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Palmetto Pharmacist The Official Journal of the South Carolina Pharmacy Association • Vol. 53, Num. 5

Palmetto Pharmacist • Volume 53, Number 5

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W h o d o y o u t r u s t t o Palmetto s u p p ly Pharmacist your pha r m a c y53? Number 5 2 • Volume


Volume 53, Number 3

June/July 2013

The Palmetto Pharmacist, the official publication of the

Volume Issue 5 Pharmacy Association, November/December 2013 South53, Carolina is distributed to The Palmetto Pharmacist, official publication of the Volume 53, Number June/July association members3 as athe membership service.2013

South Association, is publication distributed to TheCarolina Palmetto Pharmacist, theare official of the Statements of Pharmacy fact and opinion made by the authors association members as aanmembership Southand Carolina Association, distributed alone do no Pharmacy imply opinion on service. theispart of the to Statements fact and of opinion are For made by the authors association members as a membership service. officers orofmembers SCPhA. advertising rates alone and no implyand ancontact opinionSCPhA. on the part Statements of fact opinion are made byofthetheauthors and otherdoinformation, officers members of SCPhA. For advertising aloneor and do no imply an opinion on the part rates of the andofficers other information, SCPhA. or members contact of SCPhA. For advertising rates and other information, contact SCPhA. Board of Directors President/Chairman of the Board Board of Directors Steve McElmurray, RPh President/Chairman of the Board Immediate Past President Steve McElmurray, John Pugh, PharmD, RPh Immediate Past President President-Elect JohnAmick, Pugh, PharmD, Bryan PharmD,RPh RPh President-Elect Treasurer BryanWhitmire, Amick, PharmD, Pamela PharmD,RPh RPh Treasurer Low Country Region Pamela Whitmire, PharmD, RPh Kristy Brittain, PharmD, RPh Low Region PeeCountry Dee Region KristyTippins, Brittain,PharmD, PharmD,RPh RPh Jarrod Pee Dee Region Midlands Jarrod Tippins, PharmD, RPh Patti Fabel, PharmD, RPh Midlands Region Upstate Region Patti Fabel, PharmD, RPh Ed Vess, PharmD, RPh UpstateDirector Region At-Large Ed Vess, PharmD, RPh William Wynn, PharmD, RPh At-Large Speaker, HouseDirector of Delegates WilliamGleaton, Wynn, PharmD, Michael PharmD, RPh RPh Speaker, House of of Delegates Speaker-Elect, House Delegates Michael Gleaton, PharmD, RPh Sarah Braga, PharmD, RPh Speaker-Elect,CEO House of Delegates Sarah Burridge, Braga, PharmD, RPh Craig MS, CAE General Counsel CEO Jon Wallace, BS Pharm, JD Craig Burridge, MS, CAE REGION DELEGATES

Low Country Region Midlands Region Don Neuroth, RPh Craig Harmon, RPh DELEGATES David Proujan, RPh REGION Sarah Braga, PharmD, RPh LowTill, Country Midlands Region Tray RPh Region Lynn Connelly, RPh Don Neuroth, RPh Craig Brittain, Harmon,PharmD, RPh Wayne Weart, PharmD Kevin RPh David Proujan, RPh Sarah Braga, PharmD, RPh RPh MeganClark, Montgomery, PharmD, Brian PharmD, RPh Tray Till, RPh Lynn Connelly, RPh Wayne Weart, Kevin Upstate RegionPharmD Pee DeeBrittain, RegionPharmD, RPh Brian Clark,RPh PharmD, RPh David Banks, RPh Jim Shuler, Steve Greene, PharmD, RPh Kelly Jones, PharmD, RPh Upstate RegionRPh Pee Bushardt, Dee Region Walter Hughes, Dan RPh DavidReid, Banks, RPh Jim Shuler, RPh Linda RPh Steve Greene, PharmD, RPh Kelly Jones, PharmD, RPh Walter Hughes, RPh DanSTAFF Bushardt, RPh SCPhA LindaBurridge Reid, RPh Craig Chief Executive Officer Laura Reid Director of Events SCPhA STAFF Keenan Grayson Director of Membership Craig Burridge Chief Executive Officer Cassandra Hicks-Brown Director of Operations/ACPE Laura Reid Directorof ofCommunications Events Lauren Sponseller Director Keenan Grayson DirectorGeneral of Membership Jon Wallace, BS Pharm, JD SCPhA Counsel Cassandra Hicks-Brown Director of Operations/ACPE Cecily DiPiro, RPh PPN Network Coordinator Lauren Sponseller Lesesne Lauren Director of Communications Jon Wallace, BS Pharm, JD PHARMACIST SCPhA GeneralSTAFF Counsel PALMETTO Cecily DiPiro, RPh PPN Network Coordinator Jennifer Simmons Layout/Design/Content Craig Burridge PALMETTO PHARMACIST Managing EditorSTAFF Jennifer Simmons Craig Burridge

What’s Inside... Palmetto Pharmacist Palmetto Pharmacist What’s Inside... What’s Inside... 5 Metathesiophobia

President Steve McElmurray discusses the irrational fear Metathesiophobia SCPhA All Pharmacy Conference of change President Steve McElmurray discusses the irrational President Steve McElmurray talks about this exciting fear of change 7 pharmacy meeting State Phair 2013 A look at SCPhA’s 2013 Annual Convention 7 State Phair 2013 7 State Employee Rx Program Update A look at SCPhA’s 2013 Annual 16 CEO Craig Burridge discusses theConvention latest updates in the Legislative Wrap Up state employee pharmacy program At the close of the legislative session, see how things 16 Legislative Wrap Up tied up At the close of the legislative session, see how things 17 Hazard Communication tied up on howontoPet 21 Reminder handle this important information A Perspective Medications Information on veterinary medications 21 A Perspective on Pet Medications 19 Point/Counterpoint Information onrotation veterinary 25 Two students withmedications SCPhA take on the pros and My SCPhAon Rotation Journal cons of mail order and brick and mortar pharmacy SCCP Student Michelle Nations discusses her rotation 25 My SCPhA Rotation Journal with SCPhA SCCP Student Michelle Nations discusses her rotation 24 Medicaid Update with SCPhA 33 The latest update onAttracts medicaidYoung Audience Pharmacy Camp A special camp at SCCP provides a unique experience for 33 Pharmacy Camp Attracts Young Audience students special camp at SCCP provides a unique experience for Regular AColumns students 11 Members 5 5

14 SCCP Regular Columns 19 PCSP 18 SCCP Regular Columns 28 Financial Forum 32 Financial Forum 18 SCCP 30 Journal 36 JournalCE CE 32Classifieds Financial Forum 38 33 Classifieds 36 Journal CE 33 Classifieds Advertisers Advertisers 2 2 Smith SmithDrug Company Advertisers 4 Pharmacists 4 PharmacistsMutual Mutual 2 Bowl Smith 2315 of Hygeia Mutual Drug of North Carolina 4 Display Pharmacists Mutual 25 Options 34 Display Options 15 PACE Mutual Drug of North Carolina 26 PACE 42 34 Display Options 38 Jon Wallace, 43 Jon Wallace, Attorney at Law 42 PACE Attorney at Law 44 QS1 Jon Wallace, 39 43Mutual Drug ofAttorney at Law QS1Carolina 44North 40 QS/1

Layout/Design/Content Managing Editor

Palmetto Pharmacist • Volume 53, Number 3 Palmetto Pharmacist • Volume 53, Number 3 Palmetto Pharmacist • Volume 53, Number 5

Not yet a member? Check out page 6 for a membership application! Add the gift of membership to your holiday wish list. 3

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PRESIDENT’S PLATFORM

SC All Pharmacy Conference

macy professionals in one room at the same time. Feel free to send information or questions to info@ scrx.org. We look forward to watching this group prosper and lead the way for the future of pharmacy.

I had the distinguished honor to oversee the inaugural meeting along with SCPhA’s CEO Craig Burridge. Discussions took place on various facets of pharmacy, but the main issues were the same, regardless of the branch being represented. I found it extremely intriguing that we come from so many different walks of pharmacy life, each having their own set of issues and goals, but the overall theme resonated throughout the day: We all represent the same profession, and the more we work together, the more beneficial it is for all of us.

Feel free to take a look at future meeting agendas, minutes from previous meetings, and other materials related to conversations that take place within these meetings on our website at www.scrx.org, under the “Other Programs” tab, “All Pharmacy Conference”. We also welcome your feedback and ask that you consider submitting questions or issues for the group to discuss at future meetings. After all, it’s a rare opportunity to have this number (and caliber) of phar-

We all represent the same profession, and the more we work together, the more beneficial it is for all of us.

Palmetto Pharmacist • Volume 53, Number 5

One of the most gratifying parts of being the president of SCPhA is watching the changes that take place throughout my year at the helm. At the beginning of my year in office, the board set a goal to bring the pharmacy industry together in a more cohesive front. We made the decision to re-create a group that the association had several years ago, and came up with the concept of the South Carolina AllPharmacy Conference. The purpose of the group is to bring together, in one place, academia, state pharmacy organizations, state government agencies, such as the SC Board of Pharmacy, DHEC, Medicaid, and the State Solicitor’s office, as well as federal agencies such as DEA, CMS Regional and the Social Security Administration to discuss all things related to pharmacy. In addition to each of these groups, we asked certain individuals to represent their branch of pharmacy- we included pharmacists from compounding, chain/retail, hospital, long-term care and pharmacy owners to take a seat at the table. While we were hopeful that the attendees would show up, we were blown away by their eagerness to participate, as well as their desire to be open and honest. Close to sixty industry “experts” were in attendance, and gave updates in relation to their niche of pharmacy.

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SCPhA Membership 2013-2014 Ready to be a part of South Carolina’s leading professional pharmacy association? Fill out the form below and return to SCPhA with payment to join for 2013-2014 today. SCPhA’s membership year is from October 1, 2013-September 30, 2014.

Name License/Registration Number

Degree(s)

Address City

State

Phone

Zip Fax

Additional Contributions:

Email Company/Pharmacy Name Address City

State

Work Phone NABP eID

Membership Type: (Please select one) Regular RPh Member ($150) Associate (Non-RPh) Member ($150) Vested Member ($2000 one-time fee, no additional dues) First Year Practicing RPh Member ($75) Retired RPh Member ($75) Pharmacy Technician Member ($35) Spouse/Joint Membership ($250 per couple): Spouse Name:__________________

Zip Work Fax

Birth Date and Month (DDMM)

What’s new this year?  SCPhA Student Association Fall 2013

will mark the inaugural year of the South Carolina Pharmacy Student Association, under the umbrella of SCPhA and the leadership of the Junior Board.  Member Referral Program This is an exciting new incentive to encourage your peers to join SCPhA! Each time that a member refers someone who joins SCPhA, their name will be entered into a drawing to win $1,000 CASH! The winner will be drawn at SCPhA’s Annual Convention in June 2014!  New Website! The rumors are true—we are switching to a new database and website that will allow our members greater access to information 24/7!

SC Pharmacy Advocacy Committee: While your SCPhA dues automatically assist pharmacy advocacy efforts, your additional contribution to the Pharmacy Advocacy Committee supports greater advocacy in the legislative arena. Contribution Amount: $50 $100 $250 $500 $1,000 Other $______ *Contributions to the PAC are not tax-deductible.

SC Pharmacy Foundation: Help pr eser ve the past and invest in the future of pharmacy. Contributions to the SC Pharmacy Foundation are completely tax deductible. Contribution Amount: $50 $100 $250 $500 $1,000 Other $______ Payment Information: Total Due to SCPhA: $___________________ Check; check #__________ (made payable to SCPhA) Credit Card: MC Visa AMEX Discover Billing Address __________________________________ Billing City, State, Zip _____________________________ Card Number____________________________________ Exp. Date___________ CVV #____________________ SCPhA dues are NOT tax deductible as charitable contributions for income tax purposes. However, they may be tax deductible as ordinary and necessary business expenses subject to restrictions imposed by law with respect to association lobbying activities. The Revenue Reconciliation Act of 1993 states that Association dues used for lobbying activities are not deductible as a business expense. As a result 15% of SCPhA dues cannot be deducted as a business expense for federal income tax purposes.

