America's Pharmacist February 2005

america’s FEBRUARY 2005

Published by the National Community Pharmacists Association PHARMACISTTHE VOICE OF THE COMMUNITY PHARMACIST

I R.Ph.s Rate Highly In Honesty, Ethics: Gallup Poll

I What’s a Woman’s R.Ph. to Do?

I Pharmacy Industry Meetings Calendar

I Students Open Boston NCPA Chapter

I PBM Charges Credit Card Without Asking Permission

I Folic Acid A Must Before Pregnancy

I CE: R.Ph.s Can Help Smokers Quit

I Color-Coding Can Cause Ophthalmic Rx Confusion

I Congress Scraps Call For National Compounding Rules

I Practice Pharmacy On An Alaskan Island?

I NCOIL Delays Action On Rx Price-Posting Model Legislation

I A Diabetes Drugs May PA s Be Used to Treat HI m Multiple Myeloma r oo he L 8 ot e 1 n lin ge A d Pa ea e D Se america’s contents PHARMACIST Features Published monthly by the National Community Pharmacists Association

COVER Editor/VP, Publications Not Again….Another HIPAA Michael F. Conlan Deadline Looms ...... 18 [email protected]

How to prepare a risk analysis for the VP, Communications HIPAA security rule, which takes effect Mike Ford April 20. By Harry A. Lattanzio, R.Ph., with VP, Public Relations D. Joshua Potter and R. Jeffrey Hedges. 26 Deleisa Johnson

Northern Rxposure ...... 22 Managing Editor Alliant Pharmaceuticals, Roxane Chris Linville Sitka, Alaska may be off the beaten path, Laboratories, and Doak Dermatologies. but for Dirk and Trish White, there’s no Contributing Writers place they’d rather be. By Chris Linville Notes From Capitol Hill .... 52 Ed Heckman, R.Ph. John Rector, Esq. Congress scraps call for national Rx- What’s a Woman’s R.Ph. Anne Corbett, Pharm.D. candidate To Do? ...... 26 compounding standards. Predictably PBM. Medicaid Rx pricing. Small busi- Director, Design & Production The science and rationale behind bio- ness group applauds Senate leadership Enjua M. Claude identical hormone replacement therapy on retirement security. Grassroots open By Jim Paoletti, R.Ph. Graphic Designer patients’ eyes about PBMs. Probes could Sarah S. Diab pinch United Health. Top Rx benefits Pharmacy Industry Meetings Layout Production Calendar ...... 32 manager tied to $200 million in kickbacks. Express Scripts hit with class Milburn & Associates A selected list of industry events this actions in wake of lawsuit by New York year of interest to the owners and staff Manager, Sales & Marketing attorney general. By John Rector, Esq. Nina Dadgar pharmacists of independent community [email protected] pharmacies. Departments Director, Membership Catherine E. Schmutz News Up Front ...... 7 [email protected] Preserving the Future. Newswire...... 11 Your opinions and business concerns By Bruce Roberts R.Ph. matter to us. To correspond with our edi- Americans using more medications. torial department, send your letters to: NCOIL delays action on Rx price-posting LDF Contributors ...... 8 model bill. AMA votes for Rx imports, with They signed the Contract for the Future of Editorial Office—Feedback Editor strings. Study claims drug sales visits Independent Pharmacy. How about you? America’s Pharmacist 100 Daingerfield Road affect doctors little. FDA acts on Consumer Corner ...... 15 Alexandria, VA 22314-2888 Canadian Rxs. R.Ph.s rate highly in hon- [email protected] esty, ethics. Protect you child’s development with folic acid. Or fax your correspondence with a cover letter to: (703) 683-3619 fax. Inside Third Party ...... 12 ______PBM charges patient’s credit card without Medication Safety ...... 16 seeking permission. Ophthalmic color-coding may cause America’s Pharmacist Volume 127, No. 2 (ISSN 1093-5401, USPS 535-410) is pub- problems. Zetia, Zestril, Zebeta causing lished monthly by the National Com- The Audit Advisor ...... 12 pharmacy mix-ups. munity Pharmacists Association. Edito- Do prescriptions written “AS DIRECTED” rial and executive offices: 100 Dainger- increase a pharmacy’s risk in billing third- Inside Pharmacist Care ...... 37 field Road, Alexandria, VA 22314-2888, party prescriptions? By Ed Heckman, R.Ph. Wilson breaking down barriers, enhanc- (703) 683-8200. ing patient care. Drug may ward off Periodicals postage paid at Alexandria, New Independent Pharmacist .. 13 breast cancer’s return. Diabetes drugs VA, and other mailing offices. Students demonstrate leadership in phar- might treat multiple myeloma. FDA macy. Massachusetts College of approves new drug for severe pain. Postmaster: Send address changes to Pharmacy and Health Sciences-Boston America’s Pharmacist, 100 Daingerfield Campus starts an NCPA chapter. Continuing Education ...... 41 Road, Alexandria, VA 22314-2888. End nicotine addiction with smoking ces- Annual subscription rates: $50 domestic; New Product News ...... 48 sation therapy. By Brenda Jamerson, Pharm D. $70 foreign; and $15 NCPA members For your pharmacy, new products from deducted from annual dues. Momentus Solutions, Schiff, Santarus, For membership information, send an email to: [email protected].

4 america’s PHARMACIST | February 2005 www.ncpanet.org UP FRONT america’s PHARMACIST

NCPA OFFICERS

Preserving the Future President Tony Welder, P.D. he holidays are over. The 109th Congress is in session. President Bush celebrat- President-Elect ed his inauguration for a second term. New cabinet secretaries are being named James R. Rankin, P.D. T and confirmation hearings are underway. Washington is back to business. At NCPA, we are in full-throttle on the legislative front, as well. There are many Secretary-Treasurer issues that may or will affect the practice of community pharmacy that will be con- Lonny Wilson, P.D. sidered by this Congress. One of our primary areas of focus will be the Community First Vice President Pharmacy Preservation Act, sponsored by Reps. Jerry Moran (R-Kan.) and Anthony Donnie Calhoun, P.D. Weiner (D-N.Y.). This act, which will be reintroduced in this session, would accom- plish three high-priority goals for community pharmacists: Second Vice President Gerard A. Herpel, P.D. • PBM Transparency and Accountability—The scope of PBM rebate deals with manufacturers would be disclosed to plan sponsors and the Antitrust Division Third Vice President of the Department of Justice. Bradley Arthur, P.D. • Negotiations Rights—Pharmacies not owned or operated by a publicly traded Fourth Vice President company would be permitted to collectively bargain and negotiate with health Julie K. Johnson, P.D. plans and PBMs without violating antitrust laws. • Medicare—Beneficiaries would be assured access to community pharmacists Fifth Vice President through established standards. John Sherrer, P.D.

As you can see, this bill, if enacted, would greatly benefit community pharmacists EXECUTIVE COMMITTEE and the patients they serve. Chairman The Community Pharmacy Preservation Act is the perfect example of what NCPA John E. Tilley, P.D. is trying to achieve on the legislative front on behalf of community pharmacists and why we need your help. Specific to this bill, we need community pharmacists to con- Committee Members tact their representative now and urge them to co-sponsor this bill. We need a large Stephen L. Giroux, P.D. bipartisan coalition of supporters to ensure passage in the House, advancement in Holly Whitcomb Henry, P. D . Joseph H. Harmison, P.D. the Senate, and ultimately, enactment of this vital legislation. Robert Greenwood, P.D. On a larger scale, we need community pharmacists to get involved. More issues and Joseph P. Lech, P.D. legislation will arise in the coming months. The Centers for Medicare and Medicaid Services (CMS) is expected to release regulations governing the Medicare Part D drug benefit, which begins January 1, 2006, any time now. The contents of the regulations Executive Vice President & CEO Bruce Roberts, P.D. will determine the nature of amendments to the law that NCPA will pursue in the House and Senate. We will need your help in getting such amendments enacted. We will also be working with Rep. Cliff Stearns (R-Fla.) and Sen. Jim Demint Visit NCPA’s website for the latest indus- (R-S.C.) on the Consumer Medicine Tax Relief Act, which would restore first-dollar try news, continuing education programs, pharmacy management software, deductibility of prescription drugs, over-the-counter medicines, and pharmacist pro- convention information, and more. fessional services for all federal taxpayers. This legislation would provide much needed relief for the growing number of uninsured and under insured patients we serve. Website www.ncpanet.org Since our inception in 1898, NCPA has been a force on Capitol Hill. We want to ______continue that tradition. It requires the support of community pharmacists to be successful in the political arena. Your standing in your local community gives you political clout with your elected officials. Let’s use that clout for the benefit of our practices and our patients. Write your Congressman! Give to NCPA’s Legislative Defense Fund! Get involved! NCPA® represents the nation’s community Your actions today will preserve community pharmacy for the future. pharmacists, including the owners of 24,000 pharmacies. The nation’s independent pharmacies, independent pharmacy franchises, and independent chains repre- sent a $78 billion marketplace, dispensing nearly half of the nation’s retail prescrip- Bruce Roberts, R.Ph. tion medicines.

Executive Vice President & CEO ©2005 National Community Pharmacists Association. All rights reserved. www.ncpanet.org February 2005 | america’s PHARMACIST 7 Sign the Contract for the Future Of Independent Pharmacy

Gerald Shapiro, Uptown Drug Co Eric B. Belldina, Belldina Pharmacy * John Tilley, Zweber Apothecary Alva D. Bostick, Bostick’s Prescription Pharmacy * UPTO$1,000 Mell Brodsky, Calvin Anthony, Tiger Drug Keystone Pharmacy Alliance Ethan Asedo, E. T. Drugs * Samuel D. Brog, PARD Sally Brooks, Livonia Pharmacy William Brown, Tom Burris, Overturf Health Mart Waldwick Pharmacy, Inc. * Donnie Calhoun, John Bull, John Bull Pharmacy Golden Springs Pharmacy Daniel A. Busichio, Village Pharmacy Gabe Cassar, Super Care Chris Casey, Naples Pharmacy Bob Coulter, Red Cross United Drug Joe Craft, Plain City Druggist ndependent community pharma- David Creecy, Poquoson Pharmacy Walter Cwietniewicz, cists are in the fight of their lives Ronald Delgaudio, Kings Pharmacies * Ellis Pharmacy * I against PBMs for their patients Joseph P. Dibbini, Norman W. Davis, and their practices. The men and Willmont Pharmacy & Surgicals * Medical Park Pharmacy women listed below have answered Larry Doud, RDC Katrina Delridge, Eastgate Drug * the call issued by their advocate, the Tom Engel, Lexar Corp Jack H. Eaton, S Brothers Pharmacy * National Community Pharmacists Roy Greif, Kings Drug & Surgical * Dolan Edwards, Edwards Pharmacy Association. They have signed a con- Paul Grout, Medicine Shop * Franklin D. Edwards, tract for the future of independent Craig H. Haslam, Preston Drug * Edwards Pharmacy * pharmacy, pledging to support the Gerard A. Herpel, Robert Fosberry, Stones Pharmacy Legislative Defense Fund (LDF) Deep Creek Pharmacy Mark Fotakis, Hill Pharmacy * financially, become politically in- John F. Hinkle Jr., Hinkles Pharmacy Bob Gude, Pharmacy Freedom Fund volved, and recruit new members. Steve Klink, Wells, Yeager, Charles Hughes, Edgemoor Pharmacy Join them today. Best Co., Inc. Dana & Joel Hadfield, Bill & Lesley Koonce, Hadfield's Pharmacy UPTO$50,000 Spindale Drug Co Steve Hartwig, Red Cross Pharmacy Independent Pharmacy Sharlea Leatherwood, Carl Kasiar, Beck’s Drugs * Cooperative, Inc. * Valley Prescription Services Robert B. Kubasak, Medicine Center Lonnie Meredith, The Drug Store Chuck Kray, Hershey Pharmacy UPTO$5,000 Donald L. Moore, Patrick F. Lavella, Holly & Mike Henry, Rxtra Care, Inc. Moore Drug Store Inc. Library Pharmacy, Inc. * Joseph P. Lech, Lech’s Pharmacy David Morrison, D-Rex Pharmacy Jim Litmer, Ludlow Pharmacy John D. Musil, Apothecary Shop James Rankin, Family Care Pharmacy Lynn G. Massey, Joseph F. Nusbaum, Kris Ratliff, Food City Pharmacy Medical Center Pharmacy Ambulatory Care Pharmacy * David M. Smith, Morgan Moon, Moons Pharmacy Joseph Rutowski, Tile Pharmacy * Means-Lauf Super Drug Donn Neurman, Neurman Drug Stephanie Smith, Gatti Pharmacy Buddy Pigg, Sentry Drug Center UPTO$2,500 Kevin Teegarden, Medicap Pharmacy Dennis Princing, Princing's Pharmacy Stan Britten, ADC Rx Inc. Thomas H. Whitworth, Timothy Schellinger, Pattisue Carranza, Corley Drugs #3 Seymour Drugs * Family Pharmacy of Orange Beach Guy Wilson, Wilson Pharmacy and Bruce A. Semingson, United Drugs Gene Forrester, D&H Drug Store Home Health * Lorri & Tori Shaver, Super Save Drug Steve Giroux, Middleport Family Thomas W. Wilson, Tom Stahl, The Medicine Shoppe #248 Health Center Wilson’s Pharmacy * Nestor Stewart, Bryan C. McCutcheon, Stewart Plaza Pharmacy Echo Pharmacy * UP TO $500 John & Sue Sulter, John Oftebro, Kelly-Ross Pharmacies Bradley J. Arthur, Marshland Pharmacy Mark Ray, Avalon Drugs Black Rock Pharmacy * Tennis Trucks, Pattie Drug of Baldwin Bruce Roberts, NCPA George Bartell, Jr., Bartell Drugs * P. Andrew Turner, Inola Drug, Inc. *

8 america’s PHARMACIST | February 2005 www.ncpanet.org LDF CONTRIBUTORS

Luke D. Vanderbleek, Dan Morse, Anthony J. Brooklere, Fitzgerald Pharmacy Beechnut Professional Pharmacy Inc. Adamsville Pharmacy Dirk White, Whites Inc. James E. O’Connor, Palmer’s Drug * Jennifer Brumblay-Dailey, Allan Wong, Victoria Pharmacy * Popat Patel, New Rochelle Sixth Avenue Pharmacy * Prescription Center * William R. Coleman, UPTO$250 Shailesh Patel, The New Pharmacy * Red Cross Drug Store * Robert M. Amity, East Hills Pharmacy Charles Prickett, Charles J. Day, Robert T. Audet, Eastern Valley Drug Store Day’s Miami Heights Pharmacy * Pawtucket Pharmacy of Lowell Inc. J. Qummella, Frank G. Giamartino, Bonnie Lee Bobbs-DiCello, Loisaida Drugs & Surgicals, Inc. * Hotel Pharmacy Inc. Yorkville Drug Store, Inc. Michael Raduazzo, Greenvale Ralph Hunter, Big Value Drugs Robert Bowles, Jr., Big C Drugs Chemist & Surgical Co., Inc. * Marc Kassman , Stephen Brandt, Garden State Pharmacy James Reginelli, Nisenholtz Great Neck Chemists * Owners, Inc. Pharmacy/PARD Leonard E. Kaye, Kaye Pharmacy Marlin Buchholz, Bill Robinson, Oakland Pharmacy Mark Murray, Marion Professional Pharmacy Christopher Sauls, Rehoboth Pharmacy Murray’s Prairie Drug * Charlie Carvajal, Dan Severson, UDU, Inc. H. Patel, Cir-Kort Pharmacy * Carvajal Pharmacy CS Russell Sherman, Herbert Pobiner * Dexter Cordes, Big C Discount Drugs Esco Drug Co., Inc. * Kerry Prickett, Medical Ctr Pharmacy Lonnie B. Cottam, M. Sean Sturgill, Smith Drug Company Larry Ratner, Suburban Pharmacy Blythe Drug Co., Inc. Tammy S. Stutes, Ivan Saiff, Saiff Drugs and Diana S. Courtney, Cashaway Pharmacy of Abbeville Home Health Lake Shore Pharmacy * Ki Ro Sung, Smile Pharmacy * Pamela Sardo, Don V. Daschka, Victor Drugs Joseph Testa, Woodhaven Pharmacy Sardo Pharmacy Solutions * Carmen A. DiCello, Towne Drugs, Inc. Bill Thompson, Thompson Pharmacy Conrad J. Sidoti, Jim Elrod, Dart Drug & Surgical Jim Toomajian, Watervliet Pharmacy Huguenot Pharmacy * Dominic P. Fino, Linus Zumberge, Thomas F. Stonesifer, Fino’s Rexall Pharmacy Schwieterman Pharmacy Park Avennue Pharmacy Inc. Gerald Fitzgerald, Laban Young, Riverview Pharmacy * Richard Tannenbaum, Fitzgerald & Anling Pharmacy Jefferson Heights Pharmacy * Chip Forrester, APCI UP TO $200 Gordon Tweit, Fairhaven Pharmacy * Robert D. Gillis, Park Shore Drug Inc. Dawn M. Collier, Melvin Van Curen, Casey Wood Harrell, Taylorsville Pharmacy * Portville Pharmacy Inc * Rxtra Care Pharmacy Hikel Karam, Shoppers Stan W. Winters, Jeff Harrell, Rxtra Care Pharmacy Prescription Center * The Medicine Shoppe * Thomas W. Hough, Deborah Keaveny, Keaveny Drug Anson Pharmacy * Jacob Ostrow, Cambria Dan Jespersen, Pharmacies, Inc. Ben Franklin Apothecary Greg Seeber, Seeber’s Pharmacy * Gary Jones, Hawthorne Pharmacy * Danny C. Smith, Jr., Smith’s Pharmacy Note: This list will be updated monthly. S. Mark Hobbs, Hobbs Pharmacy * Edwin E. Smith, Jr., * New as of January 14, 2005. Brian Huckle, Pharmacy First * Tappahannock Pharmacy Michael Lacey, Nocchi’s Pharmacy * Charles M. West, Chabec llc Scott Louderback, Platter’s Pharmacy * UPTO$100 John Magli, Parkdale Pharmacy * Jon Antich, The Medicine Shoppe * Hossam A. Maksoud, Anne Barr, Countryside Pharmacy Manson Pharmacy * Michelle Boeck, NCPA, Brian McQuade, Midwestern University Prescription Pharmacy Services * Anthony Brooks * Garry Moreland, Moreland & Devitt www.ncpanet.org February 2005 | america’s PHARMACIST 9 NEWSWIRE

