AJP Fall 2014

Fall 2014 arizona Journal oF Pharmacy 1

Fall 2014 Vol. 6, No. 3

arizoNa JourNal oF Pharmacy THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION

BROUgHT TO YOU BY PHARMACY NETwORk OF ARIZONA

Ann Sears, R.Ph.AzPA President 2014-2015

AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN Inhalation Aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding AEROSPAN Inhalation Aerosol may reduce or eliminate the need for oral corticosteroids.Important Limitations of Use: AEROSPAN Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. AEROSPAN Inhalation Aerosol is NOT indicated in children less than 6 years of age.Important Safety Information

AEROSPAN Inhalation Aerosol is contraindicated as a primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. AEROSPAN Inhalation Aerosol is not a bronchodilator and is not indicated for rapid relief of bronchospasm. In clinical studies with flunisolide, localized fungal infections of the mouth, pharynx, and larynx have occurred. If oropharyngeal candidiasis develops, AEROSPAN Inhalation Aerosol therapy may need to be interrupted under close medical supervision. Patients should be instructed to contact their physician immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with AEROSPAN Inhalation Aerosol. During such episodes, patients may require therapy with systemic corticosteroids.

Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals and should avoid exposure to chicken pox or measles. Inhaled corticosteroids should be used with caution, if at all, in patients with untreated active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex. During reduction and withdrawal of oral corticosteroid doses, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. Patients should taper slowly from systemic corticosteroids if switching to AEROSPAN Inhalation Aerosol.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, reduce the AEROSPAN Inhalation Aerosol dose slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic corticosteroids. Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, including flunisolide. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care. Orally inhaled corticosteroids, including flunisolide, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of children and adolescents receiving AEROSPAN Inhalation Aerosol. To minimize the systemic effects, patients should be titrated to the lowest dosage that effectively controls symptoms. Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including flunisolide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of intraocular pressure, glaucoma, and/or cataracts. Bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with AEROSPAN Inhalation Aerosol, treat immediately with a fast-acting inhaled bronchodilator. Discontinue AEROSPAN treatment immediately and institute alternative therapy.

The most common adverse reactions seen in two 12-week, pivotal, double-blind, placebo-controlled, clinical trials performed with AEROSPAN (160 mcg BID) were pharyngitis (16.6%), rhinitis (15.7%), headache (13.8%), cough increased (5.5%), allergic reaction (4.6%), and vomiting (4.6%).

Indications

Please see Full AEROSPAN Prescribing Information available at this booth.

Contact Meda Pharmaceuticals Inc. at 855-653-63252014 Meda Pharmaceuticals Inc. 03/14 AER-14-0048

ICS=Inhaled corticosteroid.

Introducing The only ICS available with a built-in spacer

inhalation aerosol(flunisolide)


AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN Inhalation Aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding AEROSPAN Inhalation Aerosol may reduce or eliminate the need for oral corticosteroids.Important Limitations of Use: AEROSPAN Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. AEROSPAN Inhalation Aerosol is NOT indicated in children less than 6 years of age.Important Safety Information

AEROSPAN Inhalation Aerosol is contraindicated as a primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. AEROSPAN Inhalation Aerosol is not a bronchodilator and is not indicated for rapid relief of bronchospasm. In clinical studies with flunisolide, localized fungal infections of the mouth, pharynx, and larynx have occurred. If oropharyngeal candidiasis develops, AEROSPAN Inhalation Aerosol therapy may need to be interrupted under close medical supervision. Patients should be instructed to contact their physician immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with AEROSPAN Inhalation Aerosol. During such episodes, patients may require therapy with systemic corticosteroids.

Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals and should avoid exposure to chicken pox or measles. Inhaled corticosteroids should be used with caution, if at all, in patients with untreated active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex. During reduction and withdrawal of oral corticosteroid doses, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. Patients should taper slowly from systemic corticosteroids if switching to AEROSPAN Inhalation Aerosol.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, reduce the AEROSPAN Inhalation Aerosol dose slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic corticosteroids. Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, including flunisolide. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care. Orally inhaled corticosteroids, including flunisolide, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of children and adolescents receiving AEROSPAN Inhalation Aerosol. To minimize the systemic effects, patients should be titrated to the lowest dosage that effectively controls symptoms. Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including flunisolide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of intraocular pressure, glaucoma, and/or cataracts. Bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with AEROSPAN Inhalation Aerosol, treat immediately with a fast-acting inhaled bronchodilator. Discontinue AEROSPAN treatment immediately and institute alternative therapy.

The most common adverse reactions seen in two 12-week, pivotal, double-blind, placebo-controlled, clinical trials performed with AEROSPAN (160 mcg BID) were pharyngitis (16.6%), rhinitis (15.7%), headache (13.8%), cough increased (5.5%), allergic reaction (4.6%), and vomiting (4.6%).

Indications

Please see Full AEROSPAN Prescribing Information available at this booth.

Contact Meda Pharmaceuticals Inc. at 855-653-63252014 Meda Pharmaceuticals Inc. 03/14 AER-14-0048

ICS=Inhaled corticosteroid.

Introducing The only ICS available with a built-in spacer

inhalation aerosol(flunisolide)arizoNa JourNal oF Pharmacy

THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATIONBROUgHT TO YOU BY PHARMACY NETwORk OF ARIZONA

Vol. 6, no. 3 FALL 2014

www.azpharmacy.org

Presidents Message 4CEOs Message 5

A Look Back - Antacid Container 13Time Capsule 13CASE REPORT: Breathalyzers + Inhalers = the Potential for False-Positives 14Risk of Serotonin Syndrome with ConcomitantUse of SSRI/SNRI and Triptans 17Roundtable on Continous Quality Assurance 20Arizona Delegates Report on 66th Annual Session 25

Association News 6 New Members 6 Annual Convention Recap 8 PAPA 9Legislative Update 10Arizona State Board of Pharmacy 11Technician Spotlight 12Drug Information Question 27 Academy News Community Practice Academy 30 Geriatric Care Academy 30 Health-System Academy 31 Managed Care Academy 31 Student Pharmacist Academy 32 Technician Academy 32Continuing Education 33 Pharmacotherapy for Weight Loss 33 New Rules for CPE Monitor Reporting 37 Geriatric Patient Care: Systematic Review 38

Meda PharMaceuticals 2 PtcB 11clearant 16Paas 26PharMacy Quality coMMitMent 26PharMacists life insurance 47rx relief 48

EditorKelly Ridgway, R.Ph.ChiefExecutiveOfficer

Editorial BoardWhitney Rice, Pharm.D. Andrea Burns, Pharm.D.Christi Jen, Pharm.D. Jaime Baily, Pharm.D. Scott Hardy, Pharm.D. Kalani Anderson, C.Ph.T.

iN this issuE ....

FEaturEd articlEs

dEPartmENts

maNagiNg EditorRachel Jimenez Marketing and Communications Mgr

adVErtisErs

Presidents Message Its an honor and privilege for me to serve as the President of AzPA for 2014-2015, thank you to everyone for making me feel so welcome. I would also like to specifically thank Kelly - our CEO - the amazing AzPA staff, and the outgoing and incoming boards for their commitment to AzPA. We are truly blessed.

My vision for next year: Cooperation

When I was 12 years old, I wanted to become a pharmacist. That goal never changed. I am one of the lucky ones, because I am living my dream. Somtimes it is easy to forget about dreams when we are living the day to day.

It doesnt matter whether we are students, technicians, or pharmacists. It doesnt matter where we work. Most of us joined pharmacy or healthcare, because we wanted to make a difference. We wanted to help improve patients lives. Our last conventions theme was Pharmacists as Providers, Changing the Game. I submit to you that pharmacy and playing games actually have some similarities.

Games boil down to two types: competitive and cooperative. Pharmacy, healthcare, and life for that matter, falls into these same two categories. I believe that we make conscious and unconscious choices to be competitive or cooperative every day. We see this in our relationships at home and with our friends, on the job, in our profession and in our communities. There is nothing wrong with healthy competition; especially, if we let it bring out the best in us or make positive strides for our patients. The AzPA mission is to educate, advocate for, protect and advance the profession of pharmacy in this state. We made great strides this last year in moving forward on the Pharmacists as Providers issue, but we have a lot more work to do on many issues still ahead. The staff of AzPA, Kelly as CEO, and the Board cannot effect change in this state alone.

My mission this year is to change the game to one of cooperation, but I need your help. Join me. Become a member of AzPA if you arent already. If you are a member, get involved. Share your unique talents with us, so we can utilize your abilities in the best possible area. Members, link your Frys card to the AzPA code. Buy your gift cards from the AzPA office. Do you need something from Amazon? Go to azpharmacy.org and click on the amazon link before you shop. Those few things cost you nothing extra, but go a long way to helping the AzPA mission. Go further and support pharmacy political action by making a contribution to PharmPAC. Invite others to join AzPA. Ask them to contribute to our team. Already doing all of these things I thank you. Lets always remind each other that we all matter and we all have something important to contribute.

