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Page 1: We’re Leveling the Playing Field So You · 2020-07-20 · We partner with current and prospective pharmacy owners, pharmacy associations, buying ... sphere of influence in pharmacy
Page 2: We’re Leveling the Playing Field So You · 2020-07-20 · We partner with current and prospective pharmacy owners, pharmacy associations, buying ... sphere of influence in pharmacy

Health Mart® is designed for today’s independent pharmacy owner. Our member pharmacies are locally owned and focused on great service, but they’re also gaining a competitive edge and national recognition in ways that community pharmacies never have before. That’s what happens when thousands of independently owned pharmacies come together, using our comprehensive portfolio of marketing, clinical and business solutions to help care for the health of your patients.

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© 2015 Health Mart. All rights reserved. HM-09344-04-15

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Page 3: We’re Leveling the Playing Field So You · 2020-07-20 · We partner with current and prospective pharmacy owners, pharmacy associations, buying ... sphere of influence in pharmacy

© 2014 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, and Essential to Care are trademarks or registered trademarks of Cardinal Health. Lit. No. 1RI14-18801 (08/2014)

Improving lives is your number one priority. Making sure you have the time to care for patients is ours.

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Page 4: We’re Leveling the Playing Field So You · 2020-07-20 · We partner with current and prospective pharmacy owners, pharmacy associations, buying ... sphere of influence in pharmacy

P atient-Centered Pharmacy Home™ (PCPH™) is the latest addition to The Compliance Team’s industry leading Exemplary Provider® suite of

accreditation programs for Pharmacy Services. PCPH is designed specifi cally to promote better patient medication management through concise measures that cover access issues, provider coordination, and care planning between a patient’s pharmacy and prescribing professionals. In addition to being Medicare-approved for DMEPOS, The Compliance Team’s Exemplary Provider® accreditation for Pharmacy Services also includes tracks

for Infusion, Compounding, Specialty Drugs, In-Store Clinic, TelePharmacy, and Long-term Care. Meeting the highest standards of patient care has never been this simple. For more details, call us at 215.654.9110 or visit our web site: TheComplianceTeam.org/pharmacy_services.aspx.

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Page 5: We’re Leveling the Playing Field So You · 2020-07-20 · We partner with current and prospective pharmacy owners, pharmacy associations, buying ... sphere of influence in pharmacy

Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 5

connectsocial @jcpharmpracticecontact [email protected] www.jcphp.com

Journal of Contemporary Pharmacy Practice (ISSN 2573-2757) is published quarterly by: California Pharmacists Association (CPhA) © 2018 CPhA. All rights reserved. 4030 Lennane Drive, Sacramento, CA 95834 Phone: (916) 779-1400 | Fax: (916) 779-1401 www.jcphp.com

Journal of Contemporary Pharmacy Practice is a professional, peer-reviewed journal devoted to informing pharmacists and enabling them to better serve the health and welfare of their patients.Articles express the opinions of the authors and do not necessarily reflect the view or policies of CPhA. Nothing in this publication may be reproduced in any manner, either in whole or in part, without specific written permission of the publisher.

Journal of Contemporary Pharmacy Practice is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate is $100 per year. Periodicals postage paid in Sacramento, California and at additional mailing offices.

Postmaster, send address changes to:California Pharamcists AssociationAttn: Journal of Contemporary Pharmacy Practice4030 Lennane Drive, Sacramento, CA 95834

Publisher assumes no responsibility for unsolicited material.

executive editor letterNational Perspectives Bring Unity to Pharmacy ProfessionJon R. Roth, MS, CAE

editorialThe Donning of the White Coat

Veronica T. Bandy, PharmD, MS, FCPhA, FCSHP, BCACP

clinical practice capsuleRecommendations for Anticoagulation Selection in Atrial Fibrillation PatientsEric Pinashin, PharmD Candidate 2019; Craig S. Stern, RPh, PharmD, MBA, FASCP, FASHP, FICA, FLMI, FAMCP, FCPhA, CSP

original researchExamining the Attitudes and Beliefs of California Pharmacists Toward Dispensing Medications Intended to be LethalPaul Gavaza, PhD; Jonathan Aspe, PhD; Carina Deck; Lap-Woon Keung; Stephanie Koch LeGrand; Franky Yan; Ko Eun Yoo; Emineh Zohrabi; Jim Pinder, JD, MBA; Farnoosh Zough, PharmD, BCPS

contents

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contributeSubmit an article or peer review.Register at jcphp.com/em or scan the QR code to be contacted by an editorial staff member.

