AJP Summer 2010

ARIZONA JOURNAL A JP OF PHARMACY THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ALLIANCE

SUMMER 2010

Arizona Pharmacy Alliance 6th Annual Meeting July 15 - 18, 2010 Arizona Biltmore, Phoenix, Arizona

Changing Perceptions: Impacting Patient Health

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ARIZONA JOURNAL A JP OF PHARMACY Vol. 2, No. 2

SUMMER 2010

IN THIS ISSUE BOARD OF DIRECTORS PRESIDENT

Mark Boesen PRESIDENT-ELECT

Kelly Hampton TREASURER

Ken Mahan PAST PRESIDENT

Linda McCoy SECRETARY

Kelly Green Boesen COMMUNITY PHARMACY ACADEMY CHAIR Chad Schuster COMMUNITY PHARMACY ACADEMY CHAIR-ELECT Keith Gallus HEALTH-SYSTEM PHARMACY ACADEMY CHAIR Michael Dietrich HEALTH-SYSTEM PHARMACY ACADEMY CHAIR-ELECT Butch David SENIOR CARE PHARMACY ACADEMY CHAIR Dawn Knudsen SENIOR CARE PHARMACY ACADEMY CHAIR-ELECT Kimberly Cauthon MANAGED CARE PHARMACY ACADEMY CHAIR Kim Kelley MANAGED CARE PHARMACY ACADEMY CHAIR-ELECT Ray Clark TECHNICIAN ACADEMY CHAIR Jenny Whitney TECHNICIAN ACADEMY CHAIR-ELECT Chris Lesaca NORTHWEST DISTRICT DIRECTOR Norbert Laskowski NORTHEAST DISTRICT DIRECTOR Chuck Dutcher SOUTHWEST DISTRICT DIRECTOR Lisa Keller SOUTHEAST DISTRICT DIRECTOR John Nicolais DEANS OF COLLEGES

J. Lyle Bootman The University of Arizona College of Pharmacy Dennis McCallian Midwestern University College of Pharmacy Glendale STUDENTS

Scott Hall The University of Arizona

Mario Rosado Midwestern University INDUSTRY REPRESENTATIVE & LEGAL COUNSEL Roger Morris

Quarles & Brady EDITOR’S NOTE: Any personal opinions expressed in this magazine are not necessarily those held by the Arizona Pharmacy Alliance. “Arizona Journal of Pharmacy” (ISSN 1949-0941) is published quarterly by the Arizona Pharmacy Alliance at 1845 E. Southern Avenue, Tempe, AZ 85282-5831. PHONE (480) 838-3385, FAX (480) 838-3557, email info@azpharmacy.org. It is distributed to members as a regular member service paid for through an allocation of dues of $20.00 in advance. Non-member subscription rate is $40.00 per year.

COLUMNS President’s Message

2 CEO’s Message

3 Academy News • Community Pharmacy Academy 16 • Health-System Academy

16 • Managed Care Academy

17 • Senior Care Academy

18 • Student Pharmacist Academy 18 • Technician Academy

19 FEATURES AND ARTICLES ACOs Coming, and pharmacy can help

AzPA Career Center - Here for You

Getting Vaccinated Before You Travel

Fenofibrate

Excuse Me, Doctor...

Are Your Immunizations Up-to-Date?

Poison Bottles

Time Capsule

27 28 29

30 31 33 45

DEPARTMENTS New Members

4 Alliance News

5 PAPA

12 Legislative Update

13 Drug Information Questions

20 Student Perspective

• Strength in Numbers

22 Feature Pharmacist

• Industrial Strength Pharmacists 23 • Pharmacist + Passion = Purpose 25 Rx and the Law

34 Continuing Education

35 Financial Forum

46 EDITOR-IN-CHIEF Mindy D. Smith, R.Ph., Executive Director/CEO MARKETING AND COMMUNICATIONS Janet Weigel EDITORIAL BOARD Leslie Rodriguez, Pharm.D. Julie Hernandez, Pharm.D. Jonathan Merchen, Pharm.D., BCPS Jennifer Keonavong (Penrose), Pharm.D., BCPS Whitney Rice, Pharm.D.

Arizona Journal of Pharmacy 1

President’s Message What Happens to my Tuesday if the Arizona Pharmacy Alliance Goes Away? the contributions of the Arizona Pharmacy Alliance, the average pharmacist’s Tuesdays change quite dramatically, and for the better.

Mark Boesen, Pharm.D. AzPA President

This is my last message as AzPA President. Normally, I would spend some time talking about how bright the future looks or try to write something profound to pass along to the incoming President.

Unfortunately, the future isn’t so, in fact it’s quite challenging. The truth is membership in the Arizona Pharmacy Alliance isn’t nearly where it should be. Of the 6000± licensed pharmacists residing in Arizona, only 900 belong to AzPA. That’s only 15%!

Fifteen percent is a failing grade. Fifteen percent is the tip on your lunch tab. Without dues-paying members, the Alliance faces unprecedented financial decisions, and your Tuesday is bound to change dramatically.

Yes, your Tuesday changes if membership numbers don’t increase. Allow me to explain.

When I was a pharmacy intern working at Senator McCain’s office, one of my mentors wondered about my fascination with the political process, especially as it related to my professional development. One of the most interesting things he told me was about how politics affected his Tuesdays. The story went something like this: “I’m not sure how important our elected representatives are in Washington or Phoenix. You see, every Tuesday I get up and run through my morning routine. I go to work and care for the patients I serve. I go home to the wife and kids and it starts all over again. My Tuesday routine doesn’t seem to matter much to the sitting President or the representative from my district.”

I suppose when you measure Tuesdays one at a time, the changes that our elected officials make to our daily routines are fairly subtle. However, I would argue that due to

2 Arizona Journal of Pharmacy

For example, a year ago at this time the routine patient needing a simple flu shot needed to come complete with a prescription order from a licensed prescriber. Next Tuesday, if you see that same patient you can administer a number of CDC recommended vaccinations without a prescription order. All of this thanks to the hard work of the duespaying members of AzPA.

have let their membership lapse, membership is not an “accident.” Membership in AzPA is a commitment to your profession and an investment in the future – not just your future but the future of pharmacy.

In addition, the contributions and leadership of AzPA members make the Tuesday patients receiving pharmaceutical treatments for certain types of macular degeneration (AMD) more accessible.

Without the Arizona Pharmacy Alliance, many AMD patients would have foregone the $4000 monthly expense as the $35 drug would not be available from their retina specialist.

Should AzPA not capture more of the registered pharmacists in the state during 2010, professional job security for all the state’s pharmacists might be in jeopardy.

There is more and more energy by private and government payors to bypass professional pharmacists in favor of “cheaper” providers.

In the state of Washington, the Board of Pharmacy recently discussed the value veterinary medication wholesalers have in fulfilling prescription orders for animal owners receiving prescriptions from their veterinarian, completely bypassing the pharmacist in the care delivery process. In Arizona, there will be renewed discussions regarding the advanced role of telemedicine and technical support to replace the functions of pharmacists in remote areas of the state.

Are you an “accidental” member or a member “on purpose”?

What Can I Do? AzPA Makes It Easier in 2010

The Arizona Pharmacy Alliance relies on the revenue from membership dues to operate.

Like most professional associations, every year AzPA rides the membership renewal roller coaster: Who’s still in and who’s out?

You can help. First, make a professional commitment to always support the Arizona Pharmacy Alliance. Renew your membership every year and volunteer for service. At just 62 cents per day, it is an affordable way to remain committed to your profession. AzPA recently implemented a new monthly payment option to pay your dues. It’s easier than ever to keep your AzPA membership current. And many employers offer reimbursement for all or part of your dues.

Next, make a commitment to ask a friend or colleague to join the Arizona Pharmacy Alliance. With the new payment option, your friends and colleagues can join AzPA using a credit or debit card and pay by the month.

The AzPA Member-Get-A-Member Challenge offers an incentive to recruit new members.

Refer a new pharmacist member to AzPA and receive $25 in AzPA Buck$ that you may use toward your annual dues, annual meeting registration or other CE activity.

Of course we have the core of life-long, dedicated members who have been part of their state organization since graduation from pharmacy school. Many are longretired and still make the commitment to the Alliance. Through the years they have given back to the profession that has provided a good life, lifelong friendships and a lifetime of memories. They belong to AzPA “on purpose” – and are members with a purpose: to support pharmacy in Arizona.

But then there are those pharmacists who are “accidental” members: their membership was previously paid by an employer; they joined to take advantage of the member pricing for a CE activity; they meant to renew, but forgot (even after multiple reminders); they needed information or assistance or support from the Alliance; they can’t afford to join; they didn’t know their membership was expired; or, even worse, nobody ever asked them to join. The list of reasons is endless, but none are convincing. For those pharmacists who have not joined AzPA or

Don’t assume that your colleagues, classmates and friends are members of AzPA – there’s an 85% chance that they are not. So ask them to join – tell them what happens to their Tuesday if the Arizona Pharmacy Alliance goes away.

CEO’s Message Arizona’s Immunizing Pharmacists: Changing Perceptions One Shot at a Time In the six short months since the passage of HB2164, the pharmacists' immunization bill has made a significant impact in patient care and is changing the way we practice.

I recently received a phone call from Dr. Karen Lewis, M.D., Medical Director, Arizona Immunization Program Office, Arizona Department of Health Services, who expressed her excitement that pharmacists had reported administering over 80,000 adult vaccines since October 2009 (See Table 1 on page 4.)

Despite the incompleteness of the data, the dramatic increase in pneumococcal, seasonal flu, and H1N1 vaccines compared to previous years cannot be ignored. Compared to the previous year, in 2009 reports of adult pneumococcal vaccinations increased nearly four-fold and seasonal flu vaccinations increased nearly six-fold. The hike in H1N1 vaccinations in 2009 is likely attributed to media attention over the swine flu pandemic.

HB2164 was signed by Governor Jan Brewer on July 10, 2009, allowing pharmacists to administer adult immunizations without prescriptions, with the exception of yellow fever, Japanese encephalitis, rabies, and typhoid. Effective September 30, 2009, pharmacists were authorized to administer adult vaccines per CDC protocol starting October 5th, 2009.

Granting pharmacists permission to administer adult vaccines without a prescription has clearly increased adults’ accessibility to qualified immunizers and increased the number of adult immunizations in 2009. There is no data to confirm whether immunizations actually increased or if the increase was due to a shift in where adults were immunized (pharmacy versus office). A longer timeframe from 2009 and beyond is necessary to determine a consistent immunization trend.

The Data

The Impact

The Arizona State Immunization Information System (ASIIS) collects data on the number of adult immunizations given in the state of Arizona. Table 2 (also on page 4) shows the number of adult immunizations reported to ASIIS between October 1 and December 31 of each year for the five years before 2009.

Patients over 18 years of age are defined as adults. Prior to 2009, it was optional for pharmacies, private providers and public facilities to report adult immunization data to ASIIS. The data for 2004 through 2008 does not include any pharmacist-reported immunizations. With the enactment of HB2164, pharmacists are now required to report data to the ASIIS. Private and public providers are still exempt from mandatory reporting. Since reporting was not mandated for all health professionals, the number of immunizations reported pre-2009 may be severely underreported.

In addition to increased immunizations administered, the number of certified immunizing pharmacists increased from 650 in August 2009 to 1735 by the end of April 2010. This is an increase of 113%!

Last month The Arizona Partnership for Immunization (TAPI) presented its “Long Shot” award to AzPA. The award recognizes legislation and regulation or public policy that has helped reduce the barriers to immunizations to improve the ability to account for the immunizations of Arizona’s population. To quote from the Awards Presentation Script: “AzPA is recognized for spearheading the passage of HB2164, greatly increasing the avenues through which 2009 H1N1 influenza vaccine could be distributed. If AzPA had not supported this law, Arizona’s 2009 H1N1 influenza vaccine distribution would have been hampered. In addition, this law will allow for pharmacists to

The Background

Mindy D. Smith, R.Ph. Chief Executive Officer be an essential part of increasing adult immunizations in AZ in the future.”

The Arizona Pharmacy Alliance continues to identify opportunities for pharmacists to improve patient care. With the changes to the health care system in this country, AzPA strives to ensure that pharmacists and the profession of pharmacy are well-positioned for the future. Pharmacists delivering vital services to their patients are changing perceptions about pharmacy, one shot at a time.

Thank you to Kathy Lin, Pharm.D., Class of 2010, for her contributions to this article.

MISSION STATEMENT The Arizona Pharmacy Alliance is committed to serving and representing all practice settings.

AzPA will foster safe and effective medication therapy, promote innovative practice, and empower its members to serve the health care needs of the public.

VISION Empowering pharmacy professionals to provide optimal patient care

Arizona Journal of Pharmacy 3

New Members WELCOME NEW MEMBERS Folashade Rosa Adebayo Twen Antosz Catherine P. Araza Bradley J Arthur Stacy Baldridge Justin Frederick Beckmann Lana Bengez Sonciare B. Bozeman Rita Sheryl Chenowth Darell Dent Connor Valerie Nicole Coronado James Michael Croker Amanda Culver Hilary Davis Charlene D. Eichorn Christian Anne Eslinger Robin Espiriti Edmund Salvatore Evangelista Caren Fancher Robert C Ferguson Michael J. Flatten Andrew Gifford

Angela Gohlke Emilie Goldsberry Jerrold M. Gorsky Eshani U. Gunawardene Andrew Hall Joshua Mark Hall Valerie Harsh Shaynan Wynne Hill Jeremy Hillman Adam Hollingsworth Michael Hostetler Dawn Hunter Adrienne J. Jacobs Gene M. Jiongco Chantrelle Johnson Virginia Kaspriak-Fowler Isaac Khan Eric D Kowalek Michael James Kuratko Henry Kwo Kai Chung Anderson Lau Phillip Lawrence

Phuong H. Le Lily Lee. Monte Weston Lewis Kathy Lin Meng-Chieh Michelle Lin Desiree Moreno Jennifer A. Ng Rosalyn Nguyen Elizabeth Claire O’Brien Olajuyi Ojo Bryan J. Olenik Brendon John Parker Lori Marie Patten Stephen Jon Perona Brian Phan Jennifer Porcel Joelle E. Radosevich Rosemary Reyes Jayson Robertson Jacob M. Robison Danielle Robley Susi Schmidt

Emily R Schmitz Amelia M. Shah Kelee G. Smith Richard Steiner Tiffany Stevens Fred Stillwell Tara Storjohann Tiffanie Tam Stephan Vivier Terblanche Ann Tex Thuy T. Tran Linda J Tristani Bernadette Urlea Marcella Dale von GortlerParic Long Vu Sandra Lynn Ware Amy Warren Kateryna S Yenina Hana Yu

Tables for CEO Message Arizona’s Immunizing Pharmacists: Changing Perceptions One Shot at a Time from Page 3

Table 1:

Table 2:

Vaccines administered to adults (>18 at age of vaccine) by pharmacists between 10/1/2009 and 3/31/2010, as reported to ASIIS Vaccine Type Total DTaP/IPV 15 Hep A 43 Hep B 103 Hep A/B 66 Hib 1 HPV 17 IPV 2 MCV4 8 MMR 8 PCV 1 PPSV 895 RSV 1 Td 128 tdap 159 tetanus 1 typhoid 60 varicella 3 yellow fever 17 zoster 6,306 seasonal influenza 22,337 H1N1 51,177 Total 81,348

Immunizations Administered to Adults in Arizona October 1 - December 31 each year Vaccine Type 2004 2005 2006 2007 2008 Td 5957 5942 5404 6648 7318 Hepatitis* 3893 3498 3518 4790 6327 HPV 1 0 148 2611 2405 Meningococcal 51 240 483 1159 1068 MMR 1454 1120 1175 1389 1884 Pneumococcal 4623 3283 3490 3200 3921 Travel vaccines** 284 183 396 920 816 Varicella/Zoster 210 264 454 948 1385 Flu, Seasonal 28821 27093 25617 30923 46399 Flu, H1N1 0 0 0 0 0 Others 2734 2065 1660 2838 2673 Total 48028 43688 42345 55426 74196

4 Arizona Journal of Pharmacy

Data as of February 25, 2010 * Hepatitis A, Hepatitis B, or combination vaccine ** Includes typhoid, yellow fever and Japanese encephalitis

2009 6887 5698 1504 653 1428 15430 578 3863 274858 156476 2825 470200

Cheers for Volunteers!

The Arizona Pharmacy Alliance staff is here to support YOU - our members. We acknowledge the contributions of the volunteers who have recently made a difference for our organization and their fellow pharmacy professionals. Thank you for all you do!

Larry Dean Anderson Ron Woodbeck Crane Davis Terry Daane Bill Jones Bob Lipsy Lucas Nyabero Kimanga Lindsay Davis Carl Labbe Jon Glover Kim Kelley Julie Hernandez Leslie Rodriguez

Alliance News Stacy Haber Daniel Watterson Sam Webster Lilian Marshal Paul Smith Charity Olson Elizabeth Wilmeth Kelly Ridgway Mary Martin Jean Ritter Kerry Redman Ryan Pett Teresa Stickler Andrew Gifford Albert Flores Mindy Burnworth Sandra Leal Kelly Green Boesen Ken Baker Jeff Pesanka Amanda Carter Mike Sisk Greg Morrill

Jon Merchen Chris Tankersley Ken Mahan Steve Lemahieu Lindsay Huxtable Martha Fankhauser Kip Raney Alan Barreuther Chris Lesaca Carol Rollins Jenna Carlson Ray Clark Linda McCoy Kristina De Los Santos Eric Weber Rick Herrier Ken Fletcher Justin Brock Mark Boesen Kim Cauthon Jennifer Keonavong Lucy Chemodurow Kathy Lin Dawn Knudsen Gerber

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Rx relief’s Standards of Excellence screening Continuous assessment and client communication • Handling all types of staffing situations and emergencies • Over 60 years of pharmacy management experience • •

Rx relief ® Your Trusted Pharmacy Staffing Partner Arizona Journal of Pharmacy 5

Alliance News

Do you know someone who is not a member of the Arizona Pharmacy Alliance . . . and should be?!

Invite them to join the only statewide organization that represents the pharmacy profession in Arizona.

Membership Investment Statement Personal Information Name: Preferred Name: Address: City:

State:

Zip:

Home Phone:

(

)

Cell Phone:

Home Fax:

(

)

Referred by:

Birth Date (Month and Day only):

(

)

 Female

Gender:

 Male

Professional Information Company or Organization: Address: City: Phone:

State: (

Zip:

)

(

Fax:

)

Email Address:

Website :

School:

Degree:

Arizona License #

Arizona License Date

Professional Designations:

Degree Date:

Other State Licenses:

Primary Practice Setting:

Secondary Practice Setting:

Please check the box of the practice academy that best represents your practice:  Community Practice

 Health-System

 Managed Care

 Senior Care

 Technician

MEMBERSHIP CATEGORIES

 Pharmacist – Individual

 Student

Licensed Pharmacists with at least two years of practice SINGLE PAYMENT MONTHLY PAYMENT OPTION: I authorize AzPA to charge my credit card $20 each month x 12 for a total annual payment of $240. See below.

MONTHLY PAYMENT

$ 225.00 $ 340.00

 New Practitioner - 2 Yr

Husband and wife pharmacists SINGLE PAYMENT MONTHLY PAYMENT OPTION: I authorize AzPA to charge my credit card $30 each month x 12 for a total annual payment of $360. See below.

MONTHLY PAYMENT Persons who are not licensed pharmacists and are interested in pharmacy or are associated with businesses or professions related to the pharmaceutical profession 50% reduction for Pharmacists who are within one year after graduation from a college or school of pharmacy 25% reduction for Pharmacists who are within two years after graduation from a college or school of pharmacy

 Retired Pharmacist

Licensed pharmacists who are no longer working

$

85.00

 Resident

Pharmacists currently enrolled in a residency program

$

65.00

 Technician

Persons employed as supportive pharmacy personnel

$

40.00

 Student

Persons who are matriculating full time in a college or school of pharmacy

$

20.00

 Pharmacist – Individual*  Pharmacist – Joint  Pharmacist – Joint*  Associate  New Practitioner - 1st Yr nd

$ $

20.00 30.00

$ 225.00 $ 115.00 $ 180.00

Please make checks payable to the

My donation to the Pharmacy Political Action Committee

$

Arizona Pharmacy Alliance

My donation to the Arizona Pharmacy Foundation

$

Mail to: 1845 East Southern Avenue

Total annual payment due

$

Tempe, Arizona 85282

Payment Options  Single Annual Payment  Monthly Payment*

or fax to 480 838-3557 or call 480 838-3385

 Check Enclosed

Check # ________________

*Monthly Payment Option Available for Pharmacist-Individual, and Pharmacist-Joint. TERMS FOR MONTHLY PAYMENT: By checking the monthly payment option, I authorize AzPA to charge my credit/debit card as indicated for my membership dues payment. My credit card will be charged each month by AzPA $20 (for Individual ) or $30 (for Joint) x 12 months. Includes monthly administrative fee.

VISA ___ MasterCard ___ AMEX ____ Card # Expiration Date ____________________________

Credit Card Security Code:

Signature IMPORTANT INFORMATION REGARDING YOUR MEMBERSHIP DUES, TAXES AND DONATION TO THE APF. Of the "Membership Dues" payment, the amount listed below is deductible as a charitable contribution made to the Arizona Pharmacy Foundation (APF), a 501 (c) 3 non-profit corporation, Tax ID #86-0679270. The remaining portion is not deductible as a charitable gift, but may be deductible as a normal business expense. Membership payments to associations that are used for lobbying expenses are no longer deductible for federal income tax purposes. Of the membership dues payment to AzPA, 15% is non-deductible. Please consult your tax advisor on how these rules may apply to you.

