Pennsylvania Pharmacist March/April 2016

Page 1

Pennsylvania March/April 2016 z Volume 97 z Issue 2

The official publication of the Pennsylvania Pharmacists Association

PERMIT NO. 533

PAID

HARRISBURG PA

PRSRT STD

U.S. POSTAGE

Connect, Collaborate, Care

www.papharmacists.com


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PPA Board of Directors PPA Officers: President: Donna Hazel, R.Ph President-Elect: Eric Pusey, R.Ph, CDE First Vice President: Nick Leon, PharmD, BCPS, BCACP Immediate Past President: Eric R. Esterbrook, RPh

Our Vision

Pennsylvania pharmacists will be recognized, engaged, and fairly compensated as health-care providers.

Regional Directors: Central: Ellen Nastase, RPh Northeast: Tom Franko, PharmD, BCACP Northwest: Nickolas Kernich, PharmD Southeast: Mark Lawson, PharmD, MBA Southwest: Lauren Simko, PharmD

The Pennsylvania Pharmacists Association, as the leading voice of pharmacy, promotes the profession through advocacy, education, and communication to enhance patient care and public health.

Pennsylvania

Practice Directors: Academia: Roshni Patel, PharmD Chain Pharmacists: Cory Krebs, R.Ph. Community Independent Pharmacists/LTC: Martin J. Kendra, R.Ph and Chuck Kray, R.Ph Health System Pharmacists: Rick Demers, R.Ph, MS FASHP Manage Care/Industry/Government/Other: Julene Vidic, RPh Associates: Todd Eury Student Pharmacists: East: Hamad Juboori West: Madison Adams PPA Office Staff: CEO: Patricia A. Epple, CAE pepple@papharmacists.com Program Manager: Sara Powers spowers@papharmacists.com Government Relations Manager: Donald L. Smith, III dsmith@papharmacists.com Communications Coordinator: Danielle Adams dadams@papharmacists.com Membership Coordinator: Ashley Robbins arobbins@papharmacists.com Bookkeeper: Mia Bostic mbostic@papharmacists.com PPCN Executive Manager: Mindy Kozminski mkozminski@papharmacists.com PPCN Trainer: Brandon Antinopoulos ppcntrainer@papharmacists.com

Our Mission

Ext. 3 Ext. 2 Ext. 6 Ext. 1 Ext. 5 Ext. 4

Pennsylvania Pharmacists Association (PPA) 508 North Third Street, Harrisburg, PA 17101 (717) 234-6151 Fax: (717) 236-1618 www.papharmacists.com ppa@papharmacists.com Pennsylvania Pharmacist (ISSN 0031-4633) is the official publication of the Pennsylvania Pharmaceutical Association d/b/a Pennsylvania Pharmacists Association and is published every other month, six times per year. Annual subscription is $100 for nonmembers; for members it is included in the annual dues. Editorial information should be addressed to the PPA address listed above. Peer reviewed articles accepted according to the stated guidelines available from PPA. Editorial Board: Hershey S. Bell, M.D.,M.S.,FAAFP, Chair Kim Coley Stephanie Smith Cooney, PharmD. Bernard Graham, PhD. Brian S. Plager, RPh., MBA Associate Editor: Danielle Adams Editor/Manager: Pat Epple Designed and Published by: Graphtech Sarah DiCello, Publications Manager (717) 238-5751 x118, sarah@thinkgraphtech.com For Advertising Information: Alexis Kierce, Account Manager (717) 238-5751 x119, alexis@thinkgraphtech.com Pharmacist State Board of Pharmacy Members: Gayle A. Cotchen, PharmD., MBA – Institutional Rob Frankil – Independent Community Janet Hart – Chain Community Theresa M. Talbott, R.Ph. – Chain Community Mark J. Zilner, R.Ph. – Independent Community Board of Pharmacy Meeting Dates: March 15, 2016 April 19, 2016 May 10, 2016 June 21, 2016 On the Cover: Photos from the 2016 Mid-Year Conference. Attend the conference this year and join in the fun! Disclaimer — The opinions of the authors reflected in this publication do not necessarily reflect PPA’s official position on an issue.

MAGAZINE

Departments

President’s Message................................................................................... 3 Calendar of Events..................................................................................... 5 Campus Checkup.................................................................................... 18 PPA Rotation Reflection............................................................................ 22 We Need You!.......................................................................................... 24 New Members.......................................................................................... 42

Features Member Profile: Robert L. Maher Jr., PharmD. CGP................................... 6 Pharmacy Spotlight: NutriFarmacy.............................................................. 7 PPA Legislator Profile: Ryan Aument......................................................... 10 Affiliated County News.............................................................................. 11 Student Profile: Geoffrey Arentz................................................................ 13 Student Profile: Taylor Warmbrodt............................................................. 15

Journal A Review of Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Steroid Use................................................................................... 17

Association News PPA Welcomes New PPCN Executive Manager........................................ 25 And The Survey Says ... Who are you supporting for President................. 25 PPA Pharmacy 2016 Legislative Day........................................................ 26 PPA 2016 Mid-Year Conference Highlights............................................... 28

Industry News Act 31—Child Abuse Reporting and Training Requirements...................... 36 First Quarter 2016: Pharmacy Time Capsule............................................ 37 RX and the Law........................................................................................ 38 Remarkable Progress: A Look Back at the Provider Status Campaign in 2015................................................................................................. 40 Here Comes the DSCSA.......................................................................... 44

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RDC 23 Wilkes University 27 APSC 27 Bowl of Hyegia Award 29 AmeriSource Bergern 37 LECOM 41 Pre-Residency Excellence Program 43 Thomas Jefferson University College of Pharmacy Back Cover


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Departments

Donna Hazel, R.Ph PPA President 2015–2016

Message from the President I t was great to see so many people at our PPA Mid-Year Conference “The Future of Pharmacy: Connect, Collaborate, Care”, at the Best Western Premier, the Central Hotel & Conference Center. I have always enjoyed the Mid-Year Conference, just to see the number of students that attend from all seven schools. The students do a great job at the OTC competition, as well as all the amazing posters that are presented! It was amazing to see how many posters were completed this year, not to mention the stellar subject matter. GREAT JOB to all! This year, I really took the time to watch and witness so many of our pharmacists helping during Beer & Banter, asking many great

questions of the students regarding their posters. I also observed how passionate many pharmacists were to students, especially during the Speed Mentoring program. Observing this action really made me think of this line from the Oath of a Pharmacist: “I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.” What I observed is what every pharmacist committed to doing when they took their oath: passing down their knowledge and skill to the next generation of PPA pharmacists. I sincerely want to thank PPA’s CEO, Pat Epple, the PPA staff, and the conference committee for all their hard work. Their efforts made

I hope to see you at the Capitol in April to support our profession! I know many students and pharmacists will be talking with their Representatives and State Senators at the Capitol building. This is our time to shine and let them know what we, as pharmacists, can do for the people in the Commonwealth of PA.

our 2016 Mid-Year Conference another great success! Congratulations go to The University of Pittsburgh for winning the OTC competition. As always, it was a close game. And as mentioned, what a record number of posters seen this year. What a great job by all! Once again, the CE programs were outstanding. Thanks to everyone who moderated and presented. Thanks also to all who donated to the PPA Foundation, I know I personally went over my budget on the silent auction! If you have not saved the date of April 6, 2016 for PPA Legislative Day, please do so. I hope to see you at the Capitol in April to support our profession! I know many students and pharmacists will be talking with their Representatives and State Senators at the Capitol building. This is our time to shine and let them know what we, as pharmacists, can do for the people in the Commonwealth of PA. See you on April 6th at the Capitol.

Donna Hazel, R.Ph PPA President 2015–2016 z

Pennsylvania Pharmacist I March/April 2016 I 3


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Departments

Calendar of Events

Thank You to Our Corporate Partners These companies support PPA activities throughout the year.

DIAMOND LEVEL

March 4-7

APhA Annual Meeting • Baltimore, MD

5

PA Reception @APhA Annual Meeting

PLATINUM LEVEL

April 6

PPA’s Legislative Day

16

Duquesne Law Review

16-19

NACDS Annual Meeting • Palm Beach, FL

19-22

AMCP Annual Meeting • San Francisco, CA

GOLD LEVEL

SILVER LEVEL May 1-3

NASPA Leadership Conference • Denver, CO

2-4

NCPDP Annual Conference • Scottsdale, AZ

12

Foundation Board of Directors Meeting

12-13

PCP Law Review

14-17

NABP Annual Meeting • San Diego, CA

19

BRONZE LEVEL

PPA Board of Directors Meeting

June 11-15

ASHP Summer Meeting • Baltimore, MD

July 12-13

PPA Board of Directors Orientation/ Leadership Retreat/Meeting

23-27

AACP Annual Meeting • Anaheim, CA

August September 22-25

Annual Conference • King of Prussia, PA

25-27

ACCP Annual Meeting • Bethesda, MD

For additional events including webinars, CE opportunities, and PPA committee meetings, be sure to see our Calendar of Events on the PPA website!

