TABLE OF CONTENTS FEATURES Bentley Ushers Pharmacy Reimbursement Measure into Law |8| KPhA Board of Directors Candidates |10| KPhA Annual Meeting & Convention Agenda |16| A Lifetime of Service |18|
Mission Statement: To advocate and advance the pharmacy profession to improve the health of Kentuckians.
On the Cover Representative Danny Bentley Champions Pharmacy Legislation
IN EVERY ISSUE Editorial Office: ©Copyright 2021 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Publisher: Ben Mudd Managing Editor: Sarah Franklin Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601. Phone: 502.227.2303 Fax: 502.227.2258. Email: info@kphanet.org. Website: www.kphanet.org.
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President’s Perspective |3| My Rx |6| March CE Article |20| March CE Quiz |26| March CE Answer Sheet |27| April CE Article |28| April Quiz |34| April Answer Sheet |35| Pharmacy Law Update |38| New KPhA Members |40| Pharmacy Policy Issues |41| Campus Corner |44|
ADVERTISERS APSC |19| PTCB |36| CMP Pharma |37| APMS |37| EPIC |40| Pharmacists Mutual |46| Cardinal |47|
PRESIDENT’S PERSPECTIVE Thoughts and Reflections on Recent Phamily Achievements Happy Easter! Happy Spring! Happy Derby Day! Happiness! Yes, these are all things that should spring wonderful thoughts around your family. This is the time of year when the cold harsh winter begins to melt away and new life begins to spring eternal. This is the beginning of the year when family events and celebrations, like Easter, are celebrated. Well, at least this is how it is within my family. I come from a family of nine. My father grew up around the KY/VA border; Mother was from Lexington. They met in college and managed pharmacies, as well as a family of 7 kids thereafter. Yes, NINE people sitting around a dinner table in the 70’s/80’s and every major holiday ever since. NINE people and it was extremely dynamic with its ins and outs, but all in all, the inner workings were like the government. Yes, there were differing opinions and views to say the least; however, we were together and A FAMILY! That being said, each member of my family has vastly different personalities that range from quiet and reserved too boisterous and extroverted. I am immensely proud of all the members in my family! Not for their successes, but just because they are my siblings. I would hope at this point, each one of us could look back and say that our parents are extremely proud of what we have become and what we do for our communities and society. That's not to say that there have not been some ups and downs along the way. We all have points in our life that, when we look back, would be perceived as “interesting”. Since this article is being written by me, I, of course, was the favorite child and perfect in all ways, especially in my parents’ eyes. Some would even call me the Golden Boy, OK, maybe no one could call me the Golden Boy; however, that doesn't prevent me from continuing to aspire toward improvement.
My parents always taught us that it was much better to give than receive. I often ponder how my mother and father did it, having seven kids running amok in seven different directions. There are no two of us alike. The greatest similarities that we all contain might be around our various professions and connections in health care. As I look around at my siblings and wonder why we are what we are, I believe it goes back to watching our parents. We had a headstrong mother who was determined to fight all the odds to succeed, not only for herself but for anyone who she saw needing either a cheerleader or the support to move further. She gave us a grand sense of adventure in her ability to move from her home three hours east to an environment that was 1/10th the size and many years behind in economic development. However, she fought the odds not only as a female pharmacist, but also as a strong woman in a rural southwest Virginia community. My father was always referred to as the number’s guy. I very rarely remember my dad raising his voice; however, he was mighty with his whistle, mind, attention to detail, and subtle actions. Both parents gave us tremendous love and support; they allowed us the freedoms to explore, dream, and error. Both were optimistic in the way they approached life, even though there were difficulties surrounding the community in which I grew up. They wanted us to be the best we could be and showed that to us in their faith, not only religious, but in us as their children. They believed in us! Our |3| www.KPHANET.org
decisions to do and go wherever life led us, of course with certain parental guidance on occasion, were always welcomed at the dinner table and open for general debate. I miss my mother and father daily, but I know the gifts that they have instilled in me and my siblings are worth a lifetime.
lack of compromise tends to be the formula for little to be done in a constructive manner. However, looking back now, I do not believe the political environment of today ever met the force of a unified profession such as ours. All pharmacists and other health care colleagues got behind an injustice that has lived for too many decades to begin to correct So why do I bring up my family in this article? Perit. The passage of house bill 48 and the method in sonally, the pharmacy profession has some strong which this was accomplished (not a single negative similarities to the life I lived at home as a child and vote cast against it) is a feather EVERYONE can put growing up. As pharmacists, we are like siblings in their hats. There is no single person that detrying to learn and run in many directions; howevserves more credit than YOU! What I witnessed was er, we have in common one great theme, PHARMAsomething I hope we as a family can take and grow CY! Pharmacy brings us together in unity as a famion moving forward. If we do not forget how we felt ly, maybe better stated as PHAMILY. No matter about our profession during the last 100 days and where you work or where you are in your profeshow we worked to better the situation for every sional life, you will always have pharmacy as a part patient we will interact with, health care, especially of you. My siblings and I have been all over the as practiced by pharmacists, will stay forever world, but even though we were miles apart, we changed and improved. knew that I remain numb in belief that such a task was acwherever our parents were, we always had family complished during this time and by this manner. and a home. Pharmacy, in much the same way, House Bill 48, which finally allows the recognition gives us that unity no matter where we are in time of the services you provide as a pharmacist to be or space. billable, moves the arrow away from medicines beIn the last 100 days, at least here in Kentucky, I have ing your only point of recognition. Don't misunderseen the profession’s flame burn brighter than ever stand me, I know there were colleagues that led us before in my 30 years of practice. Going into this in this battle for recognition; however, at the end of past Legislative Session, I made no qualms about the day, not only our patients, but the profession the fact it would be one of the most difficult that I benefited the most AND WE ARE PHAMILY!!! had ever been around. Yes, as many of you know, I Traditionally, in families, people come together cerfully understand that our profession (or really any tain times of the year: birthdays, anniversaries, profession) is all politics. (See above as the remindThanksgiving, Christmas, Easter, other religious er that my family and the governmental way at Holidays, in the celebration of freedom and each which it works are very similar. Thus, dinner table other. I hope that the April Journal article from the conversations required a little “politicking” before, President will mark the point that we celebrate our during, and afterwards). Politics is what allows us to successes annually. I am only one ninth of my famidispense medications, our ability to provide the ly and an even lesser fraction of the pharmacy probest patient centered health care education, and fession in Kentucky. However, as in my family, we our ability to provide care as recognized by not only do not measure things in fractions, we all are ONE. our patients but others in society. This Session was As my mother and father allowed me and my sibconsidered a “Short Session”. Undertaken in the lings to do as we grew up, dreaming of what we middle of a worldwide pandemic, there was little, if wanted to become or where we wanted to go, I any, attendance at the State Capitol. In an environhope you feel the same inspiration to continue your ment that could be considered superbly politicized, dreams and path toward wherever you want to go the philosophy surrounding politics today seems to as a professional. A BIG THANKS to all my brothers be one of “My way or No way”. If I have the idea, it and sisters out there who are part of this phamily sounds and works great. If the idea is yours, it's horthat directly or indirectly helped in moving the arrible and there is very little collaboration across porow of our profession in a positive manner. WE DID litical parties/families. This type of confusion and |4| Kentucky Pharmacists Association | March/April 2021
IT!!! BOOOOOM!!!! IT WILL BE THE SHOT HEARD AROUND THE PROFESSION FOR GENERATIONS TO COME!!! GO FUN!!!! GO PHARMACISTS!!! GO PHAMILY!!!! Please feel invited to join the PHamily Reunion this year, IN PERSON, at the Downtown Louisville Marriott the first weekend in June. We will continue the celebration of the past successes, discuss how we will proceed to implement those victories, recognize those phamily members standing a little taller this year for the phamily photo, and party down with our sister, Cathy Hanna, as she steps into the lead role and driver’s seat of The Association. Until then, Stay Safe, Healthy, and Vigilant! Peace and God’s Blessings Your way. Joel
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Kentucky Professionals Recovery Network (KYPRN) is a free-standing organization that provides confidential monitoring of licensed professionals struggling with the disease of addiction.