original researchImpact of a Shared Tobacco Cessation Curriculum in California Schools of PharmacyRobin L. Corelli, PharmD; Nicolette A. Mehas, PharmD; Karen Cheung, PharmD; Dennis O. Ankrah, PharmD; Michael W. Blatt, PharmD; Karen Suchanek Hudmon, DrPH, FAPhA

reviewBiosimilars and the Pharmacist: A Review of the Legal and Regulatory Issues (Part 1) Donald R. Miller, PharmD, FASHP; Arianna Vidger, BS, 2019 PharmD Candidate

original researchAssessing the Acceptance of the Pay-For-Performance Model in a Segment of California PharmacistsJames Colbert, PharmD; Sarah McBane, PharmD; Michael S. Lam; Alice Blaj; Briana Zimmers; Michael Yoon; Brian Park; Thu Le; Han Dinh; Jessie Wang

business modelChange Champions Required to Promote Use of an Advanced EMR in a Mobile Community Health ClinicShane P. Desselle, RPh, PhD, FAPhA; James E. Lessenger, MD, FACOEM; Mustafa Sultani; Bushra Alsharif; Sam Pournezhad

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ISSN 2573-2757

vol. 65, no. 3 • Summer 2018 www.jcphp.com

journal of

contemporarypharmacy practice

vol. 65, no. 3 • Summer 2018

www.jcphp.com

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6 www.jcphp.com | vol. 65, no. 3 | Journal of Contemporary Pharmacy Practice

National Perspectives Bring Unity to Pharmacy Profession

executive editor letter

In March 2018, I had the great privilege of being inducted as the president of the National Alliance of State Pharmacy Associations (NASPA). The National Alliance of State Pharmacy Associations was founded in 1927 as the National Council of State Pharmacy Association Executives and is dedicated to enhancing the success of state pharmacy associations in their efforts to advance the profession of pharmacy. NASPA’s membership is composed of state pharmacy associations and over 70 other stakeholder organizations. NASPA promotes leadership, sharing, learning, and policy exchange among its members and pharmacy leaders nationwide. Although I was just recently elected as president, I have served on the NASPA Board of Directors since 2012 and, in that time, have come to appreciate the benefits and impact NASPA serves as a resource to the profession.

It is easy throughout the course of our daily work lives to get a bit of tunnel vision for the multitude of activities that are front and center on our desks. Whether it be legislation that our state pharmacy associations are advocating, curriculum and administration of our nation’s schools and colleges of pharmacy, or caring for patients in the many practice settings our pharmacists are serving, we all get busy with our daily affairs.

That is where the power of organizations like NASPA are realized. Its mission and purpose are to enhance the success of state pharmacy associations in their efforts to advance the profession of pharmacy. This is done through a number of modes that require an in-depth working relationship with multiple national pharmacy interest groups, including national pharmacy associations, federal agencies, and companies within the pharmacy space. This liaison role is critical for ensuring that those of us who represent the “boots on the ground” in our little corners of the world have a source of information and communication to understand the larger context of issues and opportunities that may be developing.

The other importance for having an organization like NASPA participating in the national discussion is its ability to take a number of similar local issues that develop organically and to produce a national compilation of policy or practice reviews. Having a national resource that provides a perspective and linkage to other regions and stakeholders experiencing the same situation is extremely helpful as the profession looks to create common best practices around the country.