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Ernie Zost, RPH 727-415-3659 Ernie@RxBrokerage.com

Pennsylvania Pharmacist I March/April 2016 I 5


Features

Member Profile Robert L. Maher Jr., PharmD. CGP Contributed By:Raymond Snyder, Duquesne University PharmD Candidate, 2016 Pharmacy/Practice Site: Director of Clinical Services Patton Pharmacy and Klingensmiths’ Drugstore Education: 1993 BS Pharmacy University of Pittsburgh and 1997 PharmD. University of Pittsburgh

What made you choose the profession of pharmacy? I grew up working in our family pharmacy, which my Father started when I was 4 years old in 1974. As a young kid, working in the pharmacy, I saw the changes in pharmacy; from filling prescriptions with a Bates stamper and typewriter, to entering the computer age in the 1980’s, to the technology of today, with

6 I Pennsylvania Pharmacist I March/April 2016

the incorporation of medication synchronization and MTM programs. I found even as a young kid, the greatest thing about being an independent pharmacist was that you had the potential to help someone’s health everyday of your life. What made you decide to join PPA? I learned at an early age, from my father and my mentors, if you are good to the pharmacy profession, this profession will be good to you. Advocacy is a responsibility of every pharmacist in this profession no matter where you practice. I feel that in order for our profession to survive and advance it is with organizations like PPA. PPA helps fight for what is right for pharmacy and the patients that they serve in the Commonwealth of Pennsylvania. What is the most important piece of advice you would give a newly licensed pharmacist on their first day of work? Remember you are not always going to know everything, but it’s the wise professional who can recognize what they don’t know, but knows how to find the answer. Remember too that no matter how stressful a day can get, each day you can make a difference in a patient’s life.

Would you recommend other pharmacists join PPA, and if so, why? As I said before, it is our duty and responsibility as pharmacists to belong to pharmacy organizations at the state and national level. It is also our responsibility to become involved in some way to help preserve and advance our profession. It can be as simple as writing or calling your representative on an important piece of legislation, or to contribute your time to a project that is being worked on in the organization. Attending the Annual or Mid-Year Conference is a great way to network and stay sharp in our profession. PPA has all pharmacists good interest in mind in helping to do those things mentioned above. When you are not working, where can you be found? I can be found with my wonderful family of Kristen, my wife, and our three kids, Abby, Robert, and Nora. They teach me every day what living is all about. In addition, I am like most Western PA people, a diehard Pittsburgh Steeler, Pirate, Penguin and Pitt Panther fan. I enjoying watching and following the sports. z


Features

Pharmacy Spotlight NutriFarmacy: Not Your Average Pharmacy By Lindsey Wenger, Philadelphia College of Pharmacy PharmD Candidate, 2016 NutriFarmacy is not your typical pharmacy and Dr. Dan Wagner, PharmD, MBA is not your typical pharmacist. Wagner considers himself a clinical and natural pharmacist with a firm belief in a holistic approach to health and medicine. Located in Wildwood, Pennsylvania, just north of Pittsburgh, NutriFarmacy offers a variety of services that cannot be found anywhere else. These services include a complete consultation of all medications and supplements, a yoga studio located within the building, massage therapy, and Wagner’s wife even does facials for customers. NutriFarmacy also provides a number of products, including informational books, organic food, supplements, herbals, and even essential oils. Dan graduated from Duquesne University School of Pharmacy in 1975. In 1993 he received an international MBA and

received his Doctorate of Pharmacy degree in 2000 from Ohio Northern University. In 1980, just five years after graduating from Duquesne, Wagner opened his own independent community pharmacy. In the mid1990’s, he was ready for a change in career and had the opportunity to travel. After 17 years of owning his own pharmacy, Dan sold his pharmacy to open up NutriFarmacy, an all-natural pharmacy. He still travels frequently, particularly to the rainforests of Belize, Costa Rica, Ecuador, Cuba, and Western Africa. Wagner is the current president of the Board of Advisors for the Student Rainforest Fund. A member of the Pennsylvania Pharmacists Association since

1971, Wagner iterated the value and importance of professional organizations like PPA. He sat on PPA’s Board of Directors and won a few of PPA’s Awards; including the Pharmacist of the Year Award in 1996. PPA is doing and has done a wonderful job over the years, according to Wagner. While he no longer is a pharmacist in the traditional sense and does not dispense prescriptions any more, Dan still retains an active pharmacist license and is now a consultant pharmacist. A professional GNC with organic food is how Dan describes his natural pharmacy. NutriFarmacy has several rooms in the back where Wagner can consult with his patients. During a typical day, he spends the majority of his day doing consultations with an average of about seven to eight patients. Patients are asked to bring in all of the medications, herbals, supplements, and vitamins that they are taking so Wagner can check for any possible drug

Pennsylvania Pharmacist I March/April 2016 I 7


Features interactions or complications. After each consultation Dr. Dan, as he is referred to by his patients, writes a report consisting of detailed information about their medications and possible herbal options and emails it to his patients. Dan spends extra time with each patient because he feels strongly that patient’s want their concerns to be heard and are not very educated about medications and herbals and mixing them. Because the average American only spends about nine minutes

actually talking to their doctor during a visit, Wagner wants to make sure that his patients are correctly informed. When asked about the challenges of owning your own pharmacy and business, Wagner responded that it can be tough on your home life. Because often times to be successful in your business, you need to be married to it, especially in the beginning of your business. It can be tough to take vacations or any time off due to the financial strain of owning

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Features

PPA Legislator Profile Ryan Aument State Senator, R-Lancaster Senator Aument is a member of the Pennsylvania Community Pharmacy Caucus. What are the key issues you would like to see addressed this session? I would like to see the General Assembly work in a bipartisan way to advance public policy that will enable us to build an opportunity society where all Pennsylvanians can experience earned success. I believe we can best accomplish this by limiting the role of government, empowering the individual, promoting strong families, supporting vibrant communities, unleashing the power of the private sector, and building a high quality education system. Specifically, I intend to continue efforts to control state spending and protect the taxpayer with a responsible state budget plan. I will continue to fight for legislation to promote student and familycentered education reform. I will also work to advance legislation to empower an independent office of inspector general to further identify and eradicate waste, fraud, and abuse in state government.

10 I Pennsylvania Pharmacist I March/April 2016

Tell our members a little about your background and why you are a legislator? I grew up in southern Lancaster County, graduating from Solanco High School in 1995. I then earned a B.S. in Education at The Citadel in 1999. Upon graduation I was commissioned a 2nd Lieutenant in the United States Army. I served as an infantry rifle platoon leader and company executive officer and deployed to Iraq in 2003. After coming home from Iraq, I returned to Quarryville and was hired as a production supervisor at ICI Paints. After being involved in local politics for a number of years, I sought and was elected to the State House in 2010 and then to the State Senate in 2014. I have long had an interest in elective politics but was motived to run for office after serving in the military, and in particular serving in combat. I was fortunate to come home and experience a homecoming that some of those I served with did not experience. I was able to marry and have two beautiful children. I have been blessed with this opportunity to serve my community and hopefully help make life better for future

generations. In a sense, I was motivated to serve because others have sacrificed so much and cannot continue their service as I can. How do you see pharmacy and its role in health care evolving in the future? I think there will be even more emphasis on a patientcentered model of care that focuses on improving the quality of care and controlling costs. I think pharmacists will play a critical role in this transition. The level of care pharmacists provide must continue to expand well beyond the traditional dispensing role. I think patients will become more accustomed to and expect to and expect their pharmacist


Features to be a critical component of a wellness team with a far broader role of comprehensive medication management. Pharmacists will work directly with patients to develop and review an entire medication regiment and management plan. The patient/ pharmacist relationship will be of event greater importance. Do you have any advice for pharmacists about the political

process? It is absolutely essentially for pharmacists to be fully engaged and work to build relationships with their elected officials. It is important for pharmacists to reach out and get to know their legislator even if they may not have a specific proposal or issue they are advocating for. Phone calls, letters, and email messages are effective. Even more effective is an in-person visit. Building a personal

rapport is vitally important. What do you do for relaxation or enjoyment? I love reading and spending time with my family – my wife Kate, son Jack (5), and daughter June (2). There is nothing more enjoyable for me than coming home after a long day and sitting by the fire with my family and reading a good book. z

Affiliated County News Allegheny County Pharmacists Association The Allegheny County Pharmacists Association was well represented at the PPA Mid-Year Conference in Harrisburg at the end of January. One of the favorite events of the conference was the OTC Jeopardy competition where teams from Duquesne and Pitt battled it out amongst all the schools of pharmacy in Pennsylvania for one year of OTC bragging rights. It was an exciting night, and the scores were close all the way until the end. Panel judge, and fellow ACPA member, Jacqueline Klootwyk Lucey, definitely had her work cut out for her! It came down to the final jeopardy question for which history is rooted in Allegheny County…the national hotline telephone number for the poison control center. Poison prevention is something ACPA member, Stan Jonas, is passionate about and works with student organizations at both schools to distribute poison prevention awareness kits each year. The awareness paid off as Pitt prevailed and won the game with, “What is 1-800-222-1222?” There are many exciting events happening in the coming months for ACPA members. Pharmacy students had the opportunity to observe an ACPA Board of Directors meeting when Brandon Antinopoulos gave an update on the Pennsylvania Pharmacists Care Network

“It was an exciting night, and the scores were close all the way until the end.” on Duquesne’s campus in February. Also, ACPA Board Members auctioned off various items to help raise funds for the ACPA Student Scholarship, awarded to a Duquesne and Pitt pharmacy student each year. The ACPA Annual General Meeting was held at the Penn Brewing Company on February 25th to coincide with the CE program/Pennsylvania pharmacy update from PPA’s Pat Epple. This was good preparation for when ACPA members, both pharmacists and students, storm the state Capitol in April for Legislative Day. Lastly, we will have an Educational Dinner Program on March 30th at The Melting Pot in Station Square Drive about an overview of Alirocumab. In other ACPA family news, 2015-2016 Secretary, Jacqueline Klootlwyk Lucey, Pharm.D., BCPS, BCACP, welcomed a new addition to her family. Maria Lucey was born on December 9th at 10 lbs 10 oz 20.5 in. Congratulations to Jackie and her family! z