Protecting the future of pharmacy in this state is in all of our hands and I hope that you feel empowered, excited, and welcome to be a part of our cooperative team. I look forward to this year and all that we can do together.

Ann Sears, R.Ph.President

AzPA Board of Directors2014-2015


CEOs Message As we approach a new fiscal year at AzPA, and charge forward with our new President, Ann Sears, the message of leadership seems to be a timely one. The pharmacy profession is reaching a tipping point. We are expanding and changing more rapidly than any other health profession and we need leaders now more than ever. Our profession is embarking on a quest to obtain national provider status for pharmacists under Medicare Part B. Most states are also modifying state practice acts to coincide with the national efforts. This requires time, money, resources, perseverance and leaders to champion this effort in our local communities.

Leadership does not require serving as a pharmacy director or on the board at a state or national pharmacy association - although those positions are important - being a leader in pharmacy starts with your daily interactions with your patients, coworkers and community. You represent our profession and you impact how people perceive pharmacists. Pharmacy leaders do all they can do to protect their patients, improve patient care, advance and protect their profession no matter what practice setting they work in, no matter their title, and no matter the years of experience, residency training, etc.

Although you have taken the important step participating in your state pharmacy association, how many of your colleagues have? I genuinely believe that involvement and engagement in your state and respective national association is essential in order to preserve and advance our profession. This is not a one way relationship. Active involvement allows you to stay connected and keeps the pharmacy fire burning, the fire that was started when you stepped onto your college of pharmacy campus for the first time, the fire that fuels the desire you feel to make a difference, the fire that produces change and innovation in our profession. Something happens when you are involved and surrounded by others who are committed to the same goal of advancing the profession; it keeps you energized and motivated about the profession of pharmacy.

One of my favorite quotes on leadership: One of two things will happen if we do not lead: Either no one will lead and there will be chaos or someone will fill the vacuum who doesnt share our values, - Condoleezza Rice

Leadership entails the ability to lead and grow your own ambitions while others, but it also means serving first. True leaders bring others along to help them grow, so that they can one day be leaders too.

I stand here, not as your state association CEO, but as a fellow pharmacist. I, like all of you, have a desire to serve and advance the profession. I need your help and expertise to make provider status for pharmacists a reality at the state level. Your national association CEOs need your help to make it happen. Get involved, bring along a friend, find a mentor and share what pharmacists can and are doing in the lives of our patients.

Kelly Ridgway, R.Ph.Chief Executive Officer

Arizona Pharmacy Association


ASSOCIATESAngie Dik John DikRachel Ray

ASSOCIATION NEWS

WELCOME NEW MEMBERSPHARMACISTSNilesh Agrawal Majed Al YamiAmy BataoelChris BrettfeldEric BurkeJamie ChichesterKenneth DanielsMissy DukeDorian Hollingworth FosterJohn HowellKimberly KustronStephanie SandersMichael SmithMargie StevensWendy TolerThomas Wennergren

TECHNICIANSAdriana CarrascoSo DongJyia GilmerElizabeth SimpsonTimothy TribbleLuz Vasquez-RashanJie Zhou

STUDENTSZachary BrownMatteo BuompensieroParis CookBob CurryMarcelia DormanCesar FigueroaAraksya GluazaryanWilliam GrandtNicole GraybillMichael GriffithDominick GrossoMaduni HemachandraYulia IlyushenkoMelissa JohnsonElvina KarabasMarilyn LaBashZachary LancasterNgoc Le

Vahe LepedjianRebecca LuntFranco MarzellaSteven MeadeHadley NeidhardtMagdalene OTooleKari QuimbiulcoEmily RamirezJoseph SimonsenLacey SimpsonPhuong TranBrian WinLoc (May) Woodland

cheers For Volunteers!

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

Talia Akoh-ArreyMark BankMark BoesenMitchell BuckleyKacey CarollDimpa ChoskiJoe ElAshkar Pearce EngelderMartin FaridianSophia GallowayDawn Knudsen GerberLisa GoldstoneJonathan GriffinTom Van Hassel Richard N. Herrier

Marcella HonkonenRebekah M. JackowskiWilliam JonesLindsay KittlerNicole KittsSara KastratiMarilyn LaBashKaren LewisBob LipsyBetty Louton Monica MalapitEvan Mallory Grant MetcalfNicole Murdock

MISSION STATEMENT

The Arizona Pharmacy Association is committed to serving and

representing all practice settings.

AzPA will foster safe and effective medication therapy, promote

innovative practice, and empower its members to serve the

health care needs of the public.

VISION

Empowering pharmacy professionals to provide optimal patient care.

Stay connected!

Like us on Facebook@AzPharmacyAssociation

Follow us on Twitter@azpharmacy


The Voice of Pharmacy in Arizona

John E. MurphySaul OrtegaReema PatelQuan Pham Elizabeth PoggeWhitney Rice Harshal ShahJay ShethElliott M. SogolRosy Vallin

Fall 2014 arizona Journal oF Pharmacy 7Association News

Dr. Oliver (Ollie) V. Waite, Jr., (1931 - May 1, 2014)

IN MEMORY OF ...

Dr. Waite was a longstanding member of AzPA. He served and fought as a Marine in the

Korean War. He worked as a pharmacist in Nebraska. Then he moved to Scottsdale, Ariz., where he conducted clinical research for 20 years and taught as a professor at DeVry University. At the age of 83, he was diagnosed with cancer and passed away a month later. We offer our condolences to Dr. Waites family: his wife Mary Anne; sons, Terry (Karen), Tim (Kristie) and Tom (Rachel); daughters, Elizabeth (Dan), Katie (Wayne), Mary Ellen (James) and Sheila (Chris); brother, Robert, and sister, Judith; as well as his 28 grandchildren and 19 great grandchildren.

SAVE THE DATE!FALL CONFERENCE

NOVEMBER 14-15, 2014Kroc Corps Community Center, Phoenix

SAVE when you register EARLY! Register today! azpharmacy.org

Friday, Nov 14

Psychiatric Certificate Program

Diabetes Certificate Program

Saturday, Nov 15

6.0 CE hours

Diabetes Meter Training Workshop

(Pharmacy Technicians only)

SGLT2 Inhibitors in Diabetes Management

Medical Devices in Pharmacy Practice

And more! #azpaFall

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Conference

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ovid

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optim

al

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nt ca

reStay connected on Social Media with hashtag

Do you know someone who is not a member of the Arizona Pharmacy Association?

Invite them to join the only statewide organization that represents the

pharmacy profession in Arizona.

Annual dues for a pharmacist are just $20 per month!

Visit the AzPA website at www.azpharmacy.org to join online or to download a printable Membership Investment Statement.

SUPPORT INGPHARMACISTSADVANCING CAREERS

Find the best jobs and highly qualifiedpharmacists Arizona has to offer.

ONLINE CAREER CENTERwww.azpharmacy.org/jobs

RECAP: 2014 Annual Convention The 2014 Annual Convention at Wigwam Resort in Litchfield June 26-29th was a success! We had about 400 pharmacy professionals attend in support of AzPA. Pharmacists, student pharmacists, pharmacy technicians and others in the industry participated in more than 20 continuing pharmacy education activities, social functions and informal product sessions. Congratulations to all convention award recipients. Thank you to our exhibitors and sponsors whose contributions helped make the annual convention a hit.

2014 AzPA Exhibitors and Sponsors

Allison Medical, Inc.American RegentAmerisourceBergenArizona Health-e ConnectionArizona Pharmacy FoundationARKRAY Astra Zeneca DiabetesAstraZeneca LPBanner HealthBoehringer IngelheimBristol-Myers SquibbCAPS/B.Braun Medical IncCardinal HealthCubist Pharmaceuticals Eli LilyExpress ScriptsFreedom PharmaceuticalsFrys PharmacyGermfree Laboratories, Inc.GrifolsHumana RightsourceRxIntelliguard Kit & Tray Management McKessonMEDA PharmaceuticalsMedImmuneMerck VaccinesMidwestern University National Alliance of State Pharmacy Assoc. National Community Pharmacits Assoc. Nephron Pharmaceuticals Corp.Noven Womens HealthNovo NordiskOtsuka America Pharmaceuticals, Inc.PfizerPharmacists Mutual Insurance CompaniesPharMEDium Services, LLCPharmacy Network of ArizonaPharmPACPhRMARare Disease TherapeuticsRoche DiabetesRxReliefSafewaySanofiSinfoniaRxStaring Down the BarrellSunovion PharmaceuticalsUniversal Medical DataUniversity of ArizonaUpsher-Smith Laboratories

CONGRATULATIONS 2014 CONVENTION AWARD WINNERS!

Oustanding Leadership AwardRay Clark, Pharm.D.

