think, according to Gary Freeman, RPh, MBA, the vice president of pharmacy for Amerinet. That holistic approach “is something they do on a daily basis, although it may not be promoted outside their own pharmacy,” Mr. Freeman said. “But just like with comparative effectiveness data, specialty pharmacies need to show measurable impact on patient outcome. That’s key for health systems and ACOs, and it’s true that we’re not quite where we need to be on that. ACOs are very focused on cost and quality of care, which is an area where specialty pharmacy can contribute. We just need to be able to make that case with data.” Specialty pharmacies interested in partnering with ACOs should make strategic decisions about where they will invest, from both the human resources and technology standpoints. “You should be challenging yourself to define repeatable processes and have measurements in place, and strive toward a consistent level of service and impact on patient health—as well as the ability to measure that,” said Randy Falkenrath, the senior vice president of specialty pharmacy at CVS Caremark. That almost certainly means improving information technology infrastructure. “Specialty pharmacies need to enhance their ability to interact on a timely basis with ACOs and health care systems, to demonstrate their capabilities in getting that real-time data back and forth between both organizations,”

‘You should be challenging yourself to define repeatable processes and have measurements in place, and strive toward a consistent level of service and impact on patient health ….’ —Randy Falkenrath

Medication adherence programs Outcomes programs

Data sharing

Care coordination N=110

Integration

Whole patient p health

Least prepared

Most prepared

Figure. Specialty pharmacy degree of preparedness to contribute competencies to an ACO. Source: Avalere Expert Webinar: “How Can Specialty Pharmacy Competencies Help Achieve ACO Goals?” February 2014; n=85 (“least prepared”), n=75 (“most prepared”). Survey respondents are a cross-section of specialty pharmacies, specialty drug manufacturers, health plans, providers and others.

‘ACOs are very focused on cost and quality of care, which is an area where specialty pharmacy can contribute. We just need to be able to make that case with data.’

—Gary Freeman, RPh, MBA

Mr. Freeman said. “These investments are needed to help demonstrate what specialty pharmacy can do.” But it’s not all about the specialty pharmacy making itself attractive to an ACO. Specialty pharmacies also should scrutinize any potential partnerships to see if the ACO is attractive to them. After all, participating in an ACO is about sharing risk. “To find a potential ACO partner, you can start by looking at your existing book of business,” Mr. Falkenrath said. “You have working relationships and you understand each other. That makes for a natural evolution of the relationship. No matter who the partner is, you should know what you’re getting yourself into. If you’re going to be handcuffing yourself to the bumper of a fast-moving initiative, you want shared expectations and the right level of control.” Some key areas to evaluate: Interoperability. Can the ACO share

data with provider partners and affiliates? Can you share data with them? What’s the timeliness of the data flow? Data analytics. Does your partner have the ability to do predictive analytics such that you can get ahead of problems and put solutions in place? Ability to engage patients. To what degree does the ACO have the ability to do patient outreach and engage patients? Financial risk structure. It’s also important to assess the financial risk structure and how the specialty pharmacy would fit in, Mr. Freeman said. “Are the incentives strictly on the up side, or both on the up side and the down side? Can you, as a specialty pharmacy provider, carve out something more discrete—something you can influence? For example, the specialty pharmacy could contract to call patients after discharge to make sure they’re on appropriate medications, or proactively

ask patients who come to the specialty pharmacy if they’ve been hospitalized in the last 30 days. That could be the start to improving care coordination.”

Shared Opportunities, Shared Risk Make sure that there are shared opportunities as well as shared risk, recommended Brett Furchner, the vice president of sales and marketing for Acro Pharmaceutical Services. “If your ACO has a certain number of patients on a certain product costing them X per year, you can use proper utilization management to review medical policies and formularies, keep [patients] adherent and make sure they’re using the drug effectively. You should see the upside from that.” Almost all decisions about signing on partners in an ACO are made at the hospital or health system C-suite level, Mr. Freeman said. “If you haven’t talked to people at that level before, you need to find a champion within the organization to help upsell you. That may be the pharmacy director ... or the patient care manager, or [someone from] the home health care organization that a hospital operates or contracts with. Tell them your story and show what you can do for them, and have them bring you up to the C-suite level, where the real decision makers are.” But before you sign that ACO contract, take time for careful consideration of what kind of service commitments your specialty pharmacy wants to make to a client. “When you partner with ACOs, given their risk-bearing nature, there will be a model that involves upsides and downsides,” Mr. Falkenrath said. “You have to understand the components driving this model. And you have to trust your partner, because you’re putting data into the ACO, and you have to be in alignment with the output that comes from these calculations. You could win big—or lose big.” The potential downsides of ACO arrangements came into stark relief last summer, when nearly a third of the health systems chosen for Medicare’s Pioneer ACO program decided to leave after the first year of the three-year initiative, according to Kaiser Health News (http://bit.ly/1lLEvjf ). On the plus side, the 32 organizations selected to participate in the program generated a gross savings of $87.6 million in 2012. But only 13 of the Pioneers actually saved enough money to share those savings with Medicare, despite having invested in the programs and staff required to better coordinate care. And two Pioneers ended up owing the Medicare program $4 million. The onus is on specialty pharmacies partnering with ACOs to learn why these programs went off the rails. —Gina Shaw

Specialty Pharmacy Continuum â&#x20AC;˘ Spring 2014

CLINICAL

Transplant specialty pharmacy:

A Win-Win Proposition Andrew Mardis, PharmD, BCPS David Taber, PharmD, BCPS Medical University of South Carolina Department of Pharmacy Services and Division of Transplant Surgery Charleston, South Carolina

pecialty pharmacy is a rapidly growing area within the practice and delivery of pharmacy services. Indeed, due to the rapid expansion of the number of highcost biologic pharmaceuticals and agents requiring surveillance through Risk Evaluation and Mitigation Strategies, specialty pharmacy has become a quintessential component of pharmaceutical care provided across a wide array of disease states. Transplant specialty pharmacy (TSP) is a subset of specialty pharmacy that provides medication procurement, distribution, billing and management services to organ transplant recipients. The most common services provided by TSP include facilitating the rapid supply of new immunosuppressants and anti-infectives to recently transplanted patients; billing Medicare Part B for outpatient prescriptions; assisting with the coordination of secondary billing; and providing medication education and monitoring services.1 The advantages of TSP are multifactorial and serve to benefit a host of groups involved in solid organ transplantation. Recent evaluations have shown that TSP has the potential to benefit the department of pharmacy, the transplant program, health insurance plans, and, most importantly, patients.1,2

ples include facilitating the process of efficient and timely medication dispensing, maintaining a high level of continuity between the health care team and the patient, and providing specialized patient education. Coupled with efforts to identify and resolve risk factors of nonadherence, transplant pharmacists can use these strategies to proactively improve patient outcomes.

With an ideal setup of TSP, the pharmacy team has a structured and consistent direct line of communication with the transplant patient and the medical team to facilitate these interventions. Thus, these services can provide the foundation for TSP to become the liaison between patients and transplant providers for all medication-related issues.

Easing Financial Concerns Early in the post-transplant period, pharmacists and financial coordinators can work to address payment issues for

high-cost immunosuppression and infection prophylaxis. The primary goal is to confirm that patients are able to secure these vitally important agents. The vast majority of kidney transplant patients are eligible for coverage of immunosuppression through Medicare Part B for 3 years after their transplant, but often these patients have additional coverage through Medicaid or private third-party programs, making the coordination of benefits necessary. Additionally, frequent adjustments and changes to medication regimens

â&#x20AC;˘

see TRANSPLANT, page 26

Spanning the Full Spectrum of Specialty Pharmacy Services

Adherence Programs Medication regimens after transplantation are complicated and change frequently. Despite the second chance at life that transplant recipients receive, many patients are nonadherent with these regimens. For example, nonadherence to vital immunosuppression regimens has been reported as high as 70%. Many factors contribute to this high level of nonadherence, including a lack of understanding and health literacy, poor communication with the health care team, polypharmacy, adverse drug effects, and financial burden. Importantly, nonadherence to immunosuppressive regimens in this patient population has been shown to increase post-transplant complications, readmissions, allograft rejection, allograft failure, and health care costs. In fact, medication nonadherence is a leading cause of late graft loss.2,3 TSP can help optimize medication safety in transplant patients via a number of strategies and interventions. Exam-

MHA Specialty Pharmacy Solutions can help you maximize opportunities for success through our full spectrum of specialty services and solutions. In an increasingly dynamic health care environment, MHA Specialty Pharmacy Solutions is dedicated to optimally position specialty pharmacy members and business partners to succeed. To learn more about MHA Specialty Pharmacy Solutions: www.mhainc.com 800.642.3020 x2870 MHASpecialty@mhainc.com

Exceptional Service. Extraordinary People.

ÂŠ MHA Specialty Pharmacy Solutions

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Specialty Pharmacy Continuum • Spring 2014

CLINICAL

DISEASE STATE SPOTLIGHT

Hemophilia: Overview and New and Emerging Treatments Hetty A. Lima, BSPharm, RPh, FASHP Vice President, Specialty Infusion & Rare Diseases Diplomat Specialty Pharmacy Flint, Michigan

Hemophilia is a chronic, lifelong, inherited bleeding disorder that has no cure. References to hemophilia and descriptions of excessive and unexplained bleeding have been around for centuries.1 Individuals with hemophilia do not bleed faster than someone without hemophilia; they tend to bleed longer or they may stop bleeding and rebleed due to impaired thrombin generation.2 This results in spontaneous bleeding as well as significant bleeding following injuries or surgery. Causes Hemophilia is a sex-linked recessive disorder caused by a mutation or change in one of the genes that provides directions for making one of the clotting factor proteins (factors VIII and IX) needed for blood to clot. The lower the amount of the clotting factor, the more severe the bleeding episodes the individual will have.3 Because the mutations affect genes on the X chromosome, hemophilia predominantly affects males, but females may exhibit some bleeding issues. There are approximately 20,000 Americans diagnosed with hemophilia and approximately 430 individuals are born with hemophilia in the United States each year.3

Diagnosis The diagnosis of hemophilia usually is made during the first year of life. Although most cases occur among those with a family history, approximately 30% of cases of severe hemophilia result from a spontaneous genetic mutation. Many times, such cases are diagnosed when an infant continues to bleed after circumcision. However, this procedure is not done on every infant boy and, therefore, some boys are diagnosed later, such as when there is continued bleeding when the child’s teeth begin to erupt, after a surgical procedure, or after a traumatic injury.4

hemophilia cases; • hemophilia B (also called Christmas disease or factor IX deficiency), which is caused by a lack of or decrease in clotting factor IX and comprises 15% to 20% of hemophilia cases; and • congenital hemophilia A, an inherited disorder that affects mostly males. Approximately 1 in 5,000 males are born with hemophilia A5 and all races and economic groups are affected equally. In about 30% of cases, there is no known family history of hemophilia A and the condition is the result of a spontaneous genetic mutation.4 Hemophilia A

The worldwide prevalence of hemophilia A varies with the reporting country, with a range of 5.4 to 14.5 cases per 100,000 males.4 Hemophilia A is classified into 3 distinct categories: mild, moderate, and severe. Each category is determined by the specific level or amount of clotting factor VIII that an

Hemophilia B

Hemophilia B is far less common than hemophilia A, with a prevalence ranging from 0.9 to 3.2 cases per 100,000 males.4 All races and economic groups are affected equally. Just like hemophilia A, hemophilia B has severity levels (mild, moderate, and severe), depending on the amount of clotting factor (in this case, factor IX) in the individual’s blood (Table 1).4,6-8