Pennsylvania Pharmacist I March/April 2016 I 11


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Features

Student Profile Geoffrey Arentz Education and Expected Graduation Year: Wilkes University Nesbitt School of Pharmacy, PharmD Candidate 2016 Internships: Pharmacy Intern at Wellspan Ephrata Community Hospital since 2011 Member since: August 2015

What is your favorite experience you have had since studying pharmacy? My favorite experience was an elective rotation where I traveled to Iquitos, Peru to study natural medicine. I had a great preceptor, who showed us how the Peruvian government is researching natural plants for medicinal purposes. The rain forest has so much to offer in the way of pharmacognosy, including the Camu Camu berry, which has promising data for helping to lower blood sugars in patients with Diabetes Mellitus. What has been your favorite rotation/internship/pharmacy related job you’ve been on and why? My favorite internship since beginning pharmacy school has come with the opportunities Wellspan Ephrata Community Hospital has given me, while I have been an intern for them. From the time I started as a technician, with very little pharmacy knowledge till now, they have prepped me to become a proficient pharmacist. They have given me countless opportunities to grow, including being able to initiate a medication reconciliation program in the emergency department. I truly enjoy the patient interaction in the ED and am thankful for the experience Wellspan Ephrata Community

Hospital has provided me throughout my education. What advice would you give first year pharmacy students? My advice to first year pharmacy students would be to get involved and to not shut any doors. By being involved in different programs and organizations I was able to see some unique aspects of pharmacy. It was important to me to experience as much as I can before I started to make decisions about my future. I have the rest of my life to hone my skills, but I only had four years to decide where I will put my skills to use. When you aren’t working where can you be found? Outside of working I am a very active person and like to get outdoors as much as possible. During pharmacy school, I did this by participating at first on the Wilkes University football and soccer team. It was hard to balance both school and sports, but a little bit of fresh air always gave me the motivation I needed to get back to the books. z

Pennsylvania Pharmacist I March/April 2016 I 13


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Features

Student Profile Taylor Warmbrodt Education and Expected Graduation Year: Lake Erie College of Osteopathic Medicine, PharmD Candidate 2016 Internships: Millcreek Community Hospital, 2013-2015 Member since: September 2013

Why did you choose to study pharmacy? Having been interested in the health field since second grade, my love for medicine and chemistry pointed me in the direc­ tion of pharmacy. After shadowing and research, I decided it would be the perfect career for me. Why did you choose to become involved in PPA? After speaking with the PPA representative for LECOM at the time, I decided that PPA was a great organization to join. I find it crucial to be an advocate for the profession that I plan to be a part of for my entire career. I also thought that being a member of PPA would provide me with a great opportunity to network with pharmacists and student pharmacists from across the state. Would you recommend joining PPA to other students and why? Absolutely! PPA is a great way to stay active and up to date on pharmacy and other legislative issues related to pharmacy. Also, the conferences are extremely beneficial and fun. They are a perfect way to bring the pharmacy community together in one place. The residency showcase is also a great way to network and explore career options for your future. What is your favorite experience

you have had since studying pharmacy? My favorite experience in pharmacy school has been participating in IPPE and APPE rotations where I am able to take the knowledge I have learned in the classroom and apply it. Working with different patient populations and pharmacy staff members has helped me grow as a person and a student pharmacist. What advice would you give first year pharmacy students? My advice for a first year pharmacy student would be to study hard and ask questions. Pharmacy school is fast paced and it’s easy to get left behind. However, I would also recommend that they make time for themselves and reward themselves for their hard work in order to stay motivated and in good spirits. z

Pennsylvania Pharmacist I March/April 2016 I 15


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Abstract: A Review of HypothalamicPituitary-Adrenal (HPA) Axis Suppression and Steroid Use Corresponding Author: Dominick P. Trombetta, Pharm D., BCPS, CGP, FASCP, Associate Professor, Pharmacy Practice, Geriatrics/ Internal Medicine Wilkes University, College of Pharmacy and Nursing, dominick.trombetta@ wilkes.edu The author involved in this paper does not have any conflicts of interest, including but not limited to: consulting fees, paid expert testimony, employment, grants, honoraria, patents, royalties, stocks, or other financial or material gain that may involve the subject matter of the manuscript. Keywords hypothalamic-pituitary axis suppression, glucocorticoids, prednisone, Cushing’s syndrome ABSTRACT: The class of drugs known as the glucocorticoids are one of the most frequently used in clinical practice. They are used for a variety of acute and chronic indications, available in multiple dosage forms. Supraphysiologic doses of glucocorticoids possess the potential to incur hypothalamic-pituitary –adrenal (HPA) axis suppression. If glucocorticoid therapy is abruptly discontinued or withdrawn too quickly, adrenal insufficiency can result in lifethreatening consequences when an individual experiences acute medical illness or needs to undergo surgical intervention. The slow tapering of glucocorticoids should be considered for prednisone doses greater than 20mg (or equivalent) for a duration of therapy longer than 3 weeks. Pharmacists play an essential role in providing patients with safety and efficacy information with both prescription and nonprescription products containing glucocorticoids. The hypothalamic- pituitary- adrenal (HPA) axis is an important regulatory system which dictates

the rate and amount of endogenous glucocorticoid secretion. The hypothalamus synthesizes and releases corticotrophin-releasing hormone (CRH) in response to stress, physical activity, illness, sleep/wake cycle which stimulates the release of adrenocorticotrophinreleasing hormone (ACTH) from the pituitary gland. The adrenal cortex releases glucocorticoid hormones (mainly cortisol) in response to ACTH. The release of cortisol is responsible for maintaining homeostasis of carbohydrate, protein, fat metabolism, the immune response, energy, and emotions. One mechanism of HPA axis regulation is via negative feedback triggered by adequate or high levels of circulating glucocorticoids.1 Conclusion: Glucocorticoid therapy is effacious for its anti-inflammatory and immunosuppressant effects in a variety of disease states. Regardless of the route of administration, glucocorticosteroids have been found to cause HPA axis suppression to varying Continued on page 27

Pennsylvania Pharmacist I March/April 2016 I 17


Departments

Campus Checkup Duquesne University Contributed by: Michaela Palermo, Communications Ambassador Duquesne University PPA Chapter started off the OTC birth control laws were discussed at our January semester with hosting a local OTC Competition. The General Meeting. As for the remainder of the semester, winners of the competition went on to compete at Duquesne PPA hopes that Donna Hazel will be the PPA Mid-Year Conference. Our chapter had six available to speak at the March General Meeting. attendees at the Mid-Year Conference. Details of the Additionally, PPA exec board hopes to have a good Mid-Year Conference were shared at the February turn out for elections during the April Meeting. We General Meeting that took place on February 18th. would like to end the semester with a Financial As per usual, the executive board will discuss recent Advisor guest speaker. We are looking forward to the events on pharmacy at the next meeting. Recent remainder of the semester. z

Jefferson College of Pharmacy Contributed by: Matthew McGuire, Communications Ambassador This semester at the Jefferson College of We will be hosting an Emergency Preparedness event Pharmacy we will be exercising our knowledge and that will relay information from the conference to commitment to help the general public receive the our student pharmacists. Other events that we have care they deserve. We are holding a “Legislative Day” planned through APhA-ASP that will involve our preparation event to inform our student pharmacists PPA members include several events at Rittenhouse about current polices and key issues that need to be Farmers Market, where the patient care organizations accurately expressed to our State Representatives and will provide education directly to the public and an Senators at Legislative Day, in Harrisburg, on April informative presentation and discussion, partnered 6th. In the beginning of February, we scheduled a with a local non-profit organization, titled “From Rx to joint event with APhA-ASP’s Operation Heart at a local Heroin: Knowing the Risks as a Health Care Provider Walgreens Pharmacy. This Provider Status Advocacy and Consumer”; building a culture of awareness & Operation Heart event is designed to demonstrate to prevent substance abuse by being a part of the how accessible quality care from a pharmacist is and conversation. z educate patients on the importance of provider status.

LECOM Contributed by: Emily Petrak, Director December afforded the students at LECOM a slight break as they were wrapping up some tests before the holiday break! To start off the month, APhA/PPA participated in a clothing drive at St. John’s Evangelical

18 I Pennsylvania Pharmacist I March/April 2016

Lutheran Church. Each year, we not only gather coats and winter accessories, but we take them down to the church and help sort and distribute the items to members of the community. In order to prepare for


Departments the holidays, Operation Diabetes of APhA/PPA held a small session at a Rite Aid near the school on December 15th. The event helped to promote wellness and gave tips on how people can live healthily during the Holiday Season. January was also a busy month as the students were preparing for finals to complete another term and hosting events in the area. Generation Rx gave a presentation to high school students at Harbor Creek High School on the issue of prescription drug abuse. Katy’s Kids also gave three presentations in the area to elementary school kids at Blessed Sacrament, Jefferson Elementary, and Diehl Elementary! The last event hosted at Diehl Elementary was an all-day event

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where APhA/PPA partnered with Safe Kids Erie to give presentations on poison control. Lastly, Operation Immunization of APhA/PPA hosted an immunization education event at LECOM offered to both pharmacy and medical students. The event/discussion was led by Dr. Ogden (Pharmacy) and Dr. Kauffman (DO) who gave helpful tips on how to talk to patients about immunizations who are against them. z

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Pennsylvania Pharmacist I March/April 2016 I 19


Departments

Philadelphia College of Pharmacy Contributed by: Ada Wu, Communications Ambassador The students at the Philadelphia College of Pharmacy are off to a great semester after their spirit filled weekend at PPA’s Mid-Year Conference in Harrisburg. With representation in the OTC Competition (from Pathik Suavarnakar ‘17, Michael Sylvester ‘17, and Jeffery Kim ‘18), the Know Pain Know Gain Competition (Mathew Forman ‘16) and at Poster Presentations (Simi Mathew ‘17 and Swana Thomas ‘18), both the students, as well as our faculty were able to show off their PCP Pride. With the start of the semester, the PCP chapter of PPA is excited for their upcoming events, such as Legislative Day, to promote advocacy for their profession! z

University of Pittsburgh Contributed by: Laura Yost, Communications Ambassador The University of Pittsburgh had an incredible MidYear Conference in Harrisburg! An impressive 65 students from Pitt presented posters to peers and pharmacists. Thank you to all the presenters for your hard work and dedication. Early in January, we held a competition among P1, P2, and P3 students to see who had the most knowledge about OTC medications. P2’s Marissa Badzik, Nicolette Diehl, and Justin Saver won the local challenge and went on to compete at the state level at Mid-Year. They made Pitt proud and won the OTC Competition!