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Board of Directors Ballot
President-Elect
Martika Martin
ASCP Opiod Stewardship Workgroup (2018-2019) Education: PharmD/MBA Sullivan University College of Pharmacy, BCGP
Current Practice Setting: Danhauer Drugs and Health Statement of interest: As an involved Equipment, Owensboro, KY. Doc Martin’s Pharmacy ConKPhA member, I would be honored to sulting, PLLC serve as President-Elect. I have endeavored to advance the practice by providing Misty Stutz patient-centered care, promoting the role of pharmacy technicians, and advocating Statement of interest: As I have had the for pharmacy on a state and federal level. pleasure of serving on the KPhA Board of Directors, along with service to other I have served on the KPhA Board as Speaker of the key committees, I have seen an enorHouse of Delegates, multiple KPhA committees and, am mous amount of growth in our profesthe current KPhA Representative for the BOP’s Pharmasion. And this growth continues. With cy Technician Advancement Committee. I am involved in the growth in Board Authorized ProtoKentucky’s Community Pharmacy Enhanced Service cols, immunization expansion, technician advancement Network, serving as coach for Flip the Pharmacy Team and now reimbursement of services, I can think of no Kentucky. I strive to stay informed on the innovative better time to be engaged in this great organization. pharmacist-led services and reimbursement opportunities. With the passage of HB 48, we need to continue the I received my undergraduate BS Pharmacy degree from momentum by providing healthcare to our patients. I the University of Cincinnati College of Pharmacy and my look forward working with KPhA to lead the profession Doctor of Pharmacy from the University of Kentucky. I into this new era. have had over 20 years in practice and over a decade in academia. I currently serve on the KPhA board of direcThe greatest strength of KPhA is its members and if tors and also on the Advancement of Pharmacy Practice elected, I intend on focusing on growing pharmacist and in Kentucky Coalition. If elected, I will bring my experitechnician membership. I want to illustrate to nonence of leadership and teamwork to meet the mission of members the benefits of KPhA and expand upon or creadvocating and advancing the pharmacy profession ate offerings that appeal to members that promote the through health and well-being, advocacy, education and vision of KPhA as a unified profession empowered to research, membership and collaboration. maximize patient and public health as integrated members of the healthcare team. State Level Leadership/Committee Participation: KPhA Leadership/Committee Participation:
Director, Board of Directors, KPhA
Speaker of the House of Delegates 2020-2021, Representative to Kentucky Board of Pharmacy, Vice-Speaker of the House of Delegates 2019-2020
Chair, Professional Affairs Committee Member, Steering Committee, Advancing Pharmacy Practice in Kentucky Coalition
Committee involvement: Government Affairs, New PractiMember, Centers of Excellence ad-hoc Committee, KPhA tioner Committee (Chair 2017-2019), Public Affairs Panelist “What you need to know about USP- Current and Future State” (KPhA Legislative Conference 2019
Member, Planning Committee NABP/ AACP District III, KBOP
National Association Leadership/ Participation:
Member, Professional Affairs Committee, KPhA
NCPA/CPESN Community Pharmacy Fellowship 20202021
Member, Board of Pharmacy Workgroup, KBOP
Delegate to APhA House of Delegates representing Kentucky (2021-2020) Alternate Delegate to APhA House of Delegates representing Kentucky (2019-2020) APhA Transitions EAB Board Member (2019-2020)
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National Level Leadership/Committee Participation: Reviewer, Accreditation Site Team for Doctor of Pharmacy Programs, American Council for Pharmacy Education Delegate, Council of Deans, American Association of Colleges of Pharmacy
Reviewer, American Journal of Pharmacy Education, Currents in Pharmacy Teaching and Learning, American Pharmacists Association, Kentucky Pharmacists Association, Office of Lifelong and Professional Development
Kyle Bryan
Kyle Bryan is a 2019 graduate of the University of Kentucky College of Pharmacy who has had a variety of pharSteering Committee, Nonprescription Medicine Academacy experiences working in indemy, American Association of Colleges of Pharmacy pendent, chain, hospital, and association management settings. After gradEducation: Doctor of Pharmacy, 2002, University of Kenuation he completed a Post-Graduate Year 1 Community tucky, Bachelor of Science in Pharmacy, 1988, University Pharmacy Residency at Wheeler Pharmacy/American of Cincinnati, Pre-Pharmacy, Marshall University Pharmacy Services Corporation through the University of Current Practice Setting, employer: Dean, Sullivan College Kentucky. He currently works as the Executive Fellow for the National Association of Chain Drug Stores Foundaof Pharmacy and Health Sciences tion where he oversees research projects for the Foundation, precepts students, and is involved with policy and Treasurer patient advocacy efforts. He currently serves on the GovChris Killmeier ernment Affairs Committee of KPhA and as Policy Committee Co-Chair for APhA Pain, Palliative Care and AddicChris Killmeier is a pharmacist with 31 tion Special Interest Group where he has strengthened years of experience. He is a graduate of his passion for advocating for patients and pharmacists. the University of Cincinnati, College of Outside of pharmacy he enjoys reading mystery/thriller Pharmacy. He is the current treasurer of books, watching movies, and baking. KPhA and has been on the Board of Directors in the past. He also serves on the Statement of Interest: I am interested in becoming a Executive Committee, Budget and Audit member of the Board of Directors because I care deeply Committee, Governmental Affairs Comabout pharmacy and am passionately invested in and mittee, and treasurer for KPERF. He has been an advodriven to see the advancement of our practice. As a fifthcate for the profession of pharmacist for many years by generation pharmacist I know how impactful a pharmavolunteering to serve on several committees for the Ken- cist can be. I’ve been fortunate to be involved in KPhA tucky Board of Pharmacy in addition to his KPhA comsince I was in pharmacy school where I served as Policy mitments. He had worked retail pharmacy for 32 years Vice President for our APhA chapter. I was able to work with Walgreens and now works in a patient assisted mail with KPhA to help advocate for and to implement Board order pharmacy, Theracom. He lives in Louisville with his Authorized Protocols through educational sessions and wife, Denise and two daughters, Bayley and Blaire, and a development of training and documentation materials. service dog, Chief. I’ve served several years on the Government Affairs Com-
Board of Directors Alex Bessler I’m excited to become more involved in KPHA. I have spent time working with other professional organizations and I would like to spend more time with a group that has a direct impact on the state I live and practice in. I feel that having a pharmacist from long term care would help represent that is provide insight into a group that commonly have laws and regulations that differ from other practices. KPhA Leadership/Committee/Participation: none to date but excited about getting involved National Association Leadership/Participation: American society of consultant pharmacist: Education committee/work group Education: University of Kentucky college of pharmacy Current Practice Setting, employer: Long term care- Med care pharmacy
mittee and have seem first-hand the impact that KPhA has had on the practice of pharmacy. I’ve found this work incredibly rewarding and would like to help contribute to this work. I would be able to utilize my hospital, chain, independent, Community Pharmacy Residency, and Executive Fellowship experiences to bring a diverse background and perspective to matters that come before the Board. I would utilize my training and efforts involving advocacy, leadership, and association involvement to help assist KPhA in its mission of addressing the problems facing pharmacy today. KPhA Leadership/Committee/Participation: KPhA Student Engagement Committee KPhA Government Affairs Committee National Association Leadership/Participation: APhA Pain, Palliative Care and Addiction Special Interest Group Policy Committee Co-Chair, Member of ASHP Education: B.S. Psychology; University of Kentucky 2015, PharmD; University of Kentucky College of Pharmacy 2019
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Current Practice Setting, employer: Association Management/Research; National Association of Chain Drug Stores Foundation Steve Hart Statement of Interest: The nomination to the Board of Directors is a great honor. I look forward to this opportunity to give back to our profession. I have been a pharmacist for thirty-seven years with a wide variety of experiences over the years. I have owned my own independent retail pharmacy, worked various positions in chain pharmacy and managed oncology pharmacies. Some of my most rewarding time was the thirteen years I spent on staff at the Board of Pharmacy, beginning as an inspector and retiring from the Board as Executive Director. I am currently a consultant pharmacist for Medical Gas and Manufacturing facilities located across Kentucky. I contract with NABP Solutions to conduct site surveys and reviews of policy and procedure for Wholesale Distributors seeking ADD (VAWD) accreditation. I believe these experiences provide me with a varied background that would be an asset to the Board of Directors. This is a critical time in the practice of pharmacy. We need to continue to be innovative and advance the practice of pharmacy. I have been a member of KSHP for most of my twentyseven years of practice in Kentucky. I am currently serving on the Professional Affairs Committee and was a member of the Kentucky Coalition for the Advancement of Pharmacy Practice. A member since 2005, I have served on the board and as president of the international regulatory association know as CLEAR (Council on Licensure, Enforcement and Regulation). My service to CLEAR includes serving as a member of several committees (Compliance and Discipline) (Regulation) and Chair of the Compliance and Discipline Committee. As an Associate member of the National Association of Boards of Pharmacy, I bring another perspective to the organizations that I serve. In addition, I have served on the MPJE Review and Item Writing Committee for the Commonwealth of Kentucky. I graduated from the McWhorter College of Pharmacy at Samford University with a Bachelor Degree in Pharmacy in 1984. Prior to Pharmacy school, I attended the University of Tennessee at Martin.
Andrea Kramer Statement of Interest: I would like to be a part of the KPhA Board of Directors because I feel that my background and experiences would bring a different perspective to the table and allow for further collaboration within the profession of pharmacy. I enjoy advancing the profession and working with others. I began working for St. Elizabeth Healthcare in 2018. I am currently the Pharmacist in Charge of our Specialty Pharmacy. My current position allows me to focus on the operations of the specialty pharmacy. Our specialty pharmacy continues to grow rapidly and this has allowed me to grow and change with the team. Previously, I worked for Kroger Pharmacy for 15 years mainly overseeing our clinical programs and patients within our patient care sites. I am passionate and understand both the clinical and operational aspects of pharmacy and I am excited about the opportunities that lie ahead of our future. I believe that we as pharmacist have the power to depict our own fate. I am excited to be a part of the KPhA Board of Directors and work with a team that is just as passionate as I am to impact the profession of pharmacy and advance patient care. KPhA Leadership/Committee/Participation: None currently National Association Leadership/Participation: ASHP Section of Specialty Pharmacy Practitioners Advisory Group on Business Development , Specialty Infusion Committee Education: University of Kentucky Pre-Pharmacy 20072003,, University of Missouri-Kansas City School of Pharmacy 2012, University of Cincinnati/Kroger Pharmacy PGY-1 2012-2013 Current Practice Setting, employer: St. Elizabeth Healthcare Specialty Pharmacy Lance Mansfield
Statement of Interest : After having worked in the profession for 9 years as a pharmacist and having experience in the independent, chain, and hospital Bio: Married to Lisa Hart, who is also a pharmacist and we settings I would like to give back to the have four grown children, Jake, Jacqui, Luke and Lauren profession that has given me so much. as well as eight grandchildren. We have all survived the If given the opportunity to serve as a COVID pandemic so far and are very thankful. We enjoy member of the KPha board, I would like playing with the grands, cooking out and swimming in to advance the profession to the next level. All three setthe backyard. tings of pharmacy that I have worked in have been in a rural area of the state where I have seen a need for more patient centered care. I would like to help our pharmacists in the state be able to work at the full extent of our license to provide the patient care that is needed.
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KPhA Leadership/Committee/Participation: KPhA member
KPhA Leadership/Committee/Participation: Grassroots email campaigns. Pharmacists Day in Frankfort, KY
National Association Leadership/Participation: NCPA member, KIPA member, Rotary President-elect
Education: Doctor of Pharmacy, University of Kentucky College of Pharmacy, 2018, Master of Business Administration, University of Kentucky Gatton College of Business and Economics, 2018
Education: PharmD from UK COP
Current Practice Setting, employer: Weathers Drugs own- Current Practice Setting, Employer: Independent Com, er/PIC munity Pharmacy Med Save Pharmacy, Wilmore After graduating from the University of Kentucky College of Pharmacy in 2012, I started my career in Hopkinsville, KY working as a full-time staff and clinical pharmacist at Jennie Stuart Medical Center as well as a part-time relief pharmacist at Rite Aid Pharmacy. In 2016, I moved to my hometown of Elkton, Ky where I started working as a fulltime staff pharmacist at Weathers Drugs. In 2018, I was presented with the opportunity to purchase the pharmacy that I grew up working in from Kenny Clayton. Since 2018, I have helped serve the community of Todd County as both a staff pharmacist and owner of Weathers Drugs. In the community I currently serve as the President-elect of our local Rotary Chapter. I am also a founding board member of the Todd County Foundation, a non-profit foundation with the sole purpose to give back to the community. Lakin Mills Statement of Interest: My professional goals are guided by two practice principles: serve my local community by providing innovative care in independent pharmacy and serve the Commonwealth by promoting and advancing the profession of pharmacy. My first two years as a professional have been focused primarily on the first principle while working in independent pharmacy settings throughout central and eastern Kentucky. My interest in the KPhA Board of Directors position is to integrate the second principle of serving the Commonwealth and the pharmacy profession into my current practice.