Clinical Manifestations Of Hemophilia The clinical manifestations of hemophilia A and B are indistinguishable. Without a properly functioning gene, patients are vulnerable to serious bleeds and related degenerative joint disease.9,10 Both types of hemophilia most often are marked by bruising that occurs easily and by recurrent bleeding into the joints and muscles. Weightbearing joints such as knees and ankles are most commonly affected, but bleeding can occur into any joint space. Chronic recurrent hemorrhages into a particular joint often cause pain and disability. Bleeding also can occur in the central nervous system (CNS), retroperitoneal cavity, or gastrointestinal tract. All of these bleeds are considered life-threatening, and patients are advised to seek treatment immediately. Symptoms of CNS bleeds include headache, lethargy, blurred vision, nausea, and vomiting. Intracranial hemorrhage accounts for 25% of deaths in hemophiliacs. Even a minor head injury can lead to a life-threatening intracranial hemorrhage.9,11 Oral bleeding requires immediate attention as does pharyngeal bleeding, which might interfere with the patient’s air supply.5 Common

Table 1. Hemophilia A and B: Classification and Levels of Severity Normal

Mild

Moderate

Severe

50-150

6-50

1-5

Incidence, %

27 (hemophilia A) 28 (hemophilia B)

20 (hemophilia A) 37 (hemophilia B)

53 (hemophilia A) 35 (hemophilia B)

Diagnosis

Late recognition, adulthood

Usually age 1-2 y

Early, age <1 y

Bleeding due to major trauma; rarely with joint problems

Variable bleeding frequency; bleed with minor trauma; may be joint problems

Frequent spontaneous muscle, joint bleeds; usually with joint problems

Uncommon

4-6 bleeds/y

2-4 bleeds/mo

% Factor activity level

Types of Hemophilia The most common types of hemophilia are2: • hemophilia A (referred to as classic hemophilia or factor VIII deficiency), which is caused by a lack of or decrease in clotting factor VIII and which comprises 80% to 85% of

individual has in his or her circulation.4,5 Normal plasma levels of factor VIII range from 50% to 150%.3 A summary of the classification of hemophilia by severity, and the types of bleeding episodes associated with each type, is listed in Table 1.4,6-8 In individuals with mild hemophilia A, 6% to 50% of the clotting factor in the circulation is normal. Individuals with mild hemophilia A usually experience bleeding problems only after serious injury, trauma, or surgery. Often, mild hemophilia is not diagnosed for many years, even into adulthood, and some patients may never experience major bleeds. Some patients with mild hemophilia do not even learn they have the condition until after an injury, surgical procedure, or tooth extraction that results in prolonged bleeding. However, it is important that these patients are treated appropriately before any surgeries or dental work to prevent bleeding.2,4 In individuals with moderate hemophilia A, 1% to 5% of the clotting factor is normal. These individuals tend to have bleeding episodes after injuries and some episodes may not have any obvious cause. These types of bleeds are called “spontaneous bleeding episodes.”2 People with severe hemophilia A make up approximately 60% of the hemophilia population; in these individuals, less than 1% of the clotting factor in their blood is normal. Individuals with severe hemophilia often experience bleeding after an injury, and they can have frequent spontaneous bleeding episodes, often into their joints and muscles, which can cause long-term damage.4,5

Type of bleeding

No abnormal bleeding

Frequency of bleeding episodes Adapted from references 4 and 6 6-8. 8.

Specialty Pharmacy Continuum • Spring 2014

CLINICAL

Table 2. Sites of Hemophilia Bleeding Serious

Life-Threatening

• Joints (hemarthrosis) • Muscles, especially deep compartments (iliopsoas, calf, and forearm) • Mucous membranes in the mouth, gums, nose, and genitourinary tract

• Intracranial • Neck/throat • Gastrointestinal

Table 5. Risk Factors For Development Of Inhibitors Age High-intensity factor treatment Continuous infusion of clotting factor vs bolus infusion

Based ased o on reference e e e ce 12.

Surgical procedure during the first 50 exposure days Severe hemophilia A

Table 3. Clinical Management: Factor Concentrates Mainstay of treatment Hemophilia A: Factor VIII concentrates Hemophilia B: Factor IX concentrates Dosing based on: Volume of distribution (intravascular and extravascular compartments) Half-life Factor level required for hemostasis Clotting factor dosed in units (U): 1 unit of factor = amount in 1 mL of normal plasma 1 unit of factor VIII/kg will raise factor VIII levels by 0.2 U/mL 1 unit of factor IX/kg will raise factor IX plasma levels by 0.01 U/mL Based on reference 14.

bleeding sites in hemophilia are listed in Table 2.12

Treatment For patients with mild to moderate hemophilia, desmopressin, a synthetic form of vasopressin, can be used to stimulate the release of stored factor VIII and von Willebrand factor (VWF) from the endothelial cells lining the inner walls of blood vessels.13 However, the mainstay of hemophilia treatment is clotting factor replacement (Table 3).14 Clotting factor products were first developed in the 1970s using plasma extracted from donors. Recombinant clotting factors were developed to address the potential for viral contamination of plasma-derived clotting factors, and the first recombinant clotting factors were approved in the 1990s.15 Additional measures used to treat acute bleeding episodes are listed in Table 4.11 Current factor treatment regimens include on-demand treatment—infusing clotting factor when a bleed occurs—or prophylaxis—infusing factor to prevent bleeds from occurring. Prophylaxis is

Table 4. Management Of Acute Bleeding Episodes Replacement of the missing clotting factor On demand

Family history Certain factor VIII and IX genetic mutations Other genetic factors (African American, Asian, and Hispanic ethnicity) Based on reference 19.

Prophylaxis DDAVP/Stimate antifibrinolytic agents Aminocaproic acid Tranexamic acid Supportive measures: RICE Rest Ice Compression Elevation DDAVP, desmopressin Based on reference 11.

intended to prevent bleeding episodes through the administration of regular infusions of clotting factor. The frequency of prophylactic infusions depends on several parameters and should be determined by the patient and his or her physician. On average, individuals with severe hemophilia A usually infuse 3 times per week to raise factor levels high enough to achieve protection from bleeds.16 Prophylaxis has been proven to significantly protect individuals from bleeds and reduce the incidence of hemophilic arthropathy and other longterm complications.13 The National Hemophilia Foundation’s (NHF) Medical and Scientific Advisory Council (MASAC) recommends “that prophylaxis be considered optimal therapy for individuals with severe hemophilia A/B. Prophylactic therapy should be instituted early (prior to the onset of frequent bleeding), with the aim of keeping the trough FVIII/IX level above 1% between doses,” which, according to the MASAC, generally can be attained with dosages of 25 to 50 IU/kg of factor VIII 3 times per week or every other day, or 40 to 100 U/kg of factor IX 2 to 3 times per week.17 Prophylactic therapy generally is well accepted in the pediatric hemophilia population and usually is initiated at an early age to prevent joint and other damage.13

Although dosing patterns will vary, a typical individual with hemophilia receiving primary prophylaxis will need approximately 2,000 IU of clotting factor 3 times per week, with the average cost per dose ranging from $1,000 to $2,000. This translates into an approximate monthly cost of $12,000 to $24,000 or $144,000 to $288,000 per year.13 Prophylaxis initiated at an early age enables the person with hemophilia to avoid or reduce the clinical effects of musculoskeletal impairment from hemophilic arthropathy. A study published in 2011 found that children who received prophylactic therapy had significantly fewer instances of hemarthrosis compared with those who received on-demand therapy and that prophylaxis greatly reduced the number of joint bleeds and improved quality of life.16

Hemophilia Complications Inhibitors

One of the most devastating complications of hemophilia is the development of neutralizing antibodies or inhibitors to the infused clotting factor.13 In some individuals with hemophilia A, the factor product used to prevent or treat bleeds is viewed as a foreign body by their immune system. When the body views the infused factor product as foreign, it reacts against it and develops an alloantibody, or inhibitor. Inhibitors render the infused clotting factor useless or greatly reduce its effectiveness—thus leaving the individual unprotected from bleeds. Inhibitors develop in approximately 30% of patients with severe hemophilia A and up to 5% of those with hemophilia B. Individuals with inhibitors are at increased risk for serious bleeding episodes, significant joint damage, and other complications.13 There are various causes of inhibitor development, both genetic and nongenetic. High-intensity treatment periods with factor replacement are a major

risk factor for inhibitor development. Although studies have attempted to identify risk factors for the development of inhibitors, the exact cause is unknown. However, several risk factors have been identified including race, age, type of hemophilia, presence of other immune disorders, and the frequency and dose of factor. Causes of inhibitor development are being researched actively; although inhibitor development is most common during the first year of treatment, often occurring within the first 100 infusions, inhibitors can develop at any time.18 Risk factors for inhibitor development are listed in Table 5.19 For people with hemophilia B, inhibitors can result in severe anaphylaxis, manifested by urticaria, restlessness, vomiting, angioedema, cough, tachycardia, bronchospasm, and/or cardiovascular collapse. Anaphylaxis and severe allergic reactions were reported in 59.6% and 40.4%, respectively, of patients with hemophilia B who developed inhibitors.20 Bleeding episodes in patients with inhibitors are difficult to treat and the treatment products and schemas used in these patients differ from those for patients who do not develop inhibitors. Therapies are more complex and may include the use of bypassing agents such as factor VIII inhibitor bypassing activity (FEIBA) or recombinant factor VIIa, or an attempt to eliminate the inhibitor through a process called immune tolerance induction (ITI).18 ITI therapy is an alternative treatment regimen to the bypassing agents and generally is started when the inhibitor is first detected. Patients on ITI therapy receive frequent high doses of factor over several months or years to desensitize the body’s immune system. ITI therapy is costly and carries the risk for thrombosis.13 Health care costs for people with inhibitors are significant, due to the larger doses of clotting factor required and/or the use of one of the more specialized bypassing agents. A study conducted in 2008 found that the average yearly expenditures for hemophilia patients with inhibitors were more than 4 times higher than for patients without inhibitors ($697,000 vs $155,000).13 Viral Pathogen Transmission

Much has been written in the literature about the viral transmission of the hepatitis C virus (HCV) and HIV to individuals with hemophilia via contaminated plasma-derived clotting factor. The development of effective clotting factor concentrates and the introduction of comprehensive hemophilia care in the 1960s and 1970s dramatically improved life for individuals with hemophilia. Unfortunately, this promise of a better life quickly deteriorated in

•

see HEMOPHILIA, page 18

Specialty Pharmacy Continuum â&#x20AC;˘ Spring 2014

CLINICAL

Filtering of Intravenous Immunoglobulins I

â&#x20AC;&#x2122;ve been involved with the development and management of intravenous immunoglobulin (IVIG) therapy for more than 30 years, and questions about the optimal use of IVIG are emailed to me on an almost daily basis. Many of those queries touch on safety issues, such as the review and monitoring of adverse reactions. I want to make this column as relevant as possible, so please send me your questions on IVIG therapy via email to Jerry.siegel.rx@gmail.com (cc: spceditor@mcmahonmed.com), and I will do my best to answer them. Each quarter, weâ&#x20AC;&#x2122;ll choose the most compelling question or patient case and use it as the basis for my column.

Q: Is it necessary to filter intravenous immunoglobulin (IVIG) solutions during administration? A: I have received numerous calls and emails related to the need to filter IVIG solutions during administration. The confusion comes from the fact that some products provide an in-line filter set and recommend its use in their package

Now Available! Our brand-new iPad app Scan here to download

Jerry Siegel, PharmD, FASHP Clinical Associate Professor The Ohio State University College of Pharmacy Columbus, Ohio

insert, but most products do not. There are several reasons for this apparent difference in product recommendations. Initially, immunoglobulin preparations were limited to intramuscular administration because when they were infused, immunoglobulin G (IgG) aggregates acted as antigens, activating the complement cascade and causing severe anaphylactoid-type reactions. Products were eventually developed that isolated the IgG from other plasma proteins using cold ethanol fractionation methods. Additional purification steps have further stabilized these preparations such that the IVIG products available in the United States today are highly purified, containing more than 95% IgG and IgG subclasses, trace amounts of IgA, and trace amounts of other immunoglobulins. The use of lower pH and refrigeration initially prevented higher rates of dimerization, but the fear of aggregate formation in the liquid state was the original reason for filtration. After hepatitis C was transmitted via certain IVIG products in the 1990s,1 the FDA imposed strict guidelines regarding the removal of viruses from these products. Methods of virus inactivation and removal include treatment with solvent/detergent (S/D) or caprylate, low-pH treatment, pasteurization, nanofiltration, and ultrafiltration. Manufacturers may combine these purification methods to maximize product safety. Plasma donors also are extensively screened to ensure the absence of viral illness. For these reasons, the IVIG products available today are considered to be some of the safest biologic products commercially available. In-line filtration would have no effect on bacterial or viral removal and should not be confused with nanofiltration or ultrafiltration used in the manufacturing process for those purposes. In-line filtration using pore sizes of 15 to 20 microns would be effective to remove large aggregates, particulates, and core materials from stoppers. Because they undergo extensive processing to ensure their safety, the IVIG products that are available today are highly purified and do not require additional microbial filtration to remove contaminants, bacteria, and viral material. The majority of available products do not require filtration during administration.