There is a saying in political circles that “all politics are local.” In pharmacy, that may be true for many more subjects than just politics, and organizations like NASPA are important to ensure there is consistency and communication between local activities and national stakeholders. You may not have ever heard of NASPA, but it should be reassuring to know that there is a national organization that is championing the linkage between what is happening in your sphere of influence in pharmacy and ensuring those important issues become part of a national conversation. If you would like to learn more, please go to www.naspa.us.

Jon R. Roth, MS, CAEExecutive Editor

executive editorJon R. Roth, MS, CAE

managing editorJoseph R. Page

editor-in-chiefKarl Hess, PharmD, FCPhA, APh

associate editorsVeronica T. Bandy, PharmD, MS, FCPhA,

FCSHP, BCACP

Jack Chen, PharmD, FASCP, FCCP,

BCPS, BCGP, APh

Sonya Frausto, PharmD, MA, FCPhA

Janice Hoffman, PharmD, EdD, APh,

BCGP, FASCP

advisory board

Gary Besinque, PharmD, FCSHP

Alexander Cao, PharmD

Valerie Clinard, PharmD

Richard Dang, PharmD, APh, BCACP

George Do, PharmD

Lauren Eichstadt Forsythe, PharmD,

FSVHP

Ethan Huynh, PharmD, BCGP

Cynthia Jackevicius, PharmD, BScPhm,

MSc, FCSHP, FAHA, FCCP, FCCS

Amy Kang, PharmD

Anandi Law, B.Pharm, MS, PhD, FAPhA

Noelle Lee, PharmD

Sarah McBane, PharmD, CDE, BCPS,

FCCP, FCPhA, APh

David Q. Pham, PharmD, BCPS, CDE,

BC-ADM

Kerry Anne Rambaran, PharmD, BCPS

Ettie Rosenberg, PharmD, JD

Craig S. Stern, PharmD, MBA, RPh

Fred Weissman, PharmD

advertisingDiana Granger Granger Marketing Works(530) 642-0111 or [email protected]

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 7

The Donning of the White Coat

editorial

As the Fall semester is upon us, it is also the time of the White Coat Ceremony at many colleges and schools of pharmacy. Many of us, myself included, are from a time before such ceremonies. I recently had the honor and privilege of attending a White Coat Ceremony at one of our California schools of pharmacy. As I peered out into the audience I was reminded that these bright and hopeful faces of new, first-year pharmacy students have entered a new phase in their educational endeavors. They have achieved a milestone of academic success in obtaining a seat at one of our professional schools of pharmacy. But many of these students did not achieve their success alone. It was most likely a similar story to which most of us can relate. Many students may have had the love and support of family, friends, colleagues, and classmates to help them achieve this current goal.

Now these new pharmacy students are bestowed a gift of a white coat, which they are helped into by a faculty member. It is a gift that comes with great responsibility. “I will apply my knowledge, experience, and skills to the best of my ability…” To do so implies that the student shall strive to achieve academic excellence in the courses provided by the pharmacy curriculum as presented by their faculty. Whether in the classroom, patient simulation experience, or introductory or advanced pharmacy practice experience they will endeavor to “…consider the welfare of humanity and relief of suffering my primary concerns.” And through the interactions with patients at healthcare outreach events or at experiential sites, “I will respect and protect all personal and health information entrusted to me.” It is a reminder that with this great honor, of the bestowing of a white coat, comes an equally great responsibility.

As a pharmacist, when we don the white coat we are reminded that we are held to a higher standard of care as we provide clinical pharmacy services to our patients across all settings of practice. “I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical, and legal conduct.” Like it or not, when we wear our actual or figurative “white coat” we are held to a higher standard than the general public. We also recall that we are where we are today because many before us paved the way and also provided assistance when needed. As I stare out at those bright-eyed new pharmacy students it is a reminder that each of us has taken a similar vow to “…utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.” Each of us in our own way is working towards this statement, whether we are directly precepting a student, sponsoring a student to attend a state or national pharmacy meeting, educating them in the classroom, writing an article for a journal, or providing them and their families with our best clinical care. In doing so we are providing both the current pharmacy students and the future students of our profession a roadmap upon which they can begin their path. I have a frame in my office with the program from the very first White Coat Ceremony that occurred at my institution and along with it the Oath of the Pharmacist. When I am having a difficult day or find myself weary, I have often looked up and read those words within the frame. They serve as a reminder and inspiration to why we chose the profession that we have undertaken and love.

