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Come see What Is Possible here. Froedtert Health’s strong partnership with the Medical College of Wisconsin has benefited patients, health care professionals and the region since 1980. With three hospitals and more than 30 primary and specialty care health centers and clinics, the Froedtert & the Medical College of Wisconsin health network provides a work environment where medical and non-clinical professionals can feel encouraged, respected, valued and highly regarded. We are currently seeking Pharmacists for our Froedtert Hospital campus who are committed to helping us maintain our strong reputation for outstanding patient care and innovative medicine.
Froedtert Hospital • Clinic Hem/Onc Staff Pharmacist • Inpatient Hem/Onc Staff Pharmacist To learn more about the Froedtert & the Medical College health network and to apply for our Pharmacist positions, please visit froedtert.com/careers. We are proud to be an Equal Opportunity Employer. As a federal contractor/subcontractor, we take affirmative action in employment based on race, sex, disability and status as a protected veteran. We welcome protected veterans to share their priority consideration status with us at 414-777-1680. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
froedtert.com/careers
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2015
contents
January/February thecover
6 The Biennial Wisconsin Pharmacist Workforce Survey: 2013 Results
pharmacypractice FEATURES
14 WPQC Update: ForwardHealth Goes Live with Aprexis Health Solutions
17 WPQC Operations: Group Coaching with MTM Workgroups: A Model for Improving MTM Performance
22 CDC Releases New Recommendations for Pneumococcal Vaccinations
63 Pharmacy Quality Measurement: Medicare Star Ratings
66 Piloting a Remote Medication Consultation Service Alongside Discharge Prescription Delivery
70 Opportunities for Advancing the Role of the Community Pharmacist
correspondence
3 Up Front: What is Wisconsin Pharmacy's Workforce Need?
5 Member Viewpoints: “What are your professional goals for yourself and/or your practice for the upcoming year?�
23 Journal Series: Statistics Review Part 9: Research in Policy
26 The Growing Population of Older Adults: A Trend That All Pharmacists Should Follow
27 Pharmacotherapy Perspectives: Tedizolid: The Newest Oxazolidinone
32 CE for Pharmacists and Technicians: Biosimilars and the Future of Biologics
PSWnews
57 The Journal 2014 Scavenger Hunt!
62 Announcements:
New Members, Conference Calendar, Advertisers
originalcontributions
40 ID Corner: A Primer on Hepatitis C
44 Role of the Pharmacist Reconciliation Process in Adults with Acute Mycocardial Infarction, Heart Failure, or Pneumonia in the Acute Care Setting
48 Pharmacist Provided Medicare Annual Wellness Visits in Collaboration with a Physician Office
54 Student Writing Club: The Pharmacist's Role in Professional and Patient Advocacy
58 Implementation and Evaluation of Guidelines for Use of a Prescription Drug Monitoring Program at a Veterans Affairs Facility
On The Cover: Pharmacist Workforce Survey PAGE 6 Pictured: Trends in Pharmacy Growing Population of Older Adults PAGE 26 Pharmacy Quality Measurement PAGE 63 Opportunities for Advancing the Role of the Community Pharmacist PAGE 70
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The Journal of the Pharmacy Society of Wisconsin is a professional publication for original research, review, experience, and opinion articles that link science with contemporary pharmacy practice to improve patient care. Together we can inspire each other to advance our profession with the single purpose of enhancing the lives of our patients. Editor ANNA LEGREID DOPP, PharmD, annad@pswi.org Managing Editor MEGAN GRANT, mgrant@pswi.org Peer Review Coordinator AMANDA MARGOLIS, PharmD, MS
Editorial Advisory Board
PSW Executive Board MIKE BETTIGA, RPh Chairman of the Board
DEAN GRUBER, RPh Treasurer
PATRICK CORY, PharmD President
CHRISTOPHER DECKER, RPh Executive Vice President & CEO
MIKE GRUNSKE, PharmD, BCPS President-Elect
PSW Board
LEENA AMINE, PharmD Clinical Pharmacist, University of Wisconsin Hospital and Clinics, Madison KASSANDRA BARTELME, PharmD, BCACP Assistant Professor of Pharmacy Practice, Concordia University Wisconsin School of Pharmacy, Mequon CARRIE BOECKELMAN, RPh Manager, Ambulatory Pharmacy Services, University of Wisconsin Hospital and Clinics, Madison
AMANDA MARGOLIS, PharmD, MS Clinical Pharmacist, William S. Middleton Memorial VA, Madison & Assistant Researcher, UW-Madison School of Pharmacy, Madison
AARON STEFFENHAGEN, PharmD, BCPS Region A Director 2013-15
JAKE OLSON, PharmD Director-at-Large 2014-16
RANDOLPH MILLER, RPh Region B Director 2014-16
TAMARA RAVN, PharmD Director-at-Large 2013-15
SUSIE MORONEY, PharmD, MS Regional Scientific Director in Immunology, Novartis, Fitchburg
JILL MICHAUD, PharmD, BCPS Region C Director 2013-15
MELISSA THEESFELD, PharmD Director-at-Large 2014-16
GEORGE GOSZ, RPh Region D Director 2014-16
DEAN ARNESON, PharmD, PhD Dean Concordia University Wisconsin
NICHOLAS OLSON, PharmD, BCACP, AAHIVP Region E Director 2013-15
STEVE SWANSON, PhD Dean UW School of Pharmacy
MICHAEL GILLARD, PharmD, BCPS Region F Director 2014-16
MARIA WOPAT, PharmD, BCACP, TTS Senior & LTC Section Chair 2014-2015
JORDAN DOW, MS, PharmD Director-at-Large 2013-15
BONNIE CHAON, CPhT Technician Section President 2014-2015
VANESSA FREITAG, PharmD Director-at-Large 2014-16
BRIDGET ELLERMAN CSPA Liaison
JANET FRITSCH, RPh Director-at-Large 2013-15
KRISTIN WIDMER President WSPS
GRETA NEMERGUT, PharmD Clinical Pharmacist, University of Wisconsin Hospital and Clinics, Madison MIKE OCHOWSKI, RPh, BBA Formulary Pharmacist, Group Health Cooperative of South Central Wisconsin, Madison
JANE S. BUBIK, PharmD Drug Information/Investigational Drugs Coordinator, Aurora St. Luke’s Medical Center, Milwaukee
ROHAN PRADHAN, PharmD Clinical Pharmacist, University of Wisconsin Hospital and Clinics, Madison
LOREN CARRELL, PharmD Clinical Pharmacist/Pharmacist in Charge, Gundersen Health System, La Crosse ANN EBERT, PharmD Perinatal Clinical Specialist, Meriter Hospital, Madison ASHLEY FELDT, PharmD, MBA Manager, Inpatient Pharmacy, Aurora St. Luke’s Medical Center, Milwaukee
KATHERINE ROTZENBERG, PharmD Drug Information Pharmacist, St. Mary’s Hospital, Madison RYAN SERVAIS, PharmD, BCPS Clinical Pharmacist, Aurora St. Luke’s Medical Center, Milwaukee ANTHONY G. STARESINIC, PharmD Clinical Pharmacy Consultant, Physicians Plus Insurance, Madison
JEFFREY FISH, PharmD, BCPS Senior Clinical Pharmacist, University of Wisconsin AARON L. STEFFENHAGEN, PharmD, BCPS Hospital and Clinics, Madison Pharmacy Manager, Patient Care Services and Emergency Preparedness, University of Wisconsin DAVE GRINDER, RPh, MS Hospital and Clinics, Madison Director of Pharmacy, Monroe Clinic, Monroe KATIE VALDOVINOS, PharmD, BCPS EMMA L. HEWS, PharmD Assistant Professor of Pharmaceutical Sciences, Manager, Inpatient Pharmacy Concordia University Wisconsin School of Aurora Sinai Medical Center, Milwaukee Pharmacy, Mequon JULIE KARPINSKI, PharmD, BCPS Drug Information Pharmacist, Pharmacy/ Drug Policy, Froedtert & The Medical College of Wisconsin, Milwaukee
PAUL WINDISCH, PharmD System Coordinator - Drug Use Policy, Aurora Health Care, Milwaukee
PSW Staff JESSICA BENJAMIN, PharmD ELLEN BRUMMEL ANNE CORY, MBA CHRISTOPHER DECKER, RPh ANNA LEGREID DOPP, PharmD ERIKA HORSTMANN, PharmD MEGAN GRANT EJA LARICO JOYLYN MOORE, PharmD
CHAD NECHVATAL, CPA ANH NGUYEN, PharmD, BCACP SARA LYNN PETERSON, PharmD LAURA RICHARDS KAY SCHELL KATHLEEN SKIBINSKI, MS, RPh SARAH SORUM, PharmD KARI TRAPSKIN, PharmD
Send correspondence to: Anna Legreid Dopp, PharmD, Pharmacy Society of Wisconsin, 701 Heartland Trail, Madison, WI 53717, phone: 608-827-9200, fax: 608-827-9292, thejournal@pswi.org Authors are encouraged to submit manuscripts to be considered for publication in The Journal. For Author Guidelines, see http://www.pswi.org/Get-Involved/Publish-articles-in-The-Journal Advertising inquiries: Megan Grant, Pharmacy Society of Wisconsin, 701 Heartland Trail, Madison, WI 53717, phone: 608-827-9200, fax: 608-827-9292, mgrant@pswi.org
JUSTIN PAUL KONKOL, PharmD, BCPS Clinical Pharmacy Manager, Froedtert & The Medical College of Wisconsin, Milwaukee The Journal of the Pharmacy Society of Wisconsin (ISSN 1098-1853) is the official publication of the Pharmacy Society of Wisconsin. Subscription included in membership dues. Non-member subscription $90 per year. Outside North America, add $60. Single copies $25 ($50 if outside North America). Periodical postage paid at Madison, WI and additional offices. Published bimonthly by the Pharmacy Society of Wisconsin, 701 Heartland Trail, Madison, WI 53717. Postmaster: Send address changes to PSW, 701 Heartland Trail, Madison, WI 53717. Opinions expressed by contributors do not necessarily reflect those of PSW.
2 The Journal January/February 2015
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correspondence
Up Front: What is Wisconsin Pharmacy’s Workforce Need?
other health care professionals to do; whether they are reimbursed in a reasonable way that will increase the interest in having people go into those professions.” Princeton health economist Uwe
by Chris Decker, RPh
Reinhardt points out that groups
Y
like the AAMC have a self-interest ou hear it so often it’s almost a cliché: The nation is facing a serious shortage of doctors, particularly doctors who practice primary care, in the coming years. But is that really the case? Kaiser Health News asked the question
to a group of experts in November. Many medical groups, led by the Association of American
Medical Colleges, say there’s little doubt. “We think the shortage is going to be close to 130,000 in the next 10 to 12 years,” says Atul Grover, the group’s chief public policy officer. But others, particularly health care economists, are less convinced. “Concerns that the nation faces a looming physician shortage, particularly in primary care specialties, are common,” wrote an expert panel of the Institute of Medicine (IOM) in a report on the financing of graduate medical education in July. The committee did not find credible evidence to support such claims. Gail Wilensky, a health economist and co-chair of the IOM panel, says previous predictions of impending shortages “haven’t even been directionally correct sometimes. Which is we thought we were going into a surplus and we ended up in a shortage, or vice versa.” Those warning of a shortage have a strong case. Not only are millions of Americans gaining coverage through the Affordable Care Act, but 10,000 baby boomers are becoming eligible for Medicare every day. And older people tend to have more medical needs. While few dispute the idea that there will be a growing need for primary care in the coming years, it is not at all clear whether all those primary care services have to be provided by doctors. “How many physicians we ‘need’ depends entirely on how the delivery system is organized,” Wilensky says. “What we allow
www.pswi.org
in saying there’s a shortage, to move more money towards the medical schools and hospitals it represents. “Anything that would move money their way they would favor,” he says. Reinhardt also says that a small shortage of physicians would probably be preferable to a surplus, because it would spur innovative ways to provide care. That is a sampling of what was found and reported by Kaiser. Consider a similar question facing pharmacy or, perhaps, with the rapid growth of pharmacy school graduates over the last decade, the opposite question is more apropos. Will there soon be too many pharmacists? The announcement by the Medical College of Wisconsin (MCW) in September, about its interest in opening a pharmacy school in Wisconsin, has many of the state’s pharmacists on edge. Mequon’s Concordia University just graduated its first class of pharmacy school graduates in May, 2014. With its current two pharmacy schools, Wisconsin will produce almost twice as many pharmacist graduates in the coming decade as during the prior twenty years. And while the number of graduates from Wisconsin’s pharmacy schools will double, which is on par with the national average, the number of pharmacy school graduates in Illinois is quadrupling. The dramatic rise is largely in response to an extended period of position vacancies, a general market undersupply of pharmacists from 1990-2010, and many academic centers seeking a business opportunity. Today, most in the pharmacy profession see equilibrium between the number of jobs and the number of jobseekers. More graduates could cause the scales to tip. There are other variables that affect the pharmacy job market in addition to current position vacancies and graduate counts. The number of pharmacist positions that require post-graduate
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3
residency training continues to rise, especially in hospitals and
profession, coupling supply with a market demand, such as in the
health systems. This growing expectation has increased interest
exploding business areas of information technology and intellectual
and demand for pharmacy residencies. Last year there were many
property, so too should health care. The pharmacy workforce
more graduates interested in a pharmacy residency program, across
should be tailored to meet the market needs, which will change.
the country, than there were residency positions—an increase in
Enabling pharmacists to practice “at the top of their licenses”,
the number of pharmacy school graduates will only further the
applying their education and skills learned in pharmacy school and
gap.
after, will be good for patients and liberating for the profession.
Conversely, there are a lot of pharmacists of baby boomer
PSW has asked MCW and the two pharmacy schools in the
age who are now nearing retirement. Will there be an increased
state to collaborate in the conduction of a Wisconsin market
rate of retirement of pharmacists over the next decade, thereby
analysis. They each enthusiastically agreed. There are manpower
causing a need for more graduates? What about the expanded
experts at the state’s universities that can evaluate the current
roles in primary care referenced in the Kaiser article? Certainly
market needs and perhaps provide insight to future needs. PSW
well-trained pharmacists could expand into these roles. Specialty
will help but, as with most professional issues, can’t act alone.
areas will continue to call for pharmacist expertise as well. But,
The state’s pharmacy practitioners, the Schools’ alumni, future
these advanced roles will likely require advanced training which, as
pharmacy school graduates, and pharmacist employers all have
mentioned, is in undersupply.
a vested interest in a well-balanced, well-trained, and aptly-
So, what is the profession to do? In my opinion, this complex and evolving market dynamic requires the profession’s leaders
distributed pharmacist and technician workforce. Wisconsin is not an island unto itself; state lines don’t inhibit
to act thoughtfully and responsibly. What does that mean? We
pharmacists from moving in one direction or another. But
must couple a long term view with short term actions. Short term
markets do tend to act regionally and PSW will do its best to
gains by universities, increasing the number of pharmacy school
enable Wisconsin to continue to be one of the very best states to
graduates, could be done-in over the long term, even in the near
pursue a pharmacy career and gain professional reward. Gauging
term, if a significant oversupply occurs.
demand, addressing supply, and creating new opportunities for
It’s commonly known that the legal profession has experienced a problem of oversupply for the past decade. Many recent law
professionally-driven pharmacists is the formula in which PSW is advocating. ●
school graduates never made it into a legal career. That’s not good for a profession or its professional schools. Adjusting supply to meet market demand, both up and down, rather than filling a certain, previously-specified number of seats is needed. And, perhaps, that is what has been occurring in pharmacy. Certainly the market was calling for more graduates over the past twenty
— Christopher J. Decker Executive Vice President & CEO
years. Will it continue? We must be vigilant and responsive to changes in the market. And, just as some specialty areas have emerged within the legal 4 The Journal January/February 2015
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correspondence “What are your professional goals for yourself and/or your practice for the upcoming year?” Editor’s note: In each issue of The Journal, PSW features Member Viewpoints – PSW member responses to key questions. Stay tuned to Fast Facts and the PSW Facebook page to weigh in on future questions. Ellina Pisetsky, PharmD PGY-2 Health-System Pharmacy Administration Resident William S. Middleton Memorial Veterans Hospital, Madison
As I am nearing the midway point of my PGY-2 year, my professional goals for the upcoming year are more malleable than in any previous years of my career. I hope to successfully carry out my PGY2 responsibilities, and start in on a new path. I envision starting a job where I feel I am impacting positive change, providing optimized patient care, advancing pharmacy practice, and leading people towards their goals. Outside of the dayto-day, I have a strong desire to become heavily involved in state and national pharmacy organizations to contribute to pharmacy advancement on a broader scale. Ed Portillo PGY-1/2 Health System Pharmacy Administration Resident William S. Middleton Memorial Veterans Hospital, Madison
One of my short-term goals for this year is to develop, implement, and analyze the impact of a new pharmacy service. I am currently working to develop a postdischarge clinic titled the “Hospital to Home Clinic” focused on medication education and disease state management. The clinic will serve patients at risk of having low-health literacy and patients will be seen by a pharmacist in-clinic within seven days of hospital discharge. In addition to gaining experience in project management, I hope to continue advancing www.pswi.org
my clinical skills this year by taking full advantage of the learning opportunities available. Steve Rough, MS, RPh, FASHP Director of Pharmacy, University of Wisconsin Hospital and Clinics, Clinical Associate Professor, UW School of Pharmacy Madison
My professional goal is to lead our talented team of 450+ pharmacy professionals at UW Health in achieving the 37 goals we have collectively set for this year. These goals align well with the UW Health Strategic Plan and are designed to advance the care of our patients and the practice of pharmacy. They fall within the following 10 domains and help to convey pharmacy’s value proposition to our organization and to the health care system: • Integration • Quality Distinction • Operational Excellence and Efficiency • Education, Training and Mentorship • Resource Utilization • Supply Chain Optimization • Revenue Cycle Optimization • Entrepreneurial Diversification • Employee Growth, Engagement and Customer Satisfaction • Corporate and Regulatory Compliance
Jessica Benjamin WPQC Operations Manager Pharmacy Society of Wisconsin Madison
As 2014 draws to a close, I reflect on this past year and the WPQC program’s accomplishments. As a WPQC Regional Implementation Specialist, I have logged thousands of miles in my car, travelling across the south central region of the state visiting community pharmacies that are providing WPQC MTM services. I have observed pharmacies initially sign up for WPQC, overwhelmed and nervous, but eager to start providing clinical services. These same pharmacies within the same year learned how to effectively recruit patients, use a MTM software platform, collaborate with physician offices to generate referrals, and improve the health outcomes and quality of life for the patients they serve! These pharmacies are an inspiration. My personal goal for 2015 is to assist the WPQC pharmacies in my region with integration of WPQC workflows into the general pharmacy workflows and making provision of WPQC services both efficient and sustainable.
March/April 2015 Member Viewpoints Question:
What one piece of advice would you provide a student graduating from pharmacy school this May? To submit a response, please email Sarah Sorum at sarahs@pswi.org. Accompanying your response should be a high resolution headshot (preferably a minimum of a wallet size at 300 dpi or greater).Deadline to submit a response is January 21st.
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thecover
The Biennial Wisconsin Pharmacist Workforce Survey: 2013 Results The most recent survey of pharmacists' work hours, compensation, and activities is summarized in the article, as an update for this traditional survey that has been conducted every two years since 1977. by David H. Kreling, PhD and David A. Mott, PhD
Abstract Objectives: Obtain current information on characteristics of the pharmacist workforce in Wisconsin. Methods: A mail survey was sent to a systematic random sample of 1,000 pharmacists to gather data on primary employment work setting and position, hours worked, and compensation (as reported hourly wage rates and calculated based on reported gross base pay per pay period). Data on additional earnings and secondary employment also were gathered. Results: A 46% response rate yielded 457 usable responses, with 382 in practice, 17 in pharmacy-related careers, 47 retired (including 12 still working), 5 in non-pharmacy careers, and 6 unemployed. The overall average hours worked per week was 41.4 hours, the average hourly rate was $60.19, and annual earnings averaged $122,307. Managers earned more and worked more hours than staff pharmacists. Pharmacists working in south-central Wisconsin had the lowest hourly pay rates and annual earnings, partly due to fewer hours worked per week by staff pharmacists. Across pharmacies, wages (and earnings) were lower for pharmacists in independent settings and highest in hospital and chain pharmacies. Change in compensation for pharmacists generally was consistent with overall inflation. Some addition to base compensation (e.g., overtime, bonus, etc.) was received by 43% of pharmacists and averaged just over $7,000. Only 8% of pharmacists reported having secondary employment adding to their total workforce contribution. Conclusions: In the past biennium, pharmacists kept pace with inflation in hourly wage rates and annual earnings but the current trend is lower than historic levels exceeding inflation, possibly signaling a more balanced supply and demand in the workforce. 6  The Journal January/February 2015
K
ey workforce characteristics for pharmacists in Wisconsin, including compensation, work hours, and other characteristics have been collected via biennial surveys since the late 1970s. The consistent surveys have allowed trends in employment, earnings, and hours worked to be tracked through the years as dynamic changes both internal and external to pharmacy and practice have occurred. Here we describe findings from the most recent 2013 survey, with a focus on employee pharmacists in Wisconsin.
Methods
We obtained a listing of licensed pharmacists with a Wisconsin address (assumed residence) from the Wisconsin Department of Safety and Professional Services. This list of 5,632 pharmacists served as a sampling frame and we selected systematic random samples from pharmacists stratified by estimated age (based on year of licensure) to achieve a total sample of 1,000 pharmacists. Our primary interest was characteristics and contribution to the workforce among working pharmacists, so we oversampled pharmacists presumed to be of working
TABLE 1. Place of Employment of Responding Pharmacists
Number of Respondents
Community Independent
43
Independent Community Pharmacy
43
Community Corporate
130
Chain Community Pharmacy
86
Mass Merchandiser
31
Supermarket Pharmacy
13
Hospital/Heatlh System
148
Inpatient Hospital
130
Outpatient Hospital
18
Specialty Patient Care/Specialty Products
64
Clinic-based Pharmacy
30
Nursing Home
29
Mail Order Pharmacy
3
Home health
2
Other Pharmacists
26
Pharmacy Benefits Administration
13
Education/Teaching
5
Other
5
Pharmaceutical Industry
3
Note: Table includes all respondents who reported practicing as a pharmacist, retired but still practicing, or employed in a pharmacy-related field. Other pharmacists included investigational drugs, informatics, staffing agencies, and waste management pharmacists.
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www.pswi.org
FIGURE 1. Wisconsin Regions
age. The final sample included 965 pharmacists (out of 5,213) estimated to be of working age (less than 65 years old), 25 pharmacists (out of 242) aged 65 to 70 years old, and 10 pharmacists (out of 197) more than 70 years old. Survey packets containing a cover letter, survey, and stamped, postage paid return envelope were mailed in late September. In late October, a second packet with a reminder letter, survey, and a stamped return envelope was sent to all non-respondents. Completed survey responses received by the end of 2013 were included in the analyses. The study was approved by the University of Wisconsin- Madison Education and Social/Behavioral Science Institutional Review Board. The survey form was similar to that used in previous studies; it included questions about work setting and position, hours worked in the respondent's primary employment, compensation (e.g. hourly wage rate and gross base pay per pay period), and time spent in different professional activities (e.g., medication dispensing, patient care services, management, etc.). A general question about whether compensation had changed in the past year and for what reasons (hours, hourly rate, position, duties) was included to allow respondents who were not interested in sharing specific compensation information to provide some insight into pay dynamics in the market. Questions about hours and compensation for secondary employment also were included. Annual earnings were calculated by the authors based on reported gross pay per pay period for primary employment. As in previous surveys and reports, the base annualized earnings were used to avoid distortions and variations from additions to earnings such as bonuses, overtime, and other additions to the base salary that can be inconsistent and irregular. The results in this report concentrate on responses from employee pharmacists working full time, defined as working 30 or more hours per week and for a full year (at least 47 weeks of the year, including paid time off). Additionally some selected results are provided www.pswi.org
for pharmacy owners and part-time pharmacists to provide broader coverage of pharmacists in the state workforce. The state of Wisconsin was divided into four regions as in previous survey reports (See Figure 1.) and responses were assigned to a region based on the zip code of the primary employment setting reported by pharmacists. For reporting, specific practice settings reported by pharmacists were categorized into five main groups, community independent, community chain, hospital, specialty patient care TABLE 2. Salary, Hourly Rate and Work Hours by Region, Setting and Position Annual Salary Average
Hourly Rate
Range
Actual Work Hours
Average
Average
Range
$60.19
41.4
30-65
Statewide Total (n=303)
$122,307
$73,320 - $184,002
Region 1 Community Independent Managers (n=4)
$108,200
$93,600 - $124,800
$52.25
41.0
36-46
Total (n=5)
$108,221
$93,600 - $124,800
$52.80
40.2
36-46
Community Chain Managers (n=13)
$124,802
$95,550 - $143,000
$61.35
41.0
30-50
Staff (n=15)
$118,478
$97,760 - $128,960
$60.43
39.9
33-48
Total (n=28)
$121,377
$95,550 - $143,000
$60.85
40.4
30-50
Hospital Managers (n=13)
$138,315
$128,924 - $149,000
$65.73
46.3
33-60
Staff (n=16)
$124,306
$109,200 - $135,200
$60.99
38.6
30-46
Total (n=22)
$129,559
$109,200 - $149,000
$62.25
40.7
30-60
Specialty Staff (n=11)
$102,901
$88,218 - $116,816
$61.25
38.2
30-50
Total (n=13)
$103,245
$88,218 - $116,816
$59.66
39.5
30-60
Total (n=70)
$119,704
$88,218 - $149,000
$60.28
40.3
30-60
$59.00
42.6
38-50
Overall
Region 2 Community Independent Total (n=5)
$130,000
$120,540 - $139,360 Community Chain
Managers (n=15)
$132,303
$100,152 - $158,002
$62.95
43.7
36-50
Staff (n=22)
$119,228
$102,336 - $133,120
$60.18
38.3
30-44
Total (n=37)
$126,310
$100,152 - $158,002
$61.46
40.5
30-50
Managers (n=7)
$141,994
$125,100 - $159,557
$65.29
48.4
40-60
Staff (n=25)
$126,558
$94,640 - $166,400
$61.10
39.1
30-60
Total (n=32)
$129,808
$94,640 - $166,400
$61.93
41.2
30-60
Hospital
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Specialty Managers (n=5)
$139,593
$128,986 - $148,200
$63.17
43.2
38-52
Staff (n=4)
$110,018
$100,100 - $120,530
$60.01
37.3
34-35
Total (n=9)
$119,543
$100,100 - $148,200
$61.36
40.6
34-52
Total (n=86)
$126,487
$94,640 - $166,400
$61.50
41.1
30-60
Overall
Region 3
Results
Community Independent Staff (n=8)
$95,319
$79,560 - $112,000
$51.39
36.5
30-50
Total (n=9)
$97,779
$79,560 - $114,998
$51.84
38.0
30-50
Community Chain Managers (n=13)
$131,000
$112,986 - $148,200
$61.31
44.4
40-50
Staff (n=15)
$119,316
$95,004 - $129,194
$61.10
38.4
30-45
Total (n=28)
$124,590
$95,004 - $148,200
$61.20
41.2
30-50
Hospital Managers (n=10)
$141,950
$114,764 - $167,440
$66.45
47.0
40-52
Staff (n=32)
$115,880
$87,100 - $143,000
$57.15
39.8
32-50
Total (n=42)
$122,899
$87,100 - $167,440
$59.63
41.5
32-52
$54.16
35.0
30-40
Other Total (n=5)
$93,990
$73,320 - $125,658 Specialty
Managers (n=3)
$113,856
$106,912 - $126,655
$54.38
48.3
45-50
Staff (n=6)
$115,823
$110,162 - $124,722
$53.00
42.3
40-46
Total (n=9)
$114,980
$105,912 - $126,655
$53.59
44.3
40-50
$58.17
41.0
30-52
NA
42.0
40-44
Overall Total (n=93)
$117,087
$73,320 - $167,440
Region 4 Community Chain Managers (n=3)
NA
Staff (n=11)
$124,383
$109,200 - $135,980
$64.18
40.1
35-60
Total (n=14)
$127,430
$109,200 - $143,156
$64.22
40.5
35-60
$69.67
54.5
45-65
Hospital Managers (n=4)
NA
Staff (n=23)
$127,029
$104,000 - $166,920
$59.62
43.1
32-55
Total (n=27)
$127,296
$104,000 - $166,920
$60.87
44.8
32-65
Specialty Managers (n=3)
$133,665
$127,941 - $137,856
$63.26
46.7
45-50
Staff (n=7)
$129,841
$117,442 - $150,410
$60.15
43.7
40-55
Total (n=10)
$130,988
$117,442 - $150,410
$60.93
44.5
40-55
$61.26
43.9
32-65
Overall Total (n=571)
$128,198
$97,364 - $184,002
Breakdowns by position and setting are shown only where 3 or more responses were available (NA for less than 3 responses). Overall totals for regions and state include all responses. The Ns reported are for hours worked; for compensation data the Ns are lower. Weekly hours are reported as actual hours worked per week as reported - scheduled hours that pay is based on are lower.
8  The Journal January/February 2015
or products, and other. Pharmacists also reported their current position as management (e.g., director, manager, assistant manager, supervisor) or staff (e.g., clinical pharmacist, consultant, staff pharmacist, relief pharmacist) in their primary place of employment. Of the 1,000 mailed surveys, 14 were not deliverable due to expired or outof-state forwarding addresses. Of the 986 presumed delivered surveys, 462 were returned, including 4 blank forms from pharmacists that did not want to participate and one form from the family of a deceased pharmacist. Of the 457 usable responses (a 46.3% response rate), 382 (83.6%) were practicing pharmacists, 17 (3.7%) were not practicing pharmacy but employed in a pharmacyrelated career, 12 (2.6%) were retired but still working as a pharmacist, 35 (7.7%) were retired and not practicing at all, 5 (1%) were employed in non-pharmacy related careers, and 6 (1.3%) were unemployed (four seeking jobs and two not seeking employment). Compared to the 2011 survey, fewer respondents were retired and still working and more were retired and not working (7.6% and 4.1%, respectively in 2011), and the response rate was lower than the 54.6% response rate in 2011.1 Table 1. shows the practice settings and main category groupings for respondents providing setting information. The current responses included slightly higher proportions of hospital and specialty care pharmacists and lower proportions of community (chain and independent) than occurred for the 2011 survey. Employee Pharamacist Results The annual salary, hourly rate and work hours for full-time employee pharmacists within each of the four Wisconsin regions is summarized in Table 2. Region 3 had the lowest overall average annual salary and hourly pay rate, with the hourly rate more than $2 below any of the other three regions. There also tended to be fewer hours worked among staff pharmacists in Region 3, contributing to the lower annual salary. As would be expected, managers earned more than staff pharmacists, but managers in chain settings throughout the
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regions had a smaller increment in hourly rate relative to staff pharmacists. Table 3. combines earnings, work hours, age, and years of experience for pharmacists categorized by setting, position, and gender. Pay rates for pharmacists in independent pharmacies were lower than other practice settings. The hourly pay rates were highest in hospital and chain pharmacies; managers in hospitals had the highest hourly pay rates (and very high hours worked per week), but staff hourly pay in chain pharmacies was highest. From a gender comparison perspective, men had higher hourly pay rates than women and several factors may contribute to that difference; men generally worked slightly more hours and they were older and had more years in practice. The oldest pharmacists were in independent staff positions and the biggest gaps in age differences between men and women pharmacists were in independent pharmacies. Compensation and hours worked by pharmacists with different years of experience are summarized in Table 4. Overall, there is a relatively flat ageexperience profile - pharmacists with the least experience (1 to 4 years) earned $56.40 per hour and pharmacists with the most experience (20 or more years) earned $61.80 per hour - this difference in hourly rate amounts to just over $11K when annualized by 2080 hours (40 hours per week for 52 weeks). Pharmacists in community chain settings had the least variability across all year of experience categories, only $1.34 difference per hour between the highest and lowest experience group averages. A contributor to this very small difference in chain pharmacist hourly rates by experience is the higher proportions of managers in the less experienced categories. Pharmacists in hospital settings had the most consistent increase in hourly pay rate as experience increased; there was over $10 difference in average hourly rate between the lowest and highest experience categories. Contributing to this difference was a consistent increase in the percent of respondents that were managers at 10 years of experience and beyond. Compensation Survey Trends Table 5. continues previous Wisconsin www.pswi.org
TABLE 3. 2013 Salary, Hourly Wage, Work Hours, Age, and Years of Practice by Gender and Practice Site Combined Totals Annual Salary
Hourly Rate
Actual Hours Per Week
Paid Hours Per Week
Age
Years in Practice
Male (n=164)
$124,760
$60.83
42.4
39.3
46.6
21.1
Female (n=159)
$118,691
$59.52
40.4
38.0
40.8
14.9
Total (n=323)
$122,080
$60.19
41.6
38.7
43.8
18.0
Community Independent Managers Male (n=3)
$122,200
$57.25
41.0
40.5
50.0
25.5
Female (n=4)
$107,666
$53.33
42.7
38.7
37.0
11.0
Total (n=7)
$115,971
$55.57
41.7
39.7
44.4
19.3
$98,866
$50.37
39.2
39.2
62.4
38.6
Female (n=10)
$102,272
$52.00
39.9
37.4
43.4
14.7
Total (n=15)
$101,137
$51.35
39.7
38.0
49.7
22.7
Staff Male (n=5)
Community Chain Managers Male (n=28)
$129,993
$62.22
43.5
40.4
43.7
16.8
Female (n=19)
$130,227
$62.02
42.4
40.7
37.8
12.3
Total (n=47)
$130,090
$62.14
43.0
40.5
41.4
15.0
Male (n=37)
$119,643
$60.74
39.4
38.3
50.3
24.6
Female (n=28)
$117,729
$61.53
37.9
37.1
41.4
16.0
Total (n=65)
$119,061
$61.03
38.7
37.8
46.5
21.0
Staff
Hospital Managers Male (n=16)
$140,098
$67.80
49.0
40.0
46.1
21.4
Female (n=13)
$141,533
$64.67
46.2
40.4
43.5
17.3
Total (n=29)
$140,702
$66.09
47.8
40.2
44.9
19.6
Male (n=44)
$122,365
$59.43
40.8
39.0
42.7
17.4
Female (n=56)
$122,439
$59.27
39.7
37.7
39.8
13.7
Total (n=100)
$122,397
$59.34
40.2
38.3
41.1
15.4
Staff
Specialty Managers Male (n=11)
$127,242
$60.73
47.3
39.9
47.7
22.2
Female (n=4)
$124,170
$58.38
44.0
39.2
44.0
20.2
Total (n=15)
$126,474
$60.19
46.4
39.7
46.7
21.7
Male (n=12)
$122,667
$59.86
41.1
38.4
47.0
22.6
Female (n=17)
$107,786
$57.79
39.8
37.6
43.9
18.3
Total (n=29)
$114,903
$58.73
40.3
37.9
45.2
20.0
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9 
Staff
January/February 2015
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Other Managers Male (n=5)
$151,541
NA
50.0
40.0
52.2
28.2
NA
NA
43.3
36.7
43.7
17.7
$135,747
$63.67
17.5
38.7
49.0
24.2
Female (n=6)
$94,895
$55.54
38.7
34.0
35.6
10.5
Total (n=8)
$99,196
$55.03
39.4
35.5
35.4
9.2
Female (n=3) Total (n=8) Staff
Note: Breakdowns by position and gender shown only where 3 or more responses were available. Combined totals include all responses. Years in practice based on year of first licensure in Wisconsin.