PHARMACIST Individual NEW PRACTITIONER 1st Year ASSOCIATE

$15 $10 $15

6 Arizona Journal of Pharmacy

Joint 2nd Year RESIDENT

$30 $15 $15

RETIRED

$10

TECHNICIAN

$ 5

STUDENT

$ 0

Alliance News APF News

PNA NEWS

In 2009 the Arizona Pharmacy Foundation (APF), a

The Pharmacy Network of Arizona (PNA) is collaborating with Clinical Support Services (CSS) to bolster its medication therapy management services (MTM) program. PNA believes CSS will be a strong partner as they have developed innovative medication, chronic care and preventative care management technology designed to improve patient care and provide demonstratable savings in time and costs. Their “customizable, web-based software, called Medication Pathfinder™, provides a clear and consistent process of data collection and workflow management, coupled with robust, in-depth reporting capabilities. Healthcare providers can directly access our Medication Pathfinder™ product to populate and query the patient registry to provide their own clinical analysis.”

PNA is excited about this new partnership with CSS. The company is founded and managed by pharmacists which ensures that they have a strong clinical foundation that can be relied upon to provide best practices solutions.

PNA expects to launch the new program in September 2010 which will give it the capability to expand programs to other interested employers across the state of Arizona.

The Pharmacy Network of Arizona is a for-profit corporation under the authority of the Arizona Pharmacy Alliance. It provides medication therapy management services through employer-based MTM programs. PNA hires pharmacists to provide diabetes disease state management to diabetics. The program began in January 2008 and has expanded throughout rural Arizona.

Qualified pharmacists interested in contracting with PNA to provide MTM services should contact Rose Martin, Pharm.D., at rmartin@pharmacy.arizona.edu or (520) 626-3784.

PNA - quality medication therapy management services, improved patient care and lower medical costs – providing the solution to health care reform.

non-profit, charitable foundation and 501 (c) 3 corporation, established the Llyn Lloyd Service to Pharmacy Scholarship Fund. Llyn Lloyd served as executive director of the Arizona State Board of Pharmacy for more than 20 years. He dedicated his life to protecting and advancing the pharmacy profession. The scholarship award exemplifies his personal and professional commitment.

Each year this scholarship recognizes a pharmacy student at each of the Colleges of Pharmacy in Arizona - Midwestern University Glendale and The University of Arizona - for their service to the profession of pharmacy.

The students each receive a $500 award from APF. In October 2009, the University of Arizona College of Pharmacy awarded this year’s Lloyd scholarship to Amy Gowler, Class of 2011.

In April 2010, Midwestern University College of Pharmacy Glendale selected Class of 2011 Pharm.D. candidate Jasmine Lee as this year’s recipient of the Lloyd Scholarship. Congratulations, Jasmine.

Dennis McCallian, Dean MWU-GCP; Jasmine Lee, MWU-CPG Class of 2011; and Jayne Knott, APF President

You can support the Arizona Pharmacy Foundation and the Llyn Lloyd Service to Pharmacy Scholarship Fund by playing in or becoming a sponsor of the APF annual “Law on the Links” golf tournament on Friday, July 16, 2010.

This best ball scramble tournament is a unique way to earn Law CE while enjoying 18-holes on the beautiful Arizona Biltmore Golf Course. Cost is just $135 per golfer. Event and hole sponsorships are also available. See page 8 for more information or visit the AzPA website at www.azpharmacy.org.

You can also help by participating in the APF Legacy Endowment program, buying a brick on the national mall at the APhA national headquarters, or making a donation.

All donations are 100% tax-deductible. Visit www.azpharmacy.org to make a donation.

Expand Your Practice.

Provide MTM services to your patients!

Medication Therapy Management Certificate Program: Delivering Medication Therapy Management Services in Your Community A Certificate Training Program Developed by The American Pharmacists Association and the American Society of Consultant Pharmacists SAVE THE DATE! Saturday, September 18, 2010 Time and location to be determined.

Contact AzPA for more information.

Arizona Journal of Pharmacy 7

Alliance News

APF

2010 Arizona Pharmacy Foundation “Law on the Links” Golf Tournament Friday, July 16, 2010 – 6:30 A.M. Shotgun Start

Arizona Biltmore Country Club, 2400 East Missouri Drive, Phoenix, Arizona Sponsorship Options/Golfer Sign-Up Information 2010 Golf Sponsorship Opportunities

 Title Sponsor  Luncheon Sponsor  Picture Sponsor  Golf Ball Sponsors  Trophy Sponsors

 Platinum Sponsorship

$10,000 $3,500 $2,000 $1,500 $500 $1000 or more

 Shirt Sponsor  Hat Sponsor  Beverage Cart Sponsor  Cart Sponsors

$5,000 $2,500 $1,500 $1,000

Golf four-some of your own creation, Hole sponsorship including logo/name Signage - Company recognition in AzPA publications - Company recognition in Meeting Program

 Gold Sponsorship

$500

Golf two-some of your own creation - Hole sponsorship including logo/name Signage - Company recognition in Meeting Program

 Hole Sponsorship

$300

Company logo/name signage on single golf hole

 Individual Golfer

$135 ** All golfers receive green fees, cart, range balls, and tournament services. ** Also included are two drink tickets and a lunch following the tournament.

Company/Individual: ____________________________________________________________________ Local Contact: _________________________________________ Title: ___________________________ Address: _______________________________________________________________________________ City: _________________ State: _______ Zip: ____________ Phone: ____________ email: __________________

If you would like to play golf, please provide the following information: [Individuals and two-somes will be paired randomly to create four-somes. Four-somes will play as listed.]

PLAYER NAME

COMPANY

1. _________________________________________

_____________________________

2. _________________________________________

_____________________________

3. _________________________________________

_____________________________

4. _________________________________________

_____________________________

On-line registration is available on the Arizona Pharmacy Alliance website at www.azpharmacy.org.

Make checks payable to: APF Annual Golf Tournament. Mail this form to: APF Annual Golf Tournament, 1845 E. Southern Ave., Tempe, AZ 85282 nd APF Tax ID #86-0679270 – proceeds to benefit 2 Annual Llyn Lloyd Pharmacy Service Scholarship Fund tax ID #86-0679270

Or fax CC info to: 480/838-3557 Credit Cards accepted: MasterCard VISA AMEX DISCOVER

Credit Card # _____________________________________________________ Exp. Date ____________ Credit Card Security Code _______ FAX COMPLETED FORM TO: 480/838-3557 OR EMAIL: kathy@azpharmacy.org. Call 480/838-3385 for more information.

Alliance News Arizona Pharmacy Alliance Announces 2010-2011 Board of Directors The Arizona Pharmacy Alliance (AzPA) announces the election of the 2010-2011 Board of Directors.

Beginning their one-year terms in July 2010 are: Kelly Ridgway, President Kevin Boesen, President-Elect Mark Boesen, Past President Ken Mahan, Treasurer Michael Dietrich, Secretary Keith Gallus, Community Pharmacy Academy Chair Justin Brock, Community Pharmacy Academy Chair-Elect Butch David, Health-System Academy Chair Jonathan Merchen, Health-System Academy Chair-Elect Ray Clark, Managed Care Academy Chair Julie Hernandez, Managed Care Academy Chair-Elect Kimberly Cauthon, Senior Care Academy Chair Dawn Knudsen, Senior Care Academy Chair-Elect Chris Lesaca, Technician Academy Chair Mike Severn, Technician Academy Chair-Elect Kerry Redman, Student Pharmacist Academy Chair University of Arizona COP Bonnie DiLorenzo, Student Pharmacist Academy Chair, Midwestern University CPG Jessica Woodling, Student Pharmacist Academy Chair-Elect,University of Arizona COP Norbert Laskowski, Northwest District Director Chuck Dutcher, Northeast District Director Lisa Keller, Southwest District Director John Nicolais, Southeast District Director Greg Morrill, Industry Representative J. Lyle Bootman, Dean, University of Arizona COP Dennis McCallian, Dean, Midwestern University CPG Roger Morris, Legal Counsel Election of the Student Pharmacist Academy ChairElect for Midwestern University Glendale College of Pharmacy will take place in Fall 2010. The 2010-2011 AzPA Board of Directors will be installed during the AzPA 6th Annual Meeting at the Arizona Biltmore Resort and Spa in Phoenix, Arizona, July 15 – 18, 2010.

Proposed Bylaws Changes put forth for Member Vote at AzPA Town Hall Meeting, Saturday, July 17, 2010 The AzPA Board of Directors has approved AzPA bylaw changes listed below. AzPA members have 90 days to review and submit any comments. The bylaw changes will be voted upon by AzPA members during the Town Hall meeting on July 17, 2010, during the AzPA Annual Meeting at the Biltmore Resort, Phoenix, AZ. There are two proposed bylaw changes which include the following: Chapter 1, Membership, Article I, II Purpose: 1. Clarifies the term “active” which meant that “pharmacists” are voting members 2. Eliminates use of words that are not parallel – “active” and “associate” did not clearly state that active meant pharmacists and associate all non-pharmacists 3. Allows the term “Associate” to clearly be defined as a type of membership category (instead of defining a nonvoting member.)

Chapter III, Organization, Article I, II and Chapter IV, Article I Purpose: 1. Ensures the existence of only ONE student academy even though both co-Chairs have a vote on the AzPA board.

2. Allows the Student Academy to have two votes on the board, so that the original intention of the bylaws, to include a student representative from each college of pharmacy be a voting member on the board, is upheld.

This ensures communication and representation of students from both colleges of pharmacy. Further defines the position as “co-Chairs” to ensure that both colleges of pharmacy work together as ONE student academy.

3. Clearly states co-Chair of the Student Academy’s role on the board.

4. Clarifies that each college of pharmacy co-Chair receives a vote on the board.

If you have any questions, comments or concerns, please submit them to Mindy Smith at mindy@azpharmacy.org before Saturday, July 17, 2010. Thank you!

To reference the complete proposed AzPA Bylaws changes click here or visit www.azpharmacy.org

Arizona Journal of Pharmacy 9

Alliance News AzPA 6th Annual Meeting is Next Month!

The 6th Annual Meeting of the Arizona Pharmacy Alliance is less than a month away! Join us July 15-18, 2010, at the beautiful Arizona Biltmore Resort and Spa in Phoenix, Arizona. This year’s conference, Changing Perceptions: Impacting Patient Health, offers an impressive selection of continuing education programs, networking sessions, opportunities for personal and professional growth, entertainment and fun!

This year’s pre-conference continuing education activity is the Anticoagulation Certificate Program.

This knowledge-based and practice-based learning activity provides 18 hours of continuing pharmacy education and equips pharmacists to expand their scope of practice to include anticoagulation management services.

The conference tees off with the annual Arizona Pharmacy Foundation Golf Tournament on Friday, July 16, 2010. Join us for Law on the Links, the popular Law CE program featuring seven case law scenarios and pharmacy statutes and/or regulations presented on each hole of the course. A portion of the proceeds from the APF tournament benefit the Llyn Lloyd Service to Pharmacy Scholarship Fund.

Don’t miss this year’s mardi gras-themed Exhibit Hall. More than 50 exhibitors will be showcasing their companies and organizations in the Arizona Biltmore Ballroom. Come for great food and prizes.

The AzPA Annual Meeting marks the transition of our organization’s leadership and recognizes the contributions and accomplishments of our members. A highlight of the event is the AzPA Awards Banquet when we recognize our Honorary Members and includes the presentation of the Technician of the Year Award, the Pfizer Pharmacist of the Year Award, the AzPA Hall of Fame Awards and the Pfizer Bowl of Hygeia Award.

The Opening Session on Friday, July 16, 2010, is Arizona Health Care Information and Technology presented by Ronald S. Weinstein, M.D., Director, Arizona Telemedicine Program, and Brad Tritle, CIPP, Executive Director, Arizona Health-e Connection.

Other keynote presenters include, Kelly Ridgway, R.Ph., Pharmacy Care Manager, Safeway Pharmacy and AzPA President-Elect; C. Edwin Webb, Pharm.D., M.P.H., Associate Executive Director, Director of Government and Professional Affairs, American College of Clinical Pharmacy; and Kristina Lunner, Vice President Government Affairs, APhA .

More than 16 hours of continuing pharmacy education are available over the three-day meeting, the largest pharmacy meeting in Arizona! The pre-meeting program and registration form are available on the Arizona Pharmacy Alliance website at www.azpharmacy.org.

NEW THIS YEAR: ONLINE REGISTRATION! Visit www.azpharmacy.org and logon today!

REGISTER TODAY! www.azpharmacy.org ArizonA PhArmAcy AlliAnce 6th AnnuAl meeting July 15 - 18, 2010 ArizonA Biltmore resort & sPA Phoenix, ArizonA

Changing Perceptions: Impacting Patient Health 10 Arizona Journal of Pharmacy

bE A pART Of ARIzOnA’S lARGEST phARmAcY mEETInG!

Alliance News AzPA 6th Annual Meeting REGISTRATION FORM First Name: ______________________________________ Last Name: _______________________________ Organization/Pharmacy:_____________________________Professional Designation ____________________ Address: ___________________________________________________________________________________ City/State/Zip:_______________________________________________________________________________ Daytime Phone: ________________________ E-mail address: ________________________________________ AzPA Member? Yes__ No __ Special Needs/Disabilities: ___________ Dietary Need: ___ Vegetarian ___ Kosher

I. Early Registration Fees until June 11, 2010

AzPA Member Pharmacist

Non-Member Pharmacist

AzPA Member Allied Pharmacy*

Non-Member Allied Pharmacy*

FULL: 3-DAY REGISTRATION SINGLE DAY __FRI __ SAT __ SUN SPOUSE/GUEST: 3-DAY

$325 $150 $225

$425 $200 $225

$200 $110 $225

$250 $160 $225

II. Standard Registration Fees after June 11, 2010

AzPA Member Pharmacist

Non-Member Pharmacist

AzPA Member Allied Pharmacy*

Non-Member Allied Pharmacy*

FULL: 3-DAY REGISTRATION SINGLE DAY __ FRI __ SAT __ SUN SPOUSE/GUEST : 3-DAY

$375 $200 $275

$475 $250 $275

$250 $160 $275

$300 $210 $275

AzPA Member Pharmacist

Non-Member Pharmacist

AzPA Member Allied Pharmacy**

Non-Member Allied Pharmacy**

$300 $350

$400 $450

$200 $250

$250 $300

III. Anticoagulation Certificate Program Fees (see page 2 for details) EARLY - UNTIL 06/01/10 STANDARD - AFTER 06/01/10

Section I Total

Section II Total

Section III Total

*Allied Pharmacy category includes associate, resident, student, pharmacy technician, nurse, industry representative, and other non-pharmacist attendees.

IV. Optional Registrations and Meal Function Tickets EVENT Friday, July 16, 2010 APF Golf Tournament Friday, July 16, 2010 Exhibit Hall Reception - Adult Friday, July 16, 2010 Exhibit Hall Reception - Child Saturday, July 17, 2010 Exhibit Hall Lunch - Adult Saturday, July 17, 2010 Exhibit Hall Lunch - Child Saturday, July 17, 2010 Awards Banquet - Single Ticket Saturday, July 17, 2010 Awards Banquet - Table of 10 Adopt-A-Student/Adopt-A-Technician Donation Name(s) of Registered Guest(s)/Spouse: Name(s) of Child(ren) Attending Events: Names(s) of Student(s)/Technician(s) [optional]

TICKET PRICE $135.00 $45.00 $10.00 $45.00 $10.00 $80.00 $750.00 $200

No. of Tickets

Section IV Total

PAYMENT INFORMATION Total Due (Sections I, II, III, IV)

$

Charge Card: Visa: ___ MasterCard: ___ Amex ____ Discover ____ Check # _____________ Card Number: ________ - ________ - ________ - ________ Exp. Date: _______ Security Code _______ Signature: _________________________________________________________________________________ Make checks payable to Arizona Pharmacy Alliance.

Arizona Journal of Pharmacy 11 Mail this form to AzPA Annual Meeting, 1845 E. Southern Ave., Tempe, AZ 85282 or fax to 480 838-3557 Phone: 480 838-3385 www.azpharmacy.org ALL TIMES AND PROGRAMS SUBJECT TO CHANGE.

PAPA WHAT IS PAPA? PAPA Mission Statement The purpose of the Pharmacists Assisting Pharmacists of Arizona (PAPA) program is to provide assistance to any pharmacist, pharmacy student or pharmacy technician with an impairment. Though emphasis is on alcohol and/or drug dependency, the program offers support or referrals to other needed programs. The PAPA program is designed to serve both a Board-mandated participant (non-confidential) and a self-referred participant (confidential).

PAPA History Due to the concern and perseverance of pharmacists - Mike Henry, Stan Sirota, Dan Boesen and Llyn Lloyd - the Pharmacists Assisting Pharmacists of Arizona was established in July 1989. The program was set up under the auspices of the Arizona Pharmacy Foundation (APF) and housed in the Arizona Pharmacy Association (APA) office, now the home of the Arizona Pharmacy Alliance.

Prior to the PAPA program, two pharmacists, Mike Henry and Stan Sirota, played an important role in intervening with pharmacists in trouble. Their role was to assist impaired pharmacists in getting into a rehab program and advocate for them when they appeared before the Arizona State Board of Pharmacy (ASBP). During this time period, the Executive Director of the Arizona Pharmacy Association, Dan Boesen, took an active role in structuring the administrative function of the PAPA program. It was with his help that the program started under the Arizona Pharmacy Foundation.

Dan, Stan and Mike worked with the ASBP and helped educate the Executive Director, Llyn Lloyd, on the importance of the program. Llyn stated, “My first exposure to recovery activities was as a representative of the NABP at the Utah School. I was the victim of an involuntary metamorphosis! I saw the light and joined the ‘recovery movement’. Through gentle persuasion and repetition I was able to convince board members that ‘recovery’ rather than punishment was the better approach in addressing illicit drug/alcohol use.” With Llyn’s compassion and desire to learn more, the relationship between PAPA and the ASBP was formed. Also, with Llyn’s help, the Arizona State Board of Pharmacy was able to pass a statute that allows the Board to contract with a program such as PAPA to obtain financial assistance from the state.

In 1994, the program established a five-member volunteer Steering Committee, including representation from the Arizona Pharmacy Association staff, a State Board of Pharmacy staff member and at least one past participant from PAPA program.

12 Arizona Journal of Pharmacy

If you or someone you care about is suffering from an alcohol and/or chemical dependency problem…

“A Partnership in Caring”

Pharmacists Assisting Pharmacists of Arizona (PAPA)

is Available For Help and Information CALL LISA YATES AT 928-532-2293 ALL CALLS CONFIDENTIAL • CALLER REMAINS ANONYMOUS

The program began with one counselor in Phoenix and in 1995 added a counselor in Tucson. Today, PAPA has two counselors in the Phoenix area that counsel four groups per week. Counselors in both the Tucson and Flagstaff area also counsel one group per week.

Today the Steering Committee is comprised of eight volunteer members, one Arizona State Board of Pharmacy staff member and one administrative coordinator.

PAPA 2010 Calendar June 20th – 25th University of Utah School of Alcoholism and Other Drug Dependencies, for more information go to http://medicine.utah.edu/uas/Pharmacy.htm July 16th – AzPA 6th Annual Meeting, sponsoring the CE program, “Drug Addiction and Recovery” Oct. 1st – 3rd SWPRN 23rd Annual Meeting, for more information go to www.SWPRN.org

Legislative Update Federal HCR/Regulatory Scorecard What is happening NOW! Proposed regulations receiving public comments • FDA: June 24–25 public workshop on reduction of medication errors through improved naming, labeling, and packaging practices (comments close July 23).

• FDA regs on direct-to-consumer advertising (comments close June 28).

• FDA collecting information on experimental study of patient information prototypes (comments close July 1).

Regulations whose comment periods have closed • DEA request for comment on interim final rule on electronic prescribing of controlled substances.

Regulations recently finalized • Medicare Coverage Gap Discount Program: When Medicare Part D beneficiaries hit the doughnut hole next year, the pharmacist will once again be a key messenger about what the 50% discount on applicable medications will mean to them. But, as APhA told CMS in comments filed on May 14, patients will need to realize that the pharmacist is only conveying information calculated by Part D plans through the claims adjudication process. APhA recommended that CMS work with APhA and other pharmacy stakeholders in developing and disseminating educational tools, point-ofservice messaging, and patient-education materials. Within a week of receiving comments, CMS finalized its guidance and acknowledged the need for education and awareness activities. It held a public hearing on June 1 to get feedback on an agreement manufacturers must sign to participate in the discount program, which launches on January 1.

Beneficiaries who hit the gap this year will receive a onetime federal payment of $250.

•

Important Tidbit: What is the name of the health care reform law? HCR took an unusual path in Congress as Democrats chose to avoid a second vote in the Senate, which had approved the bill on Christmas Eve. Thus, the HCR bill signed by President Obama on March 23 was the Patient Protection and Affordable Care Act (Pub. L. 111148). It was then amended by section 1101 of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), signed a week later. Because neither bill title alone is accurate, the Obama administration is using “Affordable Care Act,” or ACA, to refer to these bills collectively.

Arizona State Legislative Final Report 49th Legislature, 2nd Regular Session - 2010

Days of Session: 109 Adjourned, Sine Die: Thursday, April 29, 2010 at 11:07 PM General Effective Date: July 29, 2010 Bills Posted: 1,233 bills Bills Passed: 352 bills passed Bills Signed: 338 Bills Vetoed: 14 No Bills Passed Without Signature Special Sessions Called: 3 • 6th Special: Adjustments to FY ’09-’10 budget, temporary sales tax referendum • 7th Special: Adjustments to FY ’09-’10 budget, passage of FY ’10-’11 budget • 8th Special: Authorizing the Governor to sue the federal government over federal health care legislation The 2nd Regular Session of the 49th Legislature convened January 11, 2010, and is widely viewed as one of the most significant in state history, as lawmakers grappled with a $3 billion budget deficit, controversial cuts in numerous state programs and a myriad of other complex and high-impact issues.

More than 1200 bills were filed but a large majority of those never progressed beyond the committee hearing level. Other measures were rejected by members after the first floor vote while some bills (such as the repeal of Clean Elections and the Arizona Jobs Recovery Act) made it all the way out of one chamber only to be denied in the other. Many of the bills that failed to complete the legislative process are expected to return in the next session.