Americans Using More Medications

mericans are cram- AMA Votes for Rx could be counterproductive. “Thus, physicians often ming their medicine Imports, With Strings Doctors rely more heavily on discount information received A chests even fuller in The American Medical Assoc- medical journal reports on from a sales representative. the struggle to lower choles- iation (AMA) voted in favor of drugs, he said, and on practice As physicians have access to terol, treat depression, reduce efforts to import cheaper pre- guidelines issued by various alternative sources of infor- inflammation, and ease other scriptions from other countries, professional groups. mation, which are more high- illnesses. possibly adding pressure on “Many physicians are ly regarded, it is no wonder More than 40 percent of the Food and Drug Adminis- skeptical of or hold negative that the salesperson’s influ- the population is taking at tration (FDA) to reverse its attitudes toward sales repre- ence is minimal.” least one prescription drug current policy opposing such sentatives,” said Jacobson, For the study the research- and one person in six takes imports. The AMA resolution whose findings were pub- ers analyzed data for three three or more, the govern- included some conditions on lished in the December issue widely prescribed drugs. They ment reported. Both figures imports, however, including of Management Science. assessed the effects of the are up about five percentage FDA approval of the specific “Physicians recognize that numbers of sales calls and points in recent years. The drugs to be imported and the information presented is bi- free samples on how many report, “Health, United States agency being given the power ased toward the promoted new prescriptions each of 2004,” presents the latest data to ensure “authenticity and drug and is unlikely to be the 74,000 doctors wrote. collected by the Centers for integrity” of the imports. objective or even accurate,” For one top-selling drug, Disease Control and Preven- he added in a statement. which was not named, it would tion, and dozens of other fed- Study Claims Drug eral agencies and health Sales Visits Affect organizations. Doctors Little FDA ACTS On Canadian Rxs Nearly half of all women The billions that drug compa- FDA Moves To reported taking at least one nies spend on personal visits Stop Canadian prescription drug during the to promote new drugs and Rx Importer month before being surveyed hand out free samples to doc- The Food and Drug —49 percent—compared with tors have little effect on how Administration 39 percent of men. doctors prescribe drugs, acc- (FDA) has taken The report also said the ording to a recent study. action against a percent of adults using antide- Pharmaceutical companies Canadian company pressants nearly tripled to 10 spent $5.3 billion on detail- for illegally import- percent of women and 4 per- ing, or sending representa- ing unapproved, cent of men age 18 and over. tives to make personal visits potentially unsafe to promote their firm’s drugs. prescription drugs. The unapproved drugs pur- NCOIL Delays Action At these visits the reps hand- The company is Canada Care chased through the defen- Drugs, Inc., previously affiliat- On Rx Price-Posting ed out $16.4 billion worth of dants pose a public health ed with Rx Depot, Inc. In 2003, Model Bill free samples, which doctors threat because, as alleged in a federal court issued a pre- the complaint, FDA cannot The National Conference of pass along to patients. liminary injunction against Rx assure their safety and effica- Insurance Legislators (NCOIL) But a two-year study of Depot to stop it from illegally cy. The FDA has no knowledge has put off until March con- 74,000 doctors showed a sin- importing prescription drugs. how unapproved drugs are sideration of model legislation gle visit had very little effect According to a complaint made, what patient information that would require pharmacies on whether they would pre- filed in the Southern District is included with them, or what to post the prices of their 150 scribe a certain drug, and of New York on November 29, their side effects are. As a most-prescribed drugs weekly. sometimes even multiple FDA made two undercover result, they are more likely to N purchases of the FDA-approv-

O NCPA has expressed its oppo- visits had little effect. S

R ed drugs Sporanox and Neur- be contaminated, counterfeit, E

D sition to the proposal and con- Robert Jacobson, a profes-

N inherently ineffective, or con-

E ontin through Canada Care.

H tinues to work with the bipar- sor of marketing at the Univer-

L tain different amounts of the

E Instead of Neurontin, FDA A

L tisan organization of state law- sity of Washington Business : received unapproved drugs active ingredients from similar N O

I makers, whose main area of School and colleagues at Col- T called APO-Gabapentin and drugs that have been reviewed A R

T public policy concern is insur- umbia University in New York

S Novo-Gabapentin. and approved by the FDA. U L L

I ance legislation and regulation. found that in fact, the visits

www.ncpanet.org February 2005 | america’s PHARMACIST 11 take three additional visits by a past. Therefore, I agreed that he should take an pharmaceutical sales represen- Inside Third Party NSAID for awhile to maintain the cardioprotective tative to induce one new pre- effect. Besides that, it is dirt cheap and he doesn’t Eye on PBMs scription, Jacobson’s study have to pay a $70 copay. Every month, America’s Pharmacist high- found. It would take 26 addi- “Lo and behold to his surprise, what shows lights an example of PBM abuse of the nation’s tional free samples to induce up in the mail last week [early November 2004] independent community pharmacies. These trans- the average doctor to write from Express Scripts—a new 90-day supply of gressions not only hurt our business and our pro- Celebrex. My dad had no knowledge of this since one new prescription, they fession, they negatively affect our patients, their neither the mail order nor the physician contact- determined. employers, and our local economies. E-mail a ed him. recent example of a problem you’ve had with a “What is particularly egregious in my opinion is R.Ph.s Rate Highly PBM to [email protected], or fax it to (703) that they automatically charged his credit card for In Honesty, Ethics 683-3619. We may edit it for length and clarity. the co-pay without informing him. He never signed Gallup’s annual survey on the any release that gives them permission to charge honesty and ethical standards PBM Charges Patient’s Credit his credit card without his approval. Even though of various professions finds Card Without Permission they keep it on file, their practice has always been nurses at the top of the list, as “My dad lives in Pennsylvania and is retired from to ask my dad what form of payment he wanted to they have been all but one year the federal government. Unfortunately he has to use when he calls for his refills. since they were first added to do mail order for his refills on medications. The “I had him call his doctor to see if the mail the poll in 1999. Almost eight mail order pharmacy for his PPO (UPMC) is order pharmacy actually contacted him for a in 10 Americans (79 percent) Express Scripts. change in the prescription. Knowing their tactics, give the nurses a “very high” “My dad has been on Vioxx for three years, but I was interested in what the mail order told the had a hip replacement last year and is doing very doctor. They basically lied to the doctor saying or “high” rating, down slightly well. He had just received his 90-day refill two days they were calling for a script of Celebrex at the from 83 percent from 2003. before the announcement of the Vioxx withdrawal. patient’s request! Grade school teachers He contacted Express Scripts to inquire on how “My dad never requested a new prescription. come in second this year, they were going to handle it, and they told him they He only wanted to know what to do with the Vioxx. given a very high/high rating would have to get back to him. He never heard The doctor gave in and authorized a prescription by 73 percent of respondents, from them again. for Celebrex thinking my dad wanted it. I don’t followed by pharmacists and “In the meantime, he contacted his doctor. His believe they even checked whether my dad had a military officers, who are tied doctor said because he was in such great shape sulfa allergy. at 72 percent each. and because he did not have to take pain relievers “I don’t know how they can get away with More generally, 2004’s that often anymore, he just wanted my dad to try charging a purchase to a credit card without honesty and ethics poll shows Aleve for awhile to see if it would work just as well. authorization. If we were to do that in our pharma- My dad has never had problems with his stomach, cy, it would be fraud. My dad just decided to keep that Americans continue to nor is he a high ulcer risk. My dad agreed with his the drug instead of fighting with the mail order. He give their highest ratings to doctor’s opinion since the jury is still out on the will now pay a $70 copay for nothing—since he the public service professions, other Cox 2’s and has been taking Aleve for sev- has no plans to take the medicine. like the military, teachers, and eral weeks without problems. [Pfizer announced “Once again, here is an example of a mail order members of the medical pro- December 17, 2004 that it found an increased risk making a therapeutic switch purely for their prof- fession. Public protectors also of heart attacks in patients taking Celebrex in one it—not the patient. Once my dad receives his rate highly. The lowest rated of two long-term cancer prevention trials, while the credit card bill, I am thinking about contacting the professions tend to be those other trial showed no increased risk. Aleve Pennsylvania Board of Pharmacy and the attorney connected with sales or big (naproxen) also is under safety scrutiny.] general’s office. I am not sure if it will do any good business, lawyers, elected “My dad also takes cholesterol and BP meds but at least a complaint is on record. I appreciate and has had bouts with heart palpitations in the any suggestions.” officeholders, and reporters. o

THE AUDIT ADVISER If you use “as directed” to skirt TPA plan limitations you are creating a ticking time bomb. PBMs are becoming savvier at flag- U.D. Translates to Trouble ging excessive and illogical quantities and in some cases contact- Q: Do prescriptions written “AS DIRECTED” increase a pharmacy’s ing physicians to verify dosages. risk in billing third-party prescriptions? Pharmacies must resist patients who place unfair pressure A: Absolutely! Prescriptions written “AS DIRECTED” can increase upon them to boost dispensing limits. The U.D. designation a pharmacy’s risk in audit situations with third-party prescrip- may be translated by the PBM into much lower quantities than tions? Third parties are interested in controlling plan maximums in terms of days supply and quantity of medication dispensed. “As you are dispensing. Pay particular care on expensive brand directed” prescriptions create ambiguity and problems for third name medications. PBMs are also going after insulin, syringe, parties in policing these parameters. inhalers, and glaucoma drop quantities on “as directed” pre- The safest procedure for the patient and third-party billings is scriptions. to contact the prescribing physician for clearer definition. If it isn’t The moral: use common sense, protect your patients and convenient to contact the physician, ask the patient how often your practice. they take their medication. Remember to DOCUMENT this information on the hardcopy prescription. Make sure dispensing quanti- By H. Edward Heckman, R.Ph., PAAS National, the Pharmacy Audit Assistance ties stay within therapeutic guidelines. Service. For more information, call toll free at 888-870-7227.

12 america’s PHARMACIST | February 2005 www.ncpanet.org NEW INDEPENDENT PHARMACIST never have known the vast opportunities available in independent pharmacy. As Students Demonstrate Leadership In Pharmacy a member of the student leadership council, I was By Anne Corbett, month, they had a few part- dent leaders to inspire other able to meet U.S. Con- Pharm.D. Candidate ing words on what leadership pharmacy students all over gressmen and discuss with in pharmacy means to them. the nation to become in- them political issues very February we volved in pharmacy and be including wrongful tactics remember and cele- John Kollhoff, SLC President, an advocate for it. pharmacy benefit man- E brate the leaders of University of Kansas agers (PBMs) use to put this country through the To me, being a leader Kimberly Gibson, retail and independent celebration of President’s while in pharmacy school University of Arizona pharmacies out of busi- Day. For many of us, this means facilitating the Student leadership is a ness. In addition, this posi- isn’t a holiday that we take tion has allowed me to time to celebrate. But, Leaders challenge students to excel in their travel to other schools of maybe this year we should professional organizations and in class. pharmacy and discuss take the time to remember Serving on the NCPA’s SLC has given me NCPA as an organization those inspirational leaders the opportunity to talk to numerous and the opportunities and apply some of their students about independent ownership available in independent ideas to our own lives. pharmacy. Pharmacy is a Being a leader in phar- and the many benefits of ownership. very small world and macy is an important part through student leadership of becoming a professional. learning process about the vital component of a well- one can meet many influ- This is an important part of opportunities available to rounded pharmacy school ential pharmacists who can each NCPA student chapter students now, and later in experience. Student assist in providing direc- and there are many NCPA their professional prac- involvement allows one to tion post-graduation. students across the country tice. Leaders challenge stu- be exposed to different that are leaders in their dents to excel in their pro- avenues of pharmacy that Tonya LeBlanc, schools and community. fessional organizations and a classroom cannot pro- University of Houston One great way to be a in class. Serving on the vide. For example, I am Leadership is an essential leader in your school is to NCPA’s SLC has given me currently a national officer component in every pro- start a new NCPA student the opportunity to talk to for NCPA. Without holding fession, especially those chapter at your school if numerous students about this position, I would who have chosen inde- you don’t have one. A great independent ownership example is Stephanie and the many benefits of Girdley from Massachu- ownership. Without NCPA, setts College of Pharmacy many students may have Boston (see next page). gone to work for someone Another way to become else simply because they a leader and to develop your were uneducated about or leadership skills is to become unaware of independents. a member of the NCPA Stu- dent Regional and Student Ginger Raley, SLC Secretary, Leadership Councils. This Southwestern Oklahoma experience allows you to State University influence the direction of the Leadership is knowing how NCPA student section. This to give other people the month, the student section ability to lead in the Student Regional Council (SRC) and the Student Leadership will experience a change in future. The continuation of leadership. The Student independent community Council (SLC) members provide a valuable leadership role for Leadership Council (SLC) pharmacy is up to each gen- aspiring independent community pharmacists. SRC and SLC will step down and be re- eration. So many great lead- members shown here are pictured, back row (L to Right) placed by the current Student ers of NCPA have inspired Kimberly Gibson, Scott Tomerlin, John Kollhoff, Rory Regional Council (SRC). This me and given me the tools Forinash, Russell Lederhouse, and David Sedrak. Pictured, change occurs after a new to help lead independent front row (L to Right) Tonya LeBlanc, Amanda Edwards, SRC is chosen. As the SLC pharmacy into the next gen- Jennifer Johnson, Ginger Raley, Wendi Chandler, Jennifer leaves their positions this eration. It is our job as stu- Mitchell, and Alyson Land.

www.ncpanet.org February 2005 | america’s PHARMACIST 13 pendent pharmacy. It is ed profession. This has one will never regret. promote independent what drives us to serve only been true due to the Finally, a great way to pharmacy to the other stu- our customers and contin- many leadership roles become a leader is to get dents at your school is a ue providing excellent cus- pharmacists play in com- involved with your NCPA great way to be a leader. tomer service day after munity settings. My chapter at your school. So this month when you day. It would be so easy to advice to any pharmacy You can run for one of the are remembering the lead- just give up when we are student is to get involved, chapter officer’s positions, ers of our country, remem- facing challenges, but lead- build relationships, build or get involved with plan- ber that you too are a ers chose to learn from confidence, and be a ning and participating leader and your involve- those rough times. It is leader in pharmacy. activities for the chapter. ment is important to the also what has drawn me to Leadership is a decision Thinking of new ways to profession. o independent pharmacy. I want to know that I will be making a difference in Massachusetts College of Pharmacy And my patients’ lives every Health Sciences-Boston Starts NCPA Chapter day. Being on the SRC and SLC has provided me with By Stephanie Girdley, many opportunities to Pharm.D. candidate work with other students and pharmacists who I first learned about NCPA share a common belief… and the many issues facing that independent pharma- the pharmacy profession at cy must go on. If you feel the NCPA National Legisla- the need to be more of a tive Conference in Washing- leader in this profession, I ton, DC this past spring. It encourage you to consider was there that I had the applying for a SRC posi- pleasure of meeting Anne tion. NCPA needs more Corbett, NCPA Assistant students who want to step director of Student Affairs, up and spread the word who encouraged me to about what it really means begin an NCPA student Students at the Massachusetts College of Pharmacy and Health Sciences to be in independent phar- chapter on the Massachu- in Boston recently founded an NCPA student chapter. Several MCPHS macy. Remember a leader setts College of Pharmacy students attended the NCPA Convention in Boston last October. is only a leader when and Health Sciences-Boston Pictured, back row (L to Right) Dhruv Soni, Matt Parsons, and Andrew someone else will follow. Campus. After contacting numer- Pszenny. Sitting down (L to R) Stephanie Girdley, Ana Sanchez, Cindy R. Nguyen, and Jessica Poovan. Jennifer Mitchell, University of ous professors on campus Arkansas for Medical Sciences and teaming up with another changed some ideas to bring back to our respec- Pharmacy is leadership. interested student, the planning began. With limited tive chapters. The highlight of the convention for Many people look to phar- knowledge about NCPA among the student body, many of us was the NCPA Pruitt-Schutte Live macists for mounds of we did our best to spread the word. After making Student Business Plan Competition. Many of our advice in all sorts of areas. announcements in classes, students were invited to members are aspiring independent pharmacy own- The best time to become an informative meeting with Anne Corbett about ers, and our chapter here in Boston looks forward active in the profession is NCPA. This meeting was our breaking point, and to developing our own business plan and submit- during pharmacy school. thankfully the turnout was very positive. With almost ting into the competition at the 2005 convention in Students can build such thirty members, executive board elections were held Fort Lauderdale, Florida. great starts for themselves, and we were an officially recognized professional Attending the convention allowed our chapter to and gain great ideas by organization soon after. gather a lot of ideas for fundraising and profession- getting involved in phar- With all of the excitement of beginning this new al events. We were also able to meet students from macy leadership early. chapter on campus, we had to quickly get our the Worcester campus and talk about future plans Leadership in pharma- budget into Student Government in order for mem- for the two NCPA Student Chapters. cy involves standing up bers to attend the 106th Annual NCPA Convention We have planned our Chartering Ceremony for for the profession as a and Trade Exposition that was being held in Boston early 2005 to start the year off with a semi-formal eve- whole, caring for our cus- in October. In total, we had eight members attend, ning for NCPA members, MCPHS faculty, and com- tomers, and protecting the four officers and four general members. The four munity pharmacists in the Boston area. Our charter future of pharmacy. officers attended the Officer’s Breakfast that was members look forward to learning more about com- Pharmacists have been hosted by NCPA and we were able to meet mem- munity pharmacy, attending many more conventions, noted to be the most trust- bers from MCPHS-Worcester Campus and ex- and owning our own pharmacies in the future.