Biennial Pharmacist Workforce survey results on trends in pharmacist compensation relative to inflation. As with many years of results, some different signals result in the annual, hourly, and setting specific levels, but overall, pharmacist
compensation trends are quite consistent with overall inflation. The annual and hourly rate change for community pharmacists were lower than for hospital pharmacists, but combined, annual earnings grew more than inflation and
hourly rates slightly less. These changes are a rebound from changes below inflation reported in the 2011 survey results.1 Additional insights about compensation from this year's survey are available in responses to more general questions about compensation changes. When asked, 72% of responding pharmacists reported they received an increase in their base pay during the past year, with only 6% reporting a decrease and 22% reporting no change. Most commonly, for pharmacists reporting an increase in base income or compensation, it was due to a change in their hourly pay rate and the average percent change reported during the past year was 2.4%. These responses suggest that pharmacist compensation continues to increase, but not so dramatically as
TABLE 4. Salary, Hourly Rate and Work Hours by Years of Experience Annual Salary Average
Range
Weekly Hours
Hourly Rate Average
Average
Range
Percent Managers
Percent Female
1 to 4 Years Experience Community Independent (n=4) Community Chain (n=24)
$99,403
$93,600 - $104,988
$49.04
44.0
36-50
25%
100%
$125,460
$104,000 - $139,384
$61.19
42.4
35-50
54%
37%
Hospital (n=29)
$111,922
$89,960 - $128,294
$54.50
42.7
32-65
17%
45%
Specialty (n=7)
$111,638
$106,912 - $118,560
$54.41
42.1
35-50
43%
43%
Total (n=67)
$115,041
$72,000 - $139,384
$56.40
42.7
32-65
49%
46%
5 to 9 Years Experience Community Chain (n=21)
$130,041
$102,336 - $143,156
$62.46
40.3
30-50
57%
81%
Hospital (n=29)
$123,898
$88,062 - $143,996
$58.06
41.6
30-60
17%
69%
Total (n=59)
$123,552
$76,892 - $143,996
$59.21
41.1
30-60
34%
75%
$56.37
40.4
30-50
60%
80%
10 to 19 Years Experience Community Independent (n=5)
$111,128
$93,600 - $120,640
Community Chain (n=13)
$122,713
$93,600 - $148,200
$62.25
38.8
30-44
31%
31%
Hospital (n=18)
$131,421
$87,100 - $166,400
$64.14
41.4
30-60
22%
72%
Specialty (n=9)
$131,136
$110,162 - $150,410
$62.36
43.0
35-55
22%
44%
Other (n=5)
$102,729
$73,320 - $143,520
$59.09
42.0
30-55
60%
60%
Total (n=50)
$122,947
$73,320 - $166,400
$61.87
41.0
30-60
32%
56%
Community Independent (n=11)
$108,707
$79,560 - $139,360
$53.21
40.3
30-50
27%
27%
Community Chain (n=54)
$120,818
$94,286 - $158,002
$61.12
40.2
30-60
33%
31%
Hospital (n=53)
$134,628
$102,518 - $167,440
$64.56
41.7
32-60
28%
43%
20 or More Years Experience
Specialty (n=23)
$116,031
$88,218 - $144,040
$59.93
41.3
30-60
35%
48%
Other (n=5)
$145,009
$125,658 - $184,002
NA
48.0
40-60
80%
40%
Total (n=146)
$124,552
$79,560 - $184,002
$61.80
41.2
30-60
33%
38%
$60.20
41.5
30-65
33%
49%
All Pharmacists Total (n=322)
$122,075
10  The Journal January/February 2015
$72,000 - $184,002
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TABLE 5. Trends in Pharmacist Compensation 1977 to 2013 Community
Hospital
Combined
Annual Compensation
Percent Increase
Annual Compensation
Percent Increase
Annual Compensation
Percent Increase
CPI Change
1977
$17,863
---
$17,420
---
$17,642
---
---
1979
$19,552
9.5%
$20,124
15.5%
$19,838
12.5%
19.8%
1981
$22,724
16.2%
$23,192
15.2%
$22,958
15.7%
25.2%
1983
$25,688
13.0%
$27,560
18.8%
$26,624
15.9%
9.6%
1985
$29,224
13.8%
$29,744
7.9%
$29,484
10.8%
8.0%
1987
$33,176
13.5%
$33,436
12.4%
$33,306
13.0%
5.6%
1989
$38,272
15.4%
$38,844
16.2%
$38,558
15.8%
9.2%
1991
$45,136
17.9%
$43,680
12.4%
$44,408
15.2%
9.8%
1993
$51,064
13.1%
$49,140
12.5%
$50,102
12.8%
6.1%
1995
$59,592
16.7%
$56,160
14.3%
$57,876
15.5%
5.3%
1997
$62,057
4.1%
$60,556
7.8%
$61,307
6.0%
5.5%
1999
$69,304
11.7%
$66,692
10.1%
$67,998
10.9%
3.8%
2001
$81,433
17.5%
$78,564
17.8%
$79,999
17.7%
6.3%
2003
$90,921
11.7%
$91,141
16.0%
$91,031
13.9%
4.1%
2005
$96,197
5.8%
$97,625
7.1%
$96,911
6.5%
6.1%
2007
$107,560
11.8%
$110,149
12.8%
$108,855
12.3%
6.2%
2009
$113,737
5.7%
$113,584
3.1%
$113,683
4.4%
3.5%
Year
2011
$117,927
3.7%
$115,131
1.4%
$116,646
2.6%
4.8%
2013
$120,530
2.2%
$126,700
10.0%
$123,286
5.7%
3.6%
Community
Hospital
Combined
Hourly Rate
Percent Increase
Hourly Rate
Percent Increase
Hourly Rate
Percent Increase
CPI Change
1977
$7.98
---
$8.37
---
$8.18
---
---
1979
$8.54
7.0%
$9.43
12.7%
$8.99
9.8%
19.8%
Year
1981
$9.93
16.3%
$10.88
15.4%
$10.41
15.8%
25.2%
1983
$11.49
15.7%
$12.93
18.8%
$12.21
17.3%
9.6%
1985
$13.07
13.8%
$13.95
7.9%
$13.51
10.8%
8.0%
1987
$14.50
10.9%
$15.68
12.4%
$15.09
11.7%
5.6%
1989
$17.52
20.8%
$18.22
16.2%
$17.87
18.5%
9.2%
1991
$20.67
18.0%
$20.49
12.5%
$20.58
15.2%
9.8%
1993
$23.38
13.1%
$22.50
9.8%
$22.94
11.5%
6.1%
1995
$27.29
16.7%
$27.00
20.0%
$27.15
18.4%
5.3%
1997
$29.07
6.5%
$28.12
4.1%
$28.60
5.3%
5.5%
1999
$33.13
14.0%
$32.75
16.5%
$32.94
15.3%
3.8%
2001
$39.69
19.8%
$39.22
19.8%
$39.46
19.8%
6.3%
2003
$44.34
11.7%
$44.51
13.5%
$44.43
12.6%
4.1%
2005
$47.73
7.6%
$47.60
6.9%
$47.67
7.3%
6.1%
2007
$52.88
10.8%
$53.81
11.5%
$53.35
11.2%
6.2%
2009
$55.92
5.7%
$55.97
4.0%
$55.94
4.9%
3.5%
2011
$59.38
6.2%
$57.16
2.1%
$58.36
4.3%
4.8%
2013
$59.89
0.9%
$60.90
6.5%
$60.39
3.5%
3.6%
Note: Community = independent and chain pharmacists only. CPI is the consumer price index for all goods. www.pswi.org
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11 
TABLE 6. Additional Compensation (Average Amount, Percent Receiving Some Compensation, Range of Compensation) by Setting and Position Overtime
Annual Bonus
Profit Sharing
Other Earning Additions
Total Additions to Earnings
Secondary Employment
Community Independent Managers (n=7) Staff (n=15) Total (n=22)
$1,933; 43%; $800-$4,000
$6,200; 57%; $800-$16,000
$12,017; 20%; $50-$26,000
$8,454; 33%; $50-$26,000
$6,975; 27%; $50-$26,000
$7,452; 41%; $50-$26,000
$2,681; 14%; $1,044-$4,000
Community Chain Managers (n=47)
$3,084; 34%; $200-$10,000
$8,189; 62%; $137-$31,576
$5,103; 17%; $750-$17,000
$11,055; 64%; $300-$49,416
Staff (n=65)
$5,475; 34%; $285-$15,900
$2,979; 42%; $300-$6,246
$4,405; 17%; $700-$7,800
$4,556; 6%; $2,500-$10,000
$6,689; 62%; $300-$20,900
Total (n=112)
$4,468; 34%; $200-$15,900
$5,677; 50%; $137-$31,576
$4,699; 17%; $700-$17,000
$4,445; 4%; $2,500-$10,000
$8,560; 62%; $300-$49,416
$16,867; 3%; $5,000-$35,000
$8,261; 31%; $650-$30,000
$11,600; 10%; $10,000-$14,800
Hospital Managers (n=29)
$10,314; 24%; $1,400-$30,000
Staff (n=100)
$2,889; 21%; $78-$12,806
$5,442; 7%; $650-$15,000
$3,158; 4%; $200-$11,635
$2,653; 8%; $10-$10,400
$4,278; 31%; $40-$15,452
$10,351; 12%; $800-$29,437
Total (n=129)
$2,889; 16%; $78-$12,806
$7,878; 11%; $650-$30,000
$3,158; 3%; $200-$11,635
$2,337; 8%; $40-$10,400
$5,174; 31%; $40-$30,000
$11,601; 12%; $800-$29,437
Specialty Managers (n=15)
$3,950; 27%; $2,000-$6,000
$3,942; 40%; $2,000-$6,000
Staff (n=29)
$2,640; 17%; $500-$7,600
$1,933; 10%; $300-$3,500
$3,623; 21%; $600-$7,000
$3,395; 41%; $300-$14,600
Total (n=44)
$2,444; 18%; $500-$7,600
$3,086; 16%; $300-$6,000
$3,320; 16%; $600-$7,000
$3,577; 41%; $300-$14,600
$8,779; 9%; $3,118-$15,000
Other Managers (n=8)
$17,333; 37%; $2,000-$30,000
$17,333; 37%; $2,000-$30,000
$14,250; 25%; $2,000-$30,000
$12,068; 31%; $341-$30,000
Staff (n=8) Total (n=16)
Overall Managers (n=106)
$2,985; 20%; $200-$10,000
$8,332; 43%; $137-$31,576
$5,870; 8%; $750-$17,000
$1,912; 4%; $650-$4,000
$9,740; 49%; $300-$49,416
$13,845; 7%; $3,118-$35,000
Staff (n=217)
$3,914; 23%; $78-$15,900
$4,034; 19%; $50-$26,000
$3,898; 8%; $200-$11,635
$3,378; 9%; $40-$10,400
$5,461; 41%; $40-$26,000
$9,951; 8%; $800$29,437
Total (n=333)
$3,639; 21%; $78-$15,900
$6,307; 26%; $50-$31,756
$4,580; 8%; $200-$17,000
$3,123; 7%; $40-$10,400
$7,028; 43%; $40-$49,416
$11,041; 8%; $800-$35,000
Note: Ns are the total number of pharmacists in that setting and position. Data reported only where 3 or more responses occurred.
some years when pay increases exceeded inflationary trends considerably. Additional Compensation Overall, 43% of responding pharmacists reported receiving some sort of addition to their base earnings, as overtime, bonus, profit sharing, or other mechanisms. The average amount of additional compensation was just over $7,000. The 12  The Journal January/February 2015
overall proportion of pharmacists having additions to income was less than in 2011, when 62% of all respondents reported some additional compensation and the overall average amount also was less ($8,687 in 2011).1 As in previous years, bonuses were the most common additions to base earnings and bonuses were most prevalent in community settings, especially chain pharmacies. Bonuses occurred for
managers more often than for staff and typically in higher amounts. Overtime pay was the second most common addition to earnings with just over 20% of pharmacists reporting some overtime income. However, overtime earnings were less prevalent and added lower amounts to pharmacists' overall compensation in 2013 compared to the previous survey in 2011.1 The respondents that reported overtime
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additions to income were slightly younger (not significantly), and not proportionally different in representation among men and women. Contributing to the workforce via secondary employment positions occurred for 8% of the pharmacist respondents (including three individuals that had 2 second jobs) and these positions added just over $11,000 in compensation for those pharmacists. The overall rate of secondary employment was the same as in 2011, but in the current survey (2013), the proportions of manager and staff pharmacists that had secondary employment were very similar and, interestingly, the main cohort of pharmacists that took on secondary employment was hospital pharmacists. The average age of male pharmacists with secondary positions was younger whereas such female pharmacists were slightly older than their colleagues working only one job. Part-Time Pharmacists Of all respondents reporting actively practicing pharmacy, 49 (12.8%) reported working part-time (less than 30 hours per week). Table 7. summarizes the work hours and hourly pay rates for these part-time pharmacists. The part-time pharmacists were predominantly women (88%) and quite evenly distributed across practice settings. In each setting and across gender, the average hours worked were similar, approximately 20 hours per week. The
hourly rates across settings generally were consistent with full-time staff pharmacist pay rates in Table 3, but with some variation related to a high hourly rates for a few part-time pharmacists in hospital settings. There also were 12 pharmacist respondents that reported being retired, but still working part-time; all but one of these pharmacists were male (data not shown). For 10 of these pharmacists reporting hours worked, they averaged 12.9 hours per week, ranging from 3 to 25 hours engagement in the workforce; their hourly pay rate ranged from $35.00 to $64.26 and averaged $58.25 (without the $35.00 outlier). Overall, there were fewer parttime pharmacist respondents to this most recent survey. Combined, the 61 part-time pharmacists represented 13.3% of the respondents, 2.6% retired but still working; in contrast, the 2011 survey had 18.2% of respondents that worked on a part-time basis, with 8.5% retired but still working.1 Owner Pharmacists A total of 12 owners responded to the survey, 3 women and 9 men. These pharmacists worked in pharmacies throughout the state (all Regions except for Region 4) and, on average, were 50.2 years old (ranging from 40 to 66 years old). They worked an average of 44.2 hours per week (range 30 to 60 hours) with total compensation (base pay, plus all additions) averaging $145,046 (ranging from $80,892
TABLE 7. Hourly Wage and Weekly Duty Hours for Part-Time Pharmacists by Practice Setting and Gender Hourly Wage Rate Mean
Range
Actual Weekly Hours Mean
Range
Part-Time/ Full-Year Practice Setting Community Independent (n=8)
$54.89
$51.90 - $61.00
21.7
18 - 27
Community Chain (n=13)
$59.44
$56.00 - $61.50
21.2
8 - 28
Hospital (n=13)
$61.77
$52.00 - $71.81
21.6
5 - 29
Specialty (n=13)
$57.01
$46.00 - $63.00
19.9
4 - 28
Total (n=49)
$59.79
$46.00 - $85.00
21.0
4 - 29
to $240,000) among 9 owners providing earnings information. The wide variability of reported earnings reflects considerable differences in how owners structured both the level and composition of their compensation packages.
Conclusion
These latest biennial compensation survey results show that pharmacists kept pace with inflation in hourly rates and annual earnings. However, changes in compensation that merely match inflation are lower than many of the historic trends in earnings and may indicate that the pharmacist shortages that drove wages up may be abating; a more balanced pharmacist workforce supply and demand may be present. Other signals of a balanced workforce in this year's results include fewer pharmacists with secondary employment positions and a slightly higher proportion of actively practicing pharmacists working part-time but fewer retired pharmacists still working part time. Future surveys will reveal whether the most recent changes are blips in the trends, or a sign of things to come. Additional information and results will help delineate the workforce dynamics. Thanks to all the pharmacists who have been willing to respond to our survey requests and provide data to document workforce parameters and trends in Wisconsin for over three decades. â—? David H. Kreling is a Professor of Social and Administrative Pharmacy at the University of Wisconsin School of Pharmacy in Madison, WI and David A. Mott is a Professor and Hammel/ Sanders Chair in Social and Administrative Pharmacy at the University of Wisconsin School of Pharmacy in Madison, WI. Study Funding: This study was supported by general research funds and funds associated with the Hammel/Sanders Chair in Social and Administrative Pharmacy at the UW School of Pharmacy. The authors have no conflicts to report.
References
Gender Male (n=6)
$64.43
$46.00 - $75.40
20.7
16 - 24
Female (n=43)
$59.09
$55.63 - $85.00
21.1
4 - 29
1. Kreling DH, Mott DA, Faerber AE. The 2011 Biennial Wisconsin Pharmacist Workforce Survey. J Pharm Soc Wisc 2012; 3; 28-35.
Part time employment was defined as fewer than 30 paid hours per week. Number of respondents reflects the numbers reporting hours worked and total includes 2 'Other' setting respondents; numbers reporting hourly rate were lower (N = 38 total). www.pswi.org
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pharmacypractice feature
WPQC UPDATE:
ForwardHealth CMR/A Prior Authorization. Call DAPO at 1-800-947-9627 (Option 3)
ForwardHealth Goes Live with Aprexis Health Solutions Push Opportunities Released to Pharmacies By: Danielle Leach, PharmD and Kari Trapskin, PharmD
I
n August 2014, the Wisconsin Department of Health Services designated Aprexis Health Solutions™ as an approved Medication Therapy Management (MTM) vendor for Medicaid and Senior Care members. Since then, ForwardHealth has released eligibility, prescription and medical claims information for over 400,000 of its members to the Aprexis platform. On Wednesday, November 12th, the new ForwardHealth pushes were released to Aprexis pharmacy queues. Thousands of pushed opportunities were sent to the over 300 WPQC-accredited pharmacies. Intervention-based (Level I) pushes are appearing first in the queues, followed by Comprehensive Medication Review and Assessment (CMR/A) (Level II) pushes toward the end of hte list. One patient may have multiple pushes available, which can be determined by clicking the patient’s name and viewing his or her Aprexis profile. This feature is especially helpful to determine if a patient has pushed opportunities for both Level I and Level II services. For efficiency, the Level I interventions could be addressed
WPQC callout Live Aprexis Trainings Location: the Pharmacy Society of Wisconsin and Concordia School of Pharmacy Dates: January 15th and January 27th; January 16th (respectfully) Time: 10:00 am - 2:45 pm Registration: FREE! Visit http://www.pswi.org/ Education/WPQC-Aprexis-Training 14 The Journal January/February 2015
during the Level II service or could be an opportune time to interest the patient in returning for a Level II service.
ForwardHealth Level II Prior Authorizations Required Even though Aprexis is now an approved MTM vendor for ForwardHealth, pharmacies still must call Drug Authorization Policy Override (DAPO) center for a prior authorization before conducting a CMR/A service. For ForwardHealth patients, the prior authorization from DAPO for a CMR/A includes the initial visit and three subsequent follow-up visits with the following requirements:
• The initial CMR/A must be performed within 60 days of the approval date or a new authorization must be obtained. • The three follow-up visits are valid for one year from the original approval date. Since the follow-up visits are tied to the initial CMR/A, it is not necessary to obtain separate approvals from DAPO prior to performing follow-up visits. • After 365 days from the initial CMR/A date of service, the DAPO center will need to be contacted again for a new CMR/A authorization.
Adding Pulled Interventions in Aprexis Wisconsin ForwardHealth covers more members than the subset of highest-risk members whose data was sent to Aprexis. Therefore, if a patient is identified by the pharmacist as eligible for a Level I or
TABLE 1. Order of Medicaid pushes in Aprexis Pharmacy Queues Order Appearing in Queue
Service or Intervention
Identification Criteria (Based on prescription claims data)
Asthma: SABA Overuse
• On an asthma controller medication and adherent to therapy • Has filled 3 or more rescue inhalers in the last 90 days
2
Asthma: Add Controller
• Has no prescription claims for an asthma controller in the last year • Has more than 3 rescue inhalers prescribed in the last 90 days
3
Heart Failure: Target Dose ACEI/ARB
• Daily dose of FDA- approved ACE/ARB indicates the patient is not at the recommended target dose
4
Heart Failure: Target Dose Beta Blocker
• Daily dose of FDA- approved beta-blocker indicates the patient is not at the recommended target dose
5
Diabetes: Add ACEI/ ARB
• Has not filled a prescription for an ACE-Inhibitor or ARB in the last 120 days
6
Diabetes: Add Statin
• Has not filled a prescription for a statin in the last 120 days
7
Geriatrics PIM
• Is at least 65 years of age and has a prescription claim for a Potentially Inappropriate Medication (PIM) from the BEERs Criteria 2012
8
CMR/A Eligible
• Has been identified to have asthma, diabetes, heart failure and/or geriatric syndromes based on the individual's prescription claims history
1
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Level II service, but wasn’t pushed to the pharmacy, those services can be pulled into the pharmacy’s Aprexis queue. To prevent duplication and facilitate billing, the patient should be searched for in Aprexis first. Below is the process for searching and adding patients for a pulled intervention if they are not in Aprexis. Searching for Patients in Aprexis 1. Search for the patient by clicking on the “Patient” tab 2. Enter the patient's name and/or insurance ID number 3. Click “Search” 4. If the patient is not found under “Existing Pharmacy Patients”, try searching by health plan 5. If the patient is found, select his or her name to be taken to the patient's profile 6. Add the appropriate intervention by selecting the “Add Intervention” button If the Patient Search is Unsuccessful 1. Check the ForwardHealth portal to confirm the patient's membership and eligibility 2. Once confirmed to be eligible, click “Create New Patient” in the “Patient” tab to add a profile When Adding ForwardHealth Patients to Aprexis 1. Do not enter the member's Social Security Number as the Member ID number 2. Always enter the patient's current Member ID number 3. Enter the member's name exactly as it appears in the ForwardHealth
Above: Participants in the Westat site visit from Hayat Pharmacy: (from left, Jessica Benjamin, Shue Her, Hanin Jaber, Shannon Fair, Dimmy Sokhal, Omar Eliwa, Maiyas Aljamrah)
portal for billing purposes 4. Pay attention to spaces in the patient's name (e.g., if the ForwardHealth portal shows “Mc Donald”, the space should be entered in Aprexis)
Wisconsin SeniorCare and ForwardHealth Pushes Wisconsin SeniorCare patients may be pushed into Aprexis pharmacy queues if they have been identified as eligible for a Level I or Level II service opportunity. The Aprexis platform does not receive information on SeniorCare members' spend-downs or deductibles. This means that payment expectations must be discussed with patients prior to providing any WPQC service. The following is guidance on payment for SeniorCare patients: • If the SeniorCare member has not met their spend-down or deductible,
the member is responsible for reimbursement to the pharmacy for WPQC services. • The amount paid will go toward the member's spend-down or deductible, just as a prescription claim would. • If the SeniorCare member has met their spend-down or deductible, or has reached the copayment level of participation, the pharmacy will be paid directly (at the Medicaid rate) for WPQC services. Finding SeniorCare Spend-down and Deductible Status: In the ForwardHealth portal, when a user searches for a member enrolled in a ForwardHealth program for a specific date of service, the Benefit Plan Panel will display the member's deductible amount (the amount that must be met before claims can be paid) as determined by the member's benefit plan and the period during which the deductible is in effect.
Member Perspective My major residency project as a PGY1 Community Pharmacy Practice Resident is to implement a Comprehensive Medication Review and Assessment service within UW Health pharmacies. Currently, I am piloting the program at three different UW Health pharmacy sites. The project sets aside time to focus on CMR/A services and allows pharmacists the ability to rotate through MTM shifts. The ForwardHealth pushes were highly anticipated in order to make identifying eligible patients more efficient. We have also received a lot of wonderful help from our RIS, Jessica Benjamin, PharmD, on how to approach our new pushes and how to better navigate Aprexis. I highly recommend reaching out to your RIS for any help you need with planning and completing the new pushes. My hope is that this project will create enough dedicated time to provide many of these complex services, patients will benefit from the recommendations made, and the data collected will help PSW prove the worth of the WPQC program. -Danielle Leach, PharmD – UW Hospital and Clinics PGY1 Community Pharmacy Practice Resident www.pswi.org
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WPQC Call to Action
Time is of the essence. With the release of the ForwardHealth pushes, there are ample opportunities identified to benefit patients and contribute to demonstrating the value of the WPQC pharmacy in decreasing costs, improving health and health outcomes. The Centers for Medicare and Medicaid Services (CMS) Health Care Innovation Award (HCIA) funding will conclude on June 30, 2015. The Pharmacy Society of Wisconsin has until that date to collect and report WPQC data to CMS. This call to action is for every pharmacist, pharmacy technician, and pharmacy student to login to Aprexis right away and begin acting upon the new ForwardHealth pushes that are presented. In addition, please continue to assess pushes and provide services for Unity Health Insurance, UnitedHealthcare® and Network Health members. PSW needs everyone to work together to prove that the value of the WPQC program. If we succeed at demonstrating that pharmacy-provided MTM services improve health outcomes, there will be a much better possibility of obtaining future funding for the program and maintaining payer participation. The following are some tips for planning and completing pushes: Planning • Ask: What is my goal for acting upon these pushes over the next three weeks? • Ask: What support do I need from my WPQC Regional Implementation Specialist (RIS)? Tips for Completion • Begin with Level I interventions,
WPQC Registration Update (
Dec 15, 2014)
• 358 pharmacies registered/351 are WPQC-accredited • 1464 pharmacists registered/1287 are WPQC-certified • 697 technicians registered/550 are WPQC-certified • 317 students registered/257 are WPQC-certified since they take less time and generate quick revenue. • Close all interventions that do not apply (choose the appropriate declination reason). • Aprexis login questions: 1-844-Aprexis or support@aprexis.com • Aprexis functionality questions: support@aprexis.com (Please copy your RIS on the message.) • Start scheduling patients for LII services.
Aprexis Training Continues
To review the various features and functions of the Aprexis platform as well as components of the WPQC program and requirements according to the WI ForwardHealth policy, log into Aprexis and click on the “Training” tab to view the recorded webinars. Ongoing Aprexis trainings will be offered at the Pharmacy Society of Wisconsin on January 15th and January 27th and at the Concordia School of Pharmacy in Mequon on January 16th. Keep an eye on the PSW website and WPQC newsletter for additional future trainings.
WPQC Site Visit from CMS
In late October, WPQC staff members
Call To Action This call to action is for every pharmacist, pharmacy technician, and pharmacy student to login to Aprexis right away and begin acting upon the new ForwardHealth pushes that are presented. In addition, please continue to assess pushes and provide services for Unity Health Insurance, UnitedHealthcare® and Network Health members. 16 The Journal January/February 2015
as of
attended a required HCIA meeting at CMS headquarters in Baltimore, Maryland. Attendees consisted of representatives from all 107 HCIA awards. WPQC applied and was chosen to provide a general poster presentation and an oral presentation on the use of a health information technology system for the project. The meeting was informative and provided an understanding of successes and challenges of the awardees. WPQC staff was also able to meet with key CMS staff members to discuss the WPQC program. Shortly following the HCIA meeting, surveyors from the third party CMS contractor, Westat, visited with WPQC staff during a full two-day period. The surveyors met with all members of the WPQC team, pharmacy and payer members of the WPQC Steering Committee, Aprexis Health Solutions, Clinical Advisory Group members, ovserved a WPQC MTM workgroup in action and pharmacists in the field. WPQC thanks the following pharmacies for welcoming Westat surveyors to complete site visits at their pharmacies: Marshland Pharmacies, Boscobel Pharmacy, Lakeview Pharmacy and Hayat Pharmacy. The next six months of the WPQC program are key to demonstrating the value of the strong program that each WPQC pharmacist and pharmacy have built. Please join us by facilitating meaningful staff involvement and support and giving WPQC everything you have during this critical time. ● Danielle Leach is a PGY1 Community Pharmacy Practice Resident at UWHealth, Madison, WI. Danielle completed this article as part of her longitudinal rotation with PSW. Kari Trapskin is Vice President of Health Care Quality Initiatives at the Pharmacy Society of Wisconsin, Madison, WI.
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pharmacypractice feature
WPQC OPERATIONS:
Group Coaching with Medication Therapy Management Workgroups: A Model for Improving Performance by Jessica Benjamin, PharmD
P
harmacists are the medication experts, and pharmacies that provide medication therapy management (MTM) services are utilizing pharmacists’ knowledge and expertise to maximum benefit. The Wisconsin Pharmacy Quality Collaborative (WPQC) is an MTM program that brings pharmacists, payers, and patients together with the goal of improving patient outcomes and decreasing healthcare costs. While many pharmacists support MTM on a philosophical level, when the rubber meets the road pharmacists are often overwhelmed with the practice changes that are needed to effectively implement an MTM program within a pharmacy’s current workflow. The WPQC program has four Regional Implementation Specialists (RIS) who support pharmacies with program implementation by performing site visits approximately every six months, as well as provide additional touch points through email and phone follow-up. These touch points provide WPQC pharmacies with a dedicated resource that assists with communicating program updates, answering questions, and monitoring performance levels to provide a level of accountability. After a RIS visits a pharmacy, there is often an observed increase in pharmacy performance. However, after the RIS leaves, enthusiasm for providing clinical services often wanes as competing priorities divert attention from WPQC-related activities. In addition, while pharmacies usually can integrate Level I services into current workflow relatively easily, many struggle with the changes required to provide Level II Comprehensive Medication Reviews and Assessments (CMR/As) and feel they
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need additional training and/or guidance on how to incorporate MTM services into the suite of services provided by pharmacies that is efficient and ultimately sustainable. Based on this experience, the RIS realized WPQC pharmacists needed more intensive coaching and a formalized structure with more frequent touch points to ensure they progressed with implementing Level II CMR/A services at the pharmacy. The purpose of the coaching model would be to maintain enthusiasm for MTM, elevate WPQC as a priority amongst the pharmacy’s day-to-day operations, provide pharmacists with the necessary skills to implement an efficient MTM program, and provide accountability to help pharmacists achieve measurable goals that would enhance CMR/A service provision.
The Solution: WPQC Medication Therapy Management Workgroups A coaching model that has proven successful in the business world is the “mastermind” model. Napoleon Hill formally introduced the concept of the Mastermind Group in his book “Think and Grow Rich” where he described masterminds as "the coordination of knowledge and effort of two or more people, who work toward a definite purpose, in the spirit of harmony."1 Masterminds consist of a group of like-minded, creative and energetic people who meet on a regular basis to generate solutions far greater than individuals can create on their own. Participants raise the bar by challenging each other to create and implement goals, brainstorm ideas, avoid
Testimonial Participating in the workgroups have been very motivating and inspirational to grow our MTM services here at Skywalk Pharmacy. They have also been very informational. I often have questions on whether I can bill in different situations and how to bill other situations. The workgroup and Anh are always there to answer my questions I have found the doctor detailing portion helpful. I have also found the testimonials from others as to how they handle all of the computer work in Aprexis that needs to be done before, during and after each CMR. I feel working for a small company and being "in charge" of the WPQC information that the workgroups are especially helpful. Without these workgroups I would struggle answering my own questions as well as the questions that the rest of the Skywalk staff asks me. I also feel that it is very motivating having someone to share our victories and hear about others' victories when it pertains to CMRs, pushes and pulls. ~Steve Finkenbinder, Skywalk Pharmacy
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TABLE 1. WPQC MTM Workgroup Curriculum Session Topic
Testimonial Objective
1. Orientation
Understand the purpose of WPQC workgroup and the impact it will have on your WPQC MTM Practice.
2. Setting Up an Efficient MTM Service
Review components of an effective clinical service and complete a gap analysis of your WPQC MTM practice.
3. Building Relationships with Area Providers
Develop the skills needed to foster collegial relationships with other health care providers that will lead to collaborative working relationships.
4. Identifying, Recruiting and Retaining Patients for Level II
Utilize methods to identify eligible patients and increase number of patients scheduled and served.
5. Conducting a CMR/A: Patient Assessment and Work-Up
Develop and implement an efficient process for obtaining and assessing necessary information to conduct a CMR/A.
6. Conducting a CMR/A: Post-Visit Workflow and Documentation (PML and MAP)
Use technology and personnel to efficiently document CMR/A.
7. Conducting Focused CMR/A: Developing Visit Checklist
Review and understand patient assessment checklist to ensure the delivery of an effective and complete focused CMR/A.
8. Empowering Behavior Change in Patients Using Motivational Interviewing: Diabetes
Understand and utilize motivational interviewing techniques to impact patient behavior change.
9. Conducting a CMR/A: Prioritizing Problems and ReDirecting the Conversation
Improve ability to prioritize drug-related problems and to re-direct patients to make visit time efficient.