The closing of the 49th Legislature, 2nd Regular Session marked the end of the line for a remarkable number of veteran lawmakers. Roughly half of the State Senate is departing as well as 24 of 60 House Members. Many of those members are term-limited out and subsequently running for a seat in the other chamber, while others are seeking higher office or simply retiring.

The retirement announcement of Congressman John Shadegg set off a chain reaction in which several legislators resigned in order to make a bid for the soon-to-be open congressional seat, meaning their legislative seats then needed to be filled.

AzPA was very active this session and impacted several pharmacy and health care-related bills.

Page 15 contains a partial list of these bills.

AzPA Budget Monitoring • Per confirmation from AHCCCS, there was no known federal or state budget proposal that would directly impact pharmacy.

• General Medical Education (GME) centers upon physician residencies. There is no reference to pharmacists. The AHCCCS Director and the legislative liaison confirm that no pharmacy residencies are covered directly by GME. • The Pharmacy Board received an increase of $50,000 for Controlled Substance Prescription Drug Monitoring for FY2011.

Arizona Journal of Pharmacy 13

Legislative Update (continued) • 90/10 health board fund sweeps were not utilized in the budget that was adopted and signed by Governor Brewer.

• No further cuts were made to the University of Arizona Poison Control Center line-item in the ADHS budget.

Fees In the Executive’s FY2011 budget, Governor Brewer proposed that several agencies become self-sustaining through a combination of operational efficiencies and greater support (i.e. increased fees) from the constituencies they serve. The primary agencies that were the focus of this plan were Arizona Department of Water Resources (ADWR) and Arizona Departmetn Environmental Quality (ADEQ). Legislation was introduced this session relating to increased fee authority: SB1355, (ADWR), SB1359 (ADWR), HB2744 (ADWR), and HB2767 (ADEQ).

In response to the fee bills, Sen. Verschoor, in cooperation with the AZ Cattlemen, Homebuilders and Phoenix Chamber, introduced legislation (SB1335), which outlined legislative and agency requirements for authorizing, setting and revising administrative fees. The goal of the bill was a set of “fairness in fees principles”: accountability, transparency, fairness/certainty and flexibility.

As all of these bills were being considered and negotiated, the FY2011 budget was introduced and included fee authority for various agencies in line with what the Governor proposed in her budget. The environment budget reconciliatin bill authorized the directors of ADWR and ADEQ to increase fees in FY 2010-11 for services totaling $5,662,900 and $5,779,100 respectively. It exempted the agencies from rulemaking requirements until July 1, 2011, except that a specific fee plan must be developed for consideration by the Legislature by April 1, 2010.

An attempt at the development of a “fee plan” consisted of several meetings held by Sen. Verschoor, where nearly two dozen individuals participated, including Phoenix. The purpose of the meetings was for the regulated community to come to a consensus on fee legislation within the context of the “fairness in fees principles” outlined above and contained in SB1335.

Ultimately, such an endeavor provided to be too problematic for a consensus to be reached during the current legislative session.

State agencies outlined legitimate concerns with language and many solutions that ensured fee certainty for the regulated community violated Prop. 108. In the end, the only language that was agreed to by the parties required agencies with fee authority granted in the BRBs to give 30 days’ notice before increasing fees. A ten-member fee commission would also be created, consisting of appointments by the Governor and Legislature, to make recommendations for 2011. Lastly, all fee bills would contain language stating that monies raised from fee increases would be “held in trust.”

The first two pieces of the agreement were memorialized in a strike-everything amendment to HB2586. The bill was also amended to require fees assessed by agencies under authority granted in the BRBs be fairly and equally assessed to all parties for services rendered and must be assessed in a nondiscriminatory manner against both public and private parties. The “held in 14 Arizona Journal of Pharmacy

trust language” was adopted to HB2767 and SB1359 despite opposition from the House Appropriations Chairman. An additional amendment was added to HB2767 at the last minute stipulating that ADEQ can only raise fees authorized in the bill by rule one time and thereafter is required to seek new statutory authority.

During the interim, the Fee Commission authorized in HB2586 will be established. AzPA will continue to monitor and play an active role in recommendations.

Arizona FY 2011 Appropriations Report You can view the FY 2011 Appropriations Report on line at http://www.azleg.gov/jlbc/11app/apprpttoc.pdf. This link will take you to the Table of Contents for the FY 2011 Appropriations Report. The report can also be viewed as one large pdf, in the event you would like to print the entire book at http://www.azleg. gov/jlbc/11app/FY2011AppropRpt.pdf.

PHARMACISTS POLITICAL ACTION COMMITTEE OF ARIZONA The Pharmacists Political Action Committee of Arizona (PharmPAC) plays an important role in advancing the legislative action mission of the profession of pharmacy here in Arizona and in Washington, D.C. You can make your voice heard by supporting the PharmPAC! SUPPORT PHARMACY POLITICAL ACTION & RECEIVE A CHANCE TO WIN UP TO $5000*!

Ten cash prizes awarded = Ten chances to win!

You do NOT need to be present to win.

PAC Drawdown Tickets are available for $100 each.** Winners will be announced Saturday, July 17, 2010 during the AzPA Annual Awards Banquet *Assuming the receipt of 200 entries. In the event 200 entries are not received, prizes may be reduced proportionally. **Tickets may be purchased by AzPA members only.

PharmPAC contributions are not tax deductible.

Legislative Update AzPA Bill Tracking List

To view copies of bills, visit www.azleg.gov and type in the bill number in the upper right hand corner.

H2021 (Chapter 172): PHYSICIAN ASSISTANT PRACTICE ACT AzPA Monitored H2240: RECOVERY AUDITS AzPA Monitored H2468: OPTOMETRISTS; MEDICATIONS AzPA Opposed

H2499 (Chapter 92): PRESCRIPTIONS; ELECTRONIC SUBMISSION BY PATIENT AzPA Amended H2687: SALVIA DIVINORUM; UNLAWFUL ACTS AzPA Supported

S1144 (Chapter 203): DRUG OFFENSES; DEFINITIONS AzPA Amended

Updates Arizona Physician Assistant Practice Act by making numerous changes to existing statute regarding the Arizona Regulatory Board of Physician Assistants, supervising physician responsibilities and the licensing, scope of practice, and initiation of practice for physician assistants.

First sponsor: Rep. Barto

4/27 signed by governor. Chap. 172, Laws 2010.

Requires the Auditor General to contract with consultants for a recovery audit of state payments made to vendors.

First sponsor: Rep. Tobin

5/11 VETOED.

Replaces three specific macrolides with the term macrolides. First sponsor: Allows optometrists to prescribe, dispense and administer Rep. Goodale antiviral medications for treatment of diseases of the eye and its adnexa. Requiring a referral to a physician after 72 hours if the condition does not improve. Prohibits optometrists from prescribing, dispensing and administering an oral antibiotic or an oral antiviral to a person under six years of age.

See SB1285

4/7 Senate hel-med held.

Allows prescription-only drugs to be dispensed when the First sponsor: patient submits the written prescription by fax or email.

Rep. Murphy Stipulates that the patient must present a written prescription order bearing the prescribing medical practitioner’s manual signature when picking up the prescription at the pharmacy.

4/19 signed by governor. Chap. 92, Laws 2010.

Creates a Class 2 misdemeanor for the act of selling, First sponsor: dispensing, distributing, furnishing, administering or giving or Rep. Meyer offering to sell, dispense, distribute, furnish, administer or give salvia to a person who is under 21 years old. Provides an affirmative defense to prosecution if the person reasonably relied on fraudulent proof of age presented by the person who is under 21 years old.

3/25 referred to Senate Judiciary

Adds certain medications to the definition of dangerous drug offenses. Expands the definition of a vapor-releasing substance containing a toxic substance to include a fuel source or propellant that contains certain specified substances.

First sponsor: Sen. Huppenthal

4/28 signed by governor. Chap. 203, Laws 2010.

First sponsor: Sen. Leff

3/9 from Senate rules okay.

A House Judiciary Committee amendment removed certain materials, compounds, mixtures or preparations which contain chemicals associated with a depressant effect on the central nervous system from the definition of dangerous drugs.

S1258: MEDICAL RECORDS; DISCLOSURE; RELEASE AzPA Supported

S1285 (Chapter 58): OPTOMETRISTS; MEDICATIONS AzPA Opposed

S1309 (Chapter 307): PARENTS RIGHTS

Permits the authorized disclosure of medical records or information, including clinical laboratory test results, to specified individuals or entities. Allows persons or entities that provide services to a health care provider or laboratory to receive medical records or information if the person or entity maintains a business associate agreement to protect the confidentiality of the information.

Replaces three specific macrolides with the term macrolides. First sponsor: Allows optometrists to prescribe, dispense and administer Sen. Verschoor antiviral medications for treatment of diseases of the eye and its adnexa. Requiring a referral to a physician after 72 hours if the condition does not improve. Prohibits optometrists from prescribing, dispensing and administering an oral antibiotic or an oral antiviral to a person under six years of age.

Outlines parental rights related to healthcare, education, First Sponsor: recordings, scans, genetic testing and the upbringing of a Sen. C. Gray minor child. The bill was amended in the House as follows: AzPA  Removes the parental consent requirement for Monitored/Opposed/Supported prescriptions (and all prescription order language).  Allows mental health screening to occur without parental consent as follows: a) in a clinical setting; or b) in an emergency situation.  Permits parental consent for mental health screening to be written or oral.  Reinstates the ability of a minor to obtain treatment for a venereal disease without parental consent. clear

4/14 signed by governor. Chap. 58, Laws 2010.

5/10 signed by governor. Chap. 307, Laws 2010.

Arizona Journal of Pharmacy 15

Academy News Community Pharmacy Academy News Greetings from the Community Pharmacy Academy!

Recently, AzPA was recognized by The Arizona Partnership for Immunization - TAPI - with a “Long Shot” Award for its role in spearheading the passage of HB2164 which expanded pharmacists’ authority to administer immunizations to adults. The law was implemented in early October 2009, just in time for distribution of H1N1 influenza vaccine and greatly increased the avenues through which the vaccine could be distributed. If AzPA had not supported this law, Arizona’s 2009 H1N1 influenza vaccine distribution would have been hampered. In addition, this law allows for pharmacists to play a vital role in increasing adult immunizations in Arizona in the future.

Health-System Academy News Greetings, Health-System Academy Members!

The Health-System Academy held its annual conference at Banner Desert Medical Center on April 17, 2010. Experts in Critical Care, Pediatrics, Infectious Diseases and Geriatrics treated the participants to exceptional topics in Neurology.

The event ended with a timely law update on the pharmacist’s role in the 2010 Health Care Act. The conference co-chairs Heidi Mahay and Jean Patel and the entire academy wish to thank the participants, speakers and AzPA staff for making this conference another great success.

If you are not a certified immunizing pharmacist, AzPA will offer an immunization certificate program in October 2010. Watch for more information on the date and location.

This is my final CPA News contribution. Thank you for the opportunity to serve you and please continue your support of AzPA as Keith Gallus assumes the CPA Chair position. And congratulations to Justin Brock the new CPA Chair-Elect.

Sincerely, Chad Schuster, Pharm.D. Community Pharmacy Academy Chair chad.schuster@frysfood.com

l to r: Heidi Mahay, HSA Conference Co-Chair, Mike Dietrich, HSA Chair, and Jean Patel, HSA Conference Co-Chair.

On the national scene, our ASHP delegates are just returning from the ASHP annual meeting and House of Delegates held in June. We will share their report in a future HSA News.

The Summer edition of the HSA eHeartbeat will feature topics in cardiology and will be a must read, so look for this in your in-box shortly.

This is my last message as HSA Chair. Butch David will take the reins for 2010-2011. Congratulations to Jonathan Merchen on his election as HSA Chair-Elect.

I wish them much success for the coming year.

AzPA President-Elect Kelly Hampton accepted the “Long Shot” Award on behalf of AzPA from TAPI. She is pictured here with Will Humble, Director, Arizona Dept. of Health Services. AzDHS was also recognized for their support of HB2164.

16 Arizona Journal of Pharmacy

Sincerely, Mike Dietrich, Pharm.D., BCPS Health-System Academy Chair 2009-2010 mdietr@midwestern.edu

Managed Care Academy News Wizard of OZ….What Do Those People in Managed Care Do Behind the Scenes and What Will They Do With the New Health Care Reform Law? Nationally the latest reports estimate that there are over 18,000 pharmacists who are employed at health plans and pharmacy benefit management companies and even more technicians. Managed care health plans use pharmacists and technicians to assist in the design and administration of pharmacy benefits for their enrolled members. Today more than 200 million Americans obtain their prescriptions through managed care health plans. Managed care pharmacists are asked to develop benefit designs and processes to encourage effective medications for the best “value”. The ability to manage medication costs ultimately benefits their enrolled members by allowing those members to pay just a portion of their actual prescription costs. These pharmacists are asked to make “value” decisions on behalf of their members based on the evidence of safety, efficacy, and cost. They rely on their clinical experience to predict how the new medication will be prescribed for their members, what dose will likely be used for most members, how direct-to-consumer advertising may impact the trend for new prescriptions, what alternative therapy or treatment could also be used, etc.

State and Federal mandates have played a large role in how managed care pharmacists operate (Example: Medicare Part D, Medicaid Best Price, etc.) Health care reform will also have a large impact on the delivery of managed care services over the next few years. The Kaiser Family Foundation has developed excellent resources that help to explain the major elements of the new law: http://www.kff.org/healthreform/basics.cfm#explainin ghealthcarereformseries This website also includes a timeline document which describes the impact of the changes starting in 2010 and going through 2018.

Academy News There is a common objective with the new law that the managed care industry has been tasked to accomplish: “provide more people with health care coverage and lower the administrative and medical cost burdens while doing this”. It is an ambitious goal for this industry and creates opportunities for pharmacists to use their analytical skills and deep knowledge of medication therapies to efficiently drive better patient outcomes. Already changes are in progress to support better clinical trial designs and more rigorous medication studies (“evidence-based medicine”) which are critical components of the important decisions that are necessary for affordable health care in our country. All aspects of medication delivery and medication therapy management are important to the managed care industry because all aspects impact the ultimate outcome experienced by the member.

I encourage you to be involved with your academy.

The ability to network, stimulate “out of the box” thinking, and increase the professional momentum necessary to accomplish the goals stated above will depend on the synergy of our efforts. There is no disputing that team work and collective effort is uniquely powerful. Take action - recruit other pharmacists and technicians. The success of your alliance depends on good representation from our professions. Get involved - be engaged with the academy and participate on committees: http://www.azpharmacy.org/ Being involved with AzPA has brought me some of the greatest satisfaction I have experienced in my career.

I highly value the friendships and professional growth that this organization has made possible and I am grateful to have the community of AzPA to help me as I continue to play a role in the care of patients.

Sincerely, Kim Kelley, Pharm.D. Chair, Managed Care Academy kkelley@azblue.com

Arizona Journal of Pharmacy 17

Academy News Senior Care Academy News Dear SCA Members, The American Society of Consultant Pharmacists (ASCP) held their Midyear Conference and Exhibition at the JW Marriott Desert Ridge in Phoenix, Arizona from May 26th to May 28th. ASCP is a national pharmacy organization that focuses on pharmacists caring for geriatric patients. Thanks to the collaborative efforts of AzPA and ASCP, Friday, May 28th, was designated Arizona Pharmacists Day and there was a reduced one-day rate for all Arizona pharmacists. Over one thousand people were in attendance at the conference including seventy-five Arizona Pharmacists, thirty-eight Arizona pharmacy students, and nineteen Arizona exhibitors.

During the meeting’s opening session, AzPA Senior Care Academy Chair Dawn Knudsen Gerber provided welcoming remarks. AzPA also had a table display on Arizona Pharmacists Day to promote membership and advertise for the AzPA annual meeting in July.

The conference education sessions included clinical, business/regulatory, and core basics tracks. Two AzPA members were presenters at the conference. Martha Fankhauser presented Eliminating Inappropriate Antipsychotic Use and Kathryn Matthias presented The Peaks and Troughs of Therapeutic Drug Monitoring in Older Adults. The exhibition was open all three days of the conference and many different types of services were represented. Overall, the conference was a fun event and the information was helpful for healthcare professionals caring for the geriatric population.

Student Pharmacist Academy News At its April 21, 2010, meeting, the Arizona Pharmacy

Alliance Board of Directors approved formation of a Student Pharmacist Academy. The creation of this new academy provides students a more focused opportunity to be actively involved in Arizona pharmacy and help meet the needs of student pharmacists in Arizona.

This new AzPA Student Pharmacist Academy (AzPA SPA) will be made up of student members from both colleges of pharmacy and will allow both colleges to have more interaction and opportunities to collaborate. Each college will elect its own Chair and Chair-elect this year.

The Chairs from each college will be Co-Chairs of the SPA. Members of the SPA will have input for activities and programming for the coming years.

As part of the recent AzPA 2010-2011 Board of Diretors Elections, the first Chairs and Chair-Elect for the AzPA SPA were chosen. They are:

Kerry Redman, Student Pharmacist Academy Chair University of Arizona COP Bonnie DiLorenzo, Student Pharmacist Academy Chair, Midwestern University CPG Jessica Woodling, Student Pharmacist Academy Chair-Elect,University of Arizona COP Election of the Student Pharmacist Academy Chair-Elect for Midwestern University Glendale College of Pharmacy will take place in Fall 2010.

The Student Pharmacist Academy will officially be created upon approval of the bylaws changes being put forth at the AzPA Annual Town Hall for members approval.

ASCP will come back to Phoenix in November of 2011 for their annual meeting at the Phoenix Convention Center.

Sincerely, Kim Cauthon, Pharm.D., CGP Senior Care Academy Chair-Elect kbyrdx@midwestern.edu

18 Arizona Journal of Pharmacy

AzPA Senior Care Academy Chair Dawn Knudsen Gerber, Pharm.D., welcomes the conference attendees to Arizona during the Opening Session of the ASCP Midyear Meeting held in Phoenix.

Technician Academy News Greetings, Technician Academy Members!

Academy News technicians on the AzPA Board of Directors for the past two years.

The AzPA 6th Annual Meeting is just one month away.

Chris Lesaca is your new Chair for the 2010-2011 Are you registered yet? year. Congratulations to Mike Severn, your new Technician Academy Chair-Elect! I know they will The theme of this year’s annual meeting is Changing serve the Alliance and our profession well.

Perceptions: Impacting Patient Health.

Registration for technicians is just $200 for the Professionally, three-day conference offering more than 16 hours of continuing pharmacy education. All General Sessions Jenny Whitney, C.Ph.T. are accredited for both pharmacists and pharmacy technicians. Suggested Saturday breakout sessions for Technician Academy Chair pharmacy technicians include: Update in Pediatric and Adolescent Diabetes Medical Devices in Pharmacy Practice Outpatient Pain Management: What’s all this...?

DM Therapeutics Debates in Disease Management OTC and the Self-Care Challenge 2010 This is my last message as Technician Academy Chair.

I am very proud to have represented pharmacy

Arizona Journal of Pharmacy 19

Drug Information Questions Question: Is the probiotic preparation VSL#3 effective for treating ulcerative colitis?

Daniel Watterson, Pharm.D. Candidate, and Stacy L. Haber, Pharm.D., Associate Professor, Midwestern University College of Pharmacy-Glendale

Answer:

Ulcerative colitis (UC) is an inflammatory bowel disease characterized by a continuous region of ulcers in the colon, accompanied by inflammation. Abdominal pain, frequent small volume bowel movements/diarrhea with or without rectal bleeding, and fecal urgency are common findings. In North America, UC affects 8 to 15 per 100,000 persons.1 While the cause of UC is unknown, theories suggest that development of the disease may be linked to genetics, infection, and autoimmune factors. Use of NSAIDs has also been associated with UC since prostaglandins have a protective mechanism in the GI tract.2 UC involves relatively symptom-free periods (remission) that are interrupted by periods of symptom exacerbation (active UC). The goals of treatment are to induce and retain remission, which are primarily achieved through pharmacotherapy with mesalamine or its derivatives (e.g., sulfasalazine, olsalazine, or balsalazide). Other treatment options include antimicrobials, corticosteroids, immunosuppressants, and agents to inhibit the proinflammatory cytokine TNF-α. Unfortunately, medications are often unsuccessful because many patients cannot tolerate their side effects.

A possible trigger for active disease is microflora in the GI tract that may cause inflammation.3,4 This idea is supported by increased intracellular and surface-adherent bacteria in the colonic epithelium of UC patients and changes in colonic flora after development of UC.5 This has led to the investigation of probiotics, which are non-pathologic bacteria that may alter the bacterial content of the colon when consumed orally. Probiotics have several proposed mechanisms of action, including crowding out pathogenic bacteria, production of pathogen-inhibitory substances, stimulation of the host’s immune system, and promotion of trophic effects on intestinal mucosa.6 A highconcentration probiotic preparation, VSL#3, delivers 4.5 x 1011 live bacteria per dose and contains 8 bacterial strains, including 4 lactobacilli strains, 3 bifidobacteria strains, and Streptococcus thermophilus.7 This over-the-counter product is available in many pharmacies and can be ordered online. Three randomized, controlled trials have been published on the use of VSL#3 for UC and will be summarized below.8–10 Additionally, 2 references cited on the manufacturer’s website to support the use of VSL#3 for UC will be examined.11,12 In a trial by Tursi et al.,8 the safety and efficacy of 3 different UC treatment regimens were tested. The first group received balsalazide + VSL#3 (2.25 g/day + 9.0 x 1011 bacteria), the second received balsalazide 4.5 g/day, and the third received mesalamine 2.4 g/day. Ninety patients with active UC were randomized to 1 of the 3 treatment groups for 8 weeks. The primary endpoint was the proportion of patients in symptomatic remission based on patient functional assessment ratings of normal bowel movements and absence of rectal bleeding.

