AJP Spring 2009

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

SPRING 2009

Pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes.

The Future Vision of Pharmacy Practice Joint Commission of Pharmacy Practitioners

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ARIZONA JOURNAL A JP OF PHARMACY Vol. 1, No. 1

SPRING 2009

BOARD OF DIRECTORS

IN THIS ISSUE

PRESIDENT Linda McCoy PRESIDENT-ELECT Mark Boesen TREASURER Ken Mahan PAST PRESIDENT Crane Davis AzPA SECRETARY- DIRECTOR/CEO Mindy Rasmussen COMMUNITY PHARMACY ACADEMY CHAIR Kelly Hampton COMMUNITY PHARMACY ACADEMY CHAIR-ELECT Chad Schuster HEALTH-SYSTEM PHARMACY ACADEMY CHAIR Melinda Throm HEALTH-SYSTEM PHARMACY ACADEMY CHAIR-ELECT Michael Dietrich SENIOR CARE PHARMACY ACADEMY CHAIR Dawn Knudsen MANAGED CARE PHARMACY ACADEMY CHAIR Elizabeth Wilmeth MANAGED CARE PHARMACY ACADEMY CHAIR-ELECT Kim Kelley TECHNICIAN ACADEMY CHAIR Barbara Reyes TECHNICIAN ACADEMY CHAIR-ELECT Jenny Whitney MARICOPA & PINAL DISTRICT DIRECTOR Jamie Joy MARICOPA & PINAL DISTRICT DIRECTOR-ELECT Ken Baker PIMA DISTRICT DIRECTOR Leigh Lee PIMA DISTRICT DIRECTOR-ELECT Bill Fritz NORTHWEST DISTRICT DIRECTOR Norbert Laskowski NORTHEAST DISTRICT DIRECTOR Kathleen White SOUTHWEST DISTRICT DIRECTOR Tom Van Hassel SOUTHEAST DISTRICT DIRECTOR John Nicolais DEANS OF COLLEGES J. Lyle Bootman The University of Arizona Dennis McCallian Midwestern University STUDENTS

Whitney Shields University of Arizona Tyler Bingham Midwestern University INDUSTRY REPRESENTATIVE & LEGAL COUNSEL Roger Morris Quarles Brady Streich Lang

COLUMNS President’s Message CEO’s Message Academy News • Community Pharmacy Academy • Health-System Academy • Managed Care Academy • Senior Care Academy • Technician Academy

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 PENDING) 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 azpa@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.

Periodical postage paid at Tempe, Arizona, and additional mailing offices.

POSTMASTER: Send address changes to Arizona Journal of Pharmacy, 1845 E. Southern Ave., Tempe, AZ 85282-5831

FEATURES AND ARTICLES Pharmacy Principles for Health Care Reform

Career Center

Traveling Somewhere Exotic?

What’s New in Pediatric Vaccines?

Pneumococcal Vaccine Review

2009 Vaccination Update

Patient Concern with Autism and Immunizations Scratching Out Varicella Virus and Herpes Zoster MTM Summit

New Standards for CPE

Time Capsule

DEPARTMENTS New Members Student Perspective • Prescription for Opportunity • Got Time?

Feature Pharmacist Drug Information Questions Alliance News Calendar of Events Legislative Update Obituaries Rx and the Law Continuing Education Financial Forum

2 3 7 8 9 11 11 5 15 20 21 22 23 25 26 30 32 44 4 12 13 14 16 18 18 19 29 31 33 43

EDITOR-IN-CHIEF Mindy Rasmussen, RPh, Executive Director/CEO MARKETING AND COMMUNICATIONS Janet Weigel EDITORIAL BOARD Jacque Griffith, RPh Julie Hernandez, RPh, PharmD April Douthett, PharmD Candidate

Marion Slack, PhD Leslie Rodriguez, PharmD Amy K. Lai, PharmD

Cover photo: Robert Mizerek Fotolia©

Arizona Journal of Pharmacy 1

President’s Message New Look, New Vision Given the slim chance that a

“Pharmacy Phairy Godmother” will

Linda K McCoy, PharmD AzPA President

It’s a new year and it’s all about change! This inaugural issue of our new journal represents yet another step in our journey to make the Arizona Pharmacy Alliance the organization representing and promoting the value of all of our pharmacy practitioner members. Hopefully, you will view this name change as further evidence of our commitment to represent ourselves professionally and outwardly embrace the idea that we are a pharmacy community which encompasses everyone who supports and practices in our profession.

As the cover on this issue so graphically illustrates and the content further clarifies, our community has the opportunity and the responsibility to define the future of pharmacy practice in this country. Our professional pharmacy organizations have united to provide the documents and encouragement to guide us in our quest to be active participants in “health care reform”. What greater opportunity could we possibly want?

2 Arizona Journal of Pharmacy

wave a magic wand to create the ideal pharmacy practice, our reality is that it is our pharmacy community that must rise to the occasion. Each of us in our daily practice must demonstrate that we are ready to change how pharmacy care is delivered to our patients.

Utilizing the guidance provided by our pharmacy visionaries, we need to embrace this chance to promote and enhance our image as the providers of patient care that will ensure optimal medication therapy outcomes. It is time to stop hiding behind the rhetoric that speaks to what we could do, and start performing the actions that clearly demonstrate our value and what we can do.

We must work together to manage the care of our patients to ensure that expensive medication therapies are properly administered and that adherence to complicated regimens is assured. For those of you already engaged in providing this kind of care, please, whenever and however you can, share, guide and encourage your fellow practitioners to join you.

Utilize this journal and our meetings to tell your story and take every opportunity to communicate the value of your approach to others.

If you are still striving to attain this level of practice, use the services provided by AzPA to expand your expertise and broaden your contacts within our pharmacy community.

As you read the articles and information contained in this issue,

make a commitment to be one of the active participants who helps to shape the destiny of our profession.

Plan now to attend the AzPA 5th annual meeting and learn how to provide patient-focused care for chronic diseases. This year’s theme is Our Profession, Our Patients Impact Care: Effective Therapy for Chronic Diseases. This event is your opportunity to be part of our profession’s future in health care reform.

We are standing on the corner looking into the future - a pathway with guiding principles for pharmacy’s role in health care reform is awaiting are you ready to take the first steps?

“It’s choice - not chance - that determines your destiny.”

Jean Nidetch

CEO’s Message Standing on the Corner As you can see, the photo of the street sign on the front cover represents the profession of pharmacy.

We can no longer stand on the corner, waiting for someone to walk by and give us handouts. We can no longer stand on the corner and wait for a magical increase in reimbursement fees and waivers of increased accreditation mandates. And we all know that the state of the economy in America may not improve anytime soon and with that comes the issue and discussion of health care reform.

What we can do is head in the right direction and emphasize our services to each and every one of our patients.

The future vision of pharmacy must be practiced and demonstrated. This must be our vision to secure the future of our profession and the care we bring to our patients: Future Vision of Pharmacy Practice: Pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes.

On February 12, 2009, twelve pharmacy groups, including the National Community Pharmacists Association, the Academy of Managed Care Pharmacy, the American Association of Colleges of Pharmacy, the American College of Clinical Pharmacy, the American Pharmacists Association, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, the Food Marketing Institute, the National Association of Chain Drug Stores, the National Alliance of State

Pharmacy Associations, Rite Aid, and Walgreens, participated in a groundbreaking news conference at the National Press Club to formally unveil health care reform principles that, if adopted, will benefit practitioners, patients, and the system. The overarching message was quite simple: pharmacists improve patient care.

The goal was to unveil "pharmacy principles for health care reform."

After much hard work and discussion, all agreed on three broad reform principles: I.

II.

III.

Improve Quality & Safety of Medication Use Assure Patient Access to Needed Medications & Pharmacy Services Promote Pharmacy & Health Information Technology Interoperability

Lawmakers on both sides of the aisle will continue to work on plans to fulfill President Obama's pledge to bring affordable health insurance to all Americans. The debate over health care reform will be on the forefront of the agenda. These Pharmacy Principles for Health Care Reform (see pages 4 & 5) fit into many approaches of this discussion. We are all responsible for taking ownership of and communicating this vision. Every American needs access to prescription medications and to pharmacistprovided patient care services. Access to these services will help patients optimize therapeutic outcomes and reduce the risk of physically and fiscally devastating adverse events.

Appropriately-implemented health

Mindy Rasmussen, RPh Chief Executive Officer

information technology will enable us to provide better, more efficient care to our patients.

Health care reform discussions must focus on strategies that maximize the efficiency and safety of drug distribution while also providing patients with access to the full benefit of pharmacist-provided patient care services to achieve better, less costly health care.

We need to practice, demonstrate and communicate these principles on a daily basis to all stakeholders and to our patients; otherwise, we will be left standing on the corner wondering why we did not take ownership of the destination of our profession. I don’t want to be left standing on the corner, unless it is in Winslow, Arizona.

Arizona Journal of Pharmacy 3

New Members Welcome New Members

Andrew Gifford Neha Giridharan Nathan Green Lashley Hatch Kara Herko Patrick Jerome Ashley Jorgensen Joseph Kimbro Erwin Lam Richard Adam Levine Jessica Ling Emily Lundeen Kevin Malina Megan Martineau Kimia Nasrollah

Christine Aguilar Tomoko Arikawa Mary Babico Dean Bartello Golden Benjamin Berrett Matthew Bertsch Steven Bluder Connie Chau Jason Clouts Emalee D. Craft Mark Culver Ashoor Y. Dinkha, CPhT. William T. Foxx-Lupo Ashlee Gerfen

Bich Tran Nguyen Adam Nye Rachel Adhiambo Ogumbo Dezirae Oriedo David R. Ornelas Stephanie Peterson Janssen Puracan Rebecca Roush Steven E. Smith Karen Steidlmayer Gloria Sun Ashley Sweaney Diana Tang Pamela J. White Sarah Workinger

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.

Pharmacist Individual Joint (husband and wife) New Practitioner – 1st year 2nd year Retired Technician Resident Student (full-time U of A or Midwestern)

DUES $225 $340 $115 $180 $ 85 $ 40 $ 65 $ 20

Name _______________________________________ Address _____________________________________ Phone _____________ Email _____________________ Employer _____________________________________ Please check the box of the Academy that best represents your practice. Note: Please check only one box. ____Academy of Community Practice ____Academy of Health Systems ____Academy of Senior Care ____Academy of Managed Care ____Academy of Technicians IMPORTANT INFORMATION Concerning your membership dues, taxes and donation to Arizona Pharmacy Foundation: Of the “Membership Payment” shown, the amount listed below is deductible as a charitable contribution made to the Arizona Pharmacy Foundation (APF) – a 501 C(3) corporation, IRS #86-0679270. The remaining portion is not deductible as a charitable gift, but may be deductible as a normal business expense. Also under the Omnibus Budget Reconciliation Act of 1993, membership payments to associations that are used for lobbying expenses are no longer deductible for federal income tax purposes. Of the membership payment to the AzPA, 10% is nondeductible. Check with your tax advisor on how these rules may apply to you.

4 Arizona Journal of Pharmacy

METHOD OF PAYMENT Make checks payable to Arizona Pharmacy Alliance. Mail this form to: 1845 E. Southern Avenue, Tempe, AZ 85282-5821 or fax it to (480) 838-3557.

Check #_____________ Credit Card: M/C _____ VISA_____ AMEX_____ Card # _______________________________________ Expiration Date __________________________ Signature ___________________________________

Tax deductible amount from your membership dues Pharmacist: Individual: $15

Joint $30 New Practitioner: 1st year $10

2nd year $15 Individual Affiliate:

$15 Retired:

$10 Student:

$0 Technician: $5 Resident: $0

1

Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, D.C.: National Academy Press; 2000.

The IOM report, Crossing the Quality Chasm: A New Health System for the 21st Century, identifies six aims for health care system improvement: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. With these objectives in mind, we have developed three broad goals related to medication access and

PHARMACY PRINCIPLES FOR HEALTH CARE REFORM

As the Institute of Medicine1 has noted, “…because of the immense variety and complexity of medications now available…the pharmacist has become an essential resource…and thus access to his or her expertise must be possible at all times.”

Pharmacists have extensive clinical knowledge and expertise in the use of medications, and are one of the most accessible of all health care professionals. This makes them uniquely positioned in the health care system to help patients optimize appropriate medication use, reduce medication related problems and improve health outcomes through the delivery of pharmacist-provided patient care services, including medication therapy management (MTM), health promotion and education, and disease prevention and mitigation. The approximately 227,000 pharmacists in the United States practice in sites including pharmacies; hospitals; long-term care facilities; medical clinics and home health agencies; academic health centers; managed care organizations; and other health care settings where medications are used.

Proper use of prescription medications helps improve quality of life and health outcomes. However, the health care system incurs more than $177 billion annually in mostly avoidable health care costs to treat adverse events from inappropriate medication use. The proper use of medication becomes even more important as treatment of chronic disease costs the health care system $1.3 trillion annually, or about 75 cents of every health care dollar.

Policymakers are discussing options to strengthen the nation’s health care system, improve quality and safety, provide coverage and benefits for millions of uninsured and underinsured Americans, and respond to the challenge of meeting the health care needs of the American population, especially an aging America. Our nation’s pharmacists play a critical role in providing affordable, accessible and quality health care. Decisions made to reform our health care system should enhance, fully recognize and utilize the professional skills and competencies of pharmacists.

PHARMACISTS IMPROVE PATIENT CARE

Academy of Managed Care Pharmacy, American Association of Colleges of Pharmacy American College of Clinical Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, Food Marketing Institute, National Association of Chain Drug Stores, National Alliance of State Pharmacy Associations, National Community Pharmacists Association Rite Aid Corporation, Walgreen Co.

PHARMACY PRINCIPLES FOR HEALTH CARE REFORM

A viable and accessible medication-delivery infrastructure is critical to patients’ health. Patients should have ready access to both needed medications and services through a network of pharmacies and pharmacists. This is especially important given the burden of chronic illness, and impending retirement of approximately 80 million “baby boomers” who take more prescription medications on average than younger individuals.

Reform Principle II Assure Patient Access to Needed Medications & Pharmacy Services

• Principle I (A): Incorporate coverage for pharmacist-provided patient care services into public and private health care programs. These programs could include medication therapy reviews for those patients entering Medicare and for other patients with documented medical need, medication therapy management (MTM) services, as well as pharmacist-delivered immunizations.

• Principle I (B): Provide appropriate payment for pharmacist-provided patient care services. These payments could be based on pay-for-performance programs connected to specific evidence-based measures.

Health Care Reform Principles – Quality & Safety

Pharmacists also support public health prevention and education strategies. These include counseling patients on prevention and wellness issues, such as weight management and smoking cessation, as well as providing immunizations. In every state except one, pharmacists are authorized to provide one or more types of immunizations — influenza, pneumonia, and bio-defense-related vaccines — which are critical to promoting and protecting public health.

Pharmacists help achieve the best possible medical outcomes from the use of prescription medications through various types of medication-related services. These services include working collaboratively with physicians and other healthcare providers in recommending specific medications or changes in medications. Pharmacists also provide services to patients that help them better understand their medications and how to take them.

Pharmacist services help prevent drug interactions and adverse effects.

Reform Principle I Improve Quality & Safety of Medication Use

use that should be an integral part of the health reform discussion: • Recognizing the role of pharmacists to help ensure that medication therapy is safe, effective, equitable, patient-centered, and results in quality outcomes; • Ensuring that all Americans have timely access to prescription medications that are provided accurately and efficiently; • Expanding the use of health information technology to support full integration of pharmacists as part of the health care delivery team.

We ask that policymakers consider the positions of our nation’s pharmacists and pharmacies in three key areas. These recommendations are critical to helping patients make the most effective and safe use of their prescription medications and to maintaining a critical pharmacy delivery infrastructure.

Health Care Reform Principles – Infrastructure • • • •

Principle II (A): Assure that all Americans have access to the services of well-educated and trained pharmacists competent to meet specific health care needs of patients by establishing and financing a comprehensive federal health professions workforce strategy.

Principle II (B): Within the context of their prescription plan coverage, allow patients to choose the provider of both prescription medications, as well as MTM and other pharmacist-provided patient care services.

Principle II (C): Provide appropriate reimbursement to pharmacists and pharmacies for the costs associated with obtaining medications, and payment for dispensing and administration services in order to assure accurate delivery to patients. Payment for dispensing should reflect the costs to dispense.

Principle II (D): Ensure pharmacists can provide patients access to the most appropriate, cost-effective medications, including generic medications and biologicals, without any artificial impediments or barriers to generic substitution.

Reform Principle III Promote Pharmacy & Health Information Technology Interoperability Health information technology is rapidly becoming an integral part of health care delivery in the United States. The use of electronic health records and electronic prescribing has increased dramatically in recent years, and the exchange of information among providers has significantly improved the delivery and quality of health care. Pharmacists should be able to interface in an electronic, interoperable health care system to provide the best possible quality of care to patients. The information obtained through interoperability will help pharmacists ensure patient adherence to their medication regimens, reduce medication related errors, and enhance medical decision making.

Health Care Reform Principles – Health IT • Principle III (A): Provide pharmacists electronic access to critical patient health care information, including diagnosis and laboratory values. This information must be provided through an interoperable electronic health record system, including electronic prescribing, that supports multi-directional communications among various health care providers and settings.

• Principle III (B): Establish federal and state grants to health care providers, including pharmacists, that support the continued growth of an interoperable health care system.

• Principle III (C): Assure the appropriate flow of critical information within and among health care providers, including pharmacists, that is needed to make decisions regarding the best possible treatment for patients, while protecting patient information.

CONCLUSION All Americans need access to prescription medications and to pharmacist-provided patient care services to help them optimize therapeutic outcomes and reduce the risk of adverse events from medication therapy.

Health care reform provides an opportunity to advance these goals. Pharmacists are a highly trained and valuable resource, yet they are currently underutilized. Health care reform discussions should focus, in part, on strategies to maximize efficiency and safety of drug distribution while providing patients with access to the full benefit of pharmacist-provided patient care services to achieve better health care.

