march april 2015

PalmettoThe Official Journal of the South Carolina Pharmacy Association • Vol. 53, Num. 5

Palmetto Pharmacist • Volume 55, Number 2 1

South Carolina Pharmacy Association

2015 Annual Convention

June 11-14, 2015 Hilton Head Island, SC

Also inside: Legislative Updates

Member Spotlight Journal CE

Convention Registration and more!

You’re The One That We Want!

PharmacistThe Official Journal of the South Carolina Pharmacy Association • Vol. 55, Num. 2

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2 Palmetto Pharmacist • Volume 55 Number 2

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Palmetto PharmacistVolume 55, Issue 2 March/April 2015The Palmetto Pharmacist, the official publication of the South Carolina Pharmacy Association, is distributed to association members as a membership service. Statements of fact and opinion are made by the authors alone and do no imply an opinion on the part of the officers or members of SCPhA. For advertising rates and other information, contact SCPhA.

What’s Inside...

5 Advocacy for Pharmacy SCPhA President Patti Fabel discusses opportunities for advocacy for pharmacy

7 Member Profile: Brandi Johnson A look at one of SCPhA’s members

9 Legislative Look Out Pieces of legislation that SCPhA is keeping an eye on

Regular Columns 14 Presbyterian College School of Pharmacy 17 South Carolina College of Pharmacy 22 Journal CE 31 Classifieds

Advertisers 2 Smith 4 Pharmacists Mutual 15 Display Options 16 Generation Rx 18 Mutual Drug 20 PACE 31 Jon Wallace, Attorney at Law 32 QS/1

Events At-A-Glance

March 21: Tech Connection Session 1

March 27: APhA Diabetes CTPMarch 28: Cordially Yours at APhA’s

Annual MeetingApril 10: APhA Immunization CTP

April 17: APhA MTM CTPMay 9: Tech Connection Session 2May 21: All Pharmacy ConferenceJune 11-14: Annual Convention


2014-2015 Board of Directors

President/Board Chair Patti Fabel

Immediate Past PresidentSteve McElmurray

President-Elect William Wynn

Treasurer

Pamela Whitmire

Director-At-Large Michael Gleaton

Midlands Region Director

Bryan Amick

Low Country Region Director Kristy Brittain

Pee Dee Region Director

Jarrod Tippins

Upstate Region Director Ed Vess

Speaker, House of Delegates Sarah Braga

Speaker-Elect, House of Delegates

Kayce Shealy

CEO Craig Burridge

General Counsel

Jon Wallace

Midlands DelegatesLynn ConnellyBetsy BlakeBrian ClarkCraig HarmonMegan Montgomery

Low Country DelegatesJeff BrittainWayne WeartDon Neuroth

Pee Dee DelegatesJim ShulerKelly JonesDan Bushardt

Upstate DelegatesWalter HughesDavid BanksSteve GreeneLinda Reid

SCPhA StaffCraig Burridge Chief Executive Officer Cassandra-Hicks Brown Director of Operations/CELaura Reid Director of EventsLauren Palkowski Director of CommunicationsKatharine Stafford Membership CoordinatorJon Wallace General Counsel Cecily DiPiro PPN Network CoordinatorJennifer Simmons Palmetto Pharmacist Layout

4 Palmetto Pharmacist • Volume 55 Number 2 *Compensated endorsement.

Not licensed to sell all products in all states.

Learn more about Pharmacists Mutual’s solutions for you – contact your local field representative or call 800.247.5930:

www.phmic.com

Our commitment to quality means you can rest easy.

PO Box 370 • Algona Iowa 50511

Endorsed* by:

Pharmacists Mutual has been committed to the pharmacy profession for over a century. Since 1909, we’ve been insuring pharmacies and giving back to the profession through sponsorships and scholarships.

Rated A (Excellent) by A.M. Best, Pharmacists Mutual is a trusted, knowledgeable company that understands your insurance needs. Our coverage is designed by pharmacists for pharmacists. So you can rest assured you have the most complete protection for your business, personal and professional insurance needs.

Sandra LaubenthalSales Associate

800.247.5930 ext. 7249515.395.7249

The Merriam-Webster Dictionary defines advo-cacy as “the act or process of supporting a cause or proposal.” I like this definition because it includes, what I believe, are the two essential components to advocacy. First, advocacy is an act. It requires action. It is not passive. One cannot advocate for something by doing nothing. Second, advocacy is support. It requires supporting something. It is positive. It means you want to see that very something succeed. I bring this up because advocacy is what this associa-tion does. It advocates for its members and the pro-fession of pharmacy. We act on your behalf because we want you to succeed. There are numerous ways the association advocates for you and the profession, but I want to highlight two of them in this issue: legislation and events.

SCPhA’s legislative efforts are a primary component of our advocacy. We monitor legislation introduced at the state and national level. This helps us to know if something potentially unfavorable to pharmacy is submitted. We testify at hearings held at the State House to ensure pharmacy’s interests are heard and taken seriously. We also draft and file legislation to help ensure the success of our profession. Most recently, we have submitted an Immunization Scope Expansion bill. The leadership at SCPhA held several meetings with stakeholders and this bill is the result of those efforts. If Senate Bill 413 passes, it will do four important things for the profession:

1. Resurrect an interprofessional committee that will decide what vaccines pharmacists can administer without a prescription. This com-mittee is required to submit their initial recom-mendation within 4 months of passing and they are required to meet at least once a year. There will be no need for further legislation when new vaccines come to the market!

2. Allow pharmacists to administer the influ-enza vaccines to patients as young as 12 years of age.

3. Allow student pharmacists to administer vaccines provided they are currently certified and directly supervised by a certified pharmacist.

4. Allow pharmacists to administer any vac-

PRESIDENT’S PLATFORM

cine to any patient, regardless of age, pursuant to a prescription. This is clearly stated in the bill and will re-move any potential for confusion that results from differ-ent interpretations of current statute.

We have also been working on a MAC Fair Pricing bill, which at the time of writing this letter, is very close to being filed. SCPhA’s events are another essential component of our advocacy efforts. Events, such as our Annual Convention, give us the opportunity to meet with you in person and hear what matters most to you. We cannot support you if we don’t know what you need. We enjoy hearing from you throughout the year, but when we get to talk to you face-to-face it, strength-ens our relationship with you. Sometimes, a good old fashioned handshake and smile does more to build a relationship than communicating through technology. Attending our events gives us this opportunity, which is why we continue to offer live events instead of only offering CE through webinars.

Our Annual Convention, specifically, is a great op-portunity to meet and interact with the SCPhA leadership. You can attend the House of Delegates to provide input on the direction of the association. You can network with colleagues and learn about new opportunities to grow your business. You can also get some great CE credit! I love all of the events SCPhA puts on, but the Annual Convention is my favorite because it’s the only one of our events where the entire Board of Directors attends. It’s a great opportunity for the members and Board to interact in person. This year it will be held from June 11th through the 14th in Hilton Head. I hope you will attend – I’m looking forward to shaking your hand and talking to you in person!


PRESIDENT’S PLATFORM

Advocacy for Pharmacy

*Compensated endorsement.Not licensed to sell all products in all states.

Learn more about Pharmacists Mutual’s solutions for you – contact your local field representative or call 800.247.5930:

www.phmic.com

Our commitment to quality means you can rest easy.

PO Box 370 • Algona Iowa 50511

Endorsed* by:

Pharmacists Mutual has been committed to the pharmacy profession for over a century. Since 1909, we’ve been insuring pharmacies and giving back to the profession through sponsorships and scholarships.

Rated A (Excellent) by A.M. Best, Pharmacists Mutual is a trusted, knowledgeable company that understands your insurance needs. Our coverage is designed by pharmacists for pharmacists. So you can rest assured you have the most complete protection for your business, personal and professional insurance needs.

Sandra LaubenthalSales Associate

800.247.5930 ext. 7249515.395.7249


A BIG thank you to SCPhA Members for your generous contributions! The following members have signed up for our NEW membership levels that come with some great benefits!

Visionary Level $1,200

John Pugh Matthew Broome

Leader Level $600

Jessica Puckett-Beasley Zoom Heaton

Friend Level $300

William Lee Betsy Blake

Deborah Tapley Roberta Vining

Bryan Amick Janet Thames

Jason Li Patti Fabel

Trish Mauney

Besides preferred mem-ber pricing at events, legislative advocacy, networking opportuni-ties, bi-monthly journals and weekly e-newsletter,

here’s what else you get: - Preferred/reserved seating at events - Name listed in Palmetto Pharmacist - Custom Tervis Tumbler upon signing up - Level designation nametag ribbon at all major events - SCPhA bucks (To be used towards CE Escape, Spa Weekend or Convention)

Questions? Contact SCPhA at 803.354.9977 or email at [email protected].