Lisa Patton Statement of Interest : With over 20 years of experience in a rural setting, the time has come to take a more active role in issues affecting the pharmacy profession. After enduring the Covid 19 pandemic, manufacturer changes in 340B interpretations, fear of job placement for new pharmacy graduates, and hardships caused by natural disasters such as flooding within my community, I want to help affect positive change for the people I serve. I believe KPhA is the place start. KPhA Leadership/Committee/Participation: Membership Engagement Committee and Public Health Committee Education: Graduated from the UK College of Pharmacy with Pharm.D. Degree in 1999 Current Practice Setting, employer: Employed by Mercy Health-Marcum and Wallace Hospital as Pharmacy Manager in Critical Access Setting
Lisa Patton was born and raised in Waco, Kentucky where she grew up working the tobacco fields on her family farm. She completed her pre-pharmacy requirements at Eastern Kentucky University before matriculating into the University of Kentucky’s College of Pharmacy in 1995 as a member of their first all-PharmD class. Upon graduation, Lisa returned home to work at then Pattie-AClay Regional Medical Center in Richmond, KY as a staff pharmacist and then took on the role as the acting PIC As a member, I have seen the impact this organization for Marcum and Wallace Memorial Hospital in Irvine, KY has had on the practice of pharmacy in Kentucky. This via contract between the two facilities. As Marcum and has been demonstrated most clearly during the global Wallace grew, they saw the need for a full-time pharmapandemic through the work of our colleagues in all prac- cist and manager and Lisa transitioned to Marcum and tice settings educating and now vaccinating the greater Wallace solely and permanently in 2014 where she has community. While I look back on a difficult year caused worked diligently to continue their growth in pharmacy by a global pandemic, I am honored to be a pharmacist. services. In her tenure, she has developed a pharmacy Not only have I played my role on the frontlines adapting managed outpatient infusion department. In 2016, she to the challenges to serve my patients, but I have also helped to secure a 3 yr, $600K quality grant from HRSA to participated in grassroots advocacy through email camimplement an MTM program benefitting the hospital as paigns to my local representatives and senator to support well as Mercy and other network-affiliated primary care my profession. My involvement in House Bill 48 reignited clinics in the hospital’s catchment area. In 2019, she a passion for advocacy and service to the profession that I helped secure another 3 yr, $600K quality grant to develfostered during my time in school. I believe that my posi- op and institute a multidisciplinary population health tion as a new practitioner in an independent pharmacy clinic focusing on Hepatitis screening and chronic disthat is part of a small network of pharmacies across the ease state management. She has also grown the 340B state will be an asset to the association and the Board of program by adding a mixed-use program and signing on Directors. additional contract pharmacies. In her spare time, she is
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renovating her dream home, just around the corner from KY later that year. Most recently, I relocated to LexingMarcum and Wallace, with her husband and youngest ton, KY in September of 2018 and currently serve as Disson. trict Manager for the East Louisville, KY District. Jordan Propst Statement of Interest : I would first like to thank the Board of Directors and the Association’s members for their time and consideration. One of the most exciting things about our profession, and one that has captivated me since first being introduced to the practice of Pharmacy, is how much we have evolved as healthcare professionals and how much more potential we have to positively impact healthcare in the Commonwealth and across the nation. With Pharmacists once again leading the charge against an unprecedented health crisis, and provider status on the horizon, the advancement of our profession through the work of organizations like KPhA will be critical to the healthcare landscape. I would be humbled and privileged if selected to be a part of KPhA serving as a voice of my peers to help shape the direction of our profession and unlock our full capabilities. KPhA Leadership/Committee/Participation: Active Member National Association Leadership/Participation: Cystic Fibrosis Foundation, KY and WV Chapter Board Member Education: cy from
2013 Graduate, Doctorate of Pharmathe University of South Carolina
Emma Sapp Statement of Interest : I am interested in serving on the KPhA Board of Directors to help further serve the practice of pharmacy and enhance our service to the Commonwealth. The breadth of my practice experience in community, inpatient, and ambulatory settings would allow me to bring a unique and well-rounded perspective. My time as a PGY1 and PGY2 ambulatory care pharmacy resident provided me with multiple leadership opportunities including implementation of multiple pharmacy clinics. I currently am the Specialty Pharmacy Clinical Coordinator at St. Elizabeth Healthcare where I help oversee our clinical services and conduct visits with patients in our Medication Management Clinic for specialty disease states. This has provided me with leadership experience in both the clinical and operational aspects of a Specialty Pharmacy within a large health system. My passion for pharmacy and providing great patient care drive me to advocate for our patients and profession. I request your vote to allow me to serve on the KPhA Board of Directors and advocate for the advancement of our profession and improve patient care to improve the health of Kentuckians. KPhA Leadership/Committee/Participation: KPhA Opioid Stewardship Planning Committee
Current Practice Setting, employer: District Manager for Walgreens supporting our East Louisville market National Association Leadership/Participation: American Society of Health-System Pharmacists (ASHP) – Section of Ambulatory Care Practitioners Ambulatory Care PharPersonal Background: I was born in Hickory, NC, son of macotherapy Section Advisory Group, Section of AmbuMark and Kim Propst, and I have one brother, Jackson. latory Care Practitioners Pain and Palliative Care Section When I was 12 years old my family relocated to Gaffney, SC, and it was there that I became a lifelong South Caro- Advisory Group, Volunteer CV Reviewer lina Gamecock fan. I attended the University of South Carolina for both undergrad and professional Pharmacy Education: Bachelor of Science in Biology from Northern Kentucky University, Doctor of Pharmacy from University studies and was fortunate to also play baseball for the of Kentucky College of Pharmacy. Gamecocks. In 2010, we won the College World Series bringing home the school’s first major sports title, and Current Practice Setting, employer: Specialty Pharmacy shortly after I was selected by the Kansas City Royals in Clinical Coordinator; Ambulatory Care/Leadership, St. the MLB draft and began a brief Minor League career in Elizabeth Healthcare Phoenix, AZ. I returned to Columbia to complete my pharmacy degree thereafter and began practicing in Mark Taylor Lake Norman, NC upon graduation. In 2016, I was asked I am a 1997 graduate of the Unito relocate to Bowling Green, KY for a job opportunity versity of Kentucky College of and it was there that I met my wife Melissa. We now live Pharmacy. The majority of my in Lexington, KY with our newborn daughter Mallie and career has been in retail pharmadog Brooklyn. cy. Prior to pharmacy school and Professional Background: I have been with Walgreens upon graduation I worked in a for 9 years, beginning as a pharmacy intern in Gaffney, small town independent, the ownSC. In 2013, I graduated and began practice in Western er of which was like a second father to me. The work North Carolina before taking my first manager assignthere was followed by 8 years in a chain retail pharmacy ment in Charlotte, NC in 2014. In August of 2016, I acas a manager. In 2012 we decided to open our own pharcepted a position as a Pharmacy District Manager in macy, and we started Bluegrass Drug Store in Danville Winston Salem, NC before relocating to Bowling Green, Kentucky that year. I have always admired the profes-
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sion of pharmacy and have a strong desire to have positive contributions to the practice in our wonderful Commonwealth. Over the years I have volunteered for various committees, volunteered on the board with APSC, volunteered with the Board of Pharmacy's PRN committee, as well as several local community positions such as board member of local assisted living facilities . We have also greatly enjoyed local fundraising such as 5K races, and participating in and assisting in the organization of health fairs. Thank you for your consideration.
Education: Doctor of Pharmacy, University of Kentucky, Class of 2012 Current Practice Setting, employer: Chain Pharmacy, Registered District Manager for Walgreens Trevor Ray KPhA Leadership/Committee/Participation: KPhA Board of Directors, Government Affairs Committee
Alan Webb
Statement of Interest: I appreciate the consideration to become a member of Current Practice Setting, employer: Owner, Midway Pharthe KPhA Board of Directors and would macy be honored to serve as such. As our profession continues to evolve I believe that is more crucial than ever that we have voices from all aspects of pharmacy. I have long felt admiration for the pharmacists that speak out to not only drive the profession forward but to protect the sanctity of it. I am excited at the possibility of You can find the electronic ballot on the being able to carry that torch on and be a voice for those homepage of the KPhA website reluctant to speak out themselves. The ongoing pan(www.kphanet.org). If you require a paper demic has shown what pharmacists can do to have a ballot, please contact KPhA HQ at positive impact on the health of not just individuals but info@kphanet.org. Don’t forget to mark your of the whole communities in which we serve. Organizations such as KPhA will be crucial in ensuring that mocalendars for the KPhA Annual Meeting & mentum is not lost. Convention where the new officers will be
VOTING
KPhA Leadership/Committee/Participation: Pharmacist Member
installed.
National Association Leadership/Participation: Walgreens Political Action Committee Member
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KPhA Hybrid Annual Meeting & Convention - Agenda
HB 48 Implementation Jenny Arnold with the Washington State Pharmacy Association
All times are Eastern Time Zone. All activities are scheduled at the Downtown Louisville Marriott un- 12:30 – 1:30 PM Legislative Luncheon less otherwise specified. 1:30 – 1:40 PM BREAK Agenda is subject to change
Thursday, June 3, 2021 12:00 PM KPERF Golf Scramble Quail Chase Golf Course
1:40 – 2:40 PM Continuing Education Session (1.0 CE) HB 48 Session
Friday, June 4, 2021
2:40 – 3:00 PM Networking Break with Refreshments
7:30 AM Registration 8:30 AM Opening Breakfast 9:00 AM – 10:00 AM Keynote Speaker (1.0 CE)
3:00 – 4:00 PM Continuing Education Session (1.0 CE) HB 48 Session
10:00 – 10:10 AM BREAK
4:00 – 5:00 PM Continuing Education Session (1.0 CE) HB 48 Session
10:10 – 11:20 AM House of Delegates
5:00 – 7:00 PM Hall of Exhibit Reception
11:20 – 11:30 AM BREAK
7:00 – 9:30 PM Family Fun Outing – Bowling (Additional registration required)
11:30 – 12:30 PM Continuing Education Session (1.0 CE) |16| Kentucky Pharmacists Association | March/April 2021
Saturday, June 5, 2021 7:00 AM Registration Open 7:00 – 8:30 AM Reference Committee 8:00 – 8:30 AM Opening Breakfast 8:30 – 9:30 AM Continuing Education Session (1.0 CE) Law Review Ralph Bouvette, APSC 9:30 – 10:00 AM Exhibit Hall Networking Break 10:00 – 11:30 AM Continuing Education Session (1.5 CE) Roundtable Discussions 11:30 – 12:30 PM Luncheon 12:30 – 12:40 PM BREAK
12:40 – 1:40 PM Continuing Education Session (1.0 CE) “The State of the Profession: Where are we Now and Where are we Going?” Representatives from UK College of Pharmacy, Sullivan University College of Health Sciences, Kentucky Pharmacists Association and Kentucky Hospital Association 1:40 – 1:50 PM BREAK 1:50 – 2:00 PM Credentialing for Closing House of Delegates 2:00 – 3:30 PM Closing House of Delegates 3:30 – 3:50 PM Networking Break with Refreshments (student celebration) 3:50 – 4:50 PM NASPA/NMA Student OTC Competition (1.0 CE) 5:30 – 6:30 PM Presidents Reception 6:30 – 8:30 PM Ray Wirth Banquet (additional registration required)
Additional CE will be provided virtually and is included with a full Annual Meeting registration!