Adopted December 2008

William Wolfe Group Vice President, Managed Care and Government Affairs Rite Aid Corporation (717)730-8217 (main) wwolfe@riteaid.com

Carol Kelly Senior Vice President National Association of Chain Drug Stores (703)549-3001 (main) ckelly@nacds.org

Cathy Polley Vice President, Pharmacy Services Food Marketing Institute 202-220-0631 cpolley@fmi.org

Claudia Schlosberg Director, Policy and Advocacy American Society of Consultant Pharmacists (703)739-1316 ex. 128 cschlosberg@ascp.com

Bill Hermelin Director of Government Relations and General Counsel Academy of Managed Care Pharmacy (703) 683-8416 ext 611 bhermelin@amcp.org

Will Lang Vice President of Policy and Advocacy American Association of Colleges of Pharmacy (703) 739-2330 x 1038 wlang@aacp.org

Debbie Garza Divisional Vice President, Government and Community Relations Walgreens (202) 393-0414 debbie.garza@walgreens.com

John Coster Senior Vice President of Government Affairs National Community Pharmacists Association (703) 888-0859 john.coster@ncpanet.org

Becky Snead Executive Vice President and Chief Executive Officer National Alliance of State Pharmacy Associations (804) 285-4431 rsnead@naspa.us

Joe Hill Director, Federal Legislative Affairs American Society of Health-System Pharmacists (301) 664-8710 jhill@ashp.org

Kristina Lunner Vice President of Government Affairs American Pharmacists Association (202) 429-7507 (direct) klunner@aphanet.org

Ed Webb Associate Exective Director American College of Clinical Pharmacy (202) 756-4503 (direct) ewebb@accp.com

Academy News Community Pharmacy Academy News Dear CPA members, I thought I would take this opportunity to remind AzPA members what the Community Pharmacy Academy (CPA) is all about, in hopes that I might be able to ignite some passion in each of you to get more involved with AzPA and the CPA. This year will bring many challenges for pharmacy and we need your support. If you have thought about becoming more involved but just never got around to it, now is the time. We still have a lot of work to do in order to make the improvements necessary to really impact the practice of pharmacy in Arizona. We have Executive Board positions available if you want more involvement or you can volunteer for something as simple as writing an article for the journal or staffing the check-in table at the annual conference.

Any amount of time and support you can offer is appreciated.

Community Pharmacy Academy’s Mission Statement: The Community Pharmacy Academy is committed to serving and representing all voices in community pharmacy. The CPA will promote, encourage, and develop educational programs and initiatives that empower community pharmacists to become more involved in their respective practices and to promote the highest level of patient care and safety.

Call for Volunteers: CPA is currently seeking motivated community pharmacists, technicians and student pharmacists to fill the following Executive Board Positions as well as assist the CPA with upcoming events and initiatives: • Chair: Kelly Hampton • Chair Elect: Chad Schuster • Communications Representative: OPEN • Education Representative: OPEN • Membership Director: OPEN • Legislative Representative: Russ Newman • Technician Representative: OPEN

• New Practitioner Representative: OPEN • Student Representatives: OPEN If you are interested in any of these positions or would like additional information please contact Kelly Hampton CPA Annual Conference:

When: September 2009

Tentative Topic: Adherence We are in need of CPA members to help facilitate and organize this meeting. If you are interested please contact Kelly Hampton.

Legislative update: HB2164 was introduced into the Arizona House with the opening of the 2009 legislative session.

This legislation expands the pharmacist's scope of practice to allow pharmacists in Arizona to administer vaccines without a prescription to patients 18 years of age or older using board-approved protocols. On January 21, 2009, the bill passed the House Health Committee. We are working very closely with the stakeholders to ensure the bill’s language address everyone’s needs and concerns. Once the language is finalized the bill can submitted to the full House for a vote. There is still a moratorium on bills in the Senate as President Burns will not allow any bills to be heard until the budget is passed. If all goes well, the bill will be signed in to law by Gov. Brewer this session. Protocols will need to first be approved by the AZ Board of Pharmacy’s Advisory Committee before pharmacists can administer vaccines without a prescription. Stay tuned!

I want to give a special thanks to CPA members Russ Newman and Chad Schuster for all of their help and support this past year.

Sincerely, Kelly Hampton, PharmD Community Pharmacy Academy Chair Kelly.Hampton@safeway.com 480 894-4101

Arizona Journal of Pharmacy 7

Academy News Health-System Academy News

Eric Weber elected as 2009-2011 Arizona Delegate to the ASHP House of Delegates!

Greetings Health-System Academy Members!

Eric Weber, PharmD, BCPS is an Arizona native. Dr. Weber graduated from the University of Arizona in 1995, completed a pharmacy practice residency in 1996, and received board certification in Pharmacotherapy in 1998.

He practices as a clinical pharmacy specialist in ambulatory care at the Phoenix VA Health Care System. As a member of AzSHP & AzPA since 1991, he has enjoyed remaining active within the organization, serving as the Maricopa District Director, the Education Director for the HealthSystem Academy, on the annual meeting planning board, representing Arizona in the ASHP House of Delegates (2004-2006), and presenting platform presentations and posters at several annual meetings.

The strength of an organization is only as strong as its members. This is why the Health-System Academy spearheaded a short AzPA recruitment DVD to increase membership in the organization and within health-system pharmacy. The recruitment DVD debuted at the 2009 AzPA Midyear Meeting. In the future, a copy of the DVD will be distributed to all Directors of Pharmacy for viewing at facility staff meetings and a link will be posted on the AzPA website (www.azpharmacy.org). The video will also be spotlighted on the national ASHP website (www.ashp.org). The Health-System Academy (HSA) Executive Committee would like to thank the Dean’s Office of Midwestern University College of Pharmacy (MWU CPG) and MWU Media Resources for their support of this project. The Executive Committee would also like to recognize Hope Le, Katie Carey, and Brandy Griffin (MWU CPG Class of 2008) who created the script for the video. We hope you will join the HSA of AzPA and make your voice heard!

The AzPA/HSA membership committee representative, Kristen Allison [kristen.allison@va.gov] is firming up details for the creation of a valley-wide Directors Forum.

The communications committee representative, Amy Lai [amy.lai@va.gov], continues to create themed issues for each Health-System Heartbeat. Carol Rollins [crollins@ umcaz.edu], education committee represenataive, is organizing a continuing education event for our members.

The 3rd Annual Health-System Academy conference is slated for Saturday, April 25th, 2009, at Banner Gateway Medical Center and will focus on metabolic challenges (diabetes, lipids, osteoporosis, and obesity). Law credit will also be offered. The Executive Committee welcomes student representatives, Mamta Naik (MWU CPG) and Jenna Carmichael (U of A), and technician representative, Janet Bradbury, to the health-system team!

We look forward to seeing you at the 3rd Annual HealthSystem Academy conference. Register today! We appreciate your commitment to advancing health-system pharmacy practice in sunny Arizona!

Professionally, Mindy J. Throm, PharmD, BCPS Health-System Academy Chair 2007-2009 mthrom@midwestern.edu 8 Arizona Journal of Pharmacy

Please congratulate Dr. Weber on his appointment. If you have advocacy or legislative questions, please email a Delegate directly: Larry Anderson, PharmD - delegate through end of 2009; larrya@cableone.net Kristina De Los Santos, PharmD, BCPS - delegate through end of 2010; kristina.delossantos@va.gov Eric Weber, PharmD, BCPS - delegate through end of 2011; eric.weber@va.gov (delegate through end of 2011) The AzPA/HSA would like to thank Dianna BorowskiWright (Immediate Past Delegate completing her term at the end of 2008) for her dedication and advocacy. Dianna Borowski-Wright, Carol Rollins, and Mike Katz will serve as Alternate Delegates. We appreciate your advocacy and support of pharmacy in Arizona!

AzPA/HSA Annual Conference

Meeting Metabolic Challenges

Saturday, April 25, 2009

7:30am to 5:00pm

Banner Gateway Medical Center

1900 N. Higley Road

Gilbert, Arizona 85234

Visit the AzPA website for complete information www.azpharmacy.org To register online go to: http://fs7.formsite.com/AzPA/form675882747/index.html

Academy News Managed Care Academy News Hello, Managed Care Academy! Welcome to our newcomers, and greetings to all.

Positions open in the Academy We still have positions open for volunteers to fill.

Have you reflected on which position might suit you? Please check the website, and email us with any questions or thoughts. We welcome our newest volunteers who have stepped up to give their time to our academy and the association: Belinda Mims has stepped up as our Emergency/ Disaster Preparedness Task Force Representative, Kim Kelley as our Annual Meeting Committee Representative, Mike Lopour as our Legislative Committee Representative, Hanh Hyunh as our CE Committee Representative, and Ray Clark as our Membership Committee Representative.

Still available for you to consider: Professional Affairs Committee, Compounder Forum Task Force, Rx Medication Waste Disposal Task Force, MTMS Task Force, and New Practitioners Forum Task Force representatives.

Events We are gearing up for our MCA Conference, tentatively slated for Thursday, May 14, 2009. The evening will start with a symposium dinner at 5pm, and then 2 hours of CE topics: Topics to be presented are: • Copays and Consumer Economics • Community Pharmacists, Immunizations, and Managed Care; • FDA and Off-Label Prescribing/Use The evening is scheduled to finish at 8pm. Look for more information and the registration link on the website, coming soon.

Help Wanted We were unable to get much response from the AzPIN request, so we will be sending out an email to MCA members. If you work in a managed care setting and could please help, that would be great!

Julie is seeking information on both pharmacists

and technicians who work in managed care, to finish the series of articles. Technicians who may be part of the Technician Academy but work in managed care, please also send in your input! We are just looking for a very brief description of what you do in your role at your job. We aren’t including names with the descriptions in the article. Thank you in advance for your help! (email Julie Hernandez at rxchica@cox.net) Do you like to write? We are always looking for submissions for the journal or AzPIN, as well as content for our page on the AzPA website. If this seems interesting to you, contact one of us and we’ll be happy to discuss or help.

Julie Hernandez, RPh, PharmD Managed Care Academy Communications Committee Representative rxchica@cox.net

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Health Care Reform Should: • Improve Quality & Safety of Medication Use Through Pharmacist Clinical Services • Assure Patient Access to Needed Medications • Promote Pharmacy and Health Information Technology Interoperability Academy of Manag ed Care American Pharmacy, College of American Clinical Ph American Associatio armacy, Am Society of n of Colle erican Ph Consultant ges of Ph Food Mar armacists Pharmacist armacy, keting Inst Associatio s, American itute, Natio n, Walgree National Al So ci na ety of Heal l Associat n Co., liance of St th io -S n of Chain ate Pharm ystem Phar acy Associ Drug Stor m acists, es, Rite Ai ations, Natio d Corporat nal Commun ion, ity Pharmac ists Associ ation

Arizona Journal of Pharmacy 9

Academy News

“We implemented PQC in our pharmacy four months ago – it was easy. I have noticed an enhanced effort from the staff to work together to avoid and eliminate quality-related events.”

Pharmacy Quality Commitment® (PQC) is what you need!

PQC is a continuous quality improvement (CQI) 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. Do you have a CQI program in place?

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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10 Arizona Journal of Pharmacy

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Academy News Senior Care Academy News

Technician Academy News

Hello, SCA Members,

In January 2009, the Pharmacy Technician Certification Board (PTCB) announced beginning April 1, 2009, the PTCB Examination will be available in continuous testing format at Pearson Professional Centers nationwide. PTCB also announced that exam candidates will receive an official pass or fail result at the test center after the completion of the exam, effective immediately.

AzPA’s Senior Care Academy is looking for members and volunteers! Formerly the Long-Term Care Academy, we invite you get involved with your association through the SCA. Each academy selects representatives to serve on the various AzPA committees and task forces. If you are looking for a way to become more involved in our organization, here are some opportunities for you to consider: Legislative Committee – Are you an advocate? You can help promote and communicate the pharmacy profession’s perspective as it relates to proposed legislation.

Continuing Education Committee – Have an interest in education? Get involved in identifying and recommending continuing education programs for AzPA activities.

Communications Committee– Do you like to write?

We need volunteers to write SCA news and articles for the Arizona Journal of Pharmacy and other AzPA communications.

Membership Comittee – Are you a networker? This committee’s goal is to recruit and retain active AzPA members.

Annual Meeting Planning Committee – If you are an organizer/manager, this is for you! This committee oversees the smooth implementation of all aspects of the annual meeting.

Professional Affairs Committee– Are you a visionary? Be a part of the future vision of pharmacy in Arizona!

The current quarterly administration of the PTCB examination will conclude on March 31, 2009.

Eligible exam candidates applying after April 1, 2009, will be authorized to test immediately, and may schedule an exam appointment in the 90 days following approval. Candidates will continue to schedule examination appointments at any of the over 200 Pearson Professional Centers nationwide and internationally at DANTES testing centers in the continuous testing format.

For more information visit the PTCB website at www.ptcb.org Barbara Reyes , CPhT Technician Academy Chair

PTCB Certified Pharmacy Technician Trained. Tested. Trusted.

Please contact me with your interest and questions.

We want you to be involved!

The Pharmacy Technician Certification Board (PTCB)

Dawn Knudsen, PharmD, CGP Senior Care Academy Chair dknuds@midwestern.edu

PTCB’s certification program is accredited by the

was established in January 1995 to create a national certification program for pharmacy technicians.

National

Commission

for

Certifying Agencies (NCCA).

Since its inception in 1995, PTCB has certified over 320,000

Continuous Testing Begins April 1, 2009

pharmacy technicians.

Arizona Journal of Pharmacy 11

Student Perspective Prescription for Opportunity – Pharmacy Day at the Capital President’s Day 2009 marked my third year participating as a pharmacy student advocate to our state’s elected officials and I must say, this was the best one I have had the fortune to attend. However, this perception may be due to my current internship at the Arizona Pharmacy Alliance and the heightened awareness concerning advocacy that has developed from it. For those who may not know, Pharmacy Day at the Capital is an informational event conducted by the pharmacy students from Midwestern University and the University of Arizona on the front lawn of the State Capital.

This venue highlights the education of today’s pharmacist, what we can provide to the health care system and is meant to inform the electorate of our abilities. In short, we try to convey that today’s pharmacist can do a lot more for the healthcare system than count to thirty.

This year’s theme was “The Pharmacist – Your Source for MEDS”, emphasizing pharmacist’s roles in Medication use, Education of the patient, Disease management, and Screening. There were, of course, the usual booths for diabetes, smoking cessation, asthma, MTM services, heartburn and hypertension. However, this year there was greater focus on relevant legislative issues.

We showcased an Immunization booth to bring attention to the immunization bill, HB 2164. This bill will allow pharmacists to administer certain vaccinations without a prescription and is an issue AzPA has been steadily championing for the past 2 years. Passage of this bill will not only be good for the state from increased immunization rates, but also good for pharmacy in expanding the direct clinical services we can provide to the public. There were also booths concerning medication waste disposal and the University of Arizona’s Poison Control Center, both currently hot topics and issues of importance to the pharmacy profession.

The turn-out was encouraging, with more representatives and senators visiting our event than I had seen in the previous years. As a walker this year, I was presented with the opportunity to be Senator Nancy Barto’s guide. Senator Barto is the Chairperson for the Senate Health and Human Services Committee and the sponsor of the immunization bill. I was excited at the prospect of discussing pharmacy with her. We visited the booths and talked about the educational requirements of pharmacy, how the various booths illustrate the skill sets that a pharmacist can provide to patients and how, through better management of medication therapy, we can lower overall healthcare costs. More importantly, we talked about 12 Arizona Journal of Pharmacy

the existing barriers that prevent pharmacists from fully applying their craft, such as payment systems that center on dispensing and fail to recognize (or pay for) our clinical skills. We talked about the Diabetes 10 City Challenge, an offshoot of the Ashville Project, and how using pharmacists to manage diabetic patients resulted in better disease control, which translated into lower total healthcare cost.

Students explained how pharmacists have done the same with asthma, smoking cessation and many other chronic disease states. Finally, we talked about how the state’s healthcare system, AHCCCS, could benefit from utilizing pharmacists in this manner.

There was so much more that I could have discussed with her, but as I have learned from school, education takes time and too much too quickly will definitely give you a headache. I am hopeful that what was discussed with her and the other legislators will bear fruit in their understanding of our profession and our capabilities.

One of the unique facts I discovered during my rotation at AzPA is that, by next year, 1 out of every 4 physicians in Arizona will be of retirement age, further straining the ability of our medical community to provide adequate healthcare to an aging population. Pharmacists are now in a unique position to help meet some of these healthcare demands. It is only by engaging in public education and strong advocacy that we will be able to advance our cause to be providers of clinical service and not just someone who’s really good at counting to thirty.

Submitted by Steve Smith, PharmD Candidate Midwestern University - Glendale Class of 2009

Steve Smith with Rep. Nancy Barto (R) District 7

Midwestern University - Glendale students meet with Sen. Jack Harper (R) District 4

Student Perspective Got Time?

When you think of pharmacy school, what comes to mind? Studying…pharmacology… chemical structures…late night study sessions…kinetics… coffee? What about therapeutics… dedication… tests…hard work…more studying?? This list could go on for quite a while, but what may not come to mind is volunteering and community service. With all the time and focus that pharmacy school requires, it is hard to believe that students in such a program can find the time to volunteer, much less have the desire or energy to do so. Fortunately this is not the case, as pharmacy students at both the University of Arizona and Midwestern University-Glendale have clearly demonstrated.

Over the last few months, pharmacy students in both Glendale and Tucson have been successful in impacting patient care in a positive way. U of A pharmacy students provided health screenings and educational seminars to hundreds of people, including a total of 300 patients screened for hypertension, 81 patients for asthma, 183 patients for diabetes, and 350 participated in their 4 poison prevention sessions.

Besides direct patient contact, U of A students worked to make a difference in the lives of patients via participation in various charity walks, including ones for AIDS and Multiple Sclerosis. Their work outside the classroom will continue this semester as they continue planning and providing screenings/seminars, planning for the annual Women’s Health Expo in April, and forming a Kappa Epsilon pharmacy team for the Susan G. Komen Breast Cancer Walk in April.

Midwestern pharmacy students have also been busy, positively affecting patient care with their own volunteer efforts. MWU-G pharmacy students successfully provided diabetes education at the Foothills Health Fair, informing the public about diabetes prevention. Phi Delta Chi, a pharmacy fraternity, is also working to provide regular blood pressure screenings at the Foothills Recreational Center, which is just down the road from the Midwestern campus.

Midwestern students impacted patient lives in other ways, including “Prescription for Hope” for St. Jude Children’s Research Hospital and “Be a Santa to Head Start”. Phi Delta Chi held the “Prescription for

Hope” fundraiser, a letter-writing campaign to raise money for St. Jude’s Outpatient Pharmacy. Through the “Be a Santa to Head Start” event, spearheaded by Midwestern’s APhA chapter, 177 children from lowincome valley families were adopted for Christmas.

Midwestern pharmacy students’ volunteer efforts in the community will continue this year as they plan to have poster board presentations on poison prevention at the annual Cuts for Kids event, as well as participate in April’s Asthma walk as both walkers and asthma educators.

Studying…pharmacology…chemical structures… late night study sessions…kinetics… coffee… therapeutics…dedication…tests…hard work… more studying?? These words do accurately describe pharmacy school, so it is encouraging to see that students are willing to step outside of these demands and reach out, making a difference in their community.