Please return to SCPhA, along with payment, to: 1350 Browning Road, Columbia, SC 29210 or you can fax credit card payments to 803.354.9207. Register online at www.scrx.org 6 Palmetto Pharmacist • Volume 53 Number 5 For questions, call 803.354.9977


State R

State Employee Rx Program Update by: Craig M. Burridge, MS, CAE CEO, SCPhA As you all well know by now, Catamaran (PBM) won the State Employee Rx Program bid displacing long time PBM – Medco. At the time of this writing, ESI/Medco was appealing the bid award to Catamaran. You also should be aware that it has been reported to SCPhA from Catamaran that 98% of all SC pharmacies had already signed on to Catamaran’s pharmacy network, mostly through their PSAOs (independents) or directly with chains. Catamaran also assured SCPhA that they were reaching out to the 2% of pharmacies that they have not heard from yet. With the state employee plan being 10% of the state’s population and as much as 30-40% of a pharmacy’s business, this was the first major concern. I want to thank SCPhA lobbyists Richard Davis and Annie Wilson for first, arranging for a meeting with the Public Employee Benefit Authority (PEBA) to have SCPhA and SCHSP leadership discuss the new plan and for the follow up information such as the original Request for Proposals (RFP) and amendments that included FAQs from the bidders. Although the contract with Catamaran was also provided, it contained a lot of didacted information such as reimbursement and MAC list. The document looked like an Air Force UFO report. I reviewed the FAQs to see if I could get some insight into ‘where’ the state was going on this new contract. To say the least, the Request for Proposals (RFP) along with the FAQs raised some serious concerns (reimbursement) and dispelled others (mail order). As it relates to Reimbursement: In PEBA’s RFP on page 18, Section (A) (3) I quote: “The Contractor shall provide their most aggressive (italics added) and broadest Maximum Allowable Cost (MAC) pricing for generic drugs that uses a MAC pricing list that is subject to review and modification for inclusion of generic drugs rep-

Palmetto Pharmacist • Volume 53, Number 5

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State Rx Info resenting the greatest cost savings (italics added) to the Plan based on participant drug utilization.” This gives me pause. With generic drug dispensing at an historic high of over 80% and growing, at what point does ‘most aggressive’ pricing start closing pharmacies all over this state? Pharmacies cannot survive on ‘dead net cost’ and an average $1.15 dispensing fee. With the average generic prescription costing around $20.00 you’d think payers would reward pharmacies for moving generic dispensing numbers higher. Instead, they are punished. I can only hope that PEBA will use the ability to “review and modify” the MAC to make sure they continue to allow state employees and their families ‘access’ to their community pharmacy. We are counting on this as are our community pharmacies and the people they employee and the patients they serve. On the good side of the RFP – Pharmacy Network: Page 21, Section (B) (2) states that: “The Contractor shall contact all retail pharmacies chains, independent pharmacies, and nursing home pharmacies operating in South Carolina and solicit their participation in the Pharmacy Network. The SC Public Employee Benefit Authority desires the maximum participation by all willing pharmacies, whether independent or national chain, (italics added) and the greatest geographic coverage for the Network within the State, includ-

ing rural areas.” Kudos to PEBA for ensuring that businesses paying taxes and employing citizens of this state remain part of the solution for lower overall healthcare costs. PEBA stood tall over and over again in the way they addressed bidder’s questions as it related to the pharmacy network. For example: One bidder asked PEBA: “In addition to a Broad Retail Network, would a Narrow Network (read: Preferred) proposal be considered?” PEBA response: “No.” Second question same bidder: “Would a Preferred Network that meets the access definition of “Broad” but offers lower copayments – without negatively impairing the State’s total pharmacy cost – be considered?” PEBA’s response: “No.” Finally, another vendor asked: “Is PEBA willing to consider adopting CMS network access guidelines only as it relates to the Performance Guarantees?” Really? How many different ways can you ask to narrow a pharmacy network? Pharmacies across the nation have already felt that pinch as more and more Part D networks became “preferred.” Once again, kudos to PEBA for seeing right through the smoke and mirrors of the PBMs and saying “No.” Folks, what it all comes down to is this: who pays the taxes and employs the people in this state?

BREAKING NEWS SCPhA just received the PEBA contract numbers just minutes ago. The reimbursements under the new state contract with Catamaran are as follows: IMPORTANT: These are the agreed upon terms between Catamaran and PEBA. Your individual contract or PSAO contract may be more or less. Please check with your PSAO. Standard Plan: 1/1/14 - 12/31/14 Retail: Brand – AWP-15% + $1.50 Generic – AWP-78.5% + $1.50 Retail 90: Brand – AWP-18.4% + $0.00 Generic – AWP-80.5% + $0.00 Mail: Brand – AWP-22.6% + $0.00 Generic – AWP-81.5% + $0.00 Specialty: Brand – Aggregate 14% + $2.50 Generic- Aggregate 14% + $2.50 Standard Plan: 1/1/15 – 12/31/15 Retail: Brand – AWP-15% + $1.50 Retail 90: Brand – AWP-18.4% + $0.00 Mail: Brand – AWP-22.6% + $0.00 Specialty: Brand - Aggregate 14% + $2.50

Generic - AWP-79.0% + $1.50 Generic – AWP-81.0% + $0.00 Generic – AWP-22.5% + $0.00 Generic - Aggregate 14% + $2.50

Indirect EGWP - Wrap Plan: 1/1/14 – 12/31/14 (Retirees – Medicare Primary) Retail: Brand – AWP-15% + $1.50 Generic – AWP-78.5% + $1.50 Retail 90: Brand – AWP-18.4% + $0.00 Generic – AWP-80.5% + $0.00 Mail: Brand – AWP-22.6% + $0.00 Generic – AWP-81.5% + $0.00 Specialty: Brand – Aggregate 14% + $2.50 Generic – Aggregate 14% + $2.50 8

Palmetto Pharmacist • Volume 53 Number 5


Not in this photo? You should be! Save the Date for the 2014 Legislative Day March 19, 2014 Columbia, SC Palmetto Pharmacist • Volume 53, Number 5

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Political Action Committee (PAC) Quick Facts 2012 South Carolina PAC Expenditures: SC Trucking Association: $121,750

SC Optometric Association: $90,400

SC Automobile Dealers Association: $102,413

SC Trial Lawyers Association: $80,000

SC Pharmacy Association: $ 32,700

What Does This Mean For YOU?  

SCPhA membership is approximately 2,000 strong If each member would make a single contribution equal to the cost of an average dinner out ($30.00), SCPhA’s PAC would be at $60,000! A strong PAC is essential to advance our advocacy goals, and is an integral part of SCPhA’s membership. Your PAC contributions are more important now than ever!

2012-2013 Contributors to SCPhA PAC 

Julian Reynolds

Craig Harmon

Pharmacy Partners

Jessica Legge

Walter Hughes

Regina Boswell

John Pugh

Gregory Mayer

Tommy Simmons

Carolina Pharmacies Unlimited

Lynn Connelly

Spartanburg Treatment Associates

SCPhA Foundation– 8th District

Christopher James

Phillip Hall

Pamela Whitmire

Tom Simpson

Landrum Drug Company

Dawn Devine

Randy Todd

James Shuler

YOUR NAME HERE

Ways you can donate: Call our office (803)354-9977, visit our website at www.scrx.org or mail your contribution to 10 • Volume 53 Number 5 SCPhA, 1350 Browning Road, Columbia, SC 29210Palmetto (Attn: PACPharmacist Fund). We appreciate your support!


MEMBERS

Meet Willie Lee!

by Keenan Grayson, Director of Membership If you have driven Business Hwy 17 through the marsh side of Murrells Inlet, you have passed by Lee’s Inlet Apothecary. Owner and Pharmacist, Willie Lee, opened his pharmacy 11 years ago along the scenic “Restaurant Row” of Murrells Inlet. Prior to opening his own pharmacy, Willie worked for Revco and opened the Murrells Inlet CVS Pharmacy. Willie knew that he wanted to pursue pharmacy immediately after shadowing his family’s pharmacist at Southside Pharmacy in Myrtle Beach for one week when he was still in high school. Willie began the pre-pharm track as soon as he started his freshman year of college. He ended up marrying his pharmacist’s daughter later in life and they now have 4 children. Lee’s Inlet Apothecary is unique in that it has a gift shop and functional soda fountain in the pharmacy. Locals make the pharmacy a one-stop-shop for all of their medications, lunch, jewelry, and gifts. Because of this, Lee’s Inlet Apothecary has become a popular hangout and serves as a type of town hall for Murrells Inlet natives. Willie’s wife grew up in her father’s independent pharmacy and is very familiar with the business model. Before opening the pharmacy, she had a home business called “Personally Pearl,” which she translated to the front-end part of the pharmacy when it opened. The items sold in the front of the pharmacy vary from jewelry and home accents to books about the history of Murrells Inlet.

The first thing that people notice when they walk into Lee’s Inlet Apothecary is the antique soda fountain. With a great lunch menu and ice cream bar, the soda fountain adds to the personality of the pharmacy and encourages customers to “stay a while!” Willie and his wife purchased the soda fountain from an antique dealer in Oklahoma before they even had a building to open the pharmacy. The antique dealer happened to offer Willie antique apothecary shelves as well, which can now be seen lining the walls of Lee’s Inlet Apothecary. The dealer also offered to personally deliver the soda fountain and shelves to Murrells Inlet. When the new building was purchased, the soda fountain made it through the front door with only a centimeter to spare. Willie credits the Lord for the way that everything came together. Regarding the pharmacy, Willie is very honest in saying that, “Independent Pharmacy is not a cake walk.” Though Willie has seen many personal successes through customer retention and respect within his community, he is also experiencing some struggles that are familiar to most independent pharmacies here in South Carolina. Medicare Part D has been a difficult obstacle. Between the way that the pharmacies are being reimbursed, the new pricing schedule and mail order, Willie’s says, “I don’t know where we are headed.” The issue of mail order is a beast of its own. With the government financially twisting his customers’ arms, and even forcing some to go to mail order, he has lost patients who would prefer to shop with

Palmetto Pharmacist • Volume 53, Number 5

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MEMBERS him. Willie makes a good point in saying, “Where is America in that? Where is freedom in that?” In addition to the dent in his patient base, mail order causes many other concerns for Willie and others in the pharmacy industry. Mail order waste is a big issue. Willie participates in the Take Away program, which he offers to his customers for free, and sees thousands of dollars worth of inhalers and other medications being thrown away. Patient adherence and medication consultations, extreme temperatures in mailboxes, and mailbox theft are all other causes for concern. The South Carolina Pharmacy Association is doing its best to keep a pulse on these issues and the relevant legislation.

Feel like your Social Media is missing something? Connect with SCPhA on Facebook! facebook.com/ scpha

Willie Lee has been a member of SCPhA since he graduated from pharmacy school. Get involved in the Association that exists to promote and protect your profession!

SCPhA Looking to Have Office Hours That “Make Sense” Although SCPhA has a limited staff, we believe we have figured out a way where our office hours make better sense for our members. With that end in mind, we are changing our office hours from 8:30 a.m. to 5:00 p.m. to 8:30 a.m. to 4:30 p.m. At first glance, you might say that these hours are actually shorter but, they will be our ‘official’ hours for everyone but our members. The fact is, as a SCPhA member, you can contact us as early as 7:00 a.m. to register for events, ask questions, seek information. Why change? What we have heard from members, who missed a registration deadline for a CE program or an event, was that they meant to call in but got to work and were too busy and forgot. By time they got home from work, the SCPhA was closed. So, call us BEFORE you go to work! That’s right! You can call SCPhA staff from 7:00 a.m. on to register for an event or request information. We will be there to serve you! No more busy workdays to cause you to be shut out of an event. Let us start our day by helping you! You can still access information and register for all events 24/7 by going to the SCPhA website at: www.scrx.org and click on the colored box on the Home Page that relates to the event(s) you are interested in. we hope this change will better serve you.

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Palmetto Pharmacist • Volume 53 Number 5


January 17-19, 2014 Omni Grove Park Inn ● Asheville, NC Partnering State Associations: Georgia ● Kentucky ● Mississippi North Carolina ● Tennessee ● Virginia Gather your friends for a weekend of fun, facts and facials! Full registration includes: CE programming, breakfast on Saturday and Sunday, a dinner reception on Friday, an event t-shirt and gift bag! Rooms and spa appointments are available at the Omni Grove Park Inn. Call 800.438.5800 by December 17 to take advantage of our group rate! Complete this form and return, with payment, to SCPhA, 1350 Browning Road, Columbia, SC 29210 or fax to 803.354.9207. Visit www.scrx.org to register online. Questions? Call Laura Reid, Director of Events, at 803.354.9977. Members (SCPhA, GPhA, KPhA, MPhA, NCAP, TPA, VPhA) Early Bird Registration Before Dec. 17 □ Full Registration $229 □ Friday Only $129 □ Saturday Only $89 □ Sunday Only $89 □ Saturday & Sunday Only $159 □ Student Registration $149

Regular Registration After Dec. 17 $259 $149 $109 $109 $189

Extras □ Guest Registration: includes all except CE ($149) Guest Name: ________________Guest Shirt Size (S-2X): ____ □ Addt’l Friday Reception tickets ($69) Qty: _________ □ Friday Paint and Mingle tickets ($49) Qty: _________ Back by popular demand! After the reception, you can join us for a Paint and Mingle networking experience! At this optional event, you will paint a piece of artwork while getting to know fellow attendees. Take home your art to remember the weekend. No artistic ability required.