20 I Pennsylvania Pharmacist I March/April 2016

I’m Graduating this Spring, my Checklist: Attend PPA Annual Conference Attend PPA Mid-Year, present a poster, and network Register for the Law Review Renew as a Resident or New Practitioner Member Put my PPA activities on my CV/Resume Graduate! Sign up for PREP


Departments On February 5th, we held a fundraiser dinner at TGI Fridays to raise money for the Pharmacy Political Action Committee (PharmPAC), a voluntary non-profit group that supports political candidates who advocate for the profession of pharmacy. We had many faculty and students attend. Thank you for supporting PharmPAC! A number of Pitt students are enrolled in the Government Relations Advocacy for Student Pharmacists (GRASP) program in preparation for Legislative Day on April 6th. As always, we are excited to be shaping the future of pharmacy! z

Temple University Contributed by: Jennifer Nguyen, Communications Ambassador A joint general body meeting with APhA was held Mid-Year Conference to take advantage of the in mid-November. At the meeting many opportunities weekend to network, present a poster, and participate were presented for PPA members to get involved; in the OTC competition. Plans to attend the 2016 such as getting published in the Pharmacists Care APhA Annual are underway. Most excitedly, a letter blog. PY1 and PY2 students are being paired with writing campaign in conjunction with Wilkes and PCP PY3 students to help write blog posts on a desired to push Senator Toomey to sign the Provider Status healthcare topic. Members attended the 2016 PPA Legislation took place at the end of February. z

Wilkes University Contributed by: Kristen Lopatofsky, Communications Ambassador The Wilkes University PPA chapter has been At the Mid-Year Conference, we had over 30 rigorously advocating since last semester! In students in attendance, in which we had students December, we had the P1 class write advocacy letters, participate in the OTC competition, Know Pain No which were sent to their legislators. In addition, we Gain competition, and poster presentations. Prior hosted an Advocacy Event during Pharmacy Week to the conference, we hosted our first annual OTC February 15th thru February 19th. During this event, competition, on December 10th, in which three students utilized the Provider Status postcards and representatives were selected to compete at the Legislative Action Center and called their legislators to Mid-Year competition! Way to go Wilkes! z action on the various issues. Our Wilkes chapter has also been busy raising money for PharmPAC and recently raised $200 through our Keep Calm and Ask Your Pharmacist t-shirt and bake sale! Thank you to Felicia Snyder and our chapter members for your outstanding fundraising efforts.

Pennsylvania Pharmacist I March/April 2016 I 21


Departments

PPA Rotation Reflection By: Shaina Kulp, Philadelphia College of Pharmacy PharmD Candidate, 2016 Prior to starting my rotation at the Pennsylvania Pharmacists Association, I really did not know what to expect. I have to admit, my exposure to and knowledge of PPA was fairly limited, but I figured I would learn new information about current pharmacy legislation in Pennsylvania. Well, my experience involved a great deal of pharmacy legislation and government relations work, and so much more. Since I was somewhat na誰ve to just how much PPA was involved in, I thought there were probably a few bills and laws that related to pharmacy, but I quickly learned that was not the case. Pharmacy is so intertwined in the healthcare field that it is involved in a lot more legislation than many of us realize. One of the events that I enjoyed the most was meeting with my State Representatives to discuss the current legislation on PBM registration and MAC transparency. I was pretty nervous before my first meeting and I was worried I would forget what I was going to say or that I would say the wrong information, but my State Senator quickly put me at ease. He was so nice, friendly, and really receptive to what I had to say, which really surprised me. My State House Representative was equally as friendly and I had a great meeting with both of them. Before this rotation, if someone would have told me to go talk to

22 I Pennsylvania Pharmacist I March/April 2016

my State Representatives I would have thought that there was no point in going because they would not listen. However, I now know that they would be receptive to what I had to say and I would be able to conduct that meeting with confidence. Another area of this rotation that I really enjoyed was working with the Mentor Collaborative in creating the toolkits for pharmacists to use. I was able to sit in on some of their conference calls and even attended one of their meetings. I think the toolkits are a wonderful resource for pharmacists and they showed me just how much time pharmacists put into PPA and helping other pharmacists. The toolkits are just one of the projects being developed at PPA, but I found it very encouraging to see pharmacists from all areas of the state working in very different fields come together to help other pharmacists. On the second day of my rotation I was surprised to find out that the Mid-Year Conference was in three short weeks and at that time I did not realize what I had just gotten myself into. I have attended conferences in the past and definitely took for granted how much work actually goes into putting a conference together. There are so many different pieces that go into putting a conference together, both before and during the conference, in order for it to run smoothly.

I had never attended a PPA conference before this rotation, but I know I will be attending more in the future. All of the pharmacists at the conference were so friendly and welcoming; it was great to see how much they enjoyed being there. I was fortunate to be able to attend some of the meetings at the conference and was refreshed to see just how passionate the pharmacists were about the profession of pharmacy and helping others. Even though working the conference was pretty tiring, it was a great experience and I am very thankful I had the opportunity to go. My rotation at PPA involved a lot more areas of pharmacy than I ever could have imagined and I learned a great deal of information that I will take with me in the future. The opportunities I was given, the people I was lucky to meet, and the experiences I had, will help me be a better pharmacist and help me further the profession of pharmacy. z


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Departments

We Need You! PPA offers a number of opportunities for you to become connected, involved and engaged in our mission and vision! To view a full list of volunteer opportunities visit: http://www.papharmacists.com/?page=Volunteer Committee or Work Group Volunteer PPA offers a wide variety of committees and work groups, all working to benefit the profession of pharmacy. There is surely one that aligns with your interest and experience. Visit the volunteer page above to find a committee that interests you! Or contact the PPA office Forum Leader As we expand our forums, we are looking for individuals who will engage and lead discussions on the forum topics. Please contact Pat Epple, pepple@ papharmacists.com, for more information! Volunteer At A PPA Conference! For any of the conference volunteer opportunities listed below, please contact Sara Powers for more information or to sign-up; spowers@papharmacists. com. CE Faculty: PPA is always looking for qualified, dynamic speakers to present continuing pharmacy education programs at our Annual and Mid-Year Conferences and through online webinars. Read the Speaker FAQ Sheet online to learn what is expected, and also watch for calls for submissions! CE Moderators: PPA also always needs Conference CE Moderators. Read the moderator instructions online to learn about moderating a CE program at PPA’s Annual or Mid-Year Conference.

24 I Pennsylvania Pharmacist I March/April 2016

Ticket Collectors: Help PPA collect tickets and greet your peers and fellow members! Ticket collection shifts are usually 15 minutes and each shift has 2 individuals. Registration Desk Helpers: With the hustle and bustle of our conferences, PPA is always looking for smiling faces to help out at our registration table. This is a great opportunity to volunteer and to meet your fellow members. Authors and Reviewers Needed For any of the following opportunities, please contact Danielle Adams for more information at dadams@ papharmacists.com. Pennsylvania Pharmacist Authors: PPA accepts Peer Review Articles for the Pennsylvania Pharmacist. For more information please visit the at http://papharmacists.com/?page=Peer to learn more about this process! Peer Reviewers: If you are interested in serving as a Peer Reviewer for PPA please complete and return the online application. Pharmacist Care Blog Bloggers: Interested in bringing your knowledge to the web? PPA is accepting submissions from Bloggers (Blog Authors) for our blog Pharmacists Care. Blog Reviewers: PPA is also looking for blog reviewers for Pharmacists Care. z


Association News

PPA Welcomes New PPCN Executive Manager PPA recently announced the hiring of Mindy Kozminski, PharmD, BCACP as the new Executive Manager for its Pennsylvania Pharmacists Care Network (PPCN). PPCN is the collaborative organization which is developing payer based networks of pharmacists to provide direct patient care around medication management. PPA also announced that Brandon Antinopoulos, PharmD will continue to stay involved as the PPCN Trainer and will manage the medication management online and live training programs that develop pharmacists engagement in the Network. Mindy is a graduate of the University of Pittsburgh School of Pharmacy. Immediately following graduation she went on to complete a community pharmacy residency with the University of Pittsburgh School of Pharmacy in

partnership with Rite Aid. During her year as a resident she had the opportunity to work in a variety of outpatient settings, learning how the pharmacist could work as part of the health care team and contribute to improved health of the patients she cared for. She was also involved in a research project that looked at the integration of a pharmacist into primary care practices. Her research project: Pharmacist Integration into the Medical Home: A Qualitative Analysis went on to be published in the Journal of the American Pharmacist Association and win the National Wiederholt Award in 2012. After her residency, Mindy went on to work for Gateway Health Plan to focus on their Medication Therapy Management Program. While at Gateway, Mindy was heavily involved with the oversight and development of their MTM Program. She also

spent much of her time providing medication therapy management to their members and developing the training process for new pharmacists to be able to provide medication management. She is now looking forward to be able to work with PPCN to help provide new way for pharmacists to be able to provide care to their patients by meeting their medication related needs. In her free time, Mindy loves spending time with her husband and two young daughters. z

And The Survey Says ... As of February 1 Who are you supporting for President?