University of Arizona and Midwestern pharmacy students have done a lot over the course of the last few months to make a positive impact on patients, and it looks like their good work in and out of the classroom will continue!

Submitted by April Douthett, PharmD Candidate Midwestern University - Glendale Class of 2009

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

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

Phelps Dodge Tower One North Central, Suite 900 Phoenix, AZ 85004 602-307-9900 Main 602-256-3086 Direct 602-307-5853 Fax kbaker@rcdmlaw.com

Arizona Journal of Pharmacy 13

Feature Pharmacist Feature Pharmacist – Paul Hellinga By: Rebecca Roush, PharmD Candidate University of Arizona College of Pharmacy Class of 2009

According to the U.S. Census Bureau, Arizona was the second fastest-growing state in 2007-2008 . Mesa is the 3rd largest city in Arizona and the 41st largest city in America.

Population statistics estimate that 30% of the population in Mesa is under the age of 19. The proportion of pediatric patients compared to the overall population in Phoenix’s East Valley is startling, considering only 21% of the national population is under 19 years old.

To meet the demand of pediatric patients who need access to health care in the East Valley, Banner Health will open a 248-bed children’s hospital in the fall of 2009 on its existing Banner Desert Medical Center campus. As a pediatric pharmacist at Banner Children’s Hospital at BDMC, Paul Hellinga is prepared to take on the challenge of meeting the increased demand for pediatric care.

A 2006 graduate of the University of Utah in Salt Lake City, Paul Hellinga has a wealth of experience working in pediatric pharmacy. As a pharmacy student, Paul began his pediatric pharmacy career working 20-30 hours per week as a pharmacy intern at the Primary Children’s Medical Center, continuing there throughout his school years.

In addition to his hospital intern position and full-time schooling, Paul gained retail experience working 10 hours per week as an intern at Smith’s Food and Drug.

Choosing a career in pediatric pharmacy was much more than just a matter of being conveniently located next to a children’s hospital for Paul. “I’ve always had a desire to work with kids. I like pediatrics because it’s just a little more challenging. It’s not just one dose for everybody like in the adult world. You are always calculating every dose, so you always have to have your head in the game.”

His experience at Primary Children’s exposed him to the benefits of having a decentralized pharmacy model. There were only 1 or 2 pharmacists in the central pharmacy that were responsible for dispensing medications. The remaining pharmacists were on the floor. Each of the 3 floors had their own satellite pharmacy and 3 pharmacists were assigned per floor. All order entry was done at these locations, allowing the pharmacists to be available to the medical staff.

14 Arizona Journal of Pharmacy

In addition to the decentralized pharmacy model, Paul experienced technological advancements in pharmacy practice . Primary Children’s Hospital introduced a robot to pull drugs to prepare them for dispensing. Some pharmacists may fear losing their jobs, but in Paul’s mind, robotics is a good thing. While recently watching a video of an IV robot that would mix and draw up medications, he felt like he was “living in the future.”

Paul’s first institutional rotation was at Banner Desert Medical Center (BDMC). He learned of the hospital’s plans to open a pediatric tower and was excited at the opportunity to get in on the ground floor. Paul took the only position that was available at the time at BDMC as an adult pharmacist in the summer of 2006.

During his 2.5 years at BDMC, Paul notes that he is utilized as a resource by pediatric providers much more so than when he was an adult pharmacist. Doctors are in the same position as pharmacists in that there are a lot of unknowns in pediatrics. “Pediatrics is more challenging because there are not a lot of studies and so you almost always feel like you’re on the cutting edge of everything. If they (providers) don’t know something, they come to me.” Paul finds it extremely gratifying that he has been able to build strong relationships with the providers at the hospital. He knows that they could look up the information but feels valued when they pick up the phone and call him.

In order to build strong relationships with the nurses and physicians, Paul finds that good communication skills are critical. “If you give them a good, strong answer and give them what they are looking for the first two or three times they call, you will form these relationships.” The best relationship he has is with a physician’s assistant who calls him 5-6 times per day and trusts him to provide her with the information she needs.

Questions often stem from the variances in ways pharmacy references list information, particularly for pediatric dosing.

Some drug doses are listed in mg/kg/day and others are listed in mg/kg/dose. If one is not extremely familiar with pediatric pharmacy references, it can be quite confusing.

However, part of the reason Paul was drawn to pediatric pharmacy was because of the challenges this field presents.

Not only must you calculate doses individually for each child, but you often need to research the best treatments and utilize your pharmaceutical knowledge and best judgment when suggesting a treatment option. “You’re not just doing something because it’s been done that way for the last 20

Feature Pharmacist (continued from page 14 ) Have you checked out the Arizona Pharmacy Alliance Career Center yet?

Paul Hellinga, PharmD Banner Desert Medical Center

years. You’re allowed to figure out how to do something.

And if something’s never been used in a child before, there’s a lot more thought that goes into that order.”

Working in the field of pediatrics does not come without other challenges as well. Paul finds that the most challenging parts of his job are the “really emergent situations. It’s those times when they (nurses and physicians) call over and they don’t know exactly what to give or how to give it. Those (times) can be a little frazzling because you can sense the urgency in their voice and it automatically bumps up your urgency and your heart starts to beat a little quicker.” But Paul believes that these situations are where you also get the most gratification.

“Not everything is going to end up happy. But at the end of the day you know you did everything you could, and you did it as quickly as you could, and you did it as safely as you could and they got their drugs on time.”

Outside of working at a pediatric hospital, Paul has already blazed his own personal path when he officially became an Ironman this past November in the Ford Ironman Arizona triathlon. One of his proudest accomplishments was successfully completing the 2.4 mile swim, 112 mile bike, and 26.2 mile run in less than 14 hours, one hour ahead of his 15-hour goal time.

So, what’s next for this pediatric pharmacist? As Banner Children’s Hospital grows with its new pediatric tower, Paul has visions of growing right along with it starting with taking the Board Certified Pharmacotherapy Specialist (BCPS) exam. This new hospital has the opportunity to be “on the leading edge” with pharmacists playing a larger role as a part of the entire medical team. More and more, pharmacists are going out on rounds and Paul would like to be a leader in that type of a model. “I really hope that we take advantage of the opportunity to be on the floor at the new children’s tower at Banner Children’s Hospital because then you wouldn’t have to wait for someone to call you.

You can make your recommendation right there. I’d love to see it go there.”

As your primary resource for professional development and services, the Arizona Pharmacy Alliance is excited to announce a brand new addition to our website. We recently launched 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 will give you great exposure to a wide array of candidates and exciting opportunities in our professional community. The revenue generated by this service will allow us to continue meeting our goals in best serving our members and advancing the pharmacy community in Arizona.

Looking to fill a position?

• 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?

• 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 and look for the Career Center badge on the Home page. From there follow the navigation tools. It’s that simple!

Please contact Janet Weigel, AzPA Marketing and Communications Director, marketing@azpharmacy.org, with any questions you may have about using the Career Center.

Arizona Journal of Pharmacy 15

Drug Information Questions Question: Is tetrabenazine safe and effective for use in Huntington disease chorea?

by Renee Holder, PharmD Candidate, and Stacy L. Haber, PharmD, Associate Professor, Midwestern University College of Pharmacy-Glendale

Answer: Huntington disease (HD) is an autosomal dominant neurodegenerative disorder that affects 2 to 10 people per 100,000.1,2 Patients typically present in middle age, and progressive neuronal loss ensues over the following 10 to 20 years.1-3 Diagnosis is most often made upon initial presentation with motor, psychiatric, and cognitive dysfunction, including the hallmark of chorea (uncontrolled, involuntary, dance-like movements), personality changes, and inability to learn new motor skills.1-4 Chorea severity is assessed using the Unified HD Rating Scale (UHDRS) maximal chorea score, which ranges from 0 (absent) to 4 (marked/prolonged).5 Although typically progressive, chorea may be transient, so periodic reevaluation of this symptom is warranted.1,6 HD chorea is routinely treated with antipsychotics (e.g., haloperidol, fluphenazine), benzodiazepines, reserpine, or amantadine; however, these medications are associated with a high incidence of intolerable side effects, such as extrapyramidal symptoms and sedation.1,4,6,7 Tetrabenazine is a reversible, selective inhibitor of vesicular monoamine transporter 2 (VMAT2). It has been used for various movement disorders, such as tardive dyskinesia and other choreas, and has been available internationally for over 50 years.6-9 Currently, 2 observational studies and 2 randomized, controlled trials have been published on the use of tetrabenazine in HD chorea; the 2 randomized, controlled trials are summarized below.6,7,10,11 In 2006, The Huntington Study Group7 conducted a 12-week trial of 84 ambulatory patients with stable HD. Patients were randomized to receive tetrabenazine 12.5 mg (n = 54) or placebo (n = 30) daily for 1 week, and doses were titrated to a maximum of 100 mg over 6 weeks. Doses remained stable for the final 5 weeks of the trial, unless a dose reduction was required due to intolerability. The primary endpoint was change in UHDRS chorea score from baseline. The Clinical Global Impression (CGI) Global Improvement Scale and changes in the UHDRS total movement score were assessed as secondary endpoints. Adverse events were also evaluated.

Both the tetrabenazine and placebo groups exhibited reduced UHDRS chorea scores from baseline (-5.0 ± 0.5 16 Arizona Journal of Pharmacy

and -1.5 ± 0.7, respectively), and the difference between the groups was statistically significant. The CGI Global Improvement Scale analysis indicated that both groups had better functioning at 12 weeks, but there was a statistically significant difference between the groups in favor of tetrabenazine. The UHDRS total motor score was reduced from baseline in both groups (-6.8 ± 1.1 for tetrabenazine, -3.5 ± 1.5 for placebo), but the difference between the groups was not statistically significant. In the tetrabenazine group, 4 patients experienced 5 serious adverse events that warranted withdrawal from the trial (suicide, intracerebral hemorrhage, restlessness, depressive symptoms with suicidal ideation, and breast cancer). Suicide was the only serious adverse event possibly attributed to tetrabenazine.

No patients in the placebo group experienced serious adverse events. Non-serious adverse events that occurred more often in the tetrabenazine group at various points during the trial included drowsiness or somnolence (31.5% of tetrabenazine versus 3.3% of placebo patients) and insomnia (25.9% of tetrabenazine versus none of placebo patients); however, no statistically significant differences were detected between the groups at week 12. The authors concluded that tetrabenazine is safe and effective for patients with HD chorea.

In 2008, Frank et al.6 conducted a 5-day trial of 30 patients with chronic tetrabenazine use for HD. The goals were to assess the antichoreic efficacy of tetrabenazine by observing the return of chorea upon drug withdrawal and to assess the safety of short-term tetrabenazine withdrawal following chronic use. Patients on stable doses of tetrabenazine (up to 150 mg for up to 4.5 years) were randomized to 1 of 3 groups: switch to placebo on day 1 (n = 12, withdrawal group), switch to placebo on day 3 (n = 12, partial-withdrawal group), or remain on tetrabenazine (n = 6, no-withdrawal group). The primary efficacy endpoint was the change in UHDRS chorea score from day 1 to day 3 between the withdrawal group and the partial- and no-withdrawal groups combined. The secondary efficacy endpoint was Total Functional Capacity (TFC), a component of the UHDRS. Adverse events were also evaluated. With both the withdrawal group and the partial- and no-withdrawal groups combined, the chorea scores increased from baseline (+5.3 and +3.0 units, respectively), but the difference between the groups was

Drug Information Questions (continued from page 16) not statistically significant. Values for changes in TFC were not reported, but described as not statistically significant.

Four patients in the withdrawal group and 1 patient in each of the remaining groups experienced 14 adverse events; the adverse events were not reported by group and were described as mild (e.g., anxiety, decreased appetite). Based on the greater reemergence of chorea in patients in the withdrawal group, the authors concluded that tetrabenazine is effective in reducing chorea.

Some considerations with tetrabenazine include dosing, adverse effects, and administration issues. The starting dose of tetrabenazine is 12.5 mg once daily, and it should be titrated up as needed to a maximum dose of 100 mg daily, given in divided doses.7-9 The dosing may be problematic for patients in late HD with cognitive impairment who may not be able to follow titration schedules without assistance from family members or caregivers.1 The most common adverse events are dose-limiting and include sedation, fatigue, insomnia, depression, akathisia, and nausea.7-9 The product labeling for tetrabenazine includes a boxed warning for the increased risk for depression and suicidality; however, suicidality is common in HD patients, with attempt rates estimated at over 25% of diagnosed patients.1,2,7-9 Tetrabenazine is metabolized primarily by hepatic CYP2D6 to active products, so use in patients with hepatic disease is contraindicated. Patients taking a daily dose of greater than 50 mg will require genetic testing of CYP2D6 expression to screen for poor metabolizers.8,9 Tetrabenazine (Xenazine®, by Ovation Pharmaceuticals) was approved by the FDA as an orphan drug in August of 2008. Upon the product launch in November of 2008, Ovation Pharmaceuticals began offering an assistance program for patients without insurance or with a high co-pay. Because tetrabenazine is classified as an orphan drug, sales are restricted to specialty pharmacies to ensure appropriate use and accurate postmarketing surveillance in the small patient population in which it is used. Only 2 trials have been published on tetrabenazine (one of 12 weeks in duration and one evaluating the safety of its withdrawal); thus, more studies are needed to determine its long-term effects. Currently, tetrabenazine is considered to be safe and effective for HD chorea, and patients who achieved relief during clinical trials or who are unable to tolerate routine treatments are most likely to benefit from its use.

References:

2. DISEASEDEX System [online database]. Huntington’s disease – chronic.

Greenwood Village, CO: Thomson Healthcare; 2008. MWU Library subscription (accessed 2008 Sept 30).

3. Zoghbi HY, Orr HT. Huntington disease: Genetics and pathogenesis.

UpToDate [online database]. Waltham, MA: UpToDate, Inc; 2008. MWU Library subscription (accessed 2008 Sept 30).

4. Aminoff MJ. Pharmacologic management of parkinsonism & other movement disorders. In: Katzung BG, ed. Basic & clinical pharmacology. 10th ed. New York: McGraw-Hill; 2007:445-56.

5. Kieburtz K, Penney JB, Como P et al. The unified Huntington’s disease rating scale: reliability and consistency. Mov Disord. 1996; 11:136-42.

6. Frank S, Ondo W, Fahn S et al. A study of chorea after tetrabenazine withdrawal in patients with Huntington disease. Clin Neuropharmacol. 2008; 31:127-33.

7. Marshall FJ, Walker F, Frank S et al. Tetrabenazine as antichorea therapy in Huntington disease: a randomized controlled trial. Neurology. 2006; 66:366-72.

8. Facts & Comparisons 4.0 [online database]. Tetrabenazine monograph.Wolters Kluwer Health, Inc; 2008. MWU Library subscription (accessed 2008 Sept 30).

9. Xenazine package insert. Deerfield, IL; Ovation Pharmaceuticals, Inc; 2008 Sept.

10. Kenney C, Hunter C, Davidson A et al. Short-term effects of tetrabenazine on chorea associated with Huntington’s disease. Mov Disord. 2007; 22:10-3.

11. Ondo WG, Tintner R, Thomas M et al. Tetrabenazine treatment for Huntington’s disease-associated chorea. Clin Neuropharmacol. 2002; 25:300-2.

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

1. Walker FO. Huntington’s disease. Lancet. 2007; 369:218-28.

Arizona Journal of Pharmacy 17

Alliance News PNA News Pharmacy Network of Arizona (PNA) is the for-profit corporation under the auspices of the Arizona Pharmacy Alliance. Its purpose is to evaluate and monitor therapeutic regimens, establish a positive outcome-based therapy, and provide essential information from these activities to health care providers for proper provision of quality health care.

PNA launched the first ever employer-based Medication Therapy Management Services (MTMS) program in Arizona in January 2008. And the network is expanding! Employers based in Lake Havasu City, St. John’s and Nogales have joined the network.

MTMS is specifically designed to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse effects, including adverse drug interactions.

AzPA offers an MTM Toolkit to help you implement an MTM component in your practice. Developed by the Pharmacy Society of Wisconsin, the kit contains tools for TM interventions, comprehensive medication reviews, patient medication lists, and much more. The kit as available online at www.pswi.org/membership/Toolkits.htm.

Pharmacists interested in creating an MTMS practice in their community should call the Arizona Pharmacy Alliance.

AzPA Calendar of Events March 14, 2009 Senior Care Academy Conference April 15, 2009 PTC Review Class Begins April 18, 2009 Immunization Certificate Program April 25, 2009 Health-System Academy Conference May 14, 2009 Managed Care Academy Conference July 9-12 2009 AzPA 5th Annual Meeting Our Patients, Our Profession Westin La Paloma, 3800 E. Sunrise Dr., Tucson, AZ September 2009 Community Pharmacy

Academy Conference October 2009 “Ask a Pharmacist” Public Television Broadcast Empowering pharmacy professionals

APF News

to provide optimal patient care

The Arizona Pharmacy Foundation (APF) is a non-profit, charitable foundation, 501 (c) 3 corporation.

• • • • • • • • • • • • • •

Activities sponsored by the APF include: Katy’s Kids - a pharmacy-education program for elementary school children PAPA - Pharmacists Assisting Pharmacists of Arizona rehabilitation program for pharmacists with substance abuse issues CPE programs PBS program Ask a Pharmacist Law on the Links AzPA Annual Meeting AzPA Leadership Conference AzPA website You can support the Arizona Pharmacy Foundation: Play in the Annual Meeting Golf Tournament Become a sponsor of the Annual Meeting Golf Tournament Participate in Legacy Endowment program Buy a brick on the national mall at the APhA national headquarters Support the AzPA Leadership Conference Make a donation! All proceeds are 100% deductible.

18 Arizona Journal of Pharmacy

Online Law Course

Pharmacy Law/Quality Assurance Classes offered monthly beginning the second Tuesday of the month. Visit the AzPA website for course agenda and registration information. www.azpharmacy.org

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Legislative Update FY 2009 reductions for ADHS programs:

2009 Arizona Legislative Session Budget Update: The Joint Legislative Budget Committee presented information http://www.azleg.gov/jlbc/fedstimulus021909. pdf on the federal stimulus plan/bailout package totaling over $4 billion (page 24 to 32 provides a programspecific overview of certain grant programs). The amount available in FY09 may allow the legislature to avoid a second special session to offset declining tax revenues.

Senate Appropriations Chairman Russell Pearce has said that the money for Medicaid and education can be used to fill the FY09 deficit and possibly pay off a portion of the K-12 rollover. Senator Pearce, as well as many other Republicans, have expressed opposition to any idea of a tax increase to help offset the FY10 budget shortfall.