Non-Members *If renewing or joining on this form, please select from the member rates above* Early Bird Registration Before Dec. 17 □ Full Registration $319 □ Friday Only $159 □ Saturday Only $119 □ Sunday Only $119 □ Saturday & Sunday Only $219

Regular Registration After Dec. 17 $369 $179 $139 $139 $249

I would like to sponsor a student to attend: □ Full Sponsorship ($149) □ Partial Sponsorship ($99)

Extras □ Guest Registration: includes all except CE ($149) Guest Name: ________________Guest Shirt Size (S-2X): ____ □ Addt’l Friday Reception tickets ($69) Qty: _________ □ Friday Paint and Mingle tickets ($49) Qty: _________ Please see above for description.

□ Other Amount: __________

To renew or join SCPhA now, please select your member type below: □ Pharmacist ($150) □ Associate ($150) □ Retired ($75) □ First Year ($75)

□ Technician ($35)

□ Student (free!)

Registration Information: State: □ SC □ GA □ KY □ MS □ NC □ TN □ VA □ Other: ______ Full & Student Registrants, select your shirt size (S-2X): ___________ Name____________________________________________________________ □ Technician □ Pharmacist □ Student Email________________________________________________________________Phone_____________________________________ Address_________________________________________________________________________________________________________ License/Reg #___________________ NABP eID#_____________________________Birthdate (MM/DD)_____________________ Payment Information: Payment Type: □ Check _____________ Total Amount Due: $____________ Credit Card Type: □ MC □ Visa □ AMEX □ Discover Name on Card__________________________________________ Card #__________________________________________________________Exp. Date____________________CVV______________ Billing Address___________________________________________________________________________________________________

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.

The South Carolina Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Continuing education credits Palmetto Pharmacist • Volume 53, Number 5 13 will be available 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 Administrator immediately following the program.


SCCP Business Track by Joseph DiPiro, Dean SCCP

Pharmacists have to be successful businesspeople as well as good clinicians.

Being able to monitor a patient’s anticoagulation and make appropriate dosage changes is an important pharmacotherapeutic skill … but it doesn’t help you balance your books, evaluate a reimbursement contract, or deal with employee issues. Pharmacy educators have to consider those needs while ensuring that any graduate entering the pharmacy profession is fully prepared, first and foremost, to take care of their patients. One solution is for students to pursue a master’s in business administration as well as their PharmD. At the South Carolina College of Pharmacy (SCCP), we’re proud to offer joint degrees from our campuses at the University of South Carolina (USC), Medical University of South Carolina (MUSC), and Greenville Health Systems (GHS) through collaboration with USC’s Darla Moore School of Business in Columbia, S.C., and The Citadel in Charleston, S.C. However, since not all our graduates have the time or resources to get a dual degree, the SCCP is now offering a business and entrepreneurship program that can be earned at the same time as a PharmD. The business track has been developed through the Kennedy Pharmacy Innovation Center. The business track, like our track in pre-residency pharmacy, gives students an additional designation that enhances and certifies their ability, increasing their marketability in the profession. The track has specific criteria of elective coursework and experiential education which can also apply to general requirements of the PharmD program. The track helps determine which electives the student takes but minimizes additional course credit hours or additional tuition expenses beyond the PharmD requirements. The track, or the Kennedy Pharmacy Business & Entrepreneurship Program, provides an opportunity for students to get exposure to core business knowledge and pharmacy-focused business training through the selection of appropriate electives, advanced experiential rotations, extracurricular activities, and focused faculty/practitioner mentorship. 14

The program provides enhanced training in topics like: •Pharmacy ownership •Pharmacy management or administration •Entrepreneurial careers and new business models

The program is delivered through classroom learning, workshop activities, and hands-on opportunities for students to apply their knowledge and develop skills. The program is managed and administered by Bryan Ziegler, executive director of KPIC; Bob Davis, Kennedy professor with KPIC; and Kristy Brittain, director of the community pharmacy residency program. All three are faculty members with the Department of Clinical Pharmacy and Outcomes Sciences at the SCCP. “The reason we created this track is the fact that healthcare, and pharmacy, is a business,” Ziegler said. “To be successful as a pharmacist, you need to have solid business skills in addition to science and clinical knowledge. The MBA degree provides high level business training that prepares students for senior level positions. “All pharmacy students need business training, but not necessarily MBA level business training. The Kennedy Pharmacy Business and Entrepreneurship program provides a more economical and pharmacy-focused training opportunity allowing a larger number of students to learn core business skills that will make them more prepared for today’s healthcare environment. ” Students need to recognize that healthcare is a business and to grow pharmacy services and improve patient care, pharmacy leaders must be knowledgeable not only in clinical skills and science but also business skills. Employers recognize this need and have indicated that graduates with expanded business knowledge and skills will be more competitive in the pharmacist job market. At the SCCP, we are always exploring ways to make our graduates the best possible leaders in the pharmacy profession; the new business track will create an opportunity for students to enter the fast-changing work force at the speed of business. Palmetto Pharmacist • Volume 53 Number 5


Where would you prefer to have your HIPAA training?

Option A

Option B

Yep. That’s what we thought. Get your HIPAA training online, 24 hours a day, 7 days a week with SCPhA’s online HIPAA training program.

Assessing Your Pharmacy’s HIPAA Policies & Procedures created by Craig Burridge, MS, CAE, CEO, South Carolina Pharmacy Association Goals and Objectives: 1. Identify the laws covering confidentiality and their lead up to HIPAA. 2. Recognize the standard principles governing confidentiality as it relates to patient records. 3. Identify the need for and responsibilities of a privacy officer and workforce training requirements. 4. Differentiate between the proper uses and disclosers of protected health information and permitted uses and disclosures. 5. Recognize when authorization is necessary for protected information. 6. Identify the requirements for the distribution of Privacy Practices Notices. 7. Know how to develop an electronic protected health information policy. 8. Recognize how to mitigate and notify affected individuals in case of a breach of protected health information. 9. Identify the expanded HIPAA requirements under the Health Information Technology for Economic and Clinical Health Act (HITECH)

Fees: SCPhA Members: $15\Non-Members: $25 Please note that this is required in order to obtain 2 hours of CE Credit. The South Carolina Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This home study is approved for 2 contact hours of continuing pharmacy education credit (ACPE UAN: 0171-0000-13-074-H03-P). This CE credit expires 8/08/2016.

Register online at www.scrx.org, or follow the QR code to the right!

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DHEC

DHEC Head Says Pharmacies Will Submit Control Data 24 Hours Starting January 15, 2014 SCPhA was notified via ‘press conference’ that DHEC will now require all pharmacies to submit their control substance data every 24 hours instead of every 30 days. Twenty-four hour submission is supposed to commence on Thursday, January 15, 2014. Having heard this from DHEC head Ms. Catherine Templeton during a press conference held at SLED headquarters, SCPhA immediately conducted an electronic survey to find out which pharmacy software vendors our pharmacies used and if they were capable of moving form 30-days to every 24 hours so quickly. We also wanted to know if there would be any additional costs to our pharmacies. While we were doing that, Senator Ronnie Cromer was busy checking with Senate counsel to see if Ms. Templeton had the authority to make these dramatic changes without first seeking a rule making or legislative change to the law. Senator Cromer was in constant contact with our office as we too believed that proper procedures had been violated. Senate counsel agreed that Ms. Templeton had to either file for a regulatory change or have the law amended by the legislature. Senators Cromer and Bryant sent a letter to Ms. Templeton to that effect. Ms. Templeton disagreed and said that the Attorney General opined that she had the authority. Upon further evaluation and consultation, we had to concur. SCPhA’s leadership held a very cordial meeting with Ms. Templeton yesterday which was setup by our lobbyist Richard Davis. Ms. Templeton was quick to apologize for not reaching out to all the stakeholders (including SCPhA) before making her announcement about the changes. Prior to this meeting SCPhA staff worked on a survey of pharmacy owners to find out ‘who’ they used as their pharmacy software vendor and rank them by their market share. We contacted most of the vendors prior to the meeting and all were either already capable of moving to every 24-hours (only when your pharmacy is open for business as explained by Ms. Templeton at the meeting) or were already working on the code changes and all said they would be ready by the January 15th start date. We were also concerned about ‘cost’ and ‘administrative burden.’ All but one vendor said there would be no cost increase. The one vendor said there ‘may’ be a one-time small fee for setup. As far as administrative burden, please check with your individual 16

software vendor. Again, most stated that the controls reports can be done automatically during the ‘end of day’ reports. To make this transition easier, please request the automatic reports from your vendor. Please contact your software vendor representative asap and make sure you are on track to be in compliance by January 15, 2014. You may also want to ask your vendor if those 24-hour reports can be done “automatically.” Several vendors said that it can be done when you run the day’s reports for your dailies, etc. Most vendors have that capability. We suggest you go that route so that you do not miss a report. The “Top Ten” pharmacy software vendors listed in our survey who showed up as having clients in South Carolina are listed below. 1.) QS1 2.) Rx-1/HCC/Visual 3.) Rx-30 4.) Computer Rx 5.) PDX 6.) McKesson/PharmacyRx 7.) PK Software/Compounding 8.) VIP 9.) Script Pro 10.) ZADALL What About Doc’s Who Dispense Controls? SCPhA asked about that as well. Even though physicians may have state ‘waivers’ form having to report dispensed controls to the state’s PDMP program, they STILL have to follow federal DEA regulations as it relates to the purchase, storage and audits of their controlled substances and if they do not, they are subject to arrest. Several arrests have already occurred in the Richland County area for NOT following federal rules and regulations. Physicians must have a DEA license to purchase controls; a single physician CANNOT purchase controls for other physicians in a multi-physician practice. Each physician MUST have their own inventory, store controls in their own safe and conduct their own inventories for the DEA. If you have relationships with physicians in your area, you may want to share this information with them so that they don’t inadvertently get in trouble.

Palmetto Pharmacist • Volume 53 Number 5


Hazard Communication

Hazard Communication Compounding pharmacies are required to follow the provisions of the revised Hazard Communication standard to the extent that they apply to the individual workplace. Usually the minimum provisions include workplace labeling, safety data sheets, a written hazard communication program and employee training. The scope of the revised Hazard Communication standard is identical to the scope of the original rule. Some exceptions that may apply to your pharmacy include: 1910.1200 (b)(5) This section does not require labeling of the following chemicals: Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the VirusSerum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture; In the case of “raw� chemicals, the manufacturer is also required to comply, as follows: 1910.1200(f)(5) Chemical manufacturers, importers, or distributors shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged, or marked in accordance with this section in a manner which does not conflict with the requirements of the Hazardous Materials Transportation Act (49 U.S.C. 1801 et seq.) and regulations issued under that Act by the Department of Transportation. As of December 1, 2015 chemical products falling within the scope of the GHS will carry the GHS label at the point where they are supplied to the workplace, and that label should be maintained on the supplied container in the workplace. Alternately the items can be transferred into workplace containers and may be relabeled with the same label elements appearing on the shipped container or for stationary workplace

containers (e.g., storage tanks). OSHA also allows employers to use alternative means to labeling for giving workers the same information in a different written or displayed format when such a format is more appropriate to the workplace and communicates the information as effectively as the GHS label. For example, label information could be displayed in the work area, rather than on the individual containers. Some examples of workplace situations where chemicals may be transferred from supplier containers include: containers for laboratory testing, storage vessels, piping or process reaction systems or temporary containers where the chemical will be used by one worker within a short timeframe. These are the general requirements for all containers: 1910.1200 (f) Labels and other forms of warning. (f)(1) Labels on shipped containers. The chemical manufacturer, importer, or distributor shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged or marked. Hazards not otherwise classified do not have to be addressed on the container. Where the chemical manufacturer or importer is required to label, tag or mark the following shall be provided: (i) Product identifier; (ii) Signal word; (iii) Hazard statement(s); (iv) Pictogram(s); (v) Precautionary statement(s); and, (vi) Name, address, and telephone number of the chemical manufacturer, importer, or other responsible party These are the specific requirements for labeling secondary containers of hazardous materials; paragraph 1910.1200 (f)(6) below, would apply to items being poured up for use day after day into secondary containers. [Except as provided in paragraphs (f)(7) and (f)(8) of this section,] Workplace labeling. 1910.1200 (f)(6) The employer shall ensure that each container of hazardous chemicals in the workplace is labeled, tagged or marked with either of the following alternatives:

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Hazard Communication Either, (i) The (same) information specified under paragraphs (f)(1)(i) through (v) (that is required) for labels on shipped containers; [see highlighted items above] or, the (ii) Product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.

These are the exceptions that are allowed and will still be in compliance if you have these in place: 1910.1200 (f)(7) The employer may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys the information required by paragraph (f)(6) of this section to be on a label. The employer shall ensure the written materials are readily accessible to the employees in their work area throughout each work shift.