10. Conducting a CMR/A: Writing Recommendations that Prescribers Will Respond Positively To
Develop a systematic process for providing effective evidence-based recommendations through preferred communication methods.
mistakes and overcome challenges. The mastermind model also builds contacts and relationships, and provides a framework for participants who support each other with honesty, respect and accountability. The meetings can be in-person, by telephone, or by an online meeting on a regular and ongoing basis. The ideal time frame between meetings is either monthly or twice per month as this allows enough time for participants to implement goals but frequent enough touch points to provide a high level of accountability. After evaluating the needs of WPQC participants that were committed to expanding their WPQC MTM services but unsure of next steps, the RIS created the WPQC MTM Workgroups modeled after the “mastermind” framework with the goal of bringing pharmacies across the state of Wisconsin together to share best practices, troubleshoot challenges 18 The Journal January/February 2015
and equip pharmacy staff with the skills necessary to advance and increase WPQC CMR/A services. The term “mastermind” was changed to “workgroup” to concretize the concept and make it more easily understood by pharmacists who might be unfamiliar with the model.The primary components of a mastermind are the following: leadership, a defined agenda, attendance, commitment, synergy, and change. Leadership is critical in a mastermind. The leader must ensure attendance and adherence to the agenda. A rotation of leaders can happen if there is a plan to follow, for example, every 12 weeks to allow for a new perspective and leadership style. This position should be voluntary and have unanimous support of the group. Some mastermind groups do not have a leader and instead enlist the help of a facilitator to guide the conversation to ensure the group stays on task and
It has been great participating in workgroup sessions. We started WPQC back in June at Phoenix Pharmacy and I have been receiving outstanding support in getting things rolling. I had questions regarding billing, documentation, networking with providers, workflow efficiency, and many more. Workgroups allowed me to get feedback and advice from other pharmacists and it helped me through many obstacles. Anh has also been extremely helpful and always available to answer questions and provide suggestions based on what she has seen that was working. It is also a great venue to share the successes we have at our pharmacy with others, hoping it can help make WPQC a success in their pharmacy. I like that we state the goals we want to achieve at each session. It gives me motivation and held me accountable to continue furthering WPQC at our pharmacy. ~Hoa Anh Phan, Phoenix Pharmacy
achieves its desired objectives. For the WPQC MTM workgroups, RIS facilitated the workgroup calls as many participants had never been a part of a mastermind program.
WPQC MTM Workgroup Structure and Curriculum After the RIS decided to move forward with the MTM Workgroups, all WPQC pharmacists were surveyed to determine which individuals would like to participate and what MTM-related topics members felt they would benefit from discussing in a group setting. After compiling the survey results, the RIS realized a structure needed to be created that guided pharmacists through the steps required to implement an efficient MTM practice. A structure that broke the process into manageable chunks, allowed participants to share best
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FIGURE 1. Pharmacy Performance: Initial CMR/As
120 112
100 80 60 40
43
20 0
Initial CMR/As November-March
Initial CMR/As April-August
†Time period is from November 2013 through March 2014 and April through August 2014 +CMR/A numbers were evaluated from Wisconsin Forward Health utilization reports. Commercial payers excluded from analysis.
FIGURE 2. Pharmacy Performance: Follow-Up CMR/As
50 48
40 30 20 15
10 0
Follow-Up CMR/As November-March
Follow-Up CMR/As April-August
†Time period is from November 2013 through March 2014 and April through August 2014 +CMR/A numbers were evaluated from Wisconsin Forward Health utilization reports. Commercial payers excluded from analysis. www.pswi.org
practices, and involved a relatively small time investment was concluded to be the best model for participants. 1. Groups Initially 44 WPQC-certified pharmacists expressed interest in participating. These individuals were broken into seven groups of 5-8 members as that would be a sufficient number of people to generate discussion while still providing an opportunity for all participants to speak. 2. Pre-Assignments Participants were emailed a preassignment a week before the workgroup meeting as it related to the topic discussion for the workgroup call and facilitated better discussion and information sharing. 3. Topic Discussion Participants actively discussed the preassignment and any barriers or solutions they have experienced in regards to the specific topic. For example, if the topic was marketing to prescribers, participants could present solutions that had worked for them when providing outreach to local prescribers. 3. Goal Setting At the end of every workgroup call, each participant stated a goal they would like to complete and report on at the next workgroup call. The goal needed to be measurable and achievable within a two week time frame. This allowed participants to make measurable progress without feeling overwhelmed. 4. Workgroup call structure and agenda The participants met every other week at the same time for a thirty minute conference call to discuss a specific topic. Conference calls were kept to a strict thirty minutes to respect participants’ time. Every workgroup had the same agenda: each participant reported on the progress they made on the previous week's goal, the specific topic was discussed as a group with barriers and best practices shared, and then each participant reported on the goal they’d like to achieve prior to the next workgroup call. Once the workgroup structure was defined, the RIS collectively developed a curriculum they felt would cover critical topics that WPQC pharmacists need to understand and master to build a sustainable MTM practice at a pharmacy. January/February 2015
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The curriculum included ten topics that focused on the following areas: a) transitioning from a product-centered to a service-centered model b) marketing and outreach to patients and prescribers and c) creation of streamlined pre-visit, visit, and post-visit CMR/A workflows. The topics of each session for the current workgroups as well as the objective of the call can be found in Table 1.
Results: Initial WPQC MTM Workgroup Results The initial workgroup results are highly encouraging. The participants started the workgroup curriculum in April 2014 and finished in July 2014. The initial WPQC MTM workgroup was comprised of 44 pharmacists that represented 33 pharmacies. To evaluate the impact of workgroups, the number of initial and follow-up CMR/As was measured in the five month period prior to workgroups commencing (November 2013 through March 2014) as was the five months after workgroups had commenced (April 2014 through August 2014). The number of initial CMR/As increased from 43 to 112, the follow-up CMR/As increased from 15 to 48, and the total CMR/As increased from 58 to 160 (represented in Graphs 1, 2, and 3, respectively). This was a 175% increase in the total number of CMR/As when comparing the two time periods. Of note, there was significant variation in performance of CMR/As between workgroup participants. Importantly, while there were pharmacies that still had not increased their provision of
FIGURE 3. Pharmacy Performance: Total CMR/As
200
150
160
100
50
0
58
Total CMR/As November-March
Total CMR/As April-August
†Time period is from November 2013 through March 2014 and April through August 2014 +CMR/A numbers were evaluated from Wisconsin Forward Health utilization reports. Commercial payers excluded from analysis.
CMR/As as a result of workgroups, there were other pharmacies that had not performed a CMR/A prior to workgroups that were able to transform their workflows and routinely perform CMR/As every week. Additionally, the workgroups reinforced the importance of follow-ups for longitudinally monitoring the patients and for tracking positive health outcomes and this reinforcement resulted in a
higher number of follow-up visits. Lastly, an exit survey was taken by workgroup participants, and 29% strongly agreed and 71% agreed that the workgroup model improved their understanding of how to identify, recruit and retain patients for CMR/A services. Additionally, 72% of workgroup participants either strongly agreed or agreed that the workgroup
Testimonial This workgroup allowed me the opportunity to directly engage in discussions with a passionate group of WPQC pharmacists from around Wisconsin. Speaking with these WPQC pharmacists and the WPQC Regional Implementation Specialists inspired me to set, achieve, and share incremental goals to improve WPQC practice at our pharmacy sites. They helped me breakdown the challenges of WPQC implementation into more manageable and defined components. What stands out most for me from these work groups is the emphasis placed on collaboration - especially those efforts to involve the entire pharmacy team. Thesework groups reminded me that efficient and consistent MTM workflows require each pharmacy team member to embrace his or her WPQC role, whether that is identifying, scheduling, performing, documenting, and/or billing MTMs or simply positively reinforcing the incredible value of this WPQC program! ~Albert Carbo, UW Health Pharmacies
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model improved their confidence in performing CMR/As. The aforementioned positive results from the initial round of workgroups are the basis for continuing the workgroup model for interested WPQC participants.
Why Workgroups Work
The WPQC MTM Workgroups are successful because of four principle components: accountability, goal setting, positive peer pressure, and support from colleagues. Each participant is held accountable for attending workgroup calls and completing pre-assignments. This ensures they review the content and learn the skills necessary to make their pharmacy’s MTM program a success. Additionally, setting and achieving measurable goals breaks the implementation process into manageable chunks. Additional factors that affect the success of workgroups include participants’ attendance, commitment to the program, and the spirit of synergy. The RIS established specific ground rules for the MTM workgroups that were reviewed in the first week during Orientation, to set expectations and ensure program success. These ground rules outlined the importance of being on time and mentally present for workgroup calls, being accountable to one’s goals, and working together to share best practices, ideas and resources to shorten the implementation curve for participating pharmacies. The final factor that determines the success of mastermind groups is the concept of change and continuous quality improvement. If something is not working, it is important to course correct and make adjustments. After the first round of WPQC MTM workgroups, participants were sent an exit survey where they could provide feedback on how the program could be improved. A few participants stated that the workgroups were immensely helpful, but that the program was too long. Using this feedback, the curriculum for the workgroups was shortened from ten topics down to eight.
to improve MTM performance for participating pharmacies. Participants are able to share best practices, brainstorm solutions to current challenges, and be accountable towards their MTM practice goals. WPQC is committed to ensuring the success of its participating pharmacies and thus plans to continue to conduct these MTM workgroups. Currently, two rounds or workgroups have been completed, and a third round is in the planning phase. If you would like to participate in the next round of workgroups, please contact Anh Nguyen, anhn@pswi.org. ●
Jessica Benjamin, PharmD is a PSW WPQC Operations Manager and Regional Implementation Specialist for South Central Wisconsin. Acknowledgements: A special thank you to Albert Carbo, PharmD, Steve Finkenbinder PharmD, and Hoa Anh Phan PharmD for their testimonials and commitment to the WPQC program.
References
1. Hill N. Think and Grow Rich. Redford, VA: Wilder Publications, LLC. 2007.
SAVE THE DATE
2015 PSW Senior Care Conference March 4-5, 2015 Milwaukee Marriott West, Waukesha
Conclusion and Next Steps
Based on the results from the initial WPQC MTM workgroups, it is evident that this group coaching model works www.pswi.org
Visit pswi.org for more information.
January/February 2015
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pharmacypractice feature
Centers for Disease Control and Prevention Releases New Recommendations for Pneumococcal Vaccinations
C
DC released a new recommendation for the use of pneumococcal vaccination among adults. Adults aged 65 or older are now recommended to get the pneumococcal conjugate vaccine (PCV13, Prevnar-13®) and then be vaccinated with the pneumococcal polysaccharide vaccine (PPSV23, Pneumovax®23) 6-12 months later. Both PCV13 and PPSV23 provide good protection against invasive forms of pneumococcal infection. Although PPSV23 protects against more serotypes than PCV13, studies do not consistently show effectiveness against non-bacteremic pneumonia. In June 2014, the results of a large randomized placebo-controlled trial evaluating efficacy of PCV13 against community-acquired pneumonia among adults 65 years or older (CAPiTA trial) became available. The results of this trial among approximately 85,000 adults 65 years or older demonstrated 45% efficacy of PCV13 against vaccine-type community-acquired pneumococcal pneumonia and 75% efficacy against vaccine-type invasive pneumococcal disease. Thus, PCV13 helps to fill the gap in protection against non-invasive pneumococcal pneumonia. As part of the new recommendation, adults 65 years of age or older who have not previously received any pneumococcal vaccines or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed 6-12 months later by a dose of PPSV23. Adults 65 years of age or older who have previously received PPSV23 should receive PCV13 at least 1 year since their most recent dose of PPSV23. In addition to the new recommendation for pneumococcal vaccination of adults 65 years or older, it’s
22 The Journal January/February 2015
important to remember that pneumococcal vaccines are also recommended for adults 19 years or older with certain health conditions and lifestyles. “Thousands of older adults die and many more are hospitalized from pneumococcal disease every year, but many adults aren’t aware that there are vaccines that can prevent it,” said Dr. Anne Schuchat, assistant surgeon general and director of CDC’s National Center for Immunization and Respiratory Diseases. “A lot of adults get their flu shot this time of year, which is a great time to review with the patient their immunization status and recommend pneumococcal and other vaccines to those that need them.” There are also other vaccines recommended for adults besides the pneumococcal and flu vaccines, so it’s important to make sure adults are up-todate on the all the vaccines recommended for them based on their age, lifestyle, occupation, health condition, travel, or other factors. Most private health insurance covers pneumococcal vaccines. At this time, Medicare Part B typically covers only the first dose of pneumococcal vaccine for older adults and pays 100% of the cost of covered pneumococcal vaccines. l References
1. Community Acquired Pneumonia Immunization Trial in Adults (CAPITA) Abstract # 0541. 2014. at https://pneumonia. org.au/public/journals/22/PublicFolder/ ABSTRACTBOOKMASTERforwebupdated20-3-14. pdf. 2. Pneumococcal ACIP Vaccine Recommendations at http://www.cdc.gov/vaccines/ hcp/acip-recs/vacc-specific/pneumo.html. 3. Pneumococcal Vaccination at http://www. cdc.gov/vaccines/vpd-vac/pneumo/default.htm
Summary of pneumococcal vaccine recommendations for adults
PCV13 is recommended for:
• All adults 65 years or older • Adults 19 years or older with certain health conditions such as sickle cell disease or asplenia • Adults 19 years or older who are immunocompromised, including those with HIV infection
PPSV23 is recommended for:
• All adults 65 years or older • Adults 19 years or older with health conditions such as heart disease, lung disease (including asthma), sickle cell disease, diabetes, alcoholism, and cirrhosis • Adults 19 years or older who are immunocompromised, including those with HIV infection • Adults who smoke cigarettes
To learn more about the new pneumococcal recommendation for adults 65 years old or older, go to http://www.cdc.gov/mmwr/preview/ mmwrhtml/mm6337a4.htm. For a complete list of pneumococcal vaccination recommendations, go to http://www.cdc. gov/vaccines/hcp/acip-recs/vacc-specific/ pneumo.html. For more information on adult vaccine recommendations, go to CDC’s Adult Immunization Schedules page or download the CDC Vaccine Schedules app.
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JOURNAL SERIES:
Statistics Review Part 9: Research in Policy by Rachel Buchanan, PharmD, Kevin Look, PharmD, PhD, and Amanda Margolis, PharmD, MS, BCACP This article discusses the roles of studies in researching health care policy as well as transforming research into meaningful health care changes.
Objectives
1. Discuss the role of randomized controlled trials when researching health care policy 2. Identify seminal studies evaluating health care delivery and financing 3. Describe steps that may be taken to transform research into meaningful health care changes
R
esearch is conducted not only to help determine the most efficacious medicines and treatments, but it is also used to determine the best policies and methods of health care delivery. Health care in the United States is now being impacted by health care reforms such as the Affordable Care Act, which allocated $10 billion in funding to research the most effective ways to deliver health care.1 Given the ever-evolving world of health care, it is important to take a step back and look at how evidence is provided to help guide health care policies.
Methods of Health Care Policy Research Researching policies for health care is challenging. Randomized controlled trials (RCTs) are the gold standard in medical research, due to their rigorous methodology (Table 1.). However, these types of studies are rarely conducted in policy research due to the high cost, level of difficulty to perform, and ethical issues that may be encountered. For example, when evaluating policies related to health insurance coverage, it may not be ethical to randomize patients to having no health care coverage at all. Additionally, individuals who are randomized to control groups (i.e., do not receive coverage) tend to drop out of studies, making it difficult to form reliable conclusions. Due to limitations with using RCTs, www.pswi.org
observational studies are more commonly used in health care policy research. These studies typically compare patient and economic outcomes before and after a policy change is implemented, and do not randomly assign subjects to treatment and control groups. This type of study allows for broader inclusion criteria and provides more real world results applicable to a broader population. These studies are also considerably cheaper to conduct than RCTs, which allows researchers to include more patients and follow them for a longer period of time, especially if a health care study is retrospective.
Studies of Health Care Delivery and Financing Several important studies have been conducted to help shape how health care delivery and financing may be improved. The RAND Health Insurance Experiment (HIE) was a long-term randomized experimental study of health care costs, utilization, and outcomes, and was conducted between 1971 and 1982.2 Participants in the Rand HIE were randomized to one of several different coinsurance amounts for health care services, and the resulting health care utilization and outcomes were compared between the various groups. The study found that higher cost sharing amounts reduced the use of health care services compared to those with little or no cost sharing, marked by decreases in both prescriptions and physician visits. The RAND HIE study has long been considered the seminal study on the impact of cost sharing on health care use. A more recent study is the Oregon Health Insurance Experiment, which used a randomized experimental design to evaluate the impact of a Medicaid expansion program on the health care costs, utilization, and clinical outcomes of lowincome adults.3 Results of this study have
found that Medicaid enrollment resulted in increased emergency department visits, physician visits, and prescriptions, leading to an overall increase in health care costs. However, no short-term improvements were seen in patient health outcomes. The findings from this study have been highly controversial, as they raise questions about the effectiveness of state Medicaid programs These randomized controlled trials continue to shape discussions over health care policy and health care reform. However, both of these were large studies which may not be realistic for future research. As a result, many health care policy studies rely on smaller-scale RCTs or on large observational studies looking at new solutions or challenging old ideas. These studies may not individually revolutionize health care, but the accumulation of knowledge from multiple studies can lead to to the identification and development of best practices. In pharmacy, policy research has helped derive new practice models and approaches to managing patients’ health care. With a heavy reliance on observational studies or small-scale RCTs, policy research projects test and evaluate new pharmacy practice models, such as Medication Therapy Management. One such example is a study conducted in Iowa which demonstrated improvement in blood pressure control with physician and pharmacist collaboration.4 Another example is a study conducted in Wisconsin evaluating a team-based approach to caring for black patients with hypertension that involved pharmacists and technicians resulting in increased adherence to refill medications and better blood pressure control. 5 These studies of innovative programs provide evidence to policy makers of the pharmacist’s value in patient care.
Future Research Opportunities
The Affordable Care Act created the Centers for Medicare & Medicaid Services January/February 2015
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TABLE 1. Pros and Cons of Randomized Controlled Trials in Health Care Policy and Delivery Research Pros
Cons
• Eliminates bias • All unknown and known variables evenly distributed between the groups • Results suggest causality • Most reliable type of study
(CMS) Innovation Center to help explore the most effective models of health care delivery and financing. The stated goals of the Innovation Center are to test new payment and service delivery models, evaluate results, advance best practices, and engage a broad range of stakeholders.1 However, the Innovation Center has been criticized for relying heavily on demonstration projects (small-scale, nonrandomized pilot projects that test new ideas) rather than on RCTs.6 Opponents believe the opportunity to improve health care delivery is not being matched with the utilization of gold standard methodology, which would provide the soundest evidence for reorganizing our health care system. In contrast, others argue that demonstration projects provide evidence of policies being implemented in the real world. Though demonstration studies are not as rigorous as RCTs, they allow for the development of hypotheses that may be tested in future studies. One example of a demonstration project funded by CMS is the Wisconsin Pharmacy Quality Collaborative, an initiative of the Pharmacy Society of Wisconsin that aims to connect community pharmacists with patients, physicians, and health plans to improve the quality and reduce the cost of medication use across Wisconsin.7
Implementation of Research into Policy Though a study for delivering health care may have results showing potential progress in health care delivery or cost savings, implementation of these processes
• May not be ethical to randomize patients • Expensive • May not represent the “real world” • Difficult to perform
into practice are not always seen. Some studies showing significant cost savings that have been published in leading journals have not been implemented into our health care practices on a larger scale. Translating quality research into impactful changes in health care nationally may prove challenging. One essential component of public health research is understanding and advocacy by decision makers. Because health care policy change often rests in the hands of policy makers, researchers and clinicians need to better communicate and disseminate impactful changes in order for it to be implemented into health care practices nationwide. AcademyHealth has published step-by-step advice for researchers which pharmacists can adapt on how to navigate dissemination and implementation of published research (Table 2.).8 These guidelines may also be helpful to pharmacists who want to make patients, legislators, and other stakeholders aware of innovative programs or practice models they are using to improve patient care. The first steps are to define the target audience and have open discussions with policymakers to outline the need for pharmacy services or research and how these needs can best be addressed. This will also help develop relationships with important stakeholders to bridge the gap between research and actual real world changes. Pharmacists and researchers must then frame their findings in a way that is meaningful to the stakeholders. It is also important to keep in mind that policy makers may not be experienced in the health care field, so using simple language to convey results and ideas may allow for
TABLE 2. Steps to Implement Research into Health care Policy8
1. Define the target audience 2. Have open discussions with policymakers 3. Build stakeholder relationships 4. Identify meaningful findings to stakeholders 5. Develop a dissemination strategy (social media, national journals, news outlets)
24 The Journal January/February 2015
better understanding of how to implement research findings. The final step is to develop a dissemination strategy, such as using not only journals to publish results, but also using social media and news outlets. Whether research is a randomized controlled trial, or a demonstration project such as the WPQC initiative, it is important that good ideas and results are disseminated to implement meaningful change. The current time of changing health care has given pharmacy a window of opportunity help shape future health care delivery and practice. Pharmacists and pharmacy researchers must take this opportunity and meet it with preparation and continual innovation to enhance health care policy for future generations to come.
Summary
This article reviewed why randomized controlled trials are often difficult to conduct when researching health care policy, as well as past and present studies focusing on the delivery and financing of health care. Other research such as observational studies or demonstration projects may help provide evidence under real world conditions. Once high quality and meaningful research is conducted, it is important to translate this into impactful changes by involving and actively engaging policy makers. ●
Practice Questions 1.
2.
3.
What is the gold standard research methodology to develop health care policy? a. Case control study b. Cohort study c. Demonstrative study d. Randomized controlled trial The Wisconsin Pharmacy Quality Collaborative is an example of what type of study that helps research health care delivery? a. Randomized controlled trial b. Demonstrative study c. Case control study d. Cohort study Which of the following is important for pharmacists to do when trying to demonstrate the value of pharmacists' patient care services? a. Develop a dissemination strategy
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b. c. d.
Reach a target audience Build relationships with stakeholders All of the above are important to demonstrate the value of pharmacists
Answers: 1.
d Randomized controlled trials are the gold standard methodology for health care research.
2.
b Pharmacy Society of Wisconsin initiated this program which serves as a demonstrative study to improve quality of health care in Wisconsin.
3.
d All of the above answers are correct, as multiple steps need to be taken to most effectively demonstrate the value of pharmacists.
Rachel Buchanan is a PGY2 Ambulatory Care Pharmacy Resident at the William S. Middleton Memorial Veterans Hospital, Madison, WI. Kevin Look is an Assistant Professor in the Social & Administrative Sciences Division at the University of Wisconsin School of Pharmacy,
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Madison, WI. Amanda Margolis is a Lecturer at the UW-Madison School of Pharmacy and a Clinical Pharmacist at the William S. Middleton Memorial Veterans Hospital, Madison, WI.
References and suggestions for further review
1. Centers for Medicare and Medicaid Services. Innovation Center. Available at http://innovation. cms.gov. Accessed on September 23, 2014. 2. RAND Corporation. The Health Insurance Experience. Available at http:// www.rand.org/pubs/research_briefs/RB9174. html. Accessed on September 23, 2014. 3. The National Bureau of Economic Research. The Oregon Health Insurance Experiment. http://www. nber.org/oregon. Accessed on September 24, 2014. 4. Carter BL, Ardery G, Dawson JD, et al. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. 2009 Nov 23; 169(21):1996-2002. 5. Svarstad BL, Kotchen JM, Shireman TI, et al. Improving refill adherence and hypertension control in black patients: Wisconsin TEAM trial. J Am Pharm Assoc. 2013 Sep-Oct; 53(5):520-9. 6. The New York Times. Method of Study Is Criticized in Group’s Health Policy Test. Available at http://www.nytimes.com/2014/02/03/health/
effort-to-test-health-policies-is-criticized-for-studytactics.html?_r=1. Accessed on September 24, 2014. 7. Pharmacy Society of Wisconsin. Wisconsin Pharmacy Quality Collaborative (WPQC). Available at http://www.pswi.org/ WPQC. Accessed on October 30, 2014. 8. AcademyHealth. Navigating the Translation and Dissemination of PHSSR Findings. Available at http://www.academyhealth.org/files/TDguidePHSR. pdf. Accessed on September 24, 2014.
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pharmacypractice feature
The Growing Population of Older Adults: A Trend That All Pharmacists Should Follow by Angela Studnicka, PharmD, Maria Wopat, PharmD, BCACP, TTS, and Dustin Ehster, PharmD, BCPS, CGP
S
tatistics from the US Census Bureau estimate that the population of Americans aged 65 years and older will nearly double to approximately 89 million between 2010 and 2015.1 This growth is largely attributed to the aging of the “baby boomers” born between 1946 and 1964. The baby boomer generation has influenced a number of events in American society over the last 50+ years and is expected to impact the health care system as well. The care of this generation has shifted from institutional settings to various community-based living environments. As a result, the potential impact of senior care pharmacists’ involvement has greatly expanded. With this in mind, the following metrics set by the Wisconsin Pharmacy Quality Collaborative (WPQC) program related to geriatric syndromes, has helped position pharmacists as key players in geriatric care.2 • Reduce the number of actual and/ or potential adverse drug events in patients >65 years of age receiving at least one Comprehensive Medication Review and Assessment (CMR/A) by an absolute 20% by March 31, 2015. • Reduce the rate of falls in patients >65 years of age receiving at least one CMR/A by a relative 10% by March 31, 2015. • For patients taking a Potentially Inappropriate Medication (PIM) at baseline, reduce the rate of PIM’s per patient >65 years of age by a relative 15% within 6 months of receiving a CMR/A by March 31, 2015. Pharmacists in all practice settings will encounter older adults and have the opportunity to address these goals and other potential medication-related problems, as these patients face special and unique health needs. Opportunities include involvement in medication therapy management (MTM) programs, such as WPQC, or providing consulting
26 The Journal January/February 2015
services for assisted living and skilled nursing facilities. In addition, pharmacists are assisting with acute care for elders (ACE) programs during hospitalization, while others are participating in geriatricfocused clinics. Pharmacists also provide educational programming and medication reviews to seniors by partnering with the United Way at local senior centers. Historically, the PSW Senior & Long Term Care (LTC) Section was geared towards consultant pharmacists. However, the dynamic changes and new opportunities for pharmacists have allowed pharmacists from many different backgrounds to come together to promote pharmaceutical services for seniors. Members of PSW’s Senior & LTC Section are involved in all of the services listed above and many more. In addition, Section members have access to a variety of geriatric related tools, continuing education materials, and networking opportunities through their membership (Table 1.) Nearly all pharmacists will encounter a patient in the baby boomer generation and we should all be prepared to care for
these older adults as they age and live longer. We invite you to become a member of this Section or consider attending the annual conference in March. For more information on the PSW Senior & Long Term Care Section, feel free to contact a Board Member or visit http://www.pswi. org/Resources/Geriatrics-LTC/PSWSenior-Care-LTC-Section. ● Angela Studnicka works at Oakwood Lutheran Senior Ministries in Madison and is the PSW Senior & LTC Section Madison Area Director. Maria Wopat works at the William S. Middleton VA in Madison and is the current Chair of the PSW Senior and LTC Section. Dustin Ehster works at the Clement J. Zablocki VA in Milwaukee and is the current Chair-Elect of the PSW Senior & LTC Section.
References
1. Centers for Disease Control and Prevention. The State of Aging and Health in America 2013. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2013. 2. Benjamin J, Horstmann E. WPQC Operations: Measuring the Impact of WPQC on Health Outcomes. JPSW. 2013 Sept/Oct: 28-31.
TABLE 1. PSW Senior & Long Term Care Section Benefits In addition to all of the great PSW membership benefits, members of PSW’s Senior & LTC Section receive the following value-added benefits for just an additional $45 per year. E-Newsletter NewsLine is the PSW Senior & LTC Section’s monthly e-newsletter bringing you news and information related to the care of elderly adults. This timely publication provides therapeutic updates, advocacy information, and answers your consulting questions. Educational Programming The PSW Senior & LTC Section hosts high quality continuing education programming related to the care of aging adults. Each spring, plan to attend the PSW Senior Care Conference and receive registration discounts and, in the fall, the PSW Senior & LTC Section hosts the Senior Care Track within the PSW Annual Meeting. This education is sure to enhance your practice! Networking As a member of the PSW Senior & LTC Section, you’ll be eligible to participate in PSW’s Senior Care Practice Interest Network (PIN). This online forum provides members the opportunity to interact with one another in a virtual environment, asking and answering your practice-related questions. Website Links and Resources PSW’s professional staff supports the PSW Senior & LTC Section members. Members have access to a host of quality web resources and links and can contact PSW with practice-related questions. A Professional Advocacy As a long term care pharmacy or a pharmacy caring for the needs of elderly patients, your practice has unique advocacy needs. With the direction of the PSW Senior & LTC Section Board, PSW advocates on behalf of your practice at the State Capitol and in DC.
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pharmacypractice
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PHARMACOTHERAPY PERSPECTIVES:
Tedizolid: The Newest Oxazolidinone by Eileen T. Shannon, MS, 2015 PharmD Candidate and Joshua Vanderloo, PharmD
Abstract Tedizolid is approved for the treatment of ABSSSIs in adults (use in populations under the age of 18 has not been established). Tedizolid is given as 200 mg intravenously or orally once daily for six days for ABSSSI treatment. While patients are receiving tedizolid, they should be monitored for infusion site reactions (with the intravenous form), and for improvement in the infection site. If a patient is receiving tedizolid while admitted to a hospital, AST/ ALT and CBC values should be taken at baseline and monitored daily. No studies evaluate the use of tedizolid in the geriatric population or patients of difference races, but available data suggest no special considerations are necessary. No dose adjustments are necessary in the presence of renal or hepatic impairment or hemodialysis. Tedizolid is classified as Pregnancy Category C. There are no data to prove it is safe and effective in pregnant women and should be used with caution. Studies in laboratory animals demonstrated tedizolid was associated with fetal abnormalities. Tedizolid is excreted in the breast milk of rats; it is unknown if it is excreted in human breast milk and should be used with caution in women who are breastfeeding.
Tedizolid Phosphate Intravenous, Oral (SIVEXTRO®, Cubist Pharmaceuticals) Approved by the FDA on June 20th, 2014. cute bacterial skin and skin structure infections (ABSSSIs) are bacterial infections in the skin or in deeper tissue below the skin.1 These infections are increasing in prevalence; from 2000 to 2004, hospital admissions due to ABSSSI increased 29%. ABSSSIs range in severity and the infection can become complicated, leading to life-threatening disease.2 ABSSSIs are usually caused by Gram-positive bacteria.2
A
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The SENTRY antimicrobial surveillance program reported that 35.9% of ABSSSIs infections in North America are caused by methicillin-resistant Staphylococcus aureus (MRSA).3 MRSA is a burden in both communityacquired and hospital-acquired infections.4 MRSA infections lead to longer hospital stays, more expensive care, and higher mortality.4 In 2004, 64.4% of hospital acquired S.aureus infections were MRSA. The Infectious Disease Society of America (IDSA) guidelines for treatment of ABSSSIs recommend empiric coverage for community acquired (CA)-MRSA based on clinical symptoms in both outpatient and inpatient therapy.2,4 Increasing antimicrobial resistance and increasing incidence of ABSSSIs highlight the need for both parenteral and oral MRSA-active antimicrobial options. Oxazolidinones are a relatively new class of antibiotics with clinical efficacy against Gram-positive organisms, including MRSA and Vancomycin-Resistant Enterococcus (VRE), with little potency against Gram-negative bacteria. This class of antibiotics inhibits protein synthesis by interacting with the 50s subunit of the bacterial ribosome.5 Linezolid was the first FDA approved oxazolidinone on the market.5 Linezolid’s unique mechanism of action makes it an excellent option for treatment of resistant strains of bacteria; unfortunately, side effects and drug interactions may limit use.5 Linezolid can cause myelosuppression and is a weak, non-selective, reversible monoamine oxidase inhibitor (MAOI).6 The risk of serotonin syndrome emerges when patients consume a tyramine-rich meal or are taking a concomitant MAOI or serotonergic agent while also taking linezolid due to this MAOI activity.6 Serotonin syndrome is a possible life-threatening complication that manifests as agitation, mental status changes, fever, ataxia, and hyperreflexia, and can lead to rhabdomyolysis, tonicclonic seizures, and multi-organ failure.7 However, the clinical significance of these interactions is not fully established; while
there are various case reports of serotonin syndrome occurring in patients taking linezolid, there is also a body of evidence supporting the safe use of linezolid in patients concurrently taking serotonergic agents.8,9 Regardless, the drug interactions are particularly difficult to manage; SSRIs require a slow taper, and antibiotic therapy should not be delayed.9 The Food and Drug Administration (FDA) recommends that serotonergic agents be stopped for at least two weeks prior to starting linezolid therapy in non-emergency situations.10 In emergency situations where linezolid must be started immediately, the FDA recommends that the serotonergic agent be stopped without delay, and patients be monitored for serotonin syndrome for two weeks, or for 24 hours after the last dose of linezolid.10 The FDA further recommends that a serotonin agent not be started in a patient until 24 hours after the last dose of linezolid.10 Additionally, there is the potential risk of vasoconstriction (with physiologic consequences) when taking an MAOI (such as linezolid) with other vasoconstrictors, such as over the counter products like pseudoephedrine.11 Tedizolid offers the same antimicrobial spectrum as linezolid, but without drug interactions and food restrictions, and may not cause the hematologic side effect profile that limits the use of linezolid clinically.12 Additionally, tedizolid has shown to be four to eight times more potent than linezolid in vitro, and maintains activity over linezolidresistant strains of Gram-positive organisms in vitro.13,14
Pharmacology
Tedizolid, as an oxazolidinone, binds the 50s subunit of the ribosome, preventing the formation of the initiation complex to the prevent protein synthesis, and ultimately, bacterial growth.15 Linezolid resistance emerges with 23s rRNA central loop mutation, leading to linezolid’s decreased affinity for the binding site on the ribosome. This mutation is commonly found in the cfr (chloramphenicolJanuary/February 2015
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TABLE 1. Antimicrobial Activities of Tedizolid and Linezolid Against Selected Isolates13,21 Organism
Agent
Phenotype (no. of isolates)
0.25
0.25
0.25
0.25
MSSA (39)
1
2
MRSA (124)
1
2
All (7)
NA
NA
Linezolid
All (7)
NA
NA
Tedizolid
Linezolid-resistant (19)
4
8
Linezolid
Linezolid-resistant (19)
32
>128
Tedizolid
Linezolid-resistant (16)
4
4
Linezolid
Linezolid-resistant (16)
32
32
Tedizolid
Linezolid-resistant (36)
2
4
Linezolid
Linezolid-resistant (36)
32
64
Linezolid
E. faecalis
E. faecium
MIC90
MSSA (39)
S. aureus
S. epidermidis
MIC50
MRSA (124)
Tedizolid
Coagulase-negative staphylococci
MIC (ug/mL)
Tedizolid
florfenicol resistance) methyltransferase gene.13 X-ray crystallography images reveal that tedizolid contains additional binding sites when interacting with the ribosome as compared to linezolid, and these additional bonds help to stabilize the drug-protein interaction despite acquired linezolid resistance.14 However, this enhanced target affinity has not been evaluated in vivo. Based on animal studies, tedizolid activity is best predicted by the ratio of area under the curve to minimum inhibitory concentration (AUC/MIC).16
Pharmacokinetics
Tedizolid phosphate is a prodrug that is quickly metabolized in vivo to the active moiety tedizolid by serum phosphoesterases.17 The half-life of tedizolid is approximately 12 hours and the oral bioavailability is 91%.18 No dose adjustment is necessary when switching from IV to oral therapy.18 When taken with food, the Cmax is delayed but there is no effect on AUC, thus tedizolid may be taken with or without food.17 Protein binding of tedizolid is 70-90% and the volume of distribution is 67-80 L.18,19 The majority of tedizolid is hepatically metabolized to inactive metabolites in feces (82%) and urine (18%). More than 85% of tedizolid excretion happens within the first 96 hours; fewer than 3% is excreted unchanged.16
Warning and Precautions
Use of tedizolid in neutropenic patients
28  The Journal January/February 2015
is uncertain; there is no clinical data to support the use of tedizolid in patients with neutrophil counts below 1000 cells/mm3, and alternative therapy is recommended. In murine thigh models, tedizolid’s activity was impaired in animals lacking granulocytes.20 If diarrhea occurs while a patient is taking tedizolid, evaluate for Clostridium difficile-associated diarrhea.