20 Arizona Journal of Pharmacy

Secondary endpoints included time to symptomatic remission, change from baseline in the Clinical Activity Index (CAI), proportion of patients achieving an improvement in the endoscopic score evaluation, and improvement in histology.

Remission was induced in 80% of patients in the balsalazide + VSL#3 group vs. 53% of patients in the mesalamine group (p<0.02). Remission was reached in 4, 7.5, and 13 days, with balsalazide + VSL#3, balsalazide alone, and mesalamine, respectively (p<0.01). The authors concluded that balsalazide + VSL#3 was better than both of the other treatments in all parameters evaluated. This trial was limited by its small sample size, open-label design, and omission of details regarding randomization.

Recently, VSL#3 was evaluated as a treatment for UC in a multicenter, randomized, double-blind, placebo-controlled trial by Sood et al.9 The authors compared VSL#3 (3.6 x 1012 bacteria) versus a placebo powder, twice daily for 12 weeks, in patients with mild-to-moderate active UC (patients were allowed to continue other treatments). The primary endpoint was a 50% decrease in the Ulcerative Colitis Disease Activity Index (UCDAI) at 6 weeks. Secondary endpoints were remission by 12 weeks and reduction in total individual UCDAI parameters from baseline to 12 weeks. One hundred forty-seven patients were randomized in the intention-to-treat population (77 in the VSL#3 group and 70 in the placebo group); however, only 55 in the VSL#3 group and 29 in the placebo group completed the trial. A 50% decrease in UCDAI was reached in 25 of 77 (32.5%) patients in the VSL#3 group and 7 of 70 (10%) in the placebo group (p=0.001). The VSL#3 group also had significantly decreased UCDAI scores and significantly more patients achieving remission at 12 weeks. The authors concluded that VSL#3 resulted in significantly higher clinical responses and remission rates. Many patients dropped out of this trial; additionally, more patients dropped out of the placebo group than the VSL#3 group, which may have contributed to the lack of improvement in the placebo group.

In another recent randomized, double-blind, placebocontrolled trial by Miele et al.,10 VSL#3 was assessed for induction and maintenance of remission, as well as safety and tolerability, in children with active UC. A total of 29 patients were randomized to receive either VSL#3 (age/weight-based dosing, 4.5 x 1011 to 1.8 x 1012 bacteria/day) or a placebo powder in addition to mesalamine and oral methylprednisolone for 1 year. No specific endpoints were defined. Thirteen of 14 (92.8%) patients in the VSL#3 group and 4 of 11 (36.4%) patients in the placebo group experienced remission. Three of 14 (21.4%) patients in the VSL#3 group and 11 of 15 (73.3%) patients in the placebo group experienced relapse. Lastly, endoscopic and histologic scores performed at 6 months, 12 months, or at relapse were significantly lower (better) in the VSL#3 group than in the placebo group (p<0.05). The authors concluded that VSL#3

Drug Information Questions (continued from page 20) was efficacious for the maintenance and induction of remission in children with active UC. This trial was limited by its small sample size, lack of defined endpoints, and unexplained omission of 4 patients from the placebo group in the results for remission rates.

The VSL#3 manufacturer’s website references the aforementioned trial by Tursi et al.8 and 2 additional studies to support the use of VSL#3 for UC.11,12 The study by Venturi et al.11 was designed to assess whether the bacteria in VSL#3 were able to colonize the gut and if the product was able to prevent relapse. While the authors concluded that the product was able to prevent relapse in 75% of patients, this study had no control group and therefore cannot prove that VSL#3 was responsible for patient improvement. Similarly, the study Bibiloni et al.12 reported that VSL#3 was able to induce remission in 77% of patients with active UC. This study also did not have a control group and patients were allowed to continue other medications and therefore cannot prove that VSL#3 was responsible for patient improvement. Furthermore, the VSL#3 website shows a bar graph titled “Results after 12 months of VSL#3,” which clearly suggests that VSL#3 is beneficial for UC. However, it references a study by Fabia et al.,13 which did not involve VSL#3 or have data that could produce such a bar graph. This information is potentially misleading for a patient or health care provider who may be considering the use of VSL#3.

In general, probiotic preparations are considered safe and have been associated with minimal GI side effects; however, evidence on efficacy for UC is weak at this time. In a Cochrane review published in 2008 by Mallon et al.,14 the authors analyzed all relevant randomized, controlled trials regarding the use of probiotics for UC. They concluded that there is no evidence to support that probiotics are superior to placebo or aminosalicylates for the induction and remission of UC and therefore cannot be recommended. While these authors did include the trial by Tursi et al.,8 the trials by Sood et al.9 and Miele et al.10 were not published when this review was conducted. Although VSL#3 was found to be effective for UC in these 2 recent trials, they had significant limitations. Therefore, until additional, well-designed trials are conducted, VSL#3 cannot be recommended for patients with UC. References: 1) Greenberger NJ, editor. Current diagnosis and treatment gastroenterology, hepatology, and endoscopy. 3rd ed. New York: The McGraw-Hill Companies, Inc.; 2009.

2) Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, editors.

Pharmacotherapy: a pathophysiologic approach. 7th ed. New York: The McGrawHill Companies, Inc.; 2008.

3) Papadakis MA, McPhee SJ, editors. Current medical diagnosis and treatment.

49th ed. New York: The McGraw-Hill Companies, Inc.; 2009.

4) Fagbemi AO, Thomas AG, Akobeng AK. Probiotics for maintenance of remission in ulcerative colitis (Protocol). Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD007443. DOI: 10.1002/14651858.CD007443.

5) Podolsky DK. Inflammatory bowel disease. N Engl J Med 2002;347:417–29.

6) DerMarderosian A, Beutler JA, editors. Review of natural products. St. Louis: A Wolters Kluwer Company; 2009.

7) VSL#3 [homepage on the Internet]. VSL Pharmaceuticals [accessed 2010 Mar 19]. Available from: www.vsl3.com.

8) Tursi A, Brandimarte G, Giorgetti GM, Forti G, Modeo ME, Gigliobianco A. Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis. Med Sci Monit 2004;10:126–31.

9) Sood A, Vandana M, Makharia GK, Ahuja V, Singal D, Goswami P, et al. The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderate active ulcerative colitis. Clin Gastroenterol Hepatol 2009;7:1202–9.

10) Miele E, Pascarella F, Giannetti E, Quaglietta L, Baldassano RN, Staiano A. Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol 2009;104:437– 43.

11) Venturi A, Gionchetti P, Rizzello F, Johansson R, Zucconi E, Brigidi P, et al. Impact on the composition of the faecal flora by a new probiotic preparation: preliminary data on maintenance treatment of patients with ulcerative colitis.

Aliment Pharmacol Ther 1999;13:1103–8.

12) Bibiloni R, Fedorak RN, Tannock GW, Madsen KL, Gionchetti P, Campieri M, et al. VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis. Am J Gastroenterol 2005;100:1539–45.

13) Fabia R, Ar’Rajab AA, Johansson ML, Andersson R, Willen R, Jeppsson B, et al. Impairment of bacterial flora in human ulcerative colitis and experimental colitis in the rat. Digestion 1993;54:248–55.

14) Mallon PT, McKay D, Kirk SJ, Gardiner K. Probiotics for induction of remission in ulcerative colitis. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD005573. DOI: 10.1002/14651858.CD005573.pub2.

AzPA is looking for a few good educators!

The demand for Carl Labbe’s Pharmacy Technician Certification (PTC) exam review course offered through the Arizona Pharmacy Alliance has been steadily increasing as the need for certified technicians in many practice settings climbs rapidly.

This successful program is looking for motivated educators as we expand to offer parallel sessions at the Alliance office as well as at possible locations in Tucson and Flagstaff or Prescott.

The course runs for seven consecutive weekly 3-hour sessions and covers calculations, pharmacy operations, terminology, pharmacology and disease states, aseptic technique, federal regulations, ethics, and pharmaceutical care principles. A benchmark exam is given near the end of the course. A focused evaluation is provided to students based on the exam results.

Interested pharmacists and technicians will be evaluated based on resume and performance on the benchmark exam. The course is modular in nature and multiple instructors may be needed to provide one complete course. Class times have been Wednesdays, 6PM to 9PM or Saturdays, 9AM to noon, but can be adjusted as necessary.

This is a compensated activity, not a volunteer opportunity.

If you are interested in becoming an instructor for the PTC Exam Review Course, send your resume and cover letter to: Arizona Pharmacy Alliance, 1845 E. Southern, Tempe, AZ 85282 or email mindy@azpharmacy.org.

Arizona Journal of Pharmacy 21

Student Perspective Strength in Numbers On rotation at the Arizona Pharmacy Alliance, I knew I would be involved with association work and learning what the state’s pharmacy association does. My activities can be put into one of four broad categories.

1. Meetings and conference calls taking place within the confines of the AzPA offices. These included regularly scheduled conference calls with APhA, ASHP, and NCPA calls on HCR, meeting with the Pharmacy Network of Arizona President, an independent pharmacy owner’s forum, and a Board of Directors meeting.

2. Conferences outside the office. These included annual conferences for AzPA Managed Care Academy and Health-System Academy. I also attended the Western States Health-e Connection Summit, and several committee meetings at the state capitol building.

3. Informational and personal contact visits outside the office. These consisted of a visit and tour of McKesson, and interviewing three independent pharmacists.

4. Miscellaneous work which included calling members about renewing their memberships, writing grant requests for the AzPA annual meeting, reviewing collaborative practice and immunization laws in Arizona, and meeting with a pharmacist who is a candidate for state legislature.

These experiences increased my understanding of the vast amount of work done by AzPA and is especially impressive considering the small size of the staff. AzPA has ties to a large number of national organizations, and most of the local pharmacy businesses and organizations. With a paid lobbyist at the State capitol, AzPA has a significant amount of influence in matters relating to pharmacy. My insider’s viewpoint helps me realize that they cannot do all of it alone, and that students, technicians, and pharmacists are all needed to make the organization successful in its endeavors to protect pharmacy in Arizona.

Two projects I particularly enjoyed were writing a proposal to present to the Board of Directors for formation of a Student Pharmacist Academy (SPA) and interviewing three independent pharmacy owners for an article for the Arizona Journal of Pharmacy. Both of these activities took up a fair amount of time but I enjoyed them so much because of the new friends and contacts I developed.

In my work on the SPA I contacted students from Pennsylvania, Tennessee, Washington, and Virginia for their input. I partnered with the student body presidents of both Arizona colleges of pharmacy in developing the final 22 Arizona Journal of Pharmacy

draft of the presentation. This put into real practice for me the concept of collaboration to achieve great things.

As I interviewed the independent pharmacy owners I was able to go to their environment and visit them in their stores. Our discussions about pharmacy ownership were frank and open. I received good advice and gained a newfound respect for independent pharmacy. It was an opportunity for me to see someone who is directly impacted by what is happening in pharmacy, versus someone who is working in a large-chain environment.

All of these experiences really highlighted to me the value of collaborative work. I’ve learned that no matter how passionate one person may be, greater things are accomplished with greater numbers.

by Kenneth Fletcher, Pharm.D. Candidate, Midwestern University - College of Pharmacy Glendale, Class of 2010

Arizona Pharmacy Alliance presents

Online Pharmacy Law & Quality Assurance Course 15 Hours of continuing pharmacy education completely online!

This two-week course is designed to provide home study law credit to any pharmacist wanting to learn about quality assurance strategies and Arizona’s pharmacy laws, and ideal for pharmacists applying for reciprocity into Arizona, recent pharmacy school graduates preparing to take the MPJE, or pharmacists who want an update on Pharmacy Law and Quality Assurance.

Online discussion boards, instructor monitoring and interaction keep you on track throughout the course.

Assignments, tests and quizzes track your progress.

You must receive a score of 70% or higher on the final exam to pass this course and receive credit.

This course is accredited by ACPE for 15 hours of home study law education.

Course Fee including textbook: AzPA Member $215 AzPA Student Member $145 Non-Member $315 Visit www.azpharmacy.org for complete information and to register.

Feature Pharmacist Industrial Strength Pharmacists Community, hospital, long-term care. These are just a

few types of pharmacy practice settings that come to mind when you think of a pharmacist’s daily job. However, there are a number of pharmacists who have exciting, rewarding careers working for industry. In this feature pharmacist article, we profile three pharmacists who work for three different drug manufacturers.

Chris Tankersley Christina (Chris) Tankersley, Pharm.D. is a Regional Director for sanofi-aventis. She is an integral member of the medical affairs department of the corporation. Based out of Scottsdale, Arizona, Chris is an active member in the Arizona Pharmacy Alliance.

Chris graduated with her Pharm.D. from the University of Arizona in 1997 and began working at CIGNA Arizona.

She recalls, “They have a unique health care model, with a self-contained clinic that includes pharmacy, a lab, and physicians in one building. I liked that it wasn’t a traditional retail setting. You had access to patient charts and if I wanted to change something, the doctor was right there.”

Chris established a pharmacist-managed Coumadin® clinic. Years later, she was recruited to work at sanofiaventis because of her experience in anticoagulation.

For seven and a half years, Chris served as a regional medical liaison for the cardiovascular branch of sanofiaventis. In August 2009, she was promoted to regional director; now she has nine regional medical liaisons reporting to her. Sanofi-aventis’ main medications include Lovenox®, Plavix®, Multaq®, Lantus®, and Apidra®, so Chris is very involved in both cardiovascular and diabetes drug information.

Chris admits the hardest thing about leaving CIGNA was leaving direct patient contact. However, she does impact patient care in her current job. She says, “While the role I have doesn’t directly benefit patients, the education I share with the people who administer care is logarithmic compared to the care I can provide as an individual. If I can teach you how to bridge someone that’s going to have surgery, that impacts all your patients. Also sitting at that same lecture are 50 other providers that care for 500 patients.”

Increased scrutiny and regulation from the government, health care institutions, and health care professionals themselves are some of the challenges Chris faces at sanofiaventis. Chris states, “There’s a lot we want to do in the best interest of our patients, but we are restricted. Over the last year there have been increasing regulations on just how we make presentations, their content, documenting that it was an unsolicited request, maintaining those records. You

can’t proactively go out and educate people.”

It is illegal to promote off-label uses of medications, but sometimes there is a true educational need. For example, there is a lot of good data to support the use of anticoagulation medications outside of their indication.

Chris’ experience at CIGNA gives her a good perspective.

She says “I’ve been on both sides of the table so I understand where it’s coming from. It’s definitely a challenge, but I like challenges!”

Reflecting on the opportunities for pharmacists in industry, Chris says, “When people think of the pharmaceutical industry they think of sales representatives.

They don’t think of people in the liaison roles. They are two very different roles. Sales representatives have a different motivation. They are on the commercial side; they are financially driven. However, many people fail to see the benefits we provide in the medical side of sanofi-aventis.

We need to be evidence-based, we need to be fair and balanced, and we need to know our competitors.

We should not be seen as Lovenox experts, rather we are thrombosis experts. We need to know wafarin and Fragmin® just as well as we know Lovenox®. The commercial side only gets paid if an institution buys Lovenox®. On the medical side, our salaries and bonuses are not based on market shares. My job is solely to provide education. I only come if you ask, due to regulation.

That is another reason why I stay involved in Arizona Pharmacy Alliance; I know a lot of people that think of me as a thrombosis expert, so I get calls and emails from people asking me to come and share my knowledge.”

Chris Tankersley, Pharm.D.

Greg Morrill Greg Morrill, Pharm.D., works as a Medical Outcomes Specialist for Pfizer. Greg was a graduating member of the first Pharm.D. class of the University of Arizona. After completing a PGY1 residency at the Southern Arizona Veterans Administration (VA) in Tucson, he moved to the VA in Reno, Nevada. There he established pharmacist-run ambulatory care departments in areas like anticoagulation, hyperlipidemia, and hypertension. After returning to Southern Arizona VA and working as a clinical pharmacist for a few years, he was recruited to work for industry. Greg spent several years at what was then Astra-Merck before making the move to Pfizer, where he has been for the past ten years.

Arizona Journal of Pharmacy 23

Feature Pharmacist Industrial Strength Pharmacists (continued from page 23) Greg works mainly in outcomes research and education. “I work with various different business clients - health systems, hospitals like the VA, colleges (including Midwestern and the University of Arizona), medical groups, and managed care. My purpose is to ensure that my clients are achieving quality goals in terms of outcomes (both clinical and economic),” he says.

Greg states that the most challenging aspect of his job is handling change. “The industry is going through a lot of consolidation and down-sizing. Across the industry, drug manufacturers are losing patent protection. Industry is now entering an era without many new drugs in the pipeline. In addition, the outside regulatory pressures (governmental and private insurers) are difficult to deal with. Industry is definitely going through a contraction right now.” For example, Greg has been with two companies over twelve years, but he has been through five mergers.

When asked to share some words of wisdom for future pharmacists, Greg says, “Continuously learn. Become involved professionally. A professional network takes time to create but pays you back tremendously. I’ve been involved in the Arizona Pharmacy Alliance for years, and the network of friends and peers I’ve built is so rewarding.”

Greg Morrill, Pharm.D.

Ken Mahan, R.Ph..

Ken Mahan Ken Mahan is a pharmacist who works for the Johnson & Johnson subsidiary, Tibotec. Tibotec specializes in antiretroviral therapies for HIV. In addition, he is an active member of the Arizona Pharmacy Alliance and currently serves on the board of directors as treasurer.

Ken began his career in managed care, working for CIGNA Arizona. He quickly advanced to become the Director of Pharmacy. He recalls, “Industry was looking for people in the managed care business, to more effectively align their company with Managed Care.” After thirteen years with CIGNA, Syntex labs offered Ken a national accounts position, which he accepted. Shortly thereafter, the company was bought out by Roche. For twelve years, he worked in the National Accounts Department. Finally,

24 Arizona Journal of Pharmacy

in July 2005, Tibotec at Johnson & Johnson hired him to be their Western Region Access and Reimbursement Executive. He is now the senior executive for all sales in Arizona and Nevada. His job involves calling on HIV providers throughout the state to provide drug information (relating to side effects and interactions) on Tibotec’s products. Tibotec’s main prescription products include Intelence® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) and Prezista® (darunavir), a protease inhibitor.

Ken says that an attractive aspect of his current job is the fact that he is not tied to a desk or office. “You don’t have set hours. You work when you work. You make your own appointments and plan your business for the week or month. In this job, if you aren’t self-disciplined, you’re going to be a mess. There’s no one standing over your shoulder telling you what to do on a daily basis. You really have to be self-motivated.”

Ken admits there weren’t the opportunities for pharmacists in industry when he graduated from school that there are today. “There are numerous opportunities for pharmacists in industry now whether in medical information services (answering 800 calls for off-label indication information), new product marketing (assessing pipeline agents to determine how to bring to market and fill an unmet medical need), government relations (working directly on legislative issues in Washington D.C.), medical education department (coordinating educational symposiums), or scientific publications department (reviewing manuscripts), there are limitless aspects pharmacists can serve. Most students–and practicing pharmacists—have no idea.”

Though some healthcare professionals may view working for industry as “crossing over to the dark side,” Chris Tankersley says, “When I tell people I work for industry, and they, surprised, say “Really?” I take it as a huge compliment because you’re really stereotyped. But pharmacists in industry really have so much to offer to providers and patients alike.”

by Lucy Chemodurow, Pharm.D. Candidate, University of Arizona College of Pharmacy, Class of 2010

Feature Pharmacist Pharmacist + Passion = Purpose What do we find when passion collides with pharmacy?

1. An accident? 2. Nothing? 3. Purpose in what we practice in our profession? A person who embodies the third proposed answer is Laura Adams, Pharm.D., a pharmacist for the Pharmacy Network of Arizona (PNA).

Under the auspices of the Arizona Pharmacy Alliance, the PNA provides patient self-management programs for county employees with diabetes. Laura has been involved with this program since September 2009 and sees eleven patients in Parker, AZ. In addition to her duties with the PNA, Dr. Adams is the pharmacist-in-charge for Kmart in Lake Havasu City, AZ.

Passion of a Lifetime The story of Laura’s passion for helping diabetic patients manage their condition began within her family.

Ten years ago on her birthday, her then six-year old son was diagnosed with type 1 diabetes mellitus. While she was learning how to manage her son’s diabetes, she developed an understanding on the importance of checking blood sugar levels, counting carbohydrates, and dosing insulin.

With this experience, it is easy for her to relate to patients on the long-term impact of diabetes on lifestyle and health. “[My son], Jared, was my inspiration to seek the education as a pharmacist and become a diabetes educator to help him while helping my community,” Dr. Adams recalls.

In 2009, Dr. Adams earned her Pharm.D. degree at the University of Arizona, College of Pharmacy. While she was a pharmacy student, Laura actively promoted diabetes education in her community. She started out as a Diabetes Coordinator, organizing blood glucose screenings at various local pharmacies and health fairs. Subsequently, she was promoted to Vice President of Managed Care for the student chapter of the American Pharmacists Association.

During her final year of pharmacy school, Dr. Adams completed a rotation with Dr. Sandra Leal and Dr. Marisa Soto-Rowen at El Rio Health Center in Tucson, where she was thoroughly impressed by their collaborative pharmacy practice. Inspired to become a Certified Diabetes Educator, she immediately sought training to become an insulin pump trainer. In the summer of 2009, the idea of joining the PNA occurred to her when she read about the program in an issue of the Arizona Journal of Pharmacy. Dr. Adams immediately inquired about the PNA with Mindy Smith, Executive Director and CEO of the Arizona Pharmacy Alliance, who connected her to a position in Parker.

Laura’s lifelong dedication to diabetes training has enabled her to help her patients set goals to improve their quality of life. “Diabetes is more than just medication. It is a lifestyle, and I want to be a support to those patients in an

area that needs the education to manage their diabetes,” Dr. Adams stated.

Behind the Scenes with a PNA Pharmacist Two days out of the month, Dr. Adams meets with patients at the county building in Parker from 8:00 AM to 5:00 PM. New patients schedule monthly appointments with her for the first three months, followed by visits every three months. On a typical visit, Dr. Adams discusses with her patients how she can help them meet their goals. “My first goal is to meet with each individual patient to begin the process of understanding what their motivation and needs are,” Laura stated.