Specialty Pharmacy Continuum • Spring 2014

CLINICAL

Bivigam (Biotest),2 Carimune NF (CSL Behring),3 Flebogamma 5% and 10% DIF (Grifols),4,5 Gammagard Liquid 10% (Baxter),6 Gammaked 10% (Kedrion),7 Gamunex-C (Grifols),8 Octagam 5% (Octapharma),9 and Privigen 10% (CSL Behring)10 do not require filtration. However, the manufacturers of some IVIG products do require or recommend that their products be filtered during infusion to prevent infusion of particulate material. Gammagard S/D 5% is a lyophilized product that must be reconstituted before infusion.11 Baxter recommends that the products be filtered during administration. An administration set supplied with the products includes a 15-micron in-line filter that prevents the infusion of any particulate matter that could result from the reconstitution process. Baxter suggests that any administration set containing an in-line filter can be used to administer these products, but the filter pore size should be at least 1.2 micron to ensure an adequate flow rate. Bio Products Laboratory recommends a 15- to 20-micron in-line filter for use with Gammaplex 5%.12 (This filter is not supplied.) In-line filters have the potential to slow IVIG infusions and create difficulties with IV infusion pumps. Therefore, when clinicians use IVIG products for which filtration is recommended or required by the manufacturer, the filter may be placed after the infusion pump to ensure an adequate infusion flow rate. Standard sterile compounding procedures always recommend visual inspection for particulates when IVIG products are reconstituted or repackaged. IVIG products that have been frozen should not be used. Excessive shaking when handling IVIG products causes foaming, which also can result in precipitation and particulate formation. Pumps can be used to consolidate vials of IVIG into a single final container, but this should be done with care and caution to prevent foaming and breakdown of the IVIG protein.

Park, NC: Grifols Therapeutics, Inc; September 2013. 9. Octagam [Immune Globulin Intravenous (Human)] [package insert]. Hoboken, NJ: Octapharma USA, Inc; March 2007. 10. Privigen Immune Globulin Intravenous (Human), 10% Liquid [package insert]. Kanakee, IL: CSL Behring LLC; August 2013.

CA: Grifols Biologicals Inc; August 2013. 6. Gammagard Liquid Immune Globulin Infusion (Human) 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; April 2005.

Gammaked 10% [package insert]. Fort Lee, NJ: Kedrion Biopharma; September 2013.

8. Gamunex-C [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] [package insert]. Research Triangle

11. Gammagard S/D [Immune Globulin Intravenous (Human)] [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; September 2013. 12. Gammaplex Immune Globulin Intravenous (Human), 5% Liquid [package insert]. Raleigh, NC: Bio Products Laboratory; September 2009.

SCIENTIFICALLY SPEAKING, THIS IS NOT A GOOD SIGN.

References 1. Genese C, Hung MJ, Paul S, et al. Leads from the Morbidity and Mortality Weekly Report, Atlanta, GA: Outbreak of hepatitis C associated with intravenous immunoglobulin administration—United States, October 1993-June 1994. JAMA. 1994;272:424-425. 2. Bivigam Immune Globulin Intravenous (Human), 10% Liquid [package insert]. Biotest Pharmaceuticals Corporation, Boca Raton, FL: 2012. 3. Immune Globulin Intravenous (Human) Carimune NF, Nanofiltered [package insert]. Kanakee, IL: CSL Behring LLC. Clean Package Insert (50e8cd)_Version 11.0. 4. Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] [package insert]. Los Angeles, CA: Grifols Biologicals Inc; August 2013. 5. Flebogamma 10% DIF [Immune Globulin Intravenous (Human)] [package insert]. Los Angeles,

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Specialty Pharmacy Continuum â&#x20AC;˘ Spring 2014

CLINICAL continued from page 15

Table 6. Hemophilia/Bleeding Disorder Products in Development or Recently Approved Product Name

Product Type/Indication

Feature

Status

Estimated Approval/ Launch Date

Baxter

BAX 855

Pegylated rFVIII

Long acting

Phase II/III

2015

Bayer

BAY 81-8973

BDD rFVIII

Third-generation; normal half-life

Phase III completed March 2013

2014

Bayer

BAY 94-9027

Pegylated rFVIII

Long acting

Phase III

2015

Biogen Idec

BIIB 031

BDD rFVIII-Fc fusion

Long acting

Phase III completed March 2014

2013

CSL Behring

CSL627

Single-chain rFVIII

Improved stability during manufacturing; greater affinity for VWF

Phase II/III

2016

Green Cross Corporation

GreenGene F

rFVIII

Not new product but will be new in US

Phase III

2016

Novo Nordisk

Turoctocog alfa (NovoEight)

BDD rFVIII

Normal half-life

Phase III

Approved 2013

Novo Nordisk

NN7088 (N8-GP)

Glyco-pegylated rFVIII

Long acting

Phase III

2016

Octapharma

Human-cl rhFVIII

Hemophilia A

First factor concentrate to be produced from human cell rFVIII; normal half-life

Phase III

2014

Recoly NV

NecLip-pdFVIII (LongAte)

Plasma-derived factor VIII formulated with NecLip

Long acting

Approved in Russia

Baxter

BAX 326 (Rixubis)

Third-generation rFVIX

First third-generation product; normal half-life

Phase III completed July 2012

Approved June 2013

Biogen Idec/Swedish Orphan Biovitrum

BIIB 029 (Alprolix)

rFVIX-Fc fusion

Long acting

Phase III

Approved March 2014

Cangene Corporation

IB1001

rFVIX

CSL Behring

CSL654

rFVIX albumin fusion

Long acting

Phase II/III

Novo Nordisk

NN7999 (N9-GP)

Glyco-pegylated rFVIX

Long acting

Phase III

2015

2016

Manufacturer Factor VIII

Factor IX

BLA submitted April 2012; approval on hold pending data requested by FDA

Inhibitors or Factor VIIa Baxter

BAX 817

Hemophilia with inhibitors rFVIIa

Normal half-life

Phase III

Baxter

OBI-1

Hemophilia A with inhibitors or acquired hemophilia A

Recombinant (porcine)

Phase III

CSL Behring

CSL689 rVIIa-FP

Hemophilia A or B with inhibitors; rFVIIa-albumin fusion

Long acting

Phase I

Novo Nordisk

LA-rFVIIa

rFVIIa

Long acting

Phase I/II

Pfizer/Catalyst Biosciences

PF-05280602

Hemophilia with inhibitors; rFVIIa

Produced by human cell line

Phase I

Recoly NV

NecLip-rFVIIa (LongSeven)

Hemophilia with inhibitors; rFVIIa formulated with NEcLip

Long acting

Phase I/II completed

rEVO biologics/ LFB Biotechnologies

LR769

Hemophilia A or B with inhibitors; transgenic rFVIIa

Produced in rabbit milk

Phase II

Von Willebrand Disease, or Rare and Novel Treatments Baxter

BAX 111

Recombinant VWF

First recombinant VWF

Phase III

Baxter

BAX 513

Fucoidan, natural substance extracted from a brown algae

Enhances platelet activation to improve clotting

Phase I completed

Novo Nordisk

NN7415

Hemophilia A and B

Anti-TFPI

Phase I

Novo Nordisk

Catridecacog (Tretten)

rFXIII-A-subunit

First marketed rFXIIIa

BLA submitted

2016

Approved December 2013

BDD, B-domain deleted; BLA, biologic license application; Fc, constant fragment; rF, recombinant factor; TFPI, tissue factor pathway inhibitor; VWF, von Willebrand factor Based on references 21 and 22.

Specialty Pharmacy Continuum • Spring 2014

CLINICAL

the early 1980s, when the nation’s blood supply became contaminated with HIV. It is estimated that more than 50% of the 17,000 people with hemophilia and 80% of those with severe hemophilia were infected with HIV, many of whom subsequently died. The national tragedy of HIV/AIDS in the hemophilia community was recognized by the federal government in 1998 with passage of the Ricky Ray Hemophilia Relief Fund Act, which provided compassionate payments to individuals with hemophilia who contracted HIV through the use of contaminated blood products.1

1990s to Present The safety and efficacy of factor concentrates improved in the 1990s. Factor products became safer as stricter screening methods and advanced modes of viral inactivation were implemented. Additionally, synthetic factor products were manufactured using recombinant technologies. The FDA approved the first recombinant factor VIII and factor IX products in 1992 and 1997, respectively.1 Despite these safety advances, the risk remains for known and unknown infectious agents and pathogens to threaten the blood supply and blood products. In recent years, these threats have included the following agents: West Nile virus; Creutzfeldt-Jakob disease and its variant, mad cow disease (bovine spongiform encephalopathy); and parvovirus B19. The NHF has worked with the Centers for Disease Control and Prevention, pharmaceutical manufacturers, and the medical and consumer communities to assess pathogen risk and communicate information. Through the NHF, the hemophilia community is represented on the Health and Human Services Advisory Committee on Blood Safety and Availability and the FDA’s Blood Products and Transmissible Spongiform Encephalopathies Advisory Committees.1

The Role of Specialty Pharmacy in Hemophilia Care Specialty pharmacies play an important role in the management and coordination of care for people with hemophilia. The majority of clotting factor dispensed to individuals with hemophilia in the United States comes from specialty pharmacies. Treatment with clotting factor requires IV access, and patients with hemophilia and their caregivers are taught how to “self-infuse” clotting factor at home. The specialty pharmacist and nurse are important members of the hemophilia care team. Several ways that specialty hemophilia pharmacies can positively influence patient care are as follows: • Provide hemophilia disease education to families, relatives, dentists and other allied health professionals, school staff, and employers.

• Assist families with making treatment decisions for both drug and non-drug therapies to minimize side effects and adverse reactions. • Minimize barriers to ensure timely access to the appropriate clotting factor. • Provide infusion training techniques to minimize complications. • Provide medication counseling and education on factor storage, preparation, and reconstitution. • Verify that clotting factor dosages are within recommended parameters to minimize costs. • Assist patients in identifying appropriate venous access devices. • Ensure that patients have access to home nursing services, if required. • Manage refills, including the tracking and management of home shipments of factor and infusion supplies. • Conduct routine compliance and adherence calls, particularly for patients on prophylaxis and ITI regimens, to reduce nonadherence to prescribed regimens. • Ensure that the patient’s treatment regimen reflects best practices in hemophilia care. • Work with health care payors to secure reimbursement for hemophilia clotting factor; this includes communicating with insurance case managers, obtaining precertifications and prior authorizations, and securing copay and codeductible coverage.

Hemophilia Product Pipeline Since the 1980s, the hemophilia market has been dominated by recombinant clotting factor produced by Baxter, Bayer, CSL Behring, and Pfizer.10 Aside from the development of third-generation clotting factors (these factors lack bovine or human proteins in the cell culture or final products, thus carry no risk for viral transmission), no significant advancements to clotting factors have occurred. However, 2 new recombinant clotting factors were approved in 2013 and one was approved in March 2014: the factor IX products Rixubis (Baxter) and the long-acting Alprolix (Biogen Idec) as well as the factor VIII product turoctocog alfa (NovoEight, Novo Nordisk). There are additional longer-acting versions of clotting factors in development. Due to the increased use of prophylaxis and a burgeoning drug pipeline (for both short- and long-acting factors), the hemophilia market is estimated to grow an average of 5.9% over the next 5 years, from $8.5 billion in 2011 to $11.4 billion in 2016.10 Table 6 summarizes the recently approved products and those in the hemophilia pipeline.21,22 Hemophilia is a lifelong chronic illness that requires complex clinical management. With appropriate care management received at a hemophilia treatment

center and preventive care, individuals with hemophilia can have a near-normal life expectancy free from disability.23 Prevention of disease complications is critically important. There have been major advancements in the treatment and prevention of bleeds in individuals with hemophilia. Newer advancements in clotting factor treatments will further improve the quality of life of this patient population. In the future, gene therapy may provide a cure for hemophilia. In the meantime, research is focused on further improving treatment administration and increasing ease of use for doctors and patients, thus enabling patients to live a normal life.