Microbiology
The following aerobic and facultative Gram-positive bacteria have clinically been shown to be susceptible to tedizolid: Staphylococcus aureus (MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group (S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis.16 Susceptibility to Enterococcus faecium is unknown. There is in vitro data available reporting the activity of tedizolid against clinically relevant strains of Gram-positive organisms. Prokocimer et al. collected strains of bacteria from the lesions of patients in the Phase II trial of tedizolid.12 Additionally, Shaw et al. performed laboratory testing on various Gram-positive strains of clinically isolated bacteria with known resistance to linezolid.13 MICs for both tedizolid and linezolid are reported.
Clinical Trials
There were two major phase III clinical trials that brought tedizolid to market; ESTABLISH -1 and ESTABLISH-2.
ESTABLISH-1 was a multicenter, multinational, randomized, doubleblind, non-inferiority trial that compared tedizolid to linezolid in the treatment of ABSSSI.22 The predefined requirement for non-inferiority was 10% with a 95% confidence interval with 90% power. The non-inferiority requirement was based on linezolid efficacy. The primary outcome of the trial was early objective clinical response at the 48 to 72 hour assessment in the intent to treat (ITT) group. A patient achieved objective clinical response if there was no increase in lesion size at the initial assessment and the patient was alive and afebrile without having received any concomitant antibiotics. In addition to the ITT group, a clinically evaluable (CE) group was also assessed throughout the study. Patients were considered CE if at the 48 to 72 hour time point and at the end of treatment (EOT) there were no major protocol violations and no doses of steroids, antibiotics, or NSAIDs were given. EOT was defined as day 11 of the study. Post therapy evaluation (PTE) was defined as 7-14 days after the end of treatment. Investigator-assessed clinical response was defined as resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications due to the ABSSSI requiring further antibiotic therapy. The trial also had four secondary outcomes: 1. Objective, sustained clinical response at EOT in the ITT group. 2. Objective, sustained clinical response at EOT in the CE group. 3. Investigator-assessed clinical response at PTE in the ITT group. 4. Investigator-assessed clinical response at PTE in the CE group. Patients were included in the trial if they were older than 18 years, had an ABSSSI that measured at least 75 cm2 that was most likely caused by a Grampositive pathogen, and had at least one sign of both local and systemic infection. Patients were excluded: if infection was deemed uncomplicated; if ABSSI was suspected to be caused by a Gram-negative pathogen; if infection was associated with a vascular catheter site, thrombophlebitis, or a non-clean surgery site. Additionally, patients were excluded if they had received
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antibiotics with Gram-positive activity within the previous 96 hours or if the patient had taken a serotonergic agent (e.g. SSRI or SNRI) or MAOI within the past two weeks. Patients received either tedizolid 200 mg orally for six days or linezolid 600 mg orally twice daily for ten days; every patient received three tablets daily for ten days in order to maintain blinding. After recruitment and exclusion criteria were applied, 667 patients were entered into the trial and randomized; 332 received tedizolid and 335 received linezolid. There were no significant differences between the two groups in demographics or baseline characteristics. Tedizolid demonstrated non-inferiority to linezolid in the primary outcome and in all secondary outcomes. Results are outlined in Table 2 below. This trial’s generalizability is limited as all subjects that were actively taking an SSRI or a MAOI were excluded from the trial. This is a serious limitation because one of the potential advantages of tedizolid is its purported lack of interaction with SSRIs and MAOIs; this study provides no clinical insight to this issue. Additionally, ESTABLISH-1 was not powered to detect a significant difference in myelosuppression between the two treatment arms. This is a limitation because myelosuppression is the main serious side effect of linezolid therapy, and a decreased incidence of myelosuppression would be an advantage of tedizolid therapy. Additionally, the exclusion criteria for this trial were expansive, which further limits the generalizability of the results. ESTABLISH-2 was a multicenter, multinational, randomized, double-blind,
parallel-group, non-inferiority trial that compared IV tedizolid to IV linezolid with the option to step down to oral therapy.23 A double-dummy design with placebo was used in order to maintain blinding for the entire ten days of therapy. The predefined requirement for non-inferiority was 10% with a 95% confidence interval with 90% power. The non-inferiority requirement was based on linezolid efficacy. Inclusion criteria mirrored ESTABLISH-1, except that patients as young as 12 years were allowed to enroll. Exclusion criteria were also similar to the ESTABLISH-1 trial, with the addition of excluding patients: who had recently failed antibiotic therapy; who had an infection associated with prosthetic devices; with diabetic foot infections, infected burns, or chronic skin ulcers; with known bacteremia, septic shock, severe sepsis, or a history of opportunistic infections with the underlying cause still active; actively taking chronic systemic immunosuppressants or antipyretics (not including aspirin equal to or fewer than 200 mg daily); or with severe renal or hepatic disease. Any patients that had taken an SSRI, SNRI, or MAOI within the past two weeks were excluded from ESTABLISH-2. The primary outcome for ESTABLISH-2 was early objective clinical response 48 to 72 hours after treatment initiation based on objective assessment. Objective clinical response was defined as being alive at 72 hours with a 20% or greater reduction in lesion size having not received any other antibiotics with Grampositive activity. Additionally, there were five secondary, investigator-assessed endpoints in ESTABLISH-2 (investigator-assessed not
TABLE 2. Primary and Secondary Outcome Results From ESTABLISH-1 Primary Outcome
Drug Interactions
Secondary Outcome
Clinical Response at 48 to 72 hours (ITT)
Clinical Response at EOT (ITT)
Clinical Response at EOT (CE)
Clinical Response at PTE (ITT)
Clinical Response at PTE (CE)
Tedizolid
79.5%
69.3%
80.2%
85.5%
94.6%
Linezolid
79.4%
71.9%
81.1%
86%
95.4%
0.1 (-6.1 to 6.2)
-2.6 (-9.6 to 4.2)
-0.9 (-7.7 to 5.4)
-0.5 (-5.8 to 4.9)
-0.8 (-4.6 to 3.0)
Absolute Treatment Differencea a
Clinical response rate difference (95% CI)
www.pswi.org
defined): 1. Clinical response at 48 to 72 hours in the ITT group. 2. Clinical response at day seven in the ITT group. 3. Clinical response at EOT in the ITT group. 4. Clinical response at the PTE in the ITT group. 5. Clinical response at late follow-up in the ITT group. Patients received either tedizolid 200 mg IV once daily for six days or linezolid 600 mg IV twice daily for ten days, with optional oral step down. There were 332 subjects randomized to the tedizolid group and 334 randomized to linezolid. Tedizolid demonstrated non-inferiority to linezolid based on results of the primary outcome and all secondary outcomes. Additionally, mean switch time to oral therapy was not significantly different between treatment arms. Results are outlined in Table 3 below. The ESTABLISH-2 trial is limited due to the extensive exclusion criteria used to select the patient population, making the results of the trial less generalizable. Patients that had taken an SSRI or MAOI within the past two weeks were excluded from the trial, thus the results provide no insight into the risk of serotonin syndrome with tedizolid. Additionally, although patients taking tedizolid experienced significantly fewer platelet-lowering events as compared to linezolid, the study was not designed to examine this difference, and the true clinically relevant hematologic effects of tedizolid remain unknown. Furthermore, the trial evaluated the use of tedizolid in only a narrow population of ABSSI, and did not investigate its use for the variety of indications for which linezolid may be used. Neither tedizolid phosphate nor tedizolid is an inducer, inhibitor, or substrate of CYP 450 enzymes or PGP protein.16 MAO inhibition11 Tedizolid is a weak, reversible inhibitor of MAO, based on in vitro laboratory data. However, this is likely clinically insignificant, as in vivo studies imply no significant MAO inhibition. The human tyramine challenge assessed in vivo MAO January/February 2015
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TABLE 3. Primary and Secondary Outcome Results From ESTABLISH-2 Primary Outcome
Secondary Outcome
Clinical Response at 48 to 72 hours
Clinical Response at 48 to 72 hours
Clinical Response Day 7
Clinical Response at EOT
Clinical Response at PTE
Clinical Response at Late Follow Up
Tedizolid
85%
92%
93%
92%
88%
98%
Linezolid
83%
90%
92%
90%
88%
99%
2.6 (-3.0 to 8.2)
1.2 (-3.3 to 5.6)
0.9 (-3.2 to 4.9)
1.4 (-3.0 to 5.9)
0.3 (-4.8 to 5.3)
-1.1 (-3.8 to 1.3)
Absolute Treatment Differencea a
Clinical response rate difference (95% CI); secondary outcomes evaluated the ITT group
inhibition of tedizolid through increased tyramine sensitivity as indicated by increased blood pressure. The results of this study imply no significant interaction between tedizolid and tyramine. No food restrictions or warnings are recommended with tedizolid administration. Sympathomimetic Interactions11 In order to determine the vasoconstrictive effects of tedizolid when taken with a sympathomimetic agent, a pseudoephedrine challenge was conducted on human subjects. There was no significant difference seen in blood pressure or heart rate as compared to placebo. The results of this study imply no significant interaction between tedizolid and pseudoephedrine. Serotonin Interactions11 Studies documenting the frequency of head twitch in male mouse subjects provide an in vivo measure of serotonergic activity. Tedizolid did not increase the amount of head twitch in any of the doses administered, implying no significant serotonergic activity. Of note, linezolid did significantly increase the frequency of murine head twitch, as compared to placebo. No studies in humans have assessed the potential for interaction with serotonergic agents, and all patients on SSRIs were excluded from both phase III clinical trials.16
Adverse Reactions
The most common adverse effects reported for tedizolid are nausea (8%), headache (6%), diarrhea (4%), vomiting (3%) and dizziness (2%).16 In ESTABLISH-1, adverse events related to treatment were similar 30  The Journal January/February 2015
for tedizolid and linezolid and were generally moderate to mild in nature. Gastrointestinal (GI) issues were the most prevalent adverse effect; nausea was reported by 8.5% of tedizolid patients and by 13.4% of linezolid patients. Headache was the next most commonly reported event (6.3% and 5.1% respectively), and then diarrhea (4.5% and 5.4% respectively). There was no significant difference between treatment arms. Serious adverse events did not occur frequently and there was no difference between linezolid and tedizolid; five patients in the tedizolid group reported a serious adverse event as compared to four patients in the linezolid group (1.5% vs 1.2%). One death occurred in the tedizolid group but it was determined to be unrelated to treatment. In each group, two patients (0.6%) discontinued treatment due to a treatment related adverse event. Liver enzyme elevations occurred in 4.1% of tedizolid patients and 3.5% of linezolid patients; however, over one third of these patients had Hepatitis C. Lowered platelet counts occurred in 2.3% of tedizolid patients and 4.9% of linezolid patients. Half of the patients that suffered low platelet counts had Hepatitis C. Platelets counts rebounded without medical intervention in both groups. The study was not powered to determine a difference in myleosuppression with tedizolid. In ESTABLISH-2, drug discontinuation due to an adverse event occurred infrequently; one patient in the tedizolid group (<1%) and four patients in the linezolid group (1%) discontinued treatment due to an adverse event. There was one death in each arm of the study, but this was unrelated to treatment.
The number of patients that experienced a significant decrease in platelet count in the ESTABLISH-2 trial was not significantly different between treatment groups; 9% of tedizolid patients versus 13% of linezolid patients (p=0.71) had a platelet count fewer than 150 x 109/L at any point during treatment.23 There was a significant difference in the number of patients that experienced a significant decrease in absolute neutrophil count; nine of 305 patients (3%) in the tedizolid group versus 21 of 299 patients (7%) in the linezolid group (p=0.024).23
Conclusion
The results of ESTABLISH-1 and -2, although compelling, lack generalizability to most hospital patients due to the expansive exclusion criteria. However, tedzolid may be a reasonable option in the outpatient setting for the management of uncomplicated ABSSSI in a patient without significant comorbidities. The use of tedizolid in an inpatient setting may be limited due to the lack of clinical data to support the purported improved drug and food interaction profile and purported improved hematologic side effect profile as compared to linezolid. Additionally, the FDA warning that was recently added to the package insert which advises against the use of tedizolid in neutropenic patients severely limit its use in any setting that treats immunosuppressed patients. â&#x2014;? Eileen T. Shannon, is a 4th year Doctor of Pharmacy Student at University of WisconsinMadison School of Pharmacy, Madison, WI. Joshua Vanderloo is a Clinicalist at UW Hospital and Clinics, Madison WI.
The authors declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria. References
1. Wolff K, Johnson RA, Saavedra AP. Section 25. Bacterial Colonizations and Infections of Skin and Soft Tissues. Fitzpatrick's Color Atlas and Synopsis of Clinical Dermatology, 7e. New York, NY: The McGraw-Hill Companies; 2013. 2. Moran GJ, Abrahamian FM, Lovecchio F, Talan DA. Acute bacterial skin infections: developments since the 2005 Infectious
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www.fda.gov/Drugs/DrugSafety/ucm265305. Diseases Society of America (IDSA) guidelines. htm#hcp. Accessed August 14, 2014. J Emerg Med. 2013;44(6):e397-412. 3. Moet GJ, Jones RN, Biedenbach DJ, Stilwell 11. Flanagan S, Bartizal K, Minassian SL, Fang E, MG, Fritsche TR. Contemporary causes of skin Prokocimer P. In vitro, in vivo, and clinical studies and soft tissue infections in North America, Latin of tedizolid to assess the potential for peripheral or America, and Europe: report from the SENTRY central monoamine oxidase interactions. Antimicrob Antimicrobial Surveillance Program (1998-2004). Agents Chemother. 2013;57(7):3060-3066. Diagn Microbiol Infect Dis. 2007;57(1):7-13. 12. Prokocimer P, Bien P, Surber J, et al. Phase 4. Klevens RM, Morrison MA, Nadle 2, randomized, double-blind, dose-ranging study J, et al. Invasive methicillin-resistant evaluating the safety, tolerability, population Staphylococcus aureus infections in the United pharmacokinetics, and efficacy of oral torezolid States. Jama. 2007;298(15):1763-1771. phosphate in patients with complicated skin 5. Kisgen JJ, Mansour H, Unger NR, Childs and skin structure infections. Antimicrob LM. Tedizolid: a new oxazolidinone antimicrobial. Agents Chemother. 2011;55(2):583-592. Am J Health Syst Pharm. 2014;71(8):621-633. 13. Shaw KJ, Poppe S, Schaadt R, et al. 6. ZYVOX(TM) (linezolid) [package In vitro activity of TR-700, the antibacterial insert]. Pfizer, New York, NY; 2008. moiety of the prodrug TR-701, against 7. Ables AZ, Nagubilli R. Prevention, recognition, linezolid-resistant strains. Antimicrob Agents and management of serotonin syndrome. Am Chemother. 2008;52(12):4442-4447. Fam Physician. 2010;81(9):1139-1142. 14. Locke JB, Zurenko GE, Shaw KJ, 8. Lodise TP, Patel N, Rivera A, et al. Bartizal K. Tedizolid for the management of Comparative evaluation of serotonin toxicity human infections: in vitro characteristics. among veterans affairs patients receiving Clin Infect Dis. 2014;58 Suppl 1:S35-42. 15. Bozdogan B, Appelbaum PC. Oxazolidinones: linezolid and vancomycin. Antimicrob Agents activity, mode of action, and mechanism of resistance. Chemother. 2013;57(12):5901-5911. 9. Ramsey TD, Lau TT, Ensom MH. Serotonergic Int J Antimicrob Agents. 2004;23(2):113-119. and adrenergic drug interactions associated with 16. SIVEXTRO(TM) [prescribing information]. linezolid: a critical review and practical management Cubist Pharmaceuticals, Lexington, MA; 2014. approach. Ann Pharmacother. 2013;47(4):543-560. 17. Flanagan SD, Bien PA, Munoz KA, 10. U.S. Food and Drug Administration. FDA Minassian SL, Prokocimer PG. Pharmacokinetics Drug Safety Communication: Serious CNS reactions of tedizolid following oral administration: possible when linezolid (Zyvox) is given to patients single and multiple dose, effect of food, and BuySell_ads15_Layout 1 12/2/14 4:54 PM Page 5 taking certain psychiatric medications. http:// comparison of two solid forms of the prodrug.
Don’t leave money on the table when you transition the ownership of your business. Do you know the three most common mistakes that pharmacy owners make when contemplating the sale of their pharmacy? To learn what they are, and to learn much more about the services we provide for independent pharmacy owners thinking about ownership transition and/or retirement, visit our web site, www.buy-sellapharmacy.com. Click on the button on the home page that says “Pharmacy Owner’s Questions” or call your local Buy-Sell Associate directly at any time. By doing so, you will have the opportunity to earn a $100.00 GIFT of valuable marketing materials for use in your pharmacy.
Pharmacotherapy. 2014;34(3):240-250. 18. Flanagan S, Fang E, Munoz KA, Minassian SL, Prokocimer PG. Single- and Multiple-Dose Pharmacokinetics and Absolute Bioavailability of Tedizolid. Pharmacotherapy. 2014. 19. Sahre M, Sabarinath S, Grant M, et al. Skin and soft tissue concentrations of tedizolid (formerly torezolid), a novel oxazolidinone, following a single oral dose in healthy volunteers. Int J Antimicrob Agents. 2012;40(1):51-54. 20. Drusano GL, Liu W, Kulawy R, Louie A. Impact of granulocytes on the antimicrobial effect of tedizolid in a mouse thigh infection model. Antimicrob Agents Chemother. 2011;55(11):5300-5305. 21. Prokocimer P, Bien P, Deanda C, Pillar CM, Bartizal K. In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012;56(9):4608-4613. 22. Prokocimer P, De Anda C, Fang E, Mehra P, Das A. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. Jama. 2013;309(6):559-569. 23. Moran GJ, Fang E, Corey GR, Das AF, De Anda C, Prokocimer P. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, noninferiority trial. Lancet Infect Dis. 2014.
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pharmacypractice feature
PHARMACIST and TECHNICAIN CE
Biosimilars and the Future of Biologics by Danielle Leach, PharmD The author has no disclosures or conflicts of interest to report.
T
he term “biologics” encompasses a wide array of products from vaccines, blood, blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant proteins, except if chemically made.1 Biologic products often originate from natural sources, such as humans, animals, and microorganisms. However, biologics may also be produced or modified using sophisticated biotechnology for manufacturing efficiency and efficacy. Compared to small-molecule pills and tablets that dominate today’s pharmacy shelves, biologics do not have a simple, defined chemical structure. These extremely complex medications are generally produced under proprietary manufacturing techniques and within strict temperature controlled environments to prevent degradation of the product. An example of the complexity of biologic manufacturing is the production of recombinant proteins. Every protein produced by a living organism originates from a unique DNA sequence which serves as a production blue print. To make a recombinant protein, the gene that produces the desired protein must be identified and isolated from the living cell. This gene is then inserted into the DNA of a host cell, which can be bacteria, yeast, or mammalian. The host cells are then grown and multiplied, producing the desired protein along with their own. The recombinant protein is then separated from other proteins through purification techniques that generally yield 95 to 98% purity.2 The type of host cell, growth process, and purification methods used may differ between protein type and manufacturer.
CE FOR PHARMACISTS & TECHNICIANS
COMPLETE ARTICLE AND CE EXAM AVAILABLE ONLINE: WWW.PSWI.ORG
Objectives • Compare and contrast a biologic that is biosimilar to one that is also interchangeable • Describe the FDA approval process for biosimilars • Identify the responsibilities of providers and pharmacy staff in prescribing and dispensing biosimilars • Identify resources available that provide information on biosimilars • Explain the projected impact of biosimilars on formularies and health care costs
projects that biologics will account for up to 20% of total medication sales by the year 2017 (Figure 1.).4 The sales of biologics nearly doubled from $63.8 billion in 2006 to $124.6 billion in 2012 and are expected to grow to $190 to $200 billion by the year 2015.5,6 The number of new biologic products approved each year has also grown, increasing from seven products in 2004 to ten products in 2012.3 The top three highest selling medication therapies of 2013, adalimumab, infliximab, and rituximab, are all biologic products.7 All the biologics included in the 2013 list of top-selling medications (Table 1) have continued to have improved sales since 2012.7 The largest annual sales increase
from 2012 to 2013 was for insulin glargine (15.2%) and adalimumab (15%), largely due to manufacturer price increases.7
Biosimilars and Interchangeability According to the U.S. Food and Drug Administration (FDA), “a biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”8 The term “reference biologic” refers to a licensed, brand name biologic
FIGURE 1. Global Biologic Sales4
Introduction: Biologic Trends
The sales of biologics in the United States continue to rise, along with the approval of new medications.3 IMS Health 32 The Journal January/February 2015
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TABLE 1. Top Selling Biologics of 20137 Type
2013 Global Sales (US$ billions)
Patent Expiry (US)
adalimumab
Monoclonal Antibody
10.7
Dec 2016
Remicade
infliximab
Monoclonal Antibody
8.9
Sep 2018
Rituxan/MabThera
rituximab
Monoclonal Antibody
8.6
Dec 2018
Enbrel
etanercept
Recombinant Protein
8.3
Nov 2028
Brand Name
Humira
Active Ingredient
Lantus
insulin glargine
Recombinant Protein
7.8
Feb 2015
Avastin
bevacizumab
Monoclonal Antibody
7.0
Jul 2019
Herceptin
trastuzumab
Monoclonal Antibody
6.8
Jun 2019
Neulasta
pegfilgrastim
Recombinant Protein
4.4
Oct 2015
medication. An example of this concept is shown in Figure 2. No two snowflakes are ever exactly alike, even though they might look somewhat similar. When applying this concept to reference biologics and biosimilars, a biosimilar product will never be exactly the same as the reference product due to the complexity and variability of structures that occur when products are derived from living sources. They must, however, have no clinically meaningful difference in terms of safety, purity, and potency. A common error is to call these products the generic versions of reference biologics or “biogenerics”. The term “generic” should only be applied to small-molecule medications. For many pharmacies, generics are considered a product of choice that is typically substituted for the brand name medication when possible.8 If the same standards for generics are used for biosimilars, it implies that any biosimilar can be substituted in place of the reference biologic, which cannot be done. Before a biosimilar product can be substituted in place of a reference biologic, the biosimilar must be determined to be interchangeable through a separate approval process. This means that the biosimilar can be expected to produce the same clinical result as the reference biologic in any given patient.8 Additionally, the safety risk or concerns of diminished efficacy when switching to a biosimilar from the reference product will not be greater than the risk of using the reference biologic.8 Not all biosimilars www.pswi.org
will be interchangeable with their reference products since not all of them will be proven to produce the same clinical results in any given patient. Bottom Line: Biosimilars are not identical to their reference biologic and can only be substituted if they have been determined interchangeable by the FDA.
FDA Approval of Biosimilars
Most biologic products are licensed under the Public Health Service Act (PHS Act) of 1944. This is different than small-molecule drugs, which are approved under the Food, Drug and Cosmetic Act (FDCA). In 1984, the Hatch-Waxman Act allowed for an Abbreviated New Drug Application (ANDA), which is the pathway utilized for the approval of small-molecule generics. A pathway for biosimilars was
not addressed until the PHS Act was amended through the Patient Protection and Affordable Care Act (ACA) on March 23, 2010.8 This has created an abbreviated licensure pathway for biosimilars through the 351(k) application and has defined interchangeability standards.9 These statutes within the ACA are known as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).9 Prior to this act, there was no approval pathway for biosimilars to be compared with current licensed reference biologics. Under the BPCI Act, a new biologic product must prove the following to be considered biosimilar:10 • Has a reference biologic • Has the same mechanism of action as the reference biologic • Demonstrates safety and efficacy for at least one indication of the reference biologic • Has the same administration route as the reference biologic • Has the same dosage form as the reference biologic • Has the same potency as the reference biologic Guidance documents from the FDA have been drafted to help in the assessment of biosimilars and determination of interchangeability proven through analytical, animal, and new clinical studies.10,11 A “Totality of Evidence” approach will be used in the FDA’s assessment of biosimilars in comparison to a reference biologic.10 Figure 3 depicts this approach, beginning with biosimilar
FIGURE 2. Like these two snowflakes, no biosimilar will ever be identical to its reference biologic in structure, but its safety, purity, and potency must have no clinically meaningful difference.
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TABLE 2. Summary of Definitions Relating to Biologics1,8-9 Term
Definition
Biologic
Composed of a virus, serum, toxin, antitoxin, vaccine, blood, blood components, allergenics, somatic cells, gene therapy, tissues, or recombinant proteins (except if chemically made) for the prevention, treatment, or cure of a disease or condition. Generally made through a living organism or cells.
Reference Biologic
A licensed, brand name biologic
Biosimilar
A biologic that is highly similar in composition to a reference biologic and has no clinically meaningful differences in terms of safety, purity, and potency. They are not always interchangeable.
Interchangeable
A biosimilar expected to produce the same clinical result as the reference product in any given patient
Biogeneric
A misleading term that implies biosimilars are like generic small-molecule medications that can be substituted. The use of this term should be avoided.
development and focusing on baseline structural and functional characterization before narrowing the focus to clinical studies to prove no clinically meaningful differences exist in safety, purity, and potency between the biosimilar and its reference biologic. Most reference biologics were approved under the PHS Act, however, there are certain exceptions that have allowed for
biologics to be approved under the FDCA (eg, chemically synthesized biologic or a structure less than 40 amino acids). Most biosimilar applications should go through the PHS Act pathway unless there is already an approved reference biologic application that was approved under the FDCA. Starting on March 23, 2020, any application for a biologic approved under the FDCA will transition to become a BLA
FIGURE 3. The U.S. Food and Drug Administration Totality of Evidence Approach10
Clinical Studies
Animal Studies
Clinical Immunogenicity
Clinical Knowledge (Post Market Experience) Human Pharmacokinetics and Pharmacodynamics
Structural and Functional Characterization
34â&#x20AC;&#x192; The Journal January/February 2015
under the PHS Act.10 The abbreviated approval process for biosimilars is not quite the same as the abbreviated process for small-molecule generics (Figure 4.). Biosimilars require a full Biologics License Application (BLA) and more rigorous evaluation at each step of the approval process compared with small-molecular generics. This includes new clinical studies on the safety and efficacy of the medication compared to a reference biologic approved in the United States.12 The ANDA allows for a smallmolecule generic to be approved without going through the same rigorous clinical studies as its brand name precursor due to ease of structure and bioequivalence characterization. In contrast, the biosimilar 351(k) pathway requires new clinical trials to rule out clinically meaningful differences in safety, purity, and potency, but they are abbreviated from the reference biologic requirements.12 A biosimilar cannot follow the same process as a generic small molecule medication because a biosimilar is structurally different from the reference biologic. Bottom Line: Like small-molecule generics, biosimilars have an abbreviated pathway for FDA approval, but it is much more complex and requires new clinical studies.
Biosimilar Naming Debate
The naming of small-molecule medications follows the World Health Organizationâ&#x20AC;&#x2122;s (WHO) International Nonproprietary Names (INN) Programme. The purpose of an INN is to provide a unique name for the active ingredient of a product that is public property and recognized on a global scale.14 The INN is the name we see as the generic medication. There is also the United States Adopted Name (USAN) Council, which works with the INN Programme when naming products marketed in the United States. The naming of biosimilars has proven to be a controversial topic. Unlike smallmolecule generic medications, biosimilars are not structurally identical to their reference biologic product. This causes confusion as to whether or not a biosimilar should have the same INN as the reference biologic or a unique INN to distinguish between the two products. Globally, the
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TABLE 3. Summary of Approval Process Comparisons12 Governing Act
FDCA
PHS Act
Application Type
Application Pathway
Clinical Studies Required?
New Drug Application
505(b)1
Yes: full evaluation of safety and efficacy
New Drug Application
505(b)2
Yes: studies do not have to be done by application sponsor
Abbreviated New Drug Application
505(j)
No: but bioequivalence must be demonstrated
Biologics License Application
351(a)
Yes: full evaluation of purity, safety, and potency
Biosimilar BLA
351(k)
Yes: but abbreviated process
Abbreviations: BLA = Biologics License Application; FDCA = Food Drug and Cosmetic Act; PHS = Public Health Service
naming of biosimilar products has been inconsistent.15 In Europe, some biosimilars share the same INN as the reference biologic, while others have a distinct name, such as epoetin alpha and biosimilar epoetin zeta.15 Other agencies, like those in Japan and Australia, require biosimilar products to have a unique identifier code made of letters or numbers after the INN.15 The United States currently does not have specific naming mandates, and the FDA is waiting to release its final decision.15 The reasoning behind accepting a unique INN is to simplify post-marketing safety surveillance and to prevent medication errors.15 Multiple biosimilars with an identical INN may cause confusion when trying to report safety concerns and when choosing the correct product to dispense based on a provider’s prescription order. Identical INNs may also imply to pharmacy staff that substitution can occur, which is only the case if the biosimilar is interchangeable. A draft proposal on a solution to the biosimilar naming debate was released by WHO in July 2014. The INN Expert Group proposed something called a Biologic Qualifier (BQ). The BQ is a four letter alphabetic code that will be randomly assigned to a specific biosimilar product manufactured at a specific site. The code would follow the INN to make it unique for that biosimilar. The manufacturer must apply for the BQ either prospectively or retrospectively. The adoption of this naming scheme is entirely voluntary for the FDA, but was made with the intention of eliminating inconsistent naming schemes between countries and to prevent confusion.16 Changing the INN of a biologic product can sometimes affect the www.pswi.org
meaning behind the name, such as with monoclonal antibodies, like adalimumab. Guidance documents from WHO have been developed, outlining monoclonal antibody naming to consist of a prefix, two different substems (or infixes), and a suffix (Figure 5.). The prefix is chosen by the manufacturer. The common suffix for monoclonal antibodies is “mab”. The first substem indicates the target of the monoclonal antibody. Some examples include “li” (immune system modulator), “tu” (tumor), and “ci” (cardiovascular). The second substem indicates the species of origin for the monoclonal antibody. Examples include “o” for mouse, “u” for human, “xi” for chimeric (animal and human), and “zu” for humanized. Applying this naming scheme to adalimumab identifies it as an immunomodulating monoclonal antibody of human origin.17 Bottom Line: Biosimilar naming is controversial, but unique naming would prevent confusion between biosimilar products. A plan for a four letter code to follow all nonproprietary names to make them unique has been developed by WHO.
Release of Biosimilars – The U.S. and Global Markets Currently there are not any biologics that have been approved through the FDA’s biosimilar pathway.8 Recent FDA approval of ziv-aflibercept (August 2012), tbo-filgrastim (August 2012), and adotrastuzumab emtansine (February 2013) are examples of biologics that could have gone through the biosimilar approval process had it been finalized.15 With the impending patent expirations for some of the top-selling biologics, the development of biosimilar products and utilization of the FDA’s abbreviated pathway is in the near future.7 Currently, FDA has received two BLAs under the new BPCI Act for biosimilars.18 The first filing was from Sandoz in July 2014 for filgrastim (Zarzio) followed by Celltrion in August 2014 for infliximab (Remsina). These biosimilars have currently already received approval on the international market.18 In the European Union, biosimilars are approved through the European Medicines Agency (EMA).19 The very first European biosimilar, somatropin, was approved in
FIGURE 5. Meaning Behind Monoclonal Antibodies
Monoclonal Antibody Naming: Adalimumab Breakdown Prefix
Ada li(m) u mab Immune System Modulator
Suffix
Human Origin
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FIGURE 4. Comparison of U.S. Food and Drug Administration Approval Processes12, 13
New Drug Application (NDA) Pathway New Drug Developed
Preclinical Animal Testing
Investigational New Drug Application
Clinical Trials Phase I, II, III
New Drug Application
Approval
PostMarketing Surveillance
Approval
PostMarketing Surveillance
Abbreviated New Drug Application (ANDA) Pathway Generic Developed
Bioequivalence Studies
Abbreviated New Drug Application
Biologic Licensing Application (BLA) Pathway New Biologic Developed (Structure Identified)
Preclinical Animal Testing
Investigational New Drug Application
Clinical Trials Phase I, II, III, Immunogenicity
Biologic Licensing Application
Approval
PostMarketing Surveillance
Preclinical Animal Testing
Investigational New Drug Application
Clinical Trials Phase I, II, III, Immunogenicity
Biosimilar BLA 351(k)
Approval
PostMarketing Surveillance
Biosimilar Pathway New Biosimilar Developed (Analyze Structure)
the year 2006.19 Since that time, EMA has approved a total of 21 biosimilar products and has withdrawn two from the market.20 There were three new biosimilars for filgrastim, follitropin alfa, and insulin glargine approved by the EMA in 2014.20 General guidance documents for biosimilar development have been available from the EMA since 2005.21 Since the release of these documents, EMA has approved eight filgrastim biosimilars and two infliximab biosimilars compared with the recent filgrastim and infliximab biosimilar applications pending with FDA.20 Bottom Line: The United States has yet to approve a biologic as a biosimilar. Two Biologic Licensing Applications have been submitted this year to the FDA for a filgrastim and infliximab biosimilar.