14 america’s PHARMACIST | February 2005 www.ncpanet.org CONSUMER CORNER

Protect Your Child’s Development With Folic Acid

olate is a B vitamin found in a which the upper end of the neural tube amounts of folic acid. You can get folic variety of foods. It is added to fails to close. In these cases, the brain acid in your diet, but it’s hard to get F many vitamin and mineral sup- either never completely develops or is enough every day through food alone. plements as folic acid, a derivative of totally absent. Pregnancies affected by Your pharmacist can help you select an folate. It plays an important role in the anencephaly often result in miscarriages. appropriate multivitamin or folic acid pill. production of normal blood cells for Ninety-five percent of NTDs occur in adults and is critical in helping a women with no personal or family histo- It’s Safe baby’s neural tube—the part of a ry of NTDs. However, some risk factors Folic acid has no known toxic level. If developing baby that becomes the are known: you were to eat a bowl of fully fortified brain and spinal cord—develop proper- • An NTD-affected pregnancy cereal (400 micrograms), take 400 micro- ly. Deficiency in folic acid can cause a increases a woman’s chance to grams (0.4 milligram) of folic acid sup- neural tube defect (NTD). have another NTD-affected preg- plement, and eat fortified foods and The neural tube forms in the nancy approximately 20 times foods rich in folate, women of reproduc- embryo (developing baby) and then • Maternal insulin-dependent tive age would not have a problem with closes between the 17th and 30th day diabetes too much folic acid. Even in very high after conception (or four to six weeks • Anti-seizure medication use amounts folic acid is non-toxic. Never- after the first day of a woman’s last theless, it is recommended that women menstrual period). A neural tube defect The recommended intake of folic consume no more than 1,000 micro- occurs when the neural tube fails to acid to prevent spina bifida and other grams of folic acid daily. Large amounts close properly, leaving the developing neural tube defects is 400 micrograms of folic acid may hide the ability to brain or spinal cord exposed to the (0.4 milligram) daily. The best way to quickly diagnose a rare vitamin B-12 amniotic fluid. The two most common get enough folic acid is to take a multi- deficiency, pernicious anemia. This con- neural tube defects are anencephaly vitamin with 400 micrograms of folic dition primarily affects the elderly popu- and spina bifida. These birth defects acid in it or take a single pill of 400 lation and, in some cases, can lead to occur before most women know that mcg of folic acid every day (folic acid neurological damage. they are pregnant. pills are small and easy to swallow) Birth defects occur in the first few and eat a healthy diet. Foods contain- weeks, often before a woman finds out Birth Defects ing folate include fruits; green, leafy that she is pregnant. All women should Spina bifida occurs when the lower end vegetables; and dried beans and le- practice the habit of taking folic acid of the neural tube fails to close. Thus, the gumes. “Enriched” cereal grain prod- daily even when they are not planning spinal cord and backbones do not devel- ucts such as pasta, rice, bread, flour, to get pregnant. For folic acid to help, it op properly. Paralysis of the infant’s legs, and cereals have been fortified with needs to be taken every day starting loss of bowel and bladder control, water certain amounts of folic acid. before a woman becomes pregnant. on the brain (hydrocephalus), and learn- Most multivitamins have 400 micro- Remember, your community phar- ing disabilities are among the disabilities grams, but check the label to be sure. macist is your medication expert. Feel associated with spina bifida. Between 80 Even though there are several ways to get free to ask him or her about your sup- percent to 90 percent of infants born the recommended amount of folic acid plemental needs or any other concerns with spina bifida live. every day, two thirds of women in the you have about medications you may be Anencephaly is a fatal condition in United States do not consume adequate taking before and during pregnancy. o

Ask Your Family Pharmacist®

www.ncpanet.org February 2005 | america’s PHARMACIST 15 MEDICATION SAFETY

Ophthalmic Color-Coding May Cause Problems

n 1996, the American Academy of All of these ophthalmics are marketed dispensed to the patient. At the time, the Ophthalmology (AAO) urged manufac- by Falcon Pharmaceuticals, an affiliate of pharmacist was unfamiliar with Zetia. Iturers to convert to a uniform color- Alcon Laboratories, but we have had Consequently, the physician’s hand- coding system based on therapeutic class similar reports with other manufactur- written prescription appeared to be the for eye solutions and ointments. For er’s products. We’ve contacted FDA, more familiar drug Zebeta. Fortunately, example, the product caps and labels for AAO, and various manufacturers about the error was discovered after the patient antiinfectives are tan, steroids are pink, ophthalmic mix-ups within the same took only a few doses. The patient expe- mydriatics and cycloplegics are red, beta- class, but we’re not optimistic that the rienced hypotension, but no permanent blockers are yellow. (See a complete list at harm was caused. In yet another report, www.aao.org/aao/member/policy/color.cf We’ve contacted FDA, AAO, and an order for Zetia was misinterpreted as m.) The color-coding system reportedly various manufacturers about Bextra (valdecoxib). helps ophthalmologists and patients quick- ophthalmic mix-ups within the In each of these cases, similarities in ly differentiate medications. The Food and the dose, route, and frequency con- Drug Administration (FDA) and manufac- same class, but we’re not tributed to the errors. In addition, several turers have supported the initiative. optimistic that the situation letters are the same in each drug name. Although color-coding may work well will change. Purchasing When combined with poor handwriting, in an office setting or in the patient’s ophthalmic products within these similarities can lead to mix-ups. home, where only one of each product the same class from different Among other things, these examples may be available, it has contributed to show why it is so important that physi- errors made by nurses and pharmacists vendors may help prevent errors cians tell patients the name of the drug who must contend with a growing num- by minimizing the similarities. and write the purpose on the prescrip- ber of products within the same class. tion. These errors also illustrate why Considering that many products have situation will change. Purchasing oph- community pharmacists must provide similar corporate logos, fonts, and pack- thalmic products within the same class appropriate printed and verbal patient age sizes, extra precautions are necessary from different vendors may help prevent education and encourage questions. in pharmacies or on nursing units. The errors by minimizing the similarities. Also, encourage patients to check products pictured here (see photo below) their medication bottles and read were found together in the same storage Zetia, Zestril, Zebeta patient information leaflets before tak- location, even though they should have Causing Mix-Ups ing a medication and to contact the The Institute for Safe Medication pharmacy if the medication name or use Practices (ISMP) recently received a does not match what their physician report from a patient who had been tak- intended. o ing Lipitor (atorvastatin) to treat hyper- cholesterolemia. Although her cholesterol levels were under control, her This article has been provided by the Institute physician changed her therapy to one of for Safe Medication Practices (ISMP) and has the newer agents, Zetia (ezetimibe) 10 previously appeared in the ISMP Medication been stored alphabetically by generic mg daily, and phoned the prescription in Safety Alert! Community/Ambulatory Care name. A pharmacy technician confused to the patient’s pharmacy. The pharma- Edition. This newsletter is a monthly compi- these while putting away an order from cist transcribed the telephone order cor- lation of medication-related incidents and the wholesaler. rectly, but another pharmacist misread error-prevention recommendations designed We’ve also received reports of mix- the transcription and dispensed the anti- to inform and alert community pharmacy ups between cyclopentolate hydrochlo- hypertensive Zestril (lisinopril) 10 mg. practitioners to potentially hazardous situa- ride 1 percent solution and tropicamide The patient obtained three refills, each tions that may affect patient safety. It is an 1 percent solution, both packaged in time receiving the wrong medication. electronic newsletter that is delivered directly almost identical red and white cartons. Meanwhile, her blood cholesterol level to your e-mail account. Individual subscrip- The dropper bottles inside these cartons increased. tion prices are $45 per year for 12 monthly are equally similar. It takes four times ISMP has also heard about a mix-up issues. Discounts are available for organiza- longer to recover from the effects of between Zetia and the beta-blocker tions with multiple pharmacy sites. For more cyclopentolate than tropicamide, so a Zebeta (bisoprolol fumarate). Zetia 10 information contact ISMP at 215-947-7797 or mix-up could be significant. mg was prescribed, but Zebeta 10 mg was e-mail to [email protected].

16 america’s PHARMACIST | February 2005 www.ncpanet.org NOT AGAIN.... NOT AGAIN.... Another, hIPAA Deadline lOOms Preparing a Risk Analysis for the HIPPA Security Rule By Harry A. Lattanzio, R.Ph., with D. Joshua Potter and R. Jeffrey Hedges

www.ncpanet.org February 2005 | america’s Pharmacist 19 IPAA’s second act is about to open. The HIPAA Scope is meant to identify the systems and the boundaries H(Health Insurance Portability and Accountability Act) se- of the systems that need to be assessed. A typical pharmacy curity rule, the second portion of the law affecting patient may have two or three computers networked together and information, was finalized almost two years ago. But, there is maintained in the physical pharmacy itself, along with an still little understanding among most health care providers as Internet connection, and it may possibly be hooked into a to what their responsibilities actually are and how it will af- larger network that exists within the organization. All of these fect their practices. And with the rule scheduled to take effect would need to be included in the assessment. The scope is on April 20, gaining clarity quickly on this issue is critical. also important to ensure that the assessment only covers the The first part of the law, the HIPAA privacy rule, took required systems, as this will lead to the assessment’s cost ef- effect April 14, 2003. Initially, it focused on the uses and dis- fectiveness. closures of protected health information, or PHI. What the Determining how the security official attempts to ac- federal government considers to be PHI is defined in the law. complish the risk assessment provides the methodology. This The government forced pharmacy, as well as other health methodology should be clearly planned out before fumbling care providers, to create policies and procedures to protect ahead. The National Institute of Standards and Technology how they use and disclose a patient’s PHI. The security rule (NIST) has developed white papers on this subject, and for involves the safety and protection PHI held in an electronic the security official with limited or no experience, these white format. The primary focus for most providers is securing papers will offer invaluable information on how to forge PHI that is available or transmitted in electronic format, ahead in an organized fashion. since this is likely to be their largest area of exposure given Once the security official has discovered the scope and the prevalent use of computers, electronic storage devices, decided on a methodology for conducting the assessment, data collection and analysis should begin. There are a few and the Internet. ways to collect data, including interviews, questionnaires, and observation. The data should include assets, threats, vulner- New Rule Requires Designated Staffer abilities, safeguards, consequences, and likelihood of an event Unlike the privacy rule, which did not require your staff to occurring. Analyze the data by using the nine-step process have any specialized knowledge or training to begin the com- and guidelines provided by NIST (www.nist.gov) to complete pliance process, the security rule will require someone on a risk analysis. These nine steps are detailed and, for the most the pharmacy staff to serve as a security official. Pharmacy part, straightforward enough for non-geek computer people security officials will need to have an understanding of the to understand. Let’s take a look at these steps. pharmacy’s electronic information systems. They will need to understand how the computer technologies utilized within System Characterization the pharmacy for the handling of PHI work, and be able to Data collection and analysis will begin with describing the learn the operation of any additional technologies that must system characteristics. Using the scope and methodology be added. discussed previously, the security official will begin to de- Security officials are also responsible for overseeing the scribe the systems involved in the risk analysis. The system development and implementation of security rule compli- characteristics would include hardware, software, data ance. Through compliance, they will ensure electronic PHI’s contained, support staff (in-house or vendor), the system availability, confidentiality, and integrity. mission, and the data’s criticality/sensitivity. The system But, where do they start? Once security officials are ap- characteristics are needed to understand the required con- pointed, their first task is to understand the regulations and trols that would be required to ensure the availability, confi- then become familiar with the pharmacy’s computer systems dentiality, and integrity of the protected health information and setup. This should include network set-ups, hardware, within the systems. operating systems, software, and backup media. Once the security official is familiar with the information system setup, a Threat Identification risk assessment should begin. The second step would be to identify the various threats that exist to the physical facility and computer systems. A threat Risk Assessment Essentials is identified as “the potential for a threat-source to exercise What is a risk assessment, and where would your average in- a specific vulnerability.” Threat identification would run dependent pharmacy begin? A good starting point is for the concurrently with the next step, vulnerability identification. security official to identify the risk assessment’s scope and These threats could range from man-made to natural threats. methodology. Having a scope and methodology will be im- Things to consider while identifying threats would include portant to the risk assessment’s time and money investment, the potential likelihood of a threat occurring. If a threat does and usefulness. not even have a slight chance of being exercised, such as an

20 america’s Pharmacist | February 2005 www.ncpanet.org alien invasion, the security official should focus on threats Risk Determination with a higher likelihood of actually happening. The next step will determine the risk level associated with a given threat/vulnerability being exercised. NIST uses a Vulnerability Identification function based on the likelihood, the impact, and the ad- A vulnerability is identified as “a flaw or weakness in system equacy of existing or planned security controls. They then security procedures, design, implementation, or internal assign associated risk levels by using a high, medium, and controls that could be exercised (accidentally triggered or low scale. In this scale-based system, a score of high or me- intentionally exploited) and result in a security breach or a dium needs to be addressed to determine what additional violation of the system’s security policy.” As the security of- controls would reduce the score to a low rating. If the score ficial is tasked with identifying the vulnerabilities, the threats level is low, then the security official will need to determine that could exercise those vulnerabilities should be identified. if the threat/vulnerability risk level for this issue is accept- Ideally, from this step, the security official will have a list of able. If no level of risk were acceptable, then the security vulnerabilities that could be exploited by the potential threats official will need to determine what security controls would listed in threat identification. eliminate the risk.

Control Analysis Control Recommendations In this phase, the security official looks at the controls that Throughout the seven steps so far, we have been collecting are in place to ensure the HIPAA security rule standards and data and determining a value to that data: risk, likelihood, implementation specifications, threats, and vulnerabilities threats, vulnerabilities, and others. Control recommendations are sufficiently addressed. These controls are the security is where the security official will bring everything together measures to effectively comply with HIPAA regulations and and determine if the risk to the information technology sys- to eliminate or sufficiently mitigate the threats and vulner- tems is at an acceptable level. If there are still unacceptable abilities. These controls could be policies and procedures, risks that exist, the security official will need to create ad- along with physical and technical security implementations ditional controls. As the security official goes over additional that ensure and maintain PHI’s availability, confidentiality, controls, it should be noted that not all controls could be and integrity. implemented due to the complexity of the systems and the capital that is available. The security official will need to be Likelihood Determination concerned with the cost benefits associated with the control. In the likelihood determination, the security official will look at the controls that are in place for each threat and vulner- Results Documentation ability. The main goal here is to analyze their effectiveness and determine if they comply with the regulations. Do they Finally, once the previous eight steps have been completed, ensure that the vulnerabilities have been eliminated or miti- the security official will create an official report. This -re gated in the event that a specific a threat is exercised? port should be directed to the pharmacy’s management and should explain the risk analysis’s findings. The management Impact Analysis will use the report to determine where capital should be spent The next step is to determine what the impact would be or additional controls implemented to ensure compliance is if a threat is successfully exercised. The impact of a threat being accomplished. being successfully exercised will be based on three criteria: The risk analysis can be a very large project and may seem the function of the system, the criticality of the data within unimaginable, but following these steps breaks it down into the system, and the sensitivity of the data. Answer these manageable segments. The risk analysis ideally will assist in questions to figure out how much protection is needed to identifying potential problems that exist but that the phar- ensure the availability, confidentiality, and integrity of that macy never had the time to look at or previously discover. data. The answers to these questions typically come out in April 20 is not that far away and if you haven’t already the first step, system characterization. The impact mitiga- started this process, now is the time to do so. Once the risk tion is reflective of the three security goals: maintain avail- analysis is completed, you’ll be ready for the next document ability, confidentiality, and integrity. There are two other that must be prepared, the contingency plan. For more infor- impact groups need to also be considered—financial and mation on contingency planning, see my article in the Octo- reputation. Financial impacts are fairly straightforward; ber 2004 issue of America’s Pharmacist. n what will it cost to fix the problem? The impact on reputation will be harder to assess, but the impact on a pharma- Harry A. Lattanzio is president of PRS Pharmacy Services. cy’s reputation must be considered if a threat happens to be D. Joshua Potter is PRS retail operations counselor. exercised. R. Jeffrey Hedges is PRS special projects manager.

www.ncpanet.org February 2005 | america’s Pharmacist 21 Northern RxR pposu sure

Sitka, Alaska may be off the beaten path, but for Dirk and Trish White, there’s no place they’d rather be. By Chris Linville

22 america’s Pharmacist | February 2005 www.ncpanet.org o say that Sitka is remote is bit of an understatement. time charms of community pharmacy. “Living in a small It’s on an island in the Pacific Ocean off Alaska’s south- town, we knew the pharmacist, and my mom said, ‘You eastern coast, halfway between Anchorage and Seattle. know, that would be a good thing to do, and I went, ‘Yeah, I TIt’s accessible only by boat or plane, when the weather think so.’” cooperates. Prior to enrolling at Oregon State, Trish had never In other words, you’re not going to wind up there by worked in a pharmacy. While in college, she gained pharma- accident. cy experience in the summers and during the holidays, and “When the grocery store is out of milk, you better have she was convinced that she had found her calling. some powdered in the cupboard if you really need some,” “I decided, ‘Yeah, I really like this.’” says Dirk White, R.Ph. “If you want to spend money on However, by the spring of 1985, Trish wasn’t sure if transportation, a sports car is not the best investment, as we small-town life was cut out for her anymore. She was only have about 40 miles of road.” managing one of the two pharmacies owned by Fry. Trish White and his wife Trish (also an R.Ph.) own and oper- enjoyed the work, but said she was “in a rut. I felt sort of ate two pharmacies (White’s Pharmacy and Harry Race stymied.” Pharmacy & Photo) in Sitka, which has a population of Shortly before Dirk arrived in town, Trish was planning 9,100 residents. White’s Pharmacy, acquired by Dirk and on taking a job in Seattle, until Fry asked her to consider Trish in the mid-1980s, has a fairly young clientele and does buying his store from him. With her plans to leave on hold, the bulk of its business through prescriptions (about 75 Dirk went to work at Fry’s downtown store. Dirk, being a percent versus 25 percent for OTC and other products). The neutral party, served as a sounding board as Trish pondered Whites later acquired Harry Race Pharmacy & Photo, which her future. Soon, they realized that there was a mutual attrac- is located in the downtown area about seven blocks away, tion, despite some amusing first impressions. and caters primarily to older locals and cruise ship tourists “Sid asked Dirk send him a picture – I looked at it and who swell the town’s population in the summer months. thought, ‘he doesn’t look very bright,’” Trish says jokingly. “I Race’s non-prescription/prescription product ratio is about felt obligated when he came to show him around. I tried to 70 percent to 30 percent. The two locations have combined introduce him to some friends and show him what little of annual sales of about $5.2 million. The Whites have 33 em- social scene there was, and make him feel comfortable since I ployees, with five pharmacists (including themselves) and thought was leaving.” three technicians. After first meeting in the spring, they were married by September. Some of Dirk’s family members were surprised when they met his blonde-haired bride. Go North, Young Man “I called my folks back home to say I was marrying a na- While Trish was born and raised in Sitka, Dirk is a trans- tive Alaskan, and my grandfather said succinctly, ‘She’s a little planted Minnesotan. He was born in Minneapolis and spent fairer than I thought she was going to be.’” his childhood in the state. After high school, he attended the During this time, Trish decided to take up Fry’s offer to University of Minnesota-Morris, earning a biology degree in purchase one of his stores (which became White’s Pharma- 1979. His first intention was to be a veterinarian. However, cy). The downtown store, where Dirk was working, was sold those plans changed fairly quickly—“Those 4.0 GPAs aren’t to the other manager. always easy to come by,” Dirk quips. “So he didn’t end up taking my spot, because I didn’t end Later, he became interested in pharmacy, being drawn up leaving,” Trish says. “He stayed to work at the bigger store, by images of his small-town upbringing and the local phar- with the other manager. So he was not only my husband, but macy, complete with a soda fountain. He started pharmacy also my competition. The other guy didn’t think that was school at the University of Minnesota before taking a break. humorous at all.” He eventually obtained his B.S. in pharmacy from South “No he didn’t,” Dirk recalls. Dakota State University in 1985. At that point, he began The Whites say that the manager was reluctant to sell pursuing a long-time goal, which was to move to Alaska. the downtown store to them. Eventually, he gave in and the “It’s just something I always wanted to do,” he says. His Whites were able to buy it. They kept the Harry Race name placement officer from the university gave him a lead on a because of its tradition and familiarity with residents. position at a pharmacy in Sitka owned by Sid Fry, and Dirk was on his way. On his way, actually, to replace his future wife. By the A “Unique” Place spring of 1985, Trish had already been a practicing pharma- Located on Baranof Island on the outer waters of Alaska’s cist for five years. Inside Passage between the towering coastal mountains and “I rib him all the time about that,” she says, as Dirk, sit- the Pacific, Sitka is anything but ordinary. ting next to her, smiles. “Because I’ve been a pharmacist five “Sitka is unique in southeast Alaska for a lot of reasons,” years longer than him. I never let him forget that.” Trish says. “It’s harder to get to for the cruise lines. One “And I’m a year older,” Dirk responds. hundred percent of the cruise ships will go into Juneau and Trish, who obtained her B.S. in pharmacy from Oregon Ketchikan, the big ports. We maybe get 45 percent of those State University, says she, like Dirk, was drawn to the old- because we are a little harder to get to. What helps us is the

www.ncpanet.org February 2005 | america’s Pharmacist 23 ter we get the grandmas and grandpas, and their grandkids. I love it. It’s what we were hoping for.” “It’s a community asset,” Dirk says of the soda fountain. “It’s like what we remembered from when we were growing up.” The Whites say that annual growth for their stores has been steady through the years. In the late 1980s and early 1990s, business was zipping along as high as 7 percent. Things leveled off a bit after the Alaska Pulp Corp. closed its plant down about a decade ago, taking a number of good- paying jobs with it. The 9-11 terrorist attacks took a toll for a period as well. “We saw a definite drop in tourism after that,” Dirk says. “But that’s pretty much come all back.”