Send payment to: SCPhA • 1350 Browning Road • Columbia, SC 29210 or fax to 803.354.9207

or pay online at www.scrx.org

“We make a living by what we get, but we make a life by what we give.” - Winston Churchill

Peer-to-Peer Challenge There is no substitute for peer-to-peer recruitment. If every member of SCPhA recruited just one person

to become a member, not only would our membership double, but our voice would grow exponentially.

Many pharmacists are not members simply because they have not been asked by someone that they know. For each new member who you refer that joins SCPhA,

your name will be placed in a drawing for $1,000!

We’ll have a drawing at next year’s Annual Convention.

Help us grow our membership…and our voice!

THE CH

ALLEN

GE


What do you see as the greatest benefit of being a member of the South Carolina Pharmacy Associa-tion? The ability to stay current and connected with fellow pharmacists in the state.

Where did you go to pharmacy school? University of South Carolina

What was it like to transition into the professional world after pharmacy school?Pharmacy school absolutely lays a great founda-tion and provides you the knowledge necessary to perform your job. What continues to come to mind as I gain practice experience is that this is truly the “practice of pharmacy.” As a pharmacist, I feel like I am constantly growing and developing as I have successes, make mistakes, and gain knowledge and experience working with real people and real clini-cians. The comfort level and “groove” you develop over time is hard-earned. It seems so cut and dry in school, but I have quickly learned to take each day as it comes, learn as you go, and attempt to do it bet-ter tomorrow. Every day is an opportunity to learn something new, regardless of the number of years it has been since you graduated.

What made you decide to become a pharmacist? Growing up and working in the family business allowed me financial freedom in my high school years, but after my first semester at Carolina, I had an epiphany while working over Christmas break. I

Member Spotlight: Brandi Johnson, PharmD

had that first “pharmacist moment,” where you are slammed but you are helping people and making a difference, and it almost feels like you could work that way nonstop, existing on a jar of peanut butter alone! That was the moment I knew pharmacy was for me!

Tell us about your community. Aiken is a great place to call home and a great place to plant roots. I am proud to say that not only did I graduate from the high school all of my parents attended, but I also graduated from the same Col-lege of Pharmacy as my dad. Aiken has many faces, names, and local businesses that make a huge impact and leave a legacy because of its small town atmo-sphere. I am honored that our pharmacy is part of that community, and has been for nearly 30 years. We have been blessed to serve the residents of Aiken for this many years, and will continue to give back to our community through exceptional service, care, and investing our resources here locally.

What are some successes that you have experienced recently in your personal life? My greatest success so far is my beautiful 4-year-old daughter, Alexandria, however I am proud to say that as of January 2015 I officially became “marathon” runner and will also see my husband sworn in by the South Carolina Bar Association in Spring of 2015.

Brandi Johnson, PharmD, is a pharmacist at the Family Pharmacy in Aiken, SC. Brandi has been a member of SCPhA since 2005 and frequents many SCPhA events, including the Southeastern Girls of Pharmacy Leadership Weekend.

MEMBERS


*

TechnicianConnection

is back!When:Session 1: March 21, 2015 7:30 am-8 am: Check In/Breakfast 8 am-12 pm: CE

Session 2: May 9, 2015 7:30 am-8 am: Check In/Breakfast 8 am-12 pm: CE

*You may attend BOTH sessions. 4 hours of CE will be offered for each session. Each will have a different ACPE UAN to allow for attendance at both sessions.

Where:South Carolina Pharmacy Association 1350 Browning Rd., Columbia, SC 29210

Cost:SCPhA Members: $60 per session Non-Members: $90 per session REGISTER ONLINE AT WWW.SCRX.ORG or return this form, with payment, to SCPhA,1350 Browning Rd., Columbia, SC 29210or fax to 803.354.9207.

Cancellations will only be accepted if received more than 5 business days before the event. If applicable, a refund will be issued less a $15 processing fee per session.

The South Carolina Pharmacy Associationis accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Continuing education credits will be avail-able to participants who fully attend the program and then complete an online educational activity evaluation. A unique code given at each activity must be provided in the evaluation to receive credit. Grievances regarding the education program must be submitted in writing to the SCPhA ACPE Adminis-trator immediately following the program.

Registration Information:

_______________________________________________ Name _______________________________________________ Email _______________________________________________ Phone _______________________________________________ Address _______________________________________________ City/State/Zip _______________________________________________ NABP eID# Birthdate (MM/DD)

Select Session(s): □ Session 1 (March 21) □ Session 2 (May 9)

□ Session 1 and 2 (March 21 and May 9)

Payment Information: Amount Enclosed: $___________ Payment Type: □ Check; Check #_____________ Credit Card Type: □ MC □ Visa □ AMEX □ Discover

_______________________________________________ Name on Card _______________________________________________ Card # _______________________________________________ Exp. Date CVV Code _______________________________________________ Billing Address _______________________________________________ Billing Address City/State/Zip


The Pharmacy and Medically Underserved Areas Enhancement Act (S. 314) was introduced by Sens. Charles Grassley (R-IA), Sherrod Brown (D-OH), Mark Kirk (R-IL) and Bob Casey (D-PA) on Thursday, January 29th. Senate Bill 314, and it's companion bill - H.R. 592, will provide access to pharmacist provided patient care services to Medicare beneficiaries in medically underserved communities. These bills are the key priorities for the Patient Access to Pharmacists' Care Coalition (PAPCC), which the South Carolina Pharmacy Association participates in through the National Alliance of State Pharmacy Associations.

In addition, the federal provider status legislation, entitled The Pharmacy and Medically Underserved Areas En-hancement Act, was introduced in both the House of Representatives and the Senate. The House bill, H.R. 592, was introduced by Reps. Brett Guthrie (R-KY), G.K. Butterfield (D-NC), Todd Young (R-IN), and Ron Kind (D-WI). The Senate bill, S. 314, was introduced by Sens. Charles Grassley (R-IA), Sherrod Brown (D-OH), Mark Kirk (R-IL) and Bob Casey (D-PA). Similar to 2014's, H.R. 4190, the provisions will provide access to pharma-cist provided patient care services to Medicare beneficiaries in medically underserved communities. These bills are the key priorities for the Patient Access to Pharmacists' Care Coalition (PAPCC), which SCPhA participates in through the National Alliance of State Pharmacy Associations.

For updates and breaking news, check out SCPhA’s social media and Small Doses.

LegislativeLOOK OUT

LEGISLATION

10 Palmetto Pharmacist • Volume 55 Number 2 Jan. 16-18, 2015 * Omni Grove Park Inn * Asheville, NC

Thank you to all who attended the SE Girls of Pharmacy Leadership Weekend!

15 states represented.

1 great weekend!

3 days.


The Apprenticeship Carolina program is a statewide initiative that is affiliated with the SC Technical School system. The intent is to increase the skills of the states work force through apprenticeship style learning. Pharmacy Technicians are an included em-ployment category, but there may be other positions at your pharmacy that qualify. The Apprenticeship Carolina representative will meet with you to set up a structured training program for your employees. Employees can then begin complet-ing the training to learn their jobs and enhance their skills. In other words, the employees are completing the training that you probably already have them do-ing anyway....or training that you would like them to complete in the near future. The apprenticeship pro-gram provides a structured environment to complete this training program. The training can be on-the-job learning or educational opportunities (CE) depending on the needs. There is a minimum number of hours per year that must be completed per employee in order to take advantage of the tax credit. There is up to $1,000 tax credit per year per eligible employee available through this program. The credit per employee could potentially be utilized for up to 4 years depending on the nature of their job and the length of the apprenticeship training schedule. It is estimated that a typical pharmacy technician may need 1-2 years, but if there are techs that are continuing to expand their skills in specialty areas, then this could expand the opportunity. There is NO LIMIT to the number of employees that can be enrolled (as long as their job qualifies for the program). As long as the program continues to receive funding from the state legislature, then the tax credits will continue. Of inter-est.....CVS is the #1 user of this program in the state right now. They have ~1,500 employees enrolled each year.....at $1,000 tax credit each. That's $1,500,000 in tax credits PER YEAR for CVS. WHAT TYPES OF TRAINING QUALIFIES FOR THE TAX PROGRAM? This may vary from site to site depending on the train-ing program that fits the skills needed at your phar-macy. Some examples include pharmacy technician certification program, KPIC Sterile Compounding

Training CE programs, certain CE training courses, on the job training, etc. These are just a few ideas that may count, but there could be various options to consider based on the skills needed for the particu-lar jobs at hand. Apprenticeship Carolina reps will work with you to determine the best options. HOW DO I SIGN UP AND GET STARTED? All you need to do is contact the local representa-tive to set up an appointment. The program has multiple reps that are assigned certain counties for the state. A list of contacts can be found at http://www.apprenticeshipcarolina.com/contact.html. The Apprenticeship Carolina team will then walk you through everything from there. They will even have the one-page tax form and provide you instruction on completing it. WHAT IF I'M A NON-PROFIT ORGANIZA-TION, CAN I STILL USE THE PROGRAM? Yes! Non-profit organizations and government entities don't qualify for the tax credits, but can benefit from setting up a structured training program through an apprenticeship program. WHAT DOES IT COST? Nothing but time. These services provided by Ap-prenticeship Carolina are FREE.