References 1. National Hemophilia Foundation. History of bleeding disorders. http://hemophilia.org/ NHFWeb/MainPgs/MainNHF.aspx?menuid=1 78&contentid=6&rptname=bleeding. Accessed April 10, 2014. 2. National Hemophilia Foundation. Hemophilia A (factor VIII deficiency). http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx? menuid=179&contentid=45&rptname=bleeding. Accessed April 10, 2014. 3. Centers for Disease Control and Prevention. Hemophilia. http://www.cdc.gov/ncbddd/ hemophilia/facts.html. Accessed April 10, 2014. 4. Roberts HR, Key NS, Escobar MA. Hemophilia A and hemophilia B. In: Lichtman MA, Kipps TJ, Seligsohn U, Kaushansky K, Prchal JT, eds. Williams Hematology. 8th ed. New York, NY: McGraw-Hill; 2010. 5. White GC, Rosendaal F, Aledort LM, et al. Definitions in hemophilia: recommendation of the Scientific Subcommittee on factor VIII and factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost. 2001;85(3):560. 6. Pruthi RK. Hemophilia: a practical approach to genetic testing. Mayo Clin Proc. 2005; 80(1):1485-1499. Erratum in: Mayo Clin Proc. 2010;85(11):1061. 7.

Green D, Ludlam C. Hemophilia. In: Green D and Ludlam C, eds. Fast Facts: Bleeding Disorders. United Kingdom: Health Press Ltd; 2004.

8. McPherson RA, Pincus MA, eds. Henry’s Clinical Diagnosis & Management by Laboratory Method, 21st ed. Philadelphia, PA: Elsevier Saunders; 2006. 9. Hoots KW, Shapiro D. Clinical manifestations and diagnosis of hemophilia. http://www. uptodate.com/contents/clinical-manifestations-and-diagnosis-of-hemophilia. Accessed April 10, 2014. 10. Morningstar. The hemophilia market: steep but surmountable barriers for new entrants. Healthcare Observer. January 2013. http:// corporate.morningstar.com/us/html/pdf/ Healthcare-Observer-Jan-2013.pdf. Accessed April 10, 2014. 11. Lima HA. HEM-101 “The Basics of Hemophilia and the Role of the Specialty Pharmacist.” http://education.nasprx.org/products/1013/ hem-101-the-basics-of-hemophilia-and-therole-of-the-specialty-pharmacist-2-0-hours. Accessed April 10, 2014. 12. World Federation of Hemophilia. WFH Guidelines for the Management of Hemophilia, 2nd ed. http://www.guideline.gov/content. aspx?id=39323&search=hemophilia. Accessed April 10, 2014. 13. Kessler C, Santilli M. Understanding hemophilia: a managed care review. CDMI Report. Fall 2013:32-38. http://www.cdmihealth.com/ CDMI_Journal/Fall_2013/index.html#/38/.

Accessed April 10, 2014. 14. Escobar MA. Products used to treat hemophilia: dosing. In: Lee CA, Berntorp EE, Hoots WK, eds. Textbook of Hemophilia. Maiden, MA: Blackwell Publishing; 2005:153-157. 15. Pipe SW. Recombinant clotting factors. Thromb Haemost. 2008;99(5):840-850. 16. Gringeri A, Lundin B, von Mackensen S, Mantovani L, Mannucci PM, ESPRIT Study Group. A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT study). J Thromb Haemost. 2011:9(4):700-710. 17. National Hemophilia Foundation. MASAC Recommendation #179. MASAC recommendation concerning prophylaxis (regular administration of clotting factor concentrate to prevent bleeding). http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF. aspx?menuid=57&contentid=1007. Accessed April 10, 2014. 18. Astermark J, Santagostino E, Hoots KW. Clinical issues in inhibitors. Haemophilia. 2010;16(suppl 5):54-60. 19. Guelcher C. Inhibitor development. http:// www.hemophilia.org/NHFWeb/Resource/ StaticPages/menu0/menu5/menu58/menu98/ InhibitorDevelopment.pdf. Accessed April 10, 2014. 20. Chitlur M, Warriere I, Rajpurkar M, Lusher M. Inhibitors in factor IX deficiency: a report of the ISTH-SSC international FIX inhibitor registry (1997-2006). Haemophilia. 2009;15(5):1027-1031. 21. Clement P. New factor concentrates. The future is now. Parent Empowerment Newsletter. 2013;23(3):10-11. Georgetown, MA: LA Kelly Communications. https://www.kelleycom. com/pen/2013_08_PEN.pdf. Accessed April 10, 2014. 22. Gouw S, van der Bom J, Ljung R, et al. Factor VII products and inhibitor development in severe hemophilia A. N Engl J Med. 2013;368(3):231-239. 23. Addressing the needs of members with hemophilia in Medicaid managed care: issues and implications for health plans. Clinical brief. Medicaid health plans of America, Center for Best Practices. July 22, 2013. http://www. mhpa.org/_upload/MHPA%20Hemophilia%20Issue%20Brief%20final%20082113.pdf. Accessed April 10, 2014.

Hemophilia Resources Federal Organizations Centers for Disease Control and Prevention www.cdc.gov/ncbddd/hemophilia/ index.html Health Resources and Services Administration www.mchb.hrsa.gov/programs/ hemophilia National Institutes of Health Office of Rare Disease Research www.rarediseases.info.nih. gov/GARD/condition/10418/ hemophilia.aspx

Advocacy Organizations Hemophilia Federation of America www.hemophiliafed.org National Hemophilia Foundation www.hemophilia.org World Federation of Hemophilia www.wfh.org State hemophilia chapters

Specialty Products & Programs Delivered with Personalized Care

ACCREDITED

SPECIALTY PHARMACY

Advanced Care Scripts (ACS) is committ tted to ensuring that all patients have access to the highest level of clinical care and that their treatment choices arenâ&#x20AC;&#x2122;t limited by the cost of specialty prescriptions. We support physicians, healthcare staff, ff and patients with reimbursement assistance and dispensing of specialty drugs nationwide.

To learn more about how ACS can support your patients contact 877.985.6337 or visit www.acs-rx.com.

Specialty Pharmacy Continuum • Spring 2014

Omnicare Specialty Care Group

CORPORATE SPOTLIGHT

Omnicare Specialty Care Group (SCG) is a leading provider of customized commercialization solutions for specialty pharmaceutical products. Our programs provide fully integrated and unique Patient Access Solutions for specialty therapies. We provide reimbursement assistance, financial solutions, compliance and adherence programs, managed samples and specialty pharmacy services to accelerate and maximize commercial uptake. Our integrated platforms also include third-party logistics services, pharmacy solutions and reimbursement support services. Many different obstacles may exist in initiating and maintaining therapy. To address these barriers, our team designs product-specific solutions that improve access and increase speed to therapy, solve affordability issues and support compliance and adherence.

Comprehensive Specialty Pharmacy Services Omnicare SCG’s specialty pharmacy, Advanced Care Scripts (ACS), manages and dispenses specialty medications in multiple disease categories, including cancer, infectious diseases, autoimmune disorders, multiple sclerosis and hemophilia. Our comprehensive patient care model provides compliance and adherence support and cost-effective solutions for specialty medications. We support physicians, health care staff and patients nationwide.

ACS Secures More Than $75 Million in Patient Copayment Assistance Annually. Our business is built on superior customer service. We offer the following solutions to help our patients: • Timely benefit investigations, including free drug qualification: ACS handles the insurance investigation process so that patients can continue therapy without interruption. • Access to patient assistance programs and foundation support: We research all available financial assistance options to help ease patients’ financial burdens and allow them to focus on getting healthy. • Simplified medication regimens: We are the only specialty pharmacy that provides dailydose blister packing for all oral prescriptions, bringing simplicity to complex dosing schedules and increasing medication adherence. • Free distribution of medications overnight, direct to patient or office: Our goal is to ensure patients have quick, convenient access to their medications, with support from nurses to guide them throughout the process. • 24/7 access to expertly trained clinical staff: Our dedicated staff is committed to providing appropriate product training and delivering expert clinical support 24/7. • Compliance and adherence support: ACS’ customized adherence programs include nurse injection training, patient education programs, refill reminder calls and more.

Brand Support for Improved Access and Adherence Our high-touch brand support services are known for innovative solutions, outstanding execution and continuous enhancement of partner programs. ACS’ integrated model provides comprehensive patient services and enhances product access, affordability and adherence. Our dedicated case management team provides support by helping navigate through the reimbursement environment, starting with the physician and ending with product dispensing to the patient. We offer product-specific compliance solutions to assist patients in maintaining therapy. You can trust the ACS team as it supports your brand.

Proven High-Quality Care ACS was recently awarded Specialty Pharmacy Accreditation from URAC, a Washington, DC-based health care accrediting organization that establishes quality standards for the health care industry. URAC offers the only third-party, voluntary accreditation program of this scope for the pharmacy benefit management and prescription services industries. We are proud to receive this accreditation, and are dedicated to providing quality care and meeting the highest industry standards for its customers and patients.

Strategic Partnership To Support Oncology Nurses ACS is partnering with ONS:Edge, a subsidiary of the Oncology Nursing Society (ONS), throughout 2014 to support the efforts of oncology nurses nationally. Through this unique collaboration, we’ll provide tools to highlight ways nurses can help patients afford and adhere to their treatment regimens, while assisting them in their mission to provide excellent patient care.

CONTACT US TODAY To learn more about how ACS can support your patients, visit www.acs-rx.com or contact Dennis Wilson VP & General Manager 407-854-6575 Dennis.Wilson@acs-rx.com OR Steve Lynch Director of Sales 866-244-2789 Steve.Lynch@acs-rx.com

Specialty Pharmacy Continuum • Spring 2014

OPERATIONS AND MANAGEMENT

EDUCATIONAL REVIEW

Reduce Costs and Improve Quality Standards With Temperature Indicators Part 2 of a 2-Part Series WILLIAM BAILEY, RPH Chief Operating Officer CitizensRx Edwardsville, Illinois

early all specialty drugs are sensitive to

temperature extremes, with exposure to extreme heat or cold reducing drug potency. Thus,

these agents require special handling and a properly

maintained cold chain. If the cold chain is not maintained, in time these temperature-damaged drugs can become completely ineffective,1 causing serious downstream health problems for patients who may take them.

Within the specialty pharmaceutical industry, processes and procedures are in place to protect patients and their temperature-sensitive medicines using a variety of thermal packaging systems intended to maintain these drugs within specified temperature ranges. As the industry grows and an increasing number of drugs are distributed direct to patients, existing processes and procedures should be challenged to continuously improve the ways in which specialty pharmaceutical shipments are protected during the journey to the patient. The most successful specialty pharmaceutical organizations continually seek ways to reduce costs and increase efficiencies, so that optimal treatments are delivered to patients, ensuring their health and satisfaction. The ability to know if specialty medication such as a biologic has been temperature-damaged cannot be done by visual inspection or even by touching the medicine to see if it feels too warm or too cold. When patients suspect that their medicines might have been exposed to excessive temperature, generally they call the specialty pharmacy that sent it. Customer service personnel ask patients questions trying to determine if the products should be used or returned, but there is no

definitive tool to assist in this process. Ultimately, if patients are concerned about the risks of injecting drugs suspected of being damaged, specialty pharmacies will arrange to have the product returned and reshipped, even if it is believed to be unnecessary. This is an extremely costly process, considering that the product alone could cost $3,000 or more. Couple the wasted product costs with the cost of call centers and repacking and reshipping medicines, and a negative effect on profits is certain. Of equal concern is that in situations when medicines are returned unnecessarily, patients’ treatment protocols might be interrupted, potentially resulting in negative health outcomes.