The Whites’ offer state-of-the-art photo processing at their Staying Sharp downtown store. Even with a solid business, the Whites realize that they can’t become complacent. They say they are always looking to in- beauty and uniqueness of the area.” novate, to find new ways of doing things. Tourism, mainly in the summer, is among the town’s “It’s so easy anywhere to get totally stuck in what you’re significant revenue sources. Charter and commercial fish- doing and figuring that’s the right way to do it,” Trish says. ing, along with fish processing, packing, and shipping also “I think it goes double for us because we’re so far removed help drive the local economy. Other industries include from everything.” soap manufacturing, a chocolate factory, and a water bot- Dirk agrees, saying, “We’ve been insulated because of tling plant. that. We don’t have to do some things.” Sitka also has two colleges, two hospitals (one run by To stay sharp, the Whites have stayed connected, tak- the government), three hotels, and a fair number of bed and ing time to travel to trade shows and seminars. They are breakfast-style accommodations. The airport is located on regulars at the NCPA convention, and Dirk has been active another island, accessible by bridge. with a number of NCPA initiatives, serving on panel for Dirk says the town has a variety of personalities among the technology seminar held at the 2004 convention, and its residents. as a representative with the NCPA House of Delegates. “We have a pretty diverse population,” he says. “There’s a Trish has been a panelist at local community wellness lot of leftover loggers, and there’s also a lot of environmen- seminars. talists. Everybody might not have the same viewpoints, but “We’ve been doing those things for 10 to 12 years regu- it’s pretty civil.” larly,” Trish says. “We’ve made huge strides, and it’s helped us Already the sixth-largest town in sparsely populated Alas- across the board with our employees, with everything.” ka, Sitka gets a lot more crowded when the cruise ships arrive. The Whites, like most independent pharmacists, face “They do cruise ship reports on the radio—8,000 extra their share of challenges. people in town, we’re going to double our size,” Dirk says “Mail order is big in Sitka,” Dirk says. “It doesn’t matter with a tone of mocking exclamation. And the tourist trade doesn’t hurt business. if it’s cars or shoes, and pharmacy is just another commod- “Cruise ship passengers buy a lot of items” Dirk says. “That’s why we do so well. Mainly because they’re sick. They’ve spent three or four hours on airplanes, then they get on a cruise ship, and everybody’s coughing and sneezing on each other. We sell the daylights out of cough and cold medicines, Sudafed, those sorts of things. It’s sells like crazy.” The 4,400 square foot store, which has a comprehensive state-of-the-art digital photo lab, has become something of a tourist attraction. A while back, Dirk and Trish put in an old- style soda fountain (called “Harry’s Soda Shop”), which has become a hit with visitors. “People will come in and they’ll get an ice cream cone and they’ll say, ‘Can you all just stop so we can take a picture of you?’” Dirk says. Trish adds, “There a lot of nostalgia about it. In the win- The soda fountain at the Whites’ downtown store is a hit with visitors.

24 america’s Pharmacist | February 2005 www.ncpanet.org ity. We do not have a monopoly in town by any means, like people might think.” Efficiency is also important when you face situations that the everyday pharmacy doesn’t—such as waiting for the next cargo ship or plane to arrive. The Whites have been eagerly embracing technologies, such as point of sale systems, robot- ics, and integrated voice response, to name several. “All of our pharmacists have a PDA, along with our management staff,” Dirk says. “We’re getting away from the big, bulky day planners.” The Whites have also added signature capture pads, which has been a hit with customers. “We were the first town in store to have that.” Dirk says. “Visitors are impressed. They would say, ‘Wow. This is a drug The Whites’ two stores provide both prescriptions and OTC products. store and you’ve got these capture cards?’ Dirk says he and Trish are considering adding new phones to allow immediate transfer between the two stores, ments have reduced their as opposed to asking customers to hang up and call an- stress levels, and put their staff more at ease. other number. “I’ll be the first to admit that it’s not always easy working “What are the chances that that person will actually call for a husband and wife team,” Trish says. “Especially when the other store?” Dirk asks. “We want to make things as easy we were first starting out and Dirk would say one thing and I and as seamless as we can.” would say another, and we’d both be mad at each other. And The Whites admit that each bell and whistle is like a the poor sales associate who had a question would be caught new toy. in the middle. It has made things easier, more harmonious. “It’s addicting,” Trish says. “You get a little technology, People know what’s expected of them. It makes it such a and it gets easier and easier, and it’s been fun.” nicer work environment.” “It’s time saving, obviously,” Dirk says. “If you’re trying Dirk adds, “I try to enable the employees, and make their to look up a drug, and your flipping though pages—compare life easier, and hopefully technology can do that.” that to a PDA, and you’ve got it right there instantly.” Tammy Thom, who has worked for the Whites for many The Whites say it’s difficult to attach a specific dollar years and is the current manager of White’s Pharmacy, has figure on how much money they may be saving or gaining nothing but praise for Dirk and Trish. with new technology. It does seem to be paying off in other, “They are wonderful employers,” she says. “They are very equally important ways. generous, and always looking out for the staff, trying to pro- “It all boils down to putting pharmacists out in front vide the best for them.” more to work with the patient, instead of being behind the counter,” Dirk says. “It’s about trying to understand your No Place Like Home community’s needs. It’s about patient wellness and educating The Whites can’t imagine moving to the “lower 48,” or any- patients. You’re not going to do that with mail order. where else, for that matter. For them and their two grade The Whites say that the technology and process enhance- school-age children (daughter Taylor and son Soren), being in Sitka embodies the true spirit of a small-town community pharmacy and a good life, be it with a fishing rod for Dirk, in the garden for Trish, with their daughter’s girl scout and swim team activities, or with their son’s cub scout functions and paper route. “It’s about being involved,” Trish says. “Whether it’s being a scout leader or with church organizations, the chamber of commerce, or the Rotary Club. There are so many positives, because you just know everybody. When there’s a tragedy or a celebration, you are a part of that. It’s just amazing to me, it’s one of the more emotional things you experience, how much they really do count on you. That’s a huge responsibil- ity when you know them so well.” n

Chris Linville is managing editor of America’s Pharmacist.

Dirk White takes time from his busy schedule for a popcorn break.

www.ncpanet.org February 2005 | america’s Pharmacist 25 t’s been a confusing two plus years for women and their blood clots involved with the conventional therapies, have pharmacists since a government study on combination repeatedly used general terms like “estrogen replacement hormone replacement therapy was halted when data in- therapy” (ERT) or “hormone replacement therapy” (HRT). Idicated that overall risks outweighed benefits. Numerous The WHI study involved using one dose of a single combina- articles have been published debating the use of “convention therapy of conventional synthetic agents, conjugated tional” therapy versus bio-identical hormone replacement equine estrogens and medroxyprogesterone acetate. No therapy (BHRT) as an alternative. Statements made in vari- comparison was made with any other dosage or therapeutic ous publications have illustrated a lack of consistent use of regimen. ERT and HRT use to describe outcomes treats the well-defined terminology, confusion, and bias, and an ap- results as if they should be applied to every hormonal agent parent double standard applied to manufactured products in the same classes. The initiative’s researchers said the results versus any non-Food and Drug Administration (FDA)-ap- should be assumed to apply to other hormones until proven proved medical alternative. otherwise. The emphasis today on evidence-based medicine may This is a highly unscientific approach, and one that is not provide more answers for future choices in women’s health, used with other medication classes. Such an approach hasn’t but right now we need to examine the evidence that exists even been applied to the results of studies involving synthetic and use professional judgment to determine what choices we hormone treatments when the results of the study are posi- should make available for women. tive. For example, when conjugated equine estrogens were The results of the Women’s Health Initiative (WHI) trial, shown to be beneficial for the control of vasomotor symp- stopped in July 2002, and numerous other studies demon- toms, these effects were not attributed to other estrogenic

strating the risks breast cancer, heart attacks, strokes, and agents until, and if, so proven. Yet the risks demonstrated PROFESSIONAL COMPOUNDING CENTERS OF AMERICA (PCCA)PHOTOGRAPHY:

26 america’s Pharmacist | February 2005 www.ncpanet.org What’s a Woman’s R.Ph. to Do? The science and rationale behind bio-identical hormone replacement therapy

By Jim Paoletti, R.Ph with synthetic agents, both estrogenic and progestational, misleading to reassure people it’s safe without having proven have been automatically assigned by both researchers and the it’s different from what’s already available.” These types of FDA to all agents within the respective class of drugs without statements imply that that the conventional therapies have any studies to demonstrate such a cause-risk relationship undergone large trials demonstrating that they are both ef- exists. Thus the use of terms such as ERT and HRT has been fective and safe, and that conventional therapy should be the unscientific, unfair, and confusing. standard to which other therapies are compared. We need to be very specific as to what drug(s), doses, Conventional agents were designed to be replacement and duration of therapy have been studied before applying therapy, replacing the deficient hormones no longer pro- conclusions. By using terms that lump agents together and duced in sufficient quantities in the body to prevent the applying the results of a study involving one specific agent symptoms and consequences of declining hormone levels. to an entire class, we may be covering up the scientific truth The standard which conventional hormone substitutes that the agent involved may be more of a risk than the rest of should have been compared to in the first place are the that therapeutic class of drugs. hormones they where designed to replace and the effects Adding to the confusion about BHRT use are statements of those hormones in the body. Yet hormonally active sub- that bio-identical hormones need to be proven safe and ef- stances have been given to women for more than 70 years, ficacious in large trials compared to conventional therapy be- and there has never been a large controlled trial of hormone fore the bio-identicals should be used. Dr. Wulf Utian, direc- replacement therapies. The combination therapy used in tor of the North American Menopause Society, was quoted Prem-Pro (conjugated estrogens/medroxyprogesterone ac- in the Chicago Tribune regarding bio-identical hormones as etate) has been given for more than 30 years without any saying, “They haven’t proven safety and efficacy,” and, “It’s controlled trials indicating any significant health benefit. It

www.ncpanet.org February 2005 | america’s Pharmacist 27 continues to be used even though recent controlled trials and Estrogen large observational trials indicate considerable risks. Estrogen has many proven benefits beyond the treatment Low dose Prem-Pro has also been approved, although no of menopause symptoms, including hot flashes and vaginal scientific evidence exists to suggest it is any safer. We should atrophy. Estrogen therapy is known to slow bone loss and not establish as a comparison standard agents that have not aid in preventing osteoporosis. Estrogen has the multiple been fully tested themselves. A full examination of the literature actions in protecting against age associated decreases in cog- shows that the synthetic agents do not provide all the actions of nition, especially memory, and may have a role in preventing the hormones they are meant to replace, do not provide long- Alzheimer’s disease. Estrogen also plays an important role in term health benefits, and do not have established safety. maintaining oral, skin, and urinary tract health, and improv- The only way the benefits and risks of bio-identical hor- ing glycemic control in patients with non-insulin-dependent mones can be ascertained would be through large random diabetes mellitus. controlled trials. This would be prohibitively expensive, and Estrogen levels do not drop at the onset of perimeno- the motivation for such would only exist if a new delivery pause, but actually increase until the last six to 12 months system were devised that could be patented. of perimenopause. And a follicle stimulating hormone It is too often assumed that the only source of valid sci- (FSH) test cannot accurately predict the levels of estrogen entific evidence is a published trial or study examining the in a woman, as it is controlled primarily by inhibin. Since drug in question for its benefits and risks. The development the symptoms of hot flashes can be caused by numerous of a drug is hinged on the established medical knowledge of hormonal imbalances and do not necessarily indicate a lack the mechanisms of the body and disease or deficiency states. of estrogen, the first consideration in estrogen replacement With hormone replacement, the science starts with the proven therapy should be an accurate determination of a woman’s facts that have been established and published in our medical estrogen levels to establish estrogen need. reference texts. With estrogenic and progestational agents for Differentiation of the different estrogenic agents and menopause treatment and symptoms, the initial aim would endogenous hormones is essential. Estrogens of similar mo- imitate the proven actions of the endogenous hormones as lecular weight can have substantially different potencies on they declined with age. If we could start over, we would per- a weight-to-weight basis, and their potency ratios may vary haps see the wisdom in publishing results of studies indicating considerably depending on the chosen administration route. how each individual agent actually preformed all of the ex- Moreover, two estrogens may have a potency ratio for one pected actions published in the medical reference texts. quantifiable effect that is reversed when measuring another A true assessment of the value of any of these agents outcome. Comparative estrogenic potency depends on the would be which of all the beneficial actions it was able to specific target tissue. Also, some ligands can act as estrogens provide, along with any therapy risks. For example, the in one cell type or for one genomic event while behaving as vascular benefits of estradiol are published in the teaching antagonists in another estrogenic system. Therefore, differ- texts, yet years after therapy there is still debate as to whether ences in the molecular structure and administration route conventional estrogen therapy provides such protection. The can significantly influence differences in therapy outcomes. confusion again is created by drawing the conclusion that all In BHRT, all three primary estrogens can be individually agents are in question, when only limited doses of some syn- measured and replaced if desired. Most commonly, combina- thetic agents have been thoroughly studied. tions of estriol and estradiol (Bi-est) or estriol, estrone and In reality, we need to re-examine the information on both estradiol (Tri-est) are used. Topical therapy may be preferred, synthetic agents and bio-identical hormones that is available, as oral therapy with any estrogen containing estradiol and/or and let the science, in combination with professional judg- estrone can cause elevated estrone levels at a dose required ment, determine the choices that should be made available. to raise estradiol levels to normal pre-menopausal levels. We treat hypothyroidism, diabetes, growth hormone defi- Though Bi-est and Tri-est have not been studied in con- ciency, and Addison’s disease by replacing the deficient hor- trolled trials, there are studies on the use of the individual mone with the same identical molecular structure, without hormones estradiol and estriol which support their use. large, long-term controlled studies. Bio-identical hormone replacement uses molecules that are structurally identical Progesterone to the endogenous human hormones. Levels are restored to A scientific failure that adds to the confusion with HRT is the normal physiological amounts of a pre-menopausal woman. lack of recognition of the difference between progesterone Individual therapy can be monitored through hormone level and synthetic progestins. The literature clearly indicates that testing, symptom evaluation, and measurement of desired the terms progesterone and progestin are often used inter- outcome parameters. Even though we lack large, long-term changeably. trials with BHRT, there is a lot of evidence supporting BHRT, As far as the critical difference in regards to the risk of and from a fundamental standpoint it appears we are much breast cancer, the literature clearly indicates a dramatic dif- less likely to do harm in the long-term than with the use of ference between progesterone and progestins. Higher serum conventional therapy or no therapy at all. levels of progesterone at the time of breast cancer surgery