Veronica T. Bandy, PharmD, MS, FCPhA, FCSHP, BCACP

I challenge myself and each of my colleagues that tomorrow when we put on our white coat, that we take a moment and recall those first days of pharmacy school. This white piece of apparel is not just a part of my required uniform by my employer but is a powerful symbol of our profession and patient care. “I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”

Oath of a Pharmacist (1)

“I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:

I will consider the welfare of humanity and relief of suffering my primary concerns.

I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.

I will respect and protect all personal and health information entrusted to me.

I will accept the lifelong obligation to improve my professional knowledge and competence.

I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical, and legal conduct.

I will embrace and advocate changes that improve patient care.

I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”

About the AuthorDr. Veronica T. Bandy received her Doctor of Pharmacy and Master’s Degree from the University of the Pacific in California. Dr. Bandy has worked as an educator and practicing pharmacist in California for the past seventeen years. She is a fellow of both the California Pharmacist Association and the California Society of Health System Pharmacists. Dr. Bandy is the current president of the California Pharmacists Association.

References1. Oath of the Pharmacist. https://www.pharmacist.com/oath-pharmacist. Accessed Aug. 27, 2018.

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8 www.jcphp.com | vol. 65, no. 3 | Journal of Contemporary Pharmacy Practice

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 9

Recommendations for Anticoagulation Selection in Atrial Fibrillation Patients

clinical practice capsule

Introduction

Atrial fibrillation (AF) is described as a heart rhythm disorder of the atria. The heart’s natural pacemaker, found in the atria, is called the sinus node, which regulates the rate at which the atria contract and relax. In AF, a disbalance in electrical activity occurs, overriding the sinus node and causing the heart to quiver. Non-valvular AF (NVAF) is broadly described as AF in the absence of rheumatic mitral valve disease or a prosthetic heart valve.(1) NVAF is a relatively new term that has not been formally defined yet, but has increasingly been used to refer to patients who may benefit from direct oral anticoagulant (DOAC) medications.(2)

DiagnosisPatients typically do not have any symptoms of AF, but can be caught by a primary care physician (PCP). If a primary care physician (PCP) notices an irregular heart rhythm, they may send you to get an electrocardiogram (EKG) completed or

Eric Pinashin, PharmD Candidate 2019; Craig S. Stern, RPh, PharmD, MBA, FASCP, FASHP, FICA, FLMI, FAMCP, FCPhA, CSP

have you wear a 24- to 48-hour Holter Monitor to record heart activity throughout the day. An EKG consists of electrodes being placed on the skin around the heart, which records the electrical activity of the heart over a brief period of time. A patient with AF will show irregular waves between heartbeats in an EKG, as opposed to a defined P and T wave.

Therapy(4)

Cardioversion is a procedure that can be used to treat AF and NVAF in which an electrical current is used to reset the heart back to its normal rhythm. Patients should be on Warfarin for three weeks before an elective cardioversion, and Warfarin should be continued until normal sinus rhythm has been maintained for four weeks.

For patients not receiving cardioversion, anticoagulant therapy is long term and typically lasts for the remainder of the patient’s lifetime.

Figure 1: EKG showing a normal versus atrial fibrillation EKG, along with labels of P- and T-waves.3

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 11

Table 1: First-line medications along with price and condition.

CHA2DS2-VASc = Congestive heart failure, Hypertension, Age2 ,Diabetes mellitus, Stroke2, Vascular disease(prior), Age, Sex category. One point is given to every category, except for Age and Stroke, where two points are given. Each increase in total score is shown to predict ischemic stroke in linear fashion.

Prescribing ConsiderationsSelecting warfarin over DOAC is patient specific, but there are general guidelines. These are illustrated with the following patient case.