For more information:Bryan Ziegler, PharmD, MBAExecutive Director, Kennedy Pharmacy Innovation CenterClinical Assistant ProfessorSouth Carolina College of PharmacyUniversity of South Carolina Campus715 Sumter StreetCoker Life Science Building, Room 416Columbia, SC 29208803.777.4659 (phone)http://kennedycenter.sc.edu

Apprenticeship Carolina Program to Provide Opportunity for Pharmacy Technicians

TECHNICIANS


Registration Types

VIP Registration includes: • Access to all CE programming (includes CE credit) • Daily Breakfast • (1) ticket to the Welcome Reception • (1) ticket to the PC, South, MUSC or USC Alumni Luncheon • (1) ticket to the SCPhA Sockhop (includes dinner) • (1) ticket to the Exhibit Hall (includes lunch) • (1) ticket to the Awards Dinner • Event T-Shirt General Registration includes: • Access to all CE programming (includes CE credit) • Daily Breakfast • (1) ticket to the Welcome Reception • (1) ticket to the SCPhA Sockhop (includes dinner) • (1) ticket to the Exhibit Hall (includes lunch) • Event T-Shirt Student Registration includes: • Access to all CE programming (does not include CE credit) • Student specific events, including student trivia night • Daily Breakfast • (1) ticket to the Welcome Reception • (1) ticket to the SCPhA Sockhop (includes dinner) • (1) ticket to the Exhibit Hall (includes lunch) • (1) ticket to the Awards Dinner • Event T-Shirt Guest/Associate Registration includes: • Access to all CE programming (does not include CE credit) • Daily Breakfast • (1) ticket to the Welcome Reception • (1) ticket to the SCPhA Sockhop (includes dinner) • (1) ticket to the Exhibit Hall (includes lunch) • (1) ticket to the Awards Dinner (optional) • Event T-Shirt Daily/Multi-Day Registration includes: • Access to CE programming for the day(s) you attend (includes CE credit) • Breakfast for the day(s) you attend • Thursday registrants receive (1) ticket to the Welcome Reception • Friday registrants receive (1) ticket to the SCPhA Sockhop (includes dinner) • Saturday registrants receive (1) ticket to Exhibit Hall (includes lunch)

Hotel Information

Sonesta Resort 130 Shipyard Dr.,

Hilton Head Island, SC 29928

SCPhA’s group rate of $209 per

night will be available until May 11 or until rooms sell out,

whichever comes first.

Reserve your room today by calling

843.842.2400!

Optional Activities • Sunrise Service • Sunrise Service Choir • Trivia (students only) • Phun Run • Golf Tee Times

Student scholarships are available!

Apply today at www.scrx.org.


Registration Information ____________________________________________________________ Name Nickname ____________________________________________________________ Email Phone ____________________________________________________________ Mailing Address ____________________________________________________________ Mailing Address City, State, Zip ____________________________________________________________ NABP eID Birthdate (MM/DD)

Designation □ RPh □ PharmD □ CPhT □ Tech □ Student □ Other

Do you need any dietary, learning or accessibility accommodations?

____________________________________________________________

Payment Information Amount Due $__________ □ Check; Check #_________ □ Credit Card; Card Type (circle one) MC Visa AMEX Disc

____________________________________________________________ Name on Card ____________________________________________________________ Card # ____________________________________________________________ Exp. Date CVV ____________________________________________________________ Billing Address ____________________________________________________________ Billing Address City, State, Zip

Register online at www.scrx.org or complete this form and return, with payment, to SCPhA via mail (1350 Browning Road, Columbia, SC 29210) or fax

(803.354.9207). Questions? Call SCPhA at 803.354.9977.

The South Carolina Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Continuing education credits will be available to participants who fully attend the pro-gram and then complete an online educational activity evaluation. A unique code given at each activity must be provided in the evaluation to receive credit. Grievances regarding the education program must be submitted in writing to the SCPhA ACPE Administrator immediately following the program.

Cancellation Policy: cancellations will only be accepted if received more than 5 business days before the event. If applicable, a refund will be issued less a $25 processing fee. Please note that the threat of inclement weather Is not considered sufficient to override our cancellation policy.

NON-MEMBER REGISTRATION Early Bird Regular Registration Registration Before May 1 After May 1 VIP Package □ $400 □ $460 General registration plus an awards dinner ticket & alumni lunch ticket.

Awards Dinner ○ Beef ○ Chicken ○ Veggie Alumni Lunch ○ PC ○ South ○ MUSC ○ USC Shirt Size (S-XXL)__________

General Registration □ $300 □ $360

Shirt Size (S-XXL)__________

Multi-Day Registration

Thursday & Friday Only □ $220 □ $260 Friday & Saturday Only □ $250 □ $290 Saturday & Sunday Only □ $130 □ $270

Single Day Registration Thursday Only □ $100 □ $120 Friday Only □ $140 □ $160 Saturday Only □ $130 □ $150 Sunday Only □ $120 □ $140

ADDITIONAL OPTIONS Add A Guest □ $250 Includes t-shirt & awards dinner ticket. Does not include alumni lunch or CE.

Guest Name ___________________________________ (first & last) Awards Dinner ○ Beef ○ Chicken ○ Veggie Shirt Size (S-XXL)__________

Alumni Lunch TicketsUSC/SCCP-USC □ $50 Qty. _____

MUSC/SCCP-MUSC □ $50 Qty. _____ South University □ $50 Qty. _____ Presbyterian College □ $50 Qty. _____ Sockhop Tickets Adult □ $50 Qty. _____ Child □ $20 Qty. _____Awards Dinner Tickets

Adult, Beef □ $80 Qty. _____ Adult, Chicken □ $80 Qty. _____ Adult, Veggie □ $80 Qty. _____ Child □ $30 Qty. _____

Student SponsorshipsFull Sponsorship □ $250

Partial Sponsorship □ $100 Other Amount □ $_________

Add a T-Shirt □ $20 Size (S-XXL)__________ OPTIONAL ACTIVITIES

Please check all you plan to attend. □ Welcome Reception □ Sunrise Service □ Sunrise Service Choir □ Trivia (students only) □ Phun Run □ Golf Tee Times

MEMBER REGISTRATION Early Bird Regular Registration Registration Before May 1 After May 1 VIP Package □ $350 □ $400 General registration plus an awards dinner ticket & alumni lunch ticket.

Awards Dinner ○ Beef ○ Chicken ○ Veggie Alumni Lunch ○ PC ○ South ○ MUSC ○ USC Shirt Size (S-XXL)__________

General Registration □ $230 □ $280

Shirt Size (S-XXL)__________

Multi-Day Registration

Thursday & Friday Only □ $180 □ $210 Friday & Saturday Only □ $210 □ $240 Saturday & Sunday Only □ $190 □ $220

Single Day Registration Thursday Only □ $80 □ $100 Friday Only □ $120 □ $140 Saturday Only □ $110 □ $130 Sunday Only □ $100 □ $120

Student Registration □ $99 Includes t-shirt & awards dinner ticket. Does not include alumni lunch or CE.

Awards Dinner ○ Beef ○ Chicken ○ Veggie Shirt Size (S-XXL)__________

Guest/Associate Registration □ $250Includes t-shirt & awards dinner ticket. Does not include alumni lunch or CE.