Jeb Bush Ben Carson Ted Cruz

Hillary Clinton

Carly Fiorina Marco Rubio

Bernie Sanders

Donald Trump Other Replican Candidate

Pennsylvania Pharmacist I March/April 2016 I 25


Association News Schedule of Activities 8:00 a.m.

Registration begins—

East Wing Rotunda, Capitol Building

8:00 a.m. - 3:00 p.m.

Legislative appointments as scheduled with legislators or staffers

8:30 - 10:00 a.m.

Continental breakfast for attendees, invited legislators and staffers—

East Wing Rotunda

8:30 a.m. - 2:30 p.m.

Screenings and informational displays presented by schools of pharmacy—

East Wing Rotunda

9:00 a.m. - 1:00 p.m. Special meetings being planned!

1:30 – 2:30 p.m. Pharmacy Rally—

Main Rotunda

PPA will provide you with issue briefings, background papers and leave-behind packets for the major legislative issues affecting pharmacy.

Advance Webinar briefings: Webinars to

help you prepare for the issues will be held.

The Pennsylvania Pharmacists Association will be hosting its annual Legislative Day in Harrisburg on Wednesday, April 6, 2016. Come to Harrisburg and meet with your state Representative and Senator on the issues that affect you as a pharmacist, pharmacy technician and/or student pharmacist and the patients you serve! We need you to be here to speak out for the future of pharmacy and for your patients! Join us in Harrisburg on Wednesday, April 6! “I attend Legislative Day because it is exciting to participate in the legislative process. Face to face meetings with my legislators where I can share my personal experiences with the issues are the way to impact change. The meetings help to build relationships that can make such a difference.” - Stephanie Smith Cooney, President, Gatti Pharmacy

Pharmacists: Tuesday, March 29 at 2:00 p.m.* Students: Wednesday, March 30 – 2:00 p.m.* *Webinars will be recorded for those unable to participate.

26 I Pennsylvania Pharmacist I March/April 2016

“I think it’s important to come to Legislative Day because it helps get your foot in the door in the political process – while helping you to build relationships with your legislators. The more you can build upon that and impress upon them the importance of the many issues facing pharmacy, the more they will take those issues seriously.” - Rick Seipp, Vice President of Pharmacy, Weis Markets Inc. Please contact Don Smith at dsmith@papharmacists.com with any questions and be sure to visit PPA’s Legislative Day webpage for more information!


Journal Abstract: A Review of HypothalamicPituitary-Adrenal (HPA) Axis Suppression and Steroid Use continued from page 17 degrees. Extensive clinical trials are needed to develop concrete prescribing measures to ensure patient safety, particularly in the critically ill population. With the concerns of adverse effects in glucocorticoid therapy, patient education is essential. Pharmacists play an important role in providing patients with information regarding prescribed glucocorticoids, as well as when helping patients choose over the counter products containing corticosteroids. Patients and physician should be reminded about the potential adverse reactions of long-term therapy including adrenal insufficiency and musculoskeletal effects such as osteoporosis and related fractures. Pharmacists and primary care providers must educate patients about the benefits and risks of therapy as well as the importance of compliance to therapy. z

Access to the full article is available online at https://papharmacists.site-ym.com/?Articles.

Earn continuing education credit with Wilkes Enroll in our continuing education programs for pharmacists and nurses. Programs take place at Mohegan Sun at Pocono Downs in Wilkes-Barre, Pa. The cost to attend is $125 for each program. Lunch is provided.

9 a.m. to 4 p.m. Tuesday, April 19

9 a.m. to 4 p.m. Monday, May 2

Develop your skills in medication safety, medication adherence, pharmacogenomics and patient interview techniques.

Advance your knowledge in phytochemicals, nasal saline irrigation and constipation.

Register at www.wilkes.edu/continuedlearning or by calling (800) WILKES-U Ext. 5615. Wilkes is an approved provider of continuing nursing education by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. The Nesbitt School of Pharmacy at Wilkes is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.


Association News

2016 Mid-Year Conference Highights Thank you to everyone who attended “The Future of Pharmacy: Connect, Collaborate, Care” at the Best Western Premier The Central Hotel & Conference Center in Harrisburg! Over 350 attendees came to Mid-Year and attended continuing education programs, student competitions, and other social events. In 2015, PPA was pleased to experience a number of legislative successes and victories and we want to continue this progress. Contributing to 2 PharmPAC is one way to help us do this; and we are very appreciative that some of our student chapters are helping with this effort. Students at Wilkes University sold leggings and windbreakers in an annual Phi Lambda clothing sale, held a t-shirt sale and had a bake sale all to raise money for PharmPAC and presented PPA with a check for $300. In addition, students at LECOM sold white coats to raise money for PharmPAC and presented PPA with a check for $400. Thank you to both schools – and we appreciate your enthusiasm and support of PharmPAC! 1 Pictured (Wilkes) – Keri Diehl, Kristen Lopatofsky, Felicia

Snyder, Don Smith, Jennifer Smith, Christian Giovannini, and Anthony Fanucci 2 Pictured (LECOM) – Shivam Patel, Don Smith, and Emily Petrak

28 I Pennsylvania Pharmacist I March/April 2016

1


2015 Recipients of the “Bowl of Hygeia” Award

Dan McConaghy Alabama

Tom Van Hassel Arizona

Nicki Hilliard Arkansas

Robert Shmaeff California

Sherman Gershman Connecticut

Kevin Musto Delaware

Fritz Hayes Florida

Ron Stephens Georgia

Kerri Okamura Hawaii

Steven Bandy Illinois

Jane Krause Indiana

Richard Hartig Iowa

Robert Nyquist Kansas

Larry Stovall Kentucky

Lloyd Duplantis Louisiana

Kenneth McCall Maine

Butch Henderson Maryland

Paul Jeffrey Massachusetts

Derek Quinn Michigan

Jenny Houglum Minnesota

Robert Wilbanks Mississippi

Richard Logan Missouri

Gayle Hudgins Montana

Heather Mooney Nevada

Richard Crowe New Hampshire

Edward McGinley New Jersey

Amy Bachyrycz New Mexico

Benjamin Gruda New York

David Moody North Carolina

Kevin Oberlander North Dakota

Danny Bentley Ohio

Gordon Richards, Jr. Oklahoma

Ann Zweber Oregon

Thomas Mattei Pennsylvania

Deborah Newell Rhode Island

Sharm Steadman South Carolina

Renee Sutton South Dakota

Mac Wilhoit Tennessee

Jim Cousineau Texas

Marvin Orrock Utah

John Beckner Virginia

Gregory Hovander Washington

Terri Smith Moore Washington DC

David Flynn West Virginia

Brian Jensen Wisconsin

Randy Harrop Wyoming

The “Bowl of Hygeia”

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


Association News

Special Thank Yous PPA sends a special thank you to the 2016 Conference Committee: Martin Kendra (chair), Mayank Amin, Katie Battista, Ann Campagna, Tanya Dougherty, Eric Esterbrook, Kimberly Ference, Donna Hazel, D Scott Himler, Ramzan Judge, Jacqueline Klootwyk Lucey, Genevieve Levans, Alysha Lopez, Jamie McConaha, Barbara McNeal, Angela Nace, Ellen Nastase, Jennifer Nguyen, Emily Scopelliti, and Lauren Simko! Thank You Sponsors! We would like to thank our Annual Corporate Partners and Conference Sponsors! The funding and support they provide allows PPA to provide conference attendees with a remarkable experience. We thank them for their generosity to PPA! Annual Corporate Partners Diamond Level: Rochester Drug Cooperative, Inc., Pharmacists Mutual Companies, Independent Buying Group, Value Drug Company Platinum Level: Keystone Pharmacy Purchasing Alliance, Inc. Gold Level: AmerisourceBergen Silver Level: McKesson, HD Smith Bronze Level: R.J. Hedges and Associates Conference Sponsors: Diamond Level: Keystone Pharmacy Purchasing Alliance, Inc. Ruby Level: Rite Aid Pearl Level: Giant Eagle Soda Break: NACDS z

30 I Pennsylvania Pharmacist I March/April 2016


Association News

Educational Foundation Fundraisers Congratulations and thank you to all who donated, placed bids, and bought raffle tickets and mugs! We raised over $5,600 from the auction, raffle, mug contributions and Sunnyside Up breakfast ticketss. Mugs $280.00 Raffle $1,686.00 Breakfast $413.00 Auction $3,276.00 Total $5,655.00 During Mid-Year the Foundation hosted a Sunnyside Up Breakfast on Sunday, January 31st, which included presentations on the Foundation and reports from the grants that were awarded in 2015.

By showing up for breakfast and learning more about the Foundation and its grants, each attendee made a contribution, through their registration, to the Foundation! Special Sunnyside Up coffee mugs were also provided to anyone who chose to make a separate $10 contribution. z

Know Pain, Know Gain Competition Congratulations to this year’s Know Pain, Know Gain Competition winner: Alvina Tran, Duquesne University, 2017 PharmD Candidate! The other two finalists were Matthew Forman, Philadelphia College of Pharmacy, 2016 PharmD Candidate and Mariah Corso, Duquesne University, PharmD Candidate 2017. The top winner received a cash prize of $75, and the two runner-ups received $25. Another big thank you to our competition judges, Michele Musheno, Tanya Uritsky, Maria Foy and moderator, Coleen Kayden! z

Know Pain, Know Gain Judges: Michele Musheno, Tanya Uritsky, and Maria Foy.