An 89-year-old male weighing 75kg with non-valvular atrial fibrillation has a CHA2DS2-VASc score of 2, and has no renal or hepatic issues. He has been taking warfarin for a decade and has maintained a stable INR. Patient complains of monitoring and his restricted diet and would like to know if there is an alternative agent to warfarin.

Typically, most patients will be started on warfarin due to cost and decades of clinical experience, but depending on the patient’s age and lifestyle, warfarin may not be the best option. For more geriatric patients, it would be appropriate to start a DOAC rather than warfarin, to avoid having to change dietary lifestyle and not disturb the patient with frequent lab monitoring. For most patients, warfarin is first line, unless they are taking other medications that can produce an adverse drug event, or it is difficult for the patient to deal with lab monitoring and dose titrations; then a DOAC would be next in line.

Regarding DOACs, there are Dabigatran and Rivaroxaban, which are both renally cleared, and Apixaban, which is hepatically cleared. None of the DOAC medications have monitoring guidelines, and they have simple dosing regimens. However, onl-

y Dabigatran has an FDA-approved reversal agent, Idarucizumab. At this step, it is necessary to assess if the patient has renal or hepatic issues, which will make the selection process easier, but in this case, the patient is free of these issues. Therefore, Dabigatran 150mg BID for his NVAF would be a relatively safe choice as second-line therapy. In addition, Dabigatran has a reversal agent, which was the key advantage over the other DOACs listed.

About the AuthorsCraig S. Stern, RPh, PharmD, MBA, FASCP, FASHP, FICA, FLMI, FAMCP, FCPhA, CSP is the president of Pro Pharma Pharmaceutical Consultants in Chatsworth, CA, a professor of pharmacy at the University of Southern California, University of California, San Francisco and Western University of Health Sciences, an an adjunct professor and preceptor at the University of the Pacific. He is a fellow of the Academy of Managed Care Pharmacy, the American Society of Consultant Pharmacists and the American Society of Health-System Pharmacists. Dr. Stern has no bias to report.

Eric Pinashin is a Doctor of Pharmacy candidate graduating from the USC School of Pharmacy in 2019. Eric has previous experience working at CVS, Ronald Reagan UCLA Medical Center and Care Services LLC. Mr. Pinashin has no conflicts of interest to report.

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Table 2: Medications, along with starting dose, monitoring parameters, adverse effects, reversal agents, and high-risk populations.(5)

References

1. Fauchier L. How to define valvular atrial fibrillation? National Center for Biotechnology Information. http://www.ncbi.nlm.nih.gov/pubmed/26184867 . Accessed July 22, 2016.

2. Granger C. Newer Oral Anticoagulants Should Be Used as First-Line Agents to Prevent Thromboembolism in Patients With Atrial Fibrillation and Risk Factors for Stroke or Thromboembolism. Response to Granger and Armaganijan. Circulation. http://circ.ahajournals.org/content/125/1/159. Accessed July 22, 2016.

3. Sparshott A. Med in Small Doses - SVT Tachyarrhythmias. h t tp: //w w w. i v l i ne .o rg /2012 /02 /me d - in - sma l l - dose s -tachyarrhythmias.html. Published May 14, 2015. Accessed March 16, 2017.

4. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57-e185. doi:10.1016/j.jacc.2014.02.536.

5. Prevention of stroke in nonvalvular atrial f ibrillation. September 2014. https://www.aan.com/Guidelines/Home/GetGuidelineContent/635. Accessed March 16, 2017.

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 13

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Learn more at www.medicationsafety.org or call us at (866) 365-7472.The Alliance of Medication Safety (APMS) is a federally listed Patient Safety Organization (PSO).

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14 www.jcphp.com | vol. 65, no. 3 | Journal of Contemporary Pharmacy Practice

Examining the Attitudes and Beliefs of California Pharmacists Toward Dispensing Medications Intended to be Lethal

original research

AbstractObjective: This study examined California pharmacists’ attitudes and beliefs toward dispensing medications intended to be lethal.