|17| www.KPHANET.org
Feature Article A Lifetime of Service: Honoring William Danhauer By: Martika Martin William “Bill” Danhauer, or Mr.D, as he was later called by his patients and employees, began working in his father’s pharmacy, Danhauer Drugs, in Owensboro, Kentucky as soon as he was tall enough to see over the counter of the soda fountain. Along with making the floats and other sweet treats, he said he regularly made deliveries on his bicycle, although the delivery area was smaller then. After graduating from St. Frances Academy in Owensboro, Mr. D joined the Navy during WWII and afterwards attended the Louisville College of Pharmacy, graduating in 1950, the last class to fully attend classes in Louisville before the school moved to Lexington and became the University of Kentucky College of Pharmacy. After passing his licensing exam, (it was all on paper then, and only offered a couple times a year he liked to remind people), he went back to Danhauer Drugs to work with his father, William Danhauer Sr, and brother James Danhauer. Pharmacy evolved as Mr. D practiced, but his belief that “if you take care of your customers, they will take care of you,” never changed. Mr. D was a staple in his community, being active in the Kiwanis and serving on numerous committees, parish council, and other ministries through his faith community at St Stephen Cathedral. During the 1960s, Mr. D served on the Kentucky State Board of Health. This conviction of continuously giving back to the community and profession is something he promoted to pharmacy students and his staff. Mr. D worked at Danhauer Drugs for 70 years, retiring at the age of 92, making him the longest practicing pharmacist in the state of Kentucky at the time. He kept the traditions of pharmacy alive at Danhauer Drugs through compounding and, of course, taking care of patients through counseling and education. Not a day went by without at least one patient stopping in to ask his advice or even just to say hi. After assisting one patient in finding a medication for her child, he remarked, “She likes to ask me about things for her kids because she knows I raised seven of my own.” Mr. Bill Danhauer passed away peacefully in his home, surrounded by his family, on March 6, at the age of 94. He was preceded in death by his wife of 70 years, Jean and survived by his seven children, 21 grandchildren, and 40 great-grandchildren. His memory and contributions to Danhauer Drugs and practice of healthcare continue through his children, all of whom joined the medical profession, and his staff, who he treated like family. Perhaps the best description was made by Mr. D himself in the article about in in January/February 2019 issue of The Kentucky Pharmacist, “It has been a good life.”
|18| Kentucky Pharmacists Association | March/April 2021
|19| www.KPHANET.org
March CPE Article Evolution of the Federal Legal Framework for Regulation of Medications Authors: Joseph L. Fink III, B.S.Pharm., J.D., D.Sc.(Hon.), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington. The author declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Goal: To educate pharmacists and pharmacy technicians about evolution of the federal statutes and regulations related to production and distribution of medications in the U.S. thereby enhancing the readers’ understanding of the legal environment of professional practice. Universal Activity #0143-0000-21-003-H03-P &T Contact Hour (1.0 CEU) Expires:4/15/2024
KPERF offers all CE articles to members online at www.kphanet.org
Learning Objectives: At the conclusion of this knowledge-based article, the reader should be able to: 1.
Distinguish the bases of legal authority to regulate pharmacists, pharmacies and pharmaceuticals
between the federal and state governments; 2.
Identify the impetus for the 1906 Federal Pure Food and Drug Act;
3.
Identify the impetus for the Federal Food, Drug and Cosmetic Act of 1938; and
4.
Identify the impetus for Kefauver-Harris Amendments of 1963.
Introduction Taken together, when one looks at both federal and state level statutes and regulations, pharmaceuticals are among the most highly regulated products in the U.S. marketplace. They require pre-marketing approval and, if the product presents a potential for abuse, it may have an additional layer of regulation limiting its availability. Authority to regulate medications at the federal level of government comes from the Commerce Clause of the U.S. Constitution: The United States Congress shall have power “to regulate commerce with foreign Nations, and among the several States, and with the Indian Tribes.”1 Having medicinal agents that move across state lines or are composed of ingredients or packaging that did so invokes this provision in the law. At the state level the authority is rooted in what is known as the “Police Power” of state government – the authority to enact and enforce statutes and regulations related to the public health, safety and welfare. |20| Kentucky Pharmacists Association | March/April 2021
The states possess this authority because of the Tenth Amendment to the Constitution – “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”2 Although, in general, legal restrictions and expectations can emanate from either level of government, this discussion will focus solely on the evolution of regulatory frameworks originating from the federal level. This is not to diminish the impact of statelevel initiatives; rather, pharmaceuticals are principally regulated at the federal level whereas pharmacists and pharmacies are primarily the subject of statutes and regulations emanating from the state level. Import Drug Act of 1848 The first federal statute directed at protecting U.S citizens from harmful drugs was the Import Drug Act of 1848.3 This Congressional act was directed at prohibiting the importation of adulterated drugs. The motivation for this legislation was that antimalarial medication for U.S. troops fighting the Mexican-American War was found to be grossly adulterated and lacking in potency.
Sherley Amendment of 1912 The Pure Food and Drug Act of 1906 was amended during 1912 to prohibit the seller of a medication from making false or fraudulent claims of efficacy. Impetus for this change was a decision by the U.S. Supreme Court during the prior year in the case of U.S. v. Johnson, a case the federal government lost when it attempted to enforce its interpretation of the 1906 Act related to definition of drug adulteration. The nation’s highest court ruled that the 1906 statute did not prohibit false medical claims; rather, it only addresses false and misleading statements about the ingredients or identity of a drug.6 A local twist on this legislative change is that the bill that was enacted to effect this modification was introduced by Rep. Joseph S. Sherley of Kentucky, a native of Louisville!
Federal Food, Drug and Cosmetic Act of 1938
The next major revision of the legislation came in response to what now is known as the “sulfanilamide incident.” The S.E. Massengill Company of Bristol, Tennessee, marketed Sulfanilamide Elixir with the liquid vehicle for the active ingredient being diethylene glycol. That diluent was suggested by the Chief Chemist of the firm in response Federal Pure Food and Drug Act of 1906 to a request from the Marketing Department that a liquid dosage form was needed, especially for pediThis next piece of federal legislation is generally reatric patients. Sulfanilamide was used to treat hegarded as being the principal forerunner of the molytic streptococcal infections. The formula for modern federal food and drug laws. Sometimes the preparation was finalized but no toxicity tests this is referred to as the Wiley-Heyburn Act after were conducted. The product was distributed in the two sponsors of the legislation. Impetus for this commerce and it was reported that 107 people died legislation came from publication of a book, The from using this product, many of them children. Jungle, by Upton Sinclair.5 This work focused on FDA, the name adopted by the relevant agency the harsh working and living conditions of immiduring 1930, took steps to pull the product from the grants in Chicago and awakened the nation to the market basing its action on what some would call a manifestly unsanitary conditions in food processing technical labeling violation – the term elixir was reand drug manufacturing industries. Lack of purity served for a product using alcohol for the vehicle, in those products prompted federal legislative acnot diethylene glycol. Today we know that diethytion. lene glycol, used as a permanent antifreeze in vehiThis statute, signed into law by President Theodore cles, is a deadly poison. That’s why people are cauRoosevelt, prohibited adulteration and misbrandtioned that if they see antifreeze dripping from a ing of drugs shipped in interstate commerce. Revehicle in the driveway it should be promptly sponsibility for enforcing this legislation was ascleaned up because it is very sweet and therefore signed to the Bureau of Chemistry, a part of the U.S. attractive to dogs, with deadly consequences. Department of Agriculture. |21| www.KPHANET.org
This sad story of the deaths from sulfanilamide led Congress to strengthen the statute with amendments requiring that the safety of a product be established before it could be cleared for marketing. These legislative changes also included authorization for inspection of production facilities. Another significant change at this time was that while the FDA was assigned responsibility for oversight of production and marketing of prescription medications, authority to regulate the advertising of non-prescription medications was assigned to the Federal Trade Commission. That dichotomy of jurisdictions continues to this day.
the product was sold and without regard to how many local sales had occurred. The Court’s opinion was that the product continued to be in interstate commerce until “the moment of…delivery to the ultimate consumer” in a terminal transaction. The pharmacist advanced the unsuccessful argument that this interpretation of the statutory language went far beyond the authority granted to the federal government by the Commerce Clause and intruded on the power granted to the states by the Tenth Amendment.8 Durham-Humphrey Amendments of 1951
This legislation was introduced in Congress by two pharmacists elected to serve there at the time – Manufacturing Regulation Changes of 1941 Rep. Carl Durham of North Carolina and Sen. Hubert Humphrey of Minnesota (later to serve as Vice Distribution of sulfathiazole tablets that had bePresident of the United States!). This legislation atcome contaminated with phenobarbital during the tempted to clarify the distinction between those production process led to nearly 300 deaths. This medications requiring a lawfully issued prescription motivated FDA to make changes in the regulatory prior to dispensing and those that did not. These scheme for manufacturing and quality control, legislative changes also authorized prescriptions to leading to creation of what are now known as Curbe transmitted orally and made it possible for the rent Good Manufacturing Practices (CGMP’s). prescriber to authorize refills at the time of issuance of a prescription.7 United States v. Sullivan Decision of 1948 The 1938 amendments included among their prohibitions the Misbranding of Drugs “held for sale after interstate shipment.” A community pharmacist in Columbus, Georgia, had purchased a bottle containing sulfathiazole tablets from an outlet in Chicago, Illinois. That stock bottle bore a label reflecting a warning that the drug product could be toxic. The pharmacist sold twelve tablets in a box that did not bear the warning statement. He was changed with a federal offense for violating the labeling requirement. He was convicted at the trial court level and appealed. The U.S. Court of Appeals reversed his conviction on the basis that the wording of the statute – “held for sale after interstate shipment” – extended only to the first intrastate sale and did not apply to subsequent local sales after some time had lapsed. The government requested that the Supreme Court take up the case and it did, resulting in an opinion written by Justice Hugo Black. He upheld the FDA’s interpretation that such misbranding of the medication was prohibited regardless of when |22| Kentucky Pharmacists Association | March/April 2021
Kefauver-Harris Amendments of 1963 During late 1961 another medication-related tragedy began to unfold. Thalidomide, a medication directed at assisting the patient to sleep and sometimes used to treat “morning sickness” in pregnant women, was associated with extremely severe birth defects in thousands of newborns in Europe. The disorder was known as phocomelia (a condition where the arms and leg resemble “seal limbs”) and include youngsters being born with incomplete limbs, both arms and legs in some cases. Those unfortunate circumstances were associated with the mothers having consumed thalidomide while pregnant. While never lawfully completing the review to permit manufacturing and distribution for use in the U.S., the dramatic visual impact of the damages suffered by the children captured the concern of the public that was translated into legislative action. Congress added the mandate that in order to be shipped in interstate commerce a drug product must not only be shown to be safe but also had to have sufficient evidence of effectiveness. The