Awards Dinner ○ Beef ○ Chicken ○ Veggie Shirt Size (S-XXL)__________


PCSP

Promotions:Dr. Jennifer Clements has been serving as Interim Chair of the Pharmacy Practice Department since May 2014. “She has done an outstanding job manag-ing the department,” stated Dr. Cliff Fuhrman, “and I also believe the members of the department have been extremely supportive of Dr. Clements during her transition into this new position.” Effective Janu-ary 1, 2015, Dr. Clements was promoted to Chair of the Pharmacy Practice Department. She received her Doctor of Pharmacy degree from Campbell Univer-sity in 2006 and completed her PGY-1 Pharmacy Practice residency with an emphasis in primary care at the Ralph H. Johnson Veterans Affairs Medical Center in 2007. She served as an Assistant Profes-sor of Pharmacy Practice at Shenandoah University. During this time, she practiced at the Martinsburg Veterans Affairs Medical Center as a Clinical Phar-macy Specialist. Dr. Clements teaches a variety of courses in the Presbyterian College School of Phar-macy curriculum. Her research interests include clini-cal and economic outcomes in chronic disease state management among physicians and pharmacists, and innovative methods within pharmacy education among pharmacy residents and students. Currently, Dr. Clements serves as a Clinical Pharmacy Specialist at Laurens Family Medicine.

Accolades/Research: Representatives from 10 colleges and universities across the nation who hold National Institutes of Health Biomedical/Biobehavioral Research Admin-istration Development (BRAD) grants held their in-augural networking event at the Presbyterian College School of Pharmacy. Also joining the recipients was our BRAD grant program officer, Dr. Jean Flagg-Newton, the Assistant Director of Health Equity for the Eunice Kennedy Shriver National Institute of Child Health and Human Development. It is a rare event for a program officer to have a chance to visit a grantee on site and we were delighted to have Dr. Flagg-Newton and our college and university guests on our campus, all of which were very complimentary of our program and facilities.

Dr. Jack Fincham was named the College’s Research Integrity Officer for the Office of Grants and Spon-sored Programs.

Dr. Tiffany Thre-att was awarded a grant from National Health-care Corpora-tion (NHC) in the amount of $11,888.92 to enhance the training of fac-ulty practicing in Laurens County who have an in-terest or specialty in geriatrics; improve existing laboratory cours-es that focus on geriatrics, medication utilization and chronic disease management; and establish a geriatric elective course in the curriculum for 3rd year pharmacy students.

Dr. Alfonso Romero-Sandoval organized our In-augural Research Symposium. It was a wonderful program and extremely well attended. The presen-tations by the guest speakers, faculty and students were exceptional. The poster session highlighted the research that has been accomplished at PC.

Service:

Our ACCP Clinical Pharmacy Challenge team made it to the top 16 nationwide! Congratulations to our students: Jason Jones, Steven Robinette, and Caleb Wallace.

Our students also participated in a National Drug Take Back event in conjunction with the U.S. Drug Enforcement Administration and Clinton Public Safety Department. This one-day event provided Laurens County residents with a no-cost, anonymous collection of unwanted and expired medicines.

Rebecca Conley, Ro-Derick Middleton and Dylan Porter competed and won our local National Com-munity Pharmacists Association’s (NCPA) Com-pounding competition. This team will represent PC at the national competition held at the University of

Presbyterian College School of Pharmacy Update by Cliff Fuhrman, PhD, RPh, Dean


Florida.

Program Updates:Communications: We completed our Inau-gural Annual Report magazine, which was distributed to alumni, donors and Board of Trustee members in January 2015.

Center for Entrepreneurial Development (CED): The Center focuses on educational workshops and networking events. Students who complete 10 workshops earn a Certificate in Entrepreneurial Skills. Twelve students from the Class of 2015 are on target to earn their certificates. The topics for Spring 2015 include Building a Business Plan for Your Entrepreneurial Venture, Building Teams That Work and Developing a Strategy for Success for your Small Business.


SCCP

South Carolina College of Pharmacy Update

Last November, a pilot project started by the Kenne-dy Pharmacy Innovation Center (KPIC) concluded with some promising findings for pharmacists.

In 2013, KPIC launched a Comprehensive Medica-tion Management Collaborative (CMMC) with Pal-metto Primary Care Physicians (PPCP) and selected third party payers to test whether a new primary care physician-pharmacist patient-centered medical home (PCMH) model could improve quality of care, patient access and ultimately lower health care costs.The findings have a potential impact on millions -- nationally, non-adherence to medications is associ-ated with 125,000 deaths per year, 10 % of all hospi-tal admissions and an estimated $100 billion in direct and indirect health care costs.

After assessing the pilot program’s results, PPCP per-manently hired Medical University of South Carolina (MUSC) alumnus Paul Fleming, the pharmacist par-ticipating in the pilot. KPIC is now testing a second pilot in a primary care physician office in Lancaster, S.C. , where University of South Carolina (USC) alumna Kerri Brown Hatcher was recently hired as full-time pharmacist.

“We’re learning about how a primary care practice can best utilize the pharmacist, and which practices have a profile for contracting with or employing a pharmacist as a good business and patient care deci-sion,” said CMCC co-director Bob Davis, KPIC’s endowed chair at the South Carolina College of Pharmacy (SCCP).

The CMCC pilot program showed evidence of both improved healthcare outcomes and a sustainable business model.

Improved Healthcare OutcomesThere was a dramatic improvement in patients with previously uncontrolled conditions:

• Morethan79%ofhighcholesterolpatientsim-proved in their LDL-C measures • Morethan72%and81%ofhypertensivepa-tients improved their systolic (SBP) and diastolic (DBP) measures, respectively• Morethan77%ofdiabeticpatientsimprovedin

their A1c measures

Patients and physician staff were highly satisfied with the business model:

• Satisfactionsurveyresultsona5-pointLikertscaleshowed patients (4.9) and staff (5.0) overwhelmingly willing to recommend/refer patients to see the pharma-cist• 15%ofthepatientscommentedtheywouldchangebehavior based on his coaching

“We are looking outside the traditional primary care model to optimize clinical quality outcomes for our pa-tients – enhanced communication between the primary care provider, pharmacist and patient has the potential to lower medication non-adherence and minimize any confusion in a patient’s medication care plan thereby im-proving quality,” said collaborative co-director Brantley Arnau, president of PPCP.

Sustainable Business ModelThe CMMC effort was measured in provider produc-tivity, revenue, and cost avoidance - key components in determining the sustainability of the model.

Increased Productivity • Averagerevenueincreasedbymorethan15%with-out significant changes in the number of physician-pa-tient visits — fewer medication-problem patients created room for new patients and more complex cases

Pharmacist-related Revenue• Approximately75%ofthepharmacist’sexpenseswere covered when he was at 85 % patient visit capacity• Additionalvalueincludedhelpingtheteamcreatea foundation to close care gaps that could earn perfor-mance incentives, and contributing to staff education and productivity

Cost Avoidance (CA) benefitting the patient and the payer• ProjectedCAaveragedmorethan$700apatientvisitduring April, May and June of 2014.• CAiscalculatedbasedonprojectedfollowupcostsifno intervention had occurred• TheCMMCusedcommonindustrymeasuresforreporting financial impact of pharmacist’s clinical inter-

By Robert Hill, Director of Communications, SCCP


ventions (medication allergies prevented, medication rec-onciliations, changes of dose, counseling for self-care, lab evaluations and adverse effects identified and remedied).

“Essentially, the physicians in the collaborative are spending their time on managing complex diagnoses and treatments rather than filling their schedules with medication-related appointments and management,” said Davis. “With the addition of a pharmacist to the care team, physicians can practice at the ‘top of their license’ and better utilize their training, knowing they can rely on the pharmacist to manage medications and improve outcomes of select chronic diseases. That’s a great benefit to the patient, which is ultimately what this is about. Our objective was to improve quality outcomes and medica-tion adherence in an affordable way.”

The Kennedy Pharmacy Innovation Center (KPIC) is a focal point for interaction among forward-thinking pharmacists, future pharmacists and business thought leaders to cultivate innovation, drive entrepreneurial ac-tion, and conquer the challenges of a changing healthcare landscape. Created in 2010 with a $30 million donation from University of South Carolina alumni Bill and Lou Kennedy, KPIC is headquartered in the South Carolina College of Pharmacy at the University of South Carolina in Columbia.