Bowl of Hygeia State Association Challenge 2.0 – Help South Carolina Take the Lead! Goal: $600,000 Endowment Yet to raise: $150,000 How You Can Help: •

Save time: Make $10 quick donations by text RxBowl to 52000 We are encouraging all former recipients to contribute! Contact: Lynette Sappe-Watkins: lsappe-watkins@aphanet.org or 202-429-7534

Prizes

Funds for a Bowl of Hygeia Reception at your next Annual Meeting

1st Place is $2,500:

Awarded to the state raising the most over $5,000 before APhA2014*.

2nd Place is $1,000:

Awarded to the state raising the 2nd highest amount over $5,000 before APhA2014*.

3rd Place is $500:

Awarded to the state raising the 3rd highest amount over $5,000 before APhA2014*.

NEW! 1st, 2nd and 3rd place winners may have the Bowl of Hygeia sent to their meeting for your reception! * Funds must be received by the APhA Foundation by March 15, 2014

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Palmetto Pharmacist • Volume 53 Number 5


PCSP

IPPE the PCSP Way

By Cliff Fuhrman, Dean, Presbyterian College School of Pharmacy

During the years prior to the official start of its new ing modules taught in the classroom. Students learn pharmacy program, Presbyterian College was able concepts in their didactic work and then are able to to benchmark other pharmacy curriculums as a basis actively experience via specific topic assignments from which the school’s executive committee chose at the practice site that same week. This specificity to restructure the introductory clerkships in a way helps to address prior concerns regarding continuity that would improve the overall student learning of learning at the practice site. This learning coalesexperience. The “traditional” method of implementcence has also been well received by the students, as ing the introductory rotations (otherwise known as they are able to immediately put to use the lessons Introductory Pharmacy Practice Experiences or IPthey are taught. PEs) during the summer months was eliminated; instead, IPPEs are incorporated throughout the didactic “I enjoyed completing my IPPE rotations throughout school year. This new structure is more in line with the semester, as I could apply what I was learning in the latest ACPE (Accreditation Council for Pharmacy class to practical experience over 5-6 weeks. Each Education) recommendations that schools adminisweek introduced a different aspect about the comter their introductory component in a longitudinal plexity of the pharmacist’s role, not only in direct fashion; in other words, a coalescence of didactic, patient care, but through providing continuing educarecitative, experiential tion to other health care providers about medication IPPElab, theand PCSP Way learning which better enables students to achieve and demonstrate the management within an institution. During the years prior to the official start of its new program, Presbyterian College was able to required competencies in a progressive manner. -pharmacy Danielle VanDelden, P3 benchmark otherstudents pharmacy curriculums as a basis from Generally speaking, conduct their IPPEs which the school’s executive committee chose to during one day a week throughout the fall and spring PCSP enrolls approximately 80 students per class, restructure the introductory clerkships in a way that would improve the overall student learning semesters, and anThe immersive “summer week” segand the introductory rotations (otherwise known currently utilizes over 280 practice sites and as 240 experience. “traditional” method of implementing mentIntroductory Pharmacy Practice Experiences before the start of the fall semester. Throughout preceptors who represent a wide variety of patient or IPPEs) during the summer months was eliminated; the fall and spring semesters of their P1 and P2 years, careschool settings. The Office Experiential Education instead, IPPEs are incorporated throughout the didactic year. This newofstructure is more in line each rotation course is split between two practice (OEE) is tasked with implementation and oversight with the latest ACPE (Accreditation Council for Pharmacy Education) recommendations that schools sites. The third year involves a full day at the practice of the experiential component of the program curadminister their introductory component in a longitudinal fashion; in other words, a coalescence of site, so by the end of a student’s P3 year, each student riculum. The OEE is staffed by: Assistant Dean, didactic, recitative, lab, and experiential learning which better enables students to achieve and has had the opportunity to experience up to 10 differ- Dr. Lewis McKelvey, who oversees all activities demonstrate the required competencies inthat a progressive ent rotation sites. As an additional requirement withinmanner. the office; Director, Dr. Mary Douglass Smith, promotes Presbyterian College’s motto, “While We primarily responsible for preceptor development and during one day a week throughout the fall and spring Live,Generally speaking, students conduct their IPPEs We Serve,” each IPPE student completes 15 quality assurance; Assistant Director, Christopher semesters, and an immersive “summer week” segment before the start of the fall semester. Throughout hours of service learning activities that are pharmacy Rico, primarily responsible for scheduling issues the fall and spring semesters of their P1 and P2 years, rotation course isand split betweenDirector, two practice focused. In total, each IPPE student spends 335 andeach E*Value oversight; Assistant Susi hourssites. The third year involves a full day at the practice at practice sites – well in excess of the 300Carbonneau, who serves as office manager site, so by the end of a student’s P3 year,and eachpoint hour student requirement by ACPE. of contact for the office. has had the opportunity to experience up to 10 different rotation sites. As an additional requirement that promotes Presbyterian College’s motto, “While We Live, We Serve,” each IPPE student The time is balanced between community institu- thatHere at PCSP our students and faculty appreciate the completes 15 hours of service learningand activities are pharmacy focused. In total, each IPPE student tional pharmacies, as well as other direct patient care dedication and opportunities afforded to them by our spends 335 hours at practice sites – well in excess of the 300-hour requirement by ACPE. settings, e.g. clinics, and veterinary pharmacies. many preceptor colleagues. Your support is essential in our effort to provide outstanding pharmacists to The time is balanced between community and institutional pharmacies, as well as other direct patient care Eachsettings, e.g. clinics, and veterinary pharmacies. IPPE syllabus is designed to follow the learnthe profession.

Summer

Fall

P1 Year P2 Year P3 Year

1 Immersive 40 hour week 1 Immersive 40 hour week

2 Rotations: 4 hours a week for 6 weeks each 1 Rotation: 8 hours a week for 6 weeks

Palmetto Pharmacist • Volume 53, Number 5

Spring 2 Rotations: 4 hours a week for 6 weeks each 2 Rotations: 4 hours a week for 6 weeks each 1 Rotation: 8 hours a week for 6 weeks

Each IPPE syllabus is designed to follow the learning modules taught in the classroom. Students learn concepts in their didactic work and then are able to actively experience via specific topic assignments at

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Student Articles

Mail Order Vs. Brick and Mortar

POINT Krupa Vipin Patel, Pharm D Candidate 2014 The use of mail order pharmacies have been an ongoing controversial topic. Mail order services are offered through most major pharmacy benefit managers (PBMs). Many would assume this service developed as to lower healthcare cost, but instead it was developed to function in delivering medications to remote, inaccessible, and rural areas.2 With this idea, mail order pharmacy services have grown to provide convenience to a number of individuals who require maintenance medications for chronic conditions, as well as increased generic drug use. Local drugstores are known for its use for new therapy initiations, acute-care prescriptions and maintenance medication refills, while mail order services are used primarily for maintenance medications refills. Community and mail order pharmacies must find a balance on the level of competition in order to allow their patients the freedom to choose the delivery channel for their prescriptions. When given a choice 83% of customers prefer to fill at a community pharmacy and 72% oppose mandatory mail order plans.1 Currently mail order services are not the first line choice, but there are multiple advantages and disadvantages for the use of mail order pharmacy services, which will be discussed. Reliability and affordability are two key concepts mail order services strive for.2 Convenience also plays a major role in determining whether patients prefer this channel of delivery for their prescription drugs. Mail order pharmacies can be beneficial for patient with chronic conditions such as diabetes, hyperlipidemia, hypertension, and depression.2 Patients who are controlled on maintenance medication for these chronic illnesses, mail order services may be beneficial to provide convenience and help relieve some financial burden by receiving up to a 90-day supply of their medications for just one co-pay amount.2 Most plans entitle members to a discounted copay when they receive their medications through mail order. Today many plans offer the option to obtain a three-month supply of their maintenance drug through mail, after they’ve had at least two fills from a retail pharmacy in the past 90 days. Currently, the issues we have seen in many retail pharma20

cies are most plans are automatically enrolling their patients in mail order after the second refill. Many patients are being mandated to choose mail order, but some plans allow patients to call to opt out of the mail order services and retain their 90 day prescription at the retail level. Mail order services encourage generic substitution rate (GSR), when a generic is available.4 These services promote a greater generic dispensing rate (GDR) to keep up with drugstores GDR. 4 The FDA requires generic drugs to have the same quality and performance as the brand name drugs. Therefore, generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name.3 When mail order services promote GSR this allows for cheaper cost saving advantages to filling generic drugs. GSR is the direction pharmacy is headed; nearly 8 in 10 prescriptions filled in the United Sates are for generic drugs.3 The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent through 2015.3 Overall, mail order services are beneficial for those who are managing chronic conditions where therapy changes are static. Convenience is a major determining factor for many patients who choose mail order services. The availability of generic drugs at a lower cost is an advantage to mail order pharmacies. We hope that plans will allow their patients to make mail order an option, rather than a mandate. Mail order services are a great option for a select patient population who are seeking convenience, but this service should be an option to patients rather than a requirement by the plans. References 1False Savings of Mail Order Pharmacies. (2009). National Community Pharmacists Association (NCPA),1-2. 2Wertheimer, A., & Vulakh, L. (2011). Is Mail Service Pharmacy Cost Beneficial to Plan Sponsors? Innovations in pharmacy, 2(44), 1-8. 3Facts about generic drugs. (2012, September 19). U.S. Food and Drug Administration. 4Wosinska, M., et al., “Generic Dispensing and Substitution in Mail and Retail Pharmacies,” Health Affairs, July 2004.

Palmetto Pharmacist • Volume 53 Number 5


Student Articles

COUNTERPOINT Tia Ware, Pharm. D. Candidate 2014 According to the 2013 U.S. Pharmacy Study by J.D. Power and Associates, satisfaction with mail order pharmacies has continued to decline over the years and remains lower than traditional brick and mortar pharmacies. On a point scale out of 1,000, mail order pharmacies received a 797, 1 up 5 points from 2012 versus retail stores which scored 837. 2 The study, which surveyed over 13,500 customers, used four factors to determine customer satisfaction with mail order pharmacies. They included: prescription delivery, prescription ordering, customer service, and cost competiveness; the latter which seemed to decline the most significantly. 1 This could be, in part, due to recent legislation in certain states regulating mail order pharmacies. In 2011, New York passed a bill that banned mandatory mail order pharmacy plans, except for those negotiated by unions. Customers now have the option of getting the prescriptions filled through mail services or at local retail pharmacies without increased co-pays or extra fees. 3 Similarly, in Pennsylvania a law was amended in 2012 to prevent insurers from enforcing a co-pay on prescriptions filled at retail stores that otherwise would not exist using a mail pharmacy. 4 Currently there is no legislation in the state of South Carolina regulating mail order pharmacy. However, we are one amongst several other states debating restrictions against any type of mandates. The previous study noted that the widening gap between both types of pharmacies has been due to a recent increase in customer satisfaction with brick and mortar pharmacies. This is compared to a previous decline in mail order satisfaction from 2011 to 2012. It measured customer satisfaction in brick and mortar pharmacies across five factors: prescription order, store, cost, non-pharmacist staff, and pharmacist. 2 The store front may be the most apparent difference between the two types of pharmacies and the most

important when considering customer satisfaction. According to the Ashville Project, face-to-face counseling with a pharmacist can be up to three times more effective than other methods with increasing adherence. 5 This is particularly relevant considering 72% of patients engage with their pharmacists at independent stores compared to the 82% of mail order customers who seldom or never engage with a pharmacist. 6 In addition to the opportunity build a rapport with customers, pharmacists in a brick and mortar setting can provide additional services that mail order pharmacies simply cannot. These services include generic drug discount programs, health screenings, vaccinations, and more. All of which can drastically improve patient outcomes compared to mail order pharmacies. As health care reform expands, people are continuing to look for ways to lower costs without jeopardizing patient outcomes. While mail order pharmacy may appear to be the solution to this, countless studies have proven this to be wrong. Cost competitiveness and a physical store front are just two of many reasons why traditional brick and mortar pharmacies are the preferred method of obtaining prescriptions for tens of millions of patients, and it is our job as pharmacists to make sure they stick around for years to come. Referebces 1J.D. Power, “2013 U.S. Pharmacy Study,” Sept 30, 2013. 2J.D. Power, “2012 U.S. Pharmacy Study,” Sept 27, 2012. 3The New York Times, "New Law Bans Mail-Order Drug Mandates,” Hartocollis, Anemona, Dec 14, 2011. 4Atlantic Information Services, "Anti-Mail-Order Laws Pose Threat to Mail Pharmacy-Owning PBMs,” Kelly, Lauren Nov 16, 2012. 5American Journal of Managed Care, "The Asheville Project: Clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia," Bunting, Barry, Benjamin Smith, and Susan Sutherland; 2008; 48:23-31. 6Pharmacy Satisfaction PULSE, “Pharmacy satisfaction data: full industry report,” Boehringer Ingelheim Pharmaceuticals, Inc., March 2011.

Palmetto Pharmacist • Volume 53, Number 5

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Waiting is the hardest part... Getting on the waiting list is easy. Visit www.scrx.org to learn how you can get on the waiting list for SCPhA’s popular certificate training programs. As these programs are added to our course offerings, we’ll contact you and give you the first opportunity to register for these in-demand programs.