28 america’s Pharmacist | February 2005 www.ncpanet.org resulted in a significantly higher survival time, and there was pression and anxiety, progesterone and its metabolites have a higher incidence of breast cancer in women with a history shown to work on the Gaba receptors to cause a calming, of progesterone deficiency. Progestins have been shown to anti-anxiety effect. MPA can reduce bone density, while pro- increase the proliferation of breast cells induced by estradiol gesterone is a bone trophic hormone that has been shown where progesterone did not. Progesterone has been shown to to stimulate osteoblast activity. Progesterone does not affect cause natural apoptosis of cells, along with inhibiting human liver enzymes or cause liver-related side effects, while MPA cancer cell growth and invasiveness. Progesterone suppresses is contraindicated in patients with liver dysfunction. MPA metalloproteinases and upregulates various tissue inhibitors, has been found to cause deterioration of glucose tolerance or aiding tissue repair and tissue regeneration, where medroxy- hyperinsulemia, or both, where at normal physiological lev- progesterone acetate creates the opposite effect. els progesterone augments the pancreatic response to glucose A French study with topical progesterone showed no in- and increases the insulin release. MPA can cause an increase crease in breast cancer risk in women with fibrocystic breasts. in seizures, yet progesterone has been used successfully to The evidence clearly indicates progesterone as a preferred decrease the seizure incidence in women. therapy in consideration of cancer risk. Finally, progesterone has been shown to be better toler- One of the goals of hormone therapy should be cardio- ated than MPA. In one survey of women who had switched vascular health protection. Progesterone and progestins also from MPA to progesterone therapy, even after only one month differ dramatically here. The PEPI (Postmenopausal Estrogen/ in some cases, they experienced significant improvement in Progestin Interventions) trial demonstrated that while me- vasomotor symptoms, somatic complaints, and anxiety and droxyprogesterone acetate (MPA) offset the positive benefits depressive symptoms. The list of clinically significant potential of estrogen therapy on the lipid profile, progesterone did not. side effects of MPA is extensive, yet no clinical significant ad- Another conclusion from the PEPI trial was that MPA resulted verse effects have been found with the oral use of progesterone. in larger increases in C-reactive protein than estrogen-only Progesterone levels drop dramatically at the onset of therapy, while progesterone caused no additional increase. perimenopause. We need to replace progesterone to get full Progesterone also inhibits smooth muscle cell prolifera- activity of the estrogen present, to offset the extra estrogen (and reduce the risk of early onset breast cancer), treat the tion, where MPA has been shown to increase proliferation symptoms of early perimenopause, and provide the protec- of human coronary artery smooth muscle. MPA has no tive benefits of balanced hormones in the body. Progesterone vasodilator effects itself, and interferes with estradiol-in- use is not limited to those patients with an intact uterus, as duced vasodilation, while progesterone causes vasodilation its benefits have been shown throughout the entire human by triggering a release of nitrous oxide from endothelial cell body. Only synthetics, especially medroxyprogesterone ac- membranes. Progesterone is being used in stroke and brain etate, should have their use in non-hysterectomized women injury victims to prevent further vascular damage. Progester- ruled out, as they most often produce the exact opposite ef- one, but not MPA, enhances the beneficial effect of estrogen fect in most other organs of the endogenous hormone they on exercise-induced myocardial ischemia in postmenopausal were created to mimic. women. Progesterone has antihypertensive action, and can safely be used to treat preclampsia, whereas MPA may cause fluid retention and edema. Progesterone further protects the We need to be very specific as to cardiovascular system by inhibiting vascular cell adhesion molecule-1, which attracts white cells to atherosclerotic le- what drug(s), doses, and duration sions, while MPA does not. Although a thorough understanding of the effects of sex of therapy have been studied hormones on the functions of the central nervous system is before applying conclusions. By lacking, there is evidence that there are substantial differences between progestins on their effects on the brain. Proges- using terms that lump agents terone has demonstrated protective effects against glutamate toxicity, which are additive to estrogen’s protection. MPA together and applying the results does not offer protection and blocks the neuroprotective of a study involving one specific effect of simultaneously given estrogen. Estrogen and progesterone both individually and synergistically stimulate the agent to an entire class, we may antiapoptopic protein Bcl-2 in neurons, while MPA blocks the expression of Bcl-2 when co-administered with estradiol. be covering up the scientific truth There are many other areas where there are significant that the agent involved may be differences between the synthetic progestins and the only natural progestin, progesterone. Progesterone has dem- more of a risk than the rest of that onstrated to improve sleep quality, while MPA can cause therapeutic class of drugs. insomnia. Compared to MPA, which can cause mental de-

www.ncpanet.org February 2005 | america’s Pharmacist 29 Testosterone es can overlap substantially, and a com- Although there has been limited prehensive medical history, including literature to supporting their use, detailed symptomology, is required for testosterone and methyltestoster- assessing a patient’s hormonal status. one, administered by injection or Optimal hormone regulation is by mouth, has been given to meno- best accomplished by addressing the pausal women for years, often in patient lifestyle first. Exercise, sleep, combination with estrogen therapy. and proper nutrition are all important Bio-identical micronized testoster- influences on the function and metabo- one is available through compound- lism of sex hormones. Problems with ing pharmacies as oral capsules, top- cortisol, thyroid, and insulin resistance ical creams and gels, and sublingual are best addressed in this manner to lay or buccal troches and drops. Recent the foundation for the sex hormones to evidence shows the testosterone ef- work properly. fects on bone density are significant Today, many health practitioners and independent of estradiol effects. are hesitant to provide hormones of Testosterone also has been shown any type for their female patients. But to improve sexual activity, degree of we are well aware that the consequenc- pleasure-orgasm, and psychological es of chronic sex hormone deficiency well being. Improved artery vasodi- include cardiovascular disease, osteo- lation by testosterone may improve porosis, CNS deterioration, and loss of BHRT’s goal is to optimize function and cardiac health, and testosterone may sexual drive, among others. Not pro- prevent morbidity as we age, without mitigate the increased risk of breast viding any choice of hormone therapy causing harm. cancer associated with estrogen. as an option is unacceptable in terms Testosterone production in the pre-menopausal woman of proper preventative health care. is approximately 0.3 mg daily, so compared to men, much BHRT’s goal is to optimize function and prevent mor- lower doses are needed to obtain physiological levels. Ap- bidity as we age, without causing harm. If we stop and look plication of 1 gram of a 2 percent testosterone topical com- critically, the evidence supports the safety and efficacy of bio- monly used to increase sexual desire provides 67 times the identical hormone replacement, much more so than it has amount of testosterone a woman produces daily. One of the ever supported the use of synthetic hormone substitutes. We important aspects in BHRT is imitating the way the body need to stop accepting goal-orientated literature that does produces a hormone, and this would require use of substan- not show the entire picture, and question what we previously tially lower doses than have been historically used. have assumed as being supported by scientific evidence. A woman who has had her ovaries removed has lost the The information on bio-identical hormones as a po- source of up to 50 percent of her testosterone production. tential choice needs to be made available for patients. In his Without supplemental replacement, she will likely develop medical school instructional textbooks, Leon Speroff states, symptoms of decreased bone density, memory loss, fatigue, “Postmenopausal hormone therapy is an option that should weight gain, muscle weakness, and decreased sexual desire be considered by virtually all women as a legitimate part of and pleasure. Women with hypoadrenal disorders may also their preventative health program… Treatment decisions be at similar risks, since approximately half of the circulating must be informed clinical judgments, and all of the available testosterone is of adrenal origin. evidence must be included in the decision.” And the final decision should be that of a well informed patient. n Compliance Compliance has always been an issue with conventional hormone therapies, as conventional therapy is not well tolerated. Jim Paoletti, R.Ph, is a pharmacy consultant for Professional Women most often discontinue therapy due to reported side Compounding Centers of America, (PCCA), a repackager effects. BHRT compliance has been anecdotally reported as of fine chemicals and provider of ACPE-accredited technical greater than 90 percent, compared to the approximate 50 training for compounding pharmacists. Contact Paoletti at percent after one year and 20 percent after two to four years PCCA by calling 800-331-2498. with conventional therapies. Sex hormones work in harmony with each other and in- Editor’s Note: To obtain the complete list of references used teract at several levels, thus making it more difficult to attach in the article, contact Chris Linville at NCPA (703-838-2680), clinical significance to studies that isolate actions of single or at [email protected]. hormones without regard to influence from the status of other hormones. Symptoms of different hormonal imbalanc-

30 america’s Pharmacist | February 2005 www.ncpanet.org Pharmacy Industry Meetings Calendar

February • North Dakota Pharmacists Association, April 29–May 1, • National Home Infusion Association, Feb.10–13, Jamestown, ND New Orleans, LA • NACDS Annual Meeting, April 30–May 4, Palm Beach, FL • NCPA Multiple Locations Pharmacy Conference, Feb. 16–19, St. Thomas, U.S. Virgin Islands May • United Drugs, Feb. 16–19, Las Vegas, NV • NCPA Annual Conference on National Legislation and • California Pharmacists Association, February 17–20, Government Affairs, May 1–3, Washington, DC San Diego, CA • Delaware Pharmacists Society, May 12–13, Dover, DE • Michigan Pharmacists Association, Feb. 18–20, • American Society of Consultant Pharmacists, Midyear Dearborn, MI Meeting, May 16–18, Orlando, FL • Alaska Pharmacists Association, Feb. 25–27, • National Association of Boards of Pharmacy, May 21–24, Anchorage, AK New Orleans, LA 2005• Rhode Island Pharmacists Association, May 25, March Warwick, RI • Federation of Pharmacy Networks, March 3–5, Fort Lauderdale, FL June • Bellco Health, March 9, LaGuardia Marriott, NY • South Dakota Pharmacists Association, June 3–5, • APCI, March 10–12, Nashville, TN Huron, SD • NCPA Steering Committee Meetings, March 17–19, • Oregon State Pharmacists Association, June 4–5, McLean, VA Welches, OR • HDMA Marketing Conference, March 21–22, • NACDS Marketplace, June 4–7, New Orleans, LA Hollywood, FL • Washington State Pharmacists Association, June 9–12, Coeur d’Alene, ID • Iowa Pharmacy Association, June 10–13, April West Des Moines, IA • Pharmacy Group of New England/Maine Pharmacists • Maryland Pharmacists Association, June 11–14, Association, April 1–3, Portland, ME Ocean City, MD • APhA, April 1–5, Orlando, FL • ASHP Summer Meeting, June 11–15, Boston, MA • Hawaii Pharmacists Association, April 9–10, Honolulu, HI • Georgia Pharmacy Association, June 11–15, • Food Marketing Institute, Pharmacy Conference, Amelia Island, FL April 10–12, New Orleans, LA • HDMA Distribution Management Conference & Expo, • Ohio Pharmacists Association, April 15–17, Columbus, OH June 14–16, Orlando, FL • Academy of Managed Care Pharmacy, April 20–23, • F. Dohmen Co., June 15–18, Opryland, Nashville, TN Denver, CO • Arizona Pharmacy Association, June 16–19, • Associated Pharmacies, Inc., April 20–24, St. Augustine, FL Wild Horse Pass Resort, AZ • Utah Pharmacists Association, April 27–30, Mesquite, NV • Missouri Pharmacy Association, June 16–19,

• CARE Pharmacies, Inc., April 29–May 1, Williamsburg, VA Osage Beach, MO SARAH S. DIAB PHOTOGRAPHY:

32 america’s Pharmacist | February 2005 www.ncpanet.org This calendar lists selective events of interest in 2005 to the owners and staff pharmacists of independent community pharmacies. It represents the best information available in early January. For details, please contact the organizations directly.

• Pharmacists Society of the State of New York, June 22–26, August Lake George, NY • Pennsylvania Pharmacists Association, Aug. 4–7, • Arkansas Pharmacists Association, June 23–25, Champion, PA Hot Springs, AR • Virginia Pharmacists Association, Aug. 7–10, • Kentucky Pharmacists Association, June 23–26, Lexington, KY Virginia Beach, VA • Wyoming Pharmacy Association, June 23–26, • Alabama Independent Drugstore Association, Aug. 12–14, Cheyenne, WY Orange Beach, AL • Minnesota, June 23–26, Brainerd Lakes, MN • NACDS Pharmacy & Technology, Aug. 27–31, • Oklahoma Pharmacists Association, June 23–26, San Diego, CA Oklahoma City, OK • South Carolina Pharmacists Association, June 23–26, Myrtle Beach, SC September 2005• New Mexico Pharmaceutical Association, June 24–26, • EPIC Pharmacies Inc., Sept. 9–11, Tyson’s Corner, VA Albuquerque, NM • New England Pharmacists Convention (Connecticut & • Alabama Pharmacy Association, June 24–29, Massachusetts), Sept. 15–16, Ledyard, CT Panama City, FL • Pharmacy Society of Wisconsin, Sept. 15–17, Madison, WI • New Jersey Pharmacists Association, June 28–30, • Kansas Pharmacists Association, Sept. 15–18, Lawrence, KS Atlantic City, NJ • American Pharmacy Services Corp., Sept. 17–18, Lexington, KY • Illinois Pharmacists Association, Sept. 30–Oct. 2, July Springfield, IL • Compliant Pharmacy Alliance, July TBD, Washington, DC • Florida Pharmacy Association, July 6–10, Marco Island, FL • Texas Pharmacy Association, July 6–10, San Antonio, TX October • Independent Pharmacy Cooperative, July 9, • HDMA Annual Meeting, Oct. 5–7, San Diego, CA Washington, DC (with McKesson Show) • NCPA Annual Convention, Oct. 15–19, Fort Lauderdale, FL • McKesson, Pharmacy Strategies & Trade Show, July 6–10, • North Carolina Association of Pharmacists, Oct. 16–18, Washington, DC Research Triangle Park • Cardinal Health–Retail Business Conference, July 13–16, • ACCP Annual Meeting, Oct. 23–26, Dallas, TX Chicago, IL • Indiana Pharmacists Alliance, October 29–30, • AmerisourceBergen, National Healthcare Conference, July French Lick Springs, IN 13–17, Las Vegas, NV • Nebraska Pharmacists Association, July 15–17, November North Platte, NE • ASCP Annual Meeting, Nov. 9–12, Boston, MA • Tennessee Pharmacists Association, July 17–20, Perdido Beach Resort, AL December • National Pharmaceutical Association, July 22–26, 2005, • ASHP Midyear Meeting, Dec. 4–8, Las Vegas, NV Orlando, FL

www.ncpanet.org February 2005 | america’s Pharmacist 33 INSIDE PHARMACIST CARE

Wilson Breaking Down Barriers, Enhancing Patient Care

dispensing system and NDC bar code ver- By Chris Linville March Health Events Calendar ifiers. We also installed an integrated voice hen Justin Wilson, Pharm.D., response phone system that is fully inte- National Kidney Month CDM, joined Valu-Med Phar- grated with our pharmacy software sys- National Kidney Foundation W macy as its manager in July tem. This has had a tremendous impact. It www.kidney.org 2003, one of his primary goals was to has decreased the amount of phone related Hemoophilia Awareness Month break down barriers that he saw as distractions throughout the day.” National Hemophilia Foundation impediments to the pharmacy’s ability to As the barriers have decreased, patient www.hemophilia.org operate more efficiently and provide a satisfaction has increased, Wilson said. high level of patient care. The first road- “That’s the most fulfilling aspect—the American Diabetes Alert block that Wilson observed at the response we are getting from patients,” March 22 Midwest City, Oklahoma-based location he said. “It is becoming very common for American Diabetes Association was a lack of space. our patients to stop and thank us for tak- www.diabetes.org “The pharmacy is about 1,200 square ing the time to educate them on their feet, and the original design did not have medications.” National Save Your Vision Month any areas designated for counseling or In large part due to his efforts at Valu- American Optometric Association advanced patient care,” Wilson said. Med, Wilson has been selected as the www.aoa.org “We made the decision to downsize our February 2004 NCPA National Institute OTC products and were able to add a for Pharmacist Care Outcomes (NIPCO) Sleep Apnea Awareness Day March 31 semi-private counseling booth, a private division affiliate of the month. Wilson, a American Sleep Apnea Association clinical services room, and expand our May 2002 graduate of the University of www.sleepapnea.org office area.” Oklahoma College of Pharmacy in Okla- Another obstacle was pharmacist time homa City, said that NIPCO’s programs utilization. Wilson, who is also an assis- closely matched his goals in pharmacy. Diabetes Association] standard of care, tant clinical professor with the University “I have always been interested in pro- routine blood pressure, pulse and foot of Oklahoma College of Pharmacy, said viding advanced patient care in the com- exams, and progress updates and recom- that Valu-Med’s staff pharmacists were munity setting,” Wilson said. “I saw the mendations for the physician.” involved with every aspect of the dis- NIPCO programs as opportunities to Valu-Med’s Bioidentical HRT program pensing process and found that the build on the knowledge and skills I was developed by one of Valu-Med’s staff majority of their time was spent counting gained through my residency and serve pharmacists, Tiffany Baker, Pharm.D. pills, dealing with insurance companies, as a resource as I implement patient care The consultations include an extensive or handling non-patient related problems. programs in my practice.” patient history and symptom question- “To solve this issue, we implemented a naire, establishment of goals and needs, workflow model based on that used dur- SIGNATURE INITIATIVES optional saliva testing, and dosage recom- ing my residency in Maquoketa, Iowa,” Two of Valu-Med’s signature initiatives mendations and physician progress notes. Wilson said. “This model shifts the dis- are its diabetes education management “If the physician approves the recom- pensing duties to a primarily technician and hormone replacement therapy driven process. The goal is to free as (HRT) consultation services. With the Do You Know an Outstanding much pharmacist time as possible for diabetes program, Wilson hopes to NIPCO Affiliate? extensive counseling, clinical service pro- empower patients to be actively If you know of a NIPCO affiliate member vision, or compounding.” involved in the control of their health. who is providing unique and innovative “Our comprehensive program con- methods in patient care, let us know. NEW TECHNOLOGY HELPS sists of three two-hour educational ses- America’s Pharmacist is always on the Wilson also brought in new technology sions followed by three 30-minute fol- lookout for pharmacists who use creativi- to help improve processes at the 14-year- low-ups over a six-month period,” he ty and take the extra step to help their old pharmacy. said. “The service includes a patient patients live healthy lives. To nominate “It has helped improve our efficiency medical history, blood glucose monitor an individual as a NIPCO Affiliate of the and accuracy, and decrease distractions for training, blood glucose value evaluation, month, contact Chris Linville at our pharmacists and staff,” he said. “We development of a comprehensive care 703.838.2680, or e-mail: added McKesson’s Accumed automated plan based on the ADA’s [American [email protected]

www.ncpanet.org February 2005 | america’s PHARMACIST 37 mendations,” Wilson said, “We then compound patient-specific products and mon- NIPCO Affiliate itor the patient as needed to optimize res- of the Month olution of symptoms while minimizing Justin Wilson, Pharm.D., CDM, side effects.” manager, Valu-Med Pharmacy, Midwest City, Oklahoma Wilson said he has been fortunate to have a number of mentors who helped shape his pharmacy career. The most obvi- ous is his father Lonny Wilson, P.D., who has owned Valu-Med since its inception. “He has provided the support both professionally and personally to help guide my decisions throughout my life and help me to succeed,” He said of his father, who is executive director of the Pharmacy Providers of Oklahoma and NCPA’s 2004-2005 secretary-treasurer. “Without his support, I would not be in the position I am in to help advance patient care in our practice.” Wilson also credits Jack Coffey, R.Ph., Personal: associate dean for the University of Native of Midwest City, Oklahoma… Oklahoma College of Pharmacy, for “pro- father Lonny Wilson, Valu-Med’s owner, viding a source of support and guidance serves as executive director of the throughout my academic and profession- Pharmacy Providers of Oklahoma, and as 2004-2005 NCPA secretary-treasurer al career,” and his residency preceptor, Matt Osterhaus, B.S., (Osterhaus Pharm- Career: acy in Maquoketa, Iowa), “for showing Performed community care pharmacy me the importance of patient care and practice residency through the Univer- providing an excellent example of how sity of Iowa with Osterhaus Pharmacy in Maquoketa, Iowa… became manager at pharmacists can impact patients’ lives.” Valu-Med Pharmacy in Midwest City, Looking ahead, Wilson wants to keep Oklahoma, in July 2003 his focus on patient care, and to serve as a role model for future pharmacists. Academic: “My goals include continuing to May 2002 graduate of the University of Oklahoma College of Pharmacy in Okla- expand clinical services at Valu-Med homa City…passed the Certified Disease pharmacy, and to own and operate sever- Manager in diabetes exam in October al pharmacies focused on advanced 2003…recently named an assistant clini- patient care,” he said, adding, “I also want cal professor with the University of to continue to mentor students and show Oklahoma College of Pharmacy them the importance of patient care.” Quotable: Chris Linville is managing editor for “I have always been interested in provid- America’s Pharmacist. ing advanced patient care in the community setting. I saw the NIPCO programs as opportunities to build on the knowl- Drug May Ward Off edge and skills I gained through my resi- Breast Cancer’s Return dency and serve as a resource as I A newer drug prevented far more breast implement patient care programs in my practice.” cancers from recurring in older women than the old standby tamoxifen and with far fewer side effects, doctors said, citing cent of the most common type of tumors a new study. that occur in women after menopause, Cancer specialists said Arimidex compared with the 50 percent that tamox- (anastrozole) is likely to become the first- ifen is credited with warding off. choice treatment for most women who Women with early-stage breast cancer have had the disease, and they predicted who took Arimidex for five years were a wider role for similar drugs of its type, less likely to have cancer recur, develop called aromatase inhibitors. in the other breast, or spread throughout New research suggests Arimidex might their bodies than women who took be able to prevent 70 percent to 80 per- tamoxifen.