After the patients set their goals, Dr. Adams takes the time to review every medication they are taking for drug interactions and potential therapeutic issues. While talking with her patients, Dr. Adams gets a sense of the patients’ knowledge base on diabetes and customizes educational material to address their needs. She then obtains measurements of patients’ blood pressure, weight, blood glucose, and if necessary, extra labs. At the end of each appointment, the patients leave with a handout listing the goals they have set and comparisons of blood glucose and other measurements taken at each visit. By having in hand a reminder of goals that they want to achieve, patients are motivated to be involved in the long-term management of their diabetes.

But that is not all. Continuity of care plays a vital role for the success of this patient self-management program.

Dr. Adams records her notes and recommendations for each patient into computer software. This software enables her to submit her notes for each visit electronically to the patients’ physicians. When physicians are informed about the visits, they can optimize the care they provide to their patients. Although patients may only meet with Laura every three months, if they have any questions, they can reach her through multiple modes of communication, whether it is through e-mail, telephone, or at her pharmacy in Lake Havasu City.

“What I enjoy the most is getting to know the patients on a personal level, adapting the information to meet their needs, learning from my patients, and hearing about their accomplishments as they reach the goals they have set for themselves,” Laura noted.

A Pharmacist’s Impact Laura’s patience and passion has empowered her patients to take control of their diabetes and their lives.

The following comments were given by people who were impacted by her outstanding service. Note: To respect their request for anonymity, random initials were used in place of their names.

Arizona Journal of Pharmacy 25

Feature Pharmacist Pharmacist + Passion = Purpose (continued from page 25) “Meeting with the pharmacist has helped me set goals and obtain control over my diabetes. Laura seems to be genuinely excited for me when I reach a goal and never criticizes me when I do not quite meet every goal,” R.L. remarked.

Maintaining control of blood glucose can be overwhelming for people who are initially diagnosed with diabetes, because treatment involves lifestyle changes. “I look forward to the monthly visits with Laura as she is always encouraging and optimistic. If I fall off the wagon one month, she is there to help me get back on,” J.B said. Learning how to check and interpret blood glucose is also challenging, like learning a foreign language. “I have learned not to be afraid of the numbers…Laura has been very helpful with her suggestions of how to take my medications and make lifestyle changes,” T.J. said.

Even diabetic patients who have managed their condition for the longest time still look up to the pharmacist for the most updated information. “I always considered myself knowledgeable and an expert on my diabetes care. I appreciate the time Laura has taken to get to know me and answer questions that I did not think there was an answer to,” D.G. commented.

Why would Laura Adams take extra work on top of her pharmacist duties and family obligations in Lake Havasu City? Why would she want to drive 40 miles to

Parker? How does she maintain that energy and desire to give her patients the best care? To all those questions, Dr. Adams gave her thoughtful answer: “My passion for this program stems from personal experience, but my love for it continues to grow because of my patients.”

by Kathy Lin, Pharm.D. Candidate, University of Arizona College of Pharmacy, Class of 2010

Laura Adams, Pharm.D., consults with one of her patients enrolled in the PNA program.

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26 Arizona Journal of Pharmacy

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Features and Articles ACOs Coming, and Pharmacy Can Help

by L. Michael Posey, B.Pharm.

Editor, Pharmacy Today, American Pharmacists Association, Washington, D.C.

The Affordable Care Act (ACA) has been labeled the reform of the American health insurance, not care, system.

That is true to some degree, but many elements of the new law will affect the daily practice of pharmacy and medicine.

These were mostly ignored during public and congressional debate over HCR. Leaders of APhA’s three Academies were briefed in detail on April 17 about one of the most important practicerelated provisions of ACA: accountable-care organizations (ACOs). ACOs feature a new type of payment model that seeks to address some of the problems inherent in the two dominant models in use—fee for service and capitation.

Under the new law, many ACOs will likely emerge from existing patient-centered medical homes. The two terms are not synonymous. A medical home is more a care model in which primary care practitioners take responsibility for coordinating services provided to a group of patients.

Medical homes use tools such as electronic medical records and multidisciplinary care. Certified patient-centered medical homes can receive additional compensation for care coordination.

ACOs are more a payment or financing model. These organizations assume some of the risk involved in patient care, as described below. Certified patient-centered medical homes can morph into ACOs, but ACOs do not have to be medical homes.

“Patient-centered medical homes or care models will be important, and how pharmacy fits into those will be important,” Thomas E. Menighan, BPharm, MBA, ScD, Executive Vice President and CEO of APhA, told the leaders. “I’ve seen this model described as a house with information technology and systems on the first floor, primary care on the second floor, specialists on the third floor, and so on. But there’s still room for growth and improvement in the design. And we’re in a position now to design how pharmacy will fit into this model.”

What are ACOs? Essentially, an ACO shares risk between payer and provider, and providers can be reimbursed at higher levels for attaining quality goals. The cost of care is attributed to providers in the ACO, said S. Lawrence Kocot, MPA, JD, LLM, Deputy Director of the Engelberg Center for Health Care Reform at the Brookings Institution in Washington, DC, and Senior Counsel at Sonnenschein, Nath and Rosenthal, a firm that worked with APhA throughout the health care reform debate.

Take rehospitalizations, for example; under a fee-forservice model, these generate additional payments. Under capitation, each admission generates a payment based on the diagnosis, even if the hospitalization is the result of poor care during a previous stay.

Under such models, providers quickly learn how to manipulate the system, Kocot said, recalling his experiences at CMS with physician fees and imaging.

When payments for fees were restricted, service intensity and billings went up.

ACOs add cost and quality components. “ACOs allow physicians to group together, if they have a minimum of 5,000 covered lives,” Kocot said. “Physicians bill fee for service, just as they do today. But at the end of a year, 2 years, or 3 years, their goal is to look at the spending growth target, and if they beat the target, they may share in the savings. But in addition to the cost target, they must meet certain quality standards. The quality standards are there to be sure the physicians don’t skimp on the costs.

This system starts to realign the incentives so that the physician does the right thing for the patient.”

Thus, in the case of rehospitalization, all of the costs are attributed to the ACO. With too many rehospitalizations, an ACO may miss its cost target, its quality standards, or both.

ACO pilots are already under way at the Carilion Clinic in Roanoke, VA, Norton Healthcare in Louisville, KY, and Arizona’s Tucson Medical Center.

Where does pharmacy fit in ACOs? Pharmacy will play an important role in ACOs, but whether the profession does so from within the organization (and therefore accepts risk with the other providers) or as a contracted, external entity remains to be seen. But one thing seems clear, especially when it comes to cost and quality: The ACO will have difficulty meeting its goals without partnerships with pharmacists.

“The ACO will bring to physicians the recognition that there are other providers in the community who can do a lot more for them, be cost-effective, and improve their bottom line,” Kocot said. “As physicians start looking at this a little more methodically, they’re going to realize the pharmacist is their savior, not their enemy.”

Increased use of nurse practitioners and other nonphysician providers, improved care coordination, reduced waste, better management of chronic diseases, and point-of-care reminders are just some of the ways in which ACOs can control costs, Kocot said.

“Pharmacists very well could be part of an ACO,” Kocot added. “But I don’t know if that’s really that important … because any doctor in the community is going to realize that pharmacists are key to the practice. The issue is what pharmacists can do. Literature supports that pharmacists

Arizona Journal of Pharmacy 27

Features and Articles ACOs coming, and pharmacy can help (continued from page 27) play a key role in improving patient adherence to recommended care, care coordination across providers, and avoidable complications. Pharmacists have a big role in being the bricks, or the cement, for the primary care physicians, if the pharmacists position themselves right.”

The other point to remember is that ACOs are “not some big monolithic system that you have to penetrate,” Kocot said. “These are your local providers. Some ACOs are very small. There is no choice but to rely on the pharmacist.

Pharmacists need to get with these community groups as they start planning. Pharmacists need to be at these meetings to emphasize their roles from the very beginning.”

What happens next?

The next two steps spelled out in ACA are coming up fast, making it important that pharmacists engage others in their communities now. Being established in CMS is a Center for Medicare and Medicaid Innovation. It has $10 billion in authorized funds (for use over 9 years) to begin testing payment and delivery models by January 1, 2011, Kocot said. A year later, a Medicare shared-savings program based on ACOs will begin.

“The time is now to change the system,” Kocot said.

“Pharmacists can and should be a part of this.”

Reprinted with permission from the Hub on Health Care Reform column in the June 2010 issue of Pharmacy Today (www.pharmacytoday.org).

For more information about the Affordable Care Act and pharmacy’s role in shaping the outcomes of this law, access the Government Affairs section of APhA’s website, www.pharmacist.com. Copyright © 2010, American Pharmacists Association. All rights reserved.

AzPA Career Center - Here for You As your primary resource for professional development and services, the Arizona Pharmacy Alliance offers a full-service Career Center designed especially for employers and job seekers in the pharmacy industry.

Posting your positions and resumes on the AzPA Career Center gives you great exposure to a wide array of candidates and exciting opportunities in our professional community.

Looking to fill a position?

The AzPA Career Center is custom-tailored for the pharmacy industry. It’s the best way to find qualified and experienced talent.

• Gain access to Arizona’s most qualified pharmacy professionals • Post multiple positions at affordable prices • Receive Resume Alerts of recently uploaded resumes Searching for a job?

Employers, recruiters and staffing firms are constantly looking to our members to fill vacant positions in the pharmaceutical industry. The AzPA Career Center is your premier source to find the best pharmacy jobs in the state.

• • •

Create a FREE Job Seeker account Set up automated email Job Alerts Post resumes anonymously

Register today as an employer or job seeker. Visit the Arizona Pharmacy Alliance website at www.azpharmacy.org Go to the Career Center page and click on the link to the Career Center.

From there follow the navigation tools. It’s that simple. AzPA Members receive a discount on all Career Center packages.

SUPPORTING PHARMACISTS ADVANCING CAREERS Find the best jobs and highly qualified pharmacists Arizona has to offer.

ONLINE CAREER CENTER www.azpharmacy.org/jobs

28 Arizona Journal of Pharmacy

Please contact Janet Weigel, AzPA Marketing and Communications Coordinator, at janet@ azpharmcy.org with any questions you may have about using the Career Center.

The Arizona Pharmacy Alliance Career Center Your Industry • Your Community • Your Career

Features and Articles Getting Vaccinated Before You Travel

by Sam E. Webster, Pharm.D.

This time of year is a popular time for people to travel.

If your travels take you out of the United States, check with your physician or pharmacist to see if you need to be vaccinated. Some vaccines require a series of shots to be given over a few days, weeks, or months. Also, vaccinations take time to become effective in your body.

Ideally you should seek travel advice 4-6 weeks prior to your trip, but even if you are traveling in less than 4 weeks you should still seek travel advice from your doctor or immunization-trained pharmacist.

It is important to remember to keep your vaccination record current. The vaccines are necessary to protect you from diseases seen in other parts of the world not commonly seen in the United States. Visit the CDC destinations webpage to see what vaccinations are required in the country you are traveling to at http://wwwn.cdc.gov/travel/destinationList.aspx The CDC divides vaccines for travel into three categories: routine, recommended, and required. While your doctor or pharmacist can tell you which ones you need, it is good to know about them ahead of time.

1. Routine vaccinations Be sure that you and your family are up to date on your routine vaccinations. These vaccines are necessary for protection from diseases that are still common in many parts of the world even though they rarely occur in the United States. They include: a. Tetanus, diphtheria and pertussis (Td/Tdap) b. Varicella c. Measles, mumps and rubella (MMR) d. Influenza e. Herpes Zoster f. Pneumococcal 2. Recommended vaccinations These are recommended to protect travelers from illnesses present in other parts of the world and to prevent the importation of infectious diseases across international borders. They include: a. Hepatitis A b. Hepatitis B c. Polio d. Rabies e. Typhoid f. Japanese Encephalitis

3. Required vaccinations a. The only vaccine required by International Health Regulations is yellow fever vaccination for travel to certain countries in sub-Saharan Africa and tropical South America.

Visit http://wwwnc.cdc.gov/travel/yellow-fevervaccination-clinics-search.aspx to find a certified Yellow Fever Clinic. b. Meningococcal vaccination is required by the government of Saudi Arabia for annual travel during the Hajj.

If you travel with your pets be aware if the airline you are traveling with requires a certificate of health to travel. The United States and the CDC do not require a certificate of health to enter; however, pet dogs are subject to inspection at ports of entry and may be denied entry into the country if they appear to be contagious with disease that can be transmitted to humans. Dogs do need to have proof of vaccination against rabies at least 30 days prior to entry into the United States. These requirements are also required of service animals such as seeing- eye dogs. Please see the CDC webpage about traveling with pets: http://www.cdc.gov/ncidod/dq/animal/dogs.htm#faq

AzPA Calendar of Events July 15 - 18, 2010 AzPA 6th Annual Meeting September 2010 PTC Exam Prep Course September 17, 2010 Community Practice Academy Conference September 18, 2010 MTM Certificate Program October 2010 American Pharmacists Month Immunization Certificate Program Regional Rallies - Law CE November 2010 Technician Academy Conference Visit www.azpharmacy.org for all upcoming events.

Empowering pharmacy professionals to provide optimal patient care

Arizona Journal of Pharmacy 29

Features and Articles Fenofibrate

By: Lilian Marshal, Pharm.D. Candidate Class of 2010, Midwestern University College of Pharmacy-Glendale Special thanks to Dawn Knudsen Gerber, Pharm.D., CGP, Midwestern University College of Pharmacy-Glendale

While working as a pharmacy intern, I found myself preparing to fill a prescription for TriCor® or Trilipix® and often wondering what exactly the difference was between trademarked fenofibrate in my hand and the other eight brand-names of fenofibrate on the shelf.

The only observable differences seemed to be the odd variety of strengths unique to each brand, such as 145mg of TriCor® versus 134mg of Lofibra® and tablet or capsule formulation. Knowing that most of them are not interchangeable, I wondered how a nine milligram difference in strength could be worthy of an entirely new drug application. Fibric acid derivatives are a class of drugs that decrease total cholesterol, LDL, and triglycerides while increasing HDL by activation of the PPAR-alpha receptor. Fenofibrate is hydrolyzed by esterases to the active metabolite, fenofibric acid, which activates the PPAR-alpha receptor, increasing lipolysis.

This class of drugs is approved as adjunctive therapy to diet for the treatment of primary hyperlipidemia, mixed dyslipidemia, and hypertriglyceridemia. Members of this class include: Antara®, Fenoglide™, Fibricor™, Lipofen™, Lofibra®, TriCor®, Triglide®, and Trilipix®.

Lopid® (gemfibrozil) is another fibric acid derivative, however, its mechanism of action and pharmacokinetic profile set it apart and so it was not included for comparison.

By reviewing the individual products’ prescribing information and published chart from Pharmacists Letter, I created a table that illustrates the differences.

The primary difference between all these brand-name fibric acid derivatives is the bioavailability provided by a variety of patented drug-delivery systems. For example, the patented MeltDose® technology in a 120mg Fenoglide™ tablet provides the same lipid-lowering effects as the patented NanoCrystal® technology in a 160mg tablet of TriCor®. With the exception of Trilipix®, which is indicated for use in combination with a statin and offers a unique benefit to patients’ lipid profiles, these small changes in particle size are really the only difference setting all these medications apart. In addition to setting these drugs apart in bioequivalence, these small changes in particle size are also responsible for some disproportionately large differences in pricing that presents an opportunity for pharmacists to help patients save money.

30 Arizona Journal of Pharmacy

The table for this article appears on page 32 and is available in a downloadable format on the AzPA website at www.azpharmacy.org References: 1) Fenofibrate. Drug Facts and Comparisons. Drug Facts and Comparisons eAnswers [online]. 2010. Available from Wolters Kluwer Health, Inc. Accessed February 23, 2010.

2) Fenoglide. Physician Information – Full Prescribing Information and More about Fenoglide. http://www.fenoglide.com/html/professionals. html. Accessed February 23, 2010.

3) Lipofen. Lidose Technology: A Next-Generation Dosage From Technology. http://www.lipofenrx.com/HCP/lidose_technology.asp.

Accessed February 23, 2010.

4) Product information for Tricor. Abbott Laboratories. North Chicago, IL 60064. June 2008.

5) Product information for Antara. Oscient Pharmaceuticals. Emeryville, CA 94608. March 2008.

6) Product information for Triglide. Sciele Pharma, Inc. Atlanta, GA 30328. April 2008.

7) Product information for Lipofen. Kowa Pharmaceuticals America, Inc. Montgomery, AL 36117. June 2008.

8) Product information for Fenoglide. Sciele Pharma, Inc. Atlanta, GA 30328. April 2008.

9) Product information for Fibricor. Mutual Pharmaceutical Company, Inc. Philadelphia, PA 19124. August 2009.

10) Product information for Lofibra capsules. Gate Pharmaceuticals.

Sellersville, PA 18960. July 2003.

11) Product information fenofibrate capsules. Impax Laboratories, Inc. Hayward, CA 94544. January 2005.

12) Product information for Lofibra tablets. Gate Pharmaceuticals.

Sellersville, PA 18960. July 2005.

13) Product information for fenofibrate tablets. Ranbaxy Pharmaceuticals, Inc. Jacksonville, FL 32252. October 2005.

14) U.S. Food and Drug Administration. Drugs@FDA: Drug Detail – Fenofibrate. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ index.cfm?fuseaction=Search.Drug Details. Accessed February 23, 2010.

15) Product information fenofibrate tablets. Impax Laboratories, Inc. Hayward, CA 94544. June 2008.

16) Product information for Trilipix. Abbott. North Chicago, IL 60064.

December 2008.

17) Drug Topics Red Book. 2009;113:various.

REGISTER TODAY! www.azpharmacy.org ArizonA PhArmAcy AlliAnce 6th AnnuAl meeting July 15 - 18, 2010 ArizonA Biltmore resort & sPA Phoenix, ArizonA

Changing Perceptions: Impacting Patient Health

bE A pART Of ARIzOnA’S lARGEST phARmAcY mEETInG!

Features and Articles Excuse Me, Doctor…Are Your Immunizations Up-To-Date?

by Jennifer L. Keonavong (Penrose), Pharm.D., BCPS As the influenza season wraps up, the hype of H1N1

wavers, the influx of patients into our facilities gradually begins to ease, and summer approaches, it is easy to be lulled into a false sense of security. If you made it this far into 2010 without falling victim to a nasty bug, surely you are in the clear…right? Not so fast. The flu season may come and go like our nice weather, but communicable diseases are here to stay. Regardless of your practice setting, the message is simple: if you work in healthcare, you are surrounded by infectious diseases, and you are always at risk.

The practice of managing infectious diseases has been under fire for quite some time. Our antimicrobial arsenal is slowly being compromised by increasing resistance, overprescribing and overuse, and a desperate need for research and development of new antimicrobials, particularly in the area of multi-drug-resistant gram-negative pathogens.

In fact, our need for novel antimicrobials has been timely addressed by the Infectious Diseases Society of America’s (IDSA) “10 x 20’” initiative late last year. This critical initiative calls for the development of ten new antimicrobials by 2020, a much needed medical feat as ever-evolving and often lethal bugs grow increasingly resistant to our currently available antimicrobials.

Treatment options for infectious diseases are needed so desperately, in fact, that the World Health Organization (WHO) has declared antimicrobial resistance as “one of the three greatest threats to human health.”1 As healthcare providers, we can take a small step towards “un-complicating” the infectious diseases landscape by getting immunized. Vaccine recommendations for healthcare professionals cannot be emphasized enough, especially to those who are new to the profession of caring for others. Infectious diseases do not discriminate; whether you are a pharmacist, intern, technician, physician, nurse, paramedic, student, volunteer, or other allied health professional, it is critical to keep your immunization status up-to-date for the health of yourself, your patients, and your loved ones. If you go to work unvaccinated, consider the implications that your decision might have on your patients, especially those who are very young, very old, or immunocompromised. Our decision to take care of others must first be preceded by the decision to take care of ourselves.

Fortunately, recent legislation has permitted pharmacists to administer vaccinations without a prescription, and it has become easier than ever to update your immunization status. In fact, every vaccination recommended for

healthcare professionals in this article may be administered by your neighborhood pharmacist.

Immunization requirements will vary by employer, but as a general rule of thumb, the following vaccines are recommended by the Centers for Disease Control and Prevention (CDC) for all healthcare professionals.

The table for this article appears on page 32 and is available in a downloadable format on the AzPA website at www.azpharmacy.org References 1. Heys J, Czark, G. 10 x 20’: ID experts call for 10 new antibiotics by 2020.

IDSA news release. Nov 2009. Accessed online via http://www.idsociety.org/ Content.aspx?id=15755.

2. Recommended adult immunization schedule (2010). MMWR. 2010;59(1).

Accessed online via www.cdc.gov.

3. Healthcare personnel vaccine recommendations. 2009. Accessed online via www.immunize.org/catg.d/p2017.pdf.

4. Use of influenza A (H1N1) 2009 monovalent vaccine – Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR. 2009;58 (Early Release):1-8. Accessed online via www.cdc.gov.

5. Update on influenza A (H1N1) 2009 monovalent vaccines. MMWR. 2009;58(39):1100-01. Accessed online via www.cdc.gov.

Become a Certified Immunizing Pharmacist!

Arizona Pharmacy Alliance presents Pharmacy-Based Immunization Delivery

Developed by the American Pharmacists Association

Coming in October 2010 Location and time to be announced

Pharmacy-Based Immunization Delivery is an innovative and interactive training program that teaches pharmacists the skills necessary to become a primary source for vaccine information and administration. The program teaches the basics of immunology and focuses on practice implementation and legal/regulatory issues.