News reports noted that Gov. Brewer was considering a plan to place a sales tax increase on the ballot. However, she has not publically made such a statement and has only noted that “everything needs to be on the table.” Senator Pearce believes that there are the votes in the House and the Senate to pass the equalization property tax repeal, but the longer they wait to move the legislation makes passage more difficult.

Below is an overview of how the Arizona share of the money could be used to help balance the budget in FY10, as well as a summary of the $4 billion in assistance: FY ‘10 Sample Budget Scenario and Use of Federal Assistance* January JLBC Baseline FY ‘10 shortfall Continue ‘09 Special Session changes Revised shortfall - Medicaid match savings - Stabilized fund backfill

$(3.0) B .6 (2.4) B 0.7 0.6

Remaining shortfall

$(1.1) B

*Only for display purposes - does not reflect a member or staff proposal.

Summary of $4 B in Assistance

‘09 1) Primary Medicaid Match $500 M

‘10

‘11*

$700- 775 M

400 M

Stabilization Funds

$1.0 B

2) Secondary - Limited Fiscal Relief

$1.5 B

* Dates of availability through FY ‘11 vary by program

Vaccines A reduction of $4,170,200, leaving $6,132,900. The State expects a shift of vaccines funding to federal funds through federally qualified health centers and counties.

AZ Statewide Immunization Information System A reduction of $95,000 leaving $45,600.

Diabetes Prevention and Control A reduction $36,437 leaving $100,000. It will reduce community grants for diabetes education.

Teratogen Reduction of $25,000 leaving $60,000. It will suspend the DHS contribution to U of A teratogen phone line regarding hazards to fetal development.

U of A poison Center Funding Reduction of $249,500 leaving 1,275,000 in the budget. It may require the center to suspend operations.

Poison Control Center Funding Reduction of $150,500 leaving $675,000 In the budget. It may require the center to suspend operations.

Medicare Part D Reduction of $335,808 leaving $802,600. It will reduce Medicare Part D copayment to RBHAs. Children’s Behavioral Health Programs Reduction of $531,108 leaving $8,851,800. It will reduce funding for children’s Behavioral Health state-only funded services. It will affect approximately 5,581 individuals.

Seriously Mentally Ill Non-Title XIX Reduction of $4,167,002 leaving $61,116,700. It will reduce funding for SMI state-only funded services. It will affect approximately 15,326 individuals.

Arnold V. Sarn Reduction of $1,350,000 leaving $27,500,000. It will reduce funding for SMI state-only funded services. It will affect approximately 15,326 individuals.

Mental Health Non-Title XIX Reduction of $1,500,000 leaving $11,135,400. It will reduce funding for general mental health state-only funded services. It will affect approximately 15,326 individuals.

Arizona Journal of Pharmacy 19

Features and Articles Traveling Somewhere Exotic This Year? Remember: Include Vaccines on Your Pre-Trip Checklist

by Amy Lai, PharmD, BCPS Ambulatory Care Clinical Pharmacist Phoenix VA HCS, AzPA Health-System Academy Have you ever arrived home from an amazing trip only to find a few days later that you brought back more “souvenirs” than that you bargained for at the tourist shops abroad? Almost everyone can relate to coming down with a cold or fever after a seemingly short flight to visit the relatives, or catching one from a co-worker or family member who did. Today, a person can fly practically anywhere around the world in just 36 hours… and so could the virus they are carrying. After all, 36 hours is shorter than the typical incubation time for most infectious diseases. Being a smart traveler these days is more about knowing how to pack a carry-on with everything you need to avoid the extra baggage fees, it also means taking the appropriate precautions to protect the health of yourself and your fellow travelers.

When traveling abroad, the scheduled immunizations recommended by the Center for Disease Control (CDC) should be up-to-date for each traveler. For routine immunizations, it is important to consider the minimum age at which an individual is at risk for developing a disease and if they would actually be able to mount an adequate immune response to a vaccine.

In general, the minimum age for vaccines in children is 6 weeks, with the exception of the Hepatitis B shot given at birth.

For toddlers and children, you may need to determine if a scheduled vaccination may be given earlier or how quickly a series may be given. While most diseases prevented by scheduled immunizations are relatively low in incidence in the United States, this may not be the case abroad.

The same consideration should be given with any additionally recommended or required vaccinations for your destination.

There are few vaccines that are required for travel beyond those scheduled. These include the yellow river vaccine for travel 20 Arizona Journal of Pharmacy

to certain countries in sub-Saharan Africa and tropical South America, as mandated by the International Health Regulations.

While this vaccine is not typically recommended for pregnant women, infants, immunocompromised, or elderly individuals, it may still be administered if risk is high. For those traveling to Mecca during Hajj, the Saudi Arabian government requires the meningococcal and poliovirus vaccinations. For these required vaccines, it is often required to show proof of immunization, such as a certificate of confirmation provided by the clinic that administered the vaccine. You can search for these clinics as well as other information on which areas require the yellow river vaccine on the CDC website.

While most other destinations may not have required vaccinations, you can consider those additionally recommended by the CDC. The risk of contracting a disease is typically greater the longer you stay in a high-risk area. Therefore, immunizations for an endemic area may not be as necessary if your trip is of limited duration. For example, the JeVax vaccine for the Japanese encephalitis is recommended only for those visiting rural areas in high-risk Asian countries for more than 30 days. The same is true for the Typhoid fever and Parathyroid Fever vaccines. For both the oral (Ty21a, Vivotif) and injectable (Typhim Vi, VirEPA) vaccines, neither is 100% effective and elderly people may also have a lower response rate. Other recommended vaccines by destination include: hepatitis A, hepatitis B, meningococcal disease, and rabies. The rabies vaccine is recommended for those who intend to work with animals in rural areas for over a month’s duration where the virus is endemic. Having the vaccination, however, does not prevent the need for treatment if exposed, but instead shortens the duration of the disease.

Lastly, keep in mind that for immune response to develop after a given immunization it may take upwards of a month’s time. So, try to make an appointment with you health care provider for travel vaccines at least 4-6 weeks before you depart. It is possible to administer more than one inactivated vaccine along with one activated vaccine at the same time, called “simultaneous

administration,” without compromising the patient’s ability to generate an adequate immune response to each. For those with more than one live-virus vaccine, they should be spaced at least 4 weeks apart, as the immune response might be impaired. If a second live-virus is administered less than 4 weeks after a first live-virus vaccine, the second should be re-administered at least 4 weeks later. There may be travelers who need a vaccine series in a span of time shorter than the recommended limited duration between doses. While not endorsed by the CDC nor approved by the FDA, some providers may elect to shorten the duration between doses with the idea that an accelerated schedule may provide greater protection than a single dose of a series.

It is unclear what level of protection will be provided when a full series is not completed. For patients or providers who seek the minimum age and minimum interval between dosages for a series, you may refer to the CDC website: http:// www.cdc.gov/travel/yellowBookCh1GenRecVaccination.aspx.

As health care providers now able to administer vaccinations, pharmacists will continue to be sought after for up-to-date immunization information and guidance by both health-care consumers as well as fellow providers. No matter where a pharmacist is in practice, the ability to provide information on unique immunizations for travel is an excellent opportunity to administer scheduled immunizations and booster shots along with travel vaccines that might otherwise be missed. This opportunity to actively participate in preventive care is one not to be missed by the ever-evolving pharmacy profession.

For an up-to-date list of available vaccines and immunoprophylaxis, visit the CDC website: http://wwwn.cdc.gov/travel/ contentVaccinations.aspx#aware

Features and Articles

What’s New in Pediatric Vaccines?

by Leslie Rodriguez, PharmD Cigna

Pentacel

Pentacel is the first pentavalent pediatric vaccine; meaning it is 5 vaccines in one!

Protection against: • Diphtheria • Tetanus • Pertussis • Poliovirus • Haemophilius influenza B Indicated Age Range: 6 weeks to 4 years of age Dosing Schedule: Four-dose series at 2,4,6 and 15-18 months of age.

Kinrix

Protection against: • Diptheria • Tetanus • Pertussis • Poliovirus Indicated Age Range: 4 through 6 years of age Dosing Schedule: Can be used for the 5th DTaP and the 4th dose in the IPV series if previous DTaP dose have been with Pediarix and/ Infanrix for the first 3 doses and Infanrix for the 4th dose.

True

Independence

is coming...

Rotarix

Protection against: • Rotavirus gastroenteritis caused by G1, G3, G4 and G9 strains Indicated Age Range: 6 to 24 weeks of age Dosing Schedule: Two-dose series given orally starting at 6 weeks of age and spaced at least 4 weeks.

Arizona Journal of Pharmacy 21

Features and Articles Pneumococcal Vaccine Review

by Kelly Hampton, PharmD

Pneumococcal Disease: Did you know?

Pneumococcal disease is a year round threat caused by the bacterium Streptococcus Pneumonia, and is one of the leading causes of vaccine preventable morbidity and mortality in the United States. There are over 90 serotypes with 23 serotypes being responsible for greater than 85% of disease. On average there are 20,000 deaths from pneumococcal disease every year in the United States.

Pneumococcal Vaccine: • NEW - ACIP recently changed the pneumococcal vaccine abbreviation on the Immunization Schedule from PPV to PPSV • Pneumovax®23 is an inactive capsular polysaccharide vaccine containing the 23 antigens most commonly implicated in pneumococcal disease Indications: • One dose for otherwise healthy people aged 65 years and older • One dose for people 2 years and older with chronic illness:

- Pulmonary (COPD, emphysema, asthma)

NEW Indication for asthmatics

- Cardiovascular (CHF, post MI, heart anomalies)

- Metabolic diseases (Diabetes, renal dysfunction)

- Immunosuppression (Hodgkin’s disease,

lymphoma, multiple myeloma, nephrotic

syndrome, asplenia, HIV infection, organ

transplant)

- Cochlear implants

22 Arizona Journal of Pharmacy

• One dose for people with the following risk factor:

- Cigarette smoking - NEW indication Revaccination: See Flow Chart • Revaccinate people aged 65 years and older who received their first dose more than 5 years earlier and at less than age 65.

• Revaccinate those with chronic diseases 5 years after initial dose.

• Only in exceptional cases such as renal dialysis patients will anyone receive more than two doses in a lifetime.

Contraindications: • Prior severe immediate hypersensitivity reaction.

Adverse Reactions: • Injection site tenderness, erythema, swelling and pain (30-50%) • Temperature < 102 ° F (<1%) • Urticaria, cellulitis, nausea, vomiting and anaphylaxis. (rare) Storage: • Store in a refrigerator at 2°C – 8°C ( 35°F – 46°F) Administration: • A 0.5ml dose may be administered intramuscularly in the deltoid muscle or subcutaneously in the posterior lateral upper arm • Use a 25G 5/8” needle for SQ delivery. Use a 25G needle of between 1” and 1½” for IM delivery depending on patient weight.

Features and Articles Vaccination Recommendations 2009 Update

by Julie Hernandez, RPh, PharmD In January 2009, the Centers for Disease Control updated its recommended vaccination schedules for children and adults.

According to the CDC’s MMWR, the changes from the previous children’s schedule are1: • Recommendations for rotavirus vaccines include changes for the maximum age for the first dose (14 weeks 6 days) and the maximum age for the final dose of the series (8 months 0 days). The rotavirus footnote also indicates that if RV1 (Rotarix®) is administered at ages 2 and 4 months, a dose at 6 months is not indicated.

• Routine annual influenza vaccination is recommended for all children aged 6 months through 18 years. Children aged younger than 9 years who are receiving influenza vaccine for the first time or who were vaccinated for the first time during the previous season but only received 1 dose should receive 2 doses of influenza vaccine at least 4 weeks apart.

Healthy nonpregnant persons aged 2 through 49 years may receive either live attenuated influenza vaccine or inactivated influenza vaccine.

• The minimum interval between tetanus and diphtheria toxoids (Td) and tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap) for persons aged 10 through 18 years is addressed. An interval less than 5 years may be used if pertussis immunity is needed.

• Information about the use of Haemophilus influenzae type b (Hib) conjugate vaccine among persons aged 5 years and older at increased risk for invasive Hib disease has been added. Use of Hib vaccine for these persons is not contraindicated.

• Catch-up vaccination with human papillomavirus (HPV) vaccine is clarified. Routine dosing intervals

should be used for series catch-up (i.e., the second and third doses should be administered 2 and 6 months after the first dose). The third dose should be given at least 24 weeks after the first dose.

• Abbreviations for rotavirus, pneumococcal polysaccharide and meningococcal polysaccharide vaccines have been changed.

View the complete articles online for a full list of references on the above recommendations, as well as detailed explanations for all the vaccines listed in the charts on page 24.

The CDC also has recommendations for vaccinations in teens and college students. Beginning at the checkup at age 11-12 or older, they should receive the Tdap and meningococcal (MCV4) if not completed earlier, as well as any unfinished in the Hepatitis B series, Polio series, MMR series, and a 2nd dose in the Varicella series if only one has been given previously. The other vaccine recommended for teens and college students is the HPV series (AKA the “cervical cancer vaccine”), so far recommended for females only.2 Changes to the adult vaccination recommendations are3: Format Changes (Figures 1 and 2) To make the figures easier to understand, several formatting changes were implemented to both the age groupbased schedule and the medical and other indications schedule. The changes include: 1. increasing the number of age groups; 2. deleting the hatched yellow bar for tetanus, diphtheria, pertussis (Td/Tdap) vaccine while adding explanatory text to the Td/Tdap bar; 3. simplifying the figures by removing schedule text from the vaccine bars; 4. revising the order of the vaccines to more appropriately group the vaccines, and 5. adding a legend box to clarify the meaning of blank spaces in the table.

•

•

•

•

•

indicate that health-care personnel are not at increased risk because of occupational exposure, but they should be vaccinated consistent with age-based recommendations. Also, text has been added to indicate that vaccination with HPV may begin at age 9 years.

The varicella footnote (#3) has language added to clarify that adults who previously received only 1 dose of vaccine should receive a second dose.

Asthma and cigarette smoking have been added as indications for pneumococcal polysaccharide vaccination (#7). Also, text has been added to clarify vaccine use in Alaska Natives and American Indians.

The Hepatitis A footnote (#9) has additional schedule information for the 4-dose combined hepatitis A/ hepatitis B vaccine.

The Hepatitis B footnote (#10) has additional schedule information for the 4-dose combined hepatitis A/ hepatitis B vaccine, and a clarification of schedule information for special formulation indications has been added.

The meningococcal vaccine footnote (#11) clarifies that the revaccination interval is 5 years.

All of the included charts are available in PDF to print from the CDC website, as well as catch-up recommendations.

These can all also be viewed and printed in Spanish.

References: 1) Centers for Disease Control and Prevention.

Recommended immunization schedules for persons aged 0 through 18 years---United States, 2009.

MMWR 2008; 57(51&52).

2) http://www.cdc.gov/vaccines/recs/schedules/teenschedule.htm 3) Centers for Disease Control and Prevention.

Recommended adult immunization schedule---United States, 2009. MMWR 2008; 57(53).

Footnote (Figures 1 and 2) • The human papillomavirus (HPV) footnote (#2) has language added to Arizona Journal of Pharmacy 23

Features and Articles

NOTE: The above recommendations must be read along with the footnotes on pages Q2--Q4 of this schedule.

NOTE: The above recommendations must be read along with the footnotes on pages Q2--Q4 of this

schedule. View the complete article for full explanations of recommendations on each vaccine as well

as recommendations for immunocompromised individuals.

24 Arizona Journal of Pharmacy

Features and Articles Patient Concern with Autism and Immunizations Remain By: Amanda McClue, PharmD candidate

Background For almost a decade, several hypotheses have been studied and debated in efforts to explain the cause of autism.

Arguably, no hypothesis has been as controversial or persistent as that of the relationship between vaccinations and autism. The vaccine concern as related to autism is two-fold involving vaccines that contain mercury, and specifically the MMR vaccine. The MMR vaccine has never contained mercury, but rather the vaccine itself has been questioned in regards to triggering autism.1, 2 Thimerosal in Vaccines Ethylmercury, also known as thimerosal, has been used as a preservative in vaccines since the 1930â&#x20AC;&#x2122;s. Prior to 1991, combined diphtheria and tetanus toxoids and whole-cell pertussis vaccine (DTP) was the only vaccine to contain thimerosal. That year Haemophilus influenzae type b (Hib) and Hepatitis B were recommended as scheduled childhood vaccines and also contained thimerosal.3 The FDA, in response to its Modernization Act of 1997, developed a list reporting the thimerosal content of all vaccines.3, 4 It was recognized in 1999 that six month old infants, receiving scheduled recommended vaccinations, were receiving an estimated cumulative amount of ethylmercury that exceeded the recommended level of methylmercury.

Methylmercury is the environmental form of mercury. 3 The biologic equivalence of thimerosal and methylmercury is uncertain. However, in 1999, the American Academy of Pediatrics and the U.S. Public Health Service suggested, as a precautionary measure, thimerosal be reduced or removed from vaccines.3, 5 In 2001, a thimerosal-free form of all routine childhood vaccinations became available.2 MMR Vaccine In addition to the concern of cumulative levels of mercury contributing to autism, it has also been suggested that MMR vaccine contributes to the

development of autism.6 In the early 1990â&#x20AC;&#x2122;s, a second dose of MMR vaccine was recommended as an addition to the childhood vaccination schedule.7 It was at this time that rates in autism began to trend upward.

A case series published in The Lancet was the first to connect the MMR vaccine to autism. In 1998, The Lancet published a case series that suggested the MMR vaccine may trigger a regressive form of autism. The researchers suggested an association between the MMR vaccine and a regression in developmental skills in children with gastrointestinal symptoms.8 The publication received much media attention and scrutiny from the scientific community. In 2004, The Lancet published a retraction by 10 of the 13 original authors. The retraction stated that insufficient data was available to conclude a causal connection between the MMR vaccine and autism, and insisted that a connection was presented only as a possible explanation.9 Vaccinations and the Link to Autism Recent autism rates are 3-4 times higher than they were 30 years ago, and have been rising since 1989.3,6 The Autism and Developmental Disabilities Monitoring (ADDM) Network for the Centers for Disease Control and Prevention (CDC) reported in 2007, approximately 1 in every 150 children is affected by Autism Spectrum Disorder (ASD).10 ADDM reports that the 2007 ASD estimates are higher than those reported in the 1990â&#x20AC;&#x2122;s.11 Additionally, studies in California, accessing the California Department of Developmental Services (DDS) database, have found that the prevalence of autism is increasing at a rate greater than all developmental disabilities.3 The rise in autism prevalence rates corresponded closely to the addition of mercury-containing vaccines and the introduction of the MMR vaccine. It is speculated that the rise in autism rates and vaccinations are related.1 Accordingly, it was hypothesized that the incidence of autism would decrease as a result of the reduction in mercury exposure in childhood vaccines. If indeed mercurycontaining vaccines have a causative relation with autism, the incidence of

autism would drastically decrease.3 Many studies and organizations have tried to determine the trend in autism rates since the removal of thimerosal in 2001. The relationship of the MMR vaccine and autism has also been addressed.