Temperature Indicator Study Everyone—patients, payors, and pharmaceutical manufacturers—relies on specialty pharmacies to maintain systems and processes that will provide comprehensive medication management that ensures the safe delivery of medications in ways that will control use and cost. Continuous improvement in quality standards must be in the DNA of specialty pharmacies that want to keep up with the growing demands associated with the storage, handling, and shipment of specialty pharmaceuticals to patients.

Temperature indicators are one method specialty pharmacies can use to meet the growing storage, handling, and shipment demand and help ensure the safe delivery of specialty medications to patients. To evaluate the usefulness of visual temperature indicators included in shipments of specialty drugs to patients, specialty pharmacies from 5 regions within the United States participated in a product-in-use study. TransTracker F (Cold Chain Technologies) heat indicators were included in every shipment made to patients (N=65,000) from June 2012 to January 2014. Patients were given a questionnaire to assess their experiences and attitudes related to the inclusion of a temperature indicator in each shipment of medicines they received; 6,000 patient responses were included in the results. Additionally, the cost implications of including indicators in all specialty pharmacy shipments to patients were evaluated. Patient Survey Results The results show the value of temperature indicators related to cost savings and increased patient satisfaction. Arguments against using temperature indicators have included concerns that it would cause alarm among patients who would not know how to read the indicators, resulting in an increase in call center contacts and more product returns. The results of this study refute these concerns. In this study, almost 98% of patients reported that the temperature indicator was easy to read. Among the 65,000 shipments sent to patients in this study, only 1.5% of patients reported that the temperature indicator signaled that the medicine had been exposed to temperatures above the limit. Additionally, specialty pharmacies used this

science-based tool to discuss patient concerns and determine if, in fact, the medicine had been exposed to temperatures above the limit. When indicators were used, more than 95% of patients report being more confident in the medicines sent to them by their specialty pharmacy. This fact contributed to a reduction in product returns and reduced call center costs at the specialty pharmacies participating in the study. Specialty Pharmacies Results: Reduced Overall Costs Selected specialty pharmacies participating in the study reported cost advantages directly attributed to the use of temperature indicators. One specialty pharmacy conducted an assessment of shipments of a single biologic 2 months before the start of the study compared with the first 2 months of the study period when a temperature indicator was included in every shipment. The pharmacy reported that product waste was reduced by 70%, and savings associated with the cost for professional call center staff to manage customer concerns related to suspected temperature damage of their medicines added an incremental $50,000 to overall savings. For every $1 this pharmacy spent to include the temperature indicator in shipments to patients, it saved $7.50. If these numbers were projected industry-wide, the specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or wasted when patients suspect heat damage.2 Another pharmacy reported that

Specialty Pharmacy Continuum • Spring 2014

OPERATIONS AND MANAGEMENT

over a 6-week period during which it sent 850 shipments, approximately $9,200 (product cost only) was saved because a temperature indicator was included in shipments. In 2 cases, patients contacted the call center with concerns that their medicine felt too warm. After reading the indicator, which had not signaled to show temperature excursions above the limit, the patient was reassured that it was not necessary to return/ reship the product. A third participating pharmacy compared average call time spent with patients to discuss concerns about medicine temperature before the use of indicators versus during the study period with indicators. The pharmacy found that call time decreased by approximately 50%, providing additional support for the cost savings associated with the use of temperature indicators. These reports show that when temperature indicators were included in shipments of medicines to patients and used as a science-based, decision-making tool to help determine if medicines were exposed to temperatures above specified limits, costs were reduced, and pharmacies and their patients could be better assured of product integrity. By incorporating indicators into the cold chain shipping process, specialty pharmacies are responding to the needs and preferences of their customers, and are realizing cost advantages in the form of reductions in product waste, replacement and reshipping costs, and streamlined call center operations.2

Combine Packaging With Indicators To Improve Quality In addition to using temperature indicators to ensure product integrity, specialty pharmacies rely on thermal shipping containers to maintain temperatures of products being shipped within the specified range. Couple the use of visual temperature indicators with careful selection of thermal packaging containers, and the specialty pharmacy industry can improve overall quality standards and further protect the medications they ship and the patients they serve. In a recent independent study, Hutchinson tested the performance of various thermal systems.3 Five thermal control technologies were tested in a controlled laboratory setting to determine if the thermal capabilities of the technology, according to the manufacturer’s claim of temperature control within a 24-hour timeframe, were met. This baseline testing of manufacturers’ claims could then be used to assess whether visual temperature

indicators would be valuable for late shipments that required longer than 24 hours for delivery. Hutchinson evaluated the following shipping systems commonly used by specialty pharmacies to protect temperature-sensitive products for direct-to-patient delivery: an insulated bubble bag, an insulated box liner, an expanded polystyrene (EPS)-molded cooler, an insulated envelope, and an EPS panel sheet cooler. These technologies were packed to manufacturers’ recommendations and tested against the ISTA

7D thermal profile during summer and winter conditions. None of the 5 tested thermal packaging systems maintained the temperature within the recommended 2°C to 8°C range in the first 24 hours. Four of the five reached sustained temperatures that were too warm, 2 within the first 6 hours of the simulated shipment. All 5 dropped below freezing which resulted in frozen product. Three of the technologies have the potential to induce multiple “freeze– thaw” events in the specialty drug;

the multiple phase changes of liquid formulations are extremely hazardous to drug quality and nearly impossible to detect at time of receipt or use by the patient. Performance results during an additional 6-hour period (2430 hour) showed that there could be additional vulnerability in the “last mile,” when medicines are delayed or left exposed to seasonal temperature extremes at doorsteps or in mailboxes during home delivery. The insulated box liner technology Text continues on page 24

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Specialty Pharmacy Continuum • Spring 2014

OPERATIONS AND MANAGEMENT

Text continued from page 23

provided appropriate thermal control for 18 hours; temperature excursions were recorded above the limit in the 18- to 24-hour interval (Figure 1). The EPS-molded cooler held temperature for 18 hours; thermal excursions occurred during the 18- to 24-hour interval during summer profile testing (Figure 2). Pack-out design flaws in the EPS panel sheet cooler allowed the simulated drug product to freeze and remain frozen for 24 hours (Figure 3). The insulated box liner has the potential to allow multiple phase changes (freeze–thaw)

02 13

02 14

of drug products shipped during the winter season (Figure 4). The lack of performance in the first 24 hours suggests the need for specialty pharmacies to independently evaluate packaging technologies and to consider the use of temperature monitoring devices to improve existing shipping protocols.

Improving Quality Standards in Shipping Adding temperature indicators to high-quality, validated shippers are important measures to improve quality standards when shipping costly

02 15

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biopharmaceuticals during the last mile when medicines are most vulnerable. Thermal packaging systems should be scrutinized to ensure that they are performing to specifications in standard, summer and winter conditions. The combined use of temperature indicators and highquality thermal packaging systems is an important consideration for every specialty pharmacy organization. There are several criteria to consider when selecting temperature indicators and thermal packaging systems to meet the objectives of reducing costs, increasing

02 17

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Upper limit 8°C (46.4°F)

Temperature, °F

Temperature, p , °C

Ambient temperature

Temperature, °F

Temperature, °C

Ambient temperature

profits, and improving quality shipping standards: • Select temperature indicators that are manufactured under a process consistent with government or industry standardized guidelines that use pharmaceutical industry best practices. • Ask manufacturers for performance testing data versus specified claims. • Temperature indicators must perform to recommended excursion ranges specified by manufacturers. Request and review test data. • Indicators should be set to alert

Upper limit 8°C (46.4°F)

Lower limit 2°C (35.6°F)

Time, i h

Figure 1. Insulated box liner.a

Figure 2. Expanded polystyrene-molded cooler.a

The insulated box liner technology provided appropriate thermal control for 18 hours; temperature excursions were recorded above the limit in the 18- to 24-hour interval.

Based on reference 3.

02 18

02 19

02 20

02 21

The expanded polystyrene-molded cooler held temperature for 18 hours; thermal excursions occurred during the 18- to 24-hour interval during summer profile testing.

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02 13

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02 15

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02 17

Temperature, p , °C

Ambient temperature Upper limit 8°C (46.4°F)

Lower limit 2°C (35.6°F)

Upper limit 8°C (46.4°F)

Lower limit 2°C (35.6°F)

Time, h Time

Figure 3. Polystyrene panel sheet cooler.a

Figure 4. Insulated box liners.a

Pack-out design flaws in the polystyrene panel sheet cooler allowed the simulated drug product to freeze and remain frozen for 24 hours.

Based on reference 3.

The potential for multiple phase changes (freeze-thaw) of the drug product increases risk for products shipped in insulated box liners during the winter season.

Temperature, °F

Temperature, °C

Ambient temperature

Specialty Pharmacy Continuum • Spring 2014

OPERATIONS AND MANAGEMENT

based on manufacturers’ temperature excursion recommendations. • No activation required: Indicators must be simple for specialty pharmacy distribution teams to pick and pack into shipments without the need to activate the device. This eliminates the potential for error that would result in no monitoring of medications and confusion for patients. • Simple to read: Patients must be able to read the indicator easily to know if medications may have been exposed to potentially damaging temperatures. Ease of use by patients has the potential to reduce call center inquiries. The cost of adding temperature indicators to every shipment should be evaluated based on the potential cost savings. As shown during the product-in-use temperature indicator study, using reliable temperature indicators to provide an alert when your thermal packaging system may not be maintaining temperatures within proper range is an investment that could generate a 7-fold return. There are also several criteria that should be considered to evaluate existing thermal systems or to identify improved alternatives: • Specialty pharmacies need to select appropriate thermal packaging systems based on verifiable test data. • Selected thermal packaging suppliers should qualify their products to public standard thermal profiles (ISTA 7D) using pharmaceutical industry best practices.3 • Ask to see the data and consider independent thermal packaging testing if there is any doubt regarding performance in heat and cold extremes. • Develop specific procedures for the use of ice packs, cold packs, packing materials, etc, for various temperature profiles. • Ensure that these procedures are implemented consistently and support current packaging configurations. If existing packaging does not meet these criteria, a plan to phase in better systems can improve overall quality standards and reduce the costly risks associated with product returns and the liability related to negative patient outcomes.

proper temperature controls during the last mile, when medicines are shipped to patients, has always been an industry challenge. Therefore, continuous improvement of quality standards related to cold chain shipments is an important goal for every specialty pharmacy organization. It is time to consider the use of science-based temperature indicators with proven performance standards and cost-savings benefits. As shown in the recent study that included 65,000 shipments, using

a cost-effective, reliable temperature indicator can generate a 7-to-1 return on investment while increasing patient satisfaction. Additionally, thermal packaging systems tested to public standard thermal profiles that are verifiable should be selected. Specialty pharmacies can expect to strengthen quality processes already in place by using high-performance thermal shipping systems combinded with temperature indicators in every shipment of medicines to patients.

References 1.

Centers for Disease Control and Prevention. Vaccine storage & handling toolkit. November 2012. http://www.cdc.gov/ vaccines/recs/storage/toolkit/storagehandling-toolkit.pdf. Accessed April 15, 2014.

2. Bailey W, Kus D. Think outside the box: how to reduce costs of specialty pharmacy shipments and increase patient satisfaction. TempTime White Paper. 2014. 3. Hutchinson GM. The cold, hard facts: what you need to know about thermal shipping technologies. Packaging Study White Paper. Houston, TX: Modality Solutions, LLC. 2013. http://modality-solutions.com/ wp-content/themes/maximus/images/dl/ modality_specialty_pharma_whitepaper.pdf. Accessed April 15, 2014.

Strengthening the Bond Between Pharmacies and Manufacturers

We offer pharma/biotech sponsored programs and incentives as well as patient support services to keep your pharmacy healthy in a competitive marketplace.