This comprehensive immunization education and training will provide the knowledge, skills, and resources necessary to: • Establish and promote a successful immunization service • Identify at-risk patient populations needing immunization • Administer immunizations in compliance with legal and regulatory standards

Arizona Journal of Pharmacy 31

Features and Articles Product Manufacturer

Date Approved

AB Rating

Formulation

Strengths (mg)

Food

Labeled for Combo w/ Statins

11/5/04

None

NanoCrystal® Tab

48, 145

N/A

NO

Equivalent Dose (mg)*

AWP17

145

$4.34/145mg

Table: Fenofibrate Article on page 30

130

$4.52/130mg

Click here for a downloadable version of this table or visit www.azpharmacy.org

160

$4.25/160mg

150

$3.09/150mg

"Plasma concentrations of fenofibric acid after single-dose administration of Fenofibrate Tablets, 120 mg are equivalent to those of Fenofibrate 130 mg capsules under high-fat conditions."

120

$3.67/120mg

Fibricor9 (fenofibric acid) Mutual

8/14/09

None

Tablet

35, 105

N/A

NO

105

_

Lofibra10 (fenofibrate) Gate (Teva)

4/9/02

AB

Micronized Cap

67, 134, 200

WITH

NO

200

$2.98/200mg

Fenofibrate11 Global

10/27/03

AB

Micronized Cap

67, 134, 200

WITH

NO

200

$2.55/200mg

5/13/05

AB

Film-coated Tab

54, 160

WITH

NO

160

$2.98/160mg

10/31/05

AB

Film-coated Tab

54, 160

WITH

NO

160

$2.38/160mg

3/26/08

AB

Film-coated Tab

54, 160

WITH

NO

160

$2.38/160mg

12/15/08

None

Cap, Delayed Release

45, 135

N/A

YES

Tricor4 (fenofibrate) Abbott

Antara5 (fenofibrate) Oscient

Triglide6 (fenofibrate) Shionogi Lipofen7 (fenofibrate) Kowa

Fenoglide8 (fenofibrate) Shionogi

Lofibra (fenofibrate) Gate (Teva) 13

Fenofibrate Ranbaxy Fenofibrate15 Global Trilipix16 (fenofibric acid) Abbott

LDL

HDL

Trigs

"Plasma concentrations of fenofibric acid after administration of three 48mg or one 145mg tablets are equivalent under fed conditions to one 200mg capsule."

11/30/04

None

Micronized Cap

43, 87, 130

WITH

NO

"Plasma concentrations of fenofibric acid after multiple dose administration of Antara 130 mg capsules are equivalent, under low-fat fed conditions, to 200 mg Fenofibrate capsules."

5/7/05

None

IDD®-P Tab

50, 160

N/A

NO

"TRIGLIDE 160 mg tablet exhibits a similar extent of absorption but 32% higher rate of absorption compared to the 200 mg micronized fenofibrate capsule under low-fat fed conditions."

1/11/06

None

Lidose® Cap

50, 150

WITH

NO

"The extent and rate of absorption of fenofibric acid after administration of 150 mg LIPOFEN™ capsules are equivalent under low-fat and high-fat fed conditions to 160 mg Tricor® tablets."

8/10/07

None

12

Lipid Effects (mean % Δ from baseline) Tchol

MeltDose® Tab

40, 120

N/A

NO

-18.7

-20.6

11.0

-28.9

_ -5.1 16.3 -31.0 N/A $4.13/135mg "Plasma concentrations of fenofibric acid after administration of one 135 mg Trilipix delayed release capsule are equivalent to those after one 200 mg capsule of micronized fenofibrate administered under fed conditions." * Lipid effects were assessed from four, randomized, double-blind, placebo-controlled, parallel group studies. The equivalent dose listed is equivalent to the dose of fenofibrate used in the studies, per the prescribing information.

Recommended Vaccinations for Healthcare Professionals (HCP)2-5

Table: Excuse Me Doctor?

Article on page 31 Click here for a downloadable version of this table or visit www.azpharmacy.org

Vaccination Hepatitis B

Recommendations Recommended for HCP who perform tasks that expose them to blood or body fluids 3-dose series given IM at 0-, 1- and 6-month intervals Test for hepatitis B surface antibody (anti-HBs) 1-2 months after third dose

H1N1

1 dose* of: 1) inactivated influenza A vaccine given IM OR 2) live attenuated influenza A vaccine (LAIV) given intranasally

Influenza

Measles, Mumps, and Rubella (MMR)

Meningococcal

Tetanus, Diphtheria, and Pertussis

32 Arizona Journal of Pharmacy

Varicella

*More information to come in the future 1 dose annually of: 1) inactivated influenza vaccine given IM OR 2) live attenuated influenza vaccine (LAIV) given intranasally

Born 1957 or later: 2 doses given subQ 4 weeks apart ONLY IF: 1) no evidence of disease/serologic immunity OR 2) no evidence of prior vaccination Born 1957 or earlier: Considered immune. Consider 2 doses given subQ 4 weeks apart ONLY IF: 1) no evidence of disease/serologic immunity OR 2) no evidence of prior vaccination 1 dose given subQ/IM recommended for microbiologists routinely exposed to isolates of Neisseria meningitidis

1 dose of Td (Decavac®) booster given IM every 10 years Single lifetime dose of Tdap (Adacel®) given IM as a booster dose if: 1) HCP has close patient contact (especially with infants < 12 months) AND 2) HCP is < 65 years old 2 doses given subQ 4 weeks apart ONLY IF: 1) no serologic proof of immunity to varicella, 2) no prior varicella vaccination, OR 3) no history of varicella disease

Important Notes If anti-HBs is ≥ 10 mIU/mL (or positive): HCP is immune If anti-HBs is < 10 mIU/mL (negative): HCP unprotected, re-vaccinate with 3-dose series, retest anti-HBs 1-2 months after third dose If anti-HBs is negative after 6 doses of vaccine: HCP is non-responder LAIV NOT to be used in: 1) pregnant women, 2) HCP > 49 years old, OR 3) HCP with underlying medical conditions that confer a higher risk of influenza complications LAIV NOT to be used in: 1) pregnant women OR 2) HCP > 49 years old Inactivated vaccine preferred > LAIV for HCP who care for severely immunosuppressed patients All HCP should be immune to MMR Live virus vaccine – contraindicated in pregnancy and severe immunosuppression

Give Menactra® (MCV4) IM if < 56 years old Give Menomune® (MPSV4) subQ if: 1) HCP is > 55 years old OR 2) if contraindication/precaution to MCV4 Primary 3-dose series should be complete before initiating 10-year boosters

All HCP should be immune to varicella Live virus vaccine – contraindicated in pregnancy and severe immunosuppression

Features and Articles

Poison Bottles

By Robert E. Kravetz, M.D., FACP, MACG American College of Gastroenterology

Civilized man has been knowledgeable about poisons since the Greeks and the Romans. Medications which were poisonous could be applied externally or ingested in limited quantities for their therapeutic effect. It became apparent that there was a need to restrict their use and prevent accidental dispensing and ingestion of poisons.

By the Middle Ages, most European countries had passed laws to control poisons. Marking containers with the word “poison” was the most common method used.

The first law requiring the labeling of poisons was passed in America in New York in 1820. All poisons had to be marked clearly prior to sale. The American Pharmaceutical Association passed a similar law in 1853 or alternatively recommended the use of a skull and cross bones on the container as a means of identification.

The British parliament tried to enact a law in the late 1850’s requiring that all poison containers not only be embossed with the word “poison” but be made in a manner that they could be indentified when handled. Although the law was not passed, most pharmacists adopted these principles.

The first American patent for a poison bottle was obtained in 1881. In 1882, the famous Whitehall Tatum Bottle Company stated to produce a cobalt blue glass bottle with a quilted surface. The same year, the American Medical Association recommended that all druggists use colored glass containers with one rough side and the embossed word “poison” to identify the containers. The philosophy of using color, shape and embossment was to appeal to as many senses as possible to avoid any fatal mistakes.

By the 1930’s it became apparent that unusually-shaped, heavily-embossed, colorful bottles attracted the attention of children and defeated the original ideas of safety and prevention. The methods were abandoned and safety closures in plain bottles were substituted. These continue to be popular today. The first poison bottle utilizing a safety closure was introduced in New Jersey in 1886.

Poison bottles are early sought by collectors because of their unusual shapes and appealing colors. Illustrated here are three typical poison bottles in cobalt blue - the most common color, amber, and emerald green, with the embossed word “poison” and the typical raised, ribbed and quilted surface. These date from 1880 to 1920.

Arizona Journal of Pharmacy 33

Rx and the Law

AND THE LAW

by Don R. McGuire, R.Ph., J.D. This series, Pharmacy and the Law, is presented by 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.

SPOLIATION OF EVIDENCE As a pharmacist, you are aware that if you dispense an incorrect medication, you must take care of the patient. This normally includes apologizing for the error, correcting the mistake, and contacting the patient’s physician. These are all important, but you may forget that you also need to take care of yourself. If a patient receives an incorrect medication, there is always a chance they could sue you. That is why it is so important to gather and preserve all relevant information about that incident.

The best thing you can do after a dispensing error has occurred is to thoroughly document the situation. It is recommended that you record the following: how the error occurred, the date the error occurred, the date the error was discovered by the patient, the date the error was brought to the pharmacy’s attention, the amount of doses the patient believes they ingested, the amount of doses returned to the pharmacy, and the names of anyone you spoke to while resolving the issue. Document all conversations with the patient or the caregiver. Don’t use an abbreviated form of documentation. Use complete words and sentences. It may be easy for you to recall all of the details now, but it could be a year or more before a lawsuit is filed. After filling thousands of prescriptions and handling other problems, it may be impossible for you to remember anything about that specific incident. To be safe, all documentation should allow a party who was not involved to fully understand the situation.

It is worth mentioning a second time to document the amount of doses the patient brought back to the pharmacy and preserve the physical evidence. Too often a pharmacist will verify the patient received the incorrect prescription and then dispose of the medication. They have just disposed of a valuable piece of evidence. The number of doses returned to the pharmacy can help establish the maximum number of doses the patient could have ingested. At any time in the future, if the patient claims they took a specific quantity of capsules/tablets, you will be able to confirm or deny this claim with your documentation and the returned prescription vial. Count the tablets and save the bottle.

Treat this as evidence by placing it in an envelope and sealing it with your initials on the closure.

The production of evidence in litigation is governed by the Rules of Civil Procedure. The rules require a party to preserve evidence in a number of situations. It could be in situations of 34 Arizona Journal of Pharmacy

actual pending litigation or when a party is put on notice of a potential claim. It is also a requirement to keep evidence if a party reasonably anticipates that the information might be needed for future reference. As you can see, the requirement to preserve evidence is broad. It can be argued that a patient returning to the pharmacy with incorrect medication that resulted in an injury creates a situation where litigation is reasonably foreseeable. The best practice is to assume this is true and preserve the evidence.

Spoliation is the destruction or significant alteration of evidence in a case. What happens if you don’t preserve evidence? The rules also provide the sanctions available when spoliation occurs.

These sanctions run the gamut from reprimands, findings of contempt, up to dismissal of a case. Generally, it will take an egregious violation for a court to dismiss or default a case, so it is not very common.

However, it is more common for the court to allow the jury to make a negative inference from the spoliation of evidence. That is, the jury is allowed to presume that the evidence destroyed was more likely injurious to the destroying party’s case than it was likely beneficial to their case. This is really a common sense application. People are not likely to destroy things that will be helpful to them. This, of course, is not true in all cases, but what is a jury to do if the evidence is destroyed? The returned prescription might have proven your case, but if you disposed of it, the court will give the jury the spoliation instruction. This instruction can be very damaging to your case and may result in a significant verdict against the destroying party.

The bottom line is you should be able to reproduce or recall details in the future that you would have been able to answer the day the patient presented with the error. If you destroy, dispose of, or do not record some piece of evidence, it could have severe consequences. All of this documentation and preservation is in your best interest. Protect yourself, be complete. © Don McGuire, R.Ph., J.D., is a Professional Liability Claims Attorney at Pharmacists Mutual Insurance Company.

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.

Access to Good Quality Dietary Supplements

Continuing Education

Council of the Convention Section on the Quality of Food Ingredients and Dietary Supplements Mary H. Hager, Ph.D., R.D., F.A.D.A., Section Chair (American Dietetic Association); E. James Bradford, Ph.D. (AOAC-International); Marvin M. Lipman, M.D. (Member-at-Large); Lyn O. Nabors (International Food Additives Council)

Goals: The goals of this lesson are to provide background information on dietary supplements and to review proposals for consideration to further improve the quality of dietary supplements.

Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Describe the regulatory framework of dietary supplements 2. Give examples of the proposals that could be considered to further improve the quality of dietary supplements INTRODUCTION The 1994 Dietary Supplement Health and Education Act (DSHEA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) provided a regulatory framework to allow marketing of vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.

Now, more than 15 years later, a vast array of dietary supplements in different combinations and amounts are available to United States patients/consumers.

Sales of dietary supplements are approaching $25 billion/year, with about $4 billion of this amount representing sales of botanicals. While DSHEA was instrumental in providing consumers with easy access to dietary supplements, a recent U.S. Government Accountability Office (GAO) report stated that consumers of dietary supplements are not adequately protected under current U.S. law and regulations. Pre-market oversight and registration of products are recommended in the GAO report. Outside the United States, dietary supplements are frequently considered as traditional medicines with few standards and conformity assessments to these standards. In this white paper, USP’s Council of the Convention Section on the Quality of Food Ingredients and Dietary Supplements provides background information on the topic and advances proposals for consideration by the Convention membership to further improve the quality of dietary supplements.

NATIONAL APPROACHES 1.CONGRESS: PROVISIONS OF DSHEA Through DSHEA, Congress defined dietary supplements as “foods.” As with all foods, DSHEA provisions in the FDCA do not require pre-market review of a dietary supplement by the Food and Drug Administration (FDA) if the ingredients have a safe history of use in food or supplements prior to 1994. Instead, Congress put in place a notification process for a new dietary ingredient to ensure that ingredients that do not have a safe history of use are reviewed by the FDA prior to entry into the U.S. market. In addition, DSHEA essentially places the burden of proof on the FDA to demonstrate that a dietary supplement presents “significant or unreasonable risk of illness or injury” before it can be removed from the market.

With regard to the United States Pharmacopeia (USP), Section 403(s) (2)(D) of the FDCA states that if a dietary supplement is 1) covered by the specifications (tests, procedures, and acceptance criteria of a monograph) of an official compendium of the United States (USP, National Formulary [NF], or the Homeopathic Pharmacopoeia), 2) is represented as conforming to the specifications of an official compendium, and 3) fails to so conform, then the supplement is considered to be misbranded. Accordingly, unlike the provisions relating to prescription drugs (where conformance with USP standards is mandatory, whether labeled as such or not), Section 403(s)(2)(D) of the FDCA makes compliance with the specifications of an official compendium strictly voluntary for dietary supplement manufacturers (unless the manufacturer chooses to represent the product as conforming to USP). As a consequence, this statutory reference to official compendia provides legal recognition to USP, but effectively creates a disincentive for its use, because it exposes only those manufacturers who so label (and not others who make no reference to USP standards at all) to a potential misbranding

violation if found not to conform to USP. 2. THE FOOD AND DRUG ADMINISTRATION In 2007, the FDA finalized Current Good Manufacturing Practices (cGMPs) for dietary supplements. These regulations allow manufacturers to establish product specifications and to use “appropriate and scientifically valid” methods to determine whether those specifications are met.

The cGMPs do not define the words “scientifically valid” nor is validation of analytical procedures required. The FDA has indicated that “a scientifically valid method is one that is accurate, precise, and specific for its intended purpose—in other words, a scientifically valid test is one that consistently does what it is intended to do. As a result, dietary supplement manufacturers develop private procedures, tests, and assays, which may or may not receive regulatory scrutiny.

Standards for a dietary supplement under a specified name may not have comparable requirements and thus may be dissimilar in quality, benefit, and safety to consumers.

The cGMPs do not require dissolution and disintegration testing, and manufacturers set their own limits for contaminants such as heavy metals, microbial limits, fungal toxins, or pesticides. USP has published an article describing the current regulatory scheme as one that creates “standards without standardization.”

3. UNITED STATES PHARMACOPEIAL CONVENTION Following enactment of DSHEA in 1994, the 1995 USP Convention adopted Resolution 12 that encouraged the USP to explore the feasibility and advisability of establishing standards and developing information concerning dietary supplements. This resolution was taken up and implemented by USP’s Board of Trustees and Council of Experts, resulting in a well-evolved section of USP for dietary supplement monographs, with allied USP Reference Standards offered in USP’s catalogue. USP32NF27 now contains approximately 430 dietary supplement and ingredient monographs and general chapters, which Arizona Journal of Pharmacy 35

Continuing Education (continued from page 35) cover a large percentage (+90%) of the dietary supplements commonly marketed in the United States. USP’s Council of Experts Dietary Supplement Information Expert Committee applies admission criteria together with a safety review guideline to allow exclusion of some dietary supplements from USP, even though they may be legally marketed in the United States. This approach mirrors the work of the Scope Committee of the Committee of Revision (the predecessor of the Council of Experts) that ended in the 1990s. USP also includes a General Chapter on Manufacturing Practices for Dietary Supplements <2750>, which was developed prior to finalization of FDA’s cGMPs and is generally more stringent and specific than those regulations. In June 2009, USP introduced a separate USP Dietary Supplements Compendium that includes official text from USP (monographs and general chapters relating to dietary supplements) as well as authorized explanatory text and graphics intended to provide useful information to dietary supplement manufacturers.

INTERNATIONAL APPROACHES While vitamins, minerals, amino acids, botanicals, and other plant and animal substances are available in the U.S. as dietary supplements, they are variably regulated as health products, traditional medicines, or drugs in other countries.

This varied international approach on the regulation of dietary supplements provides different paradigms for consideration and exploring options for domestic regulatory oversight. Quality standards also are quite variable around the globe. Issues of quality are present in the international commerce of dietary supplements, which is evident in cases such as protein adulteration with melamine or dietary supplements containing toxic metals, high levels of pesticides or unapproved drugs. Information from the World Health Organization (WHO) details the widespread consumer misconception that “natural” always means “safe,” and a common belief that remedies from natural origin are harmless and carry no risk. Also of concern is that healthcare providers are frequently unaware of the dietary supplements their patients are taking; either because they do not ask, 36 Arizona Journal of Pharmacy

or patients do not offer the information.

Under the current law and regulations, there is no way of knowing the quality standards to which each product is held, and thus, there is no way to determine whether two products with the same dietary supplement ingredients are the same or different.

PROPOSALS The Council of the Convention Section on Food Ingredients and Dietary Supplements suggests for consideration the following opportunities for possible USP Convention action and improvement in the regulation of dietary supplements.

1. PUBLIC MONOGRAPHS AND REFERENCE MATERIALS The universe of products in the market is constantly expanding, creating gaps where monographs and reference materials are missing. To the extent feasible, documentary standards and reference materials offered by USP should expand to cover all the products in the dietary supplements market.

2. ADHERENCE TO PUBLIC STANDARDS Public quality standards arising from the open and participatory process conducted by USP conserve both regulatory and manufacturer resources.

They work to achieve consistency in the quality of a dietary supplement both within and between manufacturers, and allow updating. This consistency is more likely to be achieved if manufacturers are required to comply with public standards.

Thus, USP might consider informing and engaging in discussions with Congress about the desirability of strengthening section 403(s)(2)(D) of the FDCA to require dietary supplements and dietary supplement ingredients to conform to the standards established in USP-NF, where such standards exist. USP also might consider making Congress aware of the benefits of strengthening the adulteration provisions of the FDCA to ensure that all dietary supplements conform to the relevant standards promulgated in USPNF. However, it is not clear, at this time, that industry supports such mandatory standards.

3. INTERNATIONAL HARMONIZATION Amidst the increasingly complex global supply of dietary supplement ingredients and products, ensuring quality and

harmonization of standards is important, irrespective of how dietary supplement products are labeled and regulated— whether as traditional medicines, drugs, or supplements. Global harmonization of public standards would ensure quality, identity, and label uniformity in international commerce, and could facilitate international commerce of good quality dietary supplements. To start its work in this area, USP standards and analytical methods could complement the descriptions of quality, dosage, safety, and pharmacological activity of botanical monographs offered by other standards setting bodies of the world. For these reasons, USP should cooperate with international health organizations to promote standards for traditional medicines that are also dietary supplements in the United States.

Examples of such organizations include the WHO, the Canadian Natural Health Products Directorate in Health Canada, the European Directorate for the Quality of Medicines and HealthCare (EDQM), and the Indian and Chinese Pharmacopoeia Commissions.

4. EDUCATION There is a dearth of unbiased dietary supplement information for consumers and practitioners. Gaps in practitioner training and consumer education are clear impediments to the safe use of dietary supplements. Practitioners should receive training on proper counseling of consumers on the use of dietary supplements and consumers should be educated about the importance of disclosing such usage to healthcare providers. In this way, practitioners and consumers can monitor and prevent possible adverse effects that may occur from the combined use of certain dietary supplements and drugs.

USP could expand its educational programs to meet the needs of practitioners and patients/consumers with respect to dietary supplements. The USP Dietary Supplements Information Expert Committee earlier recommended education of practitioners regarding suitable practices for safe use and prevention of interactions with other therapeutic agents. USP should consider developing Pharmacopeial Education courses for practitioners and consumers in this regard, and additional courses

Continuing Education (continued from page 38) on compendial approaches to quality standards for dietary supplements to help manufacturers, testing labs, and regulators understand the value of USP public standards and reference materials.

5. VERIFICATION USP Verification Programs could also be used to increase confidence that ingredients and products moving in the international market comply with the quality specifications to help ensure public safety, including absence of known/ identified adulterants and contaminants.

Although FDA has not endorsed the use of third party certifications of dietary supplements, it has recognized the value of third-party certifications in its recent guidance on foods. Broad implementation of USP’s Verification Programs for dietary supplements and dietary supplement ingredients could assist in raising supplement quality, help patients make informed decisions, restore consumer confidence, and allow healthcare practitioners to recommend verified dietary supplements with some level of confidence. The various elements of USP’s Verification Programs (audits, testing, document review, and market surveillance) would act synergistically with the cGMPs already in place, thus helping conserve FDA resources. Because cGMPs provide minimum requirements, implementation of USP Verification Programs would add value for greater assurance of the quality of supplements.