www.ncpanet.org None of the studies change tamoxifen’s to a naturally occurring PPAR gamma- a microinfusion pump implanted under status as the drug of choice for women binding molecule triggered cell death. the skin that delivers drugs directly into who get breast cancer before menopause, This was also the case when the cells the fluid surrounding the spinal cord. because the newer drugs aren’t thought to were treated with the diabetes drug cigli- Ekman said 35,000 to 50,000 Amer- be effective then. tazone. Other similar anti-diabetic drugs icans have these pumps now. The FDA include rosiglitazone (Avandia) and pio- approved Prialt for patients who are Diabetes Drugs Might glitazone (Actos). already using these pumps but not get- Treat Multiple Myeloma ting effective relief from them or who In the lab, multiple myeloma cells are FDA Approves New cannot tolerate the available treatments. killed by drugs similar to existing anti-dia- Drug for Severe Pain This is the first new drug in 20 years betes drugs like Avandia or Actos, accord- Patients who suffer severe chronic pain to treat pain using such a pump. ing to researchers at the University of and are no longer helped by morphine Prialt has been studied in patients Rochester School of Medicine and Dent- will soon have a new option. The Food with cancer, AIDS, and other chronic istry, New York. and Drug Administration (FDA) recently pain, such as back pain. More than 1,200 Multiple myeloma is an uncommon approved the first in a new class of drugs patients took part in three clinical trials. cancer that arises in the bone marrow. that blocks the nerve channels responsi- The idea for the drug came from a Multiple myeloma cells express a recep- ble for transmitting pain signals. It will snail called the Conus magus that lives in tor termed PPAR gamma, and so-called be marketed as Prialt and was scheduled the South Pacific, which paralyzes its vic- “glitazone” anti-diabetes drugs bind to to be available by late January. tims with venom after capturing them, this receptor. The drug is part of a new class known the company said. Researchers set out to “We have discovered that human multi- as N-type calcium channel blockers. It is learn how to develop a drug based on ple myeloma cells die in response to exist- known chemically as ziconotide. this venom and eventually copied the ing anti-diabetic drugs,” senior investigator Morphine is standard treatment for amino acid sequence. o Dr. Richard P. Phipps said. “Such drugs severe pain from cancer, AIDS, amputa- might prove useful to treating multiple tions, and other significant illnesses, but myeloma, which is essentially incurable.” its effects eventually wear off and the “Inside Pharmacist ® In the medical journal Clinical Immu- dosage must be increased. At some Care ” is the monthly nology, Phipps and his colleagues note point, many patients switch from taking news report of NCPA’s National Institute that exposing multiple melanoma cells medication by mouth or by injection to for Pharmacist Care Outcomes division. CONTINUING EDUCATION

End Nicotine Addiction With Smoking Cessation Therapy

ered to the body following smoking is By Brenda Jamerson, Pharm.D Useful Websites approximately 1 mg to 3 mg. It takes pon successful completion of this about 10 seconds for nicotine to reach the www.cancer.org/docroot/PED/content/PED_ article, the pharmacist should be brain following inhalation. Nicotine binds 10_13X_Quitting_Smoking.asp Uable to: to central nicotinic receptors, causing American Cancer Society site provides tobacco facts and smoking cessation information. 1. Describe the pharmacology and phar- release of the neurotransmitter dopamine. macokinetics of nicotine and its addic- As a result, the cigarette smoker receives www.lungusa.org/ tive properties. a “reward” from the pleasurable effects American Lung Association site provides free 2. Recognize the adverse outcomes from associated with dopamine release. These smoking cessation publications. cigarette smoking. short-term pleasurable effects include www.cdc.gov/tobacco/ 3. List the non-pharmacological treat- relaxation, improved vigilance, anxiety Centers for Disease Control site provides edu- ments for smoking addiction. relief, and improved task performance. cational booklets to provide to patients includ- 4. Describe the pharmacological treating, You Can Quit, and Pathways to Freedom. ments for smoking addiction. Pharmacokinetics of Nicotine 5. Understand the pharmacist smoking Nicotine is a mildly alkaline tertiary www.committedquitters.quit.com cessation program guide and how it amine. Nicotine is poorly absorbed if Committed Quitters web-based smoking ces- can be implemented into community ingested orally, owing to extensive liver sation support portal from GlaxoSmithKline practice. metabolism. However, inhaled nicotine (Nicoderm CQ, Nicorette, Commit). is rapidly absorbed in the lung alveoli, www.nicotrol.com/helping_hand/index.asp Introduction causing an arterial bolus that is 10 times Helping Hand web-based smoking cessation Tobacco is the single greatest cause of dis- higher than venous concentrations. A support portal from Pfizer (Nicotrol Patch, ease and premature death in America similar phenomenon is observed when a Inhaler, Nasal Spray). today and is responsible for more than bolus of drug is administered via cocaine www.ahrq.gov/path/tobacco.htm 440,000 deaths each year. Americans smoking (i.e., crack cocaine). After smok- The Agency for Healthcare Research and Quality spend an estimated $50 billion annually ing, nicotine levels fall quickly because website provides information on smoking cessa- on direct medical care for smoking-relat- about half of the nicotine is redistributed tion for smokers, for primary care clinicians, and ed illnesses; societal costs of tobacco- throughout body compartments within for healthcare administrators, insurers, managed related death and disease approach anoth- 15 minutes to 20 minutes of the last puff care organizations, and purchasers. er $100 billion each year; and lost pro- from a cigarette. Further decline is more ductivity and forfeited earnings due to gradual, with a terminal half-life averag- smoking-related disability account for ing two hours (though this is highly vari- Dependence, Tolerance, another $47 billion per year. Despite these able across individuals). And Withdrawal alarming statistics, almost 25 percent of Liver metabolism accounts for the Tolerance and physiological dependence all adult Americans continue to smoke. majority of elimination, with approxi- can be caused by smoking. The majority The good news is that more than 70 mately 5 percent of nicotine excreted un- of smokers start by age 18. Approxi- percent of all adult smokers—an estimated changed. The primary liver metabolite of mately 33 percent to 50 percent of peo- 50 million people—have expressed a desire nicotine (cotinine) has a half-life of ple who initially start smoking cigarettes to quit smoking, and approximately 20 approximately 20 hours, is much less become dependent. Substance depend- percent try to quit each year. Of those who potent than nicotine and is practically ence is defined as the continued use of initially succeed, up to 80 percent will devoid of pharmacologic activity. Anoth- an agent despite having knowledge of relapse over a 12-month period. Because er marker for cigarette intake is carbon persistent or recurrent physical problems of this pattern, it usually takes several monoxide (CO). Although CO is the that are caused by or exacerbated by the attempts to successfully quit smoking. usual and customary marker for smoking substance. Nicotine meets these criteria cessation, it has a half-life of only four of substance dependence, and can pro- Pharmacologic Action of Nicotine hours to seven hours. Therefore, only duce dependence in similar fashion to Nicotine, the active ingredient responsi- short-term smoking abstinence (less than heroin, cocaine, or alcohol. ble for cigarette smoking’s addictive one day) can be reliably evaluated by CO Dependence is maintained by: nature, exerts excitatory and inhibitory measurement. Longer-term verification • The positive reinforcing effects of pharmacologic effects. One cigarette con- of smoking abstinence requires measure- nicotine tains approximately 6 mg to 11 mg of ment of cotinine (days to weeks). • The smoker’s avoidance of with- nicotine. The amount of nicotine deliv- drawal symptoms www.ncpanet.org February 2005 | america’s PHARMACIST 41 • The conditioned reinforcement genic or toxic compounds. Therefore, it is to an increase in oxidized LDL cholesterol associated with the task of repeti- not surprising that one in six deaths in the and artherosclerosis. Between 1995 and tively inhaling 10 to 15 puffs from a United States is attributable to cigarette 1999, there were 81,976 coronary artery single cigarette smoking. Specifically, 30 percent of all disease-related deaths and 17,445 stroke- cancer deaths and 87 percent of all lung related deaths attributable to smoking. As a result of these dependence fac- cancer deaths are attributable to smoking. Cigarette smoke causes inflammatory tors, smokers find it very difficult to quit. A positive dose-response relationship responses in the lung. Protease and oxi- Although an estimated 20 percent of exists between smoking and cancer of the dant activation play a major role in tissue smokers try to quit in a given year, only 2 bladder, kidney, lung, uterine cervix, injury and lung damage. Unfortunately, percent to 5 percent achieve long-term endometrium, stomach, and pancreas. the repair process activated by the success without supportive therapy. Succ- Some cancer risks, such as cancer of the inflammatory mechanism produces fur- ess rates can be increased to between 15 lung, are reduced to near baseline levels ther scarring and lung tissue inelasticity. percent and 30 percent with pharmaco- following cessation of smoking. Smoking is a major cause of chronic logic and behavioral therapies. Nicotine is a potent vasoconstrictor that obstructive pulmonary disease (COPD), Tolerance is defined as a decreased causes an increase in blood pressure and chronic bronchitis, and emphysema. responsiveness of nicotine at the receptor increased risk for myocardial infarction. Environmental exposure to cigarette site. Tolerance occurs after continued nico- Tobacco smoke inhalation increases CO smoke (secondhand smoke) is also a tine exposure. Therefore, following contin- arterial levels, reducing the oxygen-carry- health danger. Second hand smoke has ued smoking, there is an increased need ing capacity of red blood cells. Further been estimated to cause about 35,000 for escalating numbers of cigarettes to smoking increases oxidative stress, leading deaths per year from heart disease and achieve the same pleasurable effects. Typically, smokers begin by smoking a few Figure 1. Pharmacist Smoking Cessation Program Guide cigarettes per day or week. However, after years of continued smoking, the typical 1. Ask 4. Assist/Counsel • Systematically identify smokers when they • Help the patient establish a plan for quitting. user smokes one or more packs per day. come into your pharmacy (via a health • Ask the patient about other types of thera- Nicotine’s withdrawal effects occur screening questionnaire that can be pies they have tried in the past and edu- within hours after smoking the last ciga- included in computerized records). cate on the types of therapies currently rette and coincide with the nicotine con- available (NRT patch, spray, lozenge, gum, centration decline (terminal elimination 2. Advise inhaler, and bupropion SR). half life of nicotine equals two hours). The • Clearly and strongly, advise every tobacco • If NRT therapy is selected, help the patient onset of withdrawal symptoms is precipi- user to quit. Examples of advice: “As your with selecting an initial dose based upon pharmacist, it is important for you to tated by an approximate 60 percent reduc- degree of nicotine addiction and counsel know that it is important for your health tion in nicotine serum concentrations. the patient on proper administration (e.g., for you to quit smoking now. We can gum should be intermittently chewed and The peak withdrawal symptoms occur help you.” about 24 hours to 48 hours after the last placed in buccal area of mouth between chews, site of patch application should be cigarette, and continue up to four weeks 3. Assess rotated daily to avoid skin irritation). or longer. Withdrawal symptoms include • Ask the patient if he/she is willing to make • Provide the patient self-help written mate- dysphoria or depression, insomnia, labile a quit attempt now. • If yes, then the patient is in the preparation rials (see website resources). mood, frustration, trouble concentrating, stage. • Provide brief counseling to support the quit slowed heart rate, and increased appetite. • Assess degree of nicotine addiction via attempt: 1) help the patient establish a quit A relapse back to smoking is predicted by the Fagerstrom Tolerance Questionnaire date; 2) advise the patient to develop social the intensity of withdrawal symptoms, and continue with Assist/Arrange steps. support networks and remove all visual particularly craving. • If no, assess stage of change and provide cues such as tobacco products and ash- appropriate motivational assistance. trays from their home; 3) discuss triggers Systemic Effects Of • Precontemplator (thinks smoking is not a to smoking (such as alcohol use, familiar Cigarette Smoking problem): encourage contemplation by environments where smoking occurs, and eating) and help the patient develop a plan Smoking produces detrimental effects on providing education about the effects of to overcome those triggers; and 4) advise the body due to a couple of reasons: the smoking. The pharmacist should intro- the patient that weight gain may occur with nicotine content of cigarettes and the duce ambivalence by asking what the patient thinks about the health effects of smoking cessation; however, the patient effects related to the combustion of tobac- smoking. should not try to lose weight and stop co. The cigarette as a nicotine delivery • Contemplator (thinks smoking is a prob- smoking simultaneously. Instead, an appro- vehicle provides the substance in an lem, is ready to quit in next six months, priate weight reduction plan can be imple- extremely toxic form. Nicotine is distilled but not ready to quit now) encourage mented following maintenance of cessation. at the tip of a burning cigarette, where it preparation to quit by discussing benefits 5. Arrange Follow-Up Support is carried by tar droplets into the lungs. of stopping smoking. Personalized advice: • Arrange for a telephone follow up with the The 2,000 degree (Fahrenheit) microblast help the patient to understand the benefits patient or provide referrals to support combustion of a burning cigarette pro- of quitting smoking as it relates to their groups that help promote smoking cessation duces 4,000 chemical compounds, includ- children, significant other, current health (i.e., Nicotine Anonymous, American Lung ing CO and approximately 250 carcino- condition, or cost of cigarettes. Association or your own support group).