Pharmacy and Provider Responsibility Based on the definitions previously discussed, if a biosimilar is not interchangeable, the provider must write the prescription for that specific biosimilar, and not the reference biologic. If the provider writes a prescription for a reference biologic, the pharmacy staff must determine if there is an interchangeable biosimilar available so long as substitution 36 The Journal January/February 2015
is allowed by the prescriber. An example of this concept would be a prescription written for brand name Humira (adalimumab) after the patent expiry date and biosimilars are available. Pharmacies would only be able to substitute Humira for a biosimilar adalimumab that is interchangeable. The provider would need to write a new prescription if the products are not interchangeable, but a certain biosimilar is still desired. The Purple Book is a new reference that is available to assist pharmacy staff in this substitution process. This reference will be comprised of lists of all licensed reference biologic products, as well as any biosimilar or interchangeable products listed below them.21 Dates of reference biologic and biosimilar licensure will also be included. Currently, the Purple Book consists of two separate lists. One contains all biologics regulated by the Center for Drug Evaluation and Research (CDER), and the other contains biologics regulated by the Center for Biologics Evaluation and Research (CBER). The lists are currently sparse and only include reference biologics due to the lack of biosimilar availability.22 In the United States, there is already legislation in place or in process addressing the substitution of reference biologics with biosimilars. As of July 1, 2014, there are
23 states that are in the process of or have established state standards for substituting a biosimilar for a reference biologic (Figure 6).23 Eight of the states currently have enacted state laws, California passed a bill that was vetoed by the governor, and 14 states either have bills that are pending or have not passed.23 The content of different laws varies by state, but many contain the following common themes: 23 • The biosimilar must be deemed interchangeable by the FDA for substitution to occur • The prescriber has the power to prevent substitution • The prescriber must be notified when a substitution is made by a pharmacy • The patient must be notified when a substitution is made by a pharmacy • Records of substitution must be maintained by both pharmacist and provider • There must be a public list of interchangeable products available from the state Currently, no legislation addressing the substitution of biosimilars with a reference biologic has been introduced in Wisconsin. Bottom Line: A prescription must be written for the specific biosimilar
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intended if it is not interchangeable with a reference biologic. The Purple Book is a reference used to check biosimilars for interchangeability.
Impact on Cost and Formularies
Whether or not biosimilars will have a significant impact on biologic costs and savings in the United States is unknown. Cost projections have estimated that biosimilars are expected to result in an average price reduction of 20 to 30% from the reference biologic.12 This projected decrease in cost is small when compared with the 70 to 80% decrease seen on small-molecule generics, but the cost to produce biologics is also much higher.12 The RAND Corporation performed an analysis that predicted biosimilars would save the United States over $44 billion on biologic spending in the next decade.24 Time to approval and the investment in developing a biosimilar are more substantial than small-molecule generics. Biosimilars are an expensive investment by manufacturers with the requirement of new clinical trials in the abbreviated pathway and complicated production processes that are not always known from the reference biologic manufacturers.12 As result, biosimilar approval and market release takes a projected seven to eight years compared with eight to ten years for a reference biologic.11 In contrast, a smallmolecule generic only takes between two
to three years to be approved and released to market.11 In terms of investment, reference biologics cost about $800 million, biosimilars cost between $75 to $250 million, and small-molecule generics cost about $2 to $3 million dollars.11 Other considerations that will likely play a role in determining the place of biosimilars are the recognition of these products on commercial and federal payer formularies. Biosimilars are not generics and will most likely have to compete with their brand name reference biologic for a spot on these formularies. Interchangeability will also be a factor. Payers may be more likely to choose a biosimilar that is interchangeable for easier access to cost savings rather than adding a product that was approved as a biosimilar only. Another consideration is the indications for the biosimilar. Not all biosimilars will have the same indications as their reference biologics. They may only have some or even only one of the indications based on the submitted BLA. Finally, another important factor affecting biosimilar formulary impact is time on the market and provider and patient acceptance. Since biosimilars are not structurally identical to their reference biologic, and they will be identified by a different name, patients and providers
may be hesitant to use biosimilars. Over time, as more biosimilars enter the market and their clinical effects can be measured, their place on payer formularies, patient treatment plans, and overall value to healthcare in the United States will be determined. Bottom Line: Though some estimates project that biosimilars will save money, the true effects of biosimilars on healthcare costs and formularies are yet to be seen. Biosimilars are not generics, so they will be competing with the reference biologics.
Conclusion
With many patents for the top selling biologic products expiring before 2020, biosimilars will soon be entering the market and will have a large impact on marketplace financials and pharmacy practice. Regardless of when biosimilars are introduced, pharmacy staff will not be able to substitute biosimilars for a reference biologic until they have been approved as interchangeable by the FDA. The Purple Book will be a valuable reference for determining interchangeability and biosimilar availability. Though some estimates project that biosimilars will save money, the true impact of biosimilars on healthcare costs and formularies is yet to be seen.â&#x2014;?
FIGURE 6. Status of Biosimilar State Legislation23
Biosimilar Web Resources: The U.S. Food and Drug Administration: www.fda.gov The Purple Book: http://www.fda. gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/ approvalapplications/ therapeuticbiologicapplications/biosimilars/ ucm411418.htm The European Medicines Agency: www. ema.europa.eu Biotechnology Industry Organization: www.bio.org/category/biosimilars Generics and Biosimilars Initiative: www. gabionline.net/Biosimilars Biosimilar News: www.biosimilarnews.com
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Danielle Leach, PharmD is a PGY1 Community Pharmacy Practice Resident at the UW Hospital and Clinics, Madison, WI.
Acknowledgements: Thanks to Megan Holsopple, PharmD, BCPS, Medication Use Policy Pharmacist, Center for Medication Utilization, Froedtert and the Medical College of Wisconsin and Scott Canfield, PharmD, PGY2 Specialty Pharmacy Resident, UW Hospital and Clinics for their support in the development of this article. References
1. The U.S. Food and Drug Administration. What Are “Biologics” Questions and Answers. Updated April 14, 2009. http://www.fda.gov/AboutFDA/ CentersOffices/OfficeofMedicalProductsandTobacco/ CBER/ucm133077.htm. Accessed October 22, 2014. 2. Generic Pharmaceuticals Association. Manufacture and Characterization of Biologics and Biosimilars. Updated 2013. http://www. gphaonline.org/gpha-media/gpha-resources/ manufacture-and-characterization-of-biologicsand-biosimilars. Accessed October 29, 2014. 3. Dalzell M. In 5 years, >50% of top-selling drugs will be biologics. Managed Care. Posted October 2013. http://www.managedcaremag.com/ archives/2013/10/5-years-50-top-selling-drugswill-be-biologics. Accessed October 22, 2014. 4. IMS Health. The Global Use of Medicines Outlook through 2017. September 2013. http:// www.imshealth.com/deployedfiles/imshealth/Global/ Content/Corporate/IMS%20Health%20Institute/ Reports/Global_Use_of_Meds_Outlook_2017/ Biologics_Market.pdf. Accessed October 22, 2014. 5. GaBi Online. Biologicals sales have almost doubled since 2006. Posted July 6, 2013. http://www.gabionline.net/Biosimilars/ General/Biologicals-sales-have-almost-doubledsince-2006. Accessed October 22, 2014. 6. Amgen. Trends in Biologic Medicine Report. Thousand Oaks, CA: Amgen Inc.; 2013. 7. GaBi Online. Top 8 blockbuster biologicals 2013. Posted June 6, 2014. http://www.gabionline. net/Biosimilars/General/Top-8-blockbusterbiologicals-2013. Accessed October 22, 2014. 8. The U.S. Food and Drug Administration. Information for Consumers (Biosimilars). Updated September 9, 2014. http://www.fda. gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ ucm241718.htm. Accessed October 22, 2014. 9. The U.S. Food and Drug Administration. Information for Healthcare Professionals (Biosimilars). Updated September 9, 2014. http:// www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ ucm241719.htm. Accessed October 22, 2014. 10. Sherman RE. Biosimilar Biologic Products:
38 The Journal January/February 2015
Biosimilar Guidance Webinar. U.S. Food and Drug Administration. February 15, 2012. http://www.fda. gov/downloads/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ UCM292463.pdf. Accessed October 22, 2014. 11. U.S. Food and Drug Administration. Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product. February 2012. http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ ucm291134.pdf. Accessed October 22, 2014. 12. Lucio SD, Stevenson JG, Hoffman JM. Biosimilars: implications for healthsystem pharmacists. Am J Health-Syst Pharm. 2013;70(22):2004-2017. 13. U.S. Food and Drug Administration. Drug Approval Process. http://www.fda.gov/ downloads/Drugs/ResourcesForYou/Consumers/ UCM284393.pdf. Accessed October 22, 2014. 14. World Health Organization. International Nonproprietary Names. http:// www.who.int/medicines/services/inn/ en/. Accessed November 12, 2014. 15. Alexander EA. The biosimilar name debate: what’s at stake for public health. GaBI Journal. 2014;3(1):10-12. 16. World Health Organization. Biologic qualifier: an INN proposal. Revised July 2014. http://www.who. int/medicines/services/inn/bq_innproposal201407. pdf?ua=1. Accessed November 12, 2014. 17. World Health Organization. International Nonproprietary Names (INN) for Biological and Biotechnological Substances: A Review. Update 2011. http://www.who.int/medicines/services/inn/ BioRev2011.pdf. Accessed November 12, 2014. 18. Gaffney A. FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody. Regulatory Affairs Professionals Society. Posted August 11, 2014. http://www.raps.org/Regulatory-Focus/ News/2014/08/11/20001/FDA-Receives-FirstEver-Biosimilar-Application-for-MonoclonalAntibody/. Accessed November 12, 2014. 19. GaBi Online. Biosimilars Approved in Europe. Updated 10/17/2014. http://www.gabionline. net/Biosimilars/General/Biosimilars-approvedin-Europe. Accessed November 12, 2014. 20. European Medicines Agency. European Public Assessment Reports. Updated September 2014. http://www.ema.europa.eu/ema/ index.jsp?curl=pages/medicines/landing/ epar_search.jsp&mid=WC0b01ac058001d125. Accessed November 12, 2014. 21. European Medicines Agency. Overarching Biosimilar Guidelines. Updated September 2014. http://www.ema.europa.eu/ema/index. jsp?curl=pages/regulation/general/general_ content_000408.jsp#Overarchingbiosimilarg uidelines. Accessed November 22, 2014. 22. The U.S. Food and Drug Administration. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Updated October 1, 2014. http://www.fda. gov/drugs/developmentapprovalprocess/
howdrugsaredevelopedandapproved/ approvalapplications/therapeuticbiologicapplications/ biosimilars/ucm411418.htm. Accessed October 22, 2014. 23. National Conference of State Legislatures. State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars. Posted July 1, 2014. http://www.ncsl.org/documents/ health/Biologics_BiosimilarsNCSLReport_ July_2014.pdf. Accessed October 22, 2014. 24. Mulcahy AW. Biosimilar Medications Could Create Billions in Health Care Savings. RAND Corporation. Posted November 3, 2014. http://www.rand.org/news/press/2014/11/03. html. Accessed November 13, 2014.
Assessment Questions 1.
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3.
4. 5.
Which term matches the definition: “A biosimilar expected to produce the same clinical results as the reference product in ANY given patient.” a. Biosimilar b. Interchangeable c. Biogeneric d. Reference Biologic Which term matches the definition: “A biologic highly similar to a reference biologic with no clinically meaningful differences in terms of safety, purity, and potency, but is not proven to have the same clinical results in every patient.” a. Biosimilar b. Interchangeable c. Biogeneric d. Reference Biologic True or False. The new abbreviated biosimilar BLA pathway is just as fast as the ANDA pathway for small-molecule generics because clinical trials are not necessary for approval. a. True b. False Biosimilars must demonstrate what characteristic(s) for approval with a BLA? a. Same administration route as the reference biologic b. Different dosage form than the reference biologic c. Same efficacy for at least one indication of the reference biologic d. Both a and c In terms of interchangeability, which of the following are acceptable? a. One biosimilar is substituted for a prescription written for a different biosimilar b. A provider writes a prescription for a reference biologic, assuming that any biosimilar will be substituted c. An interchangeable biosimilar is
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substituted for a prescription written for its reference biologic d. None of the above
6.
7. 8.
True or False. If a provider writes a prescription for a brand name biologic, any biosimilar can be substituted because it has the exact same active ingredient. a. True b. False Which of the following are available biosimilar resources? a. The FDA website b. The Purple Book c. Biotechnology Industry Organization d. All of the above True or False. Though projections have been made, the true effects of biosimilars on formularies and healthcare costs remains to be seen. a. True b. False
9.
This activity met my educational needs a. Met all educational needs related to the topic b. Met some educational needs related to the topic
c. Did not meet my educational needs
10. How would you rate the ability of the author to provide a high-quality educational activity? a. Very capable, article was well done and provided good information b. Somewhat capable, most information was presented well c. Needs improvement
Did the activity meet the stated learning objectives? 11. Compare and contrast a biologic that is biosimilar to one that is also interchangeable a. Yes b. No 12. Describe the FDA approval process for biosimilars a. Yes b. No 13. Identify the respnosbilities of providers and pharmacy staff in prescribing and dispensing biosimilars a. Yes b. No
Quiz Answer Form
CE FOR PHARMACISTS & TECHNICIANS
14. Identify resources available that provide information on biosimilars a. Yes b. No 15. Explain the projected impact of biosimliars on formularies and health care costs a. Yes b. No 16.
How useful was the educational material? a. Very useful b. Somewhat useful c. Not useful
17. Learning assessment questions were appropriate a. Yes b. No 18. Were the presenters free from bias? a. Yes b. No (if you answer no, please email info@pswi.org to explain) 19. If you answered "no" to question 18, please comment 20. Please indicate the amount of time it took you to read the article and complete the assessment questions.
circle one answer per question
Continuing Education Credit Information The Pharmacy Society of Wisconsin is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Continuing education credit can be earned by completing the self assessment questions. Questions may be completed online at www.pswi.org or by mailing completed answer form to PSW, 701 Heartland Trail, Madison, WI 53717. Participants receiving a score of 70% or better will be granted 1 hour (1 CEU) credit through CPE monitor. Accurate birth date (MMDD) and CPE Monitor ID must be provided in order to receive this credit as required by ACPE. This CE offering is offered free-of-charge to all PSW members. Nonmembers are charged $20 for each exam submitted to cover administrative costs. January/February 2015
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Name______________________________Designation (RPh, PharmD, etc.)__________
Biosimilars and the Future of Biologics
CPE Monitor #_____________________________________DOB (mm/dd)__________
ACPE Universal Activity Number: 0175-0000-15-001-H03-P&T
Preferred Mailing Address________________________________________________
Target Audience: Pharmacists & Technicians Activity Type: Knowledge-based Release Date: January 1, 2015
City__________________________________State________ Zip_______________ Is this your home ❏ or work ❏ address?
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originalcontributions
ID CORNER A Primer on Hepatitis C by Laura Clark, 2015 PharmD Candidate and Margaret Cook, PharmD, BCPS
T
he ability to treat, and more importantly now, to cure, hepatitis C virus (HCV) infection has advanced dramatically in the past year with new, direct-acting antiviral agents (DAAs) able to achieve higher response rates compared to older agents. Further gains in HCV disease management are anticipated with FDA approvals of additional potent and well tolerated antivirals. The following is a summary of evolving options. Due to the rapidly changing nature of HCV management, readers are encouraged to refer to the AASLD/IDSA HCV Guidelines for up to date treatment recommendations http:// www.hcvguidelines.org/.1 An estimated 170 million people world-wide are infected with HCV. In the United States alone, 3 to 4 million people are believed to be infected, most of whom (45-85%) are unaware of their infection.1,2 Chronic HCV infection is the leading cause of liver transplantation in the U.S. Humans are the only known reservoir and transmission occurs predominantly via blood borne virus exposure (i.e. intravenous drug abuse).3 New infection most commonly occurs in young adults (age 25-34years) and may go undetected for years. While liver failure is rare with acute infection, indolent infection may lead to chronic liver disease, cirrhosis and hepatocellular carcinoma (HCC). Twenty percent of patients will clear HCV
40 The Journal January/February 2015
infection during the acute phase; but for remaining individuals, the risk of cirrhosis ranges from 5-25% over the subsequent 20 years following initial infection and varies with patient risk factors (i.e. alcohol ingestion, HIV co-infection, Hepatitis B co-infection).4 Heavy alcohol ingestion is a significant risk for progression, increasing associated risk of cirrhosis 100-fold.4 Long term, HCC will develop in 1-5% of chronically infected patients.3 There are eleven major genotypes of HCV infection and multiple subtypes (a, b, c). Genotype 1a is the most common strain in North America.2-5 Treatment regimens, duration and response vary based on genotype, stage of fibrosis, and prior treatment history. Similar to HIV infection, HCV infection is treated with combination drug therapy using agents from different drug classes to disrupt different targets in the viral life cycle. Successful treatment of HCV is defined as a sustained virologic response (SVR) or virologic cure, with undetectable viral RNA, at least 12 weeks after completion of therapy.1 Historically, interferonbased treatment regimens lasted 48 weeks, achieved SVR in about 30% of patients, and carried multiple significant adverse effects.6 New regimens achieve virologic cure rates in excess of 90% with oral regimens lasting 8-24 weeks.7,8 As expected, some populations (i.e. cirrhosis, fibrosis) have lower SVR with newer agents compared to treatment naïve populations.
Three classes of DAAs have emerged on the front lines of HCV treatment: polymerase inhibitors (i.e. sofosbuvir), protease Inhibitors (i.e. simeprevir) and NS5A inhibitors (i.e. ledipasvir, daclatasvir). Both approved in 2013, sofosbuvir (SovaldiTM) is a nucleotide NS5B polymerase inhibitor and simeprevir (OlysioTM) is an NS3/4A protease inhibitor. The combination medication ledipasvir/sofosbuvir (Harvoni®) was FDA approved in October 2014 while additional approvals are anticipated (i.e. daclatasvir, paretaprevir ombitasvir, dasabuvir). Key points regarding each new agent are listed below (Table 1); response rates are summarized in Table 2. Compliance with all regimens is essential to optimize response rates. Adverse events associated with newer agents in interferon-based combination regimens have often been a result of interferon (IFN) and ribavirinrelated toxicities and include depression, fatigue, nausea, anemia, pyrexia, neutropenia, headache, insomnia, and irritability.2,9-11 In summary, new DAAs are clearly better tolerated and in some cases, treatment has been deferred pending their arrival to the U.S. market. Additional unpublished data reports virologic cure approaching 95-100% (EASL 2014). Oral HCV treatment regimens are expected to offer high virologic cure rates, minimize the role of interferon treatment and ultimately, reduce associated disease burden on
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individuals and society.1,12 Effective, better tolerated regimens offer an important advancement for patients previously unable to consider IFN-based regimens due to treatment-limiting adverse effect profiles. Pharmacists play a key role in access, patient information, and patient education to optimize compliance and outcomes. ●
P
R
This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!
Laura Clark is a 4th year Doctor of Pharmacy student on rotation at Aurora St. Lukes Medical Center, Milwaukee, WI. Margaret Cook, PharmD is a Clinical Specialty Coordinator at Aurora St. Lukes Medical Center, Milwaukee, WI.
References
1. AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http:// www.hcvguidelines.org. Accessed October 27, 2014. 2. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368(20):1878-87.
3. World Health Organization. Global Alert and Response. Hepatitis C. http://www.who. int/csr/disease/hepatitis/whocdscsrlyo2003/en/ index2.html. Accessed October 27, 2014. 4. Ray S, Thomas D. Hepatitis C. In: Mandell GL, Bennett JE, Dolin R, eds. Principles and practice of infectious diseases. 7th ed. Philadelphia, PA: Churchill Livingston Elsevier, 2009: 2157-85. 5. Belousova V, Abd-rabou AA, Mousa SA. Recent advances and future directions in the management of hepatitis C infections. Pharmacology and Therapeutics. 2014. Available from http://dx.doi.org/10.1016/j. pharmthera.2014.09.002. (Epub ahead of print). 6. Hayashi N, Seto C, Kato M, et al. Oncedaily simeprevir (TMC435) with peginterferon /
TABLE 1. HCV Medications – Recent and Anticipated Treatment Options Agent & Administration Sofosbuvir (SovaldiTM)
Key Points: Indications, Metabolism, Elimination & Drug Interactions FDA approved for Genotypes 1,2,3,4. Substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Very few drug interactions with HIV medications.
9,10,11,13-16
Polymerase Inhibitor
Avoid with potent P-gp inducers: rifamycins, carbamazepine, oxacarbamazepine, phenytoin, phenobarbital & St. Johns Wort.
400mg tablet
Renal impairment: No dose adjustment is required for patients with mild or moderate renal impairment. No data in patients with CrCl <30mL/min.15
Administer with or without food
Hepatic impairment: No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment. Safety and efficacy has not been established in patients with decompensated cirrhosis.15 FDA approved for Genotype 1. Alternative to IFN-based regimens in combination with sofosbuvir.
Simeprevir (OlysioTM)6,16-20
Not recommended with Q80K polymorphism (predicts non-response). Screening patients with genotype 1a for an NS3 Q80K polymorphism at baseline is strongly recommended.
Protease Inhibitor 150mg tablet
Avoid in previous simeprevir, telaprevir, and boceprevir failures. Substrate of CYP 3A4 – responsible for most drug interactions. Avoid with HIV protease inhibitors. Mild inhibitor of CYP1A2, intestinal CYP3A4 & P-gp. No effect on hepatic CYP3A4.
Administer with food
Sulfonamide moiety – caution in sulfa allergic patients. Photosensitivity reported. Renal impairment: No dose adjustment is required for patients with mild or moderate renal impairment. No data in patients with CrCl <30mL/min.18 Hepatic impairment: No dose adjustment is required for patients with mild hepatic impairment. Safety and efficacy has not been studied in patients with moderate or severe hepatic impairment. Simeprevir is not recommended for patients with severe hepatic impairment due to substantially higher simeprevir exposures.18 Ledipasvir/Sofosbuvir (Harvoni®) NS5A inhibitor (ledipasvir)
7,8
FDA approved for Genotype 1. High SVR w/ one tablet, once daily (IFN-free, RBV-free). No added benefit with RBV. Avoid with potent P-gp inducers (see sofosbuvir).
90mg / 400mg
Most common adverse effects: fatigue, headache.
Administer with or without food
Renal impairment: No dose adjustment is required for patients with mild or moderate renal impairment. No data in patients with CrCl <30mL/min.7 Hepatic impairment: No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment. Safety and efficacy has not been established in patients with decompensated cirrhosis.7
Daclatasvir21 NS5A inhibitor
FDA Approval pending. High SVR with sofosbuvir vs. genotypes 1, 2, and 3 as well as non-responders to telaprevir or boceprevir therapies. Most common adverse effects: Fatigue, headache, nausea. Renal and hepatic impairment: information pending approval
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ribavirin for treatment-naïve hepatitis C genotype 1-infected patients in Japan: the DRAGON study. J Gastroenterol. 2014;49(1):138-47. 7. Harvoni full prescribing information, ION-1, ION-2, ION-3 data. Foster City, CA: Gilead Sciences; 2014. 8. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370(20):1879-88. 9. Kohli A, Shaffer A, Sherman A, Kottilil S. Treatment of hepatitis C: a systematic review. JAMA. 2014;312(6):631-40. 10. Kowdley KV, Lawitz E, Crespo I, et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet. 2013;381(9883):2100-7. 11. Lawitz E, Lalezari JP, Hassanein T, et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatmentnaive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2013;13(5):401-8. 12. Slomski A. WHO issues guidelines on HCV amid drug cost controversy. JAMA. 2014;311(22):2262-3. 13. Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013;368(1):34-44. 14. Osinusi A, Meissner EG, Lee YJ, et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. 2013;310(8):804-11. 15. Sovaldi full prescribing information, FISSION and NEUTRINO data. Foster City, CA: Gilead Sciences; 2013. 16. Drug Interactions with Hepatitis C Virus Direct Acting Antivirals and HIV Medications: A Quick Guide for Clinicians. New York and New Jersey AIDS Education and Training Center. www. nynjaetc.org Accessed October 28, 2014. 17. Fried MW, Buti M, Dore GJ, et al. Oncedaily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013;58(6):1918-29. 18. Olysio full prescribing information, COSMOS and PROMISE data. Titusville, NJ: Jannsen Therapeutics; 2013. 19. Zeuzem S, Berg T, Gane E, et al. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014;146(2):430-41.e6. 20. Marks, K. Treatment of HIV/HCV Co-infected patients. IDSA Hepatitis C Knowledge Network Webinar Series. www. idsociety.org. Accessed October 27th, 2014. 21. Sulkowski MS, Gardiner DF, Rodrigueztorres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370(3):211-21.
42 The Journal January/February 2015
TABLE 2. Hepatitis C Virus Response Rates Agent & Administration
Sofosbuvir15
Simeprevir18
Key Points: Indications, Metabolism, Elimination & Drug Interactions Treatment naïve adults treated with combined sofosbuvir, RBV & IFN based regimens for 12 weeks (NEUTRINO Trial): • Genotype 1a SVR: 92%; Genotype 1b SVR: 82%; -Genotype 4 SVR: 96% • Non-cirrhotic patient SVR: 92%; Cirrhotic patient SVR: 80% Treatment naïve adults treated with combined sofosbuvir/RBV based regimens for 12 weeks (FISSION Trial): • Genotype 2 SVR: 95%; Genotype 3 SVR: 56% • Genotype 2 non-cirrhotic SVR: 97%; Genotype 2 cirrhotic SVR: 83% • Genotype 3 non-cirrhotic SVR: 61%; Genotype 3 cirrhotic SVR: 34% Treatment response in patients with HCV Genotype 1 who relapsed after prior IFN based therapy (PROMISE Trial): • Genotype 1a without Q80K with combined simeprevir/IFN/RBV x12 weeks SVR: 78% • Genotype 1a with Q80K with combined simeprevir/IFN/RBV x12 weeks SVR: 47% • Genotype 1b with combined simeprevir/IFN/RBV x12 weeks SVR: 86% Treatment response by METAVIR Fibrosis Score in treatment naïve or prior null responders with HCV Genotype 1 receiving 12 or 24 weeks of simeprevir with sofosbuvir (COSMOS Trial): • Metavir F0-3 with combined simeprevir/sofosbuvir x12weeks SVR: 95% • Metavir F0-3 with combined simeprevir/sofosbuvir x24 weeks SVR: 95% • Metavir F4 with combined simeprevir/sofosbuvir x12 weeks SVR: 86% • Metavir F4 with combined simperevir/sofosbuvir x24 weeks SVR: 100% Response rates after 8 and 12 weeks of treatment in treatment naïve noncirrhotic patients (ION-3 Trial): • Genotype 1a with ledipasvir/sofosbuvir x8 weeks SVR: 93%; Genotype 1a with ledipasvir/sofosbuvir x12 weeks SVR: 96% • Genotype 1b with ledipasvir/sofosbuvir x8 weeks SVR: 98%; Genotype 1b with ledipasvir/sofosbuvir x12 weeks SVR: 98%
Ledipasvir/ Sofosbuvir7,8
Daclatasvir21
Response rates after 12 weeks of treatment in treatment naïve genotype 1 patients with and without cirrhosis (ION-1 Trial): • Non-cirrhotic patient SVR: 99%; Cirrhotic patient SVR: 94% Response rates after 12 and 24 weeks of treatment in patients with genotype 1 with or without cirrhosis who failed prior therapy (ION-2 Trial): • Genotype 1a with ledipasvir/sofosbuvir x12 weeks SVR:95%; Genotype 1b with ledipasvir/sofosbuvir x12 weeks SVR: 87% • Genotype 1a with ledipasvir/sofosbuvir x24 weeks SVR: 99%; -Genotype 1b with ledipasvir/sofosbuvir x24 weeks SVR: 100% • Non-cirrhotic genotype 1 with ledipasvir/sofosbuvir x12 weeks SVR: 95%; • Cirrhotic genotype 1 with ledipasvir/sofosbuvir x12 weeks SVR: 86% • Non-cirrhotic genotype 1 with ledipasvir/sofosbuvir x24 weeks SVR: 99% • Cirrhotic genotype 1 with ledipasvir/sofosbuvir x24 weeks SVR: 100% Response rates after 12 and 24 weeks of treatment with combined daclatasvir/sofosbuvir in treatment naïve patients (Phase 2 Trial, ClinicalTrials. gov number NCT01359644): • Genotype 1 x12 weeks SVR: 100%; Genotype 1 x24 weeks SVR: 100% • Combined Genotype 2 and Genotype 3 x24 weeks SVR: 93% Response rates after 12 and 24 weeks of treatment with combined daclatasvir/sofosbuvir in previously treated patients (Phase 2 Trial, ClinicalTrials.gov number NCT01359644): • Genotype 1 x24 weeks SVR: 90%
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Photo by John Maniaci/UW Hospital & Clinics
THANK YOU FOR YOUR SUPPORT AND DEDICATION!
The University of Wisconsin-Madison School of Pharmacy would like to recognize the Pharmacy Buying Group of America, Inc. (PBGA) for its remarkable philanthropic support. What began 29 years ago as an independent buying group for small Wisconsin pharmacies eventually grew into an enterprise representing more than 400 independent pharmacies throughout the United States. In 2009, PBGA decided to focus solely on providing scholarships to deserving pharmacy students. For their service to the profession and impact on future pharmacists — we are grateful to PBGA and its founding members: Ken Bentley ’51, Ken Onsrud ’61, Mel Solochek ’65, Jerry Spector ’63, Ken Plavnick ’57, Don Stoebner
School of Pharmacy
UNIVERSITY OF WISCONSIN–MADISON
To learn about opportunities to support the UW-Madison School of Pharmacy, please contact Adam Kindschy at adam.kindschy@supportuw.org or 608-265-2942
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originalcontributions
Role of The Pharmacist in the Admission Medication Reconciliation Process in Adults with Acute Myocardial Infarction, Heart Failure, or Pneumonia in the Acute Care Setting by Wesley J. Bickler, PharmD Candidate and Lindsey C. Lundeen-Hill, PharmD
Abstract Objectives: A large percentage of hospital readmissions are preventable and reducing rates of readmission is a national priority, not only to reduce health care costs, but to improve overall patient care. Recent legislation implementing penalties on health care systems and hospitals for excess readmissions has driven the evaluation of transitions of care processes, including medication reconciliation. Nursing has traditionally performed medication reconciliation upon hospital admission; one proposed mechanism for reducing readmissions is utilizing pharmacy in the admission reconciliation process. Methods: A secondary, retrospective analysis was performed with patients admitted to a community hospital in the Midwest between November 15, 2012, and May 22, 2013, with an admission diagnosis of acute myocardial infarction, heart failure, or pneumonia. One arm of the analysis included patients with admission medication reconciliation performed by nursing and the second arm included admission medication reconciliation performed by nursing with a secondary review by pharmacy. Patients' charts were revisited and evaluated for readmission within 30 days of discharge. Results: Although not statistically significant, reductions in 30 day readmission rates were observed for patients originally admitted with acute myocardial infarction and heart failure while an increase in readmissions was observed in patients admitted with pneumonia who underwent pharmacy-directed admission medication reconciliation. Conclusions: The results of this retrospective analysis merit further study into readmission rates and the health care team member best suited to provide medication reconciliation for patients at high risk of hospital readmission.
R
educing hospital readmission rates is a national priority and the Hospital Readmissions Reduction Program (established with the signing of the Affordable Care Act) was designed not only to reduce health care costs, but to improve overall patient care. This program requires the Centers for Medicare and Medicaid Services (CMS) to reduce payments to hospitals which utilize the inpatient prospective payment system (IPPS) and have excess readmissions.1 The IPPS classifies patient cases into diagnosis-related groups (DRGs); these DRGs are weight-based on resources
44 The Journal January/February 2015
used to treat Medicare benificiaries.2 The Readmissions Reduction Program defines excess readmission as hospitalization within 30 days of discharge to the same or another facility at a rate greater than that of the national average. Three disease states were initially selected by CMS for evaluation given their respective readmission rates and associated cost to the health care system: acute myocardial infarction (AMI), heart failure (HF), and pneumonia (PNA).1 Approximately one in five Medicare beneficiaries are readmitted to the hospital within 30 days of discharge, with the cost to the American public exceeding $15 billion per year.3 The Medicare Payment
Advisory Commission estimates up to three-quarters of these readmissions may be avoidable.3 In light of the high number of potentially preventable readmissions, the cost burden to the American public, and the financial penalty for admission rates over the national average, health care systems and hospitals have been searching for and implementing novel methods for preventing readmissions. One of these methods is admission medication reconciliation. The Joint Commission defines medication reconciliation as, “the process of comparing a patient’s medication orders to all of the medications that the patient has been taking. This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions.” Gathering a complete admission medication list is an essential component of the medication reconciliation process.4 Multifaceted interventions, including medication reconciliation, have been shown to successfully reduce readmission rates.5 The current literature regarding medication reconciliation and its effect on same-cause readmission rates often involves pharmacy or nursing as the provider of this service. As there is little to no reported research comparing pharmacy-provided and nursing-provided admission medication reconciliation, this analysis aims to evaluate the effect of pharmacist-provided versus nursing-provided medication reconciliation on 30-day hospital readmission rates.