Most studies examining early exposure to mercury-containing vaccines do not support a causal association to autism.12 Studies have concluded that since the removal of mercury from vaccines, trends in the prevalence of autism have continued to increase. A study analyzing data submitted to the California DDS database from 1995 to 2007 did not show a decrease in autism, despite the removal of more than trace levels of thimerosal from most childhood vaccines. The study concluded that exposure to thimerosal during childhood is not a primary cause of autism.3 Many countries have banned the use of thimerosal in vaccines including the United Kingdom, Sweden, Denmark, Japan, and Canada.13 Some of these countries continue to report an increasing trend in the prevalence of autism. A study in Denmark found an increased rate in the incidence of autism despite removing thimerosal from routine childhood vaccines.3 Children who received vaccines containing no thimerosal in Quebec were found to have a greater incidence of autistic disorder than those children receiving vaccines with thimerosal.1 Any connection of the MMR vaccine contributing to autism has also been discounted. The nation of Japan withdrew the MMR vaccine and replaced it with single vaccinations for measles, mumps, and rubella. It has been proposed that the measles component of the MMR vaccine contributes to autism. These claims are based on the coinciding increase in autism rates and the introduction of the MMR vaccine.1 The country continued to see a rise in autism despite the removal of the vaccine, disproving any connection of the MMR vaccine to the development of autism.12 In 2004, a study by the Institute of Medicine Immunization Safety Review Committee concluded autism is not induced by mercury or the MMR vaccine.1 These studies do not support any connection between the MMR vaccine and autism.

Arizona Journal of Pharmacy 25

Features and Articles Patient Concern with Autism (continued from page 25) Patients and Parents Express Concern Despite the growing body of evidence disproving a relationship between vaccines and autism, a certain hesitancy remains in some patients and parents in regard to immunizations. From 1998 to 1999, the CDC’s National Immunization Information Hotline saw a 200% increase in the number of calls received about vaccine adverse events. In 2000, more than two-thirds of physicians reported a substantial increase in the number of parents expressing vaccine concerns over the previous year.14 Many healthcare professionals are faced with parents refusing vaccinations for their children, as concerns over the safety of vaccines remains. This presents an opportunity for pharmacists to provide education to patients.

The CDC reported in August 2008, 131 cases of measles have been documented from January to July of 2008.

Over the last seven years the average number of reported measles cases was 63 per year.15 Twice as many measles cases have been reported to the CDC already this year. However, 2008 has had the lowest percentage of imported measles cases since 1996.15 Fewer infections have been caused by exposure to the virus while individuals were in countries where measles remains endemic. Rather, more cases have been caused by transmission of measles from infected individuals once they return to the United States. Due to its highly contagious nature, measles is one of the first diseases to return when vaccination rates fall.15 This data would suggest that lower vaccination rates in communities has resulted in cluster outbreaks among unvaccinated individuals.

Pharmacists’ Role Pharmacists can play a vital role as immunization educators to patients and parents. Pharmacists can reassure parents that no substantiated link has been found between vaccinations and autism, and vaccinations are important to public health by decreasing the risk of disease outbreak. In an attempt to prevent the development of autism, parents are 26 Arizona Journal of Pharmacy

placing their children at risk of infection by diseases that are preventable when they choose not to immunize. Although autism is a growing health crisis that necessitates continued future research in areas of genetics and environmental factors, vaccinations have not been linked to autism development. The benefits of immunizations far outweigh their potential risks. Vaccinations are extremely effective in preventing what can be debilitating or fatal infections from highly contagious diseases, threatening public health.

Immunizations save over 3 million lives worldwide every year.16 By maintaining high vaccination levels, public health and safety will be ensured, in addition to the individual safety of the vaccinated child.

By taking advantage of opportunities to educate patients, pharmacists can be an influential authority in changing the public misconception about vaccination safety.

Reprinted with permission from the Iowa Journal of Pharmacy, November 2008 References 1. Fombonne, E. Thimerosal Disappears but Autism Remains. Arch Gen Psychiatry. 2008;65(1)15-16.

2. Autism-Vaccine Link: Evidence Doesn’t Dispel Doubts. Autism: Searching for Answers. WebMD. http://www.webmd.com/brain/ autism/searching-for-answers/vaccines-autism.01Aug08.

3. Schecter R, Grether J. Continuing Increases in Autism Reported to California’s Developmental Services System: Mercury in Retrograde.

Arch Gen Psychiatry. 2008;65(1):19-24.

4. Thimerosal in Vaccines. U.S. Food and Drug Administration. http:// www.fda.gov/CBER/vaccine/thimerosal.htm#pres. 26Aug08.

5. Offit P. Thimerosal and Vaccines- A Cautionary Tale. N Eng J Med. 2007;357(13):1278-1279.

6. Fombonne E. The Prevalence of Autism. JAMA. 2003;289(1):87-89.

7. Immunization Administration: A Certificate Program for Pharmacists. Iowa Pharmacy Association and The Collaborative Education Institute. Feb2008. p19.

8. Wakefield A, et al. Ileal-lymphoid-nodular Hyperplasia, Non-specific Colitis, and Pervasive Developmental Disorder in Children. The Lancet. 1998;351(9103):637-641.

9. Murch S, Anthony A, Casson D, et al. Retraction of an Interpretation. The Lancet. 2004;363(9411):750.

10 Prevalence of the Autism Spectrum Disorders in Multiple Areas of the United Sates, Surveillance years 2000 and 2002. Developmental Disabilities; Centers for Disease Control and Prevention. http://www. cdc.gov/ncbddd/dd/addmprevalence.htm.1Aug08.

11. Backer, H. California’s Law to Ban Thimerosal in Vaccines: Who Shapes Vaccine Policy? California Department of Health Services.

Powerpoint Presentation. http://cdc.confex.com/recording/cdc/ nic2005/pps/free/4db77adf5df9fff0d3caf5cafe28f496/paper8828_1. pps.17Aug08.

12. ‘No Link’ Between MMR and autism. BBC News. http://news.bbc. co.uk/2/hi/health/4311613.stm. 20Aug08.

13. Mercury and Vaccines (Thimerosal).Vaccine Safety- ConcernsMercury and Vaccines (Thimerosal). Centers for Disease Control and Prevention. http://www.cdc.gov/vaccinesafety/concerns/thimerosal. htm.1Aug08.

14. Colgrove J, Bayer R. Could it Happen Here? Vaccine Risk Controversies and the Specter of Derailment. Health Affairs.

2005;24(3):729-739.

15. Update: Measles--- United States, January-July 2008. MMWR Weekly. 57(33):893-896. 22Aug08.

16. Immunization Saves Lives. World Health Organization Regional Office for Europe. http://www.euro.who.int/vaccine/20080415_1.

19Aug08.

Scratching Out Varicella Virus and Herpes Zoster: A Look at Immunizations By: Rebecca Bell, PharmD candidate

Background Varicella, a herpes virus, is a highly contagious disease that pre-vaccination would have led to approximately 7090% secondary infections in susceptible household family members.1 Between 1990 and 1994, children between 1 and 4 years of age had the highest incidence of varicella cases at 39%, with children between 5 and 9 years old following closely behind at 38%.2 Since the varicella vaccine, Varivax, was introduced in the United States in 1995, rates of varicella have decreased by 71 to 84%.3 Prevaccination, the annual number of cases was estimated at the birth cohort, or about 4 million cases, since most patients were infected by adulthood.2 Since 1981, varicella has not been a reportable disease to the Centers for Disease Control and Prevention (CDC); therefore, little information is available regarding the current number of cases. Three areas of the country (Antelope Valley, CA; Travis County, TX; and West Philadelphia, PA) are still reporting varicella and the CDC is watching their reports, but this information does not help to fully understand national varicella trends or the impact of the varicella vaccine. Although adverse effects of the varicella virus are usually mild, it can reactivate in the form of herpes zoster, commonly known as shingles.

VARICELLA The varicella virus is introduced via the respiratory tract and conjuctiva where it replicates, then moves to other organs to further replicate and infect the host. Varicella is characterized by a rapidly progressing, pruritic, vesicular rash appearing about 14 to 16 days after exposure to the virus.1,2 The rash quickly changes from macular (red lesion) to papular (raised lesion) to vesicular lesions.2 Patients are contagious 48 hours prior to the breakout of the rash, during the vesicular phase and until all lesions have crusted over. The rash is the first symptom presenting in a child, while an adult case of varicella usually involves

Features and Articles Scratching Out Varicella (continued from page 26) fever and malaise for about 1-2 days before the rash starts. A healthy child may develop 200-500 lesions over 4-5 days that are commonly accompanied by a temperature up to 102° F for 2-3 days. 2 Adults and immunocompromised patients have more severe symptoms of varicella.

Immunity is typically life long after recovery from wild-type varicella.

Treatment involves symptomatic relief of itching and fever and prevention of secondary infections by bathing regularly and cutting patients’ nails. In severe cases involving children, immunocompromised patients, and adult patients, acyclovir may be given. Children 2 years of age and older should be prescribed 20 mg/ kg of acyclovir orally four times daily for five days. Adults and children over 40 kg should be prescribed 800 mg of acyclovir orally four times daily for five days.4 A study published in the New England Journal of Medicine in 1994 found a 2% risk of complications in maternal varicella infection within the first 20 weeks of pregnancy.5 Complications to the fetus include extremity hypoplasia, skin lesions and scars, and brain and eye damage.5 If the mother contracts chickenpox 5 days prior through 2 days after giving birth, there is a much higher risk of infecting the neonate and mortality is close to 30%.2 For this reason, it is important that females of child-bearing age are up-to-date with vaccinations prior to becoming pregnant.

HERPES ZOSTER After infection with varicella, the virus lies dormant in the nerves of the spinal cord and can reactivate later in life causing herpes zoster, or shingles. Decreased immune response and increased age are factors that increase the risk of developing shingles. From 2003 to 2005, an average of 1.1 million people per year developed herpes zoster or its complications; more than half of those were over age 60.6,7 The lifetime risk of developing shingles in patients with a history of varicella is about 20%.2 When the virus reactivates, it travels from the dorsal root ganglia, down the nerve, to skin supplied by this nerve called a dermatome. Varicella outbreaks primarily occur around thoracic dermatomes, leading to rashes around

the torso.8 There are usually only a few lesions, and they continue to form for about 3 to 5 days and last about 7 to 10 days.8 Similar to varicella, shingles changes from macular to papular to vesicular lesions, and it is associated with intense pain which precedes the lesions by 48 to 72 hours.2 A severe complication of shingles is post-herpetic neuralgia (PHN), where pain can last from months to years. Higher risks of developing PHN are associated with more severe rashes, more acute pain and age ≥ 60 years old.9 PHN arises from damage to the nerves that carry the virus.

PHN is described by a sharp, stabbing, burning pain that decreases a person’s quality of life.8 Typical treatment of shingles includes an antiviral, corticosteroid and analgesic to clear up lesions more quickly, decrease pain and prevent complications such as PHN. Antiviral medications used to treat herpes zoster should be given within 72 hours of an outbreak of shingles. Antiviral medications used include acyclovir 800 mg orally five times daily for 7 to 10 days, famciclovir 500 mg orally every eight hours for 7 days or valacyclovir 1 gm three times daily for 7 days.4 Prednisone can be used if given within 72 hours of a shingles outbreak.8 The prednisone dose is 60 mg daily on days 1-7, 30 mg daily on days 8-14 and 15 mg daily on days 1521.1 For mild to moderate pain associated with shingles, over-the-counter (OTC) analgesics such as ibuprofen, aspirin or acetaminophen may be used. Narcotics, typically 30 to 60 mg of codeine every 6 hours as needed, should be reserved for more severe cases of shingles.8 Gabapentin titrated up to 1800mg daily, divided three times daily and tricyclic antidepressants (TCAs) have also been used to treat the pain associated with severe shingles and PHN.4,8 Amitriptyline 25mg given within 48 hours of the onset of the rash has been shown to decrease pain by 50%.8 Other TCAs that may be used include nortriptyline, imipramine and desipramine.8 VACCINES Varivax & ProQuad The varicella vaccine is a live, attenuated viral vaccine that was first licensed in Japan and Korea in 1988.2

The strain was isolated from vesicular fluid of an otherwise healthy child by a doctor in Japan.2 There are two licensed varicella vaccines available for prevention of chicken pox in the United States.

These include Varivax, the single-antigen containing vaccine and ProQuad (or MMRV), which combines the measles, mumps and rubella vaccine with the varicella vaccine.

Varivax is recommended for patients 12 months and older and is administered subcutaneously.2 The Recommended Childhood Immunization Schedule recommends giving the first dose between 12 and 15 months and giving the second dose between 4 to 6 years. It is also recommended that the second dose be administered at the same time as the second MMR dose.10 Varicella and all other childhood immunizations can be administered on the same day as long as they are in separate sites and with separate syringes. If MMR and varicella are not given on the same day, 28 days should elapse between doses.2 If the live viruses are given within a 28 day period, there is concern of having an incomplete response to the second vaccine given.11 It is recommended that a child over 6 years old receives the second dose if they have not already received one.2 In children under 13 years of age, a minimum of three months should elapse between the first and second varicella dose; but if the second dose is given between 28 days and three months, the second dose does not need to be repeated.2 The varicella vaccine should also be given to children and adults over the age of 13 without confirmed evidence of varicella immunity.2 In most cases, a verbal account of whether the patient has had varicella is enough, but since a majority of adolescents and adults are seropositive for varicella, an antibody screening is warranted prior to receiving the vaccination.2 If the screening does come back seronegative, the first dose should be given shortly thereafter, with a second dose after 4 to 8 weeks.2 ProQuad is recommended for children between 12 months and 12 years, and it was licensed by the FDA in 2005.2 MMRV can be used for the first and second dose of each vaccine and should be separated by at least three months.

Arizona Journal of Pharmacy 27

Features and Articles Scratching Out Varicella (continued from page 27) The ACIP removed their preference of giving MMRV over separate injections of MMR and varicella in March 2008.12 A higher rate of fevers after administration of MMRV versus the separate injections was seen in prelicensure studies, which may increase the chance for febrile seizures. After further monitoring by the Vaccine Safety Datalink (VSD), a significant cluster of seizures was observed 7- 10 days after vaccination.12 The VSD was started in 1990 as a collaborative project between the CDC and eight different managed care organizations to monitor immunization safety. The VSD initiated a study to evaluate the risk by observing 43,353 children receiving MMRV and 314,599 receiving separate vaccinations.12 In the MMRV group there was a 9 in 10,000 chance of febrile seizure observed versus a 4 in 10,000 chance of febrile seizures in the MMR and varicella injections (p<0.0001).12 There is a lower risk of seizures with the second dose, as febrile seizures are less common in 4 to 6 year olds.12 The current ACIP recommendations from 2008 give no preference to Varivax or ProQuad.12 The most common side effects of the varicella vaccine are local reactions including redness, swelling and pain at the site of injection.2 According to the Centers for Disease Control, varicella-like rashes have also occurred within 2 to 3 weeks, with an average of 5 lesions.2 Children who have received the varicella vaccine are still at risk for developing herpes zoster but at a lesser extent than those who had wild-type varicella, and their cases are less severe.2 In 2005, the Journal of the American Medical Association (JAMA) published an article on the impact of the varicella vaccine. The data for the article was collected from 1994 through 2002 to include two years of pre-vaccination.13 The study observed hospitalizations and ambulatory visits with a primary diagnosis of varicella in patients less than 50 years old.13 Patients diagnosed with herpes zoster, a combination diagnosis of varicella with herpes zoster, and patients 28 Arizona Journal of Pharmacy

over 50 were excluded to focus only on the varicella virus. Hospitalizations due to varicella fell from 2.3 per 100,000 to 0.3 per 100,000, resulting in an 88% decrease. The rate of ambulatory visits also decreased from 215 per 100,000 to 89 per 100,000, a 59% decrease from 1994 to 2002.13 ZostavaxÂŽ In May 2006, Zostavax was approved by the FDA as the first and only herpes zoster vaccine. In May 2008, the CDC recommended the shingles vaccine be given to people 60 years and older, even if they have had an episode of shingles.14 Zostavax is given as a one-time dose subcutaneously, and it contains the same varicella zoster virus in Varivax but at a much higher concentration.2 Vaccination with Zostavax does not have any role in post-exposure prophylaxis of herpes zoster, as exposure to varicella virus and herpes zoster does not cause an outbreak of herpes zoster.2 Instead, varicellazoster immune globulin (VZIG) is given within 96 hours or prophylactic antiviral medications are given if outside the 96 hour window to patients at high risk of developing complications from exposure to herpes zoster or varicella.1 Local reactions, including redness, pain, swelling and itching, are the most common side effects.2 Headaches also occur in about 1 of 70 recipients of the vaccine.15 Evidence of vaccine efficacy was first published by the Shingles Prevention Study (Department of Veterans Affairs [VA] Cooperative Study No. 403) in the New England Journal of Medicine in 2005. A total of 38,546 patients over age 60 were randomly assigned to receive the vaccine or a placebo to test their hypothesis that the vaccine would decrease the incidence, severity or both of herpes zoster and post-herpetic neuralgia.6 The study found significant decreases in the burden of illness due to shingles (61.1%), incidence of shingles (51.3%), and incidence of post-herpetic neuralgia (66.5%) and the duration and severity of herpes zoster.6 The study also showed an even greater effect on older patients in decreasing the incidence and severity of herpes zoster.6

Contraindications of varicellacontaining vaccines Contraindications and precautions are similar for all varicella-containing vaccines, as they all contain the same varicella virus. As with all vaccines, patients that have had severe allergic reactions to any component of the vaccine should not receive a dose. The varicella vaccines do contain trace amounts of neomycin and hydrolyzed gelatin but no egg protein or preservatives.2 Patients who are immunosuppressed should avoid being immunized since the vaccines contain live varicella virus.

Patients who have been on chemotherapy or radiation therapy should not be given live vaccines within 90 days of treatment.11 If patients receive a live vaccine within 90 days of chemotherapy or radiation, there is a suboptimal response to the vaccine.11 Patients on every other day, low dose (< 2 mg/kg/day), topical, aerosolized or replacement corticosteroid therapy are not considered immunosuppressed.

Ideally, patients should discontinue immunosuppressive therapy one month prior to being vaccinated. Patients with a decreased immune response due to human immunodeficiency virus (HIV) or its complications should be evaluated by their physician for a risk versus benefits analysis before vaccine administration.2 Women who are pregnant or are planning to become pregnant should avoid vaccination with a varicella-containing vaccine. There have been no reports of adverse effects to the mother or fetus, but there also have been no studies on the effects of vaccination in pregnant women.