Know Pain, Know Gain Finalists: Matthew Forman, Alvina Tran, and Mariah Corso

Know Pain, Know Gain Moderator, Coleen Kayden

Pennsylvania Pharmacist I March/April 2016 I 31


Association News

OTC Competition The signature event of the PPA Mid-Year Conference for the last several years has been the student OTC Competition sponsored by the National Alliance of State Pharmacy Associations (NASPA), Non-prescription Medicine Academy (NMA), and Proctor and Gamble. Congratulations to the University of Pittsburgh who took home the 2016 traveling plaque! Members of the winning team included Marissa Badzik, Nicolette Diehl, and Justin Saver. z

32 I Pennsylvania Pharmacist I March/April 2016


Association News OTC Competition continued

Student Poster Presentations We had a total of 38 student posters presented on Saturday evening at the MidYear Conference. The theme for the posters this year was “The Future of Pharmacy: Connect, Collaborate, Care�. Those who attended earned CE credit by learning from each student about their work. Photos and links to the poster presentations are available on our website under the Foundation Poster Presentations tab! z

Pennsylvania Pharmacist I March/April 2016 I 33


Association News

2015 Report

A special thank you is in order to all 2015 PharmPAC donors…

2015 marked another successful year for PharmPAC! PharmPAC raised a total of $42,375.78 – and personal contributions from our members gave us with the resources needed to deliver real and meaningful results! We are aiming to raise $55,000 in 2016 – and it’s a goal we can and NEED to reach. Please consider making a personal contribution today to help us reach our 2016 goal; or donate monthly via our regular credit card charge program.

Congressional Club ($1,000+)

Carmen DiCello Greg Drew John F. Hinkle, Jr.* Henry M. Katra P.J. Ortmann*

John A. Pavis* Darrin & Debra Silbaugh* Mathew P. Slakoper Mark Szilagyi Richard Williams

Keystone Club ($500+)

Andrew Altobelli Thomas A. Bradley David J. Cippel* David Cunningham* Loc N. Dao Joseph R. DiMatteo Patricia A. Epple* Michael J. Fapore Robert Frankil* Amy Baloh Anthony Bertola Joseph G. Bettinger Mel Brodsky* Eric Esterbrook* Jon & Kim Ference* William T. Ferri Dennis Fowler 34 I Pennsylvania Pharmacist I March/April 2016

Donna Hazel* D. Scott Himler* Coleen Kayden* Robert Kayden* Patrick F. Lavella* Charles E. Lebegern* George M. McAlanis* Bethany L. Miller* Joseph Scott Miskovsky*

Shawn R. Nairn* John J. Pavis* Eric Pusey* Robert S. Schreiber* Stephanie Smith Cooney* David M. Smith* Theodore R. Stoklosa William Thompson

Janet Hart* Nicholas Katra Nickolas Kernich* Robert L. Killoran* Jacqueline Klootwyk* Nicholas Leon* Robert L. Maher, Sr. Ellen Nastase*

Charles Obeid Lee Shafer Melissa Sherer Krause* Andrew O. Thomas Gilbert Zilner

Capitol Club ($250+)

1


Association News

Patriot’s Club ($100+)

Alexander Achildi Brandon Antinopoulos* Philip R. Arlia Richard Barbieri Katie Battista Joseph G. Bechtel Frederick J. Bonchosky

George Botros Richard J. Brown Douglas B. Brunner Edward Casey Robert Cohen Walter Cwietniewicz Gary Karwaski

John Keegan Melissa M. Keller Charles C. Kray Sherri Ann Lee* Enid C. McClung Cheryl J. Meek Joseph E. Millward

Douglas Allen Thomas Bowser Martin R. Brian P. Gregory Buchanan Jenna Carmichael Yoshimi Clark

James M. Dillon Tanya Dougherty Martin Farrell John Gatto* Mary Grisnik George R. Haynes Barry P. Jacobs

Deborah Augustine Lawrence R. Barnes John C. Barrett Ann Benyo Ross F. Bevevino

Richard J. Bronstein Gregory P. Buchanan David R. Crevar Richard R. DeLuca Antonio Difilippo Alfred Feroli

Ben Andrick Galen W. Bear Walter C. Daniels Donald S. Deibler

Joseph Anthony Mosso Andrea Pugh Susan C. Schropp William Sherman Thomas E. Silvonek Robert Steele Tom Stonesifer

Gregg S. Teitel Jude Vavala Alan Vogenberg Gerald J. Volgraf Megan B. Weigand

John Kearns Charles F. Kohlerman Cory Krebs James M. Loyer Bruce D. Martin Joseph F. McNeill

Maria McNeill Anthony Mortelliti Christine Roussel Maureen Scheuerman James R. Schiffer Leonard Starr

Julene White Vidic Dawn Wagoner Fred L. Weissberger Adam Welch Lori Zaleski

Gary V. Fields RobertHartzell, Jr. Robert E. Howell Andrew J. Irons Tamre Joyce Peter A. Kreckel Barry C.L. Kwasny David E. Mateer

Louis Micolucci Keith Miller Edward T. Millward Julie Olenak Maria Osborne David F. Ostrow Roshni Patel*

Richard A. Reed Thomas M. Ross Marvin Sheffler Bruce Sigman Lauren Simko* Donald Smith* Mark Szilagyi, Jr. Marlene Trambley

Thomas Lindeman Robert Maher, Jr. Michelle Mikus

Morris Ogun Thomas Olcese Adele Roman Joel Roman

James Vickery

Sustaining Members ($50+)

Contributors ($25+)

Tom Franko Gary Leroy Garrett Amanda Jaber

Donors ($10+)

1878 Society Members (Student-Only)

Mohamed Amer (LECOM) Hannah Cawoski (Duquesne University) Mariah Corso (Duquesne University) Alex Gragg (LECOM)

Keito Hoshitsuki (University of Pittsburgh) Kenneth O’Donnell (Jefferson School of Pharmacy) Terry K. Pak (Philadelphia College of Pharmacy)

Rachael Richter (Duquesne University) Jennifer Smith (Wilkes University) Felicia K. Snyder (Wilkes University)

Student Chapter Fundraisers

LECOM School of Pharmacy

Wilkes University

2

Pennsylvania Pharmacist I March/April 2016 I 35


Industry News

Act 31—Child Abuse Reporting and Training Requirements Do you know your responsibilities under this new law? ALL pharmacists must complete this training prior to the 2016 license renewal. Well you better – because effective for your next license renewal, you will need under Act 31 to fulfill a two hour training program prior to your next license renewal (9/30/2016). There is a free course that has been approved by the PA Department of Human Services and Department of State to meet mandated reporting (Act 31) license requirements. While this free program is three hours in length, you can still utilize it to meet the requirement because the State Board of Pharmacy has agreed to accept either a two hour or three hour approved course. So while there are both two and three hour courses available, both for free and for a cost, the Board will accept either the two hour or three hour course in its entirety and reduce the required amount of credit in ACPE courses to 27 or 28 hours of credit after subtracting your Act 31 credits from the total of 30 needed for renewal. To be absolutely clear, if you take a three hour Act 31 course, you will need 27 additional ACPE hours of credit. If you take a two hour Act 31 course, you will need 28 credit hours of additional ACPE. Act 31 courses do not have to also be ACPE approved but could be. They will be submitted differently and not through the CPE monitor unless they are also CE approved. Providers for this training must be approved by the PA Department of State. nformation and links to both the free course and the list of other options for approved provider can be found on the PPA website at http://www.papharmacists.com/?page=LawsRegs and the link to the Board of Pharmacy. The State Board of Pharmacy has stated that courses do not

36 I Pennsylvania Pharmacist I March/April 2016

need to be ACPE accredited as long as approved by the above agencies as fulfilling the law. PPA highly recommends NOT waiting until the last minute and working on fulfilling this requirement now and/or throughout the year ahead. It is important to note that some of the course providers only report those who have fulfilled the requirement on a bi-weekly or monthly basis, so you need to be sure to allow enough time for the Department of State/State Board of Pharmacy to get the information. You will encounter a HARD stop when you go to renew your license if you have not completed this requirement. When you go to renew your license next year in 2016, the Department of State will match the license list against the reporting of those who took an approved program. If you don’t have any record of taking an appropriate class you will be unable to renew your license! You will be unable to renew UNTIL you fulfil this requirement. If you do have a record of fulfilling the require­ ment, you will only need an additional 27 or 28 hours of ACPE, accredited continuing education, (depending on whether you took a two or three hour course for the Act 31 training). It is also important to note that for initial licenses, this includes people transferring into the state and new pharmacy interns, the three hour course is required PRIOR to obtaining the Pennsylvania license. Please feel free to contact Pat Epple at PPA if you have any questions on this. z


Industry News

First Quarter 2016: Pharmacy Time Capsule 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 America’s history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org. Pharmacy Time Capsules are written by Dennis Worthen who makes them available for state pharmacy associations to share with their members. Appropriate attribution is at the bottom. If you are publishing, please leave us a comment below.

1991 • The Joint Commission of Pharmacy Practitioners developed that mission statement for pharmacy that would be embraced by most pharmacy organizations: To help people make the best use of their medications.

1966 • 9th Floor project at Moffitt Hospital at University of California San Francisco put pharmacists on the floor to provide 24/7 unit dose dispensing and admixture program. • First ASHP Midyear Clinical Meeting held in Washington, DC attended by 250 individuals.

1941 • Japanese sneak attack on Pearl Harbor on Sunday, December 7 leads to a declaration of war on December 8. • On February 12 English Constable Albert Alexander becomes the first patient treated with intravenous penicillin. His condition improves initially but there is insufficient supply to stop the fatal infection.