Fraud, Waste and Abuse Manual Why waste your precious time starting something from scratch? Get help creating your Fraud, Waste, and Abuse Manual for your pharamcy by purchasing our starting template today! This manual outlines the regulatory environment and essential elements of a compliance program and, in Part II, includes sample policies and procedures that may be useful to pharmacies in developing or updating their compliance programs. Beyond this manual, however, each pharmacy must undertake a detailed risk assessment and self-audit to ensure that its particular compliance program is properly tailored to its business.

Pricing: SCPhA Members $195 Non-Members $495 Purchase it online at www.scrx.org!

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Palmetto Pharmacist • Volume 53 Number 5


2012 Recipients of the “Bowl of Hygeia” Award

John Harmon Alabama

Lyle Fibranz Alaska

Hal Wand Arizona

Donald L. Hedden Arkansas

Melvin K. Renge, Jr California

Jeannine Dickerhofe Colorado

Paul Limberis Colorado*

Scott Wolak Connecticut

Kimberly Couch Delaware

Angela D. Adams Florida

William Moye Georgia

Kelly S.M. Go Hawaii

Randy Malan Illinois

Gerald Roesener Indiana

Eugene Lutz Iowa

Marvin E. Bredehoft Kansas

George Hammons Kentucky

Roxie Stewart Louisiana

Joe Bruno Maine

Frank Nice Maryland

Edward S. Radock Massachusetts

Gregory Baise Michigan

Larry Leske Minnesota

Waymon Tigrett Mississippi

Matt Hartwig Missouri

Jim Seifert Montana

Edward M. DeSimone, II Nebraska

Joe Kellogg Nevada

George Bowersox New Hampshire

Frank Breve New Jersey

Kenneth Corazza New Mexico

Nasir Mahmood New York

Beverly Lingerfeldt North Carolina

Dennis DelaBarre North Dakota

Mimi Hart Ohio

John Foust Oklahoma

Marcus Watt Oregon

Richard Smiga Pennsylvania

Santa E. Nieves Puerto Rico

Michael Simeone Rhode Island

Julian Reynolds South Carolina

Galen Jordre South Dakota

Marion Crowell Tennessee

Dennis Song Texas

Lloyd J. Thomas Utah

Empsy Munden Virginia

Michelle Valentine Washington

Eric Belldina West Virginia

Gary Bongey Wisconsin

Tonya Woods Wyoming

The “Bowl of Hygeia”

The Bowl of Hygeia award program was originally developed by the A. H. Robins Company to recognize pharmacists across the nation for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the state pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bowl of Hygeia is on display in the APhA Awards Gallery located in Washington, DC. Boehringer Ingelheim is proud to be the Premier Supporter of the 2012 & 2013 Bowl of Hygeia program. *2011 recipient awarded in 2012

Palmetto Pharmacist • Volume 53, Number 5

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Medicaid

\

Medicaid Update

We wanted to make you aware of a Public Notice that was released by the South Carolina Department of Health and Human Services (SCDHHS). SCDHHS is seeking to allow hospitals to make presumptive Medicaid eligibility determinations for individuals who attest to a simplified set of eligibility requirements. Individuals who are determined presumptively eligible will be enrolled in a fee-for-service payment category based on the hospital’s assessment of categorical eligibility, household income, state residency and citizenship, status as a national or satisfactory immigration status as attested by the applicant. If you have any questions about this information, please contact Cason Gaither at Capitol Consultants at (803) 252-1087 or cgaither@capconsc.com. Presumptive Eligibility in Hospitals The South Carolina Department of Health and Human Services (SCDHHS) has given notice of the following proposed actions pursuant to the requirements of Title 42 CFR § 435.1110 regarding eligibility changes implemented in accordance with The Patient Protection and Affordable Care Act of 2010 (ACA) under the State Plan under Title XIX of the Social Security Act Medical Assistance Program (Medicaid). Effective for services provided on or after January 1, 2014, SCDHHS proposes to amend the South Carolina Title XIX eligibility methodology to include Presumptive Eligibility in Hospitals as required by the Affordable Care Act. Through the Presumptive Eligibility Program, hospitals that participate in the Medicaid program and have not been disqualified can make presumptive Medicaid eligibility determinations for individuals who attest to a simplified set of eligibility requirements for the following SCDHHS categories: Pregnant Women, Family Planning, Former Foster Care Children to Age 26, Breast and Cervical Cancer Treatment, Infants and Children under Age 19, Parents and Caretaker Relatives. SCDHHS 24

will communicate the program requirements and provide training to these hospitals. Individuals who are determined presumptively eligible will be enrolled in a fee-for-service payment category based on the hospital’s assessment of categorical eligibility, household income, state residency and citizenship, status as a national or satisfactory immigration status as attested by the applicant. The agency will provide all services covered under the plan, including EPSDT, during this Presumptive Eligibility Period. Exceptions to this include individuals found presumptively eligible for family planning will receive services limited to family planning, and individuals enrolled in the presumptively eligible category for pregnant women will only receive ambulatory prenatal care. Presumptive Eligibility Periods are limited to no more than one period within two calendar years. The Presumptive Eligibility Period begins on the date the determination is made. The Presumptive Eligibility Period ends with the earlier of: • The date the eligibility determination for regular Medicaid is made, if an application for Medicaid is filed by the last day of the month following the month in which the determination of presumptive eligibility is made; or • The last day of the month following the month in which the determination of presumptive eligibility is made, if no application for Medicaid is filed by that date. SCDHHS will require hospitals to meet performance standards that relate to the proportion of individuals determined presumptively eligible who submit a full application before the end of the Presumptive Eligibility Period and the proportion of individuals who are determined eligible for Medicaid based on the submission of an application before the end of the Presumptive Eligibility Period. Palmetto Pharmacist • Volume 53 Number 5


Medicaid According to SCDHHS, this program is designed to reach SC residents who are eligible but unenrolled which includes an estimated 162,000* individuals that are expected to enroll in Medicaid as an effect of the implementation of the Affordable Care Act. If each of these individuals is enrolled through this program and receives full Medicaid eligibility, Medicaid expenditures have the potential to increase by approximately $996.9 million state dollars during state fiscal years 2014 through 2020*. Additional costs may be incurred in the event that individuals who are not truly eligible are granted presumptive eligibility by hospitals in error. Hospitals that want to participate in the Presumptive Eligibility Program for January 1, 2014 must contact SCDHHS no later than November 1, 2013 to allow for training. Participating hospitals must agree to make determinations according to state policy. Email collaboration@scdhhs.gov, and a program representative will contact you.

Division of Display Options, Inc. Rx Planning Specialist Roland Thomas 70 years combined experience in over 2,000 pharmacies.

Copies of this notice are available at each County Department of Health and Human Services Office and at www.scdhhs.gov for public review. Additional information concerning the proposed action is available upon request at the address cited below. Written comments may be sent to the division of Eligibility, Enrollment, and Member Services, South Carolina Department of Health and Human Services, Post Office Box 8206, Columbia, South Carolina 29202-8206. Comments may also be submitted to comments@scdhhs.gov . Written and e-mailed comments must be received by November 16, 2013. Any written comments submitted may be reviewed by the public at the SCDHHS, Eligibility, Enrollment, and Member Services, 1801 Main Street, Columbia, South Carolina, Monday through Friday between the hours of 9:00 A.M. and 5:00 P.M. *Milliman ACA Impact Analysis dated January 11, 2013. This is an average estimate based on the assumption that 67% of those eligible but unenrolled join the Medicaid program as an effect of ACA implementation.

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1-800-321-4344 www.displayoptions.com

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Palmetto Pharmacist • Volume 53 Number 5


Pharmacy Nights are back!

Pharmacy Night Locations

○ Network with your peers while you eat dinner. ○ Get 2 hours of continuing education. ○ Meet SCPhA’s new CEO, Craig Burridge. ○ Get to know your Region SCPhA leadership. ○ Learn about the Association, events and activities. ○ Renew your SCPhA membership!

6:00 PM - 7:00 PM: Registration and Dinner 7:00 PM - 9:00 PM: Program (2 Hours CE) $15 for 2013-2014 SCPhA Members $25 for Non-Members $10 for Students (no CE credit provided)

August 20, 2013 and March 18, 2014: Greenville Virginia College ● 78 Global Dr., Greenville, SC September 10, 2013: Myrtle Beach Grand Strand RMC ● 809 82nd Pkwy., Myrtle Beach, SC September 24, 2013 and February 11, 2014: Columbia SCPhA Office ● 1350 Browning Rd., Columbia, SC October 2, 2013 and February 4, 2014: Charleston Bon Secours Hospital ● 2095 Henry Tecklenburg Dr., Charleston, SC October 17: Florence Virginia College ● 2400 David H. McLeod Blvd., Florence, SC November 5: Rock Hill Piedmont Medical Center ● 222 S. Herlong Ave., Rock Hill, SC January 23: Aiken Aiken Tech ● 2276 J. Davis Hwy., Graniteville, SC *Locations are subject to change. Please check www.scrx.org for specific event details closer to each Pharmacy Night.

Select the Pharmacy Night you wish to attend:

2013 □ Greenville (August 20) □ Myrtle Beach (September 10) □ Columbia (September 24) □ Charleston (October 2) □ Florence (October 17) □ Rock Hill (November 5) 2014 □ Charleston (February 4) □ Columbia (February 11) □ Greenville (March 18) □ Aiken (January 23)

*Cities with more than one Pharmacy Night will have different topics.

SCPhA Member: Qty. ______ ($15 ea.)

Non-Member: Qty. ______ ($25 ea.) Student: Qty. ______ ($10 ea.)

*If renewing or joining on this form, please select the member rate.

To renew or join SCPhA now, please select your member type below: □ Pharmacist ($150) □ Associate ($150)

□ Retired ($75)

□ First Year ($75)

□ Technician ($35)

□ Student (free!)

Name____________________________________________________________ □ Technician □ Pharmacist □ Student Email_________________________________________________________ Phone______________________________ License/Reg #________________ NABP eID#______________________ Birthdate (MM/DD)__________________ Payment Type: □ Check _________ Total Amount Due: $_____________ Credit Card Type: □ MC □ Visa □ AMEX □ Discover Name on Card________________________________________ Card #____________________________________________________ Exp. Date____________________ CVV_____________ Billing Address ___________________________________________________________________________________________

Cancellations will only be accepted if received more than 5 business days before the event. If applicable, a refund will be issued less a $5 processing fee. South Carolina Pharmacy Association is accredited by the accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity is eligible for ACPE credit; see final CPE activity announcement for specific details.

Gorilla Photo Courtesy: Ron Brasington/Riverbanks Zoo and Garden

Complete this form and return to SCPhA, with payment, to SCPhA, Road, Columbia, SC 29210 fax Palmetto Pharmacist • Volume 53, Number 5 1350 Browning 27or to 803.354.9207. Visit www.scrx.org to register online. Call 803.354.9977 with questions.