As mentioned earlier, there is a risk to the fetus if exposed to varicella therefore the ACIP recommends avoiding pregnancy for one month following vaccination.2

Patients with an acute illness should wait until the illness is resolved to avoid any complications associated with receiving a live virus.2 Storage of the vaccines

All varicella-containing vaccines must be stored at a temperature averaging 5Âş F (-15Âş C) to maintain potency.2 Most freezers are capable of storing the vaccine but small/dormitory type refrigerators are not allowed due to inconsistent

Obituaries Scratching Out Varicella (continued from page 28) temperatures.2 Diluent supplied with the vaccines must be kept at room temperature or in the refrigerator.2 Single-antigen varicella (Varivax) can be kept in the refrigerator for up to 72 hours prior to giving the dose, but Zostavax can not be stored at room temperature at any time.2 Billing for Zostavax® Exciting opportunities exist for pharmacists to administer immunizations in 49 out of 50 states and bill for the vaccination services through Medicare Part D, and, in some states, through private insurance companies. In Arizona, a prescription is required for pharmacists to vaccinate candidates for Zostavax. Starting on January 1, 2008, Medicare Prescription Drug Plans began covering the administration fees for vaccines covered under Part D, including Zostavax.16 Prior to that date, pharmacists had to bill Part D immunizations and administration fees separately to Medicare Part D and Medicare Part B, respectively.

Vaccines covered by Part D include all vaccines except influenza, pneumococcal, hepatitis B (in moderate and high risk patients) and where the vaccine is used for treatment of an injury or exposure to an infection.16 Conclusion

As with all infections, preventing their occurrence will decrease medical and emotional costs associated with the disease. Since the varicella vaccine has been introduced, hospitalizations and health care visits have decreased tremendously. With a large percentage of the population reaching 60 years and older, the incidence of shingles and its complications would likely continue to increase without the vaccination.

Pharmacists can play an active role in immunizations, not only through administration, but also by educating patients on the importance of vaccination.

Reprinted and revised with permission from the Iowa Journal of Pharmacy, November 2008

References

1. Harrison’s Principles of Internal Medicine. Varicella-Zoster Infections. http://www.accesspharmacy.com.proxy.lib.uiowa.edu/ content.aspx?aID=2871509 (Accessed 8/17/08) 2. Centers for Disease Control and Prevention. Varicella. Epidemiology and Prevention of Vaccine-Preventable Diseases. 10th ed. 2nd printing, Washington DC: Public Health Foundation, 2008:175-196.

3. Centers for Disease Control and Prevention. Varicella Active Surveillance Project. http://www.cdc.gov/vaccines/stats-surv/vasp/default.htm (Accessed 8/27/08).

4. Acyclovir, Famciclovir, Gabapentin, Valacyclovir. Clinical Pharmacology. Tampa, FL: Gold Standard. (Accessed 8/27/08 and 12/4/08).

5. Pastuszak AL, Levy M, Schick B, et al. Outcome after maternal varicella infection in the first 20 weeks of pregnancy. N Engl J Med. 1994;330:901-905.

6. Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005;352:2271-2284.

7. Soni A and Hill SC. Average annual health care use and expenses for shingles among the U.S. civilian noninstitutionalized population, 2003-2005. Statistical Brief #194. December 2007. http://www.meps. ahrq.gov/papers/st194/stat194.pdf (Accessed 8/26/08).

8. Roxas M. Herpes Zoster and Posterhepetic Neuralgia: Diagnosis and Therapeutic Considerations. Altern Med Rev. 2006;11(2):102-113.

9. Opstelten W, Zuithoff NPA, van Essen GA, et al. Predicting postherpetic neuralgia in elderly primary care patients with herpes zoster: prospective prognostic study. Pain. 2007;132:S52-S59.

10. Centers for Disease Control and Prevention. Recommended immunizing schedule for persons aged 0-6 years. http://www.cdc.gov/ vaccines/recs/schedules/downloads/child/2007/child-schedule-colorprint.pdf (Accessed 8/21/08).

11. Centers for Disease Control and Prevention. Recommendations of the Immunization Practices Advisory Committee General Recommendations on Immunizations. MMWR. 1983;32(1):1-8,13-7.

12. Centers for Disease Control and Prevention. Uptdate: recommendations from ACIP regarding administration of combination MMRV vaccine. MMWR. 2008;57(10):258-260.

13. Zhou F, Harpaz R, Jumaan AO, et al. Impact of varicella vaccination on health care utilization. JAMA. 2005;294:797-802.

14. Centers for Disease Control and Prevention. CDC recommends shingles vaccine. www.cdc.gov/media/pressrel/2008/r080515.htm (Accessed 7/31/08).

15. Centers for Disease Control and Prevention. Shingles VIS. http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-shingles.pdf (Accessed 8/21/08).

16. http://www.aetna.com/members/medicare/data/ VaccineCoverageChart.pdf. (Accessed 11-30-08).

Ask a Pharmacist Airing Statewide on PBS Stations October 2009!

Sponsorship and Volunteer Opportunities Available!

Contact the AzPA office (480) 838-3385

In Memoriam: Walter Gross Longtime resident of Tucson, Walter Gross, passed away peacefully December 10, 2008, at St. Joseph’s Hospital in Tucson, Arizona, after a long illness. Walter was born and raised in New York City, and served in the United States Army from 1954 to 1956. After serving in the military, he moved to Tucson, Arizona in 1956, and married Ina Zunin from 1957 to 1974, during which time he graduated from the University of Arizona, College of Pharmacy (1963).

As a pharmacist in Arizona, he had a lustrous career, working as a retail pharmacist along-side his father-inlaw, Louis Zunin who co-owned Casas Adobe Drug Store. He later worked as an inspector for the State Board of Pharmacy serving Tucson and the eastern area of the state. From 1977 to 1982, and was President of the Tucson Academy of Pharmacy, Walter left the board to start Sentry Wholesale Drug Company which was sold in 1982.

Afterwards, Walter and his nephew, Jack Strauss purchased Feig’s Kosher Foods. Walter is survived by his two children, Jason A. Gross, Pharm.D., living in Toronto, Canada, Jason’s wife, Germaine Gross, and their sons, Alexander, Tristan and Brandon and daughter, Jennifer A. Hasley, JD of Houston, Texas, Jennifer’s husband, Greg Hasley, JD, and their children Hunter and Katie.

Arizona Journal of Pharmacy 29

Features and Articles A Hole in One at AzPA MTM Summit

AzPA held its midyear meeting at the Resort Suites Scottsdale on January 30 & 31, 2009. More than 100 pharmacy professionals participated in the two-day event.

The theme of the meeting was that pharmacists will need to move from their role as dispensers to that of healthcare providers and that it is possible to be reimbursed for these services. The meeting featured national and local speakers who shared their experiences with MTM services and the significant impact pharmacy clinical services have on improving patient care and decreasing medical cost.

Friday’s program began with John Miall, Jr., Consultant for the APhA Foundation. He shared his experience with the Asheville Project and how it improved total aggregate healthcare costs - the bottom line for third-party payers. The Asheville Project had an innovative feature of inducing patient buy-in through elimination of co-payments on medications in exchange for an adherence contract. Participants at the meeting also learned about the “Diabetes Ten City Challenge,” which should have exciting results to publish in the next year.

Kevin Boesen, PharmD, Director for the Medication Management Center at the University of Arizona, made a presentation on the U of A’s Medication Management Center.

The program is unique in that it is directly contracted with 25 Medicare Part D providers thereby eliminating most billing and coding challenges that exist for reimbursement of MTM services.

Their MTM program targets the top seven chronic disease states, and he shared with the group individual success stories that resulted from their MTM interventions.

Other program speakers included Julie Kuhle, R.Ph., Pharmacy Manager of the Iowa Foundation for Medical Care, and member of the Pharmacy Quality Alliance (PQA). She discussed the need for setting quality treatment goals for MTM service.

Patty Kumbera, R.Ph., COO for Outcomes Pharmaceutical Healthcare, discussed how to minimize medication waste (i.e. patient non-adherence, inappropriate medication, etc.) through Targeted Intervention Programs (TIP®).

The second day of the program began with Lani Moss, RN, MN, AOCN, Clinical Educator for GlaxoSmithKline, who spoke about barriers for medication adherence and strategies to increase patient adherence. Rhonda Eustice, PharmD, CDE, and Sandra Leal, PharmD, CDE, discussed the innovative MTM services that they are providing in Arizona. Rhonda’s diabetes program is located in Show Low, Arizona, at the Navapache Regional Medical Center, and Sandra’s program is at the El Rio Health Center in Tucson, Arizona. Both programs have been a tremendous success in helping their patients learn how to take control of their diabetes. Meeting participants also learned about how they developed their business plans and marketing strategies for their service.

Michael Rupp, PhD, RPh, FAPhA, Professor at Midwestern College of Pharmacy-Glendale, concluded the summit with a discussion on improvements of the MTM coding infrastructure that will support a billing structure for cognitive services provided by pharmacists. He also shared how the current three code system limits the ability of pharmacists to accurately describe services provided and how the Pharmacist Services Technical Advisory Coalition (PSTAC) is working on new billing and coding techniques.

The summit was very informative and a great opportunity to network with professionals who are at the forefront in MTM. Thank you to our sponsors GlaxoSmithKline, Wyeth Pharmaceuticals, Cardinal Health, Walgreens and Bashas’.

l to r. Ken Bykowski, John Miall, APhA, and Bob Binder, GSK

Kevin Boesen, PharmD and Lyle Bootman, PhD, Dean-University of Arizona College of Pharmacy

30 Arizona Journal of Pharmacy

Presenters Sandra Leal, PharmD, and Rhonda Eustice, PharmD

Mary Lou Brubaker listens intently to the summit speakers.

Rx and the Law AND THE LAW

By Don R. McGuire Jr., 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.

NEGLIGENCE 101

In the past, this series has examined a number of legal and claims issues. Think back to your pharmacy law class in college.

How much do you remember about the elements of negligence?

What does a plaintiff have to prove in order to win a negligence case? Time for Negligence 101 class to begin.

The more common types of claims involving pharmacists are negligence claims. Negligence is one category of cases in the area of the law known as Torts. Negligence is defined as “the failure to exercise that degree of care which a person of ordinary prudence would exercise under the same circumstances.” As you might have guessed, negligence and neglect derive from the same root word. Negligence does not include reckless behavior or intentional behavior.

To win a negligence case, the plaintiff must prove four elements. They are; duty, breach of that duty, proximate cause, and harm. We will examine each of these elements in turn as they apply to pharmacy practice.

Duty is the requirement to behave in a certain manner for the benefit of another. Pharmacists do have certain duties to their patients. There is a long line of cases that indicate that a pharmacist has a duty to fill a patient’s prescription correctly. Previous to changes in pharmacy practice, this was the pharmacist’s only duty to their patients. Today, we have additional duties, such as patient counseling and drug regimen reviews. The courts in the various states have been slow to recognize these additions to the pharmacists’ duties. This results in differing case law from state to state. However, the pharmacist’s duties to their patients are not unlimited.

The pharmacist has to take only reasonable steps to prevent foreseeable harm. Therefore, it is not required to prevent all harm. If the plaintiff’s case involves a situation where the pharmacist did not have a duty to the plaintiff, then the case will fail.

The second element of a negligence case is whether a breach of the pharmacist’s duty to the patient has occurred. A duty can be breached in one of two ways. The required duty is not performed (nonfeasance) or the activity is performed, but it is incomplete or incorrectly done (malfeasance). This element most likely will require some proof of the standard of care. This involves the testimony of expert witnesses. The expert witness will draw on their own experience, laws and regulations, codes of ethics, and other such items to determine if the pharmacist

performed their required duties adequately. In cases where a prescription has been misfilled, this element is not hard to prove.

Case law is full of cases that state that a pharmacist must fill prescriptions correctly. If you don’t, that is a breach of duty.

However, in cases where it is alleged that the pharmacist failed to perform DUR or provide patient counseling, it can be more difficult. Many times you will have opposing testimony from experts, as well as from opposing testimony from parties. It is usually not clear-cut what the judge or the jury will decide when they are given conflicting testimony.

The third element that the patient must prove in order to prevail is that they were injured or harmed. In many cases, this is not too difficult. The patient became dizzy and fell, their blood sugar dropped precipitously, their blood pressure increases or decreases, or they suffered an allergic reaction.

Many states require a physical injury in order to make a claim for emotional injuries. The theory here is that claims for anxiety, stress, sleeplessness, etc. are more credible if they result from a bodily injury. Sometimes it is difficult to separate the symptoms complained of from the patient’s underlying pre-existing conditions. This leads us to the fourth element.

The injury that the patient suffered must have been proximately caused by the breach of duty. That is, if a prescription is misfilled, the injury suffered must be due to the misfill and not some other cause or underlying condition. For example, a person who experiences high blood pressure after taking an overdose of an antihypertensive drug would cause you to question if the misfill actually caused those symptoms.

This element becomes very important in cases where it is not clear if the patient actually took the drug in question, or that the symptoms could be caused by some other factor. Again, this is an area where the use of expert witnesses is very important. There is also another concept under this element. It is called superceding or interceding cause. Suppose that a patient had been taking the wrong medication for a couple of days when she is involved in a car accident. The impact breaks her leg and requires surgery to repair the bone. Obviously, this injury is not the result of the misfill and would not be proximately caused by it. This injury would not be compensable under the misfill claim.

In summary, for a patient to prevail in a negligence claim against a pharmacist, the patient must prove the four elements of negligence. They are duty, breach of that duty, proximate cause, and harm. If they fail to prove even one of the elements, then there will be no monetary damages awarded to them. However, in cases involving the misfiling of potent medications, such as methotrexate or warfarin, this burden of proof is not a huge obstacle to overcome. © Don R. McGuire Jr., R.Ph., J.D., is General Counsel 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 policies and procedures of their employers and insurance companies, and act accordingly.

Arizona Journal of Pharmacy 31

New Standards for Continuing Pharmacy Education The Accreditation Council for Pharmacy Education (ACPE) Board of Directors approved updated policies and procedures for the new Standards for Continuing Education. These new standards went into effect January 1, 2009. The new policies and procedures contain seven new sections that apply to providers’ CPE overall program and individual CPE activities. Most new standards will be transparent to participants that attend AzPA activities. The most significant change, and the one that will be apparent to participants of all ACPE-accredited programs in 2009, is the new Policy 2.0 CPE Activities. Continuing Pharmacy Education (CPE) activities will be categorized into three types: knowledge, application, and practice. The CPE activity type(s) conducted should be appropriate to meet the identified pharmacist and/or pharmacy technician needs.

Beginning January 1, 2009, pharmacists and pharmacy technicians should look for all ACPE-accredited programs to identify the activity type for all live and home-study programs.

The outline below will help you identify the best combination of CPE activity types to meet your learning, professional development and practice needs.

KNOWLEDGE-BASED: These CPE activities are primarily constructed to transmit knowledge (facts). The facts must be based on evidence as accepted in the literature by the health care professions. Minimum amount of credit awarded: 15 minutes (.025 contact hours).

APPLICATION-BASED: These CPE activities are primarily constructed to apply the information learned in the time frame allotted. The information must be based on evidence as accepted in the literature by health care professionals. Minimum amount of credit awarded: 60 minutes (1.0 contact hour).

PRACTICE-BASED: (Previously named Certificate Programs in Pharmacy) These CPE activities are primarily constructed to instill, expand, or enhance practice competencies through the systematic achievement of specified knowledge, skills, attitudes, and performance behaviors. The information within the practice-based CPE activity must be based on evidence as accepted in the literature by the health care professions. The formats of these CPE activities include a didactic component and a practice experience component. The provider should employ an instructional design that is rationally sequenced, curricular-based, and supportive of achievement of the stated professional competencies. Minimum credit awarded: 15 contact hours.

Please contact Kathy Harty, AzPA Continuing Education Director at azpa@azpharmacy.org or 480 838-3385 for additional information about the new standards or any of AzPA’s education programs.

What’s in an ACPE Number?

The ACPE Universal Program (UPN), often referred to as the “ACPE Number”, is an identification number assigned to each CPE activity developed and sponsored by an ACPE-accredited provider.

For example, UPN #100-000-09-013-L01-P includes key pieces of information about a specific AzPA CPE activity.

This specific UPN is a 2009 AzPA activity, program number 13. It is a live activity on a Disease State Management/Drug Therapy topic exclusively for pharmacists. There is no cosponsor.Please refer to the following tables to help you understand UPNs (ACPE numbers).

Provider Number: Identification number of the provider responsible for issuing statements of credit and updating the ACPE activity database. 100 = Arizona Pharmacy Alliance; 000 = no cosponsors; 999 = cosponsored by another ACPE provider.

Format Designators: L = live activities H = home study and other mediated activities C = activities that contain both live and home study or mediated components.

Topic Designator: 01 = Disease State Management/Drug Therapy 02 = AIDS Therapy 03 = Law (related to pharmacy practice) 04 = General Pharmacy 05 = Patient Safety 32 Arizona Journal of Pharmacy

Target Audience Designator:

P = exclusively for pharmacists T = exclusively for pharmacy technicians

Continuing Education continuing education for pharmacists Volume XXVI, No. 7

Autism and Its Treatment:

A Primer for Pharmacists

Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio and J. Richard Wuest, R.Ph., PharmD, Professor Emeritus, University of Cincinnati, Cincinnati, Ohio

Goal. The goal of this lesson is to explain autism with focus on its pathogenesis, clinical characteristics and confirmation, and treatment.

Objectives. At the conclusion of this lesson, successful participants should be able to: 1. recognize historical events concerning autism, and differentiate each component of the autism spectrum disorders from one another; 2. select important principles that characterize autism and the principles that govern its clinical confirmation and management; and 3. identify specific nonpharmacologic and pharmacologic measures that are reported to modify signs and symptoms of autism.

Autism (autistic disorder) is a complex, chronic and serious neurodevelopmental disorder that affects normal functioning of the brain, impacting development in the areas of social interaction and communication skills. The most common of the pervasive developmental disorders, autism affects an estimated one in 150 births in the United States. With the number growing at a startling rate of 10 to 17 percent per year, its prevalence could reach four million Americans within a decade. Occurring in all racial, ethnic and socioeconomic groups, autism is four times more likely to occur in males than in females. Additional information on autism can be found in the online resources listed in Table 1.

Gossel

Wuest

Background

In 1943, child psychiatrist Leo Kanner of the Johns Hopkins Hospital published the first description of “autistic disturbances of affective contact.” Kanner thus introduced the term infantile autism, or autism into the English language, which defined three symptom patterns: (1) abnormal development of social reciprocity; (2) failure to use language for communication; and (3) desire for sameness, as seen in repetitive rituals or intense circumscribed interests – symptoms that were later termed Kanner’s triad.