Specialty Pharmacy Providers

Pharma/Biotech Manufacturers

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Prescription Transfer Program

t t t t t t t

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Scalable Network of Specialty Pharmacy Providers Hub Solutions - Intake Services Industry’s Most Comprehensive Data Analytics and Reporting Proven Compliance Driven Initiatives Contracting for Pre- and Post-Product Launch Customized Programs by Disease State Implementation of Product Strategies

Conclusion Specialty pharmacies are committed to helping patients manage chronic illnesses. Delivering medicines used for treatment that have optimal potency and that arrive without temperature-related damage is a critical responsibility. Maintaining

Pioneering Solutions for Specialty Pharmacy

For more information Contact us at 866-766-4002 www.armadahealthcare.com

Specialty Pharmacy Continuum • Spring 2014

COMMENTARY

Upsurge in collaboration:

Stakeholders in Health Care, Specialty Working Together Michael J. Baldzicki, CRCM Executive Vice President Armada Health Care

ust a few years ago, most patients using specialty pharmaceuticals were being treated in infusion centers or hospitals. Today, specialty pharmacies, ancillary infusion suites, group practices and home infusion companies are more likely to be managing patients who need specialty therapies. The ability of these areas to provide safe, highquality accessible, patient-centered care is being enhanced through core collaborative efforts with key stakeholders in health care. With the implementation of health care reform measures, specialty pharmacies, hospitals, physicians and other health care groups are increasingly measured by outcomes they achieve, with penalties incurred for unnecessary cost escalation. Thus, all health care

stakeholders are in search of ways to provide higher-quality care in a more cost-efficient way. To be effective and cost-effective, specialty pharmacies need to develop key collaborations that move beyond the logical model of the specialty pharmacy distribution. To improve distribution effectiveness, quality of care, data collection and other health information, specialty pharmacies and health care groups need to focus on expanding their patient and treatment management services. They are doing so by building collaborations with third-party health care groups that provide health information technologies and services that use guidelines and treatment pathways to support higher standards of care, collect data for payors and help practices evaluate the delivery of care. These key collaboration efforts between spe-

cialty pharmacies and health care service organizations are likely to expand because specialty products now account for 21% of the total U.S. pharmaceutical market, and that percentage is expected to grow to 35% in 2014. This upsurge in collaboration is essential to all specialty stakeholders so that they can provide optimum patient care in cooperation with patients, prescribers and other members of health care organizations. Specialty pharmacies can use outside providers to support their management services, allowing them to maintain this optimum level of care and diversify their offerings. Many services are available, but the core contracted services are as follows: patient monitoring, distribution discount programs, special drug-handling and reporting programs, Risk Evaluation and Mitigation Strategies programs, prior authorization

and physician documentation, patient assistance programs, clinical programs, pharmacy and retail networks, and patient outreach programs. These collaborations allow specialty practices to focus on building therapeutic expertise and key service components, which makes them more valuable as an extension of the physician practice and payor. This allows physicians, payors and manufacturers the opportunity to use specialty pharmacies to achieve a common goal: a successful therapeutic outcome for the patient. As a result, key partnerships will continue to rise within the specialty pharmacy segments to meet the needs of these “high-touch” patients who require more time, different resources, more information, better data tracking, improved transitions of care, and optimal use of specialty pharmaceuticals. ■

CLINICAL

TRANSPLANT continued from page 13

can complicate third-party billing, and patient assistance programs and prior authorizations further muddy the waters. Pharmacists, technicians and financial coordinators trained to navigate these complicated billing processes for such a high-risk population can quickly identify potential financial barriers and work to resolve these before they negatively affect patient adherence and outcomes. One high-risk group warranting special attention is patients reaching the three-year post-transplant period. This is when these patients often will lose their Medicare coverage. Engaging these patients to establish prescription coverage or assistance programs to help cover out-of-pocket expenses is most effective when the TSP identifies such patients in advance, thus preventing potentially harmful lapses in medication therapy. Although TSP specifically addresses many of the potential barriers to medication adherence, further opportunities to optimize interventions and continually improve patient outcomes are possible. For example, to improve timely access to medication, the TSP can take steps to ensure that medications are dispensed before discharge from the hospital after transplantation. Setting up mail-order service for organ transplant drugs also can help improve rapid access to these lifesaving medications. Long-term, automated and personal refill reminders can help to ensure that patients have an adequate supply of medications. When patients continue to have

all of their medications filled from the same TSP, prospective tracking of refill information may help providers identify patients who are not taking their medications as directed and address these concerns before they lead to poor clinical outcomes, including acute rejection. Many of these efforts have been shown to improve patient outcomes. A recently published study demonstrated that TSP, when incorporated into a comprehensive quality improvement initiative, significantly decreased hospital length of stay and readmissions in adult kidney transplant recipients.4 The reduction in readmissions was accompanied by a nearly 50% reduction in adverse drug events.

A Transplant Pharmacist’s Take on Adherence Lonnie Smith, PharmD, a pharmacist at the University of Utah, in Salt Lake City, who helped to establish and expand one of the country’s foremost TSPs and who now serves as the manager of Transplant Services at the university, highlights the effect that TSP can have on adherence. “I have always liked that we have been able to call patients and remind them of their needed refills and go through their medication list with them,” he told Specialty Pharmacy Continuum. “If anything is questioned or concerns are caught by the specialty pharmacy staff, they can be relayed to the transplant team for follow-up.” Creating systems that monitor not only prescription refills but also medication safety and efficacy can allow practitioners to identify developing issues earlier. This can be accomplished through pharmacy staff contacting the patient by phone,

through electronic text communication, or simply as informal face-to-face discussions when dispensing the medications. These outreach efforts are sorely needed, because as patients get further out from transplant and remain on a stabilized medication regimen, they usually only see their transplant physicians once or twice a year at a visit focused on “the big picture.” Thus, interactions with the TSP may be the only meaningful interactions a patient has with a transplant specialist on a consistent basis. These interactions may help to elicit information from patients about poor tolerability to medications and can lead to early or more frequent follow-up with physicians to adjust therapies. These interventions can go a long way toward avoiding or limiting adverse drug effects that may be an impetus for nonadherence or poor graft function. The financial benefits of TSP are very apparent; one large transplant center reported an annual net margin from a newly implemented TSP exceeding $2 million.1 Another report of a TSP for kidney transplant recipients demonstrated statistically lower total costs, transplant-related medical costs and transplant-related prescription expenditures during the first year posttransplant compared with patients using traditional pharmacies.2 Although these margins may be important to the bottom line of transplant centers and pharmacy departments in a time of declining health care reimbursements, it is important not to lose sight of the main objective of TSP—improved patient care and outcomes. TSP has the opportunity to reinvest a portion of these profits to fur-

ther expand their services and optimize patient outcomes. Implementing more automation and mail-order systems, hiring specialtytrained clinicians and support staff and expanding the volume potential of the pharmacy can improve this program’s ability to consistently pursue the aforementioned initiatives. In the end, these programs will serve to optimize patient and graft survival through improved medication management. But the benefits don’t end there. Providing enhanced patient-centered services for transplant recipients through the use of TSP also will help foster close relationships, leading to improved communication and a customer service–based environment that is more conducive to long-term use of these services. TSP, if appropriately implemented and managed, is a win–win proposition for the transplant recipientt and d the health care system.

References 1. Hlubocky JM, Stuckey LJ, Schuman AD, et al. Evaluation of a transplantation specialty pharmacy program. Am J Health Syst Pharm. 2010;69:340-347. 2. Tschida S, Aslam S, Khan TT, et al. Managing specialty medication services through a specialty pharmacy program: the case of oral renal transplant immunosuppressant medications. J Manag Care Pharm. 2013;19(1):26-41. 3. Chisholm-Burns MA, Spivey CA, Garrett C, et al. Impact of clinical pharmacy services on renal transplant recipients’ adherence and outcomes. Patient Prefer Adherence. 2008;2:287-292. 4. Taber DJ, Pilch NA, McGillicuddy JW, et al. Improved patient safety and outcomes with a comprehensive interdisciplinary improvement initiative in kidney transplant recipients. Am J Med Qual. 2013;28(2):103-112.

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Medication Errors: A Year in Review

Horsham, Pennsylvania

medication errors is an essential

component of pharmaceutical care and must be a core mission of every pharmacy. For medication error-prevention efforts to be effective, they must become a priority. The first step in setting up an error-reduction program is to establish a multidisciplinary team to improve medication use. The team must be given reasonable time and resources to assess medication safety and implement system-wide changes that make it difficult or impossible for practitioners to make mistakes that reach the patient. This multidisciplinary team should accept ownership of the medication-use process and enthusiastically embrace the opportunity to improve medication safety. The goals of the team should include the following: • Promote a culture of safety to lower medication errors; • Increase detection and reporting of medication errors and potentially hazardous drug-use situations;

• Explore and understand the root causes of medication errors; • Educate practitioners about the system-based causes of errors and their prevention; • Recommend methods to facilitate the implementation of organization-wide, system-based changes to prevent medication errors; • Respond to potentially hazardous situations before errors occur; and • Learn from errors occurring in other organizations through the ISMP Medication Safety Alert! and other published accounts of medication errors, and proactively take measures to prevent similar errors. Text continues on page 7

KEY TO TABLES

Computerized prescriber order entry (CPOE)—A fully integrated CPOE system includes the capability to build medication safety alerts (eg, look-alike names) and clinical decision rules. Additionally, the CPOE system should directly interface with the laboratory system and pharmacy, list drug–drug and drug–disease interactions, and offer clinical order-screening capability.

Bar-code–enabled point-ofcare (BPOC) systems—These systems are designed to prevent medication errors at the point of medication administration. BPOC systems verify and record all medications administered to the patient through the use of a bar-code scanner that matches the medication to the patient by scanning a bar code on the medication and a bar code on the patient’s wristband.

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“Smart” infusion pumps—These infusion systems allow users to enter various drug infusion protocols into a drug library with predefined dose limits. If a dose is programmed outside of established limits or clinical parameters, the pump halts or sounds an alarm, informing the clinician that the dose is outside the recommended range. Some pumps can integrate patient monitoring and other patient parameters, such as age or clinical condition.

“Robust” pharmacy order entry system—This order entry system is fully interfaced with a CPOE system. The pharmacy system must be able to produce medication safety alerts as well as directly interface with a health care facility’s information systems, such as the laboratory system. Additionally, this system must be used to generate a computerized medication administration record (MAR) to be used by the nursing staff while they administer medications.

S P E C I A LT Y P H A R M A C Y C O N T I N U U M • S P R I N G 2 0 1 4

Table 1. Safety Issues Related to Labeling, Packaging, and Nomenclature Title

Problem/Discussion Point

Recommendation

Technology

Acetaminophen suspension labeling

• The word “Children’s” is on the labels of unitdose containers of 325 and 650 mg cups of acetaminophen oral suspension from Precision Dose, implying that the total dose in the cup is suitable for children. • Depending on the child’s age and weight, 325 or 650 mg might be an overdose.

• For children, pharmacies should dispense patientspecific doses of acetaminophen suspension in oral syringes. • The unit-dose cups should only be dispensed if the child’s dose is exactly the total dose in the cups (325 or 650 mg).

1,2

Confusion between ado-trastuzumab emtansine (KADCYLA, Genentech) and trastuzumab (HERCEPTIN, Genentech)

• The ISMP and the ASHP sent a warning through the NAN about possible name confusion between the newly approved ado-trastuzumab emtansine and trastuzumab. • Ado-trastuzumab emtansine may not be fully communicated or may be misread when prescribed, leading to confusion with trastuzumab.

• Alert practitioners to the risk for incomplete presentation or miscommunication of the generic name of Kadcyla. • Promote the use of both brand and generic names when communicating orders on order sets or computerized prescriber order entry systems. • For more information, view the recent NAN Alert: www.ismp.org/Newsletters/acutecare/ hazardalerts.asp.