Pharmacy Appreciation AwardJonathan Merchen, Pharm.D., BCPSMindy Throm Burnworth, Pharm.D., BCPSNicole Kitts, Pharm.D.Grant Metcalf, C.Ph.T.Ruben Vital

Honorary Life MembershipJames Morrison, R.Ph.

Distinguished Young Pharmacist of the YrRose Martin, Pharm.D.

Pharmacist of the Year AwardKevin Boesen, Pharm.D.

2014 AzPA FellowsMindy Throm Burnworth, Pharm.D., BCPSKristina De Los Santos, Pharm.D., BCPSCarol Rollins, M.S., R.D., Pharm.D., BCNSP FASPEN, FASHP

Outgoing President AwardRay Clark, Pharm.D.

Pharmacy LeadershipAnn Sears, R.Ph.

Incoming President AwardAnn Sears, R.Ph.

Generation AwardKeith Boesen, Pharm.D.

AzPA Hall of FameTerry Daane, R.Ph.Ted Tong, Pharm.D.Paul Draugalis, R.Ph.Roger Morris, R.Ph., JDHal Wand, R.Ph., MBA Dennis McAllister, R.Ph.Kathryn Kalsman, R.Ph.Michael KalsmanLlyn Lloyd, R.Ph.University of Arizona Class of 1951

Technician of the Year AwardChristina Abedi, C.Ph.T.

Elias Schlossberg AwardMary Manning, Pharm.D., BCPS

Bowl of Hygeia AwardCrane Davis, Pharm.D.Exemplary Patient Care AwardBao Nguyen, Pharm.D.

Excellence in InovationLaura Tsu, Pharm.D., BCPS, CGPNicole Murdock, Pharm.D., BCPS

Outstanding Pharmaceutical RepGreg Larson


2014 AzPA Exhibitors and Sponsors

Pharmacists Assisting Pharmacists of Arizona (PAPA)

As I approached Salt Lake City this past June, I could see the salts flats out my window for the first time while our plane was circling above the runway. I could only imagine the vehicles, trials and land speed records that have raced across the vast flat sea of white. Little could any of us have known that our week would pass with similar velocity and celebrations as students and pharmacists gathered for the 63rd annual University of Utah School on Alcoholism and Other Drug Dependencies. APhA has been helping organize a pharmacy section at this conference since the early 80s. This section is by far the largest with around 200 pharmacists and student pharmacists attending. During our first session we were exposed to the commitment and love several Old Timers had poured into the school over the years. Many of our mentors were returning for their 20th plus year. After our introductory session many students were exposed to their first ever 12 step meeting of Alcoholics Anonymous. Formalities were explained, readings read, and then the personal testimony began. It was humbling to be surround by so many miracles in Recovery. Looking around the room there seemed to be two main reactions being felt amongst first time attendees, either eyes wide open in astonishment and awe or tears of yet unexplainable emotions. Monday morning threw a quick jab our direction. It was announced that this would be the last ever Utah School as we know it. I talked to many students who prior to this announcement were already thinking about next year and who they could recruit to bring back, after only an 18 hour experience. The Utah School moved most of us immediately. But, it wasnt over yet, so we all settled in to embrace this last week. Our keynote speaker was Dr. Kevin McCauley. I urge anyone who has been touched by addiction, either personally or through a friend or family member, to spend some time learning about Dr. McCauley. His story is absolutely remarkable. He provided us all a personal encounter of the nature of addiction and did an excellent job answering the question of whether addiction is truly a disease. Look him up, its worth your time. Wednesday morning we experienced the unique opportunity of sitting in on a therapy rehabilitation small group session. Volunteers from a local facility had their small circle of 10 or so patients and counselors who were surrounded by our 200 person audience. I would have been intimidated for certain but there was something special witnessing that moment. To hear those actively being treated for addiction(s) talk through their situations, drum up old, buried emotions, and get honest with a group of strangers was no small act. Time and time again the Utah School proved to be much more than the science behind addiction and the problems that plague our pharmacies. These were real people, real stories, and real intense emotions. That evening was an open Al-Anon meeting. After several days of lectures, group discussions, and 12 step meetings those newcomers finally had a voice, a vocabulary and an opportunity. Struggles were talk mentioned, emotions validated, and love shared. Especially after attending this conference I am convinced we all have personal stories regarding addiction whether its through firsthand accounts or not. The atmosphere of that meeting and all meetings that week was of healing, hope, and community. This was a truly amazing experience! So yes, the Utah School may have held its last conference in this capacity but I have not said bye to my memories made that week. With the passion that flows though the Old Timers and into the new students, I am confident somewhere will step up. With the help of APhA and Pharmacy Recovery Networks around the country, this schools content and message will continue. The science and treatments of addiction will continue to improve. Those who first attended in the 50s probably couldnt fathom how far we have come already. In all sincerity, however, I wont remember much of the many hours of lectures. I will never forget the faces, the stories, the how the other attendees made me feel though. After going to event such as the Utah School I have little doubt that we are all the same. We all get angry, we all cry, and we all have been touched by this terrible disease. Those that are in recovery are said to share in a common peril, that of rescued shipwreck passengers. Through their common trials, and now solution, they can join in brotherly action. Those lucky enough to have attended the Utah School have forged that brotherhood. As we raced off to our ordinary lives I know we all want to be part of the solution moving forward, bringing those lessons learned of compassion and hope back into our everyday practices.

Conference at University of Utah School on Alcoholism and Other Drug Dependencies: A Personal Perspective

By Ryan

LEGISLATIVE UPDATE

Pharmacists as Providers Bill Passes in ArizonaOn April 22, 2014, Arizona joined 34 other states by recognizing pharmacists as medical providers. This legislation puts Arizona pharmacists in a better position to be reimbursed for pharmacist patient care services under a national bill, HR 4190. If enacted at the national level it would give patient access to these services under Medicare Part B in medically underserved communities.

AzPA has helped to pass a series of legislative changes that have advanced the role of pharmacists in Arizona.

2009: HB 2164 allows pharmacist to immunize adults without a prescription 2011: SB 1298 authorizes student pharmacists to vaccinate, allows pharmacists to vaccinate children 6-17 years and expands the opportunities for Collaborative Practice agreements to include any pharmacy practice setting 2013: SB 1188 clarifies the authority of Arizona pharmacists to prescribe adult immunizations and childhood flu vaccine as well prescribe and subsequently write prescription orders for any medication authorized under a provider signed Collaborative Practice Agreement 2014: SB 1043 recognizes pharmacists as medical professionals providing services within the Pharmacy Practice Act.

Passage of HR 4190 would have a big impact on Arizonas pharmacists. The bill allows for payment of services in medically underserved regions. 93% (14 out of 15) Arizona counties are deemed to be medically underserved. Thus, this bill could prompt private insurers to pay for pharmacists medical services.

2015 Legislative Agenda: Medication Synchronization o Medication synchronization refers to the process of a pharmacy coordinating all of a patients chronic prescription medications to be filled on the same date each month. o Legislation would aim to eliminate barriers to the implementation of medication synchronization, a service that has been shown to improve rates of medication adherence and thus, lower overall health care expenditures. Fair Audit o Insurers, or the insurers pharmacy benefit manager (PBM), have the ability to audit pharmacies. Well over 30 states have passed legislation to create standards for such audits. These statues create, among other things: notice requirements, establish periods of time such audits can go back, prohibit extrapolation (assuming an error rate for a small audit sample applies across all prescriptions and thus rescinding payment). Immunization Expansion: o Currently, pharmacists are limited in the ability to immunize children under age 17 (prescription only, except for flu). There is a desire to lower the 17year age limit to allow parents of older children greater access to immunizations. Others: o Additional topics were brought up. Members and the AzPA Board of Directors are discussing these topics: Any Willing Pharmacy & MAC pricing.

All AzPA members are welcome to attend the monthly meetings. If you are interested in joining the discussions, contact Mark Boesen, Legislative Committee Chair at [email protected] or Kelly Ridgway, AzPA CEO at [email protected]

Mark BoesenAzPA Legislative Affairs Committee [email protected]

Jeff Gray, R & R Partners

AzPA Lobbyist


Arizona State Board of Pharmacy

Changes to CSPMP Delegate Process

On March 24, 2014, Governor Brewer signed Senate Bill 1124, an Act amending Sections 36-2604 and 36-2608, Arizona Revised Statutes, relating to the Controlled Substances Prescription Monitoring Program. The law becomes effective on July 24, 2014.

The Bill made changes to A.R.S. 36-2604 that affect Arizona Prescribers and Dispensers. Subsection C of A.R.S. 36-2604 is changed to allow a delegate who is authorized by the prescriber or dispenser. A.R.S. 36-2604 is further changed by adding Subsection E that defines Delegate. A delegate means a licensed health care professional who is employed in the office of or in a hospital with the prescriber or dispenser or an unlicensed medical records technician, medical assistant or office manager who is employed in the office of or in a hospital with the prescriber and who has received training regarding both the Health Insurance Portability andAccountability Act privacy standards, 45 Code of Federal Regulations Part 164, subpart E, and security standards, 45 Code of Federal Regulations Part 164, subpart C.