1916 • Margaret Sanger opens the first U.S. birth control clinic in Brooklyn. z

Pennsylvania Pharmacist I March/April 2016 I 37

The Value of You. The Strength of a Network. You value your patients, your community and your independence when it comes to deciding what’s best for your business. And so does AmerisourceBergen. For more than 30 years, AmerisourceBergen and Good Neighbor Pharmacy have been committed to the future of independent community pharmacy by offering solutions that help you attract new patients, retain existing ones and operate more efficiently — all while staying true to you. For more information, contact your sales associate or email solutions@amerisourcebergen.com.


Industry News

and the Law By Don. R. McGuire Jr., R.Ph., J.D. This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

Diclosures of PHI Uses and disclosures of Protected Health Information (PHI) are allowed under the Health Insurance Portability and Accountability Act (HIPAA) as needed to perform transactions for treatment, payment, or healthcare operations (TPO). This is well known to pharmacists, but not always by patients. Patients are aware of HIPAA and some of them think that HIPAA prohibits all use and disclosure of PHI. Patients have reported claims alleging that the pharmacists violated HIPAA by contacting the prescriber to clarify a prescription. Pharmacists know that they can disclose PHI to another treating health professional under TPO. Pharmacists may be less aware of other uses and disclosures permitted under HIPAA that are not included under TPO. These can be found in the Code of Federal Regulations at 45 CFR 164.512. These uses and disclosures are not absolute. Many have conditions that must be met prior to the use or disclosure being made. The length of this article won’t allow a complete

38 I Pennsylvania Pharmacist I March/April 2016

listing of all the conditions for each. The regulations may also restrict the parties to whom the disclosure may be made. The first permitted use and disclosure is for public health activities. This allows disclosures to public health authorities, FDA and other persons in certain circumstances. One of these is an agency authorized to receive reports of child abuse or neglect. This connects to a second permitted disclosure about victims of abuse, neglect, or domestic violence. There is some overlap in these permitted uses, so caution is needed to make sure your situation fits into the parameters. There are three related disclosures that involve law enforcement. The first allows disclosures to law enforcement officials about victims of crime or about criminal conduct. Disclosure is also permitted to avert serious threats to health or safety, either to a person or to the public. This could even include disclosing PHI that would help police identify or apprehend escapees. The third permitted use here is disclosures to a coroner or medical examiner to help identify a person or help determine the cause of death.

Regulations also permit disclosures for cadaveric organ, eye or tissue donations; or for research purposes. There are a number of specific conditions regarding disclosures for research purposes. There are two exceptions involving the legal and regulatory system. The regulation provides for disclosures to a health oversight agency if the agency is performing their oversight activities. This would include audits, inspections, investigations or disciplinary actions. These are not audits conducted by third party payers. There is also an exception for court orders and subpoenas. There are conditions to be met for the subpoena exception to be valid, so use caution when responding to a subpoena. The last two exceptions are in specialized areas. The first is for specialized government functions. These include uses and disclosures for military and veterans activities, national security activities, protective services for the President, correctional institutions or to the National Instant Criminal Background Check System. The last exception is the disclosure of PHI to workers compensation


Industry News programs as required by law. Workers compensation is a statutorily-created system that regulates the care of injured workers. The lesson for pharmacists is that there are many situations other than TPO where use or disclosure of PHI is permitted without the patient’s authorization. All of the exceptions are subject to conditions and are not absolute. Also, the pharmacist should remember that they are only allowed to disclose the minimum amount of information necessary to fulfill the purpose of the disclosure. These exceptions are not authorizations to disclose all

PHI concerning an individual. When presented with a request for PHI, the pharmacist should investigate if the request is permissible under TPO or some other exception. If the request is permissible, the pharmacist should verify that all conditions have been met. The Department of Health and Human Services has a useful page on its website to help the pharmacist navigate rules and conditions. It can be found at: http://www.hhs.gov/hipaa/ for-professionals/faq. As always, the pharmacist should reach out to their local attorney if they need assistance in navigating the HIPAA waters.

Š Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company. This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly. z

Pennsylvania Pharmacist I March/April 2016 I 39


Industry News

Remarkable Progress: A Look Back at the Provider Status Campaign in 2015 An Update from Tom Menighan, CEO of APhA Each New Year, we have an oppor­ tunity to reflect on the accomplishments of the previous year. With your help, the campaign to pass The Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 314) made major strides in 2015. Re-introduced in the U.S. House in January, and introduced for the Representatives Brett Guthrie (R-KY), G.K. Butterfield (D-NC), Todd Young (R-IN), and first time as a companion bill in the Ron Kind (D-WI) U.S. Senate, provider status legislation quickly garnered widespread bi-partisan support. Within 30 days, more than 60 House members had become cosponsors and momentum never abated during the year. By June, co-sponsorship of the House bill surpassed support enjoyed by the bill in the previous Congress. A key highlight came in October when Representatives Buddy Senators Chuck Grassley (R-IA), Sherrod Brown (D-OH), Mark Kirk (R-Il), and Robert Casey (D-PA) Carter (R-GA), Doug Collins (R-GA), Austin Scott (R-GA), Rod Blum (R-IA) and David Loebsack (D-IA) discussed the importance and Focus newsletter updates, the CEO Blog, webinars, of provider status during a special floor session of commitment cards, email and media alerts, APhA the U.S. House. That same month, the bill achieved grew online support substantially. By May, five times an important milestone when the majority of House more letters from supporters were generated to members signed on as co-sponsors. Another highlight Congress than during all of 2014, and the campaign occurred in November when the APhA Academy of became the largest grassroots advocacy effort in Student Pharmacist’s hosted Representatives Debbie APhA’s 163-year history. By year’s end, the campaign Dingell (D-MI), Marsha Blackburn (R-TN) and Bill had 21,000 supporters who had sent more than Keating (D-MA) at the Midyear Regional Meetings, 36,000 letters to Congress. APhA also produced video and they spoke in support of provider status. testimonials of patient care stories from pharmacists We want to take a moment to thank the U.S. and student pharmacists from all 50 states. House and U.S. Senate members who introduced This intense effort has made a difference. As we start The Pharmacy and Medically Underserved Areas 2016, there are 262 co-sponsors in the House and 39 Enhancement Act into Congress and for their work co-sponsors in the Senate, and we are optimistic that in building its support among their colleagues. the campaign for provider status will continue its strong APhA continued its leadership role in growing progress. We urge you to continue making a difference. support for the legislation. At the start of 2015, Please take a moment to send a letter today. Go to the PharmacistsProvideCare campaign had 14,000 PharmacistsProvideCare and click “Take Action.” z supporters. Through consistent outreach via campaign

40 I Pennsylvania Pharmacist I March/April 2016


IT’S TIME TO HAVE THE TALK WITH YOUR FUTURE PHARMACISTS. As a pharmacist, you may know someone in your family or at work who’s thinking about becoming a pharmacist. Let them know pharmacy is a well-paying, patient-centered profession with a major role in health care. Then tell them about the LECOM School of Pharmacy and our innovative, affordable student-centered pathways. Tell them how the Erie three-year accelerated program can save as much as $70,000 or more* in tuition compared with more expensive, private four-year programs. Tell them how the LECOM Distance Education program allows students to learn from home without the expense or burden of moving to another city. Tell them how they can also choose the equally affordable traditional four-year program at our beautiful state-ofthe art campus in Bradenton. Tell them to choose the Lake Erie College of Osteopathic Medicine School of Pharmacy. Welcome to LECOM. Visit LECOM.edu *LECOM, PA 3-year tuition = $76,470; LECOM, FL 4-year tuition (out of state) = $101,960; LECOM Distance Education Pathway = $100,120; National Average tuitions range from $149,064 for a 3-year program to $145,500 for a 4-year program. (Source: American Association of Colleges of Pharmacy).

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Departments

Welcome! New Members PPA Welcomes the following New Members who joined the association—December 2, 2015–January 25, 2016. Please make these new members feel welcome and part of Pennsylvania pharmacy! Pharmacists Peter Abdelnour, Erie, CVS Pharmacy Gary Bowers, Punxsutawney, Mission Pharmacy Julie Cusatis, Easton, Giant Food Stores, LLC Erich Cushey, Claysville, Curtis Pharmacy David A. Haulman, Renovo, Mountain View Pharmacy Adam N. Martin, Wexford, CVS Pharmacy Nicholas Owens, Pittsburgh, UPMC Shadyside Family Health Center Heather Stanton, Allentown, G&K Pharmacy Pauline M. Vargo, Allentown, Medicap Pharmacy

Student Duquesne University – Mylan School of Pharmacy Brianna Dombrosky, Mount Pleasant Catherine Hobart, Pittsburgh Kevin Mrohs, Pittsburgh LECOM School of Pharmacy James Shoemaker, Erie Philadelphia College of Pharmacy at USP Jeffrey Kim, Philadelphia Kristen Lampley, Pittsburgh Dominic Leader, North Huntingdon Jung Min Lee, Pittsburgh Brittany N. Lewis, Pittsburgh Zachary A. Lockard, Indiana Kimberly Lor, Chalfont Pathik Suvarnakar, Clifton Michael Sylvester, Philadelphia Wilkes University – Nesbitt College of Pharmacy Himayapsill Batista Quevedo, Denver Christopher J. Hartman, Danville Corey Haupt, Lehighton Heidi Yanoski, Dickson City Jefferson Jordan Asam, Elkins Park Temple University Egla Haxhaj, Philadelphia