Method: A two-page survey instrument was administered in person and by mail to California-licensed pharmacists in 2016. The survey collected information on demographic characteristics (n=6 items), pharmacists’ attitude toward their role in the End of Life Option Act (ELOA, n=16 items), knowledge of the Act (n=4 items), and one comment section. Pharmacists rated their attitudes on a five-point bipolar Likert scale ranging from strongly disagree (1) to strongly agree (5).

Results: A total of 63 pharmacists responded, most of whom were male (n=32, 51%), considered themselves religious (n=41, 65.1%), and had an average age of 40.1 (SD=13.0) years. Only 30 (47.6%) respondents were willing to personally dispense a lethal dose of medication requested by a terminally ill patient with a valid prescription, while most agreed that they had the right to refuse to dispense a prescription intended to be lethal (n=56, 88.9%). Only 16 (25.4%) pharmacists reported having adequate knowledge to dispense and counsel on an ELOA drug. Most pharmacists called for more training on how to dispense and counsel patients about these lethal medications (n=54, 85.7%). Pharmacists’ beliefs differed by whether they were religious or not (p<0.05).

Conclusion: Fewer than half of the pharmacists were willing to personally dispense a lethal dose of medication requested by a terminally ill patient with a valid prescription. California pharmacists do not have adequate knowledge concerning the End of Life Act. Further research on pharmacists’ attitudes and beliefs is needed.

Keywords: End of Life Option Act; physician aid in dying; physician-assisted suicide; pharmacist attitudes

IntroductionIn September 2015, California became the fifth state in the United States to legalize physician-assisted suicide (PAS) with the passing of the End of Life Option Act (ELOA). The California ELOA allows California physicians to prescribe a lethal dose of medication for self-administration by a terminally ill patient, defined as a patient with less than six months to live. If the steps specified in the law are followed, the medication can be prescribed and dispensed without any of the involved health care providers facing civil or criminal liability.

California pharmacists are being presented with prescriptions

Paul Gavaza, PhD; Jonathan Aspe, PhD, 2019 PharmD candidate; Carina Deck, 2019 PharmD candidate; Lap-Woon Keung, 2019 PharmD candidate; Stephanie Koch LeGrand, 2019 PharmD candidate; Franky Yan, 2019 PharmD candidate; Ko Eun Yoo, 2019 PharmD candidate; Emineh Zohrabi, 2019 PharmD candidate; Jim Pinder, JD, MBA; Farnoosh Zough, PharmD, BCPS

for drugs intended to be lethal. Physicians can deliver these prescriptions to a participating pharmacy by hand, through the mail, or electronically. The involvement of pharmacists in the planned death of patients, wittingly or unwittingly, through the legalization of PAS in California raises several issues for pharmacists.(1) Surveys of pharmacists in other states reveal that pharmacists are divided on the issue of PAS.(1)(2) A national survey of pharmacists found that 72.6% of respondents believed that assisted death may be appropriate in some situations,(2)

and a few respondents believed that it was appropriate for pharmacists to help a patient to die. Another national survey found that a majority of pharmacists believed that PAS was appropriate in some cases.(3) In general, pharmacists support the patient’s right to participate in PAS in some cases.(1)

Past research found that pharmacists’ attitudes toward PAS differ by age (younger: more negative) and degree of religious affiliation (higher: more negative), and practice setting and personal experiences.(2)(4) Pharmacists practicing in chain stores were found to be less willing to participate in PAS than those practicing in independent and hospital pharmacies.(2)

Little is known about California pharmacists’ attitudes toward and beliefs about PAS and about their willingness to dispense a lethal dose of medication intended for use in PAS. The aim of the study is to investigate California community and retail pharmacists’ attitudes toward and beliefs about PAS and their willingness to dispense medications intended for use in PAS. The specific objectives of the study are to:

1. Determine pharmacists’ beliefs and attitudes toward dispensing medication intended for PAS.

2. Determine pharmacists’ knowledge of the provisions of the End of Life Option Act.

3. Determine the main factors that are associated with pharmacists’ attitudes and overall willingness to dispense a lethal dose of medication for PAS under the End of Life Option Act.