Pharmacy Interns, Pharmacy Technicians, and Pharmacy Technician Trainees will be allowed to request access to the database and look up patient data for the pharmacist to review and act on in filling prescriptions for patients.

The Board of Pharmacys Controlled Substances Prescription Monitoring Program (CSPMP) is working with its software vendor, Optimum Technology, to implement the software enhancements necessary to allow delegate access accounts. The process has begun, but will not be ready for use until late August or early September 2014.

The process for delegates to request access to the database will be similar to the process for prescribers and dispensers (pharmacists). The delegate will go to www.azrxreporting.com, click Register, and then pick a Job Type, either Prescriber Delegate or Pharmacist Delegate. The delegate will complete and submit the New Delegate Registration form online. Prescriber Delegates will pick a Supervisor using the Prescribers DEA number and Pharmacist Delegates will pick a Supervisor using the Pharmacists State License number. Delegates will be able to pick multiple supervisors. After a delegate submits the New Delegate

Notice to Pharmacists, Pharmacy Interns, Pharmacy Technicians, and Pharmacy Technician Trainees

Registration, the request will have to be approved by at least one supervisor before the delegate will get an email with a user name and password. A Supervisor must have a current access user account. A Supervisor will login to the Database and go to My Account to approve or revoke Delegates. When a Delegate makes a patient request for data, the Delegate will have to pick a Supervisor under whose DEA or State License the request will be made. Supervisors will be able to see all requests made by their approved delegates. If you have questions about the changes, contact Dean Wright, PMP Director at 602-771-2744 or email at [email protected] or Cindi Hunter, PMP Program Manager at 602-771-2732 or email at [email protected].

I have been a pharmacist for almost 20 years. During this time, I have seen the pharmacists role evolve and become more focused on the clinical aspect of care. As a result, the smooth and effi cient operation of todays pharmacy requires the expertise of a Certifi ed Pharmacy Technician. When considering to hire someone, I look for the familiar PTCB CPhT. When I see that initiative, I know that the applicant has, at a minimum, the basic knowledge to meet the needs of my department.

Laura Forbes, RPh, Director of Pharmacy Services, Gov. Juan F. Luis Hospital and Medical Center, Christiansted, U.S. Virgin Islands

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Certifi cation Excellence Since 1995, the Pharmacy Technician Certifi cation Board (PTCB) has certifi ed over 400,000 technicians nationwide and is the only pharmacy technician certifi cation program endorsed by the American Pharmacists Association, the American Society of Health-System Pharmacists, and the National Association of Boards of Pharmacy.

Do it for your pharmacy. Do it for your patients. Do it for you.

Encourage your technicians to become PTCB certifi ed today! Candidates may apply to take the Pharmacy Technician Certifi cation Exam online at www.ptcb.org.

Linda Peralta has been an integral part of the Medication Management Center pharmacy team at the University of Arizona Pharmacy in Tucson, AZ since she began working there three years ago. This pharmacy ensures safety and optimal healthcare for their patients by helping them and their physicians stay on top of medication regimen. Specifically, Linda reconciles medication lists over the phone

with patients and enters both prescription and OTC drugs into the pharmacy computer system which helps alert her to potential drug and illness interactions as well as cost-saving opportunities for the patient. With drug and illness interactions or other concerns, Linda immediately connects the patient to a pharmacist for counselling, who will work with the patients physician/s to determine the best course of action. For example, one patient chose to stop taking a medication they felt was redundant, but Linda recognized the problem and got the pharmacist on the phone to explain why each medication was important for their health. When Linda discovers patients who are currently taking a brand name version of a drug, she can inform the patient of generic alternatives and fax their physician for approval to switch to the generic helping keep costs down not only for the patient, but for the pharmacy as well.

Lindas pharmacy also plays a part in a smoking cessa-tion program in conjunction with MedImpact (https://www.medimpact.com/) and Ashline (http://www.ashline.org/). Linda fields phone calls from individu-als who wish to quit smoking. The pharmacist then reviews medications that can help them succeed, and Linda faxes requests to the patients physician. Upon physician approval, the patient begins the process and is connected to Ashline to work with a quit coach. Linda is involved throughout the process in a supportive role with follow up calls to the patient offering encouragement and ensuring they are doing well on their medications, providing a lifeline for people who are making a very difficult life change.

Lindas favorite part of her job is the interaction with patients over the phone, and she is very good at it too. According to her co-worker, Kelly, Lindas kind manner with patients has helped me learn to better engage the patients I speak with.

A large portion of patients who call in to this pharmacy are on Medicare Part D and are older individuals with long lists of medications, lots of questions, difficulty hearing and occasionally poor short-term memory. She says patience is a must for success in this job.

A desire to work in a healthcare profession with minimal exposure to blood or other bodily fluids led Linda to a career as a pharmacy technician. After finishing the technician training program at Apollo College (since renamed Carrington College), Linda worked at a family retail pharmacy called Jones United Drug. When Jones closed its doors, Linda began working for Reeds Compounding Pharmacy which had been part of Jones. Later she gained hospital experience working St. Marys Inpatient Pharmacy and has also spent time working in a call center doing prior authorizations for an insurance company. A combination of skills learned in all of these settings has helped Linda become a great co-worker and employee in her current work environment.

Rose, a pharmacist Linda has worked with, said Linda Peralta is an exemplary pharmacy technician. She is not only reliable and dependable, but the dedication that she has to delivering high quality patient care is something we all can strive for.

Linda feels that success for a pharmacy can be obtained by creating a solid team by facilitating fluid communication. As a technician, it is important to accept responsibility, take initiative, and go out of your way to help anyone who needs a hand. Two-way communication is crucial: technicians need to be willing to share suggestions, ask questions, and respond to new information positively and quickly. Pharmacists can help by communicating big changes in procedures as well as developments throughout a given day to technicians and other team members. Pharmacies that succeed in creating an atmosphere of openness have been at the top of Lindas list of great places to work.

In her spare time, Linda enjoys the great outdoors with her two children, walking neighborhood trails, frequenting local parks, and swimming. If you would like to contact Linda with questions or for networking, send her an email at [email protected].

INTERACTING WITH PATIENTS by Kalani Anderson, C.Ph.T

Linda Peralta, C.Ph.T.

TECHNICIAN SPOTLIGHT


A Look Back - Antacid Container By Robert E. Kravetz, MD, FACP, MACG, American College of Gastroenterology

Pharmacy Time CapsulesThird Quarter 2014

1989 - Twenty-five Years ago: The conservative Heritage Foundation published

Assuring Affordable Health Care for All Americans, which called for a mandate to purchase health insurance.

Losec (omeprazole) was first marketed in U.S. by Astra. In 1990, FDA required name change to Prilosec to avoid confusion with Lasix.

1964 - Fifty Years ago: Keflin (cephalothin sodium, Lilly) was the first

cephalosporin to be marketed in the Unites States.

Average cost of prescription was $3.41

1939 - Seventy-five Years ago: The first Blue Shield plan was begun as an

insurance to cover physicians fees. 1914 - One hundred Years ago: Cocaine, used in many patent medicines and

tonics, was widely available in pharmacies and other retail establishments until banned in 1914.

By: Dennis B. Worthen, PhD, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of Americas history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out www.aihp.org.

Illustrated is an apothecary jar from 1890 containing calcium bicarbonate and a tin of antacid powders from about 1940. Calcium carbonate was mentioned as a therapy as creta alba in the London Pharmacopoeia of 1650. Experiments neutralizing stomach acid with magnesia alka and calciae horn of deer were correctly performed and described by Joseph Black of Edinburgh in a thesis published in 1754. The first United States Pharmacopoeia, 1820, mentions calcis carbonus.

The mantra that was repeated for years: no acid, no ulcer was stated in 1910 and it became the battle cry of gastroenterologist for the next 80 years. Bertram W. Sippy of Chicago became the leader in advocating the complete neutralization of hydrochloric acid. His careful research provided the basis for the Sippy regimine. His program required hourly milk and cream feedings alternating with hourly calcium and sodium bicarbonate in vary proportions. Later very soft bland foods were added as well as atropine for its antisecretory effect and aspiration of gastric acid by an Ewald tube. Side effects of

constipation, alkalosis, mental confusion and even renal failure were not infrequent. Sometimes four to six weeks of hospitalization was required to complete the regimine. Diet, antacids, and gastric aspiration became less important after the introduction of H2 blockers for reduction of acid. Next, the proton pump inhibitors provided for complete reduction in acid and ulcer healing. Finally, the tale of H pylori emerges as the basis for peptic ulcer disease, and the many of us from previous generations who were skeptics have become convinced. We owe a great tribute and should pay homage to the giants of medicine who showed us the way.