FINANCIAL FORUM

orum

inancial

This series, Financial Forum, is presented by Pro Advantage Services, Inc., a subsidiary of Pharmacists Mutual Insurance Company, and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

Financial Considerations for 2014 2014 is really not too far away. Fall is the time of year when the financially savvy start to look for ways to reduce their taxes and make year-end moves in pursuit of key financial objectives. What might the big picture hold? Absent a crystal ball, let’s turn to the September edition of the Wall Street Journal’s Economic Forecasting Survey. The WSJ asks 52 economists for their take on things each month, and here is how they see 2014 shaping up for America: GDP of 2.8%, a jobless rate declining from the present 7.3% to 6.6% by the end of next year and consumer inflation of 2.5% or less through the end of 2015. These analysts also see the Federal Reserve keeping the benchmark interest rate at 0-0.25% for all of 2014. As for the yield on the 10-year note, their consensus projection has it hitting 3.28% in June 2014 and 3.57% in December 2014. They also see home prices rising 5.22% YOY in 2014 after a 7.85% gain across 2013. Oil, they think, will average $102.73 a barrel on the NYMEX this December, declining to $98.17 a barrel next December. For its part, the International Monetary Fund projects 3.8% inflation-adjusted global growth next year, and a 4.3% tumble for global nonfuel commodities in U.S. dollar terms. These are all macro forecasts worth keeping in mind.1,2 Now, how about your picture? Beyond these macro forecasts that may affect your business and personal 28

finances, what moves might you consider? Can you max out your IRA or workplace retirement plan contribution? If you have, congratulations (especially if you benefit further from an employer match). If you haven’t, you still have the chance to put up to $5,500 into a traditional or Roth IRA for tax year 2013, $6,500 if you are 50 or older this year, assuming your income levels allow you to do so. (Or you can spread that maximum contribution across more than one IRA.) Traditional IRA contributions are tax-deductible to varying degree. The contribution limit for participants in 401(k), 403(b) and most 457 plans and the Thrift Savings Plan is $17,500 for 2013, with a $5,500 catch-up contribution allowed for those 50 and older.3,4 Incidentally, the FY 2014 federal budget set out by the White House proposes some changes to IRAs & 401(k)-style plans in 2014. First, if an individual’s total tax-deferred retirement savings through these plans is great enough to produce yearly retirement income of $205,000 for the individual and his/her surviving spouse, then further contributions to such accounts would be nixed. (Today, it would take savings of nearly $3.5 million to produce such a retirement income stream.) Second, the Stretch IRA strategy would basically vanish: the FY 2014 budget proposes that all IRA inheritors follow the 5-year rule, in which an inherited IRA balance is reduced to zero by the end of the fifth year after the year in which the original IRA owner dies. (Disabled IRA inheritors and certain other beneficiaries would be exempt from the 5-year rule.)5

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Should you go Roth in 2014? The younger you are, the more sense a Roth IRA conversion may make. If you have a long time horizon to let your IRA grow, have the funds to pay the tax on the conversion, and want your heirs to inherit tax-free distributions from your IRA, it may be worth it. If you think you will pay less tax in the future or you might die with a large charitable bequest, then it may not be a wise move. Can you harvest portfolio losses before 2014? This is the time of year to think about tax loss harvesting – dumping the losers in your portfolio. You can claim losses equivalent to any capital gains recognized in a tax year, and you can claim up to $3,000 in additional losses beyond that, which can offset dividend, interest and wage income. If your losses exceed that limit, they can be carried over into future years. It is a good idea to do this before December, as that will give you the necessary 30 days to repurchase any shares should you wish.6 In terms of taxes, should you delay a big financial move until 2014? Talk with a tax professional about the impact that selling or buying a home or business might have on your 2013 taxes. You may want to wait. Receiving a bonus, getting married or divorced, exercising a stock option, taking a lumpsum payout – these events have potentially major tax consequences as well. Business owners may want to consider whether to make a capital purchase or not. Look at tax efficiency in your portfolio. Investors were strongly cautioned to do this at the end of 2012 as the fiscal cliff loomed; it is a good idea before any year ebbs into the next. You may want to put incomeproducing investments inside an IRA, for example, and direct investments with lesser tax implications into brokerage accounts. Finally, do you need to change your withholding status? If major change has come to your personal or financial life, it might be time. If you have married or divorced, if a family member has passed away, if you are self-employed now or have landed a much higher-salaried job, or if you either pay a lot of tax or get unusually large IRS or state refunds, you will want to review this with your tax preparer.

Pat Reding and Bo Schnurr may be reached at 800288-6669 or pbh@berthelrep.com. Registered Representative of and securities and investment advisory services offered through Berthel Fisher & Company Financial Services, Inc. Member FINRA/SIPC. PRISM Wealth Advisors LLC is independent of Berthel Fisher & Company Financial Services Inc. This material was prepared by MarketingLibrary. Net Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. All information is believed to be from reliable sources; however we make no representation as to its completeness or accuracy. Please note - investing involves risk, and past performance is no guarantee of future results. The publisher is not engaged in rendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information should not be construed as investment, tax or legal advice and may not be relied on for the purpose of avoiding any Federal tax penalty. This is neither a solicitation nor recommendation to purchase or sell any investment or insurance product or service, and should not be relied upon as such. All indices are unmanaged and are not illustrative of any particular investment Citations. 1 - online.wsj.com/public/resources/documents/infoflash08.html?project=EFORECAST07 [9/12/13] 2 - forbes.com/sites/billconerly/2013/09/02/economic-assumptions-for-your-2014-business-plan/ [9/2/13] 3 - irs.gov/Retirement-Plans/Plan-Participant,-Employee/Retirement-Topics-IRA-Contribution-Limits/ [9/12/13] 4 - shrm.org/hrdisciplines/benefits/articles/ pages/2013-irs-401k-contribution-limits.aspx [10/19/12] 5 - blogs.marketwatch.com/encore/2013/09/09/budget-talks-could-alter-401k-ira-rules/ [9/9/13] 6 - dailyfinance.com/2013/09/09/tax-loss-sellingdont-wait-december-dump-losers/ [9/9/13]

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JOURNAL CE Preventing Osteoporosis-Related Fractures: A Review of the Evidence By Kayce Shealy*, PharmD, BCPS, BCACP and Zachary Anderson, PharmD, BCACP Objectives: After completing this activity, participants should be able to:

for certain adverse effects that have been highly publicized in the media.

1. List available treatment options for patients with osteoporosis. 2. Compare and contrast evidence supporting use of particular pharmacologic agents for treating osteoporosis or preventing related fractures. 3. Understand possible mechanism(s) behind potentially severe adverse effects associated with pharmacologic agents. 4. Understand why traditional monitoring practices may not be suitable for monitoring disease progression and response to therapy with all pharmacologic agents.

Keywords: osteoporosis, fracture, prevention, evidence, bisphosphonate, calcium, vitamin D, denosumab, teriparatide, calcitonin

Summary: Osteoporosis is a prevalent and costly disease. Approximately 10 million Americans are diagnosed with osteoporosis and another 33 million are estimated to be at risk. Patients with osteoporosis are at an increased risk of fractures, and therefore other sequelae including diminished quality of life and mobility, and increased risk of death. These potential risks should be assessed and prevention treatment should be undertaken in most patients with osteoporosis. Therapy for the treatment of osteoporosis and prevention of related fractures includes a variety of pharmacologic agents. The ideal treatment modality would include an agent that has been proven to be both safe and effective in treatment of osteoporosis and prevention of related fractures. However, there is no “one size fits all� method for determining the most appropriate pharmacologic agent. The decision must be patient-specific and tailored to the needs and characteristics of each individual patient. In addition, not all options have sufficient evidence to support their use. In this follow-up article to the previously presented management of osteoporosis, readers will get the opportunity to review the available evidence for the pharmacologic agents used in the treatment and prevention of osteoporosis, as well as evidence 30

Introduction Osteoporosis is a prevalent medical condition that affects approximately 10 million Americans, with an estimated 33 million at risk due to low bone density.1 Approximately 50% of Caucasian women, as well as 20% of men, are expected to experience an osteoporosis-related fracture at some point in their lifespan. While less common, African Americans who have been diagnosed with osteoporosis are expected to experience related fractures at the same rate. Sustaining fractures related to osteoporosis can lead to impaired mobility and diminished quality of life. Hip fractures in patients with osteoporosis have also been associated with increased mortality, as high as 36% within the first year after the fracture and is greater with men.2 These potential sequelae warrant therapy for treatment and other prevention measures in most patients with osteoporosis. Therapy for the treatment of osteoporosis and prevention of related fractures includes a variety of pharmacologic agents. The ideal treatment modality would include an agent that has been proven to be both safe and effective in treatment of osteoporosis and prevention of related fractures. However, not all options have sufficient evidence to support their use. This continuing education paper seeks to review the available evidence for therapeutic options in treating osteoporosis and preventing fractures as well as evidence for certain adverse effects that have been highly publicized in the media. It is a follow-up article to previously presented management of osteoporosis.

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JOURNAL CE Calcium and Vitamin D Calcium and vitamin D are recommended for bone health in all individuals 50 years of age and older by the National Osteoporosis Foundation.1 Women aged 51 and older are recommended to receive approximately 1200 mg of calcium daily and approximately 800 to 1000 international units of vitamin D daily. Dietary modification is preferred to obtain the recommended dose of calcium, but supplementation should be used if needed. Calcium and vitamin D has been shown to reduce bone loss in postmenopausal women and men3. However, evidence for the benefit of calcium and vitamin D in postmenopausal women to prevent fractures is conflicting. A meta-analysis published in 2007 reviewed seven cohort studies and five randomized controlled trials (RCTs) evaluating calcium intake and hip fracture risk in women and men.4Studies were included if at least 100 patients were studied and followed for a minimum of 1 year. Any studies that included other pharmacologic therapy, including vitamin D supplementation, were excluded. A total of 8 cohort studies (7 with women, 5 with men) and 7 RCTs were included. Results from the pooled cohort studies revealed a lack of association of hip fracture risk and calcium intake, regardless of dose. However, results from the RCTs showed a trend towards higher risk of hip fracture in women treated with calcium supplementation alone compared to placebo. The Women’s Health Initiative (WHI) calcium and vitamin D trial included over 36,000 women and intended to prove that those who took calcium and vitamin D supplements were less likely to suffer hip fractures, or any fracture, compared to women who did not supplement.5Women between the ages of 50 and 79 who also participated in the other WHI trials were eligible to be included; those with hypercalcemia, renal caculi, or corticosteroid or cortisol use were excluded. Personal supplementation with calcium (up to 1000 mg) and vitamin D (up to 600 international units) were allowed, as were use of bisphosphonates, calcitonin, and estrogen. Women in the treatment group received calcium 500 mg and vitamin D 200 international units twice daily. The average age of those included was 62 years old, and approximately 39% of each group (treatment and placebo) were taking more than 1200 mg of calcium daily prior to enrolling in this study. The mean follow-up in the trial was seven years.

Calcium and vitamin D users had significantly higher bone mineral density at the 3-, 6-, and 9-year follow up visits. However, the intention-to-treat analysis showed no significant differences in fracture rates between those treated with calcium and vitamin D or placebo for either hip, vertebral, or wrist sites. After controlling for nonadherence, though, there was a significant reduction in fractures for the calcium and vitamin D group. So, women who were adherent to the treatment protocol were less likely to suffer a hip fracture, compared to those who were not. The Agency for Healthcare Research and Quality (AHRQ) completed a comparative effectiveness review regarding treatments for fracture prevention in men and women with osteoporosis or low bone mass and published the results in 2012.6According to the findings, calcium supplementation alone does not reduce the risks of vertebral fractures, but adherent patients may benefit with reduced risk for hip fracture. Administration of vitamin D alone compared to calcium alone resulted in no difference in fracture reduction, regardless of site and dose. Also, there is a moderate body of evidence that supports use of vitamin D in conjunction with calcium to reduce the risk of fractures in institutionalized patients. Benefit in non-institutionalized patients was conflicting. Similar to AHRQâ&#x20AC;&#x2122;s findings, a review by the United States Preventive Services Task Force (USPSTF) concluded that there is little evidence to support supplementing with calcium and vitamin D in postmenopausal women to prevent fractures and recommends against calcium supplementation <1000 mg and vitamin D supplementation <400 international units.7 The benefits of calcium and vitamin D supplementation must be weighed against the potential harms of use. While seemingly benign in nature, calcium and vitamin D use are associated with several adverse effects. Most common effects are confined to the gastrointestinal tract, including constipation, but there is a risk of hypercalcemia and vitamin D toxicity with excessive dosing. Calcium supplementation alone has also been linked to increased risks for cardiovascular events, such as myocardial infarctions, especially in patients with other risk factors or preexisting disease.8-10Patients should be encouraged to maximize dietary intake of calcium before supplementing to potentially avert these risks. Adequate calcium and vitamin D intake continues to be recommended in combination with other pharmacologic therapy due to adverse effects of other agents as well as poten-

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JOURNAL CE tial benefit of increased BMD in patients. High risk patients or those with a previous fracture history will likely need more than calcium and vitamin D alone. Bisphosphonates Bisphosphonates are the most studied and widely used agents in the prevention and treatment of osteoporosis. Whether it is the FIT trial, which assessed once weekly alendronate, the VERT study, which assessed risedronate once daily, or the HORIZON-PFT trial, which assessed once yearly zoledronic acid, bisphosphonates have demonstrated time and time again their efficacy (Table 1) at reducing the risk of vertebral, nonvertebral, and hip fracture (41-70%, 2539%, and 40-51%, respectively), as well as increase both spine and hip BMD (4.3-6.7% and 2.8-6.0%, respectively.11-13 Due to this, but not limited to, overwhelming evidence, bisphosphonates remain the first line drug of choice for the prevention and treatment of osteoporosis.1 However, in recent years, bisphosphonates have received some negative press concerning potentially significant adverse effects that may be associated with long-term bisphosphonate therapy, including atrial fibrillation, osteonecrosis of the jaw (ONJ), and atypical femoral fractures. Instead of additional exploring and exhausting the evidence of why bisphosphonates should be considered first line therapy, it is important to further investigate these media noteworthy concerns and assess whether or not there is any true cause for concern. The significance of whether or not bisphosphonates lead to, or can increase the risk of develop478 Tables: ing, atrial fibrillation is still being reviewed by the FDA. Therefore, at this time providers must examine 479 the clinical evidence in order to determine the risk. 480 Several investigators have sought to examine the 481