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Objectives1. To review hepatitis C virus (HCV) pathophysiology and risk factors for patients at risk for HCV. 2. To discuss screening recommendations for patients at risk for HCV.3. To outline the historical timeline of drug therapy utilized in HCV treatment.4. To compare new drug therapy options for HCV and understand their use in practice

Objective: The purpose of this article is to update pharmacists on the new changes in treatment recom-mendations for hepatitis C. Pathophysiology will be reviewed as well as risk factors and screening recom-mendations for patients. Finally, treatment options will be discussed with a focus on the novel direct-acting antivirals now in the guidelines.

Summary: Hepatitis C is a chronic condition that leads to a large number of liver transplants every year. Recent advancements in treatment options have been introduced to the market and are changing the way we have historically treated hepatitis C patients. Pro-viders should be aware of these new guidelines and understand the utilization of such in this special patient population.

Keywords: hepatitis, HCV, direct-acting antivirals, sofosbuvir, simeprevir

Introduction Chronic hepatitis C virus affects more than 3.2 mil-lion Americans nationwide and has recently surpassed Human Immunodeficiency Virus (HIV) in number of deaths caused each year. End stage liver disease related to hepatitis C is responsible for over 30 % of liver transplants in the US and the recent increase in hepatocellular carcinoma.1 In the United States 849 new cases of HCV were reported in 2007. However, infection rates are likely much higher due largely to the fact that 80 % of people infected are asymptomatic. The Centers for Disease Control (CDC) predicted that in 2007 alone there were over 17,000 new cases of HCV not reported.2

Because of the increasing chronic hepatitis C patient

What’s New in Hepatitis C? ACPE UAN: 0171-9999-15-001-H01-P Marla D. Koch, PharmDPGY-1 Pharmacy Practice Resident, Greenville Health System, 701 Grove Road, Greenville, SC 29605

population in the US, newer agents are being studied in hopes to improve response rates and decrease the therapy burden on patients. The purpose of this article is to briefly review disease pathophysiology of hepatitis C, to discuss patient risk factors and HCV screening recom-mendations, to outline the historical context of older therapeutic agents, and to compare the newer antiviral agents and utilization of the current guidelines.

PathophysiologyHepatitis C virus is a single-stranded positive RNA virus, usually transmitted from exposure to blood or a blood product, which infects hepatocytes. Hepatocytes are responsible for protein synthesis as well as synthesis and secretion of lipids.3 Infection occurs when the viral RNA is taken into the cell via receptor-mediated endo-cytosis and begins replication. The replication cycle of HCV RNA starts with translation of the RNA into a polypeptide, which then undergoes cleavage into smaller non-structural proteins. RNA replication follows to form the negative RNA strand which all other positive RNA viral copies can be derived from. HCV then is passed to other hepatocytes via exportation through the low density lipoprotein (LDL) receptor, a mechanism similar to very low density lipoprotein exportation.4,5

There are at least six known HCV specific strains, or genotypes, with genotype 1 being the most common in the United States.2 Up to 80 % of infected people, re-gardless of genotype, progress to chronic infection which leads to serious complications down the road including ongoing liver inflammation, liver fibrosis, cirrhosis, and hepatocellular carcinoma.5 Damage caused to the liver is predominately from a local immune response resulting in lymphocyte infiltration, necrosis, and formation of le-sions. Other underlying conditions that may affect liver inflammation, such as HIV co-infection, alcohol abuse, diabetes, and obesity, can speed up this progression.4 Morbidity and mortality associated with HCV stem from fibrotic complications caused by the liver inflammation and destruction of cells. This destruction from HCV and associated complications are ultimately a leading cause of liver transplantation today.4,5

Risk Factors and ScreeningThere are several risk factors associated with chronic

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JOURNAL CEhepatitis C viral infection: a birthdate between 1945 and 1965, clotting factors prior to 1987, blood transfusion or solid organ transplant prior to 1992, intravenous drug abuse, HIV infection, incarceration, long-term dialysis, and children born to an HCV positive mother. Work exposure via accidental needle sticks is also a risk factor, although incidence of this is much lower.2

Patients usually present asymptomatic but few patients may present with non-specific symptoms of fever, fatigue, nausea, vomiting, abdominal pain, dark urine, joint pain, and potentially jaundice. An expected time-line of symptom development is 4 to 12 weeks post-exposure.2 Routine screening tests in specific patient populations are warranted because the diagnosis cannot be made on presentation alone. Patients with risk factors mentioned previously and those endorsing symptoms

should be screened by their practitioner. Screening for adults that meet at least one criterion should be done with an anti-HCV antibody test followed by polymerase chain reaction testing for viral load in the bloodstream.2 According to the US Preventative Services Task Force, these tests are proven to be ac-curate for detecting infection and provide moderate benefit overall.6

Timeline of HCV TherapyThe available antivirals for hepatitis C virus up to this point had only moderate benefit; however, with the newer direct-acting starting to come to market this picture has changed dramatically. The goal of sustained virologic response (SVR), commonly defined by undetectable HCV RNA or viral load at 12 weeks, is increasing with every new therapy ap-

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Table 1: Hepatitis C Medications by Pharmacologic Class22, 24-30

Generic Name (Brand)

Pharmacologic Class Approval Date {Centerwatch}

Dosing

Peginterferon alfa (Pegasys) (PegIntron)

Pegylated interferon October 2002 180 mcg subcutaneously once weekly

Ribavirin (Ribasphere) (Copegus) (Rebetol)

Nucleoside analog April 2004 Weight-based dose ranging from 800mg to 1400mg twice daily with food

Boceprevir (Victrelis)

NS3/4A protease inhibitor

April 2011 4 x 200 mg three times daily (every 7-9 hours) with food

Telaprevir (Incivek)


May 2011 3 x 375 mg twice daily (10-14 hours) with food containing > 20 g of fat

Simeprevir (Olysio)


November 2013 150 mg once daily with food

Asunaprevir* NS3/4A protease inhibitor

Submitted 100 mg twice daily

Sofosbuvir (Sovaldi)

NS5B polymerase inhibitor

December 2013 400 mg daily

Ledipasvir+ NS5A inhibitor October 2014 90 mg once daily Daclatasvir* NS5A inhibitor Submitted 60 mg once daily Ombitasvir* NS5A inhibitor Submitted 25 mg once daily Dasaburvir* NS5B polymerase

inhibitor Submitted 200 mg twice daily

*These agents are not currently approved by the FDA but have been submitted for approval. +Combination product with sofosbuvir

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Table 1: Hepatitis C Medications by Pharmacologic Class22, 24-30

Generic Name (Brand)

Pharmacologic Class Approval Date {Centerwatch}

Dosing

Peginterferon alfa (Pegasys) (PegIntron)

Pegylated interferon October 2002 180 mcg subcutaneously once weekly

Ribavirin (Ribasphere) (Copegus) (Rebetol)

Nucleoside analog April 2004 Weight-based dose ranging from 800mg to 1400mg twice daily with food

Boceprevir (Victrelis)


April 2011 4 x 200 mg three times daily (every 7-9 hours) with food

Telaprevir (Incivek)


May 2011 3 x 375 mg twice daily (10-14 hours) with food containing > 20 g of fat

Simeprevir (Olysio)


November 2013 150 mg once daily with food

Asunaprevir* NS3/4A protease inhibitor

Submitted 100 mg twice daily

Sofosbuvir (Sovaldi)

NS5B polymerase inhibitor

December 2013 400 mg daily

Ledipasvir+ NS5A inhibitor October 2014 90 mg once daily Daclatasvir* NS5A inhibitor Submitted 60 mg once daily Ombitasvir* NS5A inhibitor Submitted 25 mg once daily Dasaburvir* NS5B polymerase

inhibitor Submitted 200 mg twice daily

*These agents are not currently approved by the FDA but have been submitted for approval. +Combination product with sofosbuvir


JOURNAL CEproved by the FDA.4 Initial therapy for HCV started with the combination of peginterferon and ribavirin in 2003. While considered novel antiviral therapeutic agents at the time, these therapies came at a price to the patient.