Methodology
The original investigation was performed with patients admitted to a 380-bed community hospital in the Midwest. The facility utilizes an electronic
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TABLE 1. Thirty Day Readmission Rates, Control vs Intervention 30 Day Readmission Rates (control) Acute Myocardial Infarction
Heart Failure
Pneumonia
Discharges
Readmits
Rate (%)
Discharges
Readmits
Rate (%)
Discharges
Readmits
Rate (%)
2012
645
72
11.2
287
59
20.1
294
47
16.0
2013
691
87
12.6
321
49
15.3
270
34
12.6
Total
1336
159
11.9
608
108
17.8
564
81
14.4
30 Day Readmission Rates (intervention) Acute Myocardial Infarction
Heart Failure
Pneumonia
Discharges
Readmits
Rate (%)
Discharges
Readmits
Rate (%)
Discharges
Readmits
Rate (%)
2012
16
2
12.5
11
1
9.1
7
1
14.3
2013
29
2
6.9
24
2
8.3
16
3
18.8
Total
45
4
8.9
35
3
8.6
23
4
17.4
health record (EHR) to maintain patient medication lists. This list can be modified by nursing, pharmacy, and providers throughout the health care system. Inclusion criteria in this primary analysis encompassed any patient 18 years and older admitted between November 15, 2012, and May 22, 2013, with an admission diagnosis of AMI, HF, or PNA. The exclusion criteria consisted of patients who died during their hospital admission or those having a hospital stay less of than 24 hours. Patients admitted for less than 24 hours oftentimes do not have their home medications ordered or receive very few of their maintenance medications during their short stay. This study was built on a level of care already provided to patients (medication reconciliation was already being performed by nursing and physicians, occasionally by pharmacy); formal consent from patients or delegates was not required. The secondary analysis explored in this paper is a retrospective chart review involving the 400 patients from the original investigation. There were two arms in this chart review. One arm
included patient admission medication reconciliation performed primarily by nursing (control group) and the second arm included admission medication reconciliation performed by nursing with a secondary review by pharmacy (intervention group). In the second arm, when nursing finished this process and made their recommendations to the attending provider (if any), a pharmacist, or pharmacy intern with oversight from a pharmacist, completed a secondary admission medication reconciliation review on these patients. If recommendations were appropriate, they were made to the attending provider. In the control arm of the chart review, medication reconciliation was performed solely by nursing. The charts of patients in the control and intervention groups of the study were reviewed and evaluated for readmission into one of the health systemâ&#x20AC;&#x2122;s facilities within 30 days of discharge. This chart review did not take into consideration readmissions to outside health care facilities or systems. While the intervention group only studied patients within the aforementioned time
duration, the control group included all patients discharged throughout the 2012 and 2013 calendar years with the appropriate admission diagnosis of AMI, CHF, and PNA. There was no exploration or statistical analysis comparing the baseline characteristics of the patient populations. Statistical analysis was performed on the data gathered utilizing the Z-test, with the z-score and one-sided p-value reported. An alpha level of less than 0.05 was set to determine statistical significance between the two arms of the study.
Results
Among the 400 hundred patients reviewed in the intervention group, a total of 103 were admitted with a diagnosis of AMI, HF, or PNA and 11 of these patients were readmitted within 30 days of discharge to an affiliated medical center (10.7%). The control group included a total of 2508 patients among which 348 were readmitted (13.9%). The complete breakdown of this data can be observed in Table 1. In terms of patients admitted with AMI, 11.9% of the patients in the
TABLE 2. Statistical Analysis of Total Readmission Results Statistical Analysis Acute Myocardial Infarction
Control Intervention www.pswi.org
Heart Failure
Pneumonia
Total Rate (%)
z-score
p-value
Total Rate (%)
z-score
p-value
11.9
0.616
0.269
17.8
1.40
0.081
8.9
8.6
Total Rate (%)
z-score
p-value
14.4
0.405
0.343
17.4 January/February 2015
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FIGURE 1. Thirty Day Readmission Rates Following AMI: Acute Myocardial Infarction Readmission Rates
FIGURE 2. Thirty Day Readmission Rates Following HF: Heart Failure Readmission Rates
control group were readmitted within 30 days compared with 8.9% of the patients in the intervention group. As for HF, fewer patients were readmitted in the intervention group (8.6%) compared with the control group (17.8%) over the duration of the study. Contrary to the results for the first two admission diagnoses, an increased percentage of readmissions was observed in the PNA intervention group (17.4%) versus the control group (14.4%). This was driven by an increase in readmissions in the intervention group during 2013 as illustrated in Figure 3. Figures 1-3 depict the differences between the readmission rates during 2012 and 2013 for each of the admission diagnoses. While numerical differences between the intervention and control group exist, none of the variances were deemed to be statistically significant (Table 2).
Discussion
FIGURE 3. Thirty Day Readmission Rates Following PNA: Pneumonia Readmission Rates
46 The Journal January/February 2015
More than two years have elapsed since the implementation of the Hospital Readmissions Reduction Program and health care systems and hospitals continue to search for and implement new processes and procedures to reduce readmission rates. One area often targeted for improvement is transitions of care which CMS defines as, “the movement of a patient from one setting of care (hospital, ambulatory primary care practice, ambulatory specialty care practice, long-term care, home health, rehabilitation facility) to another.” Poor care coordination and communication between hospitals and outpatient settings contributes to high costs, medical errors, and most importantly, poor outcomes.6,7 This retrospective analysis provides a window into a previously unstudied piece of admission medication reconciliation, an aspect of the transitions of care process. While medication reconciliation has been shown to reduce readmission rates,5 the profession best suited to gather and reconcile a patient’s medication list has yet to be elucidated. Admission medication reconciliation is executed by a variety of disciplines within the health care field, including nursing, medical providers, and pharmacy. In this secondary analysis, 30 day readmission rates for patients with the admission diagnoses of
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AMI, HF, or PNA were compared with the investigational variable being the profession who performed the admission medication reconciliation. In both the control and investigational groups, nursing or the admitting provider performed the medication reconciliation, however, a pharmacy professional completed a secondary review for patients in the investigational group. For the diagnoses of AMI and HF, patients who received pharmacy medication reconciliation had fewer readmissions within 30 days. However, for patients admitted with PNA, there were slightly more admissions observed in the pharmacy-driven medication reconciliation group. Beyond the retrospective nature of the analysis, other limitations exist. Only readmissions to affiliated institutions were included in the analysis while the Hospital Readmissions Reduction Program evaluates readmissions into any medical facility. Nursing and pharmacy were not evaluated head-to-head in the analysis and thus no concrete conclusions can be drawn as to which may provide the most beneficial medication reconciliation. Very few readmissions (11 patients) occurred in the relatively small intervention group (103 patients versus 2508 patients in the control group), limiting the ability to detect any statistically significant difference in readmission rates. The intervention group may have included patients with more complex medication lists and comorbidities, possibly altering readmission rate outcomes; of the 400 patients in the intervention group, pharmacy was consulted to provide medication reconciliation services for some of them while the control group consisted of a more general population (pharmacy was not consulted). Additionally, the control group included readmissions from all of 2012 and 2013 while the intervention group only selected patients from November 15, 2012, through May 22, 2013. Although not statistically significant, reductions in 30 day readmission rates were observed for patients originally admitted with AMI and HF while an increase in readmissions was observed in patients admitted with PNA who underwent pharmacy-directed admission medication reconciliation. One explanation for this www.pswi.org
observed difference may be the acute versus chronic nature of the diagnoses studied. Medication reconciliation may be less beneficial in preventing readmissions for patients admitted with a diagnosis of PNA due to the acute nature of the diagnosis; most often, these patients will continue their same home medication regimens upon discharge (with the possible addition of an antibiotic in the shortterm). Admissions for exacerbations of HF as well as an AMI frequently result in dose adjustments and new medications on top of lifestyle modifications; a properly reconciled medication list may be a step in the process of a more seamless transition of care. The results of this retrospective analysis merit further study into readmission rates and the health care team member best suited to provide medication reconciliation for patients at high risk of hospital readmission.● Wesley J. Bickler is a 4th year Doctor of Pharmacy student at the University of Minnesota College of Pharmacy, Duluth, MN. Lindsey C. Lundeen-Hill is a Pharmacist-incharge, Superior, WI. Acknowledgments: Thank you to Dr. Karen Bastianelli, for your time, guidance, and advice throughout the research and writing process, as well as Dr. Timothy Stratton for his assistance in the statistical analyses. Disclosure: The authors disclose no conflicts of interest other than employment through the health
system where the research was conducted. Both authors had full access to all the data in this study and take responsibility for the integrity of the data and accuracy of the data analysis. Neither author claims financial or proprietary interest in the subject matter/materials discussed in the manuscript.
References
1. Readmissions reduction program. Centers for Medicare & Medicaid Services Web site. http://www. cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/ Readmissions-ReductionProgram.html#. Updated 2013. Accessed 11/11, 2013. 2. Inpatient prospective payment system. America's Essential Hospitals Web site. http:// www.naph.org/Main-Menu-Category/Our-Work/ Safety-Net-Financing/Medicare/IPPS.aspx. Published 2013. Updated 2013. Accessed 11/12, 2013. 3. Medicare Payment Advisory Commission. Report to the congress: Promoting greater efficiency in medicare. http://www.medpac.gov/ documents/Jun12_EntireReport.pdf. Published 2007. Updated 2007. Accessed 11/12, 2013. 4. Joint Commission on Accreditation of Health Organizations. Approved: Modifications to national patient safety goal on reconciling medication information. Jt Comm Perspect. 2011;31(1):1, 3-7. 5. Kripalani S, Theobald CN, Anctil B, Vasilevskis EE. Reducing hospital readmission rates: Current strategies and future directions. Annu Rev Med. 2013. doi: 10.1146/annurev-med-022613-090415. 6. Kripalani S, LeFevre F, Phillips CO, Williams MV, Basaviah P, Baker DW. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA.2007;297(8):831–841. 7. Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med. 2003;18(8):646–651.
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January/February 2015
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2015
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originalcontributions
Pharmacist Provided Medicare Annual Wellness Visits in Collaboration with a Physician Office
This article originally appeared in the 2014 – Vol 98, No 3 issue of Virginia Pharmacist, published by the Virginia Pharmacists Association, Richmond, Va. Reprinted with permission.
by Kerri T. Musselman, PharmD, BCACP, Whitney Zentgraf, PharmD, Mary-Beth Plum, PharmD, BCACP, and David L. Kelly, MD Editor's Note Under the Wisconsin Pharmacy Practice Act, Chap 450.033 states that “A pharmacist may perform any patient care service delegated to the pharmacist by a physician.” This update, from 2013, opens the door for expanded opportunities for team-based care in a variety of settings. To support PSW members’ efforts to expand and implement team-based care services and collaborative practice agreements (or delegation protocols), PSW has developed a continuing educational program and toolkit for collaborative practice agreement development. Members are encouraged to visit the PSW website for more information.
W
ith the passing of the Affordable Care Act in 2010, the Centers for Medicare and Medicaid Services (CMS) expanded coverage to include an Annual Wellness Visit (AWV) for Medicare beneficiaries. An AWV is a preventive wellness visit. The AWV includes a Health Risk Assessment (HRA) which encourages the goal of health promotion and disease detection as well as coordinates the screening and preventive services that may already be covered and paid for under Medicare Part B (see Table 1).1,2 The AWV provides Personalized Prevention Plan Services (PPPS). PPPS is a 5-10 year written screening schedule given to the patient after the AWV. It is also a separate service from the Initial Preventive Physical Examination (IPPE), also known as the “Welcome to Medicare” preventive visit, that serves to introduce the beneficiary to Medicare and its covered benefits.3 The IPPE can only be provided by a physician or qualified non-physician practitioner (i.e. nurse practitioner, physician assistant, or clinical nurse specialist).3 It is not the same as a yearly physical, which is not covered by Medicare.
Who is Eligible to Provide an AWV? According to CMS, a “healthcare professional” may provide an initial and subsequent AWV.2 This includes a variety 48 The Journal January/February 2015
of medical caregivers such as physicians (doctors of medicine or osteopathy), qualified non-physician practitioners (physician assistants, nurse practitioners, or certified clinical nurse specialists), or medical professionals (including health educators, registered dietitians, nutrition professionals, or other licensed practitioners (including pharmacists), or a team of such medical professionals who are working under the direct supervision of a physician.2 Direct supervision means the physician or non-physician practitioner must be present in the office and immediately available to provide assistance and direction throughout the visit, but they do not have to be in the room where the visit is being conducted by the authorized health care professional.4
Who is Eligible to Receive an AWV?
An AWV is covered when a beneficiary is no longer within the 12 months after the effective date of his or her first Medicare Part B coverage period. The beneficiary cannot have received an IPPE or an AWV providing PPPS within the past 12 months, which means at least 11 months have passed since the month in which the IPPE or the last AWV was performed. Medicare pays for only one initial AWV per beneficiary per lifetime and one subsequent AWV per year thereafter.2 The patient becomes eligible for the initial AWV after the first 12 months of Medicare coverage.
What is Included in an Initial AWV with PPPS?2 The initial AWV emphasizes a general health risk assessment performed by the health care professional in order to collect self-reported information including demographic data, self-assessment of health status, psychological risks, behavioral risks, activities of daily living (ADLs), and instrumental ADLs. The medical and family histories are obtained during the initial AWV. This visit compiles information about past medical and surgical histories, including illnesses, hospital stays, operations, medication allergies, injuries, and treatments; use of or exposure to medications and supplements, including over-the counter products and vitamins; and medical events in the beneficiary’s family members, including diseases that may be hereditary or place the beneficiary at increased risk, such as smoking status, tobacco and alcohol use, etc. The beneficiary’s height, weight and blood pressure are also measured during the first visit. Body mass index (BMI) or waist circumference, if appropriate, is calculated and assessed, as are other routine measurements deemed appropriate based on the beneficiary’s medical and family histories. A review of the beneficiary’s potential risk factors for depression, including current or past experiences with depression
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TABLE 1. Medicare Part B Preventive Services2 Initial Preventive Physical Examination (IPPE) NOTE: A beneficiary who is eligible for an AWV is no longer eligible for an IPPE.
Intensive Behavioral Therapy (IBT) for Obesity
Bone Mass Measurements
Medical Nutrition Therapy (MNT)
Cardiovascular Screening Blood Tests
Prostate Cancer Screening
Colorectal Cancer Screening
Seasonal Influenza, Pneumococcal, and Hepatitis B Vaccinations and their Administration
Counseling to Prevent Tobacco Use for Asymptomatic Patients
Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse
Diabetes Screening Tests
Screening for Depression in Adults
Diabetes Self-Management Training (DSMT)
Screening Mammography
Glaucoma Screening
Screening Pap Tests and Pelvic Examination
Human Immunodeficiency Virus (HIV) Screening
Sexually Transmitted Infections (STIs) Screening and High Intensity Behavioral Counseling (HIBC) to Prevent STIs
Intensive Behavioral Therapy (IBT) for Cardiovascular Disease
Ultrasound Screening for Abdominal Aortic Aneurysm (AAA)
or other mood disorders are also documented during this visit. Appropriate screening tools will be used for persons without a current diagnosis of depression. In addition, the beneficiary’s functional ability, level of overall safety, hearing impairment, ability to successfully perform ADLs, fall risk, and home safety is assessed by either direct observation or use of a screening questionnaire. The beneficiary’s cognitive function is also assessed by direct observation, with due consideration of information obtained by way of patient reports and concerns raised by family members, friends, caretakers, or others. A list of current health care providers and suppliers (pharmacy, Durable Medical Equipment care provider, etc.) who are regularly involved in medical care for the beneficiary is established and documented. This element helps meet stage 2 meaningful use requirements set by CMS if the provider is using an electronic health record (EHR) by providing the names and contact information for any other health care professionals involved in the beneficiary’s care.5 For more information on meaningful use, please see http://www. cms.gov/Regulations-and-Guidance/ Legislation/EHRIncentivePrograms/index. html?redirect=/EHRIncentivePrograms/30_ Meaningful_Use.asp. A multi-faceted risk reduction strategy incorporating preventive screenings, identified risk factors and interventions to www.pswi.org
promote wellness/reduce risk is provided for the patient. A written screening schedule for the next 5-10 years will be developed and provided to the beneficiary that is based on the recommendations from the United States Preventive Services Task Force (USPSTF) and the Advisory Committee on Immunization Practices (ACIP), the beneficiary’s health status and screening histories, and age-appropriate preventive services covered by Medicare (Table 1). The health status includes a list of risk factors and conditions for which the primary, secondary, or tertiary interventions are recommended for the beneficiary. This includes any mental health conditions, any
such risk factors or conditions identified through an IPPE and a list of treatment options and their associated risks and benefits. Furthermore, the health care professional providing the wellness visit provides personalized health advice to the beneficiary and referrals for specific health education or preventive counseling services are initiated as appropriate. These referrals are focused on community-based lifestyle interventions to reduce health risks and promote self-management and wellness, weight loss, physical activity, tobacco-use cessation, fall prevention, and nutrition. In addition, the health care professional should address the existence of advanced directives and provide information on advanced directives if indicated. Table 2 provides a summary of the required elements for the AWV.
What is Included in any Subsequent AWV with PPPS?2 At subsequent AWVs, the beneficiary’s health risk assessment information is updated including demographic data, selfassessment of health status, psychological risks, behavioral risks, ADLs, and instrumental ADLs. After an initial AWV, which includes a comprehensive medical review with the beneficiary, the medical and family histories are simply updated in subsequent AWV. The beneficiary’s cognitive function must also be re-assessed by direct observation to identify any impairment.
TABLE 2. Components of the Medicare Annual Wellness Visits (AWVs)1-3 Update/Review
• • •
Assess
Vitals (i.e. Blood Pressure, Pulse, Height, Weight, BMI)
Screenings
Depression, Functional Ability, Hearing Impairment, Ability to Perform Activities of Daily Living (ADLs), Fall Risk, Home Safety, Cognitive Impairment •
Establish • • • Provide to patient
Physical Exam
Patient history: Medical, Surgical, Social, Family Current medication list and immunizations Allergies
Current list of providers and suppliers (i.e. pharmacies, durable medical equipment (DME) suppliers) List of risk factors Individualized health advice or referral (i.e. smoking cessation, weight loss, fall prevention) Written screening schedule for 5-10 years: Based on the recommendation from United States Preventive Services Task Force (USPSTF) (i.e. colonoscopy, mammogram, DEXA) and Advisory Committee on Immunization Practices (ACIP) (i.e. influenza, pneumococcal, herpes zoster, hepatitis B, tetanus, diphtheria, acellular pertussis)
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The assessment takes into account input from the patient, family members, friends, caretakers, or others. Weight (or waist circumference, if appropriate) and blood pressure are measured, as are other routine measurements as deemed appropriate based on the beneficiary’s medical and family history. This visit also requires an update of the list of current health care providers regularly involved in providing medical care for the beneficiary. The written screening schedule for the beneficiary must be updated based on the USPSTF and ACIP recommendations, the beneficiary’s health status and screening history, and age-appropriate preventive services covered by Medicare. The list of risk factors and conditions for which the primary, secondary, or tertiary interventions are recommended must also be updated. In addition, personalized health advice is provided to the beneficiary and referrals for specific health education or preventive counseling services are initiated as appropriate. These referrals are focused on community-based lifestyle interventions to reduce health risks and promote selfmanagement and overall wellness.
Billing Requirements1
The Healthcare Common Procedure Coding System (HCPCS) has developed two codes to bill for these visits. The initial AWV for the beneficiary has the code of G0438 with the short descriptor of “Annual wellness first”. Code G0439 is for any subsequent AWV with the short descriptor of “Annual wellness subseq”. These codes have been implemented through the Medicare Physician Fee Schedule Database (MPFSDB) and Integrated Outpatient Code Editor (IOCE). The amount rendered for the AWV varies geographically6 (initial AWV reimbursement approximately $172/ visit, Subsequent AWV reimbursement approximately $111/visit)7; therefore, further research into the regional reimbursement is necessary to determine the actual reimbursement. Codes G0438 and G0439 may not be submitted within 12 months of a previous billing for HCPCS codes G0402 (IPPE), G0438, or G0439 for the same beneficiary. Medicare contractors will pay these claims provided the requirements for coverage and eligibility 50 The Journal January/February 2015
are met. Claims need to be submitted by institutional providers via Types of Bill (TOB) 12X, 13X, 22X, 23X, 71X, 77X, or 85X. Types 12X and 13X are claims from the hospital inpatient Part B and hospital outpatient settings. Their payment will be made based on the Medicare Physician Fee Schedule (MPFS). TOBs 22X and 23X are from skilled nursing facilities and will be paid based on MPFS. TOBs 71X and 77X, from Rural Health Clinics and Federally Qualified Health Centers respectively, will be paid based on the all-inclusive rate; however, for these TOBs, the AWV does not qualify for separate payment with another encounter. Services performed at a Critical Access Hospital (CAH), TOB 85X, pay based on reasonable cost. CAH claims, submitted as TOB 85X with revenue codes 096X, 097X, 098X, will be paid based on the MPFS.
A Pharmacist’s Role in AWVs
Physicians and non-physician practitioners may provide the preventive services of AWVs; however, in primary care, where wellness and prevention of chronic diseases and problems are promoted, there is a shortage of clinicians.8 As fewer physicians enter primary care, the U.S. population is increasing by one percent each year, with the number of Americans over the age of 65 years set to double by 2025.9 In order to cover this shortage in primary care, other resources need to be utilized and pharmacists can be that resource. According to CMS, AWVs must be performed by medical professionals who are licensed. Although pharmacists are not explicitly named in the language of AWV providers, they are eligible and qualified to complete the visit as they are licensed personnel that fall under the “other licensed personnel” category stated by CMS. Pharmacists are professionals licensed by their state board of pharmacy. Each state has its own requirements to become licensed; however, each candidate for licensure must have passed the standardized North American Pharmacist Licensure Examination (NAPLEX) and the appropriate law examination for the specific state. Pharmacists are in a unique position to lend their clinical skills to improve
this shortage of primary care clinicians and impact patient care. Currently, pharmacists are authorized to enter into collaborative practice agreements with physicians in forty-seven states and the District of Columbia.10 Each state regulates the types of collaborative practice agreements into which pharmacists and physicians enter. These agreements help pharmacists integrate into health care teams to provide more efficient and specific care for patients under the direct supervision of the collaborating physician. Depending on the agreed upon collaborative practice criteria, pharmacists may be able to make medication-related recommendations, provide preventive care by administering immunizations, counsel patients on smoking cessation, conduct medication therapy management services, and provide current and relevant medication information to both the provider and patient.9 The collaborative practice agreement has the flexibility to address all components of the AWV depending on the participating healthcare professionals. One of the cornerstones of the AWV is the review of all medications, prescription and nonprescription, taken by the patient. Pharmacists are uniquely qualified to manage medications. If pharmacists are involved as providers of the AWVs, they can clarify medication discrepancies and resolve medication-related problems for those eligible for the service. Pharmacists perform key roles in chronic disease management, disease prevention, and ultimate wellness.
Collaborative Practice Agreements in Practice Collaborative practice agreements are formal protocol-based agreements between a physician and a pharmacist.11 The foundation of the collaborative practice agreement is based on communication, confidentiality, and voluntariness among patients, physicians, and pharmacists. Effective agreements are voluntary for the prescriber, patient, and pharmacist. The prescriber diagnoses the patient before the pharmacist enters into the collaboration. Pharmacists must communicate with the prescriber when changes to therapy have been made.12 Managing chronic disease
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states focuses on pharmacotherapy,12 this is a natural role for pharmacists to fill. The patient with chronic conditions may benefit from a pharmacist managing these chronic medications because of increased accessibility to the pharmacist as opposed to the primary care physician.12 The patient not only benefits from increased provider availability, but they may also benefit from improved outcomes with their drug therapy. Collaboration between physicians and pharmacists has been documented to improve blood pressure control in hypertension management.13 Similar results have been documented in the management of diabetes, cardiovascular disease, and asthma.14-16 This collaboration between physicians and pharmacists can facilitate patient progress while managing chronic illnesses. Pharmacists are being utilized in the Minneapolis/St. Paul, Minnesota area where they are entering into collaborative practice agreements with physicians.12 Within these agreements, pharmacists have become more assimilated into primary care teams. They may conduct one-on-one visits with patients to evaluate the appropriateness of medications when compared with identified medical conditions and treatment goals and guidelines. Patients may even be referred to pharmacists by a primary care provider if they have been targeted as being at high risk for poor medication outcomes. Within specific agreements, pharmacists can initiate therapy, alter doses and order laboratory tests within predefined practice protocols.12 In an agreement between physicians and pharmacists to treat blood pressure, it was found that results were significantly better when a pharmacist recommended therapy changes.14 Collaborative practice agreements are used all over the United States to further the practice of pharmacy. According to the Center for Disease Control and Prevention (CDC), at least 36 states allow for pharmacist collaborative practice.17 In Virginia, collaborative practice agreements can be between a pharmacist and physician, nurse practitioner or physician’s assistant. Collaborative agreements allow for “implementation, modification, continuation, or discontinuation of drug therapy pursuant to written or electronic www.pswi.org
protocols, provided implementation of drug therapy occurs following diagnosis by the prescriber; the ordering of laboratory tests; or other patient care management measures related to monitoring or improving the outcomes of drug or device therapy”.18 The patient must provide consent to participate in the collaborative agreement. North Carolina has been paving the way in collaborative practice with AWVs. Pharmacists have been providing the wellness visit in order to receive reimbursement for their cognitive services and create a sustainable pharmacy model.19 Collaborative practice agreements broaden the opportunities for pharmacists providing direct patient care.
Implementation
Speak with the compliance officer onsite or the person responsible for ensuring compliance with CMS standards. This will allow the compliance officer to give an opinion on the organization’s interest in a pharmacist performing the AWV. Next, risk management should be consulted to ensure state specific regulations allow for pharmacists to perform AWV. Once risk management and the compliance officer consent for a pharmacist to perform the AWV, identify a physician within the organization/office to work with collaboratively. Approach a physician office where an established relationship with the pharmacist exists or an office that is seeking to add other disciplines. Within that office, identify a physician who is willing to collaborate. Next, develop the collaborative practice agreement criteria based on the provider’s specifications and comfort. The agreement must comply with the state laws and regulations. To finalize the collaborative practice agreement, risk management and the physician must consent to the verbiage included in the collaborative practice agreement. Logistically, the infrastructure to carry out the collaborative practice visits can be accomplished through either part time employment of the pharmacist at the physician’s office or an agreement between a pharmacist and physician where the pharmacist provides the visits at the physician’s office during a specified time
frame. Once the approval has been obtained to proceed, create a documentation template for the AWV. This will establish a workflow for the visit and increase efficiency and standardization. The AWV can be completed in a paper chart or an electronic health record. Follow the specific documentation requirements required for the AWV.1 Begin discussing the patient schedule availability based on the day(s) and times the physician and pharmacist are available concurrently. The physician must be onsite to bill Medicare for the AWV.5 When developing the schedule, keep in mind that Medicare allocates a 40-minute time slot for AWVs; however, a recent study demonstrated an average time of 73 minutes from check in to checkout for all patients.20 Be cognizant that for an electronic health record, the information technology (IT) build for the patient schedule can take some time to complete. Start patient recruitment once the agreements are finalized and patients can schedule an appointment. The collaborating physician refers his/her patients for the visit. In addition, his/her staff can assist with patient recruitment; however, staff education is needed to increase understanding of the AWV. Staff education should include what the visit entails, the time involved for the appointment and information to provide patients prior to the visit (including the fact that a pharmacist will be conducting the visit). Staff is the first line for phone calls and scheduling. It is important that staff can answer questions and are committed to the success of the program. After the agreements are finalized, patients are scheduled and the documentation templates are set, it is time to begin conducting the visits. Incorporate areas of medication therapy management (MTM) and comprehensive medication management into the AWV. This is the perfect opportunity to utilize the unique knowledge that pharmacists can provide. Some of the elements of MTM that could be incorporated include a medication treatment plan, monitoring and evaluating response to current medication therapy, providing education about the medications, and providing a medication record after the January/February 2015
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visit.21 In addition, at the end of the AWV, a written screening schedule for the next 5-10 years should be provided to the patient. If you are using an electronic health record, be sure to hand the patient an after visit summary of what was covered during the visit in order to meet meaningful use criteria.22
Conclusion
Medicare AWVs are a relatively new service offered to Medicare beneficiaries. Many Medicare beneficiaries may not know this visit opportunity exists. Physician practices may not be billing for the services to the fullest extent. Having pharmacists provide the AWV service is a novel way for pharmacists to integrate into a physician office. It is also an avenue for pharmacists to be reimbursed for clinical services rendered and provide an added value to the physician. The increased patient visit volume and additional revenue for the practice highlight several benefits for the integration of pharmacists into provider practices. Educating the provider, staff and patient plays a key role when a new service is implemented. Pharmacists providing visits in a physician’s office can be new for the patient as well as the staff. The relationship developed with office/practice staff will enhance the service development as the staff can assist the physician with identification of eligible patients and are able to promote the service. In addition, staff will be first line when fielding questions from patients who have been referred for the visit or are scheduling a visit. AWVs can be a collaboration that is mutually beneficial for practitioners, patients and pharmacists. The collaboration allows for pharmacists to become more involved with the practitioners in their local community and for patients to learn what other health care disciplines can offer with regards to expanding medical care access and improving the overall quality of their health care. ● Kerri T Musselman is a Clinical Pharmacist Specialist at Bon Secours Virginia Health System and Bon Secours Medical Group. Whitney Zentgraf is a PGY-1 Pharmacy Practice Resident at Campbell University College of 52 The Journal January/February 2015
Pharmacy and Health Sciences at East Carolina University. Mary-Beth Plum. and David L. Kelly is the Medical Director for Quality at Bon Secours Virginia Health-System and the Bon Secours Medical Group. Acknowledgements: Sharon Gatewood, PharmD. Whitney Zentgraf, PharmD was a 4th year student pharmacist at Virginia Commonwealth University on her APPE rotation while contributing to the project
References
1. Centers for Medicare and Medicaid Services. 2011. Annual Wellness Visit (AWV), Including Personalized Prevention Plan Services (PPPS). Medicare Learning Network Matters: Information for Medicare Fee-for-Service Health Care Professionals. MLN Matters Number MM7079. Retrieved from: http://www.cms.gov/ Outreach-and-Education/Medicare-LearningNetwork-MLN/MLNMattersArticles/downloads/ mm7079.pdf (accessed 2013 Dec 30). 2. Centers for Medicare and Medicaid Services. 2012. Quick Reference Information: The ABCs of Providing the Annual Wellness Visit. Medicare: Preventive Services. ICN 905706. Retrieved from: http://www.cms.gov/ Outreach-and-Education/Medicare-LearningNetwork-MLN/MLNProducts/downloads/AWV_ chart_ICN905706.pdf (accessed 2013 Dec 30). 3. Centers for Medicare and Medicaid Services. 2012. Quick Reference Information: The ABCs of Providing the Initial Preventive Physical Examination. Medicare: Preventive Services. ICN 006904. Retrieved from: http://www.cms.gov/ Outreach-and-Education/Medicare-LearningNetwork-MLN/MLNProducts/downloads/ MPS_QRI_IPPE001a.pdf (accessed 2013 Dec 30). 4. Centers for Medicare and Medicaid Services. 2012. Frequently Asked Questions from the March 28, 2012 Medicare Preventive Services National Provider Call: The Initial Preventive Physical Exam and the Annual Wellness Visit. National Provider Calls and Events Items. Retrieved from: http://www.cms.gov/Outreachand-Education/Outreach/NPC/Downloads/ IPPE-AWV-FAQs.pdf (accessed 2013 Dec 30). 5. “Medicare and Medicaid programs; electronic health record incentive program: Stage 2,” 77 Federal Register 171 (4 Sept 2012), pp. 53968-54162. 6. American Pharmacists Association and the National Association of Chain Drug Stores. Medication Therapy Management in pharmacy practice: Core elements of an MTM service model (version 2.0). Journal of the American Pharmacists Association. 2008; 48(3): 341-353 7. Centers for Medicare and Medicaid Services. Physician fee schedule search. www. cms.gov/apps/physician-fee-schedule/search/ search-criteria.aspx (accessed 2013 Dec 30). 8. Annual Wellness Visit to Provide Personalized Preventive Plan Benefit. American College of Physicians. http://www.acponline.org/running_ practice/practice_management/payment_coding/ wellness.htm (accessed 2014 March 3). 9. Manolakis PG & Skelton JB. Pharmacists’
contributions to primary care in the United States collaborating to address unmet patient care needs: The emerging role for pharmacists to address the shortage of primary care providers. American Journal of Pharmaceutical Education. 2010;74(10) Article S7:1-9. 10. IOM (Institute of Medicine). 2008. Retooling for an aging America: Building the health care workforce. Washington, DC: The National Academies Press. 11. Weaver, K. 2013. Collaborative practice agreements vary among the states. American Pharmacists Association. Retrieved from: http://www. pharmacist.com/collaborative-practice-agreementsvary-among-states (accessed 2013 Dec 30). 12. Raju A, Sorge LA, Lounsbery J, et al. 2011. The expanding role of Minnesota pharmacists in primary care. Minnesota Medicine. Retrieved from: http://www.minnesotamedicine.com/ PastIssues/PastIssues2011/October2011/ TheExpandingRoleofMinnesotaPharmacists. aspx (accessed 2014 Jan 09). 13. Mitrany D & Elder R. Collaborative pharmacy practice: An idea whose time has come. Journal of Managed Care Pharmacy. 1999;5(6): 487-491. 14. Carter BL, Ardery G, Dawson JD, et al. Physician and pharmacist collaboration to improve blood pressure control. Archives of Internal Medicine. 2009; 169(21): 1996-2002. 15. Kiel PJ & McCord AD. Pharmacist impact on clinical outcomes in a diabetes disease management program via collaborative practice. Annals of Pharmacotherapy. 2005; 39(11): 1828-1832. 16. Murray MD, Ritchey ME, Wu J, & Tu W. Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Archives of Internal Medicine. 2009; 169(8): 757-763. 17. Cranor CW, Blunting BA, Christensen DB. The Asheville project: Long-term clinical and economic outcomes of a community pharmacy diabetes care program. Journal of American Pharmacists Association. 2003; 43(2): 173-184.Virginia Code § 54.1-3300.1. Participation in collaborative agreements; regulations to be promulgated by the Boards of Medicine and Pharmacy. Retrieved from: http://leg1.state.va.us/cgi-bin/legp504. exe?000+cod+54.1-3300.1 (accessed 2014 March 23). 18. “Select Features of State Pharmacist Collaborative Practice Laws”. National Center for Chronic Disease Prevention and Health Promotion. Center for Disease Control and Prevention (CDC). Pub. 12/2013. Retrieved from: http:// www.cdc.gov/dhdsp/pubs/docs/Pharmacist_ State_Law.PDF (accessed 2014 March 23). 19. “The pharmacy act and the drug control act with related statutes.” Department of Health Professions Virginia Board of Pharmacy. Updated July 1, 2012. pp. 69. 20. In the spotlight – June 2012. American Society of Health-System Pharmacists. Retrieved from: http://www.ashp.org/DocLibrary/ MemberCenter/SACP/Spotlight/SpotlightJune-2012.aspx (accessed 2014 Jan 09). 21. Centers for Medicare and Medicaid. 42 C.F.R. § 410.32(b)(3)(ii). (2003). 22. Washany K et al. Medicare annual wellness visits conducted by a pharmacist in an internal medicine clinic. Am J Health-Syst Pharm. 2013; 70:e108-113.