The concern about the quality and purity of ingredients moving in the international market also could be addressed through a system of USP Verification Programs’ inspecting companies and testing products overseas.

With sites in China, India, and Brazil, USP is very well positioned to contribute worldwide to raising the quality of dietary supplements. It is also possible that the challenges faced by regulatory differences with other countries could be addressed through credible USP Verification Programs.

6. REGULATORY OVERSIGHT Dietary supplement product registration or pre-market notification might be considered as a means of monitoring the number and type of dietary supplements moving in commerce in the U.S. and helping to assure the safety of dietary supplements prior to sale to the consumer.

To accomplish this, the FDA would need sufficient resources to adequately assess and address the safety of dietary supplement products, and the FDCA would need to be amended to provide the FDA with authority in this area.

The Council of the Convention Section on Food Ingredients and Dietary Supplements welcomes input on these proposals from the Convention, as well as additional comments on how USP might build upon its past efforts and expand its work to help assure the quality and appropriate use of dietary supplements worldwide.

References: 1. Government Accountability Office report. 2009 Dietary supplements. FDA Should Take Further Actions to Improve Oversight and Consumer Understanding http://www.gao.gov/new.items/ d09250.pdf.

2. Ibid.

3. It should be noted that the FDA has indicated that DSHEA will not apply to dietary supplement products intended for use in animals. As such, animal dietary supplements currently are regulated generally as “food” without the additional protection afforded human dietary supplement products under DSHEA. It is generally felt in the veterinary community that the need for evidence of quality, safety, and efficacy are similar for veterinary and human patients alike. For more information, see Safety of Dietary Supplements for Horses, Dogs and Cats, Committee on Examining the Safety of Dietary Supplements for Horses, Dogs and Cats, National Research Council, National Academic Press, 2008.

4. Miller RK, Celestino C, Giancaspro GI, Williams RL. 2008. FDA’s dietary supplement CGMPs: Standards without standardization. Food and Drug Law Journal 63 (4), 929-942+iv.

5. More information on USP dietary supplements Expert Committees is available through http://www. usp.org/support/products/uspNewslettersRequest. html 6. WHO. 2004. Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance systems.

WHO Department of Essential Drugs and Medicines Policy: Geneva. http://apps.who.int/medicinedocs/ index/assoc/s7148e/s7148e.pdf 7. Gardiner P, Sarma DN, Low Dog T, Barrett ML, Chavez ML, Ko R, Mahady GB, Marles RJ, Pellicore LS, and Giancaspro GI. 2008. The state of dietary supplement adverse event reporting in the United States. Pharmacoepidemiology and Drug Safety. 17: 962–970.

8. Ko RJ. 2004. A U.S. perspective on the adverse reactions from traditional Chinese medicines. J Chin Med Assoc. 67(3):109-116.

9. Gardiner et al, 2008 (see reference 5 above).

10. Third-party verification – The FDA is endorsing third party verification of foods through its Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds. 2009. http:// www.fda.gov/RegulatoryInformation/Guidances/ ucm125431.htm

ACPE UAN #0100-9999-10-054-H04-P

This continuing education monograph is adapted from the United States Pharmacopeial Convention (USP) series of white papers prepared by the Council of the Convention (CoC) titled “Focus On: Future Directions for USP.” The learning objectives and assessment questions were developed by National Alliance of State Pharmacy Association’s (NASPA) Continuing Education Advisory Panel.

No financial support was received for this activity. This activity may appear in other state pharmacy association journals.

ABOUT USP and NASPA The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over– the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP’s standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. More information can be found at www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved.

Arizona Journal of Pharmacy 37

Continuing Education

Migraine Headaches: A Clinical Review of Etiology, Pathophysiology, Prevention, Treatment, and the Role of the Pharmacist

by Jennifer L. Keonavong (Penrose), Pharm.D., BCPS Goal: The goal of this lesson is to educate pharmacists on the etiology, pathophysiology, prevention, treatment, and professional management of migraine headaches.

Objectives: At the conclusion of this lesson, successful participants should be able to: 1. identify risk factors for migraine headache 2. select appropriate prevention and treatment options for migraine headache and be familiar with common adverse reactions, contraindications, interactions, and other important points regarding these medications 3. effectively triage patients with migraine headache to over-the-counter remedies or physician referral Introduction1-4 Migraine headache is a chronic condition that affects nearly 30 million Americans, or roughly 13% of the United States population. Migraine can significantly and negatively impact quality of life; nearly 90% of migraineurs become impaired or disabled by migraine attacks. Sixty-three per cent of migraine sufferers experience at least one episode per month and 25% experience weekly episodes. Because this condition can be so disabling, migraine is recognized as the leading cause of employee absenteeism in the United States. In fact, the effects of migraine are responsible for 13 to 17 billion dollars in lost work productivity annually.

The peak prevalence of migraine falls between the ages of 20 and 45 years old.

Women are three times more likely to suffer from migraine than men. Up to 1 in 6 women, or 18%, suffer from migraine, while 6% of men are afflicted.

Clinical Manifestations1,3,4,5 Migraine is associated with a myriad of potential symptoms lasting anywhere from 4 to 72 hours, all of which vary greatly between individuals and attacks.

Headache pain is described as one-sided and throbbing. Individuals may also suffer from nausea, vomiting, cold hands, photophobia, phonophobia, irritability, malaise, sinus pain, and/or neck tension.

Migraine symptoms occur in three stages: prodrome, headache, and post-headache.

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The prodromal phase may present up to 48 hours prior to onset of migraine, and may be characterized by irritability, depression, frequent yawning, or hyperexcitability.

Prodromal and post-headache stages may be associated with muscle tenderness, fatigue, and mood changes.

Another significant prodromal symptom that may occur in up to 30% of individuals with migraine is termed “aura”. Often a warning sign that a migraine attack is imminent, aura typically lasts less than one hour and resolves before the migraine begins. Aura is often characterized by shimmering or flashing lights, blind spots, zigzag lines, and numbness and/or tingling in the arms, legs, and/or face.

Risk Factors1,3,4 There are several risk factors, or triggers, that may influence the onset of migraine.

Migraine triggers differ for everyone and may not reliably cause migraine in any individual. Therefore, it is important for patients and physicians to work together to identify triggers. Keeping a migraine diary and recording potential triggers can help to identify these risk factors. The following risk factors are not all-inclusive, but encompass a wide range of common migraine triggers.

Triggers for migraine may be related to diet and the consumption of alcohol, red wine, caffeine, chocolate, cheese, oranges, tomatoes, onions, aspartame (Equal®, Nutrasweet®), and monosodium glutamate (MSG). Tyramine-containing foods, such as fermented cheeses, smoked or aged meats, champagne, and avocados may cause migraine, as can nitrate-containing foods, such as bacon, hot dogs, and salami.

Fluctuations in blood sugars caused by excessive hunger or skipped meals may lead to migraine. Factors such as activity level may lead to migraine, especially if one gets too little or too much sleep or is fatigued. Environmental factors such as changes in altitude or weather, glaring or flickering lights, loud noises, cigarette smoke, perfumes, or fumes are also common risk factors.

Emotions, particularly stress or anger, can lead to a migraine attack. While certain medications are useful for aborting or preventing a migraine, others are notorious for causing them. Medications

that may cause migraines include oral contraceptives, hormone replacement therapy, nitroglycerin, histamine, reserpine, hydralazine, ranitidine, and ondansetron, to name a few. Genetics are a huge migraine risk factor. An individual has a 75 percent chance of experiencing migraines if two parents suffered from migraine, a 50 percent chance if one parent suffered from migraine, and a 20 percent chance if a distant relative suffered from migraine. Menstrual cycle also plays a large role in triggering migraine headaches. Approximately 13 million women suffer from menstrual migraines, and 60% of women complain of migraines related to their menstrual cycle. Menstrual migraine may occur before or during menstruation, at ovulation, or during menopause, but usually occurs when there are low levels of estrogen.

Pathophysiology4,6 Two different theories attempt to explain the pathophysiology of migraine: the vascular theory and the neurovascular theory.

The vascular theory suggests that migraine aura is a result of constriction of vessels in the brain. Headache pain is a result of rebound dilation of these vessels, as well as the activation of pain-receptor nerves in the brain. However, with the advent of the neurovascular theory, the vascular theory has largely fallen out of favor with healthcare professionals.

The neurovascular theory suggests that migraine aura is a result of a neuronal excitation and suppression that spreads throughout the gray matter of the brain.

This spreading phenomenon is referred to as cortical spreading depression, or CSD. Essentially, CSD causes the release of hydrogen and potassium ions into the pia mater, which activates C-fiber meningeal pain receptors. Pro-inflammatory chemicals, such as calcitonin gene-related peptide and serotonin, are then released, and plasma extravasation occurs. Ultimately, the central trigeminal system becomes activated and inflamed, and this results in dilation of blood vessels in the brain. Cutaneous allodynia, or the sensitization of the body to stimuli that are not usually considered painful (such as a gust of wind or a light touch), is a symptom experienced by some migraineurs. Cutaneous allodynia results

Continuing Education (continued from page 36) from the secondary pain pathways of the trigeminothalamic system becoming sensitized during a migraine attack.

It has been suggested that dopaminergic stimulation and magnesium deficiency may have a role in triggering migraine attacks.

Dopamine may be responsible for the prodromal symptoms that some migraineurs experience. Magnesium deficiency causes platelet aggregation and release of glutamate and 5-hydroxytryptamine, which subsequently cause vasoconstriction of blood vessels in the brain.

Diagnosis3,4,7,8 The first step to effective migraine management is an accurate diagnosis. Often undiagnosed, migraines lead to increased disability, decreased work productivity, and decreased quality of life. Furthermore, as symptoms, incidence, frequency, and disability are so highly variable and unpredictable between individuals and individual attacks, nearly half of migraineurs stop seeking medical care altogether. In response, the International Headache Society has proposed guidelines for the diagnosis of migraines.

Migraine with aura constitutes two attacks fulfilling 3 of the 4 following criteria: • one fully reversible symptom of aura indicates focal cerebral, cortical, and/or brain stem dysfunction • 1 symptom of aura develops gradually over > 4 minutes or 2 or more symptoms occur in succession • Symptoms of aura last < 60 minutes (or proportionally greater if >1 symptom exists) • Symptom-free interval < 60 minutes between aura and headache • 1 of the following criteria must be fulfilled: o Medical history and physical exam do not suggest headache associated with head trauma, vascular disorder, nonvascular intracranial disorder, substance abuse withdrawal, noncephalic disorder, metabolic disorder, cranial disorder, disorders of the neck, ear, nose, and/or throat, or cranial neuralgias o Disorder that may cause secondary headache is ruled out and/or not temporally related to headache pain Migraine without aura constitutes 5 attacks fulfilling the following criteria: • Headache lasts 4 to 72 hours • Headache fulfills 2 of the following criteria: o Unilateral pain o Pulsating/throbbing pain • Moderate/severe pain interferes with daily

activities • Pain aggravated by physical activities • During headache, 1 of the following criteria occurs: o nausea and/or vomiting o photophobia and phonophobia • Disorder that may cause secondary headache is ruled out and/or not temporally related to headache pain Prevention3-5,7,9 A mere 3 to 5% of migraineurs receive preventive migraine therapy. However, nearly half stop seeking care due to dissatisfaction with their therapy. Preventive therapy has several potential positive outcomes for migraine sufferers. In fact, the American Headache Society and the American Academy of Neurology delineate specific goals for preventive therapy: • Reduce migraine attack frequency, severity, duration, and disability • Improve function and quality of life • Improve responsiveness to acute treatment • Reduce reliance on poorly tolerated, ineffective, or unwanted acute treatments and avoid acute headache medication escalation • Educate and empower patients to take charge of their migraine management o Maintain headache diaries or calendars that measure migraine frequency, severity, duration, related disabilities, triggers, response to treatment, and adverse drug reactions o Subsequently allow the provider to more realistically address patient concerns o Maximize medication adherence The American Headache Society and American Academy of Family Physicians/ American College of Physicians-American Society of Internal Medicine (AAFP/ ACP-ASIM) suggest that patients meeting the following criteria be considered for preventive migraine therapy: • Recurring migraines that significantly interfere with daily routines, despite acute treatment (2 attacks/ month causing disability at least 3 days/month) • Frequent headaches • Contraindication to, failure of, overuse of, or adverse drug reactions from acute therapies • Use of abortive medications more than twice a week • Cost of acute therapies exceeds preventive therapies • Patient preference • Presence of uncommon migraine conditions, including hemiplegic migraine, basilar migraine, migraine with prolonged

aura, or migrainous infarction (to prevent neurologic damage) When recommending appropriate preventive migraine therapy for a patient, it is important to consider available evidence, patient medical and medication history, patient preference, and cost. Co-morbid conditions should be considered when selecting a preventive therapy so as to identify any potential contraindications; in fact, selecting a therapy that may benefit migraine prevention and a particular comorbidity is preferred. For instance, a patient with hypertension and migraines may achieve resolution of both conditions with administration of propranolol. Considering potential adverse drug reactions, drug interactions, and risks to pregnant and lactating women is also a critical element to selecting preventative migraine therapy.

When selecting and initiating preventive migraine therapy, the American Academy of Neurology recommends the following: • Select a medication with a high level of evidence • Start with the lowest effective dose to reduce risk of adverse drug reactions, and increase dose slowly as tolerated • Allow a 2 to 3 month trial before ruling the therapy a failure • Avoid interacting medications or overuse of acute medications • Use long-acting formulations to improve compliance • Taper medication doses after 3 to 6 months if migraines are well-controlled Current recommendations for migraine preventive therapy are based largely on expert clinical opinion and limited evidence. The current body of evidence is in need of additional head-to-head trials comparing various preventive therapies.

See Table 1 for a summary of the U.S. Headache Consortium and AAFP/ACPASIM guidelines for migraine preventative therapies.

Treatment1,3,7,9,10 For those migraineurs who are not candidates for or do not prefer preventive therapy, an acute treatment approach may be necessary. The treatment of acute migraine may be accomplished with over-the-counter remedies, prescription medications, and/or alternative approaches.

Non-pharmacologic therapy has shown to be helpful when used concomitantly with drug therapy. Non-pharmacologic approaches gaining popularity in the literature and in practice include proper sleep and diet habits, relaxation techniques, exercise, trigger

Arizona Journal of Pharmacy 39

Continuing Education (continued from page 39) avoidance, massage, acupuncture, thermal biofeedback with or without relaxation, electromyographic feedback, cognitive behavioral therapy with or without drug therapy, and heat/cold applications.

In terms of acutely managing migraines with medication, AAFP/ACP-ASIM guidelines recommend selecting acute therapies based on the frequency, severity, and degree of temporary disability associated with migraine, as well as associated symptoms (nausea/vomiting), medication history and response, pregnancy status, and presence of other co-morbid conditions (hypertension, heart disease, mood disorders, etc.). According to the U.S. Headache Consortium, the following points should be considered when selecting acute migraine therapy: • Educate and empower patients to take charge of their migraine management • Use migraine-specific agents (triptans, dihydroergotamine, ergotamine) if possible in patients with more severe migraine and in those with headaches that respond poorly to NSAIDs or combination analgesics (aspirin + acetaminophen + caffeine) • Select a non-oral route of administration for migraines associated with nausea and/ or vomiting, and consider concomitant treatment with an antiemetic • Consider a self-administered rescue medication for patients with severe migraine that does not respond to, or fails, acute medication • Educate and guard against medicationoveruse headache, or rebound headache, which is associated with withdrawal of analgesics or abortive medications (ergotamine, opiates, triptans, NSAIDs, and mixed analgesics containing butalbital, caffeine, or isometheptene) • Educate and guard against drug-induced headache, associated with frequent use of acute medications > 2 days/week Current recommendations for migraine treatment options are largely based on expert clinical opinion and limited evidence. See Table 2 for a summary of the U.S. Headache Consortium and AAFP/ACP-ASIM guidelines for acute migraine treatment.

The Pharmacists’ Role2 Pharmacists have a significant opportunity to assist patients in appropriate medication selection and migraine management. Up to 60% of patients self-medicate with over-thecounter (OTC) products to treat migraine attacks. Headache remedies lead the polls for over-the-counter recommendations made

40 Arizona Journal of Pharmacy

by pharmacists, with approximately 50,000 recommendations made every day.

In a review published in 2003 by Wenzel RG and colleagues, the authors suggested a four-point questionnaire for pharmacists to use when counseling patients with migraine: • What percentage of your headaches prohibits you from performing normal work, school, or household activities and/or is accompanied by vomiting?

• How many days/month are you headachefree?

• What symptoms accompany your headaches?

• What over-the-counter products have you tried?

By asking these sorts of questions, a pharmacist may determine whether recommending an over-the-counter therapy or referring the patient to a physician is more appropriate. It is important to note that each pharmacist’s management strategy will differ and depend on the particular patient in question. Wenzel and colleagues propose the following algorithm for patients who are poor candidates for over-the-counter therapy, and, therefore, candidates for physician referral: • > 50% of migraines result in morbidity or disability • > 20% of migraines are accompanied by vomiting • < 15 days/month are headache-free • Migraine worsened by routine activity • Unilateral, throbbing, or moderate-tosevere pain, photophobia, phonophobia, and nausea and/or vomiting • Has tried at least 2 OTC medications • Uses OTC medications > 2 days/week • Complains of headache related to trauma, fever or stiff neck, exertion, or neurologic deficits • > 50 years old and complains of new-onset headache • Describes headache as “worst headache ever” • Headache lasts > 72 hours • Headache worsens daily and does not ease up • Headache pain occurs daily in same location, or headache pain progresses from nonexistent to severe in a matter of seconds to minutes Wenzel and colleagues consider patients with the following criteria good candidates for over-the-counter therapy: • Tension headache with bilateral, dull-ache, mild-to-moderate pain with photophobia or phonophobia, but not both

• Has not tried any medications • Has tried one medication (try a medication from a different class) • If 2 of 3 attacks are not alleviated, consider treatment failure and try another over-thecounter therapy (or refer to a physician) Conclusion Migraine headache is a significant cause of disability and discomfort for millions of individuals around the world.

By taking the time to understand our patients’ migraine complaints, medical and medication histories, we are able to make thoughtful recommendations to improve our patients’ functional status and quality of life. Migraine headache management offers a significant opportunity for pharmacists to reach out and make a positive impact on a medical, socioeconomic, psychosocial, and personal level.

ACPE UAN #0100-0000-10-055-H01-P References 1. National Headache Foundation. Accessed online March 9 2009 via www.headaches.org.

2. Wenzel RG, Sarvis CA, Krause ML. Over-thecounter drugs for acute migraine attacks: literature review and recommendations. Pharmacotherapy.

2003;23(4):494-505.

3. Snow V, Weiss K, Wall EM, et al. Pharmacologic management of acute attacks of migraine and prevention of migraine headaches. Ann Intern Med. 2002;137:84-9.

4. Sahai-Srivastava S, Ko DY. Pathophysiology and treatment of migraine and related headache.

September 4 2008. Accessed online March 9 2009 via http://emedicine.medscape.com/article/1144656print.

5. Ramadan NM, Silberstein SD, Freitag FG, et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management for prevention of migraine. Accessed online march 9 2009 via www. americanheadachesociety.org.

6. Schreiber CP. The pathophysiology of migraine.

Clinics in Family Practice. 2005;7(3):407-21.

7. Silberstein SD. Practice parameter: evidencebased guidelines for migraine headache (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000;55:754-62.

8. Classification and diagnostic criteria for headache disorders, cranial neuralgias, and facial pain. Headache Classification Committee of the International Headache Society. Cephalagia. 1988;8 Suppl 7:1-96.

9. Multiple drug monographs accessed via LexiDrugs on Lexi-Comp.

10. Matchar DB, Young WB, Rosenberg JH, et al.

Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. Accessed online March 9 2009 via www.americanheadachesociety.org.