Tolerability of peginterferon and ribavirin combina-tion was threatened with high rates of toxicity. Pa-tients experienced harsh flu-like symptoms, changes in cell lines, fatigue, depression, thyroid dysfunction, and autoimmunity.4, 7, 8 Treatment with this combina-tion regimen was only utilized in patients with geno-type 1 HCV and duration of therapy ranged from 24 to 48 weeks or longer with failure of therapy. Pegin-terferon and ribavirin therapies resulted in a sustained virologic response of around 50 %.7,9

In 2011, the first direct-acting antivirals (DAAs) came to market: telaprevir and boceprevir. Acting on the NS3/4A protease, these “first generation” prote-ase inhibitors added complex directions for use and additional side effects without largely increasing suc-cess rates. The protease inhibitors used in combina-tion with pegingerferon and ribavirin increased SVR to roughly 70 % and required a 48 week length of therapy on average.10,11 With the approval of the new-er DAA agents, simeprevir and sofosbuvir, patients experienced less adverse reactions and had increased SVR to upwards of 90 % when used in combination with peginterferon and ribavirin.12-15 Sofosbuvir has been studied in all oral regimens (regimens excluding peginterferon) as well and has shown very strong results. Several investigational agents in combination with sofosbuvir may further improve SVR while also utilizing a shorter duration of therapy of 12 weeks.16-18 Some trials have looked at these combination oral therapies for as little as eight weeks with some success.19 Because of all this, sofosbuvir has taken over as the primary therapy agent and the “first generations” protease inhibitors are no longer recommended in the guidelines.20

Novel Direct-Acting Antivirals

SimeprevirThe first of the newer generation direct-acting antivi-rals approved in November 2013, simeprevir inhibits the NS3/4A protease enzyme required to complete viral replication.21 Efficacy of simeprevir has been established for patients with genotype 1 HCV in combination with peginterferon alfa and ribavirin.

Treatment recommendations for HCV are based on the patients’ genotype.

The recommended daily dose of simeprevir is 150 mg once daily by mouth taken with food. Capsules are available in the 150 mg strength only and should be swallowed whole.21 Treatment with simeprevir should not be dose-reduced or interrupted due to risk of treatment failure and possible transmission of HCV. However, if patients experience adverse reac-tions and therapy is discontinued, simeprevir should not be restarted. Duration of therapy for regimens containing simeprevir is usually 12 week but depends on patient specific criteria.21

Currently, no dose adjustment is required in patients with mild, moderate, or severe renal dysfunction. Simeprevir has not been studied in patients with creatinine clearances below 30 mL/min, those with ESRD, or those on dialysis.21 Kinetic changes from dialysis are thought to be minimal due to the high protein binding affinity. Similarly, no dose reduction is necessary for mild hepatic impairment (Child-Pugh Class A). The package insert supplies no recommen-dation for dose adjustments in moderate or severe hepatic impairment; however, higher exposures have been seen in clinical trials in these patients which increases the risk of adverse reactions.21

Simeprevir is primarily metabolized by CYP3A4, thusly co-administration with substances that are po-tent inducers or inhibitors of CYP3A4 is not recom-mended.21 Cytochrome P450 enzymes are minimally affected by administration of simeprevir. CYP1A2 and CYP3A4 may be mildly affected while CY-P2C19, CYP2C9, and CYP2D6 remain unaffected. After administration, peak plasma concentrations of simeprevir are reached in four to six hours.22

The most common adverse reactions associated with simeprevir therapy (incidence of 10 % or greater) are rash, photosensitivity, itching, nausea, myalgia, and dyspnea.22 Laboratory abnormalities includ-ing increased serum bilirubin and increased alkaline phosphatase may be present while taking simepre-vir. There is a potential for allergic cross-reactivity to other sulfa containing drugs because simeprevir contains a sulfonamide moiety; however, in clinical trials, an increase in rash or adverse reactions was not observed in sulfa allergic patients.21

Simeprevir is only approved as a component of


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Table 2: Commonly Seen Drug Interactions22, 24-28 Drug Name Interactions* Peginterferon alfa Clozapine

Methadone Zidovudine Theophylline derivatives

Ribavirin Azathioprine Didanosine Zidovudine NRTIs Live influenza vaccine

Boceprevir Apixaban Aripiprazole Statins Carbamazepine Colchicine Oral contraceptives Corticosteroids Dabigatran Digoxin Fentanyl Benzodiazepines Phenobarbital Phenytoin Red rice yeast Rifampin Sildenafil Ticagrelor CYP 3A4 inducers CYP 3A4 inhibitors

Telaprevir Apixaban Aripiprazole Statins Carbamazepine Colchicine Oral contraceptives Corticosteroids Dabigatran Digoxin Fentanyl Benzodiazepines Phenobarbital Phenytoin Red rice yeast Rifampin


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19

Sildenafil Ticagrelor CYP 3A4 inducers CYP 3A4 inhibitors

Simeprevir Statins Colchicine Conivaptan Dabigatran Rivaroxaban Digoxin Midazolam Milk thistle Protease inhibitors St. John’s Wort Certain chemotherapy Ledipasvir

Sofosbuvir Modafinil Oxcarbazepine Rifabutin P-glycoprotein inducers P-glycoprotein inhibitors

Ledipasvir P-glycoprotein inducers P-glycoprotein inhibitors Antacids Proton Pump Inhibitors H2 blockers Simeprevir

* List is not exhaustive but includes commonly seen medications. Always check patient-specific drug interactions

combination therapy with peginterferon alfa and/or ribavirin and any contraindications for these drugs should also apply for simeprevir. Additionally, if a component must be discontinued for any reason, simeprevir should be discontinued.20,21 Simeprevir is classified as pregnancy class X, but this is likely due to the pregnancy categories of the other drugs used in combination. Pregnancy tests should be performed prior to initiation of and monthly while on simeprevir therapy, and two forms of non-hormonal contracep-tion should be used during therapy and continued up to six months after completion of therapy.22

SofosbuvirIn December 2013, the FDA approved sofosbuvir (Sovaldi®), a novel direct-acting antiviral agent indi-cated for treatment of chronic hepatitis C in combina-tion with an antiviral treatment regimen consisting of ribavirin and/or peginterferon. Recent guidelines from the American Association of the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) released in 2014 recom-

mend sofosbuvir as a component of first-line antiviral therapy.20 Efficacy of sofosbuvir has been established for patients with genotypes 1, 2, 3, and 4, those with hepatocellular carcinoma awaiting liver transplant, and those co-infected with HIV.

Sofosbuvir, a prodrug, inhibits RNA synthesis once metabolized, by acting as a nucleotide analogue inhibiting the HCV NS5B RNA-dependent RNA polymerase required for viral replication.23 The rec-ommended daily dose of sofosbuvir is 400 mg once daily by mouth taken without regard to food. Tablets are available in the 400 mg strength only and should be dispensed in their original container.23 Dosing of sofosbuvir should also not be reduced or interrupted due to risk of treatment failure and possible transmis-sion of HCV. Treatment regimens and durations of therapy are dependent on patient factors (e.g. geno-type, need for hepatic transplant, HCV/HIV co-infec-tion). A summary of the first-line therapeutic agents for treatment naïve HCV patients is provided in Table 3.20 Additional recommendations for specific patient


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response is available in the full AASLD/IDSA 2014 guidelines but is beyond the scope of this article. The manufacturer’s labeling does not provide de-tailed recommendations regarding dose adjustment, but it is important to note that the predominant active metabolite, GS-331007, accumulates up to 20-fold in renal impairment. No dose reduction is necessary in patients with mild to moderate renal impairment (eGFR > 30mL/min/1.73m2), however, no recom-mendation is currently available in the package insert for patients with severe renal impairment (eGFR < 30mL/min/1.73m2).24 With regards to hepatic impair-ment, no dose adjustment is necessary for any stage of impairment (Child-Pugh Class A, B, or C), yet, safety and efficacy of sofosbuvir have not been stud-ied in patients with decompensated cirrhosis.24

Due to the fact that sofosbuvir is a prodrug, admin-istration in patients with decompensated cirrhosis theoretically can result in unpredictable and unfavor-able kinetic profiles. Co-administration of sofosbuvir with substances that are potent inducers or inhibitors of P-glycoprotein (P-gp) is not recommended, as this may decrease or increase sofosbuvir plasma con-centration respectively. After administration, peak plasma concentrations of sofosbuvir are reached in 0.5 to 2 hours. 24

The most common adverse reactions associated with sofosbuvir combination therapy (incidence of 5 % or greater) are fatigue, headache, insomnia, itching, anemia, rash, decreased appetite, diarrhea, myalgia, and irritability. Rare, but serious, side effects have

20

Table 3: AASLD/IDSA 2014 Recommendations for Treatment Naïve Patients20 Genotype First-Line Recommendation Duration of Therapy Genotype 1 Interferon eligible Interferon ineligible

SOF + PEG + RBV SOF + SMV + RBV

12 weeks 12 weeks

Genotype 2 SOF + RBV 12 weeks


Genotype 4 Interferon eligible Interferon ineligible

SOF + PEG + RBV SOF + RBV

12 weeks 24 weeks

Genotype 5 SOF + PEG + RBV 12 weeks


occurred, including pancytopenia and severe depres-sion with suicidal ideation.23 Laboratory values may be affected during therapy with sofosbuvir, includ-ing changes in hemoglobin, neutrophils, platelets, bilirubin, creatinine, and lipase. Changes in bilirubin usually occur in the first few weeks of treatment and resolve up to four weeks after completion of therapy. Laboratory values should be assessed at baseline and periodically throughout treatment.24 HCV RNA levels should be monitored at baseline, throughout treat-ment, after completion of treatment, or as clinically indicated.