482 483

possible mechanism(s) by which bisphosphonates may lead to, or increase the risk of developing, atrial fibrillation since the association was noticed in the FIT, FLEX, and HORIZON trials.11, 13-17 Interestingly enough, this association has only been found with the potent nitrogen-containing bisphosphonates, zoledronic acid and alendronate, which are known to inhibit protein prenylation, disrupting the function of key regulatory proteins.17 A possible mechanism as to why zoledronic acid may lead to, or increase the risk of developing, atrial fibrillation is that parenteral bisphosphonates have been found to stimulate the release of inflammatory cytokines, which have been associated with an increased risk of atrial fibrillation at increased levels.17 At this time, it is unknown if oral bisphosphonates also have the ability to stimulate inflammatory cytokine release. The last possible mechanism that will be discussed centers around bisphosphonate’s ability to ability to cause decreases in serum calcium. Generally, bisphosphonates only cause small decreases in serum calcium, but there is always the risk that it can lead to hypocalcaemia. Since the atrium of the heart is sensitive to shifts in serum calcium concentrations, it is mechanistically possible that these shifts could predispose patients to atrial fibrillation. At this time, more data is needed before guidelinebased recommendations regarding atrial fibrillation risk with bisphosphonate therapy can be made. When examining characteristics of the patient population that would typically receive bisphosphonate therapy, it is evident that there is an overlap between osteoporosis and heart disease, especially when you take into account possible confounding factors such as age, history of nicotine dependence, and thyroid

Table 1: Efficacy of Pharmacological Agents (adapted from NOF guidelines)47 % Change % Change Vertebral Nonvertebral in Spine in Hip Agent Fx Fx Hip Fx BMD BMD Bisphosphonates ↓ 41-70% ↓ 25-39% ↓ 40-51% ↑ 4.3-6.7% ↑ 2.8-6.0% Denosumab ↓ 68% ↓ 20% ↓ 40% ↑ 9.2% ↑ 6.0% Raloxifene ↓ 30% ↔ ↔ ↑ 2.6% ↑ 2.1% Estrogen (with or ↓ 33-40% ↓ 13-27% ↓ 34% ↑ 3.5-7.0% ↑ 1.7-4.1% without progesterone)

Calcitonin Teriparatide

↓ 33% ↓ 65%

↓ 53%

↔ ↔

↑ 0.7% (NS) ↔ ↑ 8.6% ↑ 3.6%

Abbreviations: BMD, bone mineral density; Fx, fracture; NS, not significant

484 485

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JOURNAL CE function. Therefore, providers must weigh the risks and benefits of bisphosphonate therapy when making the decision to initiate pharmacological therapy in the prevention and treatment of osteoporosis. In most cases, the benefits of bisphosphonate therapy will clearly and decisively outweigh any potential risks. Prior to discussing whether or not bisphosphonates may cause ONJ or atypical femoral fractures, it is important to understand the concept that long-term bisphosphonate therapy can lead to the creation of “brittle bones”, also referred to as Brittle Bone Syndrome (BBS). Bisphosphonate’s mechanism of action is to inhibit hydroxyapatite crystals in the bone, which results in the inhibition of bone turnover, which is great for increasing BMD, but bone turnover is also responsible for the repair of microdamage that occurs in the bone due to the wear and tear that body takes throughout a lifetime. Since bisphosphonates deposit in the bone with a half-life of greater than 10 years, there would seem to be the potential to cause oversuppression of bone turnover, which could lead to an accumulation of microdamage on the bone due to decreased surface mineralization. Since surface mineralization decreased by 58-92% after three years of bisphosphonate therapy, it is not unwarranted to presume that long-term bisphosphonate therapy could lead to the possibility that bones will become “brittle” and unable to repair microdamage.18 Osteonecrosis of the jaw is characterized by damage and death to areas of the jaw bone, which occurs due to decreased blood supply to the bone and surrounding tissue. This is a big issue since the jaw bone is in continual need of repair due to the activities of daily life, including chewing and speech, or other causes of bone damage, including infection, dental procedures, or other causes of trauma. Though no cases of ONJ were observed in initial clinical trials, case reports began to be published linking bisphosphonate therapy, especially parenteral bisphosphonate therapy in cancer patients, to ONJ in 2003. Thus, in 2005, the FDA began to require a class warning of ONJ with bisphosphonate therapy. As mentioned previously, the risk of ONJ is likely associated with parenteral bisphosphonate therapy, with a prevalence of 6-10% in cancer patients. In addition, an increased risk of ONJ in patients receiving parenteral bisphosphonate therapy has been observed in patients who underwent traumatic dental procedures, such as a tooth extraction. Therefore, providers should perform and stress

preventative measures, such as patient education regarding limited risk of ONJ, the need for baseline and routine dental examinations every six months, good oral hygiene, and to instruct patients to inform their dentist and hygienist of all current medications. Lastly, evidence is unclear as to whether or not bisphosphonate therapy should be held prior to and/or following dental procedures. However, one should be able to draw an appropriate recommendation based on their knowledge of the medication. Bisphosphonates have an extremely long half-life, sticking to bone for more than 10 years, so one should not expect that holding bisphosphonate therapy for a short, or even extended, period of time prior to and/or following a dental procedure would lead to a decreased risk of ONJ. If a provider knows that a patient is scheduled for a dental procedure prior to initiating bisphosphonate therapy, then it would be reasonable to delay bisphosphonate therapy until the patient has undergone the procedure. Of late, bisphosphonates have been in the media regarding recent case reports and meta-analyses that suggest a risk of atypical femoral fractures in patients on bisphosphonate therapy for longer than five years.18-21 Atypical femoral fractures occur with minimal or no trauma and are often associated with prodromal symptoms, such as thigh pain or discomfort for up to weeks prior to the fracture. It is important to note that some case reports involved patients receiving corticosteroid therapy and in most instances, patients were receiving alendronate therapy for more than five years. Due to these case reports and meta-analyses, the FDA has issued a warning of possible increased risk of atypical femoral fractures with bisphosphonate use. Despite the FDA taking a quick and firm stance on the controversy, the data is still unclear and some investigators feel that the data does not support a significantly increased risk of atypical femoral fractures due to long-term bisphosphonate therapy. Therefore, providers should not stop prescribing bisphosphonates due to concerns of atypical femoral fractures. Bisphosphonates remain the first line drug of choice in the prevention and treatment of osteoporosis. Since bisphosphonates are stored in the bone for years and with recent controversies possibly associated with long-term therapy, it would be reasonable to consider a drug holiday in patients that have received therapy for five or more years. Based on the FLEX trial, there may be no added benefit in treating

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JOURNAL CE patients with bisphosphonates for greater than five years.14 The FLEX trial showed that discontinuing alendronate therapy after five years yielded a moderate decline in BMD, but did not increase the risk of fracture other than clinical vertebral fractures versus those who continued alendronate for an additional five years. The results of the FLEX trial suggest that discontinuation for up to five years does not appear to significantly increase a patient’s risk of fracture. Patient’s at high risk for clinical vertebral fracture, including a past medical history of vertebral fracture or a T-score of the AP spine less than -3, would not benefit from a drug holiday. Denosumab (Prolia®) Denosumab is the newest agent to be marketed for the treatment of osteoporosis. In the FREEDOM trial, denosumab was associated with a reduced risk of vertebral, nonvertebral, and hip fractures (Table 1) compared to placebo.22 In this trial, 21, 56, 67, and 200 patients would need to be treated to prevent one vertebral fracture, clinical vertebral fracture, nonvertebral fracture, and hip fracture, respectively. In a post hoc subgroup analysis of women considered at high risk for new fractures from the FREEDOM trial, denosumab was associated with a reduced risk of new vertebral and hip fractures.23 In this analysis, high risk was defined as any one of the following: 75 years of age or older, prevalent vertebral fractures, femoral neck BMD T-score of -2.5 or lower. At this time, denosumab has only been compared to two bisphosphonates: alendronate and ibandronate.24-27 Based on these studies, denosumab may increase BMD more than alendronate, but may not reduce fracture risk compared to alendronate in postmenopausal women. Denosumab is also associated with increased BMD compared to ibandronate in postmenopausal women with low BMD previously treated with a bisphosphonate. Though denosumab offers a novel mechanism of action and the benefit of every six month dosing, it is likely to not be considered before bisphosphonates as the initial drug of choice in the treatment of osteoporosis for most patients. However, denosumab may be an appropriate first line option for patients that have a contraindication to bisphosphonate therapy or refuse bisphosphonate therapy. In addition, denosumab may be appropriate for patients with a history of nonadherence since it must be given in the primary care clinic, thus allowing for close adherence monitoring.

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Raloxifene (Evista®) and Estrogens Raloxifene (Evista) is known as a selective estrogen receptor modulator, or SERM, and is FDA-approved for prevention and treatment of postmenopausal osteoporosis.1 As an estrogen agonist, it inhibits bone resorption but acts like an estrogen antagonist at uterine and breast estrogen receptors. Common adverse effects include hot flashes, peripheral edema, as well as increased risk of thromboembolic events. A randomized controlled trial, the Multiple Outcomes of Raloxifene Evaluation (MORE), assessed whether raloxifene reduced fractures in more than 7000 postmenopausal women with osteoporosis.28The average age of participants was 67 years, and almost all were white. Raloxifene therapy increased bone mineral density by 2-2.5% at the femoral neck and spine after 3 years of treatment. In addition to increased bone mass, fewer patients experienced a vertebral fracture in the treatment group compared to placebo. This effect was more pronounced in women who had experienced a previous fracture. Approximately 46 women with no fracture history would need to be treated with raloxifene 60 mg for 3 years to prevent one fracture. Likewise, approximately 16 women with a history of previous fracture would need to be treated with raloxifene 60 mg for 3 years to prevent on fracture. However, there was no difference in the number of nonvertebral fractures between the raloxifene and placebo groups. While effective, raloxifene would be more appropriately utilized as a second-line agent for prevention of fractures in postmenopausal women due to its potential adverse effects and the availability of other agents that have been proven more effective at both vertebral and nonvertebral fracture prevention. Raloxifene may be particularly appropriate in postmenopausal women who also have a previous history of fractures. Estrogen therapy is FDA-approved for the prevention of osteoporosis in postmenopausal women. The recent AHRQ review found a substantial body of evidence supporting decreased vertebral and hip fractures in postmenopausal with the use of estrogen therapy.6However, evidence is lacking in women with osteoporosis. Considering increased risks for cerebrovascular and thromboembolic events, estrogen therapy with or without progestins is not recommended solely for the prevention of fractures in postmenopausal women.

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JOURNAL CE Calcitonin (Miacalcin®, Fortical®) Intranasal calcitonin appears to preserve bone mass in glucocorticoid-induced osteoporosis (GIOP) and may reduce risk for recurrent vertebral fractures by approximately 33% (Table 1), but is most likely less effective than bisphosphonates at maintaining or increasing BMD.29-32 Calcitonin is more realistically and reasonably be a third or fourth line agent for the treatment of osteoporosis due to its limited efficacy, with the exception in those patients with moderatesevere renal impairment. In addition, clinical studies have shown that intranasal calcitonin provides significant bone pain relief in as little as one week after initiating therapy, in both patients with and without a recent history of vertebral fracture.33-39 Therefore, if a patient’s osteoporosis-related bone pain is not selflimiting or adequately controlled with over-the-counter (OTC) analgesics, additional methods of analgesia may be required. These patients may benefit from combination therapy with intranasal calcitonin.40 However, intranasal calcitonin has only been studied in combination with estrogen, which showed positive results on BMD although results regarding fracture risk were unclear.41 Future studies to assess efficacy of intranasal calcitonin as add-on therapy in postmenopausal women already receiving a bisphosphonate, denosumab, or teriparatide with inadequately controlled bone pain would be beneficial. Teriparatide (Forteo®) Teriparatide is an efficacious agent (Table 1) with a novel mechanism of action, giving it its own niche in the management of osteoporosis. Teriparatide has been shown to reduce the risk for vertebral and nonvertebral fractures by 65% and 53%, respectively, in addition to increasing both spine and hip BMD by 8.6% and 3.6%, respectively.42,43 In addition, teriparatide may even be more effective than bisphosphonates for reducing nonvertebral fractures and in patients with GIOP, reducing vertebral fracture and increasing BMD. When used in combination, teriparatide and bisphosphonates may increase BMD more than each agent as monotherapy.44,45 In the recently published DATA trial, combination teriparatide and denosumab was associated with increased BMD compared to monotherapy with each agent in postmenopausal women with osteoporosis at high risk of fracture.46 Based on the clinical evidence, teriparatide seems to be a versatile agent, but therapy may be limited due to its daily subcutaneous dosage, which some patients