1,4

Confusion between “factor” and “PCC”

• Historically, several bleeding reversal products have been referred to as “prothrombin complex concentrate,” or “PCC.” • Since there is a newly approved product, KCENTRA (CSL Behring), with the actual generic name prothrombin complex concentrate, the use of “prothrombin complex concentrate” or “PCC” may result in confusion regarding which drug is intended.

• Determine which of these reversal products will be on the formulary, and educate staff about the appropriate use of each agent and the risk for confusion when using the terms “prothrombin complex concentrate” or “PCC.” • Always clarify orders requesting “prothrombin complex concentrate” or “PCC” to determine the specific brand name. An alert in electronic systems may help remind staff to do this.

1,2,4

Heparin label changes

• As of May 2013, the labeling of heparin vials must express the total amount of units in the container as well as include the units per mL in parentheses, rather than just listing the units per mL. • Older labels only list the per mL amount, leading to overdoses in which the amount per mL was thought to be the amount in the entire vial. • If heparin vials with both the old and new labels are available, the risk for mistaking the per mL amount as the total vial amount is high.

• To minimize the risk for confusion, facilities should consider transitioning fully to the newly labeled heparin, even if this means discarding older vials. • Alternatively, at a minimum, pharmacists should apply auxiliary labels to the older-style vial to highlight the total number of units in the container. • As space permits, pharmacy and nursing databases should express drug amounts the same way they are expressed on the vial label (ie, 10,000 units/10 mL [1,000 units/mL]).

Influenza vaccine—always shake well!

• An immunization-certified pharmacist said he was not aware that all injectable influenza vaccine products must be shaken before use. He said that he had not been doing this, although the implications of this omission are not clear. • The vaccine cartons are labeled “shake well,” but the vial and syringe labels of influenza vaccine that the ISMP has examined do not have this label.

• Injectable influenza vaccines are suspensions with the exception of FLUBLOK (Protein Sciences), which is a solution. • All injectable influenza vaccines including Flublok must be shaken before use, whether they are packaged in a single- or multiple-dose vial, or in a prefilled syringe. • This is a reminder for health professionals and office-based staff who administer influenza vaccine.

Name confusion between pazopanib and ponatinib

• Two new oral chemotherapy agents, pazopanib, used to treat renal cell cancer, thyroid cancer, and soft tissue sarcoma, and ponatinib, used to treat chronic myelogenous leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia, have names that may cause confusion. • Fortunately, tablet strengths and dosages differ between the drugs, which should help prevent and detect errors.

• Computer systems that list oral chemotherapeutic agents linked to available dosage strengths will help to minimize the potential for error, as will listing appropriate dosing information for labeled indications. • The use of tall man lettering with the unique letter characters differentiated (PONATinib and PAZOPanib) also can be helpful.

ASHP, American Society of Health Health-System System Pharmacists; ISMP, Institute for Safe Medication Practices; NAN, National Alert Network

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1,4

Table 2. Safety Issues Associated With Order Communication

(continued)

Title

Problem/Discussion Point

Recommendation

Technology

Apothecary strengths confused

• There is a risk for errors when apothecary strengths such as “gr” (grains) are used for certain drugs such as ferrous sulfate and PHENobarbital. • Grains could be confused with “g” (grams).

• Consider purchasing products from manufacturers that do not use apothecary strengths on labels to minimize the risk for confusion. • If this is not possible, ensure that labels generated from the pharmacy for these products do not contain apothecary strengths.

DOXOrubicin liposome injection

• A safety concern might exist in the product description field for some listings of a generic liposomal DOXOrubicin product, which was approved by the FDA in February 2013. • Listings of this product may not be reflected correctly in various drug information databases or computer systems. • Mistaking the drug for a conventional product could cause death.

• Check to see if the drug is listed correctly as “DOXOrubicin HCl liposome injection” in your computer systems. • The ISMP suggests using “HCl” instead of “hydrochloride” to place “liposome” closer to “DOXOrubicin,” which will make it easier to read. • The word “pegylated” or “peg-” (which sometimes precedes liposomal), seen in some listings, is unnecessary in formulary systems. • To make the word “liposome” stand out, some organizations include asterisks around it (*liposome*).

1,4

Methadone mistaken for metoprolol

• A nurse obtaining a drug history of a new patient inadvertently selected methadone 100 mg BID from the computer screen instead of metoprolol 100 mg BID. • The physician reviewed the medication list and continued all the medications. • The pharmacist questioned the high methadone dose, but the physician instructed to give the medication as written. • After receiving 2 doses, the patient experienced cardiorespiratory arrest.

• Require prescribers to specify the indication if methadone is prescribed. • If the patient is being treated for opioid addiction, confirm the dose with a methadone clinic. • Have the patient/caregiver confirm (even sign) the medication reconciliation list to verify accuracy. • Reinforce an expectation that all questionable orders are fully resolved before dispensing and administering the medication.

1,4

“NoAC” is an unsafe abbreviation

• Recently the abbreviation “NoAC” was mistakenly interpreted to mean “no anticoagulation.” • The prescriber intended the abbreviation to stand for “New (or novel) oral anticoagulant.”

• The ISMP will be adding “NoAC” to the “do not use” list of potentially dangerous abbreviations, and strongly suggests cautioning providers not to use it clinically.

Null sign misread

• A null sign (Ø) has been misread as various numbers: the number 8 for a lockout interval; the number 4 for a basal rate for PCA; the number 6, especially if the circle is not closed above the hash mark; and the number 9, especially if the tail of the hash mark through the circle is long.

• The null sign appears on the ISMP List of ErrorProne Abbreviations, Symbols, and Dose Designations, and should not be used on medical orders. • Also, a setting of zero for a lockout interval, which may not be an available choice with some PCA infusion pumps, is dangerous, even if the number of boluses is limited within a certain timeframe.

Protecting vulnerable patients

• Medication errors that occur in a LTC facility often originate in the hospital. • Studies show large inconsistencies between medications on discharge summaries and transfer forms, leading to error rates of 21% or higher during transitions between hospitals and LTC facilities, particularly with warfarin, insulin, opioids, and cardiovascular medications. • For example, unnecessarily including the strength of insulin (100 units per mL) without the actual dose on a transfer form led a LTC nurse to misunderstand a new resident’s dose as 100 units, which led to his death.

• Establish a list of drugs that often are not continued after hospitalization, and refer to the list during discharge medication reconciliation to determine if clarifications are needed. • Require prescribers to cosign (verify) transcribed discharge summaries, and reconcile the transfer/ referral form with the discharge summary to enhance comparison and consistency. • Have pharmacists review the prescribed medications for patients being transferred to LTC facilities, and provide reasons for differences between the discharge medications and the medications administered in the hospital. • Standardize the documents that accompany transfer forms.

1,3,4

Table continues on page 4

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Table 2. Safety Issues Associated With Order Communication

(continued)

Title

Problem/Discussion Point

Recommendation

Technology

Search function leads to wrong medication choice

• A prescriber who typed “aceta” to enter an electronic order for acetaminophen chose acetaZOLAMIDE from the search results. Fortunately, differences in the dose and frequency led to discovery of the error. • Other drug name pairs that have resulted in this kind of error are: hydroxychloroquine/ hydroxyurea; MUCOMYST (acetylcysteine)/ MUCINEX (guaifenesin); valACYclovir/ valGANciclovir; and penicillAMINE/penicillin.

• Use tall man lettering to differentiate drugs with look-alike names. • Require more than just a few letters when searching for drugs in electronic databases. (Some systems require a certain number of letters before a list will appear.) • Require entry of the intended purpose of drugs with similar names or alert the pharmacist to match the patient’s condition to the drug’s indication.

1,4

Tiotropium (SPIRIVA, Boehringer Ingelheim) dose confusion

• The recommended dose of tiotropium is 2 inhalations of the powder contents of 1 capsule. • Many order entry systems will default to a dose of 1 inhalation, and if this is changed to 2 inhalations, it may result in the patient receiving the contents of 2 capsules. • If the dose is entered as 1 capsule, the patient might receive the product orally.

• Make sure the dosing for tiotropium is expressed clearly in your order entry system to avoid use of the wrong dose or the wrong route. • Express the dose in a way that lessens the risk for confusion (eg, 1 capsule = 2 inhalations). • Provide patient education, and ensure the patient understands how to properly use the medication (and the inhalation device).

1,4

Topotecan overdoses

• The FDA and the ISMP have received reports of medication errors involving 10-fold topotecan overdoses. • Several of these errors occurred because the decimal point in the dose was overlooked when the order was read (eg, .7 mg dose misread as 7 mg; 2.5 mg dose misread as 25 mg) or because a trailing zero was used after a whole number dose (4.0 mg mistaken as 40 mg).

• Always include a leading zero (eg, topotecan 0.7 mg) and avoid using trailing zeros (eg, topotecan 2.0 mg) when expressing doses. • Include the intended dose in mg/m2, in addition to the total calculated dose, to allow other health care providers to verify that the calculated dose is correct. • Consider the use of standardized order sets to avoid topotecan dosage confusion.

1,3,4

ISMP, Institute for Safe Medication Practices; LTC, long long-term term care

Table 3. Addressing Concerns Involving Infection Control Title

Problem/Discussion Point

Recommendation

Sterile compounding practices

• An ISMP survey revealed that up to 29% of pharmacy technicians reported that contamination of compounded sterile products occurred in their facility during the past year. • The survey revealed that only 50% of the pharmacists responding were confident that contamination had not occurred. • In Massachusetts, a governor-commissioned report on sterile compounding recommends stronger oversight and licensure of compounding pharmacies and calls for pharmacy boards to review compounding activities in hospitals and other locations, such as physician offices.

• Facilities should use the Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for Safe Preparation of Sterile Compounds as a resource to identify opportunities for improvements in sterile compounding practices.

Transitioning from insulin pens to vials

• Staff accustomed to using insulin pens may lack knowledge about drawing insulin doses from a vial. • The U-100 designation on insulin vials has been misinterpreted to mean 100 units per vial, leading to overdoses. • The dose in units has been measured in mL by staff unfamiliar with the differences between an insulin syringe and other parenteral syringes, and there is a risk for these doses to be unlabeled. • Insulin vials often look alike, leading to mix-ups.

• Before transitioning from insulin pens, conduct a FMEA to proactively address problems that may arise, and reeducate staff regarding the processes associated with measuring doses, injection techniques and using insulin syringes. • Where possible, pharmacy should prepare, label, and dispense daily patient-specific basal insulin. • Rapid-acting insulin vials (3 mL preferred) should be dispensed and labeled for specific patients. • Provide insulin syringes in appropriate sizes (1 mL, 0.5 mL, 0.3 mL) to units where insulin may be administered and in hyperkalemia treatment kits.

FMEA, failure mode and effects analysis; ISMP, Institute for Safe Medication Practices

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Technology

Table 4. Problems Involving Drug Information, Patient Information and Staff Education Title

Problem/Discussion Point

Recommendation

Chemotherapy overfill confusion

• More than 1,100 patients may have received lower doses of cyclophosphamide and gemcitabine than prescribed because the hospital and compounding pharmacy that provided the chemotherapy did not have a common understanding of the amount of overfill in the containers. • Although the total amount of drug in the bag was correct, the failure to understand the final concentration and the need to infuse the total amount of fluid in the bag resulted in some patients receiving a lower dose than intended when the full volume was not infused. • Several methods can be used to prepare sterile products, each with specific means for managing the overfill volume, which can lead to confusion.

• Establish a standard process to identify the overfill volume on the pharmacy label for compounded IV chemotherapy/biotherapy solutions. • Ensure that nurses who administer these products can locate the final volume on the label, and can recognize that the correct dose requires the full volume to be infused (unless otherwise stated). • Choose the most appropriate method of preparing each medication infusion according to whether or not the volume/concentration is critical. • Obtain a list of overfill amounts of commonly used products from vendors for reference as needed. • For continuous infusions titrated to effect, ensure consistency in the preparation process to avoid variations in concentration and inconsistencies in the dose delivered. • For a single-dose drug infusion, the most critical aspect of the process is ensuring that the entire dose in the container is administered. The label should include a reminder: Infuse entire contents for full dose.