Sofosbuvir is classified as pregnancy B, but therapy is still contraindicated during pregnancy because of the required combination of drugs and their associ-ated pregnancy classes. Precautions in pregnancy with regards to testing should be followed similar to simeprevir.24

Ledipasvir/SofosbuvirIn October 2014, the FDA approved the first combi-nation tablet containing ledipasvir 90mg and sofosbu-vir 400mg (Harvoni®). This recent approval is a one tablet once daily treatment regimen for genotype 1 HCV. Duration of therapy for patients receiving ledi-pasvir/sofosbuvir ranges from 12 weeks to 24 weeks depending on prior therapy.31 Clinicians should refer to the AASLD guidelines for updates regarding this new agent’s place in therapy.

Ledipasvir/sofosbuvir package insert information fol-lows similar recommendations to those with sofos- 20

Table 3: AASLD/IDSA 2014 Recommendations for Treatment Naïve Patients20 Genotype First-Line Recommendation Duration of Therapy Genotype 1 Interferon eligible Interferon ineligible

SOF + PEG + RBV SOF + SMV + RBV

12 weeks 12 weeks



Genotype 4 Interferon eligible Interferon ineligible

SOF + PEG + RBV SOF + RBV

12 weeks 24 weeks




buvir alone. Unique drug interactions exist for the ledipasvir component. Proton pump inhibitors and H2 blockers may decrease serum concentrations of ledipasvir due to increases in gastric pH. Addition-ally, simeprevir should not be administered with le-dipasvir because the interactions results in increased concentrations of both agents.31

Patient and Provider ResourcesHepatitis C virus is a difficult to treat disease state and should be referred to infectious disease special-ists; however, it is imperative to keep up with ap-propriate knowledge on how to deal with uncommon HCV medications and screening recommendations for these patients so that they may be treated effec-tively. The American Association for the Study of Liver Diseases and Infectious Diseases Society of America 2014 guidelines titled “Recommendations for Testing, Managing, and Treating Hepatitis C” can be found online through both organizations’ web-sites. This document is updated real-time to include recommendations for newly approved drugs.20 The National AIDS Treatment Advocacy Project website (www.natap.org) is a helpful resource for providers to find patient assistance programs as well as up to date articles and information from conferences held around the country.

Patients may find information on their disease state from a number of unreliable sources and it is impor-tant for providers to be able to point their patients in the direction of accurate and easy to understand information. The HCV Advocate (www.hcvadvocate.org) provides fact sheets, news updates, and library resources for patients to better understand the disease state. Project Inform is an additional resource for patients that has information online and provides a monthly mailing publication for patients and provid-ers. Available HCV resources are valuable in helping providers stay up to date on new information and study results coming out as well as provide patients with information on assistance programs and advo-cacy organizations.

ConclusionSimeprevir, sofosbuvir, and ledipasvir are just a few examples of what’s to come in future hepatitis C treatment. Many additional agents have been submit-ted to the FDA and oral combination products are be-ing studied. Improvement in response rates and ease of oral administration may make these agents much more main stream, pending cost constraints. Phar-

macists should be knowledgeable about this disease state and associated medications to better provide care understanding to their patients.

Acknowledgement The author would like to thank Julie Ann Justo, PharmD, BCPS, AAHIVP; Assistant Professor at the South Carolina College of Pharmacy; for her subject matter expertise and review of content within this article.

References1. Chou R, Cottrell EB, Wasson N, Rahman B, Guise JM. Screening for Hepatitis C Virus Infection in Adults. Comparative Effectiveness Review No. 69. AHRQ Publication No. 12-EHC090-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2012. Accessed on July 15, 20113 at http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=12832. Centers for Disease Control and Prevention “Hepa-titis C, FAQs for HealthProfessionals” Accessed on April 18, 2014 at http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm#section1 3. Bowen, R. Hepatic Histology: Hepatocytes. Ac-cessed July 15, 2014 at http://www.vivo.colostate.edu/hbooks/pathphys/digestion/liver/histo_hcytes.html4. Feeney ER, Chung RT. Antiviral treatment of hepatitis C. BMJ 2014; 349:g3308.5. Pawlotsky, J. Pathophysiology of hepatitis C virus infection and related liver disease. Trends in Microbi-ology 2004; 12:96 -102.6. U.S. Preventive Services Task Force. Screen-ing for Hepatitis C Virus Infection in Adults: Final Recommendation Statement. AHRQ Publication No. 12-05174-EF-2.Accessed on July 15, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm7. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepa-titis C: a randomized trial. Lancet 2001;358:958-65.8. Mangia A, Santoro R, Minerva N, Ricci GL, Caretta V, Perscio M, et al. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med2005;352:2609-17.9. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, et al. Peginterferon alfa-

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2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med2009;361:580-93.10. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, et al. Tela-previr for previously untreated chronic hepatitis C virus infection. N Engl J Med2011;364:2405-16.11. Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med2011;364:1195-206.12. Jacobson IM, Dore GJ, Foster GR. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve patients: efficacy in difficult-to-treat patient sub-populations in the QUEST 1 and 2 phase III trials. Abstract 1122. 64th Annual Meeting of the American Association for the Study of Liver Dis-eases, 1-5 November 2013, Washington, DC.13. Zeuzem S, Berg T, Gane E, Ferenci P, Foster GR, Fried MW, et al. Simeprevir increases rate of sustained virologic response among treatment-expe-rienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroeneterology2014;146:430-41.14. Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavi-rin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a ran-domized, double-blind, phase 2 trial. Lancet Infect Dis2013;13:401-8.15. Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treat-ment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomized, multicentre phase 2 trial. Lancet2013;381:2100-7.16. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med2013;368:1878-87.17. Jacobson IM, Ghalib R, Rodriguez-Torres M, Younossi Z, Corregidor A, Sulkowski MS, et al. SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in cirrhotic and non-cirrhot-ic HCV genotype 1 treatment-naïve and prior null responder patients: the COSMOS study. Abstract LB-3. 64th Annual Meeting of the American Asso-ciation for the Study of Liver Diseases. Washington, DC, 1-5 November 2013. 18. Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir and sofosbuvir for

untreated HCV genotype 1 infection. N Engl J Med2014;370:1889-9.19. Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LON-ESTAR): an open-label, randomized, phase 2 trial. Lancet2014;383:515-23.20. American Association for the Study of Liver Dis-eases. Recommendations for Testing, Managing, and Treating Hepatitis C. (2014) Accessed on April 18, 2014 at http://www.hcvguidelines.org/sites/default/files/full_report.pdf21. Simeprevir [package insert]. Titusville, NJ: Jans-sen Therapeutics; November 2013.22. Simeprevir. Lexi-Comp Online, Hudson, Ohio: Lexi-Comp, Inc.; Updated July 21, 2014.23. Sovaldi [package insert]. Foster City, CA: Gilead Sciences; December 2013.24. Sofosbuvir. Lexi-Comp Online, Hudson, Ohio: Lexi-Comp, Inc.; Updated July 21, 2014.25. Peginterferon Alfa-2a. Lexi-Comp Online, Hud-son, Ohio: Lexi-Comp, Inc.; Updated July 17, 2014.26. Ribavirin. Lexi-Comp Online, Hudson, Ohio: Lexi-Comp, Inc.; Updated July 24, 2014.27. Boceprevir. Lexi-Comp Online, Hudson, Ohio: Lexi-Comp, Inc.; Updated July 21, 2014.28. Telaprevir. Lexi-Comp Online, Hudson, Ohio: Lexi-Comp, Inc., Updated July 22, 2014.29. FDA Approved Drugs. Centerwatch. Accessed July 15, 2014 at http://www.centerwatch.com/drug-information/fda-approved-drugs/30. Reynolds, A. Dawn of a New. Second Annual Hepatitis C Drug Guide in Positively Aware, July-Aug 2014, p26-52. 31. Harvoni [package insert]. Foster City, CA: Gilead Sciences; October 2014

JOURNAL CE


Self-assessment questions:

1. Which of the following risk factors should be screened for HCV at least once in their lifetime? A. Born in 1975 B. Diagnosis of HIV C. Healthcare workerD. Blood transfusion 2 years ago

2. Once a patient meets appropriate screening requirements, which of the following testing methods should be used? A. ELISA testingB. Blood culture for HCV virusC. Anti-HCV antibody test D. polymerase chain reaction testingE. C and D

3. Which of the following are side effects to monitor for sofos-buvir?

A. Euphoria B. Increase in serum creatinineC. PancytopeniaD. Lower seizure threshold

4. What would be an appropriate duration of therapy for a patient with genotype 1 HCV using sofosbuvir, peginter-feron, and ribavirin?