wish to avoid. Despite this, providers should counsel patients on the benefits of teriparatide, even if it traditional monitoring methods may not detect its degree of benefit. Patients may show little to no improvement in traditional monitoring parameters, BMD and T-scores, during or after completing teriparatide therapy due to its mechanism of action, increasing corticol thickness and trabecular bone volume, or bone formation. The full benefit of teriparatide may not be seen by monitoring BMD alone. As discussed in part one of this continuing education (CE) series, “Osteoporosis: The Basics”, bone turnover markers may help assess a patient’s response to therapy.47 Therefore, it would be reasonable for providers to monitor bone turnover markers three to six months after initiating teriparatide and after two years at the completion of therapy. Conclusion Many therapies are FDA-approved and available for use in treating osteoporosis and preventing related fractures. Some therapies have been proven to be more effective than others are preventing fractures at certain sites, such as hip or spine, and are therefore considered first line. In addition to being familiar with efficacy data, it is also important to be familiar with data regarding potential adverse events that are highly publicized in the media or associated with treatment. This knowledge ensures the pharmacist’s ability to make more informed recommendations to providers and patients regarding appropriate treatment options. References: 1. National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. Washington, DC: National Osteoporosis Foundation. 2013. 2. B. Abrahamsen, T. van Staa, R. Ariely, M. Olson, C. Cooper. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int. 2009; 20:(10):1633–1650. 3. Daly RM, Brown M, Bass S, Kukulijan S, Nowson C. Calcium- and vitaminD3-fortified milk reduces bone loss at clinically relevant skeletal sites in older men: a 2-year randomized controlled trial. J Bone Miner Res 2006; 21(3): 397-405 4. Bischoff-Ferrari HA, Dawson-Hughes B, Baron JA, et al. Calcium intake and hip fracture risk in men and women: a meta-analysis of prospective cohort studies and randomized controlled trials. Am J Clin Nutr 2007; 86: 1780-1790 5. Jackson RD, LaCroix AZ, Gass M, et al. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med 2006; 354: 669-683 6. Newberry SJ, Crandall CC, Gellad WG, et al. Treatment to prevent fractures in men and women with low bone density or osteoporosis: update of a 2007 report. Comparative Effectiveness Review No 53 (Prepared by Southern California Evidence-based Practice Center under contract no. HHSA-290-2007-10062-I). Rockville, MD: Agency for Healthcare Research and Quality; March 2012. www.effectivehealthcare. ahrq.gov/reports/final.cfm (Accessed June 22, 2013) 7. Moyer VA. Vitamin D and calcium supplementation to prevent

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JOURNAL CE fractures in adults: US Preventive Services Task Force recommendation statement. Ann Intern Med 2013; 158: 691-696. 8. Bolland MJ, Barber PA, Doughty RN, et al. Vascular events in healthy older women receiving calcium supplementation: randomized controlled trial. BMJ 2008; 336: 262-266 9. Bolland MJ, Avenell A, Baron JA, et al. Effect of calcium supplements on risk of MI and cardiovascular events: meta-analysis. BMJ 2010; 341: c3691 10. Li K, Kaaka R, Linseisen J, Rohrmann S. Associations of dietary calcium intake and calcium supplementation with MI and stroke and overall cardiovascular mortality in the Heidelberg cohort of the European Prospective Investigation into Cancer and Nutrition study (EPIC-Heidelberg). Heart 2012; 98: 920-925 11. Ensrud KE, Black DM, Palermo L, et al. Treatment with alendronate prevents fractures in women at highest risk – results from the Fracture Intervention Trial. Arch Intern Med. 1997;157:2617-2624. 12. Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis; a randomized controlled trial. J Am Med Assoc. 1999;282:1344–1352. 13. Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809–1822. 14. Schwartz AV, Bauer DC, Cummings SR, et al. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. J Bone Miner Res. 2010;25:976-982. 15. Cummings SR, Schwartz AV, and Black DM. Alendronate and atrial fibrillation. NEJM. 2007;356:1895-1896. 16. Heckbert SR, Li G, Cummings SR, et al. Use of alendronate and risk of incident atrial fibrillation in women. Arch Intern Med. 2008;168:826-831. 17. Loke YK, Jeevanantham V, and Singh S. Bisphosphonates and atrial fibrillation: systematic review and meta-analysis. Drug Safety. 2009;32:219-228. 18. Black DM, Kelly MP, Genant HK, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. NEJM. 2010;19:1761-1771. 19. Nieves JW, Bilezikian JP, Lane JM, et al. Fragility fractures of the hip and femur: incidence and patient characteristics. Osteoporos Int. 2010;21(3):399-408. 20. Nieves JW and Cosman F. Atypical subtrochanteric and femoral shaft fractures and possible association with bisphosphonates. Curr Osteoporos Rep. 2010;8:34-39. 21. Shane E. Evolving data about subtrochanteric fractures and bisphosphonates. NEJM. 2010;362(19):1825-1827. 22. Cummings SR, Martin JS, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. NEJM. 2009;361(19):756-765. 23. Boonen S, Adachi JD, Man Z. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab. 2011;96(6):17271736. 24. Lin T, Wang C, Cai XZ. Comparison of clinical efficacy and safety between denosumab and alendronate in postmenopausal women with osteoporosis: a meta-analysis. Int J Clin Pract. 2012;66(4):399408. 25. Kendler DL, Roux C, Benhamou CL, et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitional from alendronate therapy. J Bone Miner Res. 2010;25(1):72-81. 26. McClung MR, Lewiecki EM, Cohen SB, et al. Denosumab in postmenopausal women with low bone mineral density. NEJM. 2006;354(8):821-831. 27. Recknor C, Czerwinski E, Bone HG, et al. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Obstet Gynecol. 2013;121(6):1291-1299. 28. Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA 1999; 282(7): 637-645

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29. Chesnut CH, Silverman S, Andriano K, et al. A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF study group. Am J Med. 2000;109(4):267-76. 30. Cranney A, Welch V, Adachi JD, et al. Calcitonin for the treatment and prevention of corticosteroid-induced osteoporosis. Cochrane Database Syst Rev. 2000;2:CD001983. 31. Downs RW, Bell NH, Ettinger MP, et al. Comparison of alendronate and intranasal calcitonin for treatment of osteoporosis in postmenopausal women. J Clin Endocrinol Metab. 2000;85:1783-1788. 32. Tascioglu F, Colak O, Armagan O, et al. The treatment of osteoporosis in patients with rheumatoid arthritis receiving glucocorticoids: a comparison of alendronate and intranasal salmon calcitonin. Rheumatol Int. 2005;25:21-29. 33. Gennari C. Calcitonin and bone metastases of cancer. In: Pecile A (ed) Calcitonin 1980. Excerpta Medica. Amsterdam, pp 277–287. 34. Minaire P, Mallet E, Levernieux J, et al. Immobilization bone loss: Preventive effect of calcitonin in several clinical modules. Osteoporosis. 1987:603. 35. Attali G, Levernieux J, Caulin F (1987) Recent crush fracture syndrome. Effect of salmon calcitonin. Results of three double blind studies and one open study. Osteoporosis. 1987:930–932 36. Arinoviche R, Arriagada M, Jacobelli S, et al. Calcitonin in acute pain due to vertebral fractures in osteoporosis. Rev Med Chile. 1987:115:1039–1043. 37. Levernieux J, Julien D, and Caulin F. The effect of calcitonin on bone pain and acute resorption related to recent osteoporotic crush fractures: Results of a double-blind and an open study. Calciotropic Hormones and Calcium Metabolism. 1986:171–178. 38. Bordier P, Kuntz D, Miravet L, and Marie P. Treatment of primary osteoporosis by the combination of salmon calcitonin, phosphorus and magnesium, Nouv Presse Med 1979;8:444. 39. Ringe JD and Welzel D. Salmon calcitonin in the therapy of corticoid induced osteoporosis. Eur J Clin Pharm 1987;33:35–39. 40. Gennari C, Agnusdei D, and Camporeale A. Use of calcitonin in the treatment of bone pain associated with osteoporosis. Calcifi Tissue Int. 1991;49(suppl 2):S9-S13. 41. Drugs for prevention and treatment of postmenopausal osteoporosis. Med Lett Drugs Ther. 2000;42(1090):97-100. 42. Body JJ, Gaich GA, Scheele WH, et al. A randomized doubleblind trial to compare the efficacy of teriparatide [recombinant human parathyroid (1-34)] with alendronate in postmenopausal women with osteoporosis. Journal of Endocrinol & Metab. 2002;87(10):4528-4535. 43. Saag KG, Zanchetta JR, Devogelaer JP, et al. Effects of teriparatide versus alendronate for treating glucocorticoids-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. Arthritis & Rheumatism. 2009;60(11):3346-3355. 44. Cosman F, Eriksen EF, Recknor C, et al. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2001;26(3):503-511. 45. Cosman F, Nieves J, Zion M, et al. Daily and cyclic parathyroid hormone in women receiving alendronate. NEJM. 2005;353(6):566575. 46. Tsai JN, Uihlein AV, Lee H, et al. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomized trial. Lancet. 2013;382(9886):50-56. 47. US Preventative Services Task Force. Screening for osteoporosis: U.S. Preventative Services Task Force recommendation statement [published online ahead of print January 17, 2011]. Ann Intern Med. 2011;154(5):356-364.

Palmetto Pharmacist • Volume 53 Number 5


Preventing Osteoporosis-Related Fractures

Correspondence Course Program Number: 0171-9999-13-109-H01-P.

1. Complete and mail entire page. SCPhA members can take the Journal CE for free; $15 for non-members. Check must accompany test. You may 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 on any 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 pharmacy education. This article is approved for 1 contact hour of continuing pharmacy education credit (ACPE UPN 0171-9999-13-109-H01-P ). This CE credit begins 11/25/13 and expires 11/25/2016. CE credits will be uploaded to the CPE Monitor System.

Name: _______________________________________________ License #: __________________________ Address: ________________________________________________________________________________ City: ____________________________________________ State: _____ Zip: ________________________ Phone: _______________________________________ Email:____________________________________ NABP eID: _________________________________ Birth Month/Birth Date (MMDD): ________________ Evaluation: Circle the appropriate response Did the article achieve the stated objectives? Not at all 1 2 3 4 5 Completely Overall evaluation of the article? Poor 1 2 3 4 5 Excellent / Was the information relevant to your practice? No 1 2 3 4 5 Yes How long did it take you to read the article and complete the exam? ______________ CE credit will ONLY be awarded when a submitted test is accompanied by completing the evaluation above or online at www.scrsx.org LEARNING ASSESSMENT QUESTIONS: 6. A patient reports that she recently read in a women’s magazine 1. The recommended dose of calcium per day for a 67 year old that bisphosphonates can cause “jaw problems” [such as osteonewoman according to the National Osteoporosis Foundation is: crosis of the jaw (ONJ)], especially in patients who have dental A. 600 mg B. 800 mg procedures. She is concerned about starting risedronate because C. 1000 mg D. 1200 mg she has a tooth extraction scheduled in 2 weeks. What information could you provide to KF to assist in her decision about 2. The recently published comparative effectiveness research by bisphosphonate use?” AHRQ concluded that: A. ONJ is a rare but potentially serious condition. She is at high A. Calcium supplementation alone to prevent vertebral fractures. risk for developing ONJ and should avoid all bisphosphonates B. Vitamin D alone, in comparison to calcium alone, prevents B. ONJ is a rare condition that has been reported mostly in more hip fractures. cancer patients who received IV bisphosphonates. To be safe, she C. Calcium plus vitamin D reduces the risk of fracture in noninshould complete her dental work prior to starting bisphosphonate stitutionalized patients. therapy D. Calcium supplementation less than 1000 mg is effective at C. ONJ is a rare but potentially serious condition. She should preventing hip fractures. forego any treatment for osteoporosis but ensure adequate calcium and vitamin D intake and fall prevention measures in the 3. Raloxifene (Evista) is FDA-approved for: home A. Treatment of osteoporosis in men. D. ONJ is a common adverse effect associated with bisphosphoB. Prevention of osteoporosis in men. nates. However, she should not worry since she does not have C. Treatment of osteoporosis in premenopausal women. cancer D. Prevention of osteoporosis in postmenopausal women. 7. Which of the following patients would be the best candidate 4. In addition to adequate calcium and vitamin D, most patients for continuing pharmacotherapy after already receiving five years with a previous fracture history and diagnosed with osteoporosis of bisphosphonate therapy. should receive which therapy first, assuming no contraindications? A. A 77yo female with an AP spine T-score of -2.6, hip T-score A. Alendronate B. Denosumab of -2.2 C. Raloxifene D. Teriparatide B. A 68 yo female with an AP spine T-score of -3.5, hip T-score of -2.8 5. Which of the following is not a potentially adverse effect of C. A 72 yo female with an AP spine T-score of -2.9, hip T-score long-term bisphosphonate therapy thought to be linked to the of -3.1 development of “brittle bones”? D. A 76 yo female with an AP spine T-score of -2.2, hip T-score A. Osteonecrosis of the jaw of -2.7 B. Atypical femoral fractures C. Atrial fibrillation 8. Which of the following monitoring parameters might be the D. Both A and C most appropriate assay to assess disease progression and treatment response in patients receiving teriparatide therapy? A. Hip BMD B. Spine BMD C. C-telopeptide D. Serum calcium Palmetto Pharmacist • Volume 53, Number 5

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Palmetto Pharmacist • Volume 53 Number 5


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