About this same time, Austrian pediatrician Hans Asperger, based on his study of 400 children, described a milder form of the disorder that became known as Asperger’s Disorder (Asperger Syndrome).

Autism is listed in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR), the primary diagnostic reference for mental health professionals in the United States. It is one of the five pervasive developmental disorders (PDDs), more commonly referred to as autism spectrum disorders (ASDs). Each disorder is characterized by varying degrees of impairment in social interactions, communication skills and restricted, repetitive and stereotyped patterns of behavior. (Table 2) It is not uncommon for more than one of these disorders to coexist in the same family.

Table 1 Representative sources for information on autism The American Academy of Pediatrics

www.aap.org

The Autism Society of America

www.autism-society.org

Autism Speaks, Inc.

www.autismspeaks.org

First Signs, Inc.

www.firstsigns.org

The Organization for Autism Research

www.researchautism.org

National Library of Medicine and the National Institutes of Health

www.nlm.nih.gov/medlineplus/print/ autism.html

National Institute of Mental Health

www.nimh.nih.gov

National Institute of Child Health and Human Development

www.nichd.nih.gov

1

Arizona Journal of Pharmacy 33

Continuing Education (continued from page 33) Table 2

Major characteristics of pervasive developmental disorders Disorder

Age at onset (months)

Major characteristics

AD

<36

social and communication skills impairment; stereotyped, repetitive/restrictive behavior and interests

PDD-NOS

variable

symptoms not meeting other diagnoses; frequently a milder form of autism; also known as atypical autism

Asperger’s disorder

>36

impaired social interactions and restricted interests; delay in motor skills; preservation of early language skills; limited conversational abilities

CDD

>24

normal early development followed by deterioration in social skills, language, behavior, bowel/bladder control and play

Rett syndrome

5-30

progressive developmental disorder with normal early infancy, followed by loss of fine and gross motor skills, language skills, interests, and social interactions; appearance of characteristic hand-wringing movement and muscle-wasting

AD = autistic disorder; PDD-NOS = pervasive developmental disorder-not otherwise specified; CDD = childhood disintegrative disorder Adapted from Stachnik JM, Nunn-Thompson C. Ann Pharmacother. 2007.41;626-634

Pathogenesis

Although there is no known single cause for autism, it is generally accepted that it follows some abnormality in brain structure or function. Brain scans reveal differences in the shape and structure of the brain in children with autism compared to those without.

Research is ongoing in investigating possible links between heredity, genetics and medical pathology. There appears to be a pattern of autism or related neurological disabilities in many families.

Medical researchers have identified a variation in a gene that may increase the risk for developing autism, especially when the variant is inherited from mothers rather than fathers. The gene, CNTNAP2, encodes a protein that facilitates communication between brain cells through chemical signals and appears to play a role in brain cell development. Inheriting the gene variant does not imply that a child will inevitably develop autism; rather, it means that a

child may be more vulnerable to developing the disease.

Other research suggests that a cluster of unstable genes may interfere with normal brain development, resulting in autism. Pregnancy or delivery problems and environmental factors (e.g., viral infections, metabolic imbalances and exposure to environmental chemicals during pregnancy) are also being studied.

Is there a causative role for vaccines? Many studies over the years have looked at the possibility that vaccines are a cause of autism.

Autistic characteristics have been described in some children within a few weeks of receiving a vaccine.

Until 1999, vaccines intended for infants to protect them against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), and hepatitis B contained thimerosal (a mercury-based preservative). Today, with exception of some influenza vaccines, none of the preparations used in the United States to protect preschool2

aged children against 12 infectious diseases contain thimerosal. The MMR (measles, mumps, rubella) vaccine, varicella (chickenpox), inactivated polio, and pneumococcal conjugate vaccines do not and never did contain thimerosal.

The U.S. Institute of Medicine (IOM) conducted a thorough review on the issue of identifying a possible link between thimerosal and autism. The IOM report, released in May 2004, stated that there was no link. At this time, there is no conclusive scientific evidence that any component of a vaccine or combination of vaccines causes autism.

Characteristics

Characteristics (i.e., signs/symptoms) of autism may be evident as early as four months of age.

In a few cases, after developing normally, a child regresses into autism. Clinically, neurological abnormalities usually dominate the symptomatology. At the same time, it is emphatically true that intelligence diversity is a major aspect of autism. It has been reported that while approximately three-fourths of patients with autism may be mentally retarded, the IQs of persons with autism may range from severe impairment to intellectually gifted.

Impaired social interaction is the hallmark feature of autism.

Table 3 lists common characteristics.

Parents are usually the first to notice symptoms of autism. Early in infancy, a baby with autism may be unresponsive to people or focus intently on one item to the exclusion of others for long periods of time. A child with autism may appear to develop normally for a period, only to withdraw and become indifferent to social interaction.

They may fail to respond to their name and often avoid eye contact with other people. They have difficulty interpreting what others are feeling because they don’t understand social cues, such as tone of voice or facial expressions, and they don’t watch other people’s faces for clues about appropri-

Continuing Education (continued from page 34) ate behavior. They lack empathy toward others.

Many children with autism engage in repetitive movements such as rocking their head or torso and twirling their hair between fingers, or in self-abusive behavior such as biting or head-banging. They also tend to start vocalizing later than children without autism. Some speak in a high-pitched, or flat, robot-like voice, or in “sing-song” fashion (regular or monotonous rising and falling intonation) about a narrow range of favorite topics.

Many children with autism have an increased threshold to pain, but are abnormally sensitive to sound, touch, or other sensory stimulation. These reactions may contribute to behavioral symptoms such as resistance to being cuddled or hugged.

Children with autism appear to be at higher risk for certain comorbid (concomitant but unrelated) conditions, including fragile X syndrome (the most common inherited form of mental retardation) and tuberous sclerosis (a rare, genetic disorder that causes benign tumor growth in the brain and other vital organs), as well as epileptic seizures, Tourette syndrome (characterized by presence of multiple physical [motor] tics and at least one vocal [phonic] tic), learning disabilities, and attention deficit disorder. For reasons that remain unclear, about one-third of children with autism develop epilepsy by the time they reach adulthood. While persons with schizophrenia may show autisticlike behavior, symptoms usually do not appear until their late teens or early adulthood. Most persons with schizophrenia also experience hallucinations and delusions, neither of which are associated with autism.

Autism symptoms often improve with treatment and with age. Some autistic children can lead normal or near-normal lives as they grow older. Children whose language skills regress early in life, usually before three years of age, appear to be at risk of developing

epilepsy or seizure-like brain activity. Some children with autism may become depressed or experience behavioral problems during adolescence.

Persons with autism score consistently low on instruments that measure life skills. The life outcomes of autistic adults range from complete dependence on others to (rarely) successful employment.

People with autism typically die early, with death most often coming from seizures, nervous system dysfunction, drowning or suffocation (at a rate exceeding three times the general population). As mentioned earlier, epilepsy occurs in at least one-third of persons with autism. The death rate due to epilepsy is approximately 24 times higher than that of epileptic patients without autism.

Confirmation of Autism

There is no medical test for autism.

Physicians rely on a core group of behaviors to diagnose autism: • difficulty in making friends with peers; • inability to initiate or sustain conversation with others; • impairment or absence of imaginative and social interaction; • unusual, stereotyped or repetitive use of language; • patterns of interest that are abnormal in intensity or focus; • preoccupation with a particular object or subject; and • rigid adherence to established routines or rituals.

While some screening instruments rely solely on parental (or caregiver’s) observations, others rely on a combination of notes from both parent and physician. Since autism is a complex disorder, a comprehensive evaluation requires a multidisciplinary team including a neurologist, psychiatrist, psychologist, speech therapist and other professionals who have experience in diagnosing children with ASDs. Team members will conduct a thorough neurological assessment and in-depth cognitive and language testing.

Autism can often be detected as 3

Table 3 Common characteristics of persons with autism A child or adult with autism might: • not play “pretend” games • not look at objects when another person points at them • not have an interest in others • avoid eye contact • want to be alone • have trouble understanding other people’s feelings or talking about their own feelings • prefer not to be held or cuddled • appear to be unaware when other people talk to them but respond to other sounds • be very interested in people, but not know how to relate to them • repeat or echo words or phrases • have trouble expressing their needs using words or motions • repeat actions over and over • have trouble adapting to a changing routine • have unusual reactions to the way things smell, taste, look, feel or sound • lose skills they once mastered Adapted from www.cdc.gov/ncbddd/ autism/actearly/autism.html

early as 18 months. Increases in the number of autism cases in the United States may be the result of improved diagnosis and changes in diagnostic criteria.

Differential Diagnosis. Children with some symptoms suggestive of autism, but neither qualitatively nor quantitatively sufficient to permit a diagnosis of classical autism, may be diagnosed with pervasive developmental disordernot otherwise specified (PDD-NOS) (Table 2). Children with autistic behaviors whose language skills are well developed may be diagnosed with Asperger’s disorder.

Children who develop normally, and then suddenly deteriorate between three and 10 years of age and show marked autistic behaviors, may be diagnosed with childhood disintegrative disorder (CDD).

Girls with autistic symptoms may be suffering from Rett syndrome, a gender-linked genetic disorder characterized by social withdrawal,

Continuing Education (continued from page 35) regressed language skills and hand wringing.

Treatment

Although treatment has improved greatly over the past several decades, there is neither a cure for autism nor single approach to therapy. The primary goals are to minimize the core features and associated deficits, maximize functional independence and quality of life, and alleviate family distress.

Options may include behavioral and communication measures, drug therapies and complementary approaches.

Behavioral and Communication Measures. Numerous programs target the range of behavioral, social and language difficulties characteristic of autism.

Some focus on reducing problem behaviors and teaching new skills.

Others focus on teaching children how to communicate more effectively with other people or how to act appropriately in social situations.

Drug Therapies. At present, there is no medication that directly improves the core signs of autism.

However, some can help control individual symptoms. Agents most commonly employed in autism include antidepressants (especially SSRIs), used in 20 to 25 percent of patients; neuroleptics (especially second-generation antipsychotics), 10 to 15 percent; stimulants, 10 to 15 percent; alpha agonists, 10 percent; and anticonvulsants, 5 to 10 percent.

Risperidone. The FDA approved risperidone (Risperdal) for the symptomatic treatment of irritability in autistic children and adolescents. The targeted behaviors under the general heading of irritability include aggression, deliberate self-injury, temper tantrums and quickly changing moods.

No restrictions on prescribing or use in autism have been put into place to-date.

Risperidone’s effectiveness in the symptomatic treatment of irritability associated with pediatric autistic disorders was established

in two eight-week placebo-controlled trials in 156 patients aged five to 16 years of age. Outcomes demonstrated that children on risperidone achieved significantly improved scores for specific behavioral symptoms of autism compared to children on placebo. The most common side effects included drowsiness, constipation, fatigue and weight gain.

While efficacy has been demonstrated, concern remains about the misuse potential of risperidone and other antipsychotic drugs as a form of long-term chemical sedation, particularly with the most intellectually disabled children who may be the most likely to experience adverse drug effects.

The overwhelming view, however, is that if antipsychotic drugs are used appropriately, they can have a positive role in the management of aggression associated with autism.

Complementary Approaches. In the absence of specific medical interventions for autism, parents and some healthcare professionals may choose complementary (i.e., alternative) therapies, such as art or music therapy; dietary restrictions including the elimination of gluten, sugar, chocolate, preservatives and food coloring; vitamin and mineral supplements; herbal remedies; or sensory integration, which focuses on reducing a child’s hypersensitivity to touch or sound.

Almost one-third of autistic children regularly receive a complementary therapy. Various surveys indicate that only 36 to 62 percent of caregivers who treated their autistic children with complementary therapies had informed the child’s primary care physician.

Parents and caregivers should be encouraged to seek additional information when they encounter claims such as: • treatments based on overly simplified scientific theories, and those supported primarily by case reports or anecdotal data rather than carefully designed studies; • therapies claimed to be effective for multiple different, unrelated conditions or symptoms; 4

• claims that children will respond dramatically and some will be cured; and • treatments that are said to have no potential or reported adverse effects.

Early Treatment. Individuals with autism won’t outgrow it, but they can learn to function within the confines of the disorder, especially if treatment begins early. Early intervention is defined as treatment provided to children from birth to age three years. Research has clearly shown that early treatment, which consists of intensive, individualized behavioral interventions, can have a dramatic impact on reducing the symptoms of autism. Sadly, it is estimated that only 50 percent of autistic children are diagnosed before kindergarten.

Summary and Conclusions

Autism is a lifelong neurobiologic disorder that adversely affects quality of life. Early diagnosis of autism is often elusive. Its imprint on afflicted young people is so unique that the course of the disorder is difficult to predict in individual patients. In view of anticipated patterns of earlier identification and more proactive treatment of autism in years to come, the burden of autism on the health care system will continue to increase.

The content of this lesson was developed by the Ohio Pharmacists Foundation, UPN: 129-000-08-007H01-P. Participants should not seek credit for duplicate content.

continuing education for pharmacists Continuing Education Volume XXVI, No. 2

Challenges in Pharmacy Practice:

Interventions to Minimize Medication/Dispensing Errors and Maximize Patient Safety Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio and J. Richard Wuest, R.Ph., PharmD, Professor Emeritus, University of Cincinnati, Cincinnati, Ohio

Goal. The goal of this lesson is to discuss specific interventions to minimize medication and dispensing errors and maximize patient safety.

Objectives. At the conclusion of

this lesson, successful participants should be able to: 1. recognize the health and economic impact of medical errors to Americans; 2. identify specific interventions that are designed to reduce medication and dispensing errors in pharmacy practice; and 3. recognize specific strategies for pharmacists and patients to promote an error-free pharmacy practice and thus maximize patient safety.

Background The Institute of Medicine (IOM) released a book-length report in 999, which estimated that 44,000 to 98,000 deaths in the United States each year were due to medical errors. The report noted that because of the high rate of medical errors, Americans may be burdened with annual expenditures totaling $ 7 billion to $29 billion annually.

Medical Errors Medical errors may involve the diagnosis, management, ordering, and carrying out of orders; prescriptions and other medical care

Gossel

Wuest

by physicians, nurses, pharmacists, and other staff; or mistakes by patients or caregivers. It is estimated that from 3 to 12 percent of all prescriptions filled in community pharmacies involve dispensing errors by pharmacy staff. One study estimated that of the three billion prescriptions filled each year nationwide, 5 .5 million dispensing errors occur. Drug-related errors in hospitals occur in 3 to nearly 7 percent of inpatients, with a rate reported to be between 3.23 percent and 16.9 percent for inpatient drug orders.

Communication Factors Efforts are underway to improve communications between prescribers and pharmacists in order to reduce the potential for dispensing errors. Electronic prescribing (e-prescribing) involves electronic transmission of prescription information using computers and handheld PDAs (personal digital assistants). With a PDA, a prescriber can transmit a prescription

from any location to a patient’s pharmacy via a wireless Internet connection. This technology could potentially replace handwritten prescriptions, thus reducing dispensing errors due to illegible handwriting. E-prescribing can also aid the prescriber’s selection of appropriate drug therapy by checking the patient’s medical record for allergies, interactions, contraindications, duplicate therapy, as well as the drugs covered in the patient’s insurance plan.

Chart documentation can also be generated concomitantly, with appropriate information printed on an adhesive-backed label that can be affixed to the patient’s medical record.

It is thought that e-prescribing can potentially reduce the error rate by more than half, and save the federal government $26 billion in health care outlays over the next 10 years. Eliminating sources of error that are responsible for adverse events, along with checking patient eligibility, would assure the cost savings. The Pharmaceutical Care Management Association, which represents pharmacy benefits managers, has called for all prescribers and pharmacists to gear up for full use of e-prescribing by 2010.

New technology comes, however, with obstacles that must be overcome before e-prescribing will be universally accepted. Prescribers and pharmacists must familiarize themselves with the technology and be comfortable using it.

Arizona Journal of Pharmacy 37

Continuing Education (continued from page 37) Hardware/software to support the system is costly. Health professionals need to commit the time to learn a new system. Regulations at state and national levels must be enacted to accommodate the new system universally and permit exchange of medical information that will ensure patient confidentiality.

E-prescribing can also create new types of errors when the physician selects the wrong drug, dosage regimen, etc., on the PDA. It is reported that, at present, fewer than 20 percent of prescribers use e-prescribing.

Product/Drug Names Pharmaceutical manufacturers often design product packaging and labeling (“trade dress”) to be recognized across their product line.

However, this similarity in appearance of packages can contribute to serious, and occasionally fatal, drug errors.

Look-alike/Sound-alike Drug Names. Similarity between the spelling or pronunciation of drug names is responsible for approximately 7 to 15 percent of medication errors reported to the U.S.P. (United States Pharmacopeia). In the past, drug manufacturers have changed the brand names of their products to help prevent mix-ups from names that looked or sounded alike. For example, Levoxine became Levoxyl (levothyroxine) to help guard against confusion with Lanoxin (digoxin). Confusion between Lasix (furosemide) and Losec (omeprazole) prompted a name change so that Losec became Prilosec. The generic name of the positive inotropic agent, amrinone, was changed to inamrinone to help prevent confusion with amiodarone.

New procedures are now in place for choosing brand names, and manufacturers must demonstrate that there are no safety concerns with selected brand names before they are approved. As a result, some proposed product names have been changed before new drugs were released to the market.

The brand name Celebra, originally assigned to the COX-2 inhibitor celecoxib, was changed to Celebrex; and the name Zeldox for the atypical antipsychotic ziprasidone was changed to Geodon. FDA discourages assignment of new brand names for extensions of existing products (e.g., Sarafem and Prozac – both containing fluoxetine, Zyban and Wellbutrin SR – both containing bupropion) because patients could receive the same active ingredient from multiple prescribed drugs.

Pharmacists can visit www.ismp. org/Tools/confuseddrugnames.pdf for a comprehensive list of confused drug names for look-alike and sound-alike name pairs.

Tall-man and Distinctive Lettering. Some manufacturers are now using “tall man” lettering to reduce confusion between products bearing similar names. Tallman lettering capitalizes certain letters in a name for clarification (e.g., glipiZIDE and glyBURIDE).

The manufacturer of the antiepileptic drug Lamictal (lamotrigine) now prints LAMICTAL on the product label with ICTAL italicized and printed in contrasting colors to those of LAM. Also, the patient information label clearly states, “Always check that you receive Lamictal.”

The following recommendations have been suggested to aid pharmacists in reducing look-alike packaging errors: • Alert all pharmacy staff about the potential for mix-up between products; • Double-check the pharmacy inventory to confirm that the right products are in their correct storage locations; and • Consider purchasing a different brand of one of the items of a pair of look-alike products to reduce the potential for a mix-up.