FentaNYL patch fatalities

• A 15-month-old child who had been sleeping with his mother gained access to her fentaNYL patch, ingested it, and was found unresponsive when his mother awoke. • Similar events before this one have been just as tragic. • Why has so little action been taken by those in positions to educate patients about proper use and storage of fentaNYL patches? Until every health care professional and health system accepts personal responsibility for promoting safe use of this powerful opioid, we are exposing one of the most troubling examples of bystander apathy in health care: a belief that we don’t need to intervene because others will.

• No patient should be allowed to leave a doctor’s office, hospital, clinic, or pharmacy without face-to-face instructions on the use of the fentaNYL patch and related safety concerns, as well as verification of consumer understanding. • All health professionals must individually instruct patients and caregivers on the use of the patch and not rely on others to do it. The ISMP has developed a free patient education checklist and consumer leaflet that can be used during consumer education and then given to the patient for reference.

Fleet ENEMA SALINE, not plain saline

• Fleet Enema Saline contains the active ingredients sodium phosphate monohydrate 19 g and dibasic sodium phosphate 7 g. • Because the label states “saline,” the phosphate content may be overlooked. Phosphate toxicity is possible from even a single enema, although elderly patients with renal insufficiency, those using more than one enema per 24 h, and patients who do not expel the enema as directed are at highest risk.

• Avoid Fleet enemas in elderly patients with renal insufficiency and patients with diseases that decrease intestinal motility. • When they are used for other patients, the enemas should be expelled as directed after use, and a second dose should not be administered for at least 24 h. • Patients should be warned to carefully follow label directions and avoid using more than one enema in 24 h.

Syringe pull-back method unreliable

• A pharmacy technician mixed the volumes required (0.27 mL magnesium, 5.13 mL diluent) and combined 0.27 mL of a diluent with 5.13 mL of magnesium sulfate. • The syringe pull-back method was used for checking the admixture, so the error was unnoticed because it was not clear which syringe was associated with which vial. • The syringe pull-back method for checking admixtures is unreliable.

• The ISMP’s compounding safety guidelines (www.ismp.org/sc?id=251) strongly discourage the syringe pull-back method for verifying the contents of parenteral admixtures. • This method should never be used to verify contents in chemotherapy, complex solutions, pediatric/neonatal solutions, or CSPs with other high-alert medications. • The contents of these solutions should be verified immediately before adding them to the diluent, and syringes should be labeled if the verification process is not completed shortly after drawing the solution into the syringe.

Technology

CSPs, compounded sterile products; ISMP, Institute for Safe Medication Practices

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Table 5. Medical Devices and Other Discussion Items Title

Problem/Discussion Point

Recommendation

Evaluating independent double checks

• The value of a manual independent double check has been questioned by those who rarely find mistakes. • Its use has been a source of stress for busy staff and its overuse with high-alert drugs has been called to task, given its status as a weak riskreduction strategy, particularly if it is the only safeguard in place. • Inconsistent use, variability in its performance, and the superficial manner in which many checks are conducted has rendered this method less effective than anticipated. • However, studies have shown that independent double checks can detect up to 95% of errors; thus, carrying out a manual independent double check is worth the time and effort if done correctly.

• Manual double checks are most effective when conducted independently in a cognitive manner, and when used judiciously for selected high-risk tasks or high-alert medications. • Evaluate the procedures for which you require a double check, monitor compliance, assess how often the checks are conducted as designed, and then make the necessary revisions to promote effectiveness. • Avoid sole reliance on double checks as a safety strategy. Fewer double checks strategically placed at the most vulnerable points of the medication use process will be much more effective.

Tuberculin syringes to measure U-500 insulin

• As use of U-500 insulin grows, so do the number of errors, mostly related to dosing confusion caused by not having a syringe with a U-500 scale. • Health care providers and patients rely on syringes meant for U-100 insulin to measure U-500 insulin doses. • This results in communicating the dose by the number of units that correspond to the U-100 syringe. • Another source of confusion is name similarity: HUMULIN R is the name for both U-100 insulin and U-500 insulin.

• Until U-500 syringes or pens are available, use tuberculin syringes to measure doses by volume using a dosing conversion chart. • Total doses should be expressed in both units and volume (eg, 200 units [0.4 mL]). • To minimize name confusion, ensure that the strength is listed with HUMULIN R insulin products during order entry. • Separate U-100 insulin and U-500 insulin vials.

Venous access devices

• Confusion exists about the syringe size needed for IV drug administration via venous access devices. • The Infusion Nursing Society has identified that if the pressure generated by the flush is too high, the catheter can be damaged. • Smaller syringes create greater amounts of pressure than larger syringes during injection.

• The ISMP clarified this issue with the nursing society and a representative from Bard Access Systems. • The representative from Bard told the ISMP that, with the exception of a 1 mL prefilled syringe, a strategy now being sanctioned for the company’s catheters and ports is to initially assess catheter patency with a saline flush using a syringe with the diameter of a 10 mL one. • Once the patency of the catheter is assured, medication administration in a smaller diameter syringe is acceptable.

ISMP, Institute for Safe Medication Practices

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Technology

Table 6. ISMP’s 2014-2015 Targeted Medication Safety Best Practices

(continued)

Title

Problem/Discussion Point

Goal/Recommendations

Technology

Methotrexate dosing regimens

• Since early 1996, and as recently as 2013, fatal errors have been reported to the ISMP about the accidental daily dosing of oral methotrexate that was intended for weekly administration. • Prescribing errors occur when physicians, who are accustomed to prescribing many medications for daily administration, erroneously prescribe this medication daily instead of weekly use. • Dispensing errors occur in much the same way, when pharmacy technicians and pharmacists inadvertently select/approve daily instead of weekly administration during order entry or verification.

• The goal of this best practice is to prevent errors involving inadvertent daily dosing of oral methotrexate, both in the inpatient setting and after discharge. • Use a weekly dosage regimen default for oral methotrexate. • If weekly default is overridden to daily, require a hard stop verification of an appropriate oncologic indication. • Provide patient education by a pharmacist for all weekly oral methotrexate discharge orders. • Ensure that patients are given written drug information leaflets that contain clear instructions about the weekly dosing schedule. • Have patients repeat back the instructions to ensure that they understand the weekly dosing schedule and that the medication is not to be used “as needed” for symptom control.

1,4

Oral dosing devices

• The ISMP has received more than 50 reports of mix-ups between milliliter (mL) and household measures such as drops and teaspoonfuls, some leading to injuries requiring hospitalization. • Use of the apothecary system also has caused mix-ups between drams and mL and other non-metric measurements, such as ounces and tablespoons. • The ISMP first reported confusion in 2000 and has continued to receive reports of medication errors related to mix-ups between metric and non-metric units of measure.

• The goal of this best practice is to use liquid medication dosing devices (specifically oral syringes, cups, and droppers) that display volume using only the metric scale. • Purchase oral liquid dosing devices (oral syringes, cups, droppers) that display only the metric scale. • Additionally, if patients are taking an oral liquid medication after discharge, supply them with (or provide a prescription for) oral syringes, to enable them to measure oral liquid volumes in mL.

Oral liquid preparation

• The ISMP continues to receive reports of patients accidentally being given an oral liquid medication by IV, which on some occasions has been fatal. • This happens most often when an oral liquid is prepared extemporaneously or dispensed in a parenteral syringe that connects to vascular access lines. • Fatalities also have occurred when the contents of liquid-filled capsules (eg, nimodipine) were drawn for oral administration via a nasogastric or other tube with a parenteral syringe and then administered IV. • The oral syringe tip is designed to be incompatible with vascular lines to prevent it from being attached inadvertently.

• The goal of this best practice is to prevent the unintended administration of oral medications via the IV route. • Ensure that all oral liquids that are not commercially available as unit-dose products are dispensed by the pharmacy in an oral syringe. • Use only oral syringes that are marked “For oral use only.” • Ensure that oral syringes that are used cannot connect to any type of parenteral tubing. • Also, use of an auxiliary label “For oral use only” is recommended if it does not obstruct critical information because the print on the oral syringe is small.

Table continues on page 8

Text continued from page 1

Effective results depend on understanding the entire medication-use process through varied perspectives and disciplines. ISMP is a nonprofit organization that works closely with health care practitioners and institutions, regulatory agencies, professional organizations, and the pharmaceutical industry to provide education about medication errors and their prevention. ISMP independently reviews medication errors that practitioners and patients have submitted voluntarily to the ISMP Medication Error Reporting Program. ISMP is an

accessible resource for any pharmacist or organization interested in implementing the actions recommended herein. Among the many products and services that ISMP offers is the ISMP Medication Safety Alert!! Acute Care Edition, a biweekly newsletter that provides timely information related to error prevention. It identifies errors that have been reported by other organizations and offers recommendations to prevent those errors from occurring in the pharmacy. The information in the tables of this review summarizes many of the significant error-prevention Text continues on page 8

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Table 6. ISMP’s 2014-2015 Targeted Medication Safety Best Practices

(continued)

Title

Problem/Discussion Point

Goal/Recommendations

Technology

Patient weight

• Official product labeling for medications provides weight-based dosing using only the metric system (eg, mg/kg). • Significant medication errors have occurred when the patient’s weight is documented in non-metric units of measure (eg, pounds) and it was confused with kilograms (or grams). • Numerous mistakes have been reported when practitioners convert weights from one measurement system to another, or weigh a patient in pounds but accidentally document the value as kilograms in the medical record, resulting in more than a twofold dosing error.

• The goal of this best practice is to standardize the measurement and communication of patient weight using only metric units of measure (grams [g] and kilograms [kg]). Measure and express patient weight in metric units only. • Ensure that scales used for weighing patients are set and measure only in metric units. • Replace current scales that measure in pounds with new scales that only measure weight in grams or kilograms. • If scales can measure in pounds and grams/kilograms, modify the scale to lock out the ability to weigh in pounds. • Ensure that computer information systems and medication device screens (eg, infusion pumps), printouts, and preprinted order forms list or prompt for weight only in grams (for neonates) or kilograms. • Discontinue the documentation of patient weight in pounds in all locations, and instead document patient weight using only metric designations. • Use measured weight rather than a stated, historical, or estimated weight.

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VinCRIStine in a minibag

• To date, there are 120 published cases of accidental administration of vinCRIStine by the intrathecal route when the drug was dispensed in a syringe, and zero cases when it is dispensed in a minibag. • When vinca alkaloids are injected intrathecally, destruction of the central nervous system occurs. • Despite repeated warnings from national and international safety agencies, deaths from this kind of error continue to occur.

• The goal of this best practice is to ensure that vinca alkaloids are administered by the IV route only. Dispense IV vinca alkaloids in a minibag of a compatible solution, and never dispense and/or administer these drugs using a syringe. • Dilute the drug in a minibag that contains a volume that is too large for intrathecal administration (eg, 25 mL for pediatric patients and 50 mL for adult patients). • Prohibit IV vinca alkaloids in areas where intrathecal medications are administered and/or stored. • Confirm that any prescribed intrathecal medications have been administered before dispensing IV vinca alkaloids.

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strategies that were recommended in the ISMP Medication Safety Alert! Acute Care Edition during 2013. The errors presented in the tables are actual or potential errors reported to ISMP. Each table consists of 4 columns. The first column lists the medications, devices, or other problematic issues involved. The second column describes the specific error or problem involved. The third column contains ISMP’s recommendations to proactively address and prevent errors from occurring. The fourth column lists technology that may help prevent these errors. Technology can be a powerful tool in the fight against medication errors but only when it

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

is used appropriately within a well-designed medication-use system. The key summarizes the technology addressed in the tables, along with specific criteria that ISMP recommends should be included.

Suggested Reading Cohen MR, ed. Medication Errors. 2nd ed. Washington, DC: American Pharmacists Association; 2007. Institute for Safe Medication Practices. ISMP Medication Safety Alert! Acute Care Edition newsletters 2013. www.ismp.org/newsletters/ default.asp. Accessed March 20, 2014. Institute for Safe Medication Practices website: www.ismp.org.