namesakes of this legislation were Sen. Estes Kefauver of Tennessee and Rep. Oren Harris of Arkansas. The bill was signed into law by President John F. Kennedy. It is sometimes referred to as the Drug Efficacy Amendment.9
Orphan Drug Act of 1983
At the urging of pharmaceutical manufacturers, Congress enacted legislation known as the Orphan Drug Act in 1983.10 Those who did the research and produced the pharmaceuticals pointed out that New Drug Application process that was in place Drug Efficacy Study Implementation was too onerous and expensive to encourage development of drugs for illnesses suffered by a relaDuring 1968, FDA created a program to retrospectively small number of patients. This initiative was tively review the effectiveness of medications introto facilitate such innovations. duced to the marketplace between 1938 and 1962, an interval when only safety was required to be shown. This change was the result of a study and Drug Price Competition and Patent Term Restorarecommendations from the National Academy of tion Act of 1984 Sciences. These became known as “DESI Drugs”. Known variously as the Waxman-Hatch Act (then) or the Hatch-Waxman Act (now), this 1984 legislaPatient Package Inserts Become Required tion authorized FDA to approve marketing of a generic version of an earlier approved brand name In 1970 the FDA began to require patient package medication without the manufacturer conducting inserts be distributed with certain medications. My expensive and time-consuming studies of safety memory tells me that the first such product was and efficacy. The legislation, sponsored by Rep. the Isuprel Mistometer®, an inhalation version of Henry Waxman of California and Sen. Orrin Hatch isoproterenol. of Utah, also permitted manufacturers of brand name products to apply to “get back” up to five years of additional patent exclusivity time to reOver-the-Counter Drug Review place that lost while awaiting FDA approval.11 FDA launched this initiative during 1972 to enhance the safety, effectiveness and review the labeling of non-prescription pharmaceuticals. This massive re- Prescription Drug Marketing Act of 1987 view of hundreds of thousands of OTC products The concern being addressed by this legislative acwas led by pharmacists on the staff of FDA. To tion related to diversion of pharmaceuticals out of make it more manageable it was approached on a the traditional system for distribution of these sentherapeutic category basis. sitive products that needed assurance of integrity. This legislation created limits on sales of pharmaceuticals, and a special focus was on sales reTamper-Resistant Packaging Regulations strictions and recordkeeping for transfer of samples During 1982, FDA enacted regulations to create eviof prescription drugs. Finally, it prohibited hospitals dence that an outer container, e.g., box or carton, of from reselling pharmaceuticals and required that a product had been opened earlier. This was done states adopt regulations governing drug wholesalin response to the Tylenol® tampering incident of ers.12 that year in the metropolitan Chicago area. Seven deaths were the result of a nefarious individual tampering with commercial packaging by adding Prescription Drug User Fee Act of 1992 potassium cyanide to the capsules while on the This legislation adopted in 1992 was designed to shelf awaiting sale. address the fact that FDA was receiving an everincreasing number of New Drug Applications for review and, hopefully, approval but Congress was reluctant to increase its budget allocation to cover |23| www.KPHANET.org
that workload. The solution was to pass the cost directly to those who had the potential to reap the financial benefit, the manufacturers. This legislation authorized the FDA to charge fees, known as PDUFA Fees, to manufacturers who sought review of applications to market their products. The legislation contained a provision that this approach – funding from applicants – would need to be reauthorized every five years.13
This law clarified FDA’s authority to direct that product labeling be changed to enhance safety. It also authorized FDA to mandate that manufacturers could be required to conduct post-approval clinical studies related to product safety, so-called Phase IV Studies. It also authorized the agency to require risk evaluation and mitigation strategies (REMS) communications to enhance patient safety while using selected FDA-approved products.16
Food and Drug Administration Modernization Act of FDA Safety and Innovation Act of 2012 1997 This legislation began as an attempt to extend the Congress wanted to send FDA a message that it Prescription Drug User Fee revenue stream for the was seeking action by the agency to eliminate a FDA. It expanded the coverage of that fee apbacklog of review of NDA submissions and to bring proach to generic products and biosimilars. Along a more timely approach to their review activities. the way the legislation picked up other provisions This legislation, known as FDAMA, authorized the directed at reducing counterfeiting of dosage agency to create a “fast-track” process for handling forms, reducing drug product shortages, reducing NDA’s for medications proposed to be used for seri- the importation of adulterated products, and facilious or life-threatening diseases. It also created an tating sharing of drug diversion information by information databank to compile information state agencies across state lines.17 about clinical trials and freed to some extent the ability of manufacturers to promote off-label use of their approved products. With regard to OTC prod- Drug Quality and Security Act of 2013 ucts, this legislation set standards for including in This legislation amended the Federal Food Drug product labeling inactive ingredients.14 and Cosmetic Act to clarify that pharmacies may compound custom medications for their patients pursuant to a prescription or in anticipation of a Drug Facts Label Required for OTC Products patient-specific prescription. It also created a new In 1999 the FDA created a uniform format for medi- category known as “outsourcing facilities” that may cation information appearing on the packaging or do preparation of medication dosage forms for hoslabeling of non-prescription pharmaceuticals. This pitals without having a patient-specific prescripis referred to as the Drug Facts Label. tion/medication order. It also created a nationwide system used to track pharmaceuticals through the various stages of the supply chain to secure and FDA Regulation of Tobacco as a Drug verify the integrity of the products. This has come During 2000 the U.S. Supreme Court turned down to be known as “track and trace.”18 an attempt by FDA to regulate tobacco as a drug. The case was designated Food and Drug AdminThe 21st Century Cures Act of 2016 istration v. Brown & Williamson Tobacco Corp. The vote was 5-4.15 This statute, sometimes referred to as the “Cures Act”, authorized innovation in clinical trial design to facilitate collecting information needed to prepare Food and Drug Administration Amendments Act of submissions to FDA. It also addressed again the 2007 idea of facilitating approval of medications to treat certain serious or life-threating conditions.19 Congress returned its attention to FDA regulated products with this statute adopted during 2007. |24| Kentucky Pharmacists Association | March/April 2021
Conclusion
5. Sinclair UB. The Jungle New York: Doubleday (1906).
The history of federal legislative and regulatory action related to assuring the safety and efficacy of medications is replete with examples of action oc6. curring only in response to tragedy. This pattern, seen all too frequently especially with legislative action, is that a tragedy occurs and then there is a 7. legislative response as opposed to anticipating negative events. More recent changes have taken a somewhat more pro-active approach and we can 8. only hope that this will continue.
221 U.S. 488 (1911).
21 U.S.C. §353(b).
332 U.S. 689 (1948).
9. More than a few of these legislative and regulatory changes have brought more requirements for the 10. pharmacist that can be onerous but it’s important to “keep your eye on the ball” – the ultimate objective is protecting the patient and enhancing chances for a positive outcome. And that’s what pharma- 11. cy is all about anyway.
76 Stat. 780.
12.
P.L. 100-293.
13.
P.L. 102-571.
14.
P.L. 105-115.
15.
529 U.S. 120 (2000)
16.
P.L.110-85.
17.
P.L. 112-144.
18.
P.L. 113-54.
19.
P.L. 114-255.
Disclaimer: The information in this is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation and render advice in accordance with the full information.
P.L. 97-414.
P.L. 98-417.
References 1.
U.S. Constitution, Art. I, Sec. 8, Cl. 3.
2.
U.S. Constitution, Amendment X.
3.
9 Stat. 237.
4.
34 Stat. 768.
|25| www.KPHANET.org
March 2021—Evolution of the Federal Legal Framework for Regulation of Medications 1. The first federal statute designed to address drug quality was adopted by Congress during:
6. The 1938 legislation was prompted by a tragic incident involving:
A. B. C. D.
A. B. C. D.
1780 1824 1848 1906
2. Federal authority to regulate medications comes from a provision in the U.S. Constitution known as: A. B. C. D.
Due Process Clause Commerce Clause Health and Safety Clause Business Clause
3. Authority of state-level agencies to regulate people, places and activities related to distribution of medications is rooted in a legal concept known as: A. B. C. D.
Health and Safety Authority Law Enforcement Authority Public Health Power Police Power
Rofecoxib Thalidomide Sulfanilamide Quardracycline
7. The requirement that safety be established before approval for marketing was a result of legislation enacted in: A. B. C. D.
1880 1906 1938 1963
8. The requirement that efficacy be established before approval for marketing was a result of legislation enacted in: A. B. C. D.
1880 1906 1938 1963
4. Regulation of pharmaceutical principally occurs at the _____ level of government whereas regulation of pharmacists and pharmacies primarily occurs at the _____ level of government.
9. What was unique and of particular interest to pharmacists about the sponsors of the DurhamHumphrey Amendments of 1951?
A. B. C. D.
A. B. C. D.
Federal/State State/Federal State/County Federal/County
5. Initially, enforcement of federal laws related to assuring drug quality was assigned to the: A. B. C. D.
Department of the Interior Department of Health and Human Services Department of Health and Family Services Department of Agriculture
|26| Kentucky Pharmacists Association | March/April 2021
Both were physicians Both were pharmacists Both later held a higher national elected office Both were from the same state
10. Several pieces of legislation during the past twenty -five years had the goal of speeding up FDA processes for: A. Review and approval of medications for serious or life-threatening diseases B. Review and approval of medications for veterinary patients C. Review and approval of oral dosage forms of formerly injectable-only medications D. Review and approval of medications to treat disorder unique to children
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.
Expiration Date: 4/15/2021 Successful Completion: Score of 80% will result in 1.0 contact hours TECHNICIANS ANSWER SHEET. March 2021—Evolution of the Federal Legal Framework for Regulation of Medications Universal Activity # 0143-0000-21-003-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D
3. A B C D 4. A B C D
5. A B C D 6. A B C D
7. A B C D 8. A B C D
9. A B C D 10. A B C D
Information presented in the activity:
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)
PHARMACISTS ANSWER SHEET March 2021—Evolution of the Federal Legal Framework for Regulation of Medications Universal Activity # 0143-0000-21-003-H03-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________
PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)
The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education. |27| www.KPHANET.org
April CPE Article Review of Injectable Vitamins and Trace Elements in Adult Parenteral Nutrition Author: Shaina Smoger, PharmD Candidate 2021, Christopher Miller, PharmD, MS, MBA, BCNSP Clinical Associate Professor, Department of Pharmacy Practice & Science, University of Kentucky, College of Pharmacy0 The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity #0143-0000-21-004-H01-P &T 1.0 Contact Hours Expires 4/15/2024 Goals: To provide education on the historical development of current micronutrient recommendations for parenteral nutrition in adult patients and describe clinical importance of administering micronutrients and review micronutrient management during commercial product shortages. Objectives: Pharmacists 1.
Describe the evolution of recommendations of micronutrients (vitamins and trace elements) in adult parenteral nutrition
2.
Discuss importance of providing micronutrients to prevent deficiencies in parenteral nutrition dependent adult patients
3.
Recognize the current recommended doses of parenteral vitamins and trace elements, and the commercially available products which provide these doses
4. Identify strategies to overcome national product shortages of parenteral multivitamins and multitrace elements Technicians 1.
Distinguish vitamin and trace element components provided in parenteral nutrition
2.
Identify the commercially available multivitamin and multi-trace element products used in preparing parenteral nutrition
3.