In addition, manufacturers can be encouraged to take steps to ensure that packaging, labeling, and product appearance are distinct and clearly identify different products.

2

Standardized Bar Coding Bar coding technology is a promising strategy that can help prevent medication errors. A linear bar code consists of a cluster of symbols representing data that can be read electronically using scanning equipment. It is already widely used and well accepted by industries within and outside of health care because of its ease of use and high degree of reliability. Bar code information is associated with an error rate of one in 10,000 characters, versus keyboard data entry that has an error rate of one in 100 characters.

Many drug products contain a bar code for their respective National Drug Code (NDC) number.

FDA guidelines now require manufacturers to implement uniform bar codes on human prescription drug products, biological products, and over-the-counter drug products that are dispensed pursuant to an order and commonly used in hospitals. The code includes the NDC number, as well as the product’s lot number and expiration date, to help prevent outdated or recalled drugs from being dispensed or administered to a patient.

Patients in acute-care settings may derive the greatest benefit from bar coding. A nurse can scan his/her identification badge, the patient’s identification wristband, and the drug product’s bar code at the bedside. This information is then processed via computer to ensure that the medication is correct and in its prescribed dose and formulation, and that it is being administered properly to the right patient. The computer can also check for alerts or reminders about the drug.

Work Environment Considerations Evidence suggests that high prescription volume is an important factor associated with dispensing errors. In fact, pharmacists’ workload is reported to be the most significant cause of dispensing errors

Continuing Education (continued from page 38) in both community and institutional settings. One report notes a linear relationship between pharmacists’ error rate and corresponding daily prescription load. In this report, information was analyzed from 672 pharmacies in 18 metropolitan areas across the nation.

The typical pharmacist was shown to fill approximately 14 prescriptions per hour. With each additional prescription, the risk of making a potentially harmful dispensing error increased by 3 percent. At some high-volume pharmacies, almost 10 percent of prescriptions filled were potentially problematic.

Another study corroborated this by noting an increase in the risk of overlooking a potential drug-drug interaction with increased pharmacist workloads.

Even with the increasing number of pharmacists graduating each year in the United States, there still remains a shortage – with reported vacancy rates of 7 percent in retail pharmacies, 9 percent in hospitals, and almost 18 percent in the military. These deficiencies will likely increase along with workloads as professional roles for pharmacists continue to increase.

As the U.S. population – especially elderly Americans – enlarges, prescription drug use increases. A large number of pharmacy graduates delay entering the workforce while they seek residencies or fellowships that require additional formal training.

At the beginning of each month, the government distributes payments to the elderly, the sick and the poor. As these populations receive their checks, they tend to fill and refill their prescriptions, thereby causing an increase in pharmacy workload. Pharmacists, therefore, may be more prone to error at these times in the filling and labeling of prescriptions and may have less time to counsel patients on proper medication usage.

The pharmacy work environment can also contribute to dispensing errors. Considerations include lighting, distractions, noise and interruptions. Appropriate

lighting of the work space, for example, is important with dispensing errors increasing as the amount of available light decreases. In one study, three different pharmacy illumination levels were evaluated (450 lux, 1,100 lux, and 1,500 lux).

The medication-dispensing error rates were significantly lower (2.6 percent) at an illumination level of 1,500 lux (highest level), compared to an error rate of 3.8 percent at 450 lux. This outcome is consistent with findings from other settings that demonstrate task performance improves with increased light levels.

Interruptions in work can also increase the chance for pharmacist error. It may be helpful to assign a technician, for example, to answer the telephone; meet and greet patients; perform routine tasks such as data entry, counting, and labeling prescription containers; and handling insurance claims. Work areas should provide an uncluttered workspace with comfortable lighting and temperature, that are as free from interruptions as possible.

There are other considerations as well. Error rate is increased as time spent in management activities increases. Considerations known to decrease the dispensing error rate include professional satisfaction, number of years from the pharmacist’s initial licensure (i.e., the more experience, the fewer errors), and membership in professional organizations. In this latter instance, perhaps such membership indicates more professionallycommitted pharmacists who may be more involved in patient care.

Or, perhaps professional pharmacy organizations educate their members on dispensing errors as well as the means to reduce them.

Patient Guidelines Actively engaging patients in their therapy is another means in helping prevent medication errors. An active patient counseling program plays a significant role as a final check in error prevention, with

Table 1 Steps to Help Eliminate Dispensing Errors • Design an efficient dispensing environment that optimizes work flow and reduces distractions • Utilize labels and computer alerts to help prevent mix-ups with drugs and drug products having look-alike/sound-alike names • Keep the original prescription, label, and medication container together throughout the dispensing process • Use a second, trusted, individual to check all completed prescriptions, whenever possible • Check the contents of the prescription container against the original prescription, rather than prescription label, in case the label was generated incorrectly • Employ bar coding when possible • Provide pharmacist-patient counseling with emphasis on stimulating the patient to repeat back information and to ask if information is not clear

more than 80 percent of mistakes being discovered during counseling sessions. Pharmacists can create an appropriate environment, then communicate, educate, and listen to patients effectively. In this manner, detected errors can be corrected before an adverse event can occur. The steps listed in Table 1 can help improve the accuracy of prescription dispensing and eliminate errors.

Handling Errors That Occur When an error has been identified after dispensing the prescription to the patient, it is important to act quickly and professionally.

Emotions can modify the outcome greatly. Pharmacists can experience feelings of panic, disappointment, defensiveness or self-protection, while patients may be scared, anxious, frustrated, or angry.

These and other emotions must be

Continuing Education (continued from page 39) Table 2 Selected Internet Resources for Information on Medical Errors* Internet Site www.ahrq.gov www.ashp.org www.fda.gov/cder/drug/ MedErrors/nameDiff.htm www.ihi.org www.iom.edu www.ismp.org www.jointcommission.org www.medpathways.info/ medpathways/index.jsp www.nccmerp.org www.npsf.org www.patientsafety.gov/ rca.html www.usp.org

Organization Agency for Healthcare Research and Quality American Society of Health-System Pharmacists FDA Center for Drug Evaluation and Research Institute for Healthcare Improvement Institute of Medicine Institute for Safe Medication Practices The Joint Commission Pathways for Medication Safety National Coordinating Council for Medication Error Reporting and Prevention National Patient Safety Foundation U.S. Department of Veterans Affairs United States Pharmacopeial Convention

*This list can be used as a starting point for information on medical errors.

controlled in order to resolve the problem effectively. It is important for pharmacists to offer their full attention to the patient in a quiet environment, away from other patients if possible, and avoid using phrases such as “calm down,” or “these things happen.” A patient’s concern over the error should be acknowledged early on.

The physician should be contacted immediately to be informed of the error so that both pharmacist and physician can discuss the best course of action. A physician who has been told exactly what has happened can often squelch undue patient concern and action against the pharmacist.

The mistake should then be communicated to the patient and corrected, retrieving the incorrect prescription medication and container, if possible. The patient needs to understand the potential effects of the error.

Patients are more likely to be forgiving if they feel the pharmacist is speaking honestly and not trying to cover up or de-emphasize the error, and if the patients are being treated with respect and concern.

The patient should be offered a sincere apology for any inconvenience. Apologizing for incon-

40 Arizona Journal of Pharmacy

venience does not admit liability.

Both the error and how it was resolved should be documented completely, and appropriate individuals, such as upper management and the insurance liability carrier, should be notified according to company policy.

Documenting Errors. Regardless of how insignificant a mistake seems, all errors should be documented. The focus should be upon improving the system, rather than incriminating and/or punishing an individual. Noting how an error occurred can help others learn from the mistake and help prevent the same problem from recurring. The Medication Errors Reporting Program (MERP) operated by the U.S. Pharmacopeia (U.S.P.), in cooperation with the Institute for Safe Medication Practices (ISMP), is a confidential national voluntary reporting program that provides expert analysis of the system causes of medication errors, and suggests recommendations for prevention of their recurrence. Regulatory agencies and manufacturers are notified when changes in products are needed to assure safety. Without reporting, such events may go unrecognized and thus important epidemiological and preventive information would 4

be unavailable. Case studies are published to alert health care professionals and others about recommendations to prevent further errors.

Overview and Summary The literature on medical errors is vast, complex, and growing rapidly. Medication Errors: Causes, Prevention, and Risk Management (Sudbury MA; James and Bartlett; Cohen MR, ed.) is a good comprehensive reference on dispensing error risks for pharmacists. ISMP’s Medication Safety Alert! Newsletter (www.ISMP.org) and FDA’s MedWatch E-List (www.fda.gov/medwatch) are also excellent resources.

Table 2 contains a list of additional resources on avoiding medical errors to improve patient care.

The content of this lesson was developed by the Ohio Pharmacists Foundation, UPN: 129-000-08-002H05-P. Participants should not seek credit for duplicate content.

continuing education quiz

Continuing Education Quiz

Autism and Its Treatment: A Primer for Pharmacists 1. In the U.S., autism affects an estimated one in: a. 150 births. c. 15,000 births. b. 1500 births. d. 150,000 births.

This program was developed by the Ohio Pharmacists Association for pharmacists.

The Arizona Pharmacy Alliance and the Ohio Pharmacists Association are accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education.

7. All of the following are included in the core group of behaviors physicians use to diagnose autism EXCEPT: a. difficulty feeding and dressing oneself. b. inability to sustain conversation with others. c. preoccupation with a particular object. d. rigid adherence to established routines.

2. The term autism has been defined as all of the following symptom patterns EXCEPT: a. abnormal development of social reciprocity. b. failure to use language for communication. c. desire for sameness. d. inability to perform mathematical tasks.

8. Girls with some autistic symptoms who also exhibit social withdrawal, regressed language skills, and hand wringing are most likely suffering from: a. Aspergerâ&#x20AC;&#x2122;s disorder. b. childhood disintegrative disorder. c. pervasive developmental disorder not otherwise specified. d. Rett syndrome.

3. According to the Table listing Major characteristics of pervasive developmental disorders, autistic disorder has an onset of: a. <12 months of age. b. <24 months of age. c. <36 months of age. d. <48 months of age.

9. The most common therapeutic agents employed to treat autism are the: a. neuroleptics. c. stimulants. b. anticonvulsants. d. antidepressants.

4. The U.S. Institute of Medicine has stated that: a. there is a link between thimerosal and autism. b. there is no link between thimerosal and autism.

10. Common characteristics of persons with autism include all of the following EXCEPT: a. avoiding eye contact. b. begging to be held or cuddled. c. having trouble adapting to a changing routine. d. repeating actions over and over.

5. It has been reported that approximately threefourths of patients with autism may be: a. intellectually gifted. b. mentally retarded.

6. By the time they reach adulthood, about onethird of children with autism develop: a. schizophrenia. c. epilepsy. b. hallucinations. d. delusions.

Arizona Pharmacy Foundation

Autism and Itâ&#x20AC;&#x2122;s Treatment: A Primer for Pharmacists ACPE UPN#100-999-09-020-H01-P

How do you rate this course? (Good) 5 4 3 2 1 (Poor) This is to certify that this continuing education course was completed by:

Name __________________________________________________________

Address ________________________________________________________

City, State, Zip ___________________________________________________

5

This course is a benefit to AzPA members.

Non-members of AzPA must enclose a $10 check payable to the Arizona Pharmacy Foundation.

A grade of 70% or above is required for successful completion of the CPE activity.

This program is accredited for 1.5 hr. (CEUs 0.15) Not accepted after 03/31/2010 Send this page to: APF, 1845 E. Southern Ave. Tempe, AZ 85282 Certificates will be mailed within 30 days

Arizona Journal of Pharmacy 41

continuing education quiz

Continuing Education Quiz

Challenges in Pharmacy Practice: Interventions to Minimize Medication/ Dispensing Errors and Maximize Patient Safety

This program was developed by the Ohio Pharmacists Association for pharmacists.

The Arizona Pharmacy Alliance and the Ohio Pharmacists Association are accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education.

1. It is estimated that of all prescriptions filled in community pharmacies, the following percentage involve dispensing errors by pharmacy staff. a. 3 to 12 percent c. 23 to 32 percent b. 13 to 22 percent d. 43 to 52 percent

6. The most significant cause of dispensing errors in both community and institutional settings is reported to be: a. poor lighting. c. distractions. b. workload. d. interruptions.

2. Which of the following best describes the electronic equipment used to transmit prescription information from prescriber to pharmacy through e-prescribing systems? a. iPod b. Dedicated cell phone c. Intercom network d. Personal digital assistant (PDA)

7. In the medication error study noted in this lesson, which of the following increased the error rate? a. Increased time spent in management activities b. The number of years from the pharmacist’s initial licensure c. Membership in professional organizations

3. According to the U.S.P., the similarity between the spelling or pronunciation of drug names is responsible for approximately what percentage of medication errors? a. 1 to 6 percent c. 16 to 21 percent b. 7 to 15 percent d. 22 to 31 percent

8. What percentage of medication errors are discovered during active patient counseling? a. 20 percent c. 60 percent b. 40 percent d. 80 percent 9. The Medication Errors Reporting Program is operated by: a. APhA. c. FDA. b. CDC. d. U.S.P.

4. The “tall man” concept for lettering on product labels to reduce confusion among products with similar names involves which of the following methods? a. Placing the product name high on the label b. Using a font size larger than 10-point c. Capitalizing certain letters in the product name

0. The Medication Safety Alert! Newsletter is published by: a. ASHP. c. ISMP. b. FDA. d. NPSF.

5. FDA guidelines now require manufacturers to implement uniform barcodes on human prescription drug products that include all of the following EXCEPT: a. NDC number. c. generic name. b. expiration date. d. lot number.

Arizona Pharmacy Foundation Interventions to Minimize Medication/Dispensing Errors and Maximize Patient Safety ACPE UPN#100-999-09-021-H05-P

How do you rate this course? (Good) 5 4 3 2 1 (Poor) This is to certify that this continuing education course was completed by:

Name __________________________________________________________

Address ________________________________________________________

City, State, Zip ___________________________________________________

5

This course is a benefit to AzPA members.

Non-members of AzPA must enclose a $10 check payable to the Arizona Pharmacy Foundation. A grade of 70% or above is required for successful completion of the CPE activity.

This program is accredited for 1.5 hr. (CEUs 0.15) Not accepted after 03/31/2010 Send this page to: APF, 1845 E. Southern Ave. Tempe, AZ 85282 Certificates will be mailed within 30 days

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.

GETTING TO KNOW THE ECONOMY Prudent investing takes more than detailed knowledge about different types of investment strategies. It also requires a clear understanding of the economy and how it works. That said, here is a description of some of the more important economic reports that you as an investor need to know about: Gross Domestic Product (GDP): Provided quarterly by the Bureau of Economic Analysis, GDP offers the proverbial "big picture" on the U.S. economy. It measures the value of all goods and services produced in the United States during a calendar year -- minus exports, government spending and products made by U.S. companies in foreign markets.

When GDP increases, the economy is said to be growing or expanding. When GDP declines, the economy is said to be slowing or decelerating. When GDP declines for two consecutive quarters, many economists consider the economy to be in recession.

Consumer Confidence Index: This index can give you a good idea of how Americans generally feel about the current economic environment and future expectations. The index is published monthly by the Consumer Research Center of the Conference Board and is based on a representative sample of 5,000 U.S. households.

When people are positive about these issues, the index tends to go up. When they are pessimistic, it tends to decline. A rise or decline in the Consumer Confidence Index can have a major effect on the way Americans spend money. This is important because consumers make up about two-thirds of U.S. economic activity.

Employment Cost Index: This index is used to monitor inflation by measuring changes in labor costs for money wages and salaries and non-cash fringe benefits in non-farm private industry and state and local governments for workers at all levels of responsibility. It is provided quarterly by the Bureau of Labor Statistics.

Index of Leading Economic Indicators (LEI or ILEI): The Conference Board provides this index every quarter. It consists of 11 economic reports, such as initial unemployment claims, stockmarket activity, building permits, new orders for consumer goods, plant and equipment orders and sensitive material prices.

Since the LEI consists of so many varied economic reports, it is generally considered to be a helpful gauge of future economic activity. In fact, three consecutive increases in the LEI suggest that the economy may have begun a longer-term expansion.

Industrial Production: This index, provided each month by the U.S. Federal Reserve, offers an informed view on how key industries are faring. Specifically, it shows the change in output for three sectors: manufacturing, mining, and the gas and electric utility industries.

Consumer Price Index (CPI): This index tells you whether prices are rising or falling. It's published each month by the Bureau of Labor Statistics. The CPI tracks the price changes for a fixed basket of goods and services, from bread and milk to cars and energy.

Rising inflation is negative for the economy because consumers must spend more money to buy the same basket of goods and services. A decline in inflation is generally positive because consumers can spend less to buy the same basket of goods and services, leaving them more disposable income to help prop up the economy. However, negative inflation, or deflation, is unfavorable, because both people and businesses minimize spending in hopes of getting the same goods and services at lower prices later.

Unemployment Rate and First-Time Jobless Claims: The unemployment rate is the percentage of American workers who are out of work. â&#x20AC;&#x153;First-time jobless claimsâ&#x20AC;? is the number of people filing for unemployment benefits for the first time. These important indicators are provided by the Department of Labor.

When unemployment rises, fewer people are working and, therefore, fewer consumers are spending money -- a negative for the economy. When the job market shows strength, more people are working, so more consumers are spending money, which indicates economic growth.

A Final Word All of these economic indicators can affect the stock and bond markets, but other factors also move prices -- such as short- and long-term interest rates, corporate earnings and earnings guidance from chief executives, geopolitical events and general investor sentiment.

When you confer with a financial professional, you can get a sense of how these factors may affect the financial markets. More importantly, your financial professional can help you understand the potential impact of these and other economic indicators on your investment portfolio.

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.

Arizona Journal of Pharmacy 43

Time Capsule Pharmacy Time Capsules First Quarter 2009 1984—Twenty-five years ago: • Drug Price Competition and Patent Term Restoration passed. The major provisions of the law: o expedited the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. o provided brand-name companies up to five years additional patent protection for new medicines to make up for time in FDA’s approval process.

• Schering Corporation budgeted $4 million for first “Ask Your Pharmacist” campaign to encourage the public to ask their pharmacists about their medicines

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44 Arizona Journal of Pharmacy

1959—Fifty years ago • American Hospital Formulary Service launched by American Society of Hospital (now Health-Systems) Pharmacists 1934—Seventy-five years ago • The American Pharmaceutical (now Pharmacists) Association headquarters building, the American Institute of Pharmacy, on the National Mall in Washington, DC. was dedicated 1909—One hundred years ago • Opium Exclusion Act of 1909 prohibited the importation of opium to the United States.

By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH 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

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