A. 24 weeksB. 48 weeksC. 8 weeksD. 12 weeks

5. The novel oral anticoagulants interact with all of the following HCV antivirals except which one?

A. SofosbuvirB. SimeprevirC. BoceprevirD. Telaprevir

6. Which of the following is an explanation for why bo-ceprevir and telaprevir are no longer first-line recommen-dations in the 2014 guidelines?

A. They were found to be inactive toward the HCV VirusB. The increased side effects and difficult instructions for useC. These medications have been removed from the marketD. They are more expensive than newer agents

JOURNAL CEWhat’s New in Hepatitis C? Correspondence Course Program Number: ACPE# 0171-9999-15-001-H01-P

also complete the test and submit payment online at www.scrx.org.2. Mail to: Palmetto Pharmacist CE, 1350 Browning Road, Columbia, SC 29210-6309.3. Continuing Education statements of credit will be issued within 6 weeks from the date the quiz, evaluation form and payment are received.4. Participants scoring 70% or greater and completing the program evaluation form will be issued CE credit. Participants receiving a failing grade onany examination will have the examination returned. The participant will be permitted to retake the examination one time at no extra charge.

South Carolina Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as providers for continuing phar-macy education. This article is approved for 1 contact hour of continuing pharmacy education credit (ACPE# 0171-9999-15-001-H01-P)

and es .

Name________________________________________________License #______________Birth Month/Day (MM/DD)____________

Address_______________________________________________________________________________________________________

NABP eID_____________Phone____________________________Email__________________________________________________

EVALUATION (circle the appropriate response)

1. Did the article achieve the stated objectives? (Not at all) 1 2 3 4 5 (Completely)

2. Overall evaluation of the article? (Poor) 1 2 3 4 5 (Excellent)

3. Was the information relevant to your practice? (No) 1 2 3 4 5 (Yes)

4. How long did it take you to read the article and complete the exam? ______________ .

01/21/2015 01/21/2018

GAMECOCK/USC MERCHANDISEOfficial collegiate licensed merchandise for sale. T-shirts, car flags, tailgate gear. All de-signed by a SC Pharmacist. Please email Daniel Bundrick at [email protected] or call/text 803.603.8622. Original designs, unique, edgy new designs too. Also look for our two mobile stores, our huge vans that go to events and football games. Check us out online at www.carolinagamecocktees.com STORE FIXTURES/PLANNING

Planning to expand, remodel or open a new pharmacy? Since 1973 Display Options, Inc. has provided professional store planning, In-stallation, quality store fixtures and customer service to Pharmacies across the Southeast. Please allow us the opportunity to assist you with your plans & dreams. Call us toll free at (800)321-4344 or visit our web site at www.displayoptions.com.

TRANSFORMING THE SOUL OF PHARMACY, BY MINISTERING TO THE

HEARTS OF PHARMACISTSChristian Pharmacists Fellowship International, a nonprofit organization, is a worldwide fellow-ship of individuals working in all areas of phar-maceutical services and practices. For member-ship information, call (888) 253-6885 or visit our website at www.cpfi.org.

FOR SALENEED HELP WITH MEDICATION

THERAPY MANAGEMENT?Contact: Bryan Ziegler, PharmD, MBA, Pharmacy Service Consulting, LLC Phone: (803) 269-6333 Email: [email protected] Provided: MTM education, Identifi-cation of MTM Opportunities, Staff Training, Workflow Analysis, Business Analysis

PHARMACY OPERATIONS CONSULTANTPharmacists interested in changing you existing design and operation of your pharmacy - let the best in the business help you make those changes. Contact: Paul J. Hyer, Jr., RPh, PD at 843-814-2542 or write to 301 S. Magnolia St. Summerville, SC 29483.

PHARMACIST SEEKING EMPLOYMENTSouth Carolina Licensed Pharmacist would like to work in an independent pharmacy, prefer small-town setting. Tim McKittrick 704-585-6690

FOR SALE: MORTAR AND PESTLESSet of 8 Schering Pharmaceutical Corporation commemorative bronzed-like metal mortar and pestles, dated from the late 1960s and 1970s. They have been on display in our independent pharmacy in Florence, SC for over 40 years. We know those who are familiar with these will appreciate them and want them for their collections. They are all about 4 inches tall by 4 inches wide. They are in good condition. Call 843-992-0981 with offer, plus $30 ship-ping. Nights and weekends call 843-669-7439 or email [email protected]

RELIEF RPh

Services

RELIEF PHARMACIST AVAILABLEExperienced (retail, clinic, consulting, nursing home)pharmacist available on PRN or regular basis. Will travel. Competitive Rate. M-F, oc-casional Sat. JOHN W. OWEN, [email protected], (H)803-783-2979 (C)803-466-4783

ETC.

FOR SALE: OWENS ILLINOIS PROMOTIONAL CHINA

Owens Illinois Promotional China, glass ware and “silver” cutlery. About 85 assorted pieces. Please e-mail me at [email protected] if you are interested. I can send you a list if you wish. Ralph Wilkie, 843-884-5751

CLASSIFIEDS

BEACH HOME FOR SALE OR RENTPawley’s Island Beachhome - 5 Bedroom and 5 Baths. Beautiful view on the creek with eleveator. For sale or rent. Checkout [email protected].

FOR SALE: ROBOTFor sale: Innovation PharmASSIST Robot X automated dispensing system. Any inquiries should be directed to Kenneth Mungin, Phar-macy Manager at (803) 731-0203 Ext 126 or at [email protected].


BOOKS FOR SALEChristian Book Available at Amazon, Barnes and Noble, and etc. It is Called Choices ( The secret to Making Wise Choices) by Carolyn Gault wife of pharmacist Horace Gault Jr. The book is about our moments in history as we face choices that are confusing, in out rapidly changing culture. The proceeds will go to Mission to the World to help missionaries and their families.

OXYGEN EQUIPMENT18-Portable oxygen cylinders, 1 devilbiss oxygen conservator, 1-5 liter concentrator invacare, 7-oxygen regulators,1-Salter labs ul-trsonic oxygen indicator. Call 864-843-9207, liberty family pharmacy $400

♦ South Carolina Board of Pharmacy/licensing matters

♦ Corporate legal counsel specific to pharmacies including purchase and sale

♦ OBRA-90 and South Carolina patient counseling requirements

♦ HIPAA and related privacy issues

♦ Third Party issues including pharmacy benefit managers

♦ Medicaid audits

♦ DHEC and DEA/controlled substances

♦ Risk management

♦ Pharmacy Technicians

♦ Federal compliance

Jon A. Wallace, B.S.Pharm., J.D.

602 Rutledge Avenue ♦ Charleston, SC 29403 ♦ (843) 266-2626 ♦ [email protected]

715 King Street, Charleston, SC 29403 • Direct Dial (843) 266-2625 • [email protected]


“With QS/1, you just don’t have to worry about being ready for the next regulatory change. We’ve watched competitors close because they couldn’t keep up with changes in the business, but that just doesn’t happen with QS/1. That confidence and the built-in flexibility of the system enables us to serve our customers how we want. There’s a product for every aspect of our business. PrimeCare allows us to handle both retail and long-term care, Point-of-Sale handles the front end, and SystemOne manages the details of HME.”Learn how QS/1’s flexibility can help you serve your customers the way you want. Call 866.929.9067 or visit www.qs1.com today.

“They enable us to service our customers the way we want.”

– Camille DeVille Boyken, RPh

©2015, J M SMITH CORPORATION. QS/1, PrimeCare and SystemOne are registered trademarks of the J M Smith Corporation.

866.929.9067 www.qs1.com

march april 2015

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