Recognize how national product shortages may affect provision of vitamins and trace elements in parenteral nutrition
Introduction In cases of patients unable to receive appropriate nutrition orally or enterally- whether due to disease state, malabsorption, or poor tolerance- nutrition may be delivered parenterally. The main components of parenteral nutrition (PN) are macronutri|28| Kentucky Pharmacists Association | March/April 2021
ents and micronutrients (MN). While macronutrients (protein, carbohydrates, fat) provide the caloric intake for energy provision in a PN-dependent patient, MNs are essential to maintaining various fundamental functions of the body including metabolism and utilization of macronutrients, growth, com-
ponents of cofactors and coenzymes, and many others1,2. MNs are made up of vitamins, organic substances unable to be synthesized by the human body, and trace elements (TE), metals at very low concentrations in the body.3 These are considered essential nutrients and are therefore critical to provide to patients who are dependent on PN. This review focuses on the recommendations of vitamins and TEs in PN administered to adult patients.
min B1 (thiamine), vitamin B6 (pyridoxine), and vitamin B9 (folate), as well as the suggestion of adding vitamin K. These vitamin changes, however, were not FDA mandated until 2000.4-6
Most recently in 2012, based on the findings from a 2009 workshop analyzing then-available MN solutions, the American Society for Parenteral and Enteral Nutrition (ASPEN) published a position statement calling for new product developments to betHistorical Development of Current MN Recommen- ter address the needs and safety of patients on PN. dations for Commercial PN Products With regards to parenteral MVI, available products were deemed to meet the needs for most patients Recognition of the need to include MNs in the forwith an added recommendation to develop an indimulations of PN occurred in the 1970s, which develvidual injectable vitamin D to be given for depleted oped concurrently as cases for deficiencies in MNs patients not responsive to oral supplementation. were being highlighted. Separate cases were pubParenteral MTE products required the most uplished of patients on PN for weeks to years who dedates, which included a decrease in manganese to veloped symptoms consistent with deficiencies in 55 mcg and an increase in selenium to 60-100 mcg either zinc or chromium that resolved with admin(Table 1). Despite earlier calls for decreased mangaistration of the respective deficient element.1 nese and copper due to reports of toxicity and orThroughout the 1970s, expert panels and symposigan accumulation, available MTE products continums were held involving most notably the Nutrition ued to contain excessive doses. Since chromium is Advisory Group of the American Medical Associaa common contaminant of PN components, ASPEN tion (NAG-AMA) and the Food and Drug Adminsupported manufacturing an MTE product without istration (FDA). The resulting efforts culminated in chromium in addition to those that already conthe initial recommendations for the parenteral protained the recommended amount of chromium.4,6 vision of MNs. This included the development of guidelines for an injectable multivitamin (MVI) for- Importance of Micronutrient Inclusion in PN Formumulation, sent to the FDA for approval in 1975; later lation and Clinical Practice in 1979, the FDA approved an adult MVI formulation While deficiencies and toxicities are more of a conproviding 4 fat-soluble and 8 water-soluble vitacern in monitoring long-term PN, it is nevertheless mins.1,4-6 Also in 1979, guidelines were published important to monitor for in the acute care setting recommending daily doses of 4 TEs- zinc, copper, due to product shortages affecting MN status; if pamanganese, and chromium- to be delivered in tients on PN require prolonged hospitalizations; or adult PN. if PN needs to be ruled out as a cause of admission Since the initial provisional guidance for MNs in the for a patient on long-term PN. Presented below is a 1970s, the recommendations have been evolving as discussion of the functions, doses, and deficiency more data emerged on essential MNs and as toxici- and toxicity states of vitamins and TEs. ty became a concern. Seen in Table 1, recommendaVitamins tions for multi-trace elements (MTE) have been updated to include the following: addition of selenium Vitamins, in general, are critical in order to maintain and decreased copper dosage (1984); increased se- functions such as metabolism, growth, and cellular integrity. Provision of vitamins during PN is relenium dose range, decreased manganese and quired when oral or enteral routes are not feasible chromium dose ranges (1994); then a slight deor sufficient since these are organic substances crease in the recommended selenium dose range (1998, 2004). A second conference to address insuf- cannot be synthesized by the body2. The fatficient replacement of water-soluble vitamins took soluble vitamins recommended for inclusion in MVI products for PN are vitamins A, D, E, and K, and the place in 1985 which established increased dosage recommendations of vitamin C (ascorbic acid), vita- water-soluble vitamins include thiamine, B2 |29| www.KPHANET.org
(riboflavin), B3 (niacin), B5 (pantothenic acid), pyridoxine, B7 (biotin), folate, B12 (cyanocobalamin), and ascorbic acid.4 One of the most critical vitamins monitored for deficiency in patients on PN is thiamine. This vitamin acts as a cofactor in glycolysis, and as carbohydrate intake, so too does thiamine intake requirements.4 A deficiency in thiamine can be observed in a malnourished patient with refeeding syndrome, in which rapid intracellular shifts of fluids, electrolytes, and micronutrients occur triggered by carbohydrate reintroduction, particularly large doses2. National shortages of parenteral MVI have led to cases of thiamine deficiencies in PN patients which resulted in lactic acidosis, Wernicke’s encephalopathy, and beriberi.1 Toxicity from thiamine on the other hand has not been reported.4,6 The standard composition of MVI preparations per ASPEN guidelines are listed in Table 2, which are compared to the oral Recommended Dietary Allowance (RDA) or Adequate Intake (AI) values. Doses for fat-soluble vitamins provided by current MVI products are similar to the RDA or AI of each respective vitamin. Though bioavailability is expected to be greater when given intravenously (IV) versus when given enterally, support for providing a higher effective dose was rationalized given that the patients requiring PN are more likely to have established deficiencies prior to starting PN; have possible malnutrition; and may have altered metabolism affected by their acute and/or chronic disease. Water-soluble vitamins are provided at or more than double the RDA or AI per vitamin for the same aforementioned reasons with the additional consideration of greater urinary excretion. Despite higher doses, toxicity due to vitamins in PN had not been reported since before ASPEN’s re-evaluation of MNs in 2012, therefore no changes to MVI products were recommended.4,6 However, a request was made for development of an individual injectable vitamin D due to experts questioning the adequacy that daily doses of 200 IU in MVIs could prevent deficiency, which has yet to be commercially produced.1,4 Currently there are only two adult formulations of MVIs: Infuvite Adult and M.V.I Adult.4 Another formulation cited in ASPEN’s 2012 position statement, |30| Kentucky Pharmacists Association | March/April 2021
M.V.I-12, provided all but vitamin K but has since been withdrawn from the market. Both formulations adhere to the recommended doses per ASPEN, as shown in Table 2. Trace Elements The 2012 ASPEN recommendations for MTE doses in PN are: 0.3-0.5 mg copper; 10-15 mcg chromium (ASPEN also endorsed a formulation without chromium); 55 mcg manganese; 60-100 mcg selenium, and 2.5-5 mg zinc. The MTE products on the market at the time of the 2012 publication (Multitrace-4, Multitrace-5) required dose adjustments based on these recommendations.4 These have since been discontinued while a new injectable MTE, Tralement, was FDA approved in 2020. The formulation, shown in Table 3, aligns with the doses for zinc, copper, manganese, and selenium required by ASPEN, and does not contain chromium as requested.7 Chromium is necessary for glucose metabolism through its role in insulin-binding to insulin receptors. Rarely has chromium deficiency been reported, with possible symptoms including hyperglycemia refractory to insulin, neuropathy, and weight loss.4,8 Depending on valency, chromium can be carcinogenic, but an analysis of PN formulations showed it solely presents in the trivalent form which is considered nontoxic.4 There are no reports of symptomatic chromium toxicity in adults while on PN despite an overall excessive intake due to presence of chromium as a significant contaminant of other PN components, such as dextrose solutions. Newer estimates of parenteral chromium requirements are much lower than currently recommended (0.1-0.9 mcg/day), based on gastrointestinal (GI) absorption rates and the oral AI value of chromium.4,8 Therefore, the 10-15 mcg/day recommendation requires further evaluation and led ASPEN to recommending an MTE product be made without chromium in addition to those that already provided it.4 Copper is a cofactor within several metalloenzymes that function in numerable reactions (connective tissue formation; metabolism of catecholamines, iron, glucose; serotonin synthesis; many more). A deficiency in copper could present as anemia, neutropenia, thrombocytopenia, osteopenia, and neu-
rologic abnormalities.4,8 Monitoring for severe deficiency can reliably involve serum copper and ceruloplasmin levels, but results should be interpreted in context of whether a patient is in an inflammatory state with markers, such as C-reactive protein (CRP), due to an increase in levels during an acute phase response.1,8 It is mainly excreted in bile, therefore hepatic accumulation may result in toxicity, which can occur in reduced baseline hepatic function or develop during PN-associated liver dysfunction and cholestasis.8 For this reason, decreasing or omitting copper from PN during hepatic dysfunction or cholestasis can be seen in clinical practice. Acute toxicity could involve GI disturbances, acute renal failure, hepatic necrosis, even death; chronic accumulation in the liver and kidneys can result in organ dysfunction, and neurologic disorders from brain accumulation.4 Manganese is also incorporated into metalloenzymes with functions in energy metabolism and bone formation. While deficiency is not of much concern during PN use, symptomatic toxicity has been reported resulting in neurotoxicity that can present as a Parkinsonian-like tremor as well as gait disturbances, headache, peripheral neuropathy, confusion, and others.8 Increased signal intensities have been seen on brain magnetic resonance imaging (MRI) in patients on long-term PN and correlated with increased serum manganese levels.4,8 The most recent ASPEN recommendation for manganese in MTE products calls for 55mcg/day based on a dose-finding study, which contrasts with previous recommendations nearly 5 to 10 times this amount. Along with copper, manganese is excreted mainly in bile and should be decreased or withheld during severe cholestasis or hepatic dysfunction.4 Selenium functions within selenoproteins to protect against oxidative stress and regulate activity of thyroid hormone. Symptoms of a deficiency include muscle weakness, skeletal myopathy, nail bed whitening, hair and skin pigmentation loss, and severe effects including cardiomyopathy with some fatal cases. Serum and plasma selenium levels can be used to help identify a deficiency, but levels can decrease proportionally with the extent of an inflammatory response so should be interpreted alongside inflammatory markers (e.g. CRP).1,8 Cases of toxicity have not been reported in patients on PN.8
Zinc as an enzymatic cofactor is involved in the metabolism of macronutrients, immune function, gene regulation, and growth and development. Before zinc was routinely added to PN, published case series described zinc deficiencies while on PN presenting as a combination of skin lesions (acrodermatitis enteropathica), alopecia, perioral dermatitis, diarrhea, and depression, which reversed with zinc administration.1 Other signs of deficiencies include impaired wound healing and immune dysfunction, as well as altered smell and taste.4,9 Toxicity with PN is most likely to develop from large dose errors.8 This may present acutely as GI disturbances or chronically as impaired immune function, hypocupremia, reduced HDL cholesterol.4,9 Plasma zinc will be low in severe deficiency, though levels can be difficult to interpret since levels may be maintained within a normal range until a prolonged and severe zinc restriction.8 Also, since zinc is bound to albumin and albumin is a negative acute phase protein, zinc levels may decrease during an acute phase response.1 Considerations in Times of Product Shortages Over the past 30 years, there have been intermittent periods of product shortage for nearly all PN components. Several contributing factors can affect the availability of these products such as drug recalls or discontinuations, issues with raw materials, natural disasters, and many others.10 Since it is an ongoing impediment in the care of PN-dependent patients, ASPEN has outlined strategies of handling provision of PN components during shortages, including parenteral MVIs and MTEs. For a shortage of MTE products, all patients should be assessed for the appropriateness of PN for their indication. Oral and enteral nutrition are preferred whenever possible. If it is not feasible but patients may take medications orally or enterally, consider providing TEs via appropriately dosed MVI/mineral tablets or solutions by mouth or tube in patients without malabsorption issues. When there is limited availability, IV MTE products should be reserved for patients solely on PN therapy or in cases of therapeutic necessity. When IV MTE products are not available at all, administer individual IV TEs per dosing guidelines of the 2012 ASPEN position paper as shown in Tables 1 and 3.11
|31| www.KPHANET.org
Table 1. Comparison of historical recommendations for multi-trace element dosing4 1979
1984
1994
1998, 2004
2012
Copper (mg)
0.5-1.5
0.3-0.5
0.3-0.5
0.3-0.5
0.3-0.5
Chromium (mcg)
10-15
10-20
10-15
10-15
10-15*
Manganese (mcg)
150-800
400-800
60-100
60-100
55
Selenium (mcg)
---
50-60
40-80
20-60
60-100
Zinc (mg)
2.5-4
2.5-4
2.5-4
2.5-5
2.5-5
Similarly, during a shortage of MVI products, PN indication should be assessed to determine if oral or enteral nutrition would be appropriate or if can switch to oral MVI products. Reserve IV MVI products for patients solely on PN therapy or in cases of therapeutic necessity. When IV MVI products are not available at all, administer individual IV vitamins. Unless a patient is not suspected to have a deficiency, ASPEN specifically outlines that thiamine, ascorbic acid, pyridoxine, and folate be given IV daily at the doses in Table 2. Consider also administering vitamin K IV at either 0.5-1mg/day or 510mg/week, as well as cyanocobalamin intramuscularly 100-1000mcg once monthly.12 During shortages for both IV MTE and MVI, pediatric formulations should not be used to supplement adult PN so as to prevent shortages or worsening shortages in this patient population. Healthcare institutions should only purchase as much supply as needed to serve their patients since stockpiling may affect patient care nationally. Once options to obtain injectable MTE or MVI are exhausted, in the interest of prolonging any current inventory at any facility, consider rationing by reducing daily doses by as much as 50% or administer three times weekly.11,12 Conclusion The continuous guideline revisions of micronutrient dosing and appeals by clinical nutrition organizations for products adhering to these recommendations reflects a focus on improving MN provision for the benefit of PN-dependent patients. In the United States, there are currently two marketed MVI products- Infuvite Adult and M.V.I. Adult- and one marketed MTE- Tralement- which meet the requirements of standard adult doses as outlined by ASPEN. Vitamins and TEs are critical components when prescribing PN and both require monitoring of signs and symptoms of deficiency or toxicity. |32| Kentucky Pharmacists Association | March/April 2021
This need is intensified during national product shortages affecting parenteral MVIs and MTEs which are a periodic obstacle. As such, practitioners must remain vigilant in creating policies and procedures to address compounding PNs so as to limit poor outcomes in affected patients. References 1.