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Rosalind Franklin University Writing Club:
The Pharmacist’s Role in Professional and Patient Advocacy by Alyssa B. Wenzel, 2015 PharmD Candidate
Abstract From pill-counters to health care providers, the profession of pharmacy has evolved tremendously in the public eye. Pharmacists have established themselves as critical players within health care by showing that they do not merely regulate medications, but also play an integral role in improving health and safety outcomes of patients. Pharmacists’ fight for provider status has shown us how effective professional advocacy can be. However, advocating for the proper recognition of pharmacists is only one component of health advocacy. Health advocacy includes promoting the continued improvement of community health and supporting initiatives that enhance patients’ safety, quality of life and access to health care. Many times this encompasses educating legislators on patients’ behalf and supporting policies that facilitate positive change. Each year Rosalind Franklin University supports one student’s trip to Washington, DC so that they may participate in an annual advocacy event sponsored by the National Brain Tumor Society. During “Head to the Hill”, hundreds of brain tumor advocates from across the nation meet in Washington, DC to educate their legislators on the key issues that directly affect the brain tumor community. In 2013, I was fortunate enough to attend this event as part of a service learning project. Student involvement in these areas not only benefits the patients they are supporting but also strengthens students’ professional and personal advancement. Advocating for specific patient populations or for the advancement of our health care system is part of our responsibility as health care providers.
54 The Journal January/February 2015
F
rom pill-counters to health care providers, the profession of pharmacy has evolved tremendously in the public eye. Pharmacists have established themselves as critical players within the health care system by showing that they do not merely regulate medications, but also play an integral role in improving health and safety outcomes of patients. Pharmacists’ fight for the deserved recognition of provider status has achieved a new milestone with the introduction of bill HR 4190. By making legislators aware of the value pharmacists add to the health care team, we were able to gain much support of this bill. HR 4190 has shown us how effective professional advocacy can be. As a result, we are now on our way to being recognized as “health care providers” nationally. Without the immense efforts of pharmacists and students across the nation, we could not have come so far in advancing the profession of pharmacy. However, advocating for the proper recognition of pharmacists is only one component of health advocacy. Health advocacy includes promoting the continued improvement of community health and supporting initiatives that enhance patients’ health, safety, quality of life and access to health care. Our patients are not always backed by large influential organizations and many do not have access to resources necessary to affect health care policies. Through advocacy we can help educate legislators on patients’ behalf to gain support of polices that facilitate positive change. Advocating where they cannot is just as much a part of our role as health providers as making sure they are using the correct medication safely and effectively. The accrediting body for colleges of pharmacy in the US, ACPE, supports
the pharmacist’s role in patient advocacy in their 2016 draft standard 3.3 which requires colleges to prepare students that are able to represent the best interests of their patients. They also address public health in their guideline 12.1 which states that graduates must be competent to “promote the availability of effective health and disease prevention services and health policy through the ability to apply population-specific data, quality improvement strategies, informatics, and research processes to identify and solve public health problems and to help develop health policy.” Service learning programs are one way to get students involved in these types of activities early on in their careers. At Rosalind Franklin University of Medicine and Science (RFUMS) students are required to complete a service learning project prior to the close of their P3 year. The projects offered to students at RFUMS have revolved around the provision of many different types of pharmacy services, such as delivering flu vaccines to the medically underserved and providing educational outreach on healthy eating habits to children. In addition, each year RFUMS supports one student’s trip to Washington, DC so that they may participate in “Head to the Hill”, an annual event sponsored by the National Brain Tumor Society (NBTS). My 2013 service learning project allowed me to attend Head to the Hill and the experiences I had there brought me back to DC in 2014. The NBTS represents the largest nonprofit organization dedicated to the brain tumor community in the United States. In addition to their patient advocacy efforts, they lead research initiatives aimed at finding a cure and improving the quality of life for those suffering from brain tumors. During their
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annual Head to the Hill advocacy day, hundreds of brain tumor advocates from across the nation meet in Washington, DC to educate their legislators on the key issues that directly affect the brain tumor community. Head to the Hill lasts two days and is designed to provide education and training before participants meet with their legislators on the Hill. Participants spend day one learning about brain tumor facts and the key issues impacting this patient population. This day is essential to educating participants on policy changes that have a potential to drastically improve the quality of life and health outcomes for these patients. I learned first-hand the amount of people affected and the minimal advancement they have seen in drug therapies in the past 30 years with only four new FDA treatments coming to fruition. Participants are also educated on effective and ineffective advocacy techniques, after which, they are given time to practice in small groups where they anticipate questions legislators may have and prepare presentations for the following day. Through this education, participants gain the ability to effectively advise legislators on issues relating to health care, research, funding and policies that they may not be familiar with. At the close of the first day, the advocates meet for a dinner. I found this to be the most inspiring element of the two day event. Advocates share the stories of what brought them to Head to the Hill. I met people who have suffered personally or lost a loved one to a brain tumor. Family members and survivors described the grueling process of frequent doctor office visits, chemotherapy treatments, and what keeps them motivated to continue advocating. One advocate was driven to join the NBTS after she lost her eleven year old son to a brain tumor. Brain tumors are not uncommon in children and many times, the cancer spreads significantly before the time of diagnosis. After learning of my educational pursuits, she shared the story of her son and the comfort she received from forming relationships with those who cared for him. She was especially grateful for her pharmacist who got to know her family and expressed interest in making www.pswi.org
sure her son was comfortable and cared for. This story truly demonstrates the power of patient advocacy. Even though we cannot always have a direct impact on a patientâ&#x20AC;&#x2122;s prognosis, we can still have an impact on their lives. On day two, participants storm the capital equipped with fact-sheets and wellprepared presentations. Advocates rush to appointment after appointment where they share their stories and information with senators, house representatives and staff members, all with hopes of gaining support for policies that directly affect patients with brain tumors. The lack of oral chemotherapy parity
is one issue that particularly concerned me as a pharmacy student. The NBTS has been battling this issue over the last several years and it is frequently discussed on the Hill. Oral chemotherapy parity assures that payers cover the cost of oral chemotherapy similar to intravenous chemotherapy. This issue is relevant to all chemotherapytreated cancer patients and not just those suffering from a brain tumor. As oral chemotherapy becomes a treatment option for more and more cancer patients, a lack of parity presents a huge cost barrier to its utilization. While many states, such as Wisconsin, have passed a bill at the state level, there is no federal law that ensures January/February 2015
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oral chemotherapy for all. Oral chemotherapy gives patients autonomy over their treatment and relieves them from the restraint of having to make frequent clinic visits. In many cases, oral formulations can be cost effective by taking away the expense of IV administration and staffing as well as costs related to missed work and childcare. Coverage of these drugs would allow doctors to prescribe treatments based on evidence-based medicine and clinical judgment rather than financial obstacles because in many cases there is not an IV chemotherapy substitute. What is more concerning is that this problem will be exacerbated as more oral chemotherapy drugs in the pipeline enter the health care market and are not utilized by patients in need. One oral chemotherapy agent in particular, temozolomide, is used frequently in the treatment of certain types of brain tumors. Temozolomide is covered under many insurers as a pharmacy benefit, rather than a medical benefit, leaving patients to pay outrageous out-of-pocket costs for their chemotherapy or regress to the IV form. As future pharmacists, we are continuously taught the importance of patient-centered treatment plans. Making sure medications are not only medically appropriate but also customized to fits patients’ values, beliefs, and lifestyles is a key element of pharmacy practice. So far, 28 states have passed chemotherapy parity laws, but a federal law is still needed to correct the problem under self-insured health plans. After Head to the Hill 2014, eleven new members signed up to co-sponsor the Cancer Drug Coverage Parity Act (HR 1801). Training from the NBTS coupled with
my pharmacy education added weight to my conversations with legislators and allowed me to have a strong impact on the Hill. I’m proud to report that included in these co-sponsors is Congressman James Sensenbrenner of Wisconsin’s fifth district who signed up to support HR 1801 shortly after Head to the Hill in 2014. I grew both professionally and personally through my participation at Head to the Hill. The communication skills I gained through preparing for and meeting with legislators, many times one on one, are invaluable. I learned to condense information and prepare presentations that are not only attention grabbing, but thorough and easy to understand. I gained a better perspective of what it is like for individuals as well as their families to acquire a life-changing diagnosis and was able to have these conversations outside of the clinical environment. Through this I developed the compassion and empathy needed to become an effective patient advocate and health care provider. Involvement in advocacy opportunities like Head to the Hill is precisely what will shape pharmacy students as future public health leaders. As “health care providers” we have a responsibility to assess and conquer all of our patients’ health-related issues. The gap of knowledge between politics and medicine generates many obstacles to improving public health. Legislators and politically influential people dictate the laws that affect health care, yet most have no prior health care experience or expertise. Advocacy is essential to bridging the gaps between health care and politics. How can we expect politicians to be informed of the needs of their constituents if we do not attempt to educate them on
these important issues? Without input from citizens and healthcare providers, legislators cannot create policies in our patients’ best interest. It is essential that this education is carried out by knowledgeable constituents who are not financially motivated, but rather looking to improve their patients’ quality of life. Pharmacists have in-depth knowledge of health care and are well equipped to identify problems that exist and recommend the necessary solutions. Student involvement in these areas not only benefits the patients they are supporting but also strengthens students’ professional and personal advancement. Advocating for specific patient populations or for the advancement of our health care system, as we’ve seen with HR4190, is our responsibility as health care providers. Reflecting on my time with the NBTS, I’ve realized how much it has shaped the type of practitioner I aspire to become and has demonstrated the powerful impact political policies can have over patients’ lives. For these reasons, I look forward to continuing my involvement with the NBTS and making patient advocacy a career-long endeavor. ● Alyssa B. Wenzel is a 4th year Doctor of PharmacyCandidate at Rosalind Franklin University of Medicine and Science, Chicago, IL.
Disclosure: The author declares no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.
Stay up-to-date on weekly statewide and national news that is relevant to Wisconsin pharmacy profession. FastFacts is a weekly newletter distributed to all PSW members every Friday Morning. To view the FastFacts archive, visit www.pswi.org/Communications/Newsletter-Archive/Fast-Facts-Archive
56 The Journal January/February 2015
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PSWnews
2014 Scavenger Hunt! 1. What issue is this quote from and who wrote it? What was the article really about? “Pharmacists are the underestimated fat kid of the football team of medicine” 2. In what Technician CE in 2014 did they outline the “Signs and Symptoms” of Deep Vein Thrombosis, Pulmonary Embolism, Stroke, and Bleeding? 3. How many PSW logos are in the Nov/Dec issue? 4. Based on the percent of responders, “Which purveyor of fine cheese cuisine provided the best overall curd experience,” based on the Post-Crawl survey questions? 5. For the WPQC Sticker Challenge, how many stickers does a Follow-up CMR/A earn the pharmacy? (Asthma, Diabetes, Heart Failure, or Geriatric) 6. In the PSW Public Affairs Update article, what were the three main priorities of PSW public affairs for 2014? 7. Over ___ pharmacists, pharmacy technicians, and pharmacy students attended PSW’s 2014 Legislative Day. 8. What lovable cartoon did Pat Cory mention in his 2014 presidential speech at the Annual Meeting? 9. In the New Options for Disposal of Controlled Substances article, what is the requirement for Receptacle Labeling?
The winner will take home a $10 gift card to Starbucks! If you don't have all of the 2014 Journal's, please visit the Journal archive on the PSW website. Submit your answers to Megan Grant at mgrant@pswi.org. The first entry to get all 9 questions correct will receive the prize.
HAPPY HUNTING! www.pswi.org
January/February 2015
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Implementation and Evaluation of Guidelines for Use of a Prescription Drug Monitoring Program at One Veterans Affairs Facility by Ellina Pisetsky, PharmD, Andrew Wilcox, PharmD, Amanda Margolis, PharmD, MS, BCACP, Diane Johnson, Pharm D, BCPS, and Arthur Schuna, MS, BCACP
Abstract Objectives: The objective of this quality improvement project was to evaluate the implementation and use of guidelines created for the Wisconsin Prescription Drug Monitoring Program (PDMP) database at one Veterans Affairs (VA) facility. Methods: A survey was sent to ten primary care providers (PCPs) and five pharmacists. Individuals were selected based on their use of the database. The survey asked questions related to provider satisfaction, provider use, perceived value, time spent, and effect on patient care from implementation. Results: All 15 surveys were returned. Both pharmacists and PCPs believe the PDMP website is clear and understandable, easy to use, and does not require a lot of mental effort. The PCPs believe PDMP improves their job performance, whereas pharmacists do not agree. Both pharmacists and PCPs are in agreement that PDMP does not increase productivity, however both groups find the information obtained from PDMP useful. Both pharmacists and PCPs responded that PDMP improves patient care and facilitates better patient care decision-making. Pharmacists and PCPs agree it takes a moderate or significant amount of time for follow up care if something of concern is found in the database. All primary care providers answered that they check the database more often than the minimum. Referral rates to specialty services, such as pain clinic, controlled substance advisory board, and addiction services, have increased. Conclusion: The implemented guidelines for utilization of the Wisconsin PDMP at the William S. Middleton Memorial Veterans Hospital are useful, simple to use, and may improve patient care. 58 The Journal January/February 2015
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ontrolled substances and prescription opioid medications can introduce large public health risks when used inappropriately.1 An article published in 2012 from the Centers for Disease Control and Prevention (CDC) stated that there are over 27,000 deaths from prescription opioid overdoses in the United States per year.2 This equates to one death every 19 minutes. In addition, the number of overdose deaths from prescription opioids out numbers those from cocaine and heroin combined. Inappropriate use of opioids not only affects mortality, but also morbidity. The CDC also estimates that for every one death that occurs from an opioid overdose, there are nine hospital admissions, 35 emergency department visits, 161 reports of drug abuse, and 461 reports of nonmedical uses. Although controlled substances and opioids can be obtained illegally, the vast majority are obtained via legitimate prescriptions.1 Many prescribers who are writing these prescriptions are likely unaware of the potential abuse or misuse that occurs as a result. Additionally, doctor shopping may occur, which describes when a patient goes to many different prescribers to obtain multiple prescriptions, then proceeds to fill these prescriptions at many different pharmacies.3 Forty-nine states, including Wisconsin, have created prescription drug monitoring programs (PDMPs) to help combat misuse of opioid prescriptions, as well as other controlled substances.4,5 Although these databases may differ from state to state, the PDMPs track dispensing data encompassing all controlled substances and sometimes additional medications. From the Wisconsin Prescription Drug Monitoring Program website, “The primary
purpose of the PDMP is to improve patient care and safety and reduce the abuse and diversion of prescription drugs in Wisconsin while ensuring patients with a legitimate medical need for the drugs are not adversely affected.”5 The Wisconsin Prescription Drug Monitoring Program began collecting dispensing data in January 2013 and was available for query in June 2013.5 In February 2013, the Department of Veterans Affairs (VA) began allowing providers to access state prescription drug monitoring program databases.6 Prior to the amendment to VA regulations in February 2013, federal law governing confidentiality of VA records did not permit access to, or disclosure of, information to state run PDMPs.5 Patients may receive comprehensive health care within the VA system, including use of an outpatient pharmacy to receive all of their medications.7 Veterans’ electronic health records are specific to the VA system, therefore information regarding health care received outside of the VA system is not readily available to VA providers. Thus, if a patient were to receive care from an outside provider, and fill a controlled substance at a non-VA pharmacy, a provider within the VA system may be unaware of this information. With the advent of the Wisconsin PDMP, and the new guidance from the National VA to access state PDMPs, the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin sought to create specific guidelines for their providers regarding access of the database. There is a lack of literature describing implementation of PDMP guidelines in a health system and best practices are geared towards stand-alone retail pharmacies.8 These best practices are not directly applicable to a hospital that utilizes its own outpatient
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pharmacy. In order to facilitate creation of PDMP use guidelines, a stakeholder work group was formed that involved the Chief of Pharmacy, a pharmacy resident, the pain clinic pharmacist, the chief of primary care, the clinical primary care leader, a pain clinic nurse, and the pain programs coordinator. Between the months of July 2013 and January 2014, the stakeholder work group met three times. There were also smaller meetings with the privacy officers and other specific focus groups. The guidelines were made available in January 2014 and included the following points: • Primary care providers would check the database for all new patients and new controlled substance prescriptions they would be ordering. • The outpatient pharmacy would check the database once every six months for any patient on a controlled substance. The most recent date of checking would be noted in the patient’s pharmacy record. • If something of concern was found in the database, the prescriber would be notified and this would also be documented in the patient’s pharmacy record. This documentation would prompt the pharmacist to check PDMP for every controlled substance the patient would receive from that point forward. A note template was created and embedded into the electronic medical record to assist practitioners in documentation of PDMP results. Additionally, a quality analysis was developed to elicit feedback on the implemented guidelines.
Methods
A survey was created to evaluate the new guidelines. This survey was purposefully engineered through literature review to answer questions regarding provider satisfaction, provider use, perceived value, time spent, and effect on patient care.9 Fifteen respondents were chosen based on their use and experience with the database. Five outpatient pharmacists who were regularly utilizing PDMP (eg. pharmacists processing controlled substance prescriptions) were asked to participate. Ten primary care www.pswi.org
TABLE 1. Responses to Survey Questions Question Theme
Ease of use
Survey Question
Respondent*
Low
Moderate
High
Clear and understandable
RPh
0%
60%
40%
PCP
10%
30%
60%
RPh
20%
40%
40%
PCP
30%
50%
20%
RPh
0%
40%
60%
PCP
10%
20%
70%
Improves job performance
RPh
60%
0%
40%
PCP
10%
40%
50%
Increases productivity
RPh
100%
0%
0%
PCP
80%
10%
10%
RPh
0%
60%
40%
PCP
10%
0%
90%
Improves patient care
RPh
0%
40%
60%
PCP
10%
10%
80%
Improves Decisions
RPh
0%
40%
60%
PCP
10%
10%
80%
Caring for patients easier
RPh
20%
40%
40%
PCP
30%
40%
30%
Satisfied with system
RPh
40%
20%
40%
PCP
40%
30%
30%
Recommend the system
RPh
40%
0%
60%
PCP
40%
20%
40%
RPh
0%
60%
40%
PCP
30%
40%
30%
RPh***
40%
20%
20%
PCP
80%
10%
10%
Easy to use
Mental effort**
Perceived Usefulness for Self
Is useful
Perceived Usefulness for Patient
Satisfaction with System
Querying a patient Time Spent Something of concern found *RPh = pharmacist PCP = primary care provider **High response = low mental effort ***One pharmacist did not respond to this question
providers (PCPs), who were recognized as early adopters by the Chief of Primary Care, were also asked to participate . The group of primary care providers included physicians and nurse practitioners, and represented clinicians from the VA’s community based outpatient clinics (CBOCs). The survey was distributed February 2013, approximately four weeks after use of the database began. The survey consisted of 15 questions with Likert scale answers on a scale of either three or seven responses (figure 1). The seven response questions were adapted from a validated health care article.9 The
three response questions were written specifically for this program evaluation. Questions were grouped under themes of ease of use, perceived usefulness for provider, perceived usefulness for patient, utility in caring for patients, overall satisfaction, time spent, frequency of PDMP checking, and effect on referral rates to specialty services. All 15 surveys were returned. Descriptive statistics were used to assess survey results.
Results
Responses were grouped into low, moderate, and high categories (Table January/February 2015
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FIGURE 1. Survey: Evaluation of the implementation of the Wisconsin Prescription Drug Monitoring Program (PDMP) For each statement, please place an X in the box you feel most accurately reflects your opinion. The Wisconsin Prescription Drug Monitoring Program (is): Perceived ease of use
Not at all
A little
Some
Moderate amount
Pretty much
Quite a lot
A great deal
A little
Some
Moderate amount
Pretty much
Quite a lot
A great deal
A little
Some
Moderate amount
Pretty much
Quite a lot
A great deal
Pretty much
Quite a lot
A great deal
Clear and Understandable Easy to use Requires a lot of mental effort Checking the Wisconsin Prescription Drug Monitoring Program: Perceived usefulness for self
Not at all
Improves job performance Increases productivity Is useful Checking the Wisconsin Prescription Drug Monitoring Program: Perceived usefulness for patient
Not at all
Improves patient care Facilitates better patient care decision making Makes caring for patients easier Thinking of how often you have been asked to check the database, are you/would you: Primary care: at least for new patients/new prescriptions Pharmacy: once every 6 months Satisfaction with system
Not at all
A little
Some
Moderate amount
Satisfied with system of checking the database Recommend the system to a friend at another hospital How much time does checking the database take (please think only of the time it takes to query a patient, and do not include any time spent on follow up care if a concerning finding arises): Time
Significant
Moderate
How much time is spent on follow up care if something of concern is found in the database? Time
Minimal
Time Spent
Significant
Moderate
Minimal
Time Spent
PRIMARY CARE PROVIDERS ONLY: I check the database more often than for just new patients/new prescriptions: Query beyond minimum
Not at all
A little
Some
Moderate amount
Pretty much
Quite a lot
A great deal
Satisfied with system of checking the database Since you started utilizing the database, your referral rate to the controlled substance advisory board, pain clinic, ADTP, or other services has: Referrals
Increased
Decreased
Not changed
Referral Rate Your time is greatly appreciated! Please contact Ellina.Pisetsky2@va.gov with questions. 60â&#x20AC;&#x192; The Journal January/February 2015
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1). Under the theme of “ease of use,” both pharmacists (RPhs) and primary care providers (PCPs) believe the PDMP website is clear and understandable (100% of RPhs/90% of PCPs), easy to use (80% of RPhs/70% of PCPs), and does not require a lot of mental effort (100% of RPhs/90% of PCPs). Regarding “perceived usefulness for self,” the majority of pharmacists (60%) do not think PDMP improves their job performance, whereas the PCPs (90%) do believe use of the PDMP improves their job performance. Both pharmacists (100%) and PCPs (80%) are in agreement that PDMP does not increase productivity, however both groups find the information obtained from PDMP useful (100% of RPhs/90% of PCPs). When asked about “perceived usefulness for patients,” both pharmacists and PCPs responded that PDMP improves patient care (100% of RPhs/90% of PCPs) and facilitates better patient care decision-making (100% of RPhs/90% of PCPs). Mixed results were seen when asked if PDMP makes caring for patients easier, although the majority still revealed moderate or high responses (80% of RPhs/70% of PCPs). Regarding satisfaction with policy frequency for clinician use of PDMP, mixed results were seen again (60% of RPhs/60% of PCPs), though a larger percentage of pharmacists feel more strongly that they would recommend the system to another hospital (60% of RPhs/40% of PCPs). Under the theme of “time spent,” pharmacists (100%) believe that checking a patient in the database takes either minimal or moderate time. Similar responses were found for PCPs, although a few PCPs (30%) believe checking a patient takes a significant amount of time. The majority of both pharmacists (60%) and PCPs (90%) are in agreement that it takes a moderate or significant amount of time for follow up care if something of concern is found in the database. All primary care providers answered that they check the database more often than the minimum, with 70 percent responding in the moderate or high categories. Lastly, half of the PCPs responded that their referral rates to specialty services, such as addiction clinic, pain clinic, or controlled substance advisory board, have increased as a result of PDMP use. Many surveys received where the www.pswi.org
referral rate was not changed commented that they expect their referral rates to increase as they gain more experience with the database.
Discussion
An interesting finding was that pharmacists do not believe PDMP improves job performance, however the majority of PCPs do believe PDMP improves job performance. For both groups, the PDMP takes time and perhaps reduces efficiencies, but PCPs still believe the PDMP improves their job performance. It’s possible that the pharmacists surveyed view their performance in number of prescriptions filled over time, whereas PCPs view their job performance in terms of providing high quality care. The increase in referrals to specialty services is an important discovery. It shows that checking PDMP may have a direct effect on patient care. As providers discover concerning findings, patient care resources are now more frequently utilized and as a result, improved patient care may occur. Another key finding is that all PCPs are checking more often than the minimum. As PCPs are already checking more often than expected, and pharmacists cannot quickly identify which patients a PCP has already checked, it is likely that pharmacists are double-checking many patients that PCPs have already queried. As revision to the guidelines moves forward, this finding may allow for a decrease to the pharmacy work burden.
One limitation to this study is the limited experience with the Wisconsin PDMP prior to initiating the survey. The guidelines were launched in January of 2014, and the surveys were distributed in February 2014, reflecting approximately four weeks of experience with PDMP. Additionally, the small survey size is a limitation, as it decreases the generalizability to the rest of the institution. There may have also been some variation in question interpretation. For example, although an attempt was made to be clear regarding questions asked on the survey, it is possible respondents were thinking about the PDMP website itself versus the guidelines created in answering overall satisfaction questions. Strengths of this study include 100% response rate and the capture of viewpoints from both pharmacists and primary care providers. As a result of this survey, revisions to the guidelines may be made. Future research is needed to investigate the effect of PDMP guideline use on patient care.
Conclusion
The guidelines created to check the Wisconsin PDMP have proven to be useful and are relatively easy to use within the William S. Middleton Memorial Veterans Hospital system. PCPs are checking more often than the minimum guidelines and referrals to specialty services have increased. Future directions include revision of the guidelines to prevent re-work, creating a January/February 2015
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larger evaluation including in person interviews, and contribution to the literature as there is current lack regarding implementation of PDMP guidelines into a health care facility. ●
New Members Welcome to the newest members of PSW (10/13/2014 to 12/05/2014)
Christina Barkow, Green Bay Michelle A. Becerril, Oneida Health Center Pharmacy, Oneida Rich Calteux, Good Value Pharmacy LTC, Kenosha Cassandra Dillon, Duluth, MN Ryan Feldman, Milwaukee Angela Ann Green, Madison Grace Heacock, Johnson Drug at ARMC, Amery Theodore Houston, Oak Creek Benita E. Jones, Milwaukee Mohammad Kharbat, Greenfield Diane M. Kimball, La Crosse Jeffrey Wayne Krueger, Middleton Michelle Kutcher, New Berlin Emily K. Langlois, Wauwatosa Elizabeth Laubach, Richfield Kelly Luschen, Taylors Falls Jessica Michaud, Wauwatosa Katheryn Pride, Madison PSW_ShieldLogo_3c Alma Princip, Mallat's Pharmacy and Costumes, Madison Laura Ann Puccetti, Sun Prairie This article has been peer-reviewed. The contribution in Laura Schanen, AstraZeneca, Sussex reviewingis greatly appreciated! Beatrice F. Stockheimer, Stratford Mike Storck, Monore Clinic, Monroe
Ellina Pisetsky, PharmD is a PGY2 Health-System Pharmacy Administration Resident at William S. Middleton Memorial Veterans Hospital in Madison, WI. Andrew Wilcox, PharmD is the Chief, Pharmacy Service, Pharmacy Administration Residency Program Director at William S. Middleton Memorial Veterans Hospital in Madison, WI. Amanda Margolis, PharmD, MS, BCACP is a Clinical Pharmacist at William S. Middleton Memorial Veterans Hospital in Madison, WI. Diane Johnson, Pharm D, BCPS is a Clinical Pharmacy Specialist at William S. Middleton Memorial Veterans Hospital in Madison, WI. Arthur Schuna, MS, BCACP is a Pharmacy Practice Residency Program Director at William S. Middleton Memorial Veterans Hospital in Madison, WI.
P
R
Disclosure: The author(s) declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.
References
1. McDonald DC, Carlson KE. Estimating the prevalence of opioid diversion by "doctor shoppers" in the United States. PLoS One. 2013;8:e69241. 2. CDC Grand Rounds: Prescription Drug Overdoses – a US Epidemic. Centers of Disease Control and Prevention. http://www.cdc.gov/mmwr/ preview/mmwrhtml/mm6101a3.htm#fig1. Accessed February 13, 2014. 3. Baehren DF, Marco CA, Droz DE, et al. A statewide prescription monitoring program affects emergency department prescribing behaviors. Ann Emerg Med. 2010;56:19-23.e1-3. 4. US Department of Justice Drug Enforcement Administration. Office of Diversion Control. State Prescription Monitoring Programs: Questions and Answers. http://www.deadiversion. usdoj.gov/faq/rx_monitor.htm. Accessed June 5, 2014. 5. Frequently Asked Questions. Wisconsin Prescription Drug Monitoring Program. http://www.dsps.wi.gov/pdmp/faq. Accessed February 13, 2014. 6. Silverman R, Tuttle J. State Prescription Drug Monitoring Programs VHA Participation. http://www.pdmpassist.org/pdf/TTAC_Veterans_ Affairs_webinar_20140319.pdf page 8. Accessed June 5, 2014. 7. Chua FB, Rumage C, Santos SL, Helmer D. Facilitating Reintegration for Veterans: Patient-Centered, Comprehensive Care. http://www. warrelatedillness.va.gov/WARRELATEDILLNESS/research/articles/2013ChuaF-facilitating-reintegration-for-veterans.pdf. Accessed June 5, 2014. 8. Clark T, Eadie J, Knue P, et al. Prescription Drug Monitoring Programs: An assessment of the evidence for best practices. September 20, 2012. http://www.pdmpexcellence.org/sites/all/pdfs/Brandeis_ PDMP_Report_final.pdf. Accessed February 13, 2014. 9. Holden RJ, Brown RL, Scanlon MC, Karsh BT. Pharmacy workers’ perceptions and acceptance of bar-coded medication technology in a pediatric hospital. Res Social Adm Pharm. 2012 Nov-Dec8(6) 509-22.
PMS 7729
2015 PSW CONFERENCE CALENDAR March 4-5, 2015 PSW Senior Care Conference Marriott Milwaukee West, Waukesha
September 10-13, 2015 PSW Annual Meeting Hyatt Regency Milwaukee, Milwaukee, WI
March 18, 2015 PSW Legislative Day Madison Concourse Hotel, Madison
October 16-17, 2015 PSW Technician Educational Forum Blue Harbor Resort, Sheboygan, WI
April 9-10, 2015 PSW Educational Conference Monona Terrace, Madison
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62 The Journal January/February 2015
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Pharmacy Quality Measurement Medicare Part D Star Ratings - A Practitioner's Q&A by Lisa Schwartz, PharmD
This article originally appeared in the August 2014 issue of America’s Pharmacist, published by the National Community Pharmacists Association, Alexandria, Va. Reprinted with permission.
T
he Medicare Part D Star Ratings program has generated a lot of buzz in the past year, and pharmacy owners are asking questions about quality measurement, the ratings, and what effect they will have on their pharmacy. NCPA is running a series of short articles that discuss each of the measures published by the Pharmacy Quality Alliance, beginning with the five that are part of the Medicare Part D Star Ratings program. The first article appeared in the June 2014 issue; this and all subsequent articles will be available at www.americaspharmacist.net.
How Do I Find Out My Pharmacy's Star Rating? At this time, Medicare does not give individual pharmacies a star rating. Pharmacy claims data is analyzed in the aggregate to assign a star rating to a Medicare Part D Prescription Drug Plan (PDP) or Medicare Advantage Plans with prescription drug benefits (MA-PD).
How Do I Find Out If My Pharmacy is Helping or Hurting the Plans' Ratings? The first company to market a tool for the management of pharmacy quality measure reporting is Pharmacy Quality Solutions. PQS accesses claims data to determine pharmacy performance on key areas that influence Part D Star Ratings, and creates a pharmacy-specific scorecard or dashboard to track performance. Several wholesalers, pharmacy services administration organizations, franchises, and other groups have announced that www.pswi.org
their customers have access to PQS’s EQuIPP dash- board. A list of these groups is available on the News page of www. pharmacyquality.com.
What are the Pharacy Quality Measures That Factor into Plans' Star Ratings? They are high-risk medication use, diabetes treatment, medication adherence for oral diabetes medications, medication adherence for hypertension (in patients with diabetes), and medication adherence for cholesterol. Technical definitions for calculating these scores is available in the technical notes for the 2013 plan year.
Why is There a Sudden Interest in Measuring Pharmacy Performance? Recent changes to health care laws have put a greater emphasis on paying for health care that creates improved patient outcomes and reducing spending that does not. Health plans want healthy members and want to avoid spending money on services, tests, and treatments that do not improve patient health outcomes. Medicare Part D plans with five stars are allowed to market the plan year round and beneficiaries may make a one-time switch into a five-star plan. Plans that have lower than a three-star rating may be terminated after three years.
How Do I Improve My Performance on the Five Quality Measures Tracked by Medicare?
resources and tools available to help improve patient adherence to prescription drugs. Coordinated refills and regular contact with a local pharmacy have been shown to improve adherence. Many pharmacy software systems have programs that help pharmacies identify maintenance medications due for refill, but automatic refills fall short when communication with the patient is not part of the picture. Contact NCPA for information about the Simplify My Meds® coordinated refill adherence program (www.ncpanet.org/ smm).