Continuing Education (continued from page 40)

Migraine Headaches: A Clinical Review of Etiology, Pathophysiology, Prevention, Treatment, and the Role of the Pharmacist

Click here for a downloadable version of this table or visit www.azpharmacy.org Table 1: Prophylactic Treatment of Migraines Medication(s) Adverse Drug Reactions Contraindications Amitriptyline 30-150 mg/day

Other Important Information Medium to High Efficacy, Strong Evidence, Range of Severity and Frequency of Adverse Drug Reactions (Recommended) Boxed warning: suicidal ideation and Hypersensitivity to TCAs May be better for mixed migraine/tension-type behavior

headache or patients with depression, neuropathic

Pregnancy and breastfeeding pain Sedation, weight gain, anticholinergic

Counseling points: symptoms, orthostatic hypotension MAOI within last 14 days 1) take at bedtime

2) do not stop abruptly Acute recovery phase following MI 3) avoid grapefruit juice

Propranolol (80-240 mg/day)

Timolol (20-30 mg/day)

Fatigue, depression, nausea, dizziness, insomnia, decreased libido

Divalproex sodium (500-1500 mg/day)

Sodium valproate (800-1500 mg/day)

Boxed warnings: hepatic failure, pancreatitis, increased risk of suicidal ideation and behavior

Nausea, vomiting, abdominal pain, dark urine, yellow skin or sclera, dizziness, somnolence, insomnia, weight gain, hair loss, tremor, asthenia

Hypersensitivity to beta-blockers

Pregnancy (especially after 2nd trimester)

Uncompensated CHF

Cardiogenic shock

Severe sinus bradycardia, 2nd or 3rd degree heart block

Severe asthma or COPD Hypersensitivity to divalproex sodium or sodium valproate

Pregnancy (neural tube defects) and breastfeeding

Significant hepatic impairment

Urea cycle disorders

4) avoid alcohol and other sedating products 5) take precautions for increased sun sensitivity (use sunscreen, limit exposure) Option for patients with migraine and hypertension

Counseling points: 1) take medication consistently with regard to time of day and consumption of food 2) avoid alcohol and other sedating products

May be useful in migraine with prolonged or atypical aura

Option for patients with migraine and seizures or mood disorders

Counseling points: 1) take without regard to food 2) limit caffeine intake 3) do not stop abruptly 4) avoid alcohol and other sedating products

Low Efficacy, Limited Evidence, Mild to Moderate Adverse Drug Reactions Beta-blockers: atenolol, metoprolol, nadolol Calcium channel blockers: nimodipine, verapamil Feverfew (caution: may increase risk of bleeding when combined with anticoagulants or in hypocoaguable state) Fluoxetine Gabapentin Guanfacine Vitamin B12 Magnesium Nonsteroidal anti-inflammatory drugs (NSAIDs): aspirin, fenoprofen, flurbiprofen, ketoprofen, mefenamic acid, naproxen Anecdotally Efficacious, but No Evidence Antidepressants: buproprion, doxepin, fluvoxamine, imipramine, mirtazapine, nortriptyline, paroxetine, sertraline, trazodone, venlafaxine Cyproheptadine Diltiazem Ibuprofen Tiagabine Topiramate Medium to High Efficacy, Good Evidence, Serious Adverse Drug Reactions Methysergide No Efficacy Compared to Placebo Beta-blockers: acebutolol, pindolol Calcium channel blockers: nicardipine, nifedipine Carbamazepine Clomipramine Clonazepam Clonidine Lamotrigine NSAIDs: indomethacin, nabumetone

Arizona Journal of Pharmacy 41

Continuing Education (continued from page 41) Table 2: Acute Migraine Treatment Medication(s) Adverse Drug Reactions

Contraindications Proven Benefit (Recommended) Hypersensitivity to ASAP, ASA, and/or caffeine

Pregnancy and breastfeeding

Acetaminophen (APAP) + aspirin (ASA) + caffeine

Insomnia, GI symptoms (nausea/vomiting, gastritis, heartburn, blood in stool)

Aspirin (ASA)

GI symptoms (nausea/vomiting, gastritis, heartburn, blood in stool)

Hypersensitivity to ASA

Pregnancy (especially 3rd trimester) and breastfeeding

Asthma, rhinitis, nasal polyps, children < 16 years old positive for viral symptoms

Dizziness, vertigo, drowsiness, nausea, vomiting, blurred vision, constipation, nasal irritation, nervousness, insomnia, taste perversion, dependency

Hypersensitivity to butorphanol

Pregnancy and breastfeeding

Opioid-dependent patients who have not been detoxified

IM/IV/SQ: nausea, vomiting, dysphoria, flushing, restlessness, anxiety, irritation at injection site

IN: rhinitis, nasal congestion and irritation, dizziness, somnolence, nausea, vomiting, taste perversion

Hypersensitivity to DHE

High-dose ASA therapy

Pregnancy and breastfeeding

Ischemic heart disease, uncontrolled HTN, angina pectoris, history of MI, silent ischemia, coronary artery vasospasm

Hemiplegic or basilar migraine

PVD, sepsis, severe hepatic or renal dysfunction, following vascular surgery

Do not use within 24 hours of triptan/ergot, OR within 2 weeks of discontinuing MAOI

Do not use with potent CYP3A4 inhibitors Hypersensitivity to NSAIDs

Pregnancy and breastfeeding

Perioperative pain in the setting of CABG

Butorphanol (intranasal)

Dihydroergotamine

Ibuprofen Naproxen sodium

GI symptoms (nausea/vomiting, gastritis, heartburn, blood in stool), headache, constipation

Almotriptan PO Eletriptan PO Frovatriptan PO Naratriptan PO Rizatriptan PO, ODT Sumatriptan IN, PO, SQ

Sumatriptan + naproxen sodium (Treximet®) PO

Zolmitriptan IN,PO, ODT

SQ: dizziness, drowsiness, flushing, pain at injection site, paresthesia, chest pain/tightness/heaviness/p ressure

IN: taste perversion, nausea, vomiting, dizziness, nasal/throat discomfort

PO/ODT: dizziness, drowsiness, malaise, fatigue, chest pain/tightness/heaviness/ pressure, GI symptoms Dizziness, sedation, blurred vision, dry mouth, weight gain, constipation, nervousness, decreased libido

Prochlorperazine IV

Hypersensitivity to triptans

Pregnancy and lactation

Heart disease, basilar or hemiplegic migraine, uncontrolled hypertension

Do not use within 2 weeks of discontinuing MAOI

Do not use within 24 hours of a triptan or ergot

Hypersensitivity to prochlorperazine or other phenothiazines

Severe CNS depression, coma

Pediatrics < 2 years old or < 9 kg, Reye’s syndrome Moderate Benefit

APAP + codeine Butalbital + ASA + caffeine + codeine Butorphanol IM Chlorpromazine IM, IV Ergotamine + caffeine + pentobarbital + Belafolline® Isometheptene compound PO Lidocaine IN Meperidine IM, IV Methadone IM Metoclopramide IV Prochlorperazine IM/PR NSAIDs: diclofenac potassium, flurbiprofen, ketorolac IM, naproxen Butalbital + ASA + caffeine PO Ergotamine +/- caffeine PO Metoclopramide IM/PR APAP PO Chlorpromazine IM Granisetron IV Lidocaine IV

Conflicting Evidence

Ineffective Compared to Placebo

Insufficient Evidence Corticosteroids: dexamethasone IV, hydrocortisone IV – rescue therapy in status migrainosus

Other Information First-line for acute migraine treatment

Counseling points: 1) take with food 2) do not take for > 48 hours 3) caution with anticoagulants, APAP, NSAIDs 4) caution with liver disease, GI disease, and asthma 5) avoid alcohol and other sedating products First-line for migraine

Counseling points: 1) take with food 2) do not take for > 48 hours 3) caution with anticoagulants, NSAIDs 4) caution with liver disease, GI disease, and asthma 5) avoid alcohol and other sedating products Only first-line opioid for moderate-to-severe migraine

Use as a rescue medication; limit use

Intranasal option for patients with nausea/vomiting

Counseling points: 1) sit down before and one hour after use 2) avoid alcohol and other sedating products First-line for moderate-to-severe migraine (when NSAIDs or combination analgesics fail)

Option for mild-to-moderate migraine not responding to NSAIDs or combination analgesics

Option for patients with nausea/vomiting

Counseling points: 1) avoid grapefruit juice 2) avoid cigarette smoking

First-line for mild-to-moderate migraine

Counseling points: 1) take with food 2) caution with kidney or GI disease, hypertension, CHF 3) caution with anticoagulants and NSAIDs 4) avoid alcohol First-line for moderate-to-severe migraine (when NSAIDs or combination analgesics fail)

Option for mild-to-moderate migraine not responding to NSAIDs or combination analgesics

Option for patients with nausea/vomiting (IN, SQ, ODT)

Counseling points: 1) take medication at onset of migraine 2) avoid alcohol 3) take medication in a familiar setting until you know how you will respond 4) do not combine with ergots, MAOIs, or other triptans Option for migraine associated with nausea/vomiting

Counseling points: 1) avoid alcohol and other sedating products 2) take precautions for increased sun sensitivity (use sunscreen, limit exposure) 3) stay hydrated in hot weather

Continuing Education Quiz Access to Good Quality Dietary Supplements 1. The Dietary Supplement Health and Education Act was introduced in what year? a. 1993 b. 1994 c. 1995 d. 1996 2. Sales of botanicals are approximately ___ of an almost $25 billion/year business. a. 1 billion b. 2 billion c. 3 billion d. 4 billion 3. Through the Dietary Supplement Health and Education Act (DSHEA) Congress defined dietary supplements as which of the following? a. Drugs b. Vitamins c. Foods d. Botanicals 4. Which of the following is considered an official compendium of the United States a. Unites States Pharmacopeia b. National Formulary c. Homeopathic Pharmacopeia d. All of the above 5. In which year was the Current Good Manufacturing Practices (cGMPs) for dietary supplements finalized by the FDA? a. 2000 b. 2003 c. 2007 d. 2009

This activity was developed by the National Alliance for State Pharmacy Associations (NASPA) for pharmacists as a knowledge-based learning activity. The Arizona Pharmacy Alliance and NASPA are accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education.

6. Which of the following is false regarding cGMPs? a. They were finalized by the FDA b. They do not define the words “scientifically valid” c. They allow manufacturers to establish product specifications d. They require dissolution and disintegration testing

9. Which of the following is available in the U.S. as a dietary supplement? a. Vitamins b. Minerals c. Amino acids d. All of the above

10. Which of the following is true regarding public quality standards? a. They conserve only regulatory resources 7. In what year did the USP Convention adopt b. They work with only certain manufacturers a resolution that encouraged the USP to explore c. They do not allow updating the feasibility and advisability of establishing d. They arise from the open and participatory standards and developing information process conducted by USP concerning dietary supplements? a. 2005 11. Global Harmonization would ensure b. 1965 a. Quality c. 1995 b. Identity d. 1985 c. A+B d. None of the above 8. Which of the following includes official text from USP as well as authorized explanatory 12. USP does NOT have a site in which of the text and graphics intended to provide following countries? useful information to dietary supplement a. France manufacturers? b. China a. USP Dietary Supplements Compendium c. India b. Manufacturing Practices for Dietary d. Brazil Supplements c. Homeopathic Pharmacopeia d. None of the above

Arizona Pharmacy Foundation Access to Good Quality Dietary Supplements ACPE UAN# 0100-9999-10-054-H04-P This activity is accredited for 1.5 hours of CPE credit (CEUs 0.15)

This activity is a benefit to AzPA members. Non-members of AzPA must enclose a $25.00 check payable to the Arizona Pharmacy Foundation.

In order to qualify for ACPE credit, participants must achieve a grade of 70% or above on the quiz and submit a completed activity evaluation.

ACTIVITY EVALUATION – Please indicate if the activity met the stated learning objectives: 1. Describe the regulatory framework of dietary supplements

2. Give examples of the proposals that could be considered to further improve the quality of dietary supplements

Name __________________________________________________________

Activity accredited date: 06-30-2010 Expiration date: 06-30-2011 Send this page to: APF, 1845 E. Southern Ave., Tempe, AZ 85282

Address ________________________________________________________

Email ________________________________________________________

City, State, Zip ___________________________________________________

No

AGREE DISAGREE AGREE DISAGREE

Will the information presented cause you to make any changes to your style or method?

Yes If you answered “yes” please list one or two things you will do differently: _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ Overall evaluation of the article content: (please circle one)

Poor 1 2 3 4 5 Excellent

Certificates will be mailed within 60 days.

Arizona Journal of Pharmacy 43

Continuing Education Quiz Migraine Headaches: A Clinical Review of Etiology, Pathophysiology, Prevention, Treatment, and the Role of the Pharmacist 1. Emotional anguish, a family history of migraines, tyramine-containing foods, and ondansetron are NOT common triggers for migraine headache. a. true b. false

following preventive migraine therapies is MOST appropriate for DK? a. divalproex sodium b. amitriptyline c. butorphanol d. aspirin + acetaminophen + caffeine

2. LG, a 54 year-old woman, presents to your pharmacy with stiff neck, blurred vision, slurred speech, tingling in her right-side extremities, and a headache that she describes as “the worst she has ever experienced”. Upon further questioning, LG reports a history of hypercholesterolemia and hypertension. What is the MOST appropriate course of action? a. advise patient that she is having a migraine and recommend Excedrin® and rest b. recommend patient chew a baby aspirin and follow-up with her provider tomorrow if no improvement c. advise patient that she may have had a stroke and to make an appointment with her doctor d. advise patient that she may have had a stroke and call 9-1-1 on her behalf

5. Which of the following is NOT a widely established risk factor for migraine headache? a. monosodium glutamate b. second hand smoke c. pet dander d. Ortho Novum 7-7-7®

8. For which of the following patients may triptan use be recommended? a. 88 year-old male with a blood pressure that averages 169/94 b. 44 year-old woman taking Fioricet® and topiramate c. 26 year-old woman in her second trimester of pregnancy d. 76 year-old male with ischemic coronary artery disease

6. GK, a 22 year-old female, presents to your pharmacy complaining of one-sided headache pain that occurs during the first three days of her menstrual cycle each month, then subsides. She has no known allergies, no medical conditions, is not pregnant or lactating, and only uses NuvaRing® for contraception. GK would like a recommendation to ease her headache pain during the first three days of her cycle.

Which of the following is the most appropriate recommendation? a. ibuprofen b. Exedrin Migraine® c. refer GK to a physician for a prescription d. a or b

3. Which of the following triptans is the LEAST appropriate choice for a patient with migraineinduced nausea and vomiting? a. naratriptan b. sumatriptan c. zolmitripan d. a and c

7. RJ is a 50 year-old male who presents to your pharmacy complaining of throbbing on one side of his head, sensitivity to light and sound, and mild nausea. He has a history of active peptic ulcer disease and mild kidney dysfunction secondary to diabetes. Which of the following is the most appropriate over-the-counter remedy for RJ’s migraines? a. acetaminophen b. Aleve® c. Exedrin® d. feverfew

4. DK, a 33 year-old male, was in a serious car accident two years ago and continues to suffer from neuropathic pain secondary to his injuries.

He has tried gabapentin, pregabalin, and lidoderm patches without much success. DK has suffered from migraines since childhood, has never managed them, but is tired of suffering. His migraines and pain have become so bothersome, he has had some difficulty sleeping. Which of the

This activity was developed by the Arizona Pharmacy Alliance (AzPA) for pharmacists as a knowledge-based learning activity. AzPA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

9. BB is a 42 year-old male presenting to his physician’s office for acute migraine therapy.

He has a history of atrial fibrillation, high blood pressure, CABG x 2, cardiac stent placement, and hypercholesterolemia. BB takes warfarin, metoprolol succinate, lisinopril, isosorbide dinitrate, simvastatin, fenofibrate, clopidogrel, and lansoprazole. Which of the following medications is the most appropriate for BB’s acute migraine therapy? a. naproxen sodium b. Treximet® c. aspirin + acetaminophen + caffeine d. acetaminophen + codeine 10. CJ is a 32 year-old female with a history of post-partum depression and suicide attempts.

Which of the following is an appropriate preventive migraine therapy for CJ? a. divalproex sodium b. propranolol c. amitriptyline d. none of the above

Arizona Pharmacy Foundation Migraine Headaches: A Clinical Review of Etiology, Pathophysiology, Prevention, Treatment, and the Role of the Pharmacist ACPE UAN #0100-0000-10-055-H01-P This activity is accredited for 1.5 hours of CPE credit (CEUs 0.15)

This activity is a benefit to AzPA members. Non-members of AzPA must enclose a $25.00 check payable to the Arizona Pharmacy Foundation.

In order to qualify for ACPE credit, participants must achieve a grade of 70% or above on the quiz and submit a completed activity evaluation.

ACTIVITY EVALUATION – Please indicate if the activity met the stated learning objectives: 1. Identify risk factors for migraine headache

2. Select appropriate prevention and treatment options for migraine headache and be familiar with common adverse reactions, contraindications, interactions, and other important points regarding these medications

3. Effectively triage patients with migraine headache to over-the-counter remedies or physician referral

Will the information presented cause you to make any changes to your style or method?

Yes If you answered “yes” please list one or two things you will do differently: _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ Overall evaluation of the article content: (please circle one)

AGREE DISAGREE AGREE DISAGREE AGREE DISAGREE No

Name __________________________________________________________

Activity accredited date 06-30-2010. Expiration date 06-30-2011 Send this page to: APF, 1845 E. Southern Ave., Tempe, AZ 85282

Address ________________________________________________________

Email_________________________________________________________

City, State, Zip ___________________________________________________

Poor 1 2 3 4 5 Excellent

Certificates will be mailed within 60 days.

Time Capsule Pharmacy Time Capsules Second Quarter 2010 1985 - Twenty-five years ago:

1910 - One hundred years ago:

• The Campbell University School of Pharmacy is founded in Buies Creek, NC. • Pharmacy Directors of Pediatric Hospitals (PDPH) formed in 1985. Name changed to Pediatric Pharmacy Administrative Group (PPAG) in 1987.

• The Carnegie Foundation supported Abraham Flexner’s study of the state of medical education in the United States and Canada, thus changing medical education forever. Pharmacy leaders later approached Flexner to do a similar study. He refused noting that pharmacy was not a profession.

• Sir Edward Albert Sharpey-Schafer hypothesized that diabetes was the consequence of deficit of a pancreatic chemical which he called insulin - 11 years before the discovery of Banting and Best.

1960 - Fifty years ago: • Enovid (Searle) was the first combination (norethynodrel with ethynylestradiol 3-methyl ether) oral contraceptive approved by the FDA. • The 1960 Lilly Digest reported that the average prescription price was $3.19.

1935 - Seventy-five years ago: • Property owned by the American Pharmaceutical Association in the District of Columbia where the headquarters was to be erected was exempted from general taxes as long as it was to be used by the Association.

• The Rockefeller Foundation developed the first vaccine for Yellow Fever, once prevalent in the southern United States. It was tested and released the following year.

One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history.

Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org

Certified Pharmacy Technician

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Continuous Testing and Immediate Pass/Fail Results Now Available The PTCB Certification Program is the only pharmacy technician certification endorsed by the American Pharmacists Association (APhA), the American Society of Health-System Pharmacists (ASHP), the National Association of Boards of Pharmacy (NABP) and other professional pharmacy organizations. In 2008, PTCB tested over 50,000 pharmacy technicians and has certified over 330,000 CPhTs since 1995.

Arizona Journal of Pharmacy 45

Financial Forum

FINANCIAL FORUM 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.

LEARN ABOUT THE ADVANTAGES OF MUTUAL FUND INVESTING

In basic terms, a mutual fund is a company whose main objective is to professionally invest a pool of money in securities and earn a positive return for shareholders. In this way, these companies allow you to “mutually” share the rewards and risks of investing, hence their name.

Buying shares in a mutual fund actually gives you stock or bond holdings in various companies, based on the underlying investments. Your shares are pooled together with other investors’ shares, and the combined assets give you access to a level of diversification that you may not otherwise be able to obtain. It’s always important to remember that mutual fund investing involves risk, and your investment may be worth more or less than the original cost when redeemed. Your principal and investment return will fluctuate in value, so it’s important to understand a few basics about these funds.

Mutual fund investing may offer several benefits for individual investors. For starters, funds are managed by experienced, full-time money managers. They research market and economic trends, and then use the information they gather to make decisions about buying, holding or even selling securities to enhance returns.

Another distinct advantage is diversification, one of the basic tenets of successful investing. By spreading your money over a number of investments, a mutual fund doesn’t depend on any one investment for your return. And on the other side of the coin, the impact of one poor performer on your entire portfolio is also reduced.

Mutual funds also offer several convenient features, such as automatic reinvestment, systematic payments and no-cost exchanges. If you choose to, you can automatically reinvest any dividends and capital gains (profits) to purchase more mutual fund shares. Mutual funds can also provide you with monthly or quarterly automatic withdrawals.

You can often exchange assets from one fund to another fund within the same group of funds — also known as a fund family — without incurring any additional sales charges. However, be aware that some funds may impose short-term or other redemption fees. Be sure to read the fund prospectus for details, and know that exchanges between funds may be a taxable event.

Relatively speaking, mutual funds can be purchased with a low minimum investment. After an initial payment of $250 (some funds may require more or less), most mutual funds require as little as $25 or $50 at a time for additional investments. If you think about how many individual securities you could purchase for that same amount, you can see the benefits of investing in funds instead. These low minimums can make it easier for you to 46 Arizona Journal of Pharmacy

build a well-diversified investment portfolio.

One other advantage to mutual funds is their liquidity. Many funds offer you the ability to sell any or all of your fund shares on any business day the markets are open. A fund’s net asset value — often referred to as NAV — is the dollar value of one share in the fund, and the price a fund pays you per share when you sell. The NAV is calculated by totaling the value of all the fund’s holdings, subtracting expenses, and dividing by the number of shares.

Your redemption value when you decide to sell shares of a fund you own will be based on the next closing NAV minus sales charges, if any. Most funds impose a sales charge at the time of purchase, but some choose to impose a charge upon redemption instead. Because of these charges, and fluctuations in the NAV, mutual-funds are considered long-term investments.

There are literally thousands of mutual funds available today, offering a wide range of investment objectives and specializing in specific categories or types of securities. With all the options out there, chances are you will be able to find funds that fit in your overall investment mix.

Provided by courtesy of Pat Reding, CFPTM of Pro Advantage Services Inc., in Algona, Iowa. For more information, please call Pat Reding at 1-800-288-6669.

Registered representative of and securities offered through Berthel Fisher & Company Financial Services, Inc. Member NASD & SIPC Pro Advantage Services, Inc./Pharmacists Mutual is independent of Berthel Fisher & Company Financial Services Inc. Berthel Fisher & Company Financial Services, Inc. does not provide legal or tax advice.

Before taking any action that would have tax consequences, consult with your tax and legal professionals. This article is for informational purposes only. It is not meant to be a recommendation or solicitation of any securities or market strategy.

Kenneth R. Baker, RPh, JD Legal and Consulting Practice

Pharmacy Law Pharmacy Regulation Risk Management Insurance Pharmacy Quality Programs (CQI) Medication Error Reduction

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Is a continuous quality improvement program missing from your checklist?

Are you concerned about how you will meet the challenge of the growing demand for assuring the quality of the pharmacy services that you provide? Are you searching for a practical tool to use to collect and analyze information regarding quality-related events, such as errors and omissions in prescription dispensing, that occur at your pharmacy?

Pharmacy Quality Commitment速 (PQC) is what you need! PQC is a continuous quality improvement program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law and mandates for CQI programs under state law. When PQC is implemented in your pharmacy, you will immediately improve your ability to assure quality and increase patient safety.

Call toll free (866) 365-7472 or go to www.pqc.net for more information.

PQC is brought to you by your state pharmacy association.

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