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CASE REPORT: Breathalyzers + Inhalers

= the Potential for False-PositivesBy Alina Kurita PharmD Candidate 2015, Amanda Huels PharmD BCPS, Amy Leung PharmD BCPS

Description:EB is a 64 year old white male who called to inquire if any of his medications would contribute to a false positive on his breathalyzer test. A veteran recently charged with driving under the influence with current probation requirement of random breathalyzer home tests. Prior to breathalyzer, the veteran uses his albuterol to allow for optimal exhalation and to prevent shortness of breath.

Past Medical History: Asthma, Hyperlipidemia, Seizures, Hypertension, Fatty Liver Disease, Chronic Obstructive Lung Disease

Active Medications:Ergocalciferol 50,000 unitsLisinopril 40mgMeloxicam 15mgDoxazosin Mesylate2mgDivalproex 250mg & 500mgPrimidone 250mgBudesonide/Fomoterol 160/4.5mcgAlbuterol 90mcgSildenafil Citrate100mgTiotropium Bromide 18mcgAspirin EC 325mg Ibuprofen 800mg

The breathalyzer is one of the most commonly used tools in detecting the level of alcohol consumed; however, it has been proposed that metered dose inhalers (MDIs) can potentially elevate the alcohol levels in the lungs thus resulting in a false positive test. The rationale behind this is that the alcohol content in MDIs is high enough to be detected by a breathalyzer. The minimum registered value that can be detected by a breathalyzer is as low as 0.02% which is equivalent to 0.02g/dL of alcohol (210L breath). Arizona law abides by the zero tolerance policy, so driving under the influence (DUI)citation are given as long the breath-alzyer gets any positive reading (confirmed with a blood alcohol lab). Breath alcohol concentration (BrAC) less than 0.08% is considered to be the legal limit to drive; however, in the case that you are pulled over and any level of EtOH is detected, then a DUI may be issued. There are many type of breathalyzers that detect alcohol in different ways. For example, one may measure the amount of alcohol by the intensity of electrical current from the oxidation of alcohol into acetic acid. Another may use infrared spectroscopy to

detect alcohol, and others still might use scalar color changes from chemical reaction with alcohol and silver nitrate. While these tools are very reliable, they cannot distinguish between different types of alcohol and this is where the potential problem arises. The role of alcohol in inhalation medications is to solubilize the surfactant to allow better penetration of the medication into the lungs. The amount of alcohol in the medication is not enough to have systemic effects and will only act locally where it is inoculated. In December 2008, the utilization of inhalers containing chlorofluorocarbons (CFCs) were mandated to be phased out due to an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer. The agreement included the transition of CFC propelled inhalers to hydrofluoroalkane (HFA) - propelled inhalers. Not all HFA MDIs have an alcohol component. The next page includes a table of inhalers that contain or do not contain alcohol. For example, EB Albuterol HFA inhaler does contain alcohol propellants but Budesonide/Formoterol HFA inhaler does not. There are various websites containing information on how medications such as inhalers, cough syrup, and cold sore gels can cause false positive breathalyzer results.However, these websites may lack sufficient evidence or references; this can cause misunderstandings. Despite the conversion to HFA inhalers after 2008, there have not been any new studies examining this phenomenon; however, there are older studies that have looked at this association of alcohol-containing inhalers and false positives. For the purpose of this summary, study results presented were converted to g/dL to allow for comparison to levels previously mentioned as detectable on a breathalyzer test. One study conducted by Ignacio-Garcia et al. examined 69 patients to further understand this relationship. The study compared alcohol-containing MDIs to alcohol-free MDIs and to dry powder inhalers. The patient population ranged from 14-65 years old with clinically stable asthma and who were currently using one of the study inhalers on a regular basis. All patients took 1-2 inhalations of each studied inhaler and breathalyzer test measurements were taken at 1 minute and 5 minutes after inhalation. All participants had a confirmed negative breathalyzer test at baseline. The results showed that the Advair Diskus had no sign of alcohol at either minute 1 or minute 5 after inhalation, however 90% of MDIs tested positive or had invalid results after 1 minute. At 5 minutes, all test subjects were registering negative results on the breathalyzer. An issue with the study is the investigators combined both MDI groups and did not differentiate if the positives were from one or both groups.

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CASE REPORT Another study by Barry and OCallaghan observed 10 adults ranging from 24 to 36 years old using salbutamol (Airomir). This was conducted on 3 separate days and all patients were required to take 2 inhalations and to either use good technique (actuating inhaler at beginning of inhalation), poor technique (actuating inhaler after inhalation), or an AeroChamber on each respective day.Measurements were taken before initial inhalation, after inhalation, at 2 minutes after, and at 5 minutes after. The results showed that there was an immediate increase in alcohol levels after inhalation in all three techniques; however, poor technique had the greatest increase overall, with a mean (range) increase from baseline to immediately after the inhalation of 0.073g/dL (0.048-0.102). The good inhaler technique had a mean (range) increase of 0.038g/dL (0.015-0.054) and the aerochamber technique had a mean (range) of 0.023g/dL (0.01-0.04). The majority of the patients had alcohol-free levels at 2 or 5 minutes after inhalation. One additional study that looked at this relationship was conducted by Bruce et al. to compare HFA-MDI to CFC-MDI and placebo-MDI. They also observed the effects of alcohol consumption as well. Thirty-one patients were recruited for this double-blind study. Patients were grouped as either asthmatics or to the normal control group. Measurements were taken by using a breathalyzer prior and after the first dose at 2 minutes, 5 minutes, and 15 minutes after inhalation with all of the inhalers used in the study in a random order. These measurements were taken similarly after alcohol consumption separate from the inhaler use. The results showed that HFA inhalers had a detectable level in alcohol concentration in both asthmatics and the normal control after the first inhalation, 0.004 to 0.029g/dL (P = 0.0001) and 0.002 to 0.033 g/dL (P = 0.002), respectively. These results were statistically significant for both groups; however the measurements at 5 minutes showed

negligible amounts of alcohol. One of the manufacturers, Boehringer Ingelheim Pharmaceuticals conducted their own trials to observe the effect of alcohol content in Atrovent HFA on breathalyzer results. This was an open-label, randomized clinical trial of 20 patients who took 1, 2, and 4 inhalations at a time, with each inhalation containing 15.6mg of alcohol. Following each sequence of inhalation, they measured both the detection of alcohol in the patients expiratory breath and duration of effect. For all the inhalation sequences, there was a rapid increase up until 30 seconds before quickly falling. Mean duration of detected alcohol was directly related with dose/number of inhalations. The mean duration of detected alcohol in the expiratory breath was 5.1 +/- 1.5 minutes, 8.3 +/- 1.9 minutes, and 13.5 +/- 1.2 minutes with 1, 2, and 4 inhalations respectively. It can be concluded that there is a plausible relationship between MDI use and breathalyzer results, however further research is required to better solidify this information. The take-home point is that there is the possibility of someone testing falsely positive for alcohol if utilization of a HFA MDI inhaler occurred prior to testing. However, this spike in alcohol level only occurs immediately after inhalation and this duration does not last more than a few minutes. Unfortunately, one of the greatest limitations in referring to these past studies is that medication formulations do change from time to time. And so as clinicians, it is important to realize that inhaler selection can ultimately affect results and understand the significance of that. For example, for our veteran EB, his vehicle contained a court-mandated computer device called the Interlock that required a negative BrAC level before permitting the driver to start the ignition. If the computer detects alcohol, it will lock his car and not allow him to drive. This then gets reported

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*Reference from drug package inserts for the following: Advair, Alvesco, Atrovent, Dulera, Flovent, ProAir, Proventil, Qvar, Symbicort, Ventolin, and Xopenex

Contains alcohol (+) Does NOT contain alcohol (-)

Alvesco (Ciclesonide) Advair (Fluticasone Propionate/Salmeterol Xinafoate)

Atrovent(Ipratropium Bromide) Flovent (Fluticasone Propionate)

Dulera (Mometasone Furoate/Formoterol Fumarate) Symbicort (Budesonide/Formoterol)

ProAir (Albuterol Sulfate) Ventolin (Albuterol Sulfate)

Proventil (Albuterol Sulfate)

Qvar (Beclomethasone Dipropionate)

Xopenex (Levalbuterol Hydrochloride)

CASE REPORTto the central office to alert them that there was an attempt in trying to drive under the influence. These results can have not only social but also more pressingly legal ramifications. Therefore, it is important to understand how to accurately assess these screening tests for substance use, including what factors can potentially impact the results. The current interlock minimum detection level for the state of Arizona is at 0.03% (0.03g/dL) and will potentially decrease the minimum detection level to 0.025% (0.025g/dL) in the future. Patients who are concerned about having a false positive breathalyzer test due to the recent utilization of an inhaler, can do one of the following. One, they can ask to opt for a blood alcohol test or two, they can ask to wait 15-20 minutes before taking the breathalyzer after inhaler utilization. While this may not be a relevant counseling point for all patients, it may be one that makes an impact in a patients life above and beyond better breathing.