42 america’s PHARMACIST | February 2005 www.ncpanet.org 3,000 deaths per year from lung cancer in Table 1. Meta-Analysis: ery system. Therefore, patients often find non-smokers. For infants and children, Estimate of Single Agent that NRT does not provide the same satis- second hand smoke exposure health risks Efficacy Rates faction as smoking. However, patients are particularly high. Specifically, asth- Pharmacotherapy Estimated should be reminded that the NRT goal is ma, middle ear infections, cancer, and Abstinence Rate to reduce cravings to a manageable level eczema are higher in children who are that helps ease the transition to successful exposed to cigarette smoke in the home. Placebo 12 cessation, as opposed to completely replacing the pleasures of smoking. Nicotine Inhaler 22.8 Smoking Cessation Therapies NRT is available in five dosage forms, The Public Health Services (PHS) Guide- Nicotine Nasal Spray 30.5 namely, patch, gum, inhaler, spray, and line on Treating Tobacco Dependence lozenge. All of the nicotine products are states that clinicians should intervene in Nicotine Patch 17.7 contraindicated in patients who are assessing a smoker’s readiness to quit. The Nicotine Gum 23.7 hypersensitive to nicotine or the drug five steps (5A’s) consist of: delivery components. Patients with life- • Asking the patient if he/she uses Bupropion SR 30.5 threatening arrhythmias, and severe or tobacco worsening angina should not take NRT • Advising him/her to quit quit in the next six months. In the con- therapy. Nicotine is a known teratogen in • Assessing the willingness to templation stage, the smoker recognizes animals. Therefore, NRT therapy should try quitting that smoking is a problem, and is intend- be used in pregnant women only if there • Assisting those willing to make ing to quit in the next six months. In the are no appropriate alternatives and the a quit attempt preparation stage, the smoker wants to potential benefit outweighs the risks. • Arranging for follow up to quit and has made plans to quit within prevent relapse the next 30 days. In the action stage, the Table 2: Estimate Of Combination Efficacy Rates smoker has quit. At any given time, If a patient is willing to try and quit approximately 20 percent of smokers are Pharmacotherapy Estimated smoking, the guidelines state that every in the preparation stage and 40 percent Abstinence Rate patient should be provided both counsel- are in the contemplation or precontem- ing and pharmacotherapy (if there are no plation stage. This model may be used to NRT patch alone 17.4 contraindications). The pharmacist may stage a smoker and assess how and when Bupropion SR + NRT patch 35.5 offer counseling by communicating mes- to implement smoking cessation inter- sages and written materials that provide ventions (Figure 1, previous page). NRT+ NRT 28.6 education, support, and skills training. First-line pharmacotherapy should be Pharmacotherapy Drug interactions with NRTs are pri- provided as one form of the nicotine NRT and bupropion SR are Food and marily related to sudden smoking cessa- replacement therapies (NRT) or bupropi- Drug Administration (FDA)-approved first tion. Since smoking induces liver me- on SR. The pharmacotherapy choice is line pharmacologic agents for smoking tabolism of certain drugs, smoking ces- largely based upon patient preference cessation. These agents approximately sation may require a dosage decrease of and/or need to avoid specific side effects double the chance of quitting compared certain agents. Commonly used drugs that may be unique to the patient’s con- to a placebo alone (Table 1, above). which may be affected by smoking ces- dition or concurrent drug use. Combination therapy provides for a high- sation include, but are not limited to, er percentage of patients who achieve acetaminophen, bronchodilators, caf- Counseling/Behavioral smoking cessation compared to single feine, imipramine, oxazepam, pentazo- Intervention agent therapy (Table 2, at right). A combi- cine, propoxyphene, propranolol, lab- BEHAVIORAL APPROACH — nation approach should be considered for etolol, prazosin, and insulin. MOTIVATIONAL INTERVIEWING a patient who has made several unsuc- The trans-theoretical model for readiness cessful attempts at quitting. Nicotine Patch to change has been widely used and pre- The NRT patch is manufactured under viously applied to smoking cessation Nicotine Replacement the trade names of Nicoderm CQ and counseling by pharmacists and other Therapy (NRT) Nicotrol. The patches are designed to health care providers. The model out- The model for NRT efficacy is to replace a deliver approximately 1 mg of nicotine lines the following stages of change: smoke-based inhalational form of nicotine per hour and achieve steady state con- • Precontemplation with a more benign form. NRT generally centrations within three days. NRT 24- • Contemplation replaces between 50 percent to 60 percent hour patches (Nicoderm CQ) are avail- • Preparation of the nicotine that is delivered via a ciga- able in 21 mg, 14 mg and 7 mg dosage • Maintenance rette, and provides for a more constant strengths. The NRT 16-hour patch (Nico- nicotine level compared to the peak and trol) is available in 15 mg, 10 mg, and 5 In the precontemplation stage, the trough levels that occur with smoking. mg dose strengths. The advantage of the smoker does not believe there is a prob- Compared to a cigarette, a smaller amount 24-hour NRT patch is that it provides for lem with smoking and does not intend to of nicotine is replaced by the NRT deliv- a relatively consistent level of nicotine www.ncpanet.org February 2005 | america’s PHARMACIST 43 plasma concentrations over a 24-hour keep in mind that the nicotine contained 25 or more cigarettes per day. Patients period. As a result, morning withdrawal in a used patch might be of a sufficient should begin therapy with 10 pieces to 15 symptoms may be attenuated and dose to poison a child or pet. The patch pieces per day scheduled every one to two relapse prevented. However, in some should be disposed of by folding the hours. After an initial six to eight weeks of patients, sleep disturbances and night- sticky ends together and placing it in a therapy, the patient may reduce to bet- mares may occur. In these patients, the sealed plastic bag. ween five and eight pieces per day. As 16-hour patch may be a more appropri- Adverse reactions that are specific to with all NRT products, continual usage of ate choice to allow a nicotine-free inter- the patch include mild skin irritation at more than six months may indicate sub- val during sleep. the site of application (up to 50 percent). stituted dependence on the NRT. Gum To initiate smoking cessation therapy, To avoid this adverse effect, the patient specific adverse reactions include gas- the patch strength should match the should rotate the areas for patch place- trointestinal disturbance associated with degree of nicotine dependence. The de- ment daily. Patients may also experience swallowing large amounts of nicotine pendence degree can be estimated by insomnia. If this occurs, the 24-hour (which can occur if the gum is improperly using the brief Fagerstrom Tolerance patch can be removed at bedtime or a 16- used and chewed continuously). Also, the Questionnaire (Figure 2, below). Alterna- hour patch can be used. gum is contraindicated in individuals with tively, a key question to determine smok- temporomandibular joint disease (TMJ) ing dependence is the time to first ciga- Nicotine Gum and in pregnant women. rette. Smokers who routinely have their NRT gum is marketed in 2 mg and 4 mg first cigarette within 30 minutes of wak- strengths under the trade name Nicorette. Nicotine Inhaler ing are moderately to heavily dependent. Nicotine is bound to an ion exchange resin The NRT inhaler is marketed under the Those who have their first cigarettes that releases nicotine when the gum is trade name Nicotrol. This dosage form is more than 30 minutes after waking are chewed. The nicotine in the gum is abs- an inhalational system intended to mimic lightly dependent. A patient who is heav- orbed through the buccal mucosa and is the hand-mouth characteristics associat- ily addicted should begin with the 21 mg essentially not absorbed if swallowed. ed with cigarette smoking. The inhaler is patch, while those with moderate addic- Therefore, proper administration requires supplied as a plastic mouthpiece with tion should start at 14 mg, and those the gum be parked in the buccal area and individual cartridges. Once the patient with light at 7 mg. The manufacturer only chewed intermittently over a 30- inserts the cartridge into the mouthpiece, recommends starting with the 21 mg minute timeframe. To achieve sufficient the cartridge seal is broken and nicotine patch in those patients who smoke more absorption, the patient should not drink is released with each inhalation. The acti- than 10 cigarettes per day. Patients who acidic beverages (soft drinks, fruit juices, vated cartridge may be used for one day. are started on the 21 or 14 mg patch coffee) or eat food immediately before Nicotine is not absorbed via the lungs should taper down to the next lowest using the gum (saliva that is acidic hinders with the inhaler, but instead is deposited patch strength at four to six weeks. At nicotine absorption). Similar to the patch, in the oral cavity. Each inhaler contains the beginning of each day, a new patch the 4 mg gum should be used for heavily 10 mg of nicotine and 1 mg menthol should be applied to a hairless part of the or moderately addicted smokers. The (menthol added to reduce the nicotine body between the neck and waist. When manufacturer recommends starting with oral irritation). Approximately 80 puffs disposing the patch, the patient should the 4 mg gum in those patients who smoke on the inhaler deliver a dose of nicotine similar to smoking a cigarette (1 mg). To Figure 2. Modified Fagerstrom Tolerance Questionnaire achieve adequate nicotine levels, the normal daily dose is between six and 16 1. How soon after you wake up do you 4. How many cigarettes per day do you inhaler cartridges. The recommended smoke your first cigarette? smoke? therapy duration is 12 weeks. Adverse __ Within 5 minutes (3 points) __ 10 or less (0 points) reactions, which are specific to the __ 6–30 minutes (2 points) __ 11–20 (1 point) inhaler, include local mouth irritation, __ 31–60 minutes (1 point) __ 21–30 (2 points) coughing, and rhinitis. Following contin- __ After 60 minutes (0 points) __ 31 or more (3 points) ued use, the irritation associated with the 2. Do you find it difficult to refrain from 5. Do you smoke more frequently during inhaler may become more tolerable. smoking in places where it is forbid- the first hours of waking than during den (e.g., church, library, cinema)? the rest of the day? Nicotine Nasal Spray __ Yes (1 point) __ Yes (1 point) The nicotine nasal spray is available only __ No (0 points) __ No (2 points) by prescription and marketed as Nicotrol NS. The nasal spray delivers approximate- 3. Which cigarette would you hate most 6. Do you smoke if you are so ill that ly 0.5 mg per spray with peak concentra- to give up? you are in bed most of the day? tions occurring within 15 minutes. The __ The first one in the morning __ Yes (1 point) rate and extent of absorption is slower in (1 point) __ No (0 points) patients with rhinitis or the common cold. __ All others (0 points) The nasal spray delivers nicotine more Score > 6 indicate a high degree of physiological dependence. The patient is a candidate for a slowly than smoking a cigarette, but faster higher dosage of a nicotine replacement therapy. than any other NRT dosage. Therefore,

44 america’s PHARMACIST | February 2005 www.ncpanet.org the spray may be suited for smokers with trations of dopamine and norepineprhine the CYP2D6 pathway. Therefore, if drugs high degrees of craving. The spray is are thought to minimize the withdrawal are administered which are metabolized administered in each nostril once or twice and craving that occurs following cessa- by this pathway, lower doses of one or every hour while awake. The usual dose tion of smoking. Specifically, dopamine is both agents may be needed. is a minimum of eight sprays per day, and associated with the reward and pleasure an upper limit of 40. Adverse reactions pathway of nicotine addiction, while the Other Therapies occurring with the nasal spray include noradrenergic effects are related to Pharmacists should be aware that other nasal and throat irritation, rhinorrhea, increased attentiveness and improved therapies have been evaluated for smok- and nausea. Additionally, nicotine nasal performance in repetitive tasks. ing cessation. Lobeline (a nicotine ago- spray is not recommended in patients Bupropion SR is to be administered nist) has been examined in placebo-con- with nasal disorders (e.g., allergy, rhinitis, at a starting dose of 150 mg once daily trolled trials, but to date, no evidence nasal polyps, and sinusitis). for three days, and then increased to exists for its efficacy. Silver acetate (gum, 150 mg twice daily for the duration of spray, lozenge) is thought to work by pro- Nicotine Lozenge therapy. The patient initiates Zyban ducing an unpleasant taste when com- The nicotine lozenge is marketed in 2 mg while still smoking to allow for concen- bined with cigarettes. However, it has not and 4 mg strengths under the tradename trations to achieve steady state levels. been shown effective for smoking cessa- Commit. Similar to the patch and gum, After three days to seven days of thera- tion. Similarly, herbal agents do not cur- the higher dose strength is appropriate for py, the patient should set a quit date and rently have controlled studies supporting moderate to heavily addicted smokers stop smoking completely. The patient their efficacy. Clonidine has been shown and the lower dose strength is appropriate should continue to take Zyban for a effective for smoking cessation and has for the lightly addicted smoker. The man- minimum of seven weeks. Continued been recommended as second-line thera- ufacturer recommends using the time to therapy up to one year has been shown py by the Agency for Healthcare Re- first cigarette to determine which stren- to be effective to maintain cessation and search and Quality (AHRQ). However, gth of lozenge to use. Each lozenge is to be to prevent relapse. side effects such as dizziness and hypo- dissolved (not swallowed or chewed) in The most serious adverse effect asso- tension, as well as withdrawal effects, the mouth over 20 minutes to 30 minutes. ciated with bupropion SR is seizure that may limit its use. Finally, other antide- Compared to nicotine gum, the nicotine is dose dependent (300 mg dose is associ- pressants, specifically fluoxetine (a selec- lozenge delivers 25 percent higher plasma ated with a 0.1 percent incidence). To tive serotonin reuptake inhibitor), and concentration (as measured by area under avoid seizure risks, patients should not nortriptyline (a tricyclic antidepressant) the curve) after a single dose. take bupropion SR if they have a seizure have been evaluated for smoking cessa- However, in one study, plasma concen- disorder, are currently taking a MAOI or tion. Of these agents, nortriptyline shows trations were 25 percent lower for the have been diagnosed with anorexia ner- evidence as a smoking cessation aid, lozenge after a multiple dose regimen vosa or bulimia. Factors which increase while fluoxetine is not effective. comparing every 60-minute administra- the seizure risk include taking concomi- Although the generic form of nortripty- tion for the gum and every 90-minute tant medications, which lower the seizure line is inexpensive, the use of this agent as administration for the lozenge. To improve threshold (i.e., theophylline, systemic a smoking cessation aid is limited because the chances of quitting, the patient should steroids, other antidepressants), excessive of anticholinergic side effects such as dry use at least nine lozenges per day (but not use of alcohol, use of over the counter mouth and light-headedness. For similar more than 20 per day) for the first six stimulants, or agents which may precipi- reasons, using moclebemide for smoking weeks. The recommended duration of tate hypoglycemia such as diabetics treat- cessation is limited because of drug inter- therapy is eight weeks. Adverse events ed with insulin and oral hypoglycemics. actions that are problematic while taking specific to the nicotine lozenge are similar Other common adverse events are monoamine oxidase inhibitors. to those seen for the nicotine gum. headache, dry mouth and insomnia. Unlike NRT therapies, bupropion is cate- Telephone Quitlines Bupropion SR gorized as pregnancy category B (animal Bupropion SR is marketed under the studies have not demonstrated a risk to American Lung Association trade name Zyban and is the only non- the fetus, but there are no human stud- 1-866-QuitYes nicotine replacement therapy agent ies). It is recommended that bupropion approved for smoking cessation. Invest- be used with caution during pregnancy. American Cancer Society igation into bupropion as a possible aid to Drug interactions may occur with 1-800-ACS-2345 smoking cessation began when it was drugs that are metabolized by a similar serendipitously observed that smokers pathway as bupropion (cytochrome P450 Department of Health and Human Services who were prescribed bupropion for their IIB6 [CYP2B6]). These drugs include 1-800-QUITNOW depression reported a decreased smoking orphenadrine, cyclophosphamide, and desire. The action mechanism of bupropi- ifosfamide. Care should be taken to mon- on is not clearly known, but the drug is itor for effects that may result from in- Brenda Jamerson, Pharm.D, is an associate theorized to exert its effect through inhi- creased drug concentrations of either drug. professor in the Department of Clinical bition of dopamine and norepinephrine Further, bupropion and it’s major metabo- Research at Campbell University School of reuptake. The increased synaptic concen- lite hydroxybupropion are inhibitors of Pharmacy in North Carolina.

www.ncpanet.org February 2005 | america’s PHARMACIST 45 7. Which statement is true 12. Which statement is true con- CONTINUING EDUCATION QUIZ regarding withdrawal after cerning the counseling method to Select the correct answer. cigarette smoking? assess the patient’s motivation to a. The peak withdrawal symptoms make a quit attempt? 1. Approximately what percentage occur within 24–48 hours. a. In the precontemplation stage, of adult Americans smoke? b. Withdrawal is precipitated by an the patient believes that smoking a. 40 percent approximate 10 percent decline in is harmful, but is not ready to make b. 10 percent the serum level of nicotine. a quit attempt. c. 25 percent c. Symptoms of withdrawal include b. In the contemplation stage, the d. 35 percent hypersomnia and decreased appetite. patient believes that smoking is d. Relapse to smoking is predicted by harmful, and wants to quit within 2. Which of the following state- the intensity of hypersomnia. the next six months. ments is true? e. All of the above. c. In the preparation stage the patient a. Relapse to smoking is common and has quit smoking and is attempting occurs in approximately 80 percent 8. The risks associated with smok- to prevent relapse. of smokers. ing include which of the following? d. All of the above b. Relapse to smoking is uncommon due a. Nicotine is a potent vasoconstrictor to the efficacy of current smoking resulting in increased blood pressure. 13. Which statement is true cessation aids. b. Environmental smoke causes more regarding NRTs? c. Relapse to smoking is common, but than 35,000 deaths per year. a. All these agents approximately triple the majority of smokers can stay quit c. Smoking is the primary cause of chron- the chance of quitting vs. placebo if they use the current smoking ic obstructive pulmonary disease. alone. cessation aids. d. All of the above b. NRTs are designed to replace up to d. None of the above 90 percent of the nicotine content 9. The Public Health Service from cigarettes. 3. What time frame does it take guidelines on Treating Tobacco c. NRTs should be used in pregnant nicotine to reach the brain follow- Dependence state that: women only if the risks outweigh ing inhalation of cigarette smoke? a. The clinician should recommend the benefits. a. Approximately one minute pharmacotherapy only if the patient d. There are no known contraindica- b. Approximately two minutes has not previously taken a smoking tions to NRTs. c. Approximately 30 seconds cessation aid. d. Approximately 10 seconds b. Every patient should be asked if 14. Which statement is true he/she uses tobacco and advised to regarding NRT patches? 4. Nicotine binds to which type quit if they are a tobacco user. a. A single patch may be worn for up of brain receptors? c. If pharmacotherapy is recommended, to two days. a. Serotonergic receptors the patient should initiate therapy only b. The patch is designed to deliver b. Norepinephrine receptors with a nicotine replacement product. nicotine at a release rate similar c. Nicotinic receptors d. Counseling should be provided to a cigarette. d. Dopamine receptors primarily for those that are heavily c. Initial NRT patch dose selection e. None of the above nicotine dependent. should be based on the level of e. All of the above nicotine dependence. 5. Which statement below is true? d. If sleep disturbances are problematic, a. The half life of nicotine is 20 hours 10. Which agent(s) is/are first-line a patient may better tolerate the 24- b. Nicotine is largely metabolized by pharmacotherapy? hour patch. the liver a. NRT gum and patch only c. The major metabolite of nicotine b. NRT gum, NRT patch, and NRT 15. Which statement is true is cotinine lozenge only regarding nicotine dependence? d. A and B c. All forms of NRT products a. Patients who smoke their first ciga- e. B and C d. All forms of NRT products and rette within the first 30 minutes of bupropion SR waking may be considered moderate- 6. Which agent(s) produce ly to highly dependent. substance dependence? 11. Drug interactions with NRTs b. The Fagerstrom test is a tool used a. Heroin are caused by: to assess nicotine dependence. b. Cigarettes a. Nicotine inhibition of liver metabolism c. The dose of bupropion SR should c. Alcohol b. Competition with nicotine for renal be selected based upon degree of d. All of the above elimination nicotine dependence. c. Sudden cessation of smoking which d. A and B only normalizes liver metabolism e. A, B and C d. None of the above

46 america’s PHARMACIST | February 2005 www.ncpanet.org 16. Which statement is true End Nicotine Addiction With regarding NRT gum? Smoking Cessation Therapy a. The nicotine from the gum is absorb- February 2005 (expires February 1, 2008) ed from saliva that is swallowed. FREE ONLINE C.E. Pharmacists now have online access to NCPA’s CE programs b. Patients should be instructed to chew through Powered by CECity. By taking this test online—use the CECity link on the gum over a 10-minute timeframe. c. The patient should begin therapy NCPA’s website www.ncpanet.org—you will receive immediate online test results with 10 to 15 pieces of gum per day. and certificates of completion at no charge. d. All of the above To earn continuing education credit: ACPE Program 207-000-05-002-H01 17. Which statement is true regarding NRT inhaler? A score of 70% is required to successfully complete the CE quiz. Failure to achieve a a. Approximately 80 puffs of the inhaler passing score will result in one free reexamination. Please allow at least four weeks deliver a dose similar to one cigarette. for notification of scores and issuance of CE certificates. b. The inhaler contains both nicotine and menthol. Record your quiz answers and the following information on this form. K c. Nicotine from the inhaler is absorbed NCPA Member License via the oral cavity. NCPA Member No. ______State ______No.______K d. All of the above Nonmember State ______No.______State ______No.______18. Which statement is true Mail this form and $7 for manual processing to: regarding NRT nasal spray? NCPA, 100 Daingerfield Road, Alexandria, VA 22314 a. Similar to other forms of NRT thera- Name ______py, the spray is available OTC. Pharmacy Name ______b. The nasal spray delivers nicotine at the Address ______fastest rate of any NRT dosage form. City ______State ______Zip ______c. The rate of absorption may be faster Phone Number (store) ______(home)______in patients with rhinitis. Store E-mail ______Date quiz taken ______d. All of the above

Quiz: Shade in your choice 19. Which statement is true regarding NRT lozenge? a b c de abcde a. The lozenge should be chewed for 1. KKKKK 11. KKKKK adequate nicotine absorption. 2. KKKKK 12. KKKKK b. The recommended duration of 3. K K K KK 13. K K K KK therapy is six months. 4. KKKKK 14. KKKKK c. The patient should use a minimum 5. KKKKK 15. KKKKK of nine lozenges per day for the first six weeks. 6. KKKKK 16. KKKKK d. All of the above 7. K K K K K 17. K K K K K 8. KKKKK 18. KKKKK 20. Which statement is true 9. K KKKK 19. K KKKK regarding bupropion SR? 10. K K K K K 20. K K K K K a. The mechanism of action is thought to Quiz: Circle your choice be via inhibition of dopamine reuptake. b. When starting therapy, patients should 21. Is this program used to meet your mandatory C.E. requirements? a. yes b. no be instructed to continue smoking for 22. Type of pharmacist: a. owner b. manager c. employee at least three days before setting a quit 23. Age group: a. 21–30 b. 31–40 c. 41–50 d. 51–60 e. Over 60 date and stopping smoking. 24. Did this article achieve its stated objectives? a. yes b. no c. Continued therapy for up to one year has been demonstrated effective to 25. How much of this program can you apply in practice? prevent relapse. a. all b. some c. very little d. none d. Patients should not take bupropion How long did it take you to complete both the reading and the quiz? ____ minutes SR if they have a seizure disorder. e. All of the above NCPA® is approved by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. NCPA has assigned two contact hours (0.2 CEU) of continuing education credit to this article. Eligibility to receive continuing education ® credit for this article expires three years from the month published.