PQA Published Measures 1. Proportion of days covered
2. Antipsychotic use in children under 5 years old 3. Adherence to non-warfarin oral anticoagulants 4. Diabetes medication dosing 5. Diabetes: appropriate treatment of hypertension 6. Medication therapy for persons with asthma 7. Use of high-risk medications in the elderly 8. Drug-drug interactions 9. Cholesterol management in coronary artery disease 10. Completion rate for comprehensive medication review 11. Antipsychotic use in persons with dementia
Three of the five measures are adherence-related. There are many January/February 2015
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PQA Published Measures High Risk Medications Pharmacy Quality Measures Explained By Sarah Squires, MBA, PharmD (Editor’s Note: This is another in a continuing series of information articles for independent pharmacists on the Star Ratings program and pharmacy performance measurement.) Where does this measure fit into the overall Medicare Part D Star Ratings? This measure is classified under “Drug Pricing and Patient Safety” in the Part D Domain and specifically targets patient safety. What does this measure analyze? This measure compares the number of patients who received at least two prescription fills for the same high-risk medication during the measurement period with the number of people in the eligible population. The eligible population is defined by patients who are 66 years or older on the last day of the measurement year (typically 12 months), continuously enrolled, and have at least two prescription fills for any medication over the course of the measurement period. What impact can this have on my pharmacy? This measure, related to the number of patients in your pharmacy that fit the eligible population criteria regarding high risk medications, can affect the star rating of plans that include your business in their network. Should your population of patients on high-risk medications reduce the plan’s star rating rather than improving it, your pharmacy may not be included in their network in the future. What impact does this have on patient safety? High-risk medications in patients over 65 have everything to do with patient safety. The Beers’ list, updated in 2012 by the American Geriatrics Society, is referenced for this Medicare Part D Star Rating measure. Patients who fit criteria of this measure are deemed to be at a higher risk for an adverse drug event (ADE) than they would be if they were on a medication not recognized as “high-risk.” If patients who fit the criteria remain on high-risk medications and have an ADE due to that medication, the star rating of the plan and the patient’s health and safety would suffer. What can I do improve performance in my pharmacy? Patients who are age 65 or older and are on at least one high-risk medication that has been filled at least two times over the measurement period could be compiled into a list for reference purposes to reconcile these problems. Medication therapy management (MTM) sessions could be conducted in the pharmacy to evaluate the status of these patients’ regimen. It would be beneficial to describe to patients what adverse drug events could take place with the high-risk medication and for what signs or symptoms they are looking. With the consent of the patient and physician, therapy changes may be made to switch the high-risk medication to an alternative not found on the Beers’ list. Sarah Squires, MBA, PharmD, is a 2014 graduate of the Harding University College of Pharmacy.
64 The Journal January/February 2015
I Understand That Network Pharmacies Contribute to the Plan's Star Rating, But What Else Figures into the Rating? In total, there are 18 measures for PDPs and 51 for MA-PDs. Plans are rated on customer services (such as call center hold times, timely enrollment, complaints, and members leaving the plan), pharmacy hold time at the call center, the appeals process, patient safety, and, specific to MA-PDs: health screenings, vaccination, and managing chronic conditions (such as diabetes, osteoporosis, blood pressure, and fall risk). Patient safety measures are more heavily weighted and the pharmacy measures fall into this category.
Do Non-Part D Plans have Star Ratings? No and yes. The Star Ratings program belongs to the Centers for Medicare & Medicaid Services and Medicare Part D (there is also a Star Ratings program for nursing homes). That said, the pharmacy quality measures that CMS uses are published by the Pharmacy Quality Alliance (PQA) and it is likely they will be used by plans and pharmacy benefits managers to build networks if they are not already doing so. PQA has published 11 pharmacy quality measures (see box), though only five are used by CMS. For more information about PQA’s published measurements and measurements under development, visit http://pqaalliance.org/ measures/.
How Soon Will the Star Ratings Program Affect My Pharmacy? The Star Ratings Program affects your pharmacy right now. Medicare Part D plans have been given Star Ratings since the 2012 plan year, which means data as far back as 2010 was analyzed to rate the plans before open enrollment in October 2011. While the preferred networks that popped up in the 2012 plan year appear to be based on business negotiations instead of performance, CMS has released reports of claims data analysis that show preferred networks did not always lead to savings
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over pharmacies not in the preferred network. Legislation (H.R. 4577) has been introduced that would allow any pharmacy located in a medically underserved area to participate in all Medicare Part D Plan networks, including the plan’s discounted or “preferred” network.
What Happens If I Do Nothing?
If you are already meeting performance goals, the answer might be nothing. Keep in mind that the Star Ratings program may add additional pharmacy quality measurements or change the goals. The hope early was that high-performing pharmacies could negotiate higher reimbursement, but it’s more likely that high-performing pharmacies will be allowed to stay in the network. If you are not meeting performance goals, it is possible that the patients of your pharmacy are not meeting drug therapy goals or are taking inappropriate medications. A Medicare Part D Plan could exclude you from its network to improve its Star Ratings. By dropping underperformers, the plan can steer patients to a pharmacy that is meeting performance goals. ● Lisa Schwartz, PharmD, is NCPA senior director, management affairs
Additional Resources
1. Use of High-Risk Medications in the Elderly (HRM): http://pqaalliance.org/images/uploads/ files/HRM%20Measure%202013website.pdf 2. Pharmacy Quality Alliance: http:// pqaalliance.org/measures/cms.asp 3. Beers’ list: http://www.americangeriatrics.org/ files/documents/beers/PrintableBeersPocketCard.pdf
JOB NETWORK POSTING ONCOLOGY CLINICAL PHARMACISTS Aurora St. Luke’s Medical Center in Milwaukee, Wisconsin continues to expand its cancer services and is interested in oncologytrained pharmacists to provide patient-centered clinical pharmacy services. The pharmacist is part of a multi-disciplinary team providing care to patients with a wide variety of cancer diagnoses. Opportunities exist to provide direct patient services on our 48bed inpatient oncology patient care area, as well as, in one of our 22 ambulatory oncology clinics. In addition to working with physicians and nurses to promote evidence-based drug therapy, pharmacists provide medication counseling to patients and transition of care services. Pharmacists also precept PharmD students, PGY1 residents and PGY2 residents. Aurora Health Care offers an exceptional compensation and benefits package, along with the pharmacy department’s career ladder that acknowledges your professional growth. Qualified candidates will have earned a PharmD degree, completed a PGY1 residency and be licensed or eligible for licensure in Wisconsin. PGY2 oncology residency preferred. ONCOLOGY CLINICAL COORDINATOR Aurora Health Care continues to expand its oncology services across its 15 hospitals and 22 ambulatory oncology clinics. We are seeking pharmacists interested in taking a leadership role in the practice and progressive development of oncology pharmacy services as a clinical coordinator. This position includes providing exemplary patient care, teaching, staff development, program development and overall coordination of pharmacy management for the oncology patient population. The oncology clinical coordinator works closely with physicians, nurses and other leaders in the organization to optimize care for patients. Aurora offers an exceptional compensation and benefits package. Qualified candidates will have earned a PharmD degree, completed a PGY1 residency and be licensed or eligible for licensure in Wisconsin. PGY2 oncology residency, or comparable experience, preferred. Aurora supports a safe, healthy and drug-free work environment through criminal background checks and pre-employment drug testing. We maintain a smokefree environment at all our locations. We are an equal opportunity employer and maintain an environment that attracts, recruits, engages and retains a diverse workforce.
Visit careers.pswi.org for more details www.pswi.org
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originalcontributions
Piloting a Remote Medication Consultation Service alongside Discharge Prescription Delivery Abstract
by Jessica Zahn, PharmD and Allan Loeb, RPh, MS
T
he Centers for Medicare & Medicaid Services (CMS) describes telemedicine as a means for improving a patient’s health by permitting two-way, real-time interactive communication between a patient and a healthcare provider at a distant site.1 Telemedicine services utilize a variety of different technologic mediums such as video communication, email, smart phones, etc. in order to provide clinical services to patients. The American Telemedicine Association (ATA) also makes the distinction that telemedicine is sometimes closely linked with the term health information technology (HIT). However, HIT more commonly refers to electronic medical records and related information systems, while telemedicine refers to the actual delivery of remote clinical services using technology.2 Telepharmacy operations and services may include, but are not limited to, drug review/monitoring, dispensing, oral and sterile compounding verification, medication therapy management (MTM), patient assessment, and patient counseling.3 The American Society of Health-System Pharmacists (ASHP) has recognized the growth in technology and its use in pharmacy practice and is currently in the review process of drafting their official stance in support of its growth.
Aurora Health Care – Current Practice This pilot took place at Aurora Health Care, a fully integrated health-system consisting of 15 hospitals, more than 150 clinic sites, and over 70 retail pharmacies located mainly in eastern Wisconsin and northern Illinois. As a part of Aurora Health Care’s Pharmacy Goals for 2014, 66 The Journal January/February 2015
Objectives: The purpose of this project was to test the functionality and characterize various teleconferencing technologies to best provide medication education to discharging patients. This remote consultation service was inserted into the current discharge prescription delivery service at Aurora Health Care, providing convenient access to a pharmacist as medications were delivered bedside. Methods: A literature search was conducted on the application, clinical outcomes, and patient satisfaction of pharmacist-run telehealth services. The inpatient surgery unit at Aurora St. Luke’s Medical Center was chosen as the primary implementation unit given its quicker patient turn over and general characteristics of prescription type and volume. Workflows were created to fit into the current discharge prescription service if the patient accepted the offer for consultation at the time of medication delivery. Various video-conferencing mediums were evaluated based on feasibility, cost, and ease of use. Remotely located pharmacists were oriented to the inpatient electronic health record and the inpatient pharmacist discharge process. Pharmacy technicians were trained to set up a remote discharge consultation for the patient using the evaluated technology. Frequency of use of the service and general pharmacy technician and patient satisfaction were evaluated. Results/Conclusion: At the conclusion of the one-week pilot, a total of 14 patients received discharge consultation from the remote pharmacist. Zero to six consultations were completed each day, averaging 7.4 minutes in length. Patients reacted overwhelmingly positive to pharmacists providing medication consultation via video teleconference technology. The majority of patients felt the sound and video quality were acceptable. All 14 patients felt comfortable speaking with a pharmacist with the teleconferencing technology and the majority had no preference between speaking with a pharmacist in person or via teleconference. It was determined that Microsoft® LyncTM meets Aurora St. Luke’s Medical Center’s needs in providing quality picture and sound to perform medication consultation to patients.
the pharmacy department has charged itself with piloting and expanding teleservices. Currently, a few pockets within the system have established uses for two-way video communication; however its use is not widespread. Aurora’s retail pharmacies use video conferencing technology to communicate with remote dispensing sites for both prescription checking with pharmacy technicians and medication consultation with patients. Within Aurora’s clinic sites and hospitals, pharmacists are able to provide remote medication checks for pharmacy technicians within sterile product areas in operating rooms and chemotherapy hoods. Some hospital sites are also piloting ways to remotely obtain medication histories from patients upon admission to the hospital. This pilot was conducted at the largest hospital within the Aurora Health Care
system, Aurora St. Luke’s Medical Center (ASLMC), in Milwaukee, Wisconsin. In February of 2014, ASLMC established a bed-side prescription delivery service on an acute patient care floor. The Discharge RX program utilizes technicians to enroll patients interested in the service, with the intent of delivering prescriptions to the bedside before the patient discharges. The service had previously been using decentralized pharmacists, residents, and pharmacy students to provide medication education to these patients. The focus of the pilot was to use similar technology utilized by Aurora’s remote dispensing sites to provide remote medication consultations to patients discharging from ASLMC. The purpose of this study was to 1) test the functionality and characterize various teleconferencing technologies within Aurora Health Care, 2) utilize
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FIGURE 1. Adding the Remote Discharge Counseling Workflow to the Bedside Prescription Delivery Program.
pharmacist then and direct instruction on the process was accessed the finalized provided. Communication was enhanced discharge medication throughout the process by utilizing Pharmacy staff triggered by in-basket message that patient list to further tailor the teleconferencing platform’s dual is discharing, custom built report identifies patients utilizing his/her consultation. capabilities as an instant messaging and discharge prescription delivery program Finalized video conferencing program. Reactions Current Work Flow Adding the Teleconsult prescriptions were to the new service were captured to assess After discharge Med Rec complete, Inpatient RPh performs Med Rec, sent to the on-site patient opinion with a brief online survey remote RPh identifies new meds new RXs from outpatient identified and gathers teaching information outpatient pharmacy completed by the remote pharmacist. for filling. An Patients’ perception of the sound and video Inpatient RPh/resident/APPE gathers outpatient pharmacy quality, comfort level in speaking with a When RXs are delivered, tech offers teaching information and counsels remote consultation technician was pharmacist via teleconference, preference in patient on new RXs they will be trained to collaborate communication forum with a pharmacist, receiving from outpatient electronically as well as any additional comments were If patient is agreeable, tech Inpatient RPh documents patient with the remote recorded. connects to remote RPh, adjusts education in electronic health pharmacist, via an volume, screen angle, provides record show and tell instant messaging Results system, to establish Skylight® iCareChat had been Remote RPh documents in Technician delivers medications an estimated time of previously tested during a similar pilot electronic health record and to floor independently prior to prescription delivery project in 2011. This system was eliminated completes survey of patient discharge reactions to service and to then initiate as an option based on past experiences a video conference from the 2011 pilot and poor video quality. call to provide Both PolycomTM and Cisco® provided remotely located pharmacists to provide medication counseling upon delivery to excellent video and sound quality, but were inpatient discharge consultation to patients the patient’s room. At the completion eliminated for this pilot based on high cost of medication counseling, the remote receiving their medications through the of equipment. Within Aurora Health Care, pharmacist was able to utilize the same bedside delivery program, and 3) assess Microsoft Lync® is primarily used as an documentation process as a site-based if remote medication consultation can interdepartmental instant messaging system pharmacist to document the medication feasibly be inserted into the current in addition to holding meetings with education and the patient’s response to the bedside prescription delivery process while screen sharing capabilities; however it also “tele-consult.” maintaining patient satisfaction. provides a video conferencing feature that Aurora Health Care utilizes several is widely under-utilized. It is available on different forms of teleconferencing Methods almost all pharmacy department computers technology, including: Skylight® iCareChat, (both inpatient and outpatient) making This pilot was submitted to Aurora PolycomTM, Cisco®, and Microsoft® LyncTM. this an appealing platform. Equipment Health Care’s Institutional Review Board (IRB) and was determined to be exempt Each platform was characterized by cost, costs were also low, as only a computerfrom further oversight. Workflows were video and sound quality, past history of on-wheels loaded with the Microsoft first designed to fit in seamlessly with the use, staff familiarity, and ease of use. Lync® software and a camera were required standing discharge prescription model A one-week pilot was conducted in for the outpatient pharmacy technician. (Figure 1.). All Pharmacists are triggered coordination with the outpatient pharmacy This allowed the technician to remain electronically when a patient’s discharge technicians. The remote consultation mobile from patient room to patient orders are entered by the physician into service was provided Monday through room. Equipment required for the remote the electronic health record. Once the Friday from 0700-1630. Tip sheets were pharmacist consisted of a desktop or laptop computer loaded with the Microsoft Lync® triggered electronic message was received, disseminated to pharmacy technicians the remote pharmacist entered the FIGURE 2. Characterizing Teleconferencing Technologies Available within Aurora Health Care discharging patient’s profile and conducted a brief profile review to obtain relevant Video Quality Cost Equipment Other Comments information to best tailor his/her consult. Skylight® Poor $$ Webcams mounted in Unsuccessful 2011 pilot iCareChat each patient room on acute patient care floor Site-based pharmacists conducted all discharge medication reconciliations, Excellent $$$ Specialty Camera Prior successful use PolycomTM with medication history resolving discrepancies with providers. pharmacy technicians An electronic marker was then placed ® Excellent $$$ Specialty Camera Prior successful use with Cisco on the patient’s profile by the site-based remote dispensing site pharmacist as an indication to all pharmacy pharmacists staff that the discharge medication Good $ Laptop on wheels, web High staff familiarity with Microsoft® reconciliation was complete. The remote LyncTM cam software Adding Teleconsults to the Current Work Flow
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FIGURE 3. Survey Responses
Was the picture clear? Were you able to see the pharmacist well? Answered: 14
Skipped: 0
Yes
Somewhat
No
0%
10%
20%
30%
40%
50%
60%
70%
Answer Choices
Responses
80%
90%
100%
Yes
85.71%
12
Somewhat
14.29%
2
No
0.00%
0
Total
14
Was the sound quality acceptable? Answered: 14
Skipped: 0
Yes
Somewhat
No
within 24 hours upon admission to the hospital. At the time of discharge, patients were excluded from the service for a number of reasons: eight patients opted out of the program at discharge by foregoing the service and leaving the hospital prior to filling their prescriptions; four patients no longer qualified for the service as there were no new medications prescribed at the time of discharge; three patients’ discharges were expedited, leading to miscommunication with the pharmacy technician and requiring the site based pharmacist to provide medication consultation instead; two patients had late discharges and received their prescriptions after remote pharmacist hours; and one patient was discharged to another level of care where the patient would not be responsible for administering his/her own medications (i.e. long term acute care facility, nursing home, inpatient rehabilitation, etc.). Zero to six consultations were completed each day, averaging 7.4 minutes in length. Patients responded positively to the sound and video quality of the teleconferencing technology, 86% and 79% respectively, felt the quality was acceptable (Figure 3.). All 14 patients felt comfortable speaking with a pharmacist with the teleconferencing technology. The majority of patients (n=10) had no preference between speaking with a pharmacist in person or via teleconference. Three out of 14 patients felt more comfortable speaking with a pharmacist via teleconference and only 1 patient felt more comfortable speaking with a pharmacist in person.
Discussion 0%
10%
20%
30%
40%
Answer Choices
50%
60%
70%
80%
90%
100%
Responses
Yes
78.57%
11
Somewhat
21.43%
3
No
0.00%
0
Total
software and an inexpensive webcam. Given the limited amount of barriers with this form of teleconferencing technology, Microsoft Lync® was chosen to best suit ASLMC’s needs (Figure 2.). At the conclusion of the one-week pilot, a total of 14 patients received discharge 68 The Journal January/February 2015
14
consultation from the remote pharmacist. A total of 64 patients were discharged from the pilot acute care floor over the course of the week. 50% of discharging patients (n = 32) on the floor took part in the bedside delivery program. Patients were enrolled into the program on a voluntary basis,
America’s seniors have historically been late adopters to the world of technology compared to their younger counterparts;4 however it is interesting to note a shift in technology use among older adults over time. In April 2012, the Pew Research Center found for the first time that more than half of older adults (defined as those ages 65 or older) were internet users. Given the reaction of patients to this pilot, the idea of utilizing telemedicine was found anecdotally to be more convenient among patients. Quotes like “very convenient, especially since patients leaving the hospital are not feeling well” and “this is great, I talk online with my family all of the time,” were just a few of several statements made
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Did you feel comfortable speaking with a pharmacist via tele-consult?
by patients throughout the course of the pilot. Perhaps the concept of telemedicine is not as novel in comparison to the current technological climate. Limitations to the pilot include its small sample size. With the limited amount of opportunity to provide medication consultation remotely to patients, it cannot be assumed that the majority of hospital patients will feel comfortable utilizing technology versus a face-to-face consultation with a pharmacist. Gaps in staff communication and patient expectations of delivery time were among the main causes of missed consultation opportunities. Further study is needed to understand the true impact of remote discharge consultation as a large scale, stand alone service.
Answered: 14
Yes
No
0%
10%
Conclusion
Overall, patients reacted overwhelmingly positive to pharmacists providing medication consultation via video teleconference technology. Microsoft® LyncTM meets Aurora St. Luke’s Medical Center’s needs in providing quality picture and sound to perform medication consultation to patients. Future efforts will include expanding the program to more units within Aurora St. Luke’s Medical Center, exploring collaboration opportunities with dispensing sites and remote consultation pharmacists, as well as exploring the potential for after-hours consultations at different sites within the Aurora Health Care system.●
Disclosure: Nothing to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation
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20%
30%
40%
50%
60%
70%
80%
90%
100%
Answer Choices
Responses
Yes
100.00%
14
No
0.00%
0
Total
14
Would you prefer one method of communication with a pharmacist over another? Answered: 14
Skipped: 0
I prefer to speak to a pharmacist in person I prefer to speak to a pharmacist via teleconsult
No preference
Jessica Zahn, PharmD is a PGY2 Health System Pharmacy Administration Resident at Aurora Health Care, Milwaukee, WI. Allan Loeb, RPh, MS is a Senior Director of Pharmacy Operations at Aurora Health Care, Milwaukee, WI. Acknowledgements: Abtract and poster for this manuscript were presented at the Pharmacy Society of Wisconsin’s Educational Conference, April 2014 in Madison, WI; abstract and summary presentation of this work were presented at the Great Lakes Pharmacy Residency Conference, April 2014 at Purdue University in West Lafayette, IN All sources of funding, including technological equipment, were provided by Aurora Health Care
Skipped: 0
0%
10%
20%
30%
40%
50%
60%
Answer Choices
70%
80%
90%
100%
Responses
I prefer to speak to a pharmacist in person
7.14%
1
I prefer to speak to a pharmacist via teleconsult
21.43%
3
No preference
71.43%
10
Total
References 1. Telehealth services. 42 CFR 410.78. Available at: http://cfr.vlex.com/vid/410-78-telehealthservices-19805820 (accessed 2014 June 15). 2. American Telemedicine Association. What is telemedicine? Available at: www.americantelemed.org/ learn/what-is-telemedicine (accessed 2014 June 15). 3. American Society of Health-System Pharmacists
14
(ASHP). Draft ASHP statement on telepharmacy. Available at: http://www.ashp.org/DocLibrary/ BestPractices/DraftDocs/DraftStatementTelepharmacy. aspx (accessed 2014 June 15). 4. Smith A. Older adults and technology use. Available at: http://www.pewinternet. org/2014/04/03/older-adults-and-technologyuse/ (accessed 2014 June 15).
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originalcontributions
Opportunities for Advancing the Role of the Community Pharmacist by Katie Gaertner, 2015 PharmD Candidate, Katherine Seidler, 2015 PharmD Candidate, and Bradley Schermetzler, PharmD, BCACP
N
early one out of every two American adults suffers from at least one chronic disease requiring the daily use of a prescription medication.1 It is estimated that managing and treating chronic conditions accounts for 75% of the health care costs in this country. As the number of Americans living with a chronic condition continues to climb, the urgency of working with patients to manage these disease states becomes more apparent: • Uncontrolled hypertension was found in 69 percent of patients having their first heart attack, 77 percent of patients having their first stroke, and 74 percent of patients with heart failure. Hypertension is listed as the main cause of death on 15 percent of death certificates in the United States.2 • Almost 90 percent of patients with chronic obstructive pulmonary disease (COPD) struggle daily with debilitating symptoms of COPD such as coughing, shortness of breath or nighttime awakening due to breathing problems. Among COPD patients over the age of 45, almost half of them will make an unscheduled visit to their doctor’s office or emergency department in a year.3 • Non-adherence to medications or suggested lifestyle modifications was the main contributing factor in 33 percent of almost one million hospitalizations annually in patients 65 years and older with heart failure2,4,5 • In 2013, 23.7 percent of patients with type 2 diabetes in Wisconsin had a hemoglobin A1c of greater than 9 percent, far surpassing the national average of 16.3 percent of patients.6 Diabetes is also the primary cause in
70 The Journal January/February 2015
44 percent of all new cases of kidney failure, with over 225,000 people requiring chronic dialysis or a kidney transplant as a result of diabetes.7 Hypertension, COPD, heart failure, and diabetes are just a few of the multitude of chronic diseases that Americans are living with daily. As the data show, the consequences of not effectively managing these disease states can lead to patients dealing with daily symptoms of their disease, increased risk of hospitalization, and even death. Encouraging adherence to medications, recommending changes in drug therapy according to clinical guidelines and supporting patients with initiating lifestyle changes are but a few steps pharmacists can take to help their patients better manage these chronic diseases.
A Shortage of Primary Care Providers Patients living with a chronic condition require necessary follow-up to ensure the effectiveness and safety of a prescribed medication regimen. Despite the overwhelming number of Americans living with a chronic disease, recent trends indicate there is a shortage of primary care providers positioned to provide the necessary care. It is estimated that 56 million Americans do not have access to a primary care physician due to provider shortages. This problem is likely to continue, as the proportion of medical students in the United States entering into primary care has declined by 50 percent since 1997.8,9 In Wisconsin alone, an additional 942 primary care physicians will be required by 2030 in order to maintain current access levels.10 To balance the shortage of primary
care physicians, other healthcare professions have seen an increase in the number of graduates entering into a primary care setting. Nationwide, approximately 52 percent of graduating nurse practitioners and 43 percent of physician assistants entered into a primary care setting in 2010.11 As the makeup of a primary care practice continues to evolve and access to care remains an issue, community pharmacists continue to be the most accessible health care professionals available to patients. In order to meet the needs of patients managing complex chronic diseases, pharmacists are able to build interdisciplinary relationships to help make appropriate therapeutic recommendations.12
The Role of the Community Pharmacist As medication experts, pharmacists are trained to know the disease states, correct indications for medications, possible adverse events and monitoring parameters of medication therapies. Community pharmacists who practice without access to electronic health records should not view this as a hindrance to providing therapy assessments to their patients and providers. Pharmacists and their staff members can make many subjective observations of their patients when they visit the pharmacy. These can include: yellowing skin as a sign of jaundice, worsening bruises as a sign of a possible bleeding risk, or a shorter gait when walking to the counter as a risk factor for a fall. Community pharmacists can then utilize the subjective data, as well as available objective data, to make recommendations to other healthcare providers. One study determined that patients who received medication therapy management (MTM) services from a pharmacist were three times less likely to be admitted to the hospital compared to those who did not receive the services.13 Additionally, community pharmacists can help determine efficacy and safety of medications in collaboration with other healthcare professionals. In a review of over 600 recommendations made by pharmacists to other healthcare providers,
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92 percent of the recommendations were accepted, ultimately improving the safety of medication regimens in 90 percent of the recommendations.14 The role of the community pharmacist is rapidly progressing to include more patient focused services. While providing MTM services remains one of the key methods for community pharmacists to positively impact their patientsâ&#x20AC;&#x2122; health; new opportunities to have an even greater impact on patient care are on the horizon. Community pharmacists are taking on a larger role in providing care to patients through the use of collaborative practice agreements (CPA) and working as part of team based care models.
Collaborative Practice and Team Based Care Wisconsin has already taken a step toward provider status for pharmacists when Governor Scott Walker signed Wisconsin Act 294 into legislation in April 2014. Wisconsin Act 294 allows licensed pharmacists to perform patient care services delegated to them by a licensed physician. www.pswi.org
The Wisconsin Medical Society backs this legislation noting that both the medical and pharmacy profession have a mutual goal to provide the best patient care. Collaborative practice agreements have been established and are in use throughout the state even prior to the enactment of Wisconsin Act 294. A CPA allows pharmacists to enter a contract with a physician to provide specific services outlined in the agreement. Examples include implementing or modifying drug therapy of individual patients or groups of patients with chronic disease states such as diabetes, asthma, or hypertension, and ordering and evaluating the results of laboratory tests directly relating to drug therapy. Perhaps the most common CPA seen in a community pharmacy is one allowing for the administration of immunizations. With the continued shortage of primary care providers, community pharmacists will need to take on a more prominent role with regards to patient care through participation in a team based care model. One study found the average amount of time spent discussing a new prescription
with a patient by the provider was 49 seconds.15 The pharmacist on the other hand has much more time to ensure the patient receives the necessary information about their new therapy in order to manage their disease state. Many studies have shown the inclusion of a pharmacist to the health care team improves patient outcomes. A pharmacistâ&#x20AC;&#x2122;s expertise in reconciling medication, disease state management and monitoring, and transition and coordination of care is complementary to the skill set of other primary care clinic team members.16 One study looking at patients with chronic disease states estimated that 50 percent of pharmacists' recommendations were accepted by the physician.16 Another study of more than 4,800 patients who received medication therapy management over a ten-year period resulted in a 55 percent improvement in chronic disease management, and provided an estimated $86 in cost savings per encounter.16 Pharmacists play a critical role on the healthcare team. Current problems faced include reimbursement for services that are provided by the pharmacist. Federal January/February 2015
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provider status would allow pharmacist provided services to be reimbursed through Medicare Part B.
On the Horizon: Federal Provider Status Federal legislation, H.R. 4190 is now in the United States House of Representatives. This is a significant advancement for the profession of pharmacy. Avoidable adverse events from inappropriate medication use cost $290 billion per year.17 Non-adherence resulting in hospitalization costs $100 billion per year.18 The Joint Commission of Pharmacy Practitioners stated: “Patients achieve optimal health and medication outcomes with pharmacists as essential and accountable providers within patientcentered, team-based healthcare”.19 Medicare beneficiaries will be able to access patient care services under Medicare Part B by amending section 1861(s)(2) of the Social Security Act. These services would be reimbursable under Medicare Part B if they are provided in medically underserved communities and consistent with the scope of practice in the state. Wisconsin has 54 counties (75%) classified by the Health Resources and Services Administration as medically underserved areas.20 The goal of H.R. 4190 is to provide services to areas that already have limited access to care. As the shortage of primary care providers increases, the access to care will continue to decrease. Pharmacists have received the proper training to provide services to patients that they may otherwise be unable to receive. The proposed legistation aims to help provide costeffective services in an effort to minimize long-term healthcare costs.
Conclusion
Chronic diseases account for the majority of patient health care visits. When left untreated, these diseases can lead to many complications and early death. The primary care model is utilized to manage chronic diseases in the United States, where a worsening shortage of primary care providers is projected. Studies have demonstrated positive outcomes with pharmacist inclusion in disease state monitoring through medication 72 The Journal January/February 2015
therapy management and collaborative practice agreements. Through Act 294, Wisconsin has taken an important step toward recognizing the pharmacist role and advancing the pharmacy profession. The next step for the pharmacy profession is gaining support for H.R. 4190, which would grant provider status to pharmacists at the Federal level and allow for reimbursement for services through Medicare Part B.● Katie Gaertner is a 4th year Doctor of Pharmacy Candidate at the University of Wisconsin School of Pharmacy. Katherine Seidler is a 4th year Doctor of Pharmacy Candidate at the University of Wisconsin School of Pharmacy. Bradley Schermetzler, PharmD, BCACP is the Pharmacy Clinical Coordinator at Aurora Pharmacy, Inc. in Milwaukee, WI.
References
1. Prevention and Health Promotion. Centers for Disease Control and Prevention National Center for Chronic Disease Website. Available at: http://www.cdc.gov/chronicdisease/ index.htm. Accessed October 2014. 2. Go AS, Mozaffarian D, Roger VL, et al.; on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013; 127:e6-e245. 3. Confronting COPD in America: Executive Summary. American Lung Association Website. Available at: http://www.lung.org/assets/documents/ EXESUM.pdf. Accessed October 2014. 4. Annema C, Luttik ML, Jaarsma T. Reasons for readmission in heart failure: perspectives of patients, caregivers, cardiologists, and heart failure nurses. Heart Lung. 2009;38(5):427-434. 5. Ambardekar AV, Fonarow GC, Hernandez AF, Pan W, Yancy CW, Krantz MJ. Characteristics and in-hospital outcomes for nonadherent patients with heart failure: findings from the Get With The Guidelines-Heart Failure (GW TG-HF). Am Heart J. 2009;158(4):644-652. 6. Managed Care Digest Series: Diabetes Portal. Sanofi-aventis US. Available at: https://www.managedcaredigest.com/DB2/ default.aspx. Accessed October 2014. 7. Statistics About Diabetes, Data from the National Diabetes Statistics Report 2014. American Diabetes Association Website. Available at: http:// www.diabetes.org/diabetes-basics/statistics/. Updated September 2014. Accessed October 2014. 8. Access transformed: Building a Primary Care Workforce for the 21st Century. National Association of Community Health Centers, Robert Graham Center, The George Washington University School of Public Health and Health Services. Available at: http://www.nachc.com/ research-data.cfm. Accessed October 2014.
9. Pho K. Shortage of primary care threatens health care system. USA Today. March 13, 2008. 10. Wisconsin: Projecting Primary Care Physician Workforce. Robert Graham Center Website. Available at: http://www.grahamcenter.org/online/. Accessed October 2014. 11. The Number of Nurse Practitioners and Physician Assistants Practicing in Primary Care in the United States. Agency for Healthcare Research and Quality Website. Available at: http://www. ahrq.gov/research/findings/factsheets/primary/ pcwork2/index.html. Accessed October 2014. 12. Partnering with Pharmacists in the Prevention and Control of Chronic Diseases. Centers for Disease Control and Prevention National Center for Chronic Disease Website. Available at: http:// www.cdc.gov/dhdsp/. Accessed October 2014. 13. Szczerba R. Meet The Newest Member of Your Personal Healthcare Team. June 5, 2014. Forbes. http://www.forbes.com/ sites/robertszczerba/2014/06/05/meet-thenewest-member-of-your-personal-healthcareteam/. Accessed October 2014. 14. Lee AJ, Boro MS, Knapp KK, Meier JL, Korman NE. Clinical and economic outcomes of pharmacist recommendations in a Veterans Affairs medical center. Am J Health Syst Pharm. 2002;59(21):2070-2077. 15. Tarn DM, Paterniti DA, Kravitz RL, et al. How much time does it take to prescribe a new medication?. Patient Educ Couns. 2008;72(2):311-319. 16. Smith M, Bates DW, Bodenheimer TS. Pharmacists belong in accountable care organizations and integrated care teams. Health Aff (Millwood). 2013;32(11):1963-1970. 17. Network for Excellence in Health Innovation. Thinking outside the pillbox: A System-wide approach to improving patient medication adherence for chronic disease. 2009. Available at: http://www.nehi.net/publications/17-thinkingoutside-the-pillbox-a-system-wide-approach-toimproving-patient-medication-adherence-forchronic-disease/view. Accessed October 2014. 18. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487–497. 19. Joint Commission of Pharmacy Practitioners. Vision Statement. Available at: https://www.accp.com/docs/positions/misc/ JCPPVisionStatement.pdf. Accessed October 2014. 20. U.S. Department of Health and Human Services: Health Resources and Service Administration (HRSA). Available at: http:// muafind.hrsa.gov/. Accessed October 2014.
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