References:1. Ignacio-Garca JM, Almenara-Barrios J, et al. A comparison of standard inhalers for asthma with and without alcohol as the pro-pellant on the measurement of alcohol in breath. J Aerosol Med 2005; 18(1):193197.2. Barry PW, OCallaghan C. New formulation metered dose inhaler increase breath alcohol levels. Respir Med. 1999; 93:167-8.3. Bruce C, Chan HP, Mueller L, et al. Effect of hydrofluoroalkane-alcohol inhalers on estimated alcohol levels in asthmatic subjects. Respirology. 2009 Jan; 14(1):112-6.4. Boehringer Ingelheim Pharmaceuticals, Inc Medical Information Atrovent HFA. 2014.

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Risk of Serotonin Syndrome with Concomitant Use of SSRI/SNRI and Triptans

Serotonin syndrome is an adverse drug reaction that occurs when a medication, a combination of medications, or other substances (e.g. cocaine) increase serotonin levels in the body.1 Increased stimulation of the serotonin receptors, specifically 5-HT2A, cause neuromuscular dysfunction and autonomic hyperactivity.1,2 Classic symptoms of serotonin syndrome are tremor, clonus, hyper-reflexia, agitation, diaphoresis, tachycardia and muscular rigidity.3 These symptoms may progress to life threatening events such as seizures, rhabdomyolysis, renal failure or disseminated intravascular coagulation.3 The incidence of serotonin syn-drome has been rising since it was first described in several studies investigating high dose and combination serotonergic medication use in the 1960s.4 This rise could be due to the increasing number of serotonergic agents available to patients and better recognition and reporting by healthcare professionals.5 Increased stimulation of serotonin receptors can be caused by several mechanisms including decreased serotonin uptake or metabolism, increased serotonin synthesis or release, and direct activation of serotonin receptors.5 Medications implicated in serotonin syndrome include but are not limited to selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), serotonin-norepinephrine reuptake inhibitors (SNRI),monoamine oxidase inhibitors (MAOI), triptans, St. Johns Wort and opioids.1 Illicit substances such as amphetamines, cocaine, and ecstasy (MDMA), can also potentially cause serotonin syndrome.6-8 Table 1 includes a list of medications and illicit substances associated with serotonin syndrome.5-9 Most case reports of serotonin syndrome have occurred in patients who received multiple serotonergic agents or had exposure to one agent for an extended period of time.5 In addition, medications and disease states that decrease cytochrome P450 enzyme activity, specifically 2D6 and 3A4, may cause higher serotonin levels than expected at normal therapeutic doses due to slower metabolism of medications processed by these particular enzymes.3,5 This is important as many serotonergic antidepressants are metabolized by one or both of these enzymes and some antidepressants, most notably fluoxetine and paroxetine, are potent inhibitors of either 2D6 and/or 3A4.10 In 2006, the FDA released an alert that use of triptans in combination with SSRI/SNRI may lead to potentially life-threatening serotonin syndrome.11 The FDA recommends that patients treated with both agents be informed of the possibility of serotonin syndrome and carefully monitored. This alert was based on biological

By Lisa Goldstone, MS, PharmD, BCPS, BCPP, Assistant Professor at University of Arizona College of Pharmacy, University of Arizona Medical Center - South Campus, & Wendy M. Gabriel, PharmD, BCPS, University of Arizona College of Pharmacy, University of Arizona Medical Center - University Campus

plausibility and twenty-seven case reports of serotonin syndrome reported to the FDA. Since the alert, warning labels have been added to the products and the interaction has been classified as severe in most medication interaction software.12 By labeling the interaction as severe, this can potentially lead to under treatment of either depression or migraine which are two disease states that commonly coexist in patients.12,13 It is estimated that in 2007 and 2008, 1.3 million patients in the United States were prescribed both triptans and either an SSRI or SNRI.14 Prior to the FDA warning, two studies looked at adverse reactions for patients taking both antidepressants and sumatriptan. Blier et al. published a study in 1994 that followed fourteen patients over one year to determine if certain triptans were safe to administer to patients on serotonergic medications.13 Twelve patients were on one serotonergic medication and two patients were on two serotonergic medications. Medications included fluoxetine, fluvoxamine, sertraline, moclobemide, lithium and buspirone. The article did not mention specific medication doses, however the author commented that in ten of fourteen patients, the antidepressant dose was higher than the minimal recommended dose. Patients were treated for a cumulative of 103 migraines during the study with sumatriptan 100 mg. Patients did not take more than 100 mg of sumatriptan per day. Serotonin syndrome or symptoms associated with serotonin syndrome was not reported by patients or study investigators. In 1999, Putnam et al. looked at medication interactions with subcutaneous sumatriptan administration in 12,339 patients.15 Study protocol allowed up to two 6 mg injections one hour apart, however the authors did not disclose the average dose of sumatriptan per day. Twenty-nine percent of the patients were on an SSRI, TCA, MAOI or bupropion. There was no increase incidence of adverse medication events in these patients within 24 hours of sumatriptan administration. The authors did not comment on the dose of antidepressants used in the study. The two reasons cited by the FDA in support of the 2006 alert are biological plausibility and twenty seven case reports.11 However, due to the selectivity of the triptans for specific serotonin receptors as well as differing profiles among the triptans, biological plausibility seems less likely. Serotonin syndrome is thought to be due to activation of 5-HT1A and 5-HT2A receptors.1,16 Triptans are highly selective for the

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5-HT1B and 5-HT1D receptors, with little activity on 5-HT1A.1,16 Because triptans are not active at the 5-HT2A serotonin receptors that are thought to be most respon-sible for serotonin syndrome, it cannot be assumed that they can cause serotonin syndrome based on their mechanism of action.1,16 In addition to minor activity at the 5-HT1A and no activity at the 5-HT2A receptors, sumatriptan has very low CNS penetration as measured in murine models.1,16 However, sumatriptan may increase serotonin via an indirect method. A murine study con-ducted in 2003 showed that after 21 days of sumatriptan administration, there was a significant increase in sero-tonin synthesis.17 The exact mechanism is unknown, but could be due to down-regulation or desensitization of 5-HT1 receptors that signal to the body that more se-rotonin is needed. Newer triptans, such as eletriptan, naratriptan, rizatriptan and zolmitriptan, have a slightly different pharmacokinetic and pharmacodynamic profile from sumatriptan. They are more lipophilic and have a higher specificity for the 5-HT1D receptor.18 Increased lipophilicity allows the medication to cross the blood brain barrier more effectively and thus lower doses provide therapeutic levels in the central nervous system. De-creased affinity for 5-HT1B, in addition to reduced dosing requirements, lessens the risk of coronary vasoconstric-tion commonly seen with less lipophilic and less specific agents such as sumatriptan (17). However, similar to su-matriptan, these agents have little activity at the 5-HT1-A and 5-HT1-B receptors that are responsible for serotonin syndrome. No literature exists stating that more lipophil-ic triptans have more or less risk of serotonin syndrome when compared to sumatriptan. Evans et al. analyzed the 27 case reports referred to in the 2006 FDA alert to determine if each one met the Sternbach and/or Hunter criteria for serotonin syn-drome.1 Because there is no laboratory test for serotonin syndrome, specific criteria are used to assist in accurate diagnosis. The first is the Sternbach criteria.4 It requires that there is no other cause for the syndrome, no recent addition or dosage increase of a neuroleptic agent, presence of a recent addition or dosage increase of a serotonergic agent, and presence of at least three symp-toms of serotonin excess.4,19 These symptoms include mental status change, agitation, myoclonus, hyper-reflex-ia, diaphoresis, shivering, tremor, diarrhea, incoordination and fever. The Hunter criteria is a newer tool that is more sensitive (84%) and specific (97%) than the Sternbach cri-teria.1,19 The Hunter criteria require that one set of symp-toms exist in the presence of a serotonergic medication.19 The symptom sets are: spontaneous clonus alone; induc-ible clonus and agitation or diaphoresis; ocular clonus and agitation or diaphoresis; tremor and hyper-reflexia; hyper-tonicity and temperature > 38C; and ocular clonus or inducible clonus. Only seven of the 27 case reports met

the Sternbach criteria and zero met the Hunter criteria.1 No case met both the Sternbach and Hunter criteria. Only eight of the case reports were published and the remain-der were submitted through the MedWatch reporting sys-tem. Three were submitted by pharmaceutical representa-tives using second hand and vague information and many of the cases did not have enough information included to use either criteria fully. Heavily based on the above paper, the American Headache Society released a position paper in 2010 stating that there was insufficient evidence to determine if there is an increased risk of serotonin syndrome when SSRIs/SNRIs are used in combination with triptans.2 A rebuttal letter to the editor from the FDA-Center for Drug Evaluation and Research commented that there are now 60 reported cases of serotonin syndrome associated with SSRI/SNRI and triptans.20 The author explained that they do not use the Hunter criteria because it has not been validated and that the Sternbach criteria do not have the sensitivity for evaluating post marketing safety reporting. The author acknowledged the existence of reporting bias and incomplete information in most reports. There is inconclusive evidence that use of SSRIs or SNRIs in combination with triptans at recommended doses cause serotonin syndrome at an incidence high enough to merit such a warning from the FDA. The evidence sup-porting and refuting the incidence is of low quality. It is possible that serotonin syndrome is under-reported to the FDA and there is still uncertainty if case reports cited by the FDA are actually serotonin syndrome caused by trip-tans used with SSRI/SNRI. Furthermore, many of the case reports complete with medication doses report unusual dosing.1 For example, several patients were taking sched-uled triptans daily, high doses of antidepressants (venla-faxine 300 mg daily or citalopram 60 mg daily), or multiple serotonergic agents during intentional overdose.1