Blaauw R, Osland E, Sriram K, Ali A, Allard JP, Ball P, Chan LN, Jurewitsch B, Logan Coughlin K, Manzanares W, Menéndez AM. Parenteral provision of micronutrients to adult patients: an expert consensus paper. Journal of Parenteral and Enteral Nutrition. 2019 Mar;43:S5-23.
2.
Derenski K, Catlin J, Allen L. Parenteral nutrition basics for the clinician caring for the adult patient. Nutrition in Clinical Practice. 2016 Oct;31(5):578-95.
3.
Sriram K, Lonchyna VA. Micronutrient supplementation in adult nutrition therapy: practical considerations. Journal of Parenteral and Enteral Nutrition. 2009 Sep;33(5):548-62.
4.
Vanek VW, Borum P, Buchman A, Fessler TA, Howard L, Jeejeebhoy K, Kochevar M, Shenkin A, Valentine CJ, Novel Nutrient Task Force, Parenteral Multi‐Vitamin and Multi–Trace Element Working Group, American Society for Parenteral and Enteral Nutrition (ASPEN) Board of Directors. ASPEN position paper: recommendations for changes in commercially available parenteral multivitamin and multi–trace element products. Nutrition in Clinical Practice. 2012 Aug;27(4):44091.
5.
Vanek VW, Borum P, Buchman A, Fessler TA, Howard L, Shenkin A, Valentine CJ, Novel Nutrient Task Force, Parenteral Vitamin and Trace Element Working Group; and the American Society for Parenteral and Enteral Nutrition (ASPEN), Vanek VW, Borum P, Buchman A. A call to action to bring safer parenteral micronutrient products to the US market. Nutrition in Clinical Practice. 2015 Aug;30(4):559-69.
6.
Buchman AL, Howard LJ, Guenter P, Nishikawa RA, Compher CW, Tappenden KA. Micronutrients in parenteral nutrition: too little or too much? The past, present, and recommendations for the future. Gastroenterology. 2009 Nov 1;137(5):S1-6.
7.
Tralement [package insert]. Shirley, NY: American Regent, Inc. 2020.
8.
Fessler TA. Trace elements in parenteral nutrition: a practical guide for dosage and monitoring for adult patients. Nutrition in Clinical Practice. 2013 Dec;28(6):722-9.
9.
Sriram K, Lonchyna VA. Micronutrient supplementation in adult nutrition therapy: practical considerations. Journal of Parenteral anhd Enteral Nutrition. 2009 Sep;33(5):548-62. Table 6, Trace Elements; p. 557-558
10.
Holcombe B, Mattox TW, Plogsted S. Drug shortages: effect on parenteral nutrition therapy. Nutrition in Clinical Practice. 2018 Feb;33(1):53-61.
11.
Plogsted S, Adams SC, Allen K, Cober MP, Greaves J, Mogensen KM, Ralph A, Robinson D, Ward C, Ybarra J, Holcombe B. Parenteral nutrition trace element product shortage considerations. Nutrition in clinical practice: official publication of the American Society for Parenteral and Enteral Nutrition. 2016 Dec;31(6):843-7.
12.
Plogsted S, Adams SC, Allen K, Cober MP, Greaves J, Mogensen KM, Ralph A, Ward C, Ybarra J, Holcombe B, Product CP. Parenteral nutrition multivitamin product shortage considerations. Nutrition in clinical practice: official publication of the American Society for Parenteral and Enteral Nutrition. 2016 Aug;31(4):556-9.
13.
Infuvite [package insert]. Boucherville, QC, Canada: Sandoz Canada Inc.; 2016
14.
M.V.I. Adult [package insert]. Lake Forest, IL: Hospira Inc; 2020.
Table 2. Comparison of available parenteral multivitamins in the United States to oral Recommended Dietary Allowance and ASPEN daily parenteral vitamin recommendations Recommended Dietary Allowance2
ASPEN daily PN vitamin recommendations2
Infuvite Adult (per 10 mL)12
MVI-Adult (per 10 mL)13
Vitamin A (IU)
M 3000 F 2333
3300
3300
3300
Vitamin D (IU)
19-70 yo 600 >70 yo 800
200
200
200
Vitamin E (IU)
22
10
10
10
Vitamin K (mcg)
M 120* F 90*
150
150
150
Vitamin B1 (mg)
M 1.2 F 1.1
6
6
6
Vitamin B2 (mg)
M 1.3 F 1.1
3.6
3.6
3.6
Vitamin B3 (mg)
M 16 F 14
40
40
40
Vitamin B5 (mg)
5*
15
15
15
Vitamin B6 (mg)
19-50 yo 1.3 M >50 yo 1.7 F >50 yo 1.5
6
6
6
Vitamin B7 (mcg)
30*
60
60
60
Vitamin B9 (mcg)
400
600
600
600
Vitamin B12 (mcg)
2.4
5
5
5
Vitamin C (mg)
M 90 F 75
200
200
200
Abbreviations: M, male; F, non-pregnant or lactating female; yo, years old *Recommendations based on adequate intake (AI)
Table 3. Comparison of available parenteral multi-trace elements in the United States to ASPEN daily parenteral trace element recommendations
Copper (mg)
ASPEN daily PN trace element recommendations2 0.3-0.5
Tralement (per 1 mL)6 0.3
Chromium (mcg)
10-15*
---
Manganese (mcg)
55
55
Selenium (mcg)
60-100
60
Zinc (mg)
2.5-5
3
*In addition to the products available at the time which provided chromium within the range shown above, ASPEN recommended development of a product without chromium |33| www.KPHANET.org
April 2021—Review of Injectable Vitamins and Trace Elements in Adult Parenteral Nutrition 1. What trace element is not currently recommended to be included in MTE products for use in PN? A. Manganese B. Zinc C. Iron D. Copper 2. Which of the following is a commercially available MTE product in the United States that adheres to the ASPEN recommendations? A. Multitrace-5 B. Tralement C. Addamel N\ D. No such product exists
6. Factor leading to ASPEN recommending an MTE commercial product be made without chromium: A. Multiple cases of symptomatic toxicity while on PN B. High levels of chromium contaminating other PN components C. High levels of carcinogenic versions of chromium in PN D. Chromium is not necessary for functions within the body
7. Parkinsonian-like tremor is a sign of neurotoxicity due to _____ toxicity: A. Thiamine B. Manganese 3. A 56-year-old female is admitted with abdominal C. Zinc pain secondary to necrotizing pancreatitis and started D. Copper on PN. She reports eating little to nothing for over a week and is determined to be at risk for refeeding 8. The recommended dose of selenium was ____ to syndrome. Which of the following should be adminis- _____ mcg by ASPEN in 2012 tered to prevent complications from refeeding? A. Increased; 20-60 A. Cyanocobalamin B. Increased; 60-100 B. Thiamine C. Decreased; 20-60 C. Ascorbic acid D. Decreased; 60-100 D. Vitamin E 9. Why are parenteral water-soluble vitamin doses in 4. Which of the following commercially available mul- PN higher than oral RDA doses? tivitamin product(s) are currently on the market that A. Increased urinary excretion adhere(s) to the ASPEN dose recommendation? B. Patients at increased risk of deficiency or malnuA. M.V.I Adult trition B. M.V.I-12 C. Decreased bioavailability C. Infuvite D. a and b D. a and c 10. Concerns have been raised about the daily dose 5. Which of the following is not recommended during adequacy in MVIs of what fat-soluble vitamin? a national shortage of adult MVI or MTE products? A. Vitamin A A. Assess the indication for PN B. Vitamin D B. Administer oral supplements if able or tolerated C. Vitamin E C. Compound PN with appropriately dosed individ- D. Vitamin K ual injectable components D. Use pediatric formulations
|34| Kentucky Pharmacists Association | March/April 2021
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.
Expiration Date: 4/15/2024 Successful Completion: Score of 80% will result in 1.0 contact hours TECHNICIANS ANSWER SHEET. April 2021—Review of Injectable Vitamins and Trace Elements in Adult Parenteral Nutrition Universal Activity # 0143-0000-21-004-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D
3. A B C D E 4. A B C D
5. A B C D 6. A B C D
7. A B C D 8. A B C D
9. A B C D 10. A B C D
Information presented in the activity:
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)
PHARMACISTS ANSWER SHEET April 2021—Review of Injectable Vitamins and Trace Elements in Adult Parenteral Nutrition Universal Activity # 0143-0000-21-004-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________
PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D
3. A B C D 4. A B C D
5. A B C D 6. A B C D
7. A B C D 8. A B C D
9. A B C D 10. A B C D
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
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The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education. |35| www.KPHANET.org
Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines
The following broad guidelines should guide an author to completing a continuing education article for publication in The Kentucky Pharmacist.
Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred). Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not pertinent to technicians, that needs to be stated clearly at the beginning of the article.
Article should begin with the goal or goals of the overall program – usually a few sentences.
Include 3 to 5 objectives using SMART and measurable verbs.
Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.
|36| Kentucky Pharmacists Association | March/April 2021
Include a quiz over the material. Usually between 10 to 12 multiple choice questions.
Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.
When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.
Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles.
Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.
https://cmppharma.com/
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|38| Kentucky Pharmacists Association | March/April 2021
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Welcome new Members
We’re so happy to have you!
The list reflects new memberships received from January 1, 2021— February 28 2021.
If you see one of these new members, please welcome them to the KPhA family! Hannah Couch, Lexington Pharmacist Member
Jason Hoskins, Manchester Pharmacist Student
Gary Davis, Fort Mitchell Pharmacist Member
Tina Hudgins, Lexington Pharmacist Member
Jami Dutton, Lexington Pharmacist Member
Angela Johnson, Richmond New Practitioner 1st Year Member
Charles Gore, Nicholasville Pharmacist Member
Phillip Roper, Glasgow Pharmacist Member
Brian Heng, Ashland New Practitioner 1st Year Member
Jennifer Walston, Paducah New Practitioner 1st Year Member
|40| Kentucky Pharmacists Association | March/April 2021
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jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions.
|42| Kentucky Pharmacists Association | March/April 2021
The Kentucky Renaissance pharmacy museum is seeking the support of students and other ambassadors of the Museum to create short videos for posting on our Facebook pages. We are launching our efforts at the KPHA annual meeting in Louisville June 3-6th.
Our goal is to secure insights and reflections of the profession from practicing pharmacists throughout our profession. Singular topics and/or questions will be reviewed and discussed with those you wish to participate. Multiple segments on a single subject may be grouped to tell more expansive stories.
Oral history projects are a powerful tool for meaningful learning. Interviews often reveal personal, social, economic or cultural factors that affect a person’s experiences, perspective and identity. Oral histories bring the human element to a theme of a story. Oral histories create a more personal understanding of the story of life, of our profession. While some stories will be collected at the meeting, many more stories will be collected over the months by any and all pharmacists continuing to provide care and services to others.
|43| www.KPHANET.org
Campus Corner
of Pharmacy (UKCOP) faculty, challenged the pharmacy community to do better when holding its peers accountable. Coming forward about sexual harassment experiences isn't a cut-and-dry process. When people decide to come forward, they run the risk of suffering social and professional consequences. This fear of retaliation is reinforced by workplace power differentials that work to maintain the status quo. "You have to consider a lot of things before outing someone for sexual harassment,” Bissell said. “You run the risk of the person using this against you at a local level, but also if the person has a large national presence, they can keep you out of organizations or involvement that can hurt you professionally.” However, once Bissell realized that the situation impacted others and not only herself, she decided it was time to confront the problem head-on.
How Women Pharmacists Sparked a National Conversation around Sexual Harassment By: Jacob Lewis and Kristie Colón In 2017 the #MeToo Movement took the world of Hollywood by storm as dozens of women came forward with their experiences with sexual harassment. These stories created a domino effect in other industries as more women began to come forward, and the world began to see what women already knew: sexual harassment was a universal problem. As other industries worked on dealing with these "revelations," the field of pharmacy remained quiet.
"It wasn't until I heard that some of these interactions that I had previously gone through had occurred to a student,” Bissell said. “The student was hesitant to come forward because they'd heard that I had gone through this harassment and continued a professional relationship with the harasser. That was a turning point for me. It was then that I realized that if myself and others do not take action, then the situation would only continue." Bissell and Smith's efforts opened the floodgates for women to have their voices heard. As the voices of those impacted by sexual harassment reached a fever pitch, people began to come out in support of Bissell and her colleagues. One of those voices was Dr. Jimmi Hatton Kolpek, president of the American College of Clinical Pharmacy (ACCP). “The courage, determination, and commitment demonstrated by Dr. Bissell and her colleagues are transforming professional organization’s policies, procedures, and processes,” Hatton Kolpek said.”Embracing diversity, addressing harassment, and uniting to end discrimination will strengthen the future of our profession. I couldn’t be more grateful for her leadership and the opportunity to support these voices throughout my service as President of ACCP.”
Dr. Jackie Johnston from the Rutgers Ernest Mario School of Pharmacy and Stephanie Sibickly from It stayed this way until August 2020 when Dr. ReNortheastern University School of Pharmacy were becca Smith, of the University of Arkansas for Medi- among the women who told their stories and made cal Sciences, came forward via Twitter to call out the push for accountability. These stories prompted the pharmacy community for continuing to supa much broader conversation about how our culport pharmacists who have a past with sexual har- ture has and continues to enable predatory behavassment. These claims were significantly bolstered ior by men. when Dr. Brittany Bissell, critical care pharmacist at UK Health Care and University of Kentucky College When men exhibit inappropriate behavior towards |44| Kentucky Pharmacists Association | March/April 2021
women, it is frequently explained away and justified as "boys being boys" or "that’s just the way it is." Still, for many, the way sexual harassment has been normalized is an indicator of an overarching cultural issue that presents itself across the board regardless of industry.
to work without taking on any additional emotional stress. While hopeful, Bissell acknowledges they have a long way to go.
"The phrase #MeToo was started by Tarana Burke, a Black woman, back in 2006 for women of color to acknowledge and support one another with their "Reflecting on my own experiences, being sexually experiences with sexual abuse,” Bissell said. harassed initially didn't raise any red flags for me,” “Keeping that in mind, I think we must take an inBissell shared. “As a woman in this country, I think tersectional approach to these issues and we've become desensitized to off-handed and inacknowledge how people's identities will shape the appropriate remarks, and it has become something way they feel and how they respond to these interwe just expect." actions. So taking into consideration people's gender identity, sexuality and culture will help us to The way sexual harassment is ingrained in our culaddress harassment on a much broader scale." ture can lead women to believe that they have no other option but to endure it. This sort of thinking Thus far, Bissell's efforts have resulted in staterequires women to take on additional emotional ments from the American Society of Health-System labor to deal with regular workplace stressors on Pharmacists, the American College of Clinical Phartop of harassment. macy, and the American Pharmacists Association. Still, she doesn't plan on stopping there. Bissell's "All women want to do is come to work, do their petition to these organizations for better protecjob, and be good at it. I want to spend my time fotions for female students has garnered over three cusing on my patients and my students but dealing thousand signatures and counting. The efforts of with these kinds of situations requires me to take Bissell and other women like her are reshaping the time out of the day to talk about the harasser," Bisway we look at the pharmaceutical education insell said. "I know lots of strong women that put up dustry and have further implications for workplaces with it because they refuse to let the harasser win. in general. The second that we start dedicating time to our harasser, we are letting them take up more of our time and have a presence in our lives that they don't deserve." The process for reporting harassment is long and strenuous, especially for the victim. The process is often cyclical, requiring the victim to go through several different channels and relive their experience repeatedly. Many times, their effort results in no meaningful change or consequences. “The process can be incredibly frustrating,” Bissell said. “You almost need to make criminal complaints and have the worst of the worst happen to you before many organizations think to look.” While systemic change can be a longer process, Bissell said there are simple changes people can make to hold themselves and others accountable, thus creating a safer space for everyone. "We need a lot more people to be willing to have the difficult conversations and be willing to put in the work to make these changes,” Bissell added. “As more and more women come forward, I don't think many people are completely shocked by what's been going on. People will hear rumors about something that happened, but we need to start encouraging those people to follow up.” Bissell and her colleagues are working hard to help usher in a new era of pharmacy, one where sexual harassment is not the norm, and people can come |45| www.KPHANET.org
|46| Kentucky Pharmacists Association | March/April 2021
|47| www.KPHANET.org
KPhA BOARD OF DIRECTORS
KPERF BOARD OF DIRECTORS
Don Kupper, Louisville donku.ulh@gmail.com
Chair
Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu
Chair
Joel Thornbury, Pikeville jthorn6@gmail.com
President
Treasurer
Cathy Hanna, Lexington channa@apscnet.com
President-Elect
Chris Killmeier, Louisville cdkillmeier@hotmail.com
President, KPhA
Brooke Hudspeth, Lexington brooke.hudspeth@uky.edu
Secretary
Joel Thornbury, Pikeville jthorn6@gmail.com
Chris Killmeier, Louisville cdkillmeier@hotmail.com
Treasurer
Kevin Lamping, Lexington kevin.lamping@twc.com
Lewis Wilkerson, Frankfort rphs2@aol.com
Past President Representative
Paul Easley, Louisville rpeasley@bellsouth.net Pat Mattingly, Lebanon pat@patspharmacy.com
Directors Ronnah Alexander, Providence ralexander@hfchc.net
Sam Willett, Mayfield willettsam@bellsouth.net
Jessika Chilton, Beaver Dam jessikachilton@ymail.com
Adrienne Matson, Lexington Adrienne.matson@uky.edu
Kyle Harris, London kyleharrispharmd@yahoo.com Jacob Barnett, Lexington jacobbarnett15@gmail.com
University of Kentucky Student Representative
Chad Corum, Manchester pharmdky21@gmail.com
KPhA Staff Ben Mudd Executive Director bmudd@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org
Cassy Hobbs, Louisville cbeyerle01@gmail.com Thao Le Batovsky, Louisville tle3380@my.sullivan.edu
Secretary
Sullivan University Student Representative
Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Martika Martin, Owensboro Speaker of the House 12marmar@gmail.com Nathan Hughes, Louisville Vice Speaker of the House njhughes1980@gmail.com Trevor Ray, Caneyville trevor@midwaypharmacy.com Cory Smith, Barbourville corysmith6155@gmail.com Misty Stutz, Crestwood mstutz@sullivan.edu
|48| Kentucky Pharmacists Association | March/April 2021
Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org Kristen Blankenbecler, PharmD Director of Clinical Outreach kristen@kphanet.org Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness michele@kphanet.org Lisa Atha Office Assistant/Member Services Coordinator latha@kphanet.org
“Pharmacists are faced with the alternative of contributing to the design of the emerging health care system, such as the Kennedy Bill, or learning to live in a system determined by more vociferous interest groups. The key to professional power, if not survival, is political association—and this political power is needed now while the structure of a national health insurance program is being determined.” -From The Kentucky Pharmacist, April 1971 Volume XXXIV, Number 4
Frequently Called and Contacted Kentucky Board of Pharmacy
Kentucky Society of Health-System Pharmacists
National Community Pharmacists Association (NCPA)
P.O. Box 4961
100 Daingerfield Road Alexandria, VA 22314
(502) 564-7910
Louisville, KY 40204 (502) 456-1851 x2 www.kshp.org info@kshp.org
www.pharmacy.ky.gov
Kentucky Regional Poison Center
Pharmacy Technician Certification Board (PTCB)
(800) 222-1222
State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601
2215 Constitution Avenue
American Pharmacists Association (APhA)
Washington, DC 20037-2985
2215 Constitution Avenue NW
(800) 363-8012
Washington, DC 20037-2985
www.ptcb.org
(800) 237-2742
(703) 683-8200 www.ncpanet.org info@ncpanet.org National Association of Chain Drug Stores (NACDS) 1776 Wilson Blvd., Suite 200 Arlington, VA 22209 www.nacds.org 703-549-3001
www.aphanet.org
KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd. Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) info@kphanet.org www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.youtube.com/KyPharmAssoc |49| www.KPHANET.org
THE
Kentucky PHARMACIST 96 C Michael Davenport Blvd. Frankfort, KY 40601