www.ncpanet.org February 2005 | america’s PHARMACIST 47 FOR YOUR PHARMACY

New Product News

Methylin Oral Solutions for ADHD treatment. Methylin Momentus Promotes Chewable Tablets are available in a 2.5 mg, 5 mg and 10 mg Good Health With dose. The Methylin Oral Solution is available in 5 mg/ 5 ml and Healthy Moments 10 mg/ 5 ml dose. For more information, visit www.alliant- Momentus Solutions, LLC a New pharma.com. Jersey-based company, has recently launched Healthy Moments, a diet- Roxane Receives Approval ary intake for adults and children. For Two New Rx Tablets Healthy Moments are flavored, Roxane Laboratories, a subsidiary of Boehringer Ingelheim, micro-thin strips that has received approval products equivalent to Larima and dissolve on the tongue and pro- Lithobid. Mefloquine Hydrochloride Tablets, 250 mg, will be vide 100 percent of recommended dietary available in unit-of-use bottles of 25 and are AB rated to intake. For more information please contact Larima (mefloquine hydrochloride) Tablets, 250 mg. Roxane Diane Scherrer, public relations, at has also announced the approval of Lithium Carbonate Idea Lab Inc., at 856-642-0007, or via e-mail: Extended Release Tablets USP, 300 mg. The product will be [email protected]. available in bottles of 100 and 500, and is AB rated to Lithobid (lithium carbonate, USP) slow-release tablets, 300 mg. Full prescribing information is available on the Roxane website (www.roxane.com) or by calling 800-962-8364. Schiff Launches Lubriflex Joint Care Supplement Doak Dermatologies Schiff has introduced Lubriflex, a joint care supplement. Products Clearly Treat Acne Lubriflex combines three formulas, Uniflex, an antioxidant that Doak Dermatologies, a subsidiary of Bradley Pharmaceuticals, protects cartilage and joints; Joint Fluid, a compound that helps Inc., has introduced Zoderm 6.5 percent cream, Zoderm 6.5 joints glide easily and smoothly; and Glucosamine, an ingredi- percent cleanser, and Zoderm 6.5 percent gel for acne treat- ent known for supporting joint cartilage and maintaining ment. Zoderm 6.5 percent is for the majority of patients, while healthy joint function. The result: a supplement that can pro- Zoderm 4.5 percent is the option for patients with dry and sen- vide relief from joint discomfort and improve flexibility and sitive skin that requires milder topical formulation. Zoderm 8.5 joint function in just a few days. For more information, call 800- percent is for patients with noticeably oily skin which requires 526-6251 (8 a.m. to 5 p.m., MST) or visit www.lubriflex.com. a stronger topical formulation. For more information, call 800- 929-9300, or visit www.bradpharm.com. Santarus Introduces Zegerid As Treatment for GERD Santarus, Inc. has launched Zegerid (omerazole) powder for oral suspension. This will provide a new treatment option for patients with gastroesphageal reflux disease (GERD). Zegerid is an immediate-release PPI that achieves peak plasma levels in approximately 30 minutes and provides 24-hour acid control. Zegerid exerts strong acid suppression shortly after administration of the first dose when taken before the first meal and continues to suppress gastric acidity throughout the day. Zegerid is indicated for treatment of symptomatic GERD, for short-term treatment of erosive esophagitis, to maintain healing of erosive esophagitis, and for short-term treatment of duodenal ulcer. For more information, call 888-778-0887 or visit www.zegerid.com.

Alliant Announces FDA Approval for Methylin Chewable and Oral ADHD Rxs Alliant Pharmaceuticals Inc., has announced Food and Drug Administration approval of Methylin Chewable Tablets and

48 america’s PHARMACIST | February 2005 www.ncpanet.org continued from page 52 provide to Medicaid recipi- But until that happens, There would be an annual ents, Barton said…. Medicaid drug reimbursement limit of $20,000 on the amount “because they are so hesitant The discrepancy between will remain a fleecing of Amer- an individual could exclude to address pricing in the pri- costs and reimbursements ica, with plenty of blame to go from federal taxes each year. vate sector.” was just one of several prob- around. For a typical American in the The report makes three lems that led George Reeb, an Chip Reid, NBC News, 25 percent tax bracket, this recommendations to CMS to assistant inspector general in December 7, 2004 would provide an annual tax address reimbursement dis- the Department of Health and savings of up to $5,000. parities: that the agency Human Services, to conclude Small Business Group The Senate bill joins its share average manufacturer that “the Medicaid program Applauds Senate companion House version price data with states; that it continues to pay too much for Leadership On (HR 4849), which has been conduct further research on prescription drugs.” Retirement Security lead by Rep. Nancy Johnson the factors that affect state In one example, Medicaid Americans for Secure (R-CT), Rep. John Tanner (D- Medicaid drug prices; and could have saved more than Retirement—a coalition repre- TN), Rep. Phil English (R-PA), that it annually review states’ $85 million in 2001 if drug senting a broad cross-section and Rep. Stephanie Tubbs reimbursement data to target payments were uniform of interests from women’s Jones (D-Ohio)…. technical assistance to higher across all states, Reeb said. groups and rural organizations Groups who traditionally paying states. States also do a poor job to consumer advocacy and have not had access to ade- Martin Sipkoff, Drug Topics, managing the rebate payments taxpayer organizations—today quate pension coverage are November 8, 2004 they receive from drug manu- commended Senators Gordon especially at risk. They in- facturers that take part in the Smith (R-OR) and Kent Conrad clude women, farmers, the Pharmacists Accused Medicaid program, he said. (D-ND) for their leadership on self-employed, part-time Of Inflating Prices Mark Sherman, retirement security following workers, employees of small On Pearl Harbor Day, the Associated Press, their introduction of the Retire- firms, and minorities, many House Energy & Commerce December 7, 2004 ment Security for Life Act in of whom are middle income. Subcommittee on Oversight the United States Senate. According to Census Bureau revealed the results of infor- Congress Investigates The bill is designed to give data, about 60 percent of mation supplied by large Medicaid Rx Prices Americans more control over workers with household in- retail pharmacy chains in Are the nation’s pharmacies their retirement standard of comes of less than $50,000 response to subpoenas issued fleecing America? living and empower them to lack pension coverage. a year ago. “It seems to me this is the receive a steady income for Members of the coalition “Evidence gathered by proverbial $500 toilet seat of life. According to the co-spon- include a growing list of di- the committee suggests that Medicaid,” says Rep. Greg sors, the bill was introduced verse organizations, including Medicaid reimbursement is Walden, R-Ore. in the final days of the 108th the following: American Agri- more generous than that of An example—Fluoxetine— Congress to establish a clear culture Movement of Arkansas, most private payers,” said the generic version of the pop- priority for attention by the American Agri-Women, Amer- Rep. Joe Barton, (R-Texas), ular antidepressant Prozac. 109th Congress. [It was sched- ican Corn Growers Associa- chairman of the House Here’s how congressional in- uled to be reintroduced again tion, American Council of Life Energy and Commerce vestigators say it works: phar- when the new Congress con- Insurers, Business and Profes- Committee. The panel’s macists pay 36 cents a capsule, vened in January]. A similar sional Women/USA, Citizens investigation into Medicaid but are reimbursed 98 cents a bill introduced in the House Against Government Waste, drug prices was the subject capsule by Medicaid, nearly earlier [in 2004] has already Committee of Annuity Insur- of a hearing Tuesday. three times the real price. garnered significant bipartisan ers, Financial Services Round- Information supplied by Under the current system, support, particularly from table, Hispanic Business five large retail pharmacy that Medicaid reimbursement House Ways & Means Comm- Roundtable, National Assoc- chains showed that drug rate is set by the drug manu- ittee members. iation for Variable Annuities, stores paid an average of 22 facturers. Committee investiga- The Retirement Security National Association of Farmer cents for seven widely pre- tors say in-house e-mails show for Life Act provides a tax Elected Committees, National scribed generic medicines, drug companies and pharma- incentive that would encour- Community Pharmacists but received 56 cents in reim- cists have worked together to age retirees to choose retire- Association, National Con- bursements from Medicaid, keep Medicaid reimbursement ment vehicles for their indi- sumers League, National Tax- the investigation found…. rates artificially high… vidual after-tax savings, such payers Union, Small Business Barton said pharmacists “The system is broken and as annuities, that provide a Survival Committee, Soybean generally acknowledge that there really needs to be a reim- guaranteed lifetime income. Producers of America, the they are paid too much for bursement rate set by some- Under the proposal, individu- Latino Coalition, U.S. Chamber some drugs. But they argue body outside,” says Pamela als would not pay federal of Commerce, Women Entre- that the inflated prices are Marrs, the senior vice presi- taxes on one-half of the in- preneurs, Inc., Women Impact- necessary to offset inadequate dent and CFO of drug manu- come generated by annuities ing Public Policy, Women’s fees for other services they facturer Dey, Inc. that make lifetime payments. Institute for a Secure Retire-

50 america’s PHARMACIST | February 2005 www.ncpanet.org ment, Women in Farm Econo- So it’s time to exploit your nothing more than an old- Fraud, an advocacy group mics and, Women Presidents’ customer’s frustration—time fashioned kickback,” based in Washington, D.C. Organization. to co-opt him in your crusade Meehan stated at the time. Ed Silverman, Newark PRNewswire, against the PBM forces of “This case serves as an [NewJersey] Star-Ledger, December 7, 2004 darkness. Send him out there, example that the conse- December 2, 2004 empowered with his anger quences of stepping over Grassroots and armed with documenta- [the] line can be costly.” Express Scripts Hit Open Patients’ tion straight to his health Skolnick points to that case With Class Actions In Eyes About PBMs plan administrator’s office. as a precedent, adding that Wake of Lawsuit By [LETTER TO DRUG TOPICS] Let him ask the tough ques- Medco’s payment to United New York Attorney The next time your HMO tions and demand answers. Health is “precisely the kind General customer complains about Together we can win. of business transaction you St. Louis—Pharmacy Benefit his increased co-pay or lack Thanks, Eliot. would expect the Department management giant Express of coverage for the drug his Steven Smolin, New York, of Justice to look at” now.… Scripts Inc. has been hit with physician prescribed, edu- November 8, 2004 Indeed, Skolnick down- at least four class lawsuits cate him! Let him know that graded United Health from alleging that the company arti- his PBM is probably a wolf Probes Could Pinch buy to neutral in mid-October ficially inflated its stock prices in sheep’s clothing, lining United Health due to her worries about the by making false and mislead- its own pockets at the Already, federal prosecutors Spitzer investigation. Skolnick ing financial statements dur- expense of his employer’s have begun examining a trans- reasons that Spitzer’s probe, ing late 2003 and 2004. insurance premium burden, action—described as a kick- which started with insurance The lawsuits were trig- resulting in skyrocketing back—involving the giant broker Marsh & McLennan, gered by the Aug. 4 an- premiums and less corpo- health insurer [United will spread throughout the nouncement of a $100 mil- rate monies available for Health]. Meanwhile, insurance industry to include lion lawsuit against salary increases and job a veteran health care analyst health care companies. And Express Scripts filed by security. has warned that New York she fears that a “messy state New York Attorney Gen- Your customer is not inter- Attorney General Eliot Spitzer exam” could make United eral Eliot Spitzer (D) alleg- ested in the “AWP-18 percent” could single out United Health especially vulnerable. ing that the company had think or your paper thin mar- Health in his own examina- Specifically, Skolnick says diverted millions of dollars gins, but making him realize tion of kickbacks inside the that United Health failed to in drug company rebates that he and his employer are insurance industry. file its so-called plan of broker to itself from the state of being “used” and probably In court documents filed in commissions for at least two New York, had inflated the “scammed” if not “ripped off” late November, the U.S. attor- years in New York. Moreover, cost of generic drugs, and by his PBM should spark his ney’s office in Philadelphia she notes, health insurers are had otherwise violated its interest… announced plans to question relying on such plans to justi- contract with the state…. Mr. Spitzer [N.Y. Attorney Gino Tenace—later identified fy commissions as legitimate Named as defendants General Eliot Spitzer] also as a United Health employ- payments instead of improper along with the company are joined in an action against ee—as part of a big whistle- kickbacks. several of the company’s Medco Health Solutions with blower investigation of phar- Melissa Davis, The Street.com, directors. Barrett Toan, chief 19 other states. A settlement macy benefit manager Medco. December 6, 2004 executive officer, and George was reached with this PBM Paz, chief financial officer for $29 million for drug PAST PRECEDENT Top Rx Benefits until March 2004, were switching practices. Accord- Fulcrum analyst Sheryl Manager Tied named in all four of the law- ing to Mr. Spitzer, “Medco Skolnick senses possible To $200 Million In suits. Edward Stiften, chief encouraged physicians and trouble… Kickbacks information officer beginning other prescribers to switch For one thing, Skolnick As drug prices rise, though, in March 2004, was named in patients to different prescrip- says, federal prosecutors al- these middlemen have become three of the lawsuits. Edward tion drugs without disclosing ready have cracked down on the focus of increasing govern- J. Tenholder, chief informa- that the switches benefited a similar arrangement. In late ment scrutiny. Federal and tion officer and principal Medco by increasing rebate July, U.S. Attorney Patrick state officials want to know accounting officer, was payments from drug manu- Meehan—whose office is now whether pharmacy benefits named in two of the lawsuits. facturers. Medco represented leading the Medco probe— managers are passing along David Lowenberg, chief oper- to prescribers that a switch fined Schering-Plough $345 their best prices to state agen- ating officer, and Darryl would result in savings to pat- million for making question- cies and consumers. Weinrich, chief accounting ients and health plans, when, able payments to Cigna in “Ultimately, consumers officer and controller, were in fact, at times the drug exchange for business. and taxpayers are footing named in one of the lawsuits. switches increased costs, pri- “Schering used terms like the bill in the form of BNA Pharmaceutical Law & marily in follow-up doctor ‘data fee’ and ‘value added’ increased costs,” said Patrick Industry Report, visits and tests.” as camouflage for what was Burns of Taxpayers Against October 8, 2004

www.ncpanet.org February 2005 | america’s PHARMACIST 51 NOTES FROM CAPITOL HILL

Congress Scraps Call For National Rx-Compounding Standards

ommunity pharmacists Drug Compounding TARGET: PBM III succeeded in getting Language Revised In Mark Your Calendar! C Don’t miss NCPA’s 37th Annual Conference on House and Senate conferees Recently Passed National Legislation and Government Affairs. Spending Package to strip from the omnibus Held at the new Mandarin Oriental Hotel, appropriations report lan- NATIONAL STANDARD Washington, D.C., May 1–3, 2005. guage a provision that could SCRAPPED For more information, call 800-544-7447, or visit www.ncpanet.org. have led to “national enforce- The report accompanying the To register visit our website at www.ncpanet.org. able standards” for com- Senate agriculture spending pounding prescription drugs. bill called for “enforceable compounding. The FDA [had] percent reduction in national However, the report language national standards” for drug 60 days to respond to the com- spending on Medicaid. still urges the U.S. Pharmaco- compounding… plaint, filed Sept. 27. Extrapolating that to all peia (USP) to expand the The language contained in The suit, brought by both Medicaid drug expenditures, number of monographs for the omnibus appropriations veterinary and human drug that could mean an annual compounded preparations. bill recognizes that “re-existing pharmacies, was prompted in Medicaid savings of $4 billion The Senate Appropriations monographs…would infringe part by an internal FDA policy a year—which has some pow- Committee had surprised the on the professional obligation banning the compounding of erful federal legislators taking National Community Pharm- of a medical practitioner to animal drugs from bulk ingre- notice. acists Association when it call- prescribe optimal medications dients. The FDA has taken the The report “raises alarms ed for the national monograph for their patients”… position that compounded that warrant immediate atten- standards, but an NCPA source John Rector, senior vice drugs are “new drugs” subject tion and action,” Senate Fin- says the group lobbied hard president and general counsel to the same application pro- ance Committee chair Chuck against it. of the National Community cess as manufactured drugs. Grassley (R-Iowa) told the “The conferees do not Pharmacists Association, said But the agency has exercised Boston Globe. “I can think include the language in the such language could have hurt enforcement discretion to of 86.7 million reasons why Senate report on human drug community pharmacists. “The allow legitimate forms of [the Centers for Medicare & compounding,” according to end result is a good result for pharmacy compounding. Medicaid Services] should the new report language. the typical community phar- Catherine Hollingsworth, fix this problem.” “The conferees believe that macist,” he said. BNA Industry Law & Industry, “It’s highly ironic that OIG drugs for human use com- Ten compounding pharma- December 3, 2004 would take this stance,” pounded by pharmacists in cies recently filed suit against agreed John Rector, senior response to a lines on quality, the Justice Department and Medicaid Rx Pricing vice president for government purity, and strength, and FDA (Food and Drug Admin- OIG STUDY ON MEDICAID affairs and general counsel preparation-specific mono- istration), claiming that the DRUG PRICES INFURIATES for the National Community graphs when they exist.” agency has taken illegal, arbi- R.PH.S Pharmacists Association, FDA Week, trary enforcement against A recent Office of Inspector December 3, 2004 them for engaging in drug General study of how much continued on page 50 states pay R.Ph.s for Medicaid drugs outrages some industry Predictably PBM leaders… Titled “Variation in State Copy Cat? Conspirator? Medicaid Drug Prices,” issued Within recent weeks, both Medco and Caremark have radically September 24, the OIG report increased the transaction fees charged to pharmacies in their sampled Medicaid prices for 28 respective networks. The Medco increase yields in one year enough cash to cover their two recent major settlements with brand-name and generic drugs 21 state attorneys general and health plans. You have to won- in 42 states. OIG concluded der whether they have informed their clients about this unjusti- that those states could have fied cost shift to NCPA members, especially in various states, saved $86.7 million in 2001 if including South Carolina, Oklahoma, Ohio, and Virginia, where they had uniformly paid the Medco has contracts for the state employee programs. NCPA lowest prices. For the sampled BY JOHN RECTOR, ESQ., Sr. Vice has protested these arbitrary PBM surtaxes. drugs, the states would have President for Government Affairs saved $13 million, for a 13 and General Counsel for NCPA.

52 america’s PHARMACIST | February 2005 www.ncpanet.org