At this time, the use of triptans in patients receiv-ing SSRI or SNRIs may be appropriate when the benefit outweighs the risk. While serotonin syndrome is a very serious adverse drug event, the overall incidence in the population is very low with only 60 cases reported to the FDA while approximately 1.3 million Americans have been prescribed both medications.14,20 Incidence of linezolid associated serotonin syndrome was estimated to be 0.24% in one large review, which is much larger.21 To reduce the risk of serotonin syndrome when a SSRI or SNRI is used concomitantly with a triptan, doses of both agents should remain within FDA approved parameters and additional serotonergic agents should be avoided when at all pos-sible. Although the likelihood of developing serotonin syndrome with this combination is rare, patients should always be educated on the signs and symptoms of serotonin syndrome and how to properly administer their triptan as overuse could increase the chance of developing serotonin syndrome.

RISK OF SEROTONIN SYNDROME

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Table 1: Medications Associated with Serotonin Syndrome5-9

Buspirone Meperidine Carbamazepine Methadone Chlorpheniramine Methamphetamine Cocaine Metoclopramide Codeine Nefazodone Cyclobenzaprine Ondansetron Dextroamphetamine Reserpine Dextromethorphan Ritonavir "Ecstasy" Selegiline Ergot alkaloids Sibutramine Fentanyl SNRI Ginseng SSRI Granisetron TCA Levodopa Tramadol Linezolid Trazodone Lithium Triptans MAO Inhibitors Valproic acid Ecstasy=3,4-methylenedioxymethamphetamine; MAO=monoamine oxidase; SNRI=serotonin-norepinephrine reuptake inhibitors; SSRI=selective serotonin reuptake inhibitor; TCA=tricyclic antidepressants

RISK OF SEROTONIN SYNDROME

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References1. Evans RW. The FDA alert on serotonin syndrome with combined use of SSRIs or SNRIs and triptans: an analysis of the 29 case re-ports. MedGenMed 2007; 9(3): 48.2. Evans RW, Tepper SJ, Shapiro RE, et al. The FDA alert on serotonin syndrome with use of triptans combined with selective serotonin reuptake inhibitors or selective serotonin-norepinephrine reuptake inhibitors: American headache society position paper. Headache 2010: 1089-99.3. Woytowish MR, Maynor LM. Clinical relevance of linezolid-associ-ated serotonin toxicity. Ann Pharmacother 2013; 47: 388-97.4. Sternbach H. The serotonin syndrome. Am J Psychiatry 1991; 148: 705-13.5. Ables AZ, NAgubilli R. Prevention, diagnosis, and management of serotonin syndrome. Am Fam Physician 2010; 81(9): 1139-42.6. Parrott AC. Recreational ecstasy/MDMA, the serotonin syn-drome, and serotonergic neurotoxicity. Pharmacol Biochem Behav. 2002;71:837-44.7. Mugele J, Nanagas KA, Tormoehlen LM. Serotonin syndrome associated with MDPV use: a case report. Ann Emerg Med. 2012;60(1):100-2.8. Malik HU, Kumar K. Serotonin syndrome with escitalopram and concomitant use of cocaine: a case report. Clin Med Insights Case Rep. 2012;5:81-5.9. Bienvenu OJ, Neufeld KJ, Needham DM. Treatment of four psychi-atric emergencies in the intensive care unit. Crit Care Med 2012; 40: 2662-70.10. Spina E, Santoro V, DArrigo. Clinical relevant pharmacokinetic drug interactions with second-generation antidepressants: an up-date. Clin Ther. 2008;30:1206-27.11. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPa-tientsandProviders/DrugSafetyInformationforHeathcareProfession-als/ucm085845.htm. Accessed March 5, 2014.12. Kogut SJ. Do triptan antimigraine medications interact with SSRI/SNRI antidepressants? What does your decision support sys-tem say? JMCP 2011; 17(7): 547-50.13. Blier P, Bergeron R. The safety of concomitant use of sumatriptan and antidepressant treatments. J Clin Psychopharma-col 1995; 15: 106-9.14. Putnam GP, OQuinn S, Bolden-Watson CP, et al. Migraine polypharmacy and the tolerability of sumatriptan: A large-scale, prospective study. Cephalalgia 1999; 19: 668-75.15. Sclar DA, Robison LM, Castillo LV, et al. Concomitant use of triptan, and SSRI or SNRI after the US food and drug administration alert on serotonin syndrome. Headache 2012; 52: 198-203.16. Gillman PK. Triptans, serotonin agonists, and serotonin syndrome (serotonin toxicity): A Review. Headache 2010; 50:264-72.17. Dobson CF, Tohyama Y, Diksic M, Hamel E. Effects of acute or chronic administration of anti-migraine drugs sumatriptan and zolmitriptan on serotonin synthesis in the rat brain. Cephalalgia 2004; 24: 2-11.18. Millson DS, Tepper SJ, Rapoport AM. Migraine pharmacothera-py with oral triptans: a rational approach to clinical management. Expert Opin Pharmacother 2000; 1(3): 391-404.19. Dunkley EJC, Isbister GK, Sibbritt D, Dawson AH, Whyte IM. The Hunter serotonin toxicity criteria: simple and accurate diagnostic decision rules for serotonin toxicity. Q J Med 2003; 96: 635-42. 20. Fine A, Bastings E. Triptans and serotonin syndrome [letters to the editor]. Headache 2012; 52(7): 1184-5.21. Butterfield JM, Lawrence KR, Reisman A, Huang DB, Thompson CA, Lodise TP. Comparison of serotonin toxicity with concomitant use of either linezolid or comparators and serotonergic agents: an analysis of Phase III and IV randomized clinical trial data. J Antimicrob Chemother 2012; 67: 494-502.

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An Expert Roundtable on Continuous Quality Assurance in Pharmacy

By Jill Augustine, PharmD, MPH, PhD Student, University of Arizona College of PharmacyPatrick Campbell, PharmD Candidate Class of 2014, University of Arizona College of PharmacyTerri Warholak, RPh, PhD, Associate Professor, University of Arizona College of PharmacyKen Baker, B.S.Pharm, JD, Of Counsel / Pharmacy Consultant, Renaud Cook Drury Mesaros, PAAndrea Bishop, PhD, Postdoctoral Fellow, St. Marys University Department of PsychologyTodd A. Boyle, PhD, Associate Professor, St. Francis Xavier University Gerald Schwartz School of BusinessDavid Nau, PhD, RPh, CPHQ, FAPhA, President, Pharmacy Quality Solutions, Inc. Neil J. MacKinnon, BSc(Pharm), MSc(Pharm), PhD, Dean, University of Cincinnati James L Winkle College of Pharmacy

Panel Members:

Ken Baker (KB) is the founder of Ken Baker Consulting, a company that is dedicated to assisting pharmacists from across the country in reducing medication errors. Additionally, he is the attorney of counsel for Renaud Cook Drury Mesaros (PA) and a consultant for Pharmacists Mutual Insurance Company. He is a national expert of pharmacy litigation and has experience with pharmacy regulation, risk management, insurance and pharmacy quality programs, continuous quality improvement (CQI), and reduction of compounding and medical errors.

Andrea Bishop (AB), Ph.D., is a Postdoctoral Fellow in the Department of Psychology at Saint Marys University in the fields of organizational safety culture and patient safety.

Todd Boyle (TB), Ph.D., is an Associate Professor of Operations Management and the Canada Research Chair in Quality Assurance in Community Pharmacy at St. Francis Xavier University. He is also the lead investigator of the SafetyNET-Rx quality improvement initiative for community pharmacies in Canada. His research focuses on the determinants of quality related event (QRE) (i.e. medica-tion error and near miss) reporting and learning in community pharmacies, and how CQI programs can help to enhance QRE reporting and learning activities.

Neil MacKinnon (NM), Ph.D., is the Dean of the University of Cincinnati College of Pharmacy. He was previously a Professor and Director for the Center for Rural Health at the University of Arizona Mel and Enid Zuckerman College of Public Health. His research has focused on improving the quality and safety of the medication-use sys-tem in both Canada and in the United States.