University of Pittsburgh Dylan Ahrens, Butler Marijanel Alilio, Furlong Haley Baker, Pittsburgh Melanie Beers, Brockport Kathryn Bress, Pittsburgh Wenqi Chen, Pittsburgh Jesse Cheng, Pittsburgh Anthony Chiappelli, Pittsburgh Kathryn Ching, Bensalem Jessica Cole, Monroeville Timothy Crabtree, Tyrone Liam Dadey, Wexford Connor Deri, North Huntington Kathleen Dillon, Syracuse Douglas Drab, Pittsburgh Rami G. El Chammas, Pittsburgh Alyssa Faipler, Erie Doreen M. Foy, Germantown Elizabeth Garcia, New York Alexis Giles, Finleyville Tyler Ginn, Doylestown Kimberly Goehring, Pittsburgh Olivia G. Goss, Pittsburgh Tyler Graham, Pittsburgh Jillian Grapsy, Pittsburgh Matthew Gray, Pittsburgh

Kelsey Haller, Pittsburgh Katherine Halza, Pittsburgh Emma Hayes, Pittsburgh Kristopher Henninger, Altoona Phuong Hoang, Annandale Mason I. Jaynes, Connellsville Richard A. Jones, Pittsburgh Dilafruz Khakimova, Monroeville Allyson Kraft, Cranberry Township Abigail Z. Kraus, Pittsburgh Ann McAndrew, Downingtown Marc McCann, Pittsburgh Kayla M. McFeely, Charleroi Eleni M. Mermigas, Pittsburgh Brent Milovac, Pittsburgh Carley J. Mingone, Finleyville Sneha Mitra, Allentown Melinda Moran, Pittsburgh Amy Muniriji, Pittsburgh Chenling Ni, Pittsburgh Steve Nzele, Gaithersburgh Mara Ott, Wexford Bobby Pardini, Pittsburgh Carly P. Parris, Pittsburgh Jessica Palolko, Albion Marissa J. Puc, North Huntingdon

Jesse Quintiliani, Pittsburgh Anam Raza, Murraysville Shelby Resch, Zelienople Aislinn D. Roberts, Cranberry Marin F. Rubin, Pittsburgh Alyson Sapirstein, Holland Hangil Seo, Pittsburgh Alexandra T. Sharer, Pittsburgh Iris Tang, Pleasanton Megan Thornberg, Halifax Top Triamwong, Pittsburgh Esther R. Tse, Allison Park Holly Unger, Danville Kaela-Marie Walsh, Yorktown Colin Wolf, Pittsburgh Bradley Wong, Pittsburgh James Wu, Warwick Yi Shuan S. Wu, Pittsburgh Kelly Xu, Pittsburgh Xinyan Ye, Oakdale Huiling Zhang, Pittsburgh Lauren Zapsic, Beaver West Virginia University Jessica Fiant, Mohnton

2016 Pharmacy Law Review 2016

42 I Pennsylvania Pharmacist I March/April 2016

“Before anything else, preparation is the key to success.” -Alexander Graham Bell Go into your MPJE prepared! PPA is proud to present this year’s MPJE Law Review Course. This is an opportunity for pharmacy student’s to brush up on knowledge of Federal and Pennsylvania laws prior to sitting for exams.

“Before anyt

Go into yo Review C on knowl

Duquesne University th April 16

Philadelphia College of Pharmacy th th May 12 -13

AT http://papharmacists.sitehttp://papharmacists.site-ym.com/?page=lawreview

Ph


Announcing

PREP Pre-Residency Excellence Program Start your residency off on the right track! Out shine your competition! Designed specifically to assist individuals entering a pharmacy residency program, this program will give you tips, direction, ideas, and review your skills so that you can be better prepared to jump-start your residency year. Set yourself on course to be as successful as possible! Register Online Today at http://www.papharmacists.com/?page=PREP

The PREP Recorded Webinar Series consists of a series of modules focusing on how to be an excellent resident, pharmacy practice, and skill review. All modules are optional and you can listen to/watch any or all, at your convenience. Most modules are broken into a few 20-30 minute “bite-sized” videos to allow maximum flexibility. Test your knowledge on a topic before and after a module to measure your growth. Engage in discussion with faculty and other incoming residents on an online forum. Modules will be released in early April.

Module Topics Include:            

Emotional Intelligence Resident Research Pennsylvania Law as it Relates to Clinical Practice Evaluating Primary Literature Information Mastery Teaching Skills MTM Overview Pharmacist Documentation Drug Dosing in Kidney and Liver Disease Pharmacokinetic Drug Dosing ID Boot Camp Continuing Development after Graduation PPA Members Non-Members

Group Rate*

PREP

$89

$99

$85

PPA Resident Membership+

$35

$40

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*Group Rate is available to Residency Programs registering two or more residents +Optional (Regular Resident Dues: $54)

Presented by the Pennsylvania Pharmacists Association 717-234-6151 ppa@papharmacists.com


Industry News

Here Comes the DSCSA By: Gregory Smith, PhD Without a 3rd enforcement delay from the FDA, pharmacy level provisions of the Drug Supply Chain Security Act (DSCSA) take full effect on March 1. To help pharmacies prepare, this article reviews the key things that pharmacists need to know.

The DSCSA The Drug Supply Chain Security act imposes licensing and track and trace requirements on distributors and pharmacies. Full enforcement may begin March 1, 2016. The DSCSA is federal legislation from 2013 which, principally, imposes track and trace requirements on the prescription drug supply chain. Its language and requirements suggest that its principal goal is to keep ‘illegitimate product’ out of the supply chain. To do that, it includes provisions that (a) require all prescription drug supply chain participants to be ‘authorized’, (b) require for specific product tracing information to be passed from one trading partner to another and (c) mandate records retention and supporting policies. Requirements that impact pharmacists—called dispensers in the DSCSA—are summarized in the table below.1 Requirement

RELEVANT TEXT2, 6

EFFECTIVE DATE

MEANING

Authorized Trading Partners

“the trading partners of a dispenser may be only authorized trading partners” §582 (d)(3)

January 1, 2015

Pharmacies must buy only from properly licensed distributors.

Transaction Records

“a dispenser … shall not accept ownership of a product, unless the previous owner … provides transaction history, transaction information, and a transaction statement”3 §582 (d)(1)(A)(i)

July 1, 2015; enforcement delayed to March 1, 2016.

Pharmacies must receive DSCSA compliant transaction records.

Records Retention

“a dispenser … shall capture [transaction records], as necessary to investigate a suspect product, and maintain [them] for … 6 years….” §582 (d)(1)(A)(iii)

July 1, 2015; enforcement delayed to March 1, 2016.4

Pharmacies must maintain access to transaction records for 6 years.5

Verification Systems

January 1, 2015 “verification … a dispenser shall have systems in place to enable the dispenser to comply with the following requirements [to quarantine and investigate suspect product; keeping records on this for 6 years].” §582 (d)(4)

44 I Pennsylvania Pharmacist I March/April 2016

Dispensers need policies for suspect product investigations that meet DSCSA requirements.


Industry News Note that some of these provisions have been in full effect since January 1, 2015.

Compliance Strategies Ultimately, of course, each pharmacy must decide how to comply. Obvious options range from the extremes of (a) physically retrieving and filing every inbound transaction record while explicitly checking the distribution license for every vendor used to (b) ignoring the DSCSA and hoping it goes away, or at least that someone else (e.g. a distributor) is taking care of things for you.

Key Requirements • Use properly licensed distributors. • Receive DSCSA mandated transaction records. • Maintain transaction records for 6 years. • Implement verification systems. While (a) is clearly impractical, there actually are software solutions (with monthly fees) offered that allow pharmacists to capture and electronically file inbound transaction records. Option (b) is equally impractical, but is also close to what many pharmacists hope they might do.

An alternative approach lies between those extremes. Pharmacies can implement intelligent buying policies backed by research on distributor policies that let them rely as much as possible on distributors, but which still demonstrate positive compliance actions. For instance, policies limiting routine purchases to distributors known to (i) automatically supply DSCSA compliant records and (ii) maintain and make those records available to customers for 6 years goes a long way. This accomplishes two important things, helping meet three of the requirements: • Because the DSCSA required transaction statement includes a declaration that the seller is authorized, that meets the authorization requirement. • If the records are automatically supplied, compliant, and retained with pharmacy access, then the transaction record and record retention requirements are met. As part of this, it would be important to keep track of how to retrieve the transaction records, and to carefully vet distributor polices. In addition, pharmacies would also need to set up policies that meet the verification system requirements. None of this should be unreasonably difficult for a

pharmacy to accomplish. And, just as for strategy (a) above, there are vendors with know-how solutions to support this approach, saving pharmacists the effort of doing the research and preparing policies.

Conclusion Sooner or later, the FDA will enforce the DSCSA at pharmacies. Given two past delays, March 1, 2016 is the likely date. Over all, the DSCSA mandates the use of only licensed distributors, the exchange and retention of specific transaction information, and implementation of policies to support verification that product is legitimate. There are several options for compliance, which boil down to checking that pharmacy suppliers are supplying DSCSA compliant transaction records, establishing a process for maintaining access to those records, and setting up verification systems. For those so inclined, there are commercial products aimed at supporting this effort.

What to do Establish proactive polices to use vetted distributors who reliably hold records for pharmacies; know how to retrieve the records; include verification systems. z

1Disclaimer: This is simply an informative summary; for full information pharmacists should refer to the DSCSA, and to related FDA guidance. 2Citations are to the FD&C act as amended by the DSCSA. 3Space does not permit a full discussion of these three elements of DSCSA transaction redords. Refer to the DSCSA itself, or FDA guidance, for specifics (http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm427033.htm) 4http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM453225.pdf 5And produce them within two business days §582 (d)(1)(D). 6Citations are to the FD&C act as amended by the DSCSA. 7Examples include: TrackTraceRx (http://www.tracktracerx.com/), TraceLink (http://www.tracelink.com/) and Infinitrak (http://infinitrak.us/). 8Here, consider the Dispenser Ready program (https://rxredi.com).

Pennsylvania Pharmacist I March/April 2016 I 45


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