David Nau (DN), PhD, RPh, CPHQ, FAPhA, is the President of Pharmacy Quality Solutions, a joint venture of the Pharmacy Quality Alliance (PQA) and CECity. His work has focused on the improvement of medication-use within the healthcare system and has been recognized by several organizations for his leadership in the field of quality improvement for pharmacy services. He is one of the few pharmacists to hold the designation of Certified Professional in Healthcare Quality (CPHQ).

Terri Warholak (TW), RPh, PhD, is an Associate Professor at the University of Arizona College of Pharmacy. Her work has

focused on reducing medication errors in the healthcare system, the use and development of health information technology, and bringing pharmaceutical care to underserved populations.

Goal Statement: This article was developed to discuss the benefits,implementation, and maintenance of a continuous quality assurance (CQA) or continuous quality improvement (CQI) program.

Background:The concept of quality as an integral component of healthcare has become increasingly more popular with the onset of healthcare reform. Medicare Star Rating Quality Measures and Accountable Care Organizations are two examples of current monetary incentives surrounding quality healthcare. These programs primarily assess quality on a macro scale but the ideals of these programs should resonate with individual healthcare professionals and be an impetus to change in practice settings. In the realm of pharmacy, one method of ensuring improved patient care is through the utilization of a Continuous Quality Assurance (CQA) program. The Arizona legislature defines a CQA Program as a planned process designed by a pharmacy permittee to identify, evaluate, and prevent medication errors. Since the CQA process is a continuous cycle of improvement, it has the potential to impact healthcare processes by: mitigating error frequency, enhancing workflow processes, and creating a culture of continual growth and development. Subsequently, CQA programs may lead to enhanced quality of care for patients. Knowing these benefits, the Arizona legislature passed the Pharmacy Continuous Quality Assurance Law. This law requires community pharmacies to develop, utilize and maintain a CQA system.

Round Table Discussion:

Neil MacKinnon (NM): We have gathered together a panel of North American experts on quality and safety in community pharmacy. This round table discussion will help Arizona pharmacists with issues about quality and safety, quality assurance, and how pharmacists can comply with regulations. The first question is for Ken Baker: What happens when a pharmacist has a CQA

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system but errors still occur in his or her pharmacy?

Ken Baker (KB): Errors occur even with a well-implemented CQA system. A CQA system is one that reduces the risk of a second error occurring; it is not one that eliminates all errors. I do not care how good a CQA system a pharmacy has, how robust it is, there will be another error. When an error occurs, it is important to take a look at the system and answer the question: How did the error occur? In other words: what was the flaw in the system or what was missed or what steps or safeguards need to be added? So it is a way of learning from the system. That is why we call it continuous quality improvement (CQI) or continuous quality assurance (CQA) because the idea is to continuously improve. It is important for the pharmacist to be able to do is to show that an error occurred in spite of the fact that a CQI system is in place; in spite of the fact that the CQI system is used, an error still occurred. That becomes the best defense against possible litigation: Ive got a CQA system, I use the CQA system, and I still had a mistake.

NM: Okay, youve talked about when a pharmacy has a CQA system, but what happens when a pharmacy does not have a formalized CQA system and an error occurs?

KB: Such a pharmacy is going to have errors. However, if a pharmacy does not have a CQA system, the problem is that the pharmacists and all involved (i.e., staff, technicians, owners) are now acting recklessly because there is no CQI system to help prevent errors. From the Board of Pharmacy perspective, they are probably going to discipline a pharmacy without a CQI system, where they may not discipline a pharmacy that was using a CQI system.

NM: Joining us as part of this roundtable discussion are two experts in CQA in community pharmacy from Nova Scotia, Canada. Nova Scotia has had similar regulations requiring the implementation of CQA in community pharmacies since 2010. My first question is for Dr. Andrea Bishop. In your opinion, what are the main challenges that pharmacists face in implementing CQA and how can these challenges be overcome?

Andrea Bishop (AB): One of the main key challenges is the lack of time for pharmacies to have a well-implemented CQA system. That includes medication error and near miss (i.e., errors that get caught before they get to the patient) reporting and those quality assurance activities related to the learning and sharing components as well. One of the practical things that weve seen people implement in Nova Scotia is to make sure to use the CQA system to improve the pharmacy work flow. SafetyNET-Rx, our CQA program, is a standardized program but it also allows pharmacists to tailor the program for each pharmacy. This includes using a hybrid approach to reporting quality related events or

QREs (i.e., errors and near misses) where the pharmacist or pharmacy technician write down the QRE on paper as soon as it happens but then also taking the time or designating a student pharmacist to input the informa-tion into an online error reporting system for analysis. Another challenge faced by pharmacies is when and where to discuss QREs. Most pharmacies have regularly scheduled staff meetings already; so many pharmacy managers include quality assurance activities in that meeting. The discussion does not necessarily need to be part of a formal staff meeting; it can also be done as part of informal conversations on a day-to-day basis. The key is to find opportunities throughout the day to make sure pharmacists and staff have those conversations. This also applies to addressing the peoples fear of error report-ing. If Im the pharmacist in charge, how can I make error reporting a more comfortable situation to discuss among my staff? Should I do it as an off-hand remark and start to get that conversation building that way, rather than gathering everyone around the table? The real question is how do I make it my own? In Nova Scotia, have seen those success stories. We were able to see some of those little things that people are trying to do to make this work.

NM: What could a pharmacist say to an employer who forces them to work fast and what can CQA do to help address problems with workflow?

David Nau (DN): I think thats why it is important to collect data on an on-going basis. This allows for a pharmacist to know when and where errors are occur-ring. He/she can track prescription volume on certain days or in certain portions of the system and identify select times of the day when more errors may occur. So that way, after data analyses is completed, anyone can go back and say when there were certain times that we saw an increase in the error rates and was it correlated with certain levels of volume or certain staffing configurations or a combination. This can be the starting point to diagnosing how workload is, or is not, related to error rates in the pharmacy. In my opinion, this is why having data helps a pharmacist speak more intelligently on what is happing in his/her store.

Terri Warholak (TW): Additionally, one should review the published literature. The literature has provided ample evidence that having a heavier workload increases errors. In fact, it is a curvilinear relationship whereas at very low prescription volume errors increase. There seems to be a point where optimal flow is reached, then, once that point is exceed, the errors increase again. So, there are published studies in the literature to show that there is a point at which work-

EXPERT ROUNDTABLE

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flow exceeds safety.

DN: I think that in the extreme of workloads, one tends to see extreme increases in error rates. It has been hypothesized that the very low ends of workload this type of increase in error rates is seen. It may be because of cognitively one may not be engaged and not in the zone. So when I have reviewed workload and error rates with pharmacies, I have noticed that Sundays seem to be time when workload got very low volume but higher error rates. So perhaps a pharmacist is not cognitively prepared and oriented for low volume. Or, as we found in one pharmacy, the pharmacist was distracted by watching football on Sundays because he thought that the store was so slow, he thought he could watch television and work. So there could be a number of reasons to explain how the low workload correlates to more errors. Plus, typically, on low volume days, fewer staff members are present. So it becomes a function of workload relative to staffing. I believe that there is published literature that has looked at prescription volume; it becomes complex when one starts to count the number of prescriptions and thinking about e-prescriptions or refills. If I remember correctly, once a pharmacy fills about 15 prescriptions per pharmacist per hour, there is an increased slope in the error rate.

KB: I take a little bit of a different view on that question. I am not willing to let the pharmacist off the hook quite that easily. It is the pharmacist who is the professional. It is the pharmacist who fills the prescription. Its the pharmacist whose duty it is to care for the patient. If it is particularly busy one day and the pharmacy is under-staffed, the pharmacist still has the obligation to fill only one prescription at a time. If there are 23 people in line waiting to be helped, this does not mean that the people in that line have any different expectations or any different needs than when there are two people who need assistance. I think the statement The pharmacist must ensure that all prescriptions are filled within 20 min-utes, as outlined by our promotions campaign somewhat allows the pharmacists to take blame off of themselves for an error. The pharmacist is a professional who needs to ensure they take the appropriate amount of time to fill every prescription correctly. The greatest pressure is currently on the pharmacists and pharmacy technicians to reduce errors, yet correctly fill a particular number of prescriptions per day (or per hour). For this reason, an interesting aspect of the new Walgreens workflow design is that the company has tried to insulate the technicians from the pressure of waiting customers by having a patient pick-up their prescriptions out of visual sight of the technician so they can focus on filling the prescription.

Todd Boyle (TB): In Canada, there have been pharmacy staff who have said, Hey, look, its too busy, I have to stop, I need to take a break for a minute because if I do not, I am actually going to make an error. Our CQA program includ-ed pharmacies that, through the data they collected, were able to pinpoint what days they are likely to have errors. The pharmacies take this information to their corporate offices and use it to create a case for getting additional staff members on days more prone to errors.

DN: I think really it becomes a complex issue to try to build an administrative rule around volume like some states have attempted to do. Sin

AJP Fall 2014

Documents

Transcript of AJP Fall 2014