MethodsThe protocol of this cross-sectional study was approved by the Loma Linda University Health Institutional Review Board. The study utilized a two-page survey instrument to collect data from California-licensed pharmacists in June and July 2016. The questionnaire was developed primarily from existing pharmacy and medical literature on PAS.

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 15

The sur vey co l lec ted in fo rmat ion on demographic characteristics (n=6 items), pharmacists’ attitude toward their role in ELOA (n=16 items), knowledge of the Act (n=4 items), and one comment section. Pharmacists rated their attitudes and beliefs on a five-point bipolar Likert scale ranging from strongly disagree (1) to strongly agree (5).

The paper surveys were distributed in person by members of the Loma Linda University California Pharmacy Student Leadership (CAPSLEAD) 2016-2017, mostly in Southern California. Other surveys were distributed by mail by CAPSLEAD members. The questionnaire and a cover letter explaining the purpose of the study were either personally handed to each of the conveniently selected pharmacists or mailed to them. Only registered and currently active pharmacists practicing in California who consented to participate were included in this study. CAPSLEAD members selected the pharmacists to target, mostly those they knew and had interacted with in the past. All nonactive California pharmacists, interns, and those practicing in other states were excluded from this study.

Pharmacists were asked to complete and return the questionnaires to the researchers. Pharmacists were offered an aggregated summary of the study results as an incentive to respond. The estimated time required to complete the questionnaire was 10 minutes. Questionnaires were not marked with an identification number.

Data AnalysisData were entered in Microsoft Excel® 2010 and uploaded to Statistical Package for Social Sciences® (SPSS) version 22.0 for analysis. Descriptive statistics were computed for all study variables. Independent sample t-tests and Analysis of Variance (ANOVA) with Tukey’s post-hoc comparisons were conducted. A p-value of ≤ 0.05 was considered statistically significant.

ResultsMost respondents were male (n = 32, 50.8%), practiced in the community setting (n = 35, 55.6%), and considered themselves religious or spiritual (n = 41, 65.1%) (Table 1). The respondents were on average 40.1 years old (SD=13.0; range: 24-84 years) and had been practicing for 10 years or less (n= 37, 58.7%). Twenty-one (33.3%) and 19 (30.2%) respondents were Catholics and Protestants, respectively (Table 1).

Thirty (47.6%) pharmacists agreed/strongly agreed that they were willing to personally dispense a lethal dose of medication requested by a terminally ill patient with a valid prescription (Table 2). Most pharmacists agreed that they had the right to refuse to dispense a prescription intended to be lethal (n=56, 88.9%, Table 2).

Only 25.4% (n=16) of pharmacists agreed/strongly agreed that they had adequate knowledge to dispense and counsel patients about an End of Life Option Act drug, while most pharmacists agreed that there should be more training on how to dispense and counsel patients about these lethal medications (n=54, 85.7%, Table 2).

Twenty-four percent of pharmacists agreed that they had adequate knowledge about the End of Life Option Act, whereas 46% said that they did not (Table 3).

In the comments section of the survey, many pharmacists expressed concern that they lack the training to dispense prescriptions for lethal medications and provide adequate counseling. Some of the comments made by respondents

include: “Needs to be more education on this topic,” “This is new and I need to learn more about it,” “Would like to know about the Act,” and “Would appreciate if Board of Pharmacy would post guidelines on their website.”

Factors Associated with Pharmacists’ Beliefs and AttitudesAfter excluding those who were unsure, those who considered themselves religious were more negative on 11 of the 16 attitudes items regarding the End of Life Option Act (p<0.05). For example, the respondents who rated themselves as being not religious were more willing to personally dispense a lethal dose of medication requested by a terminally ill patient with a valid prescription (mean = 4.11 ±0.74) than those who rated themselves as being religious (mean = 2.98±1.35) (t= -4.178; df = 56.3, p < 0.001).

Male pharmacists were more supportive of the End of Life Option Act than female pharmacists on three of the 16 items (p<0.05). There was no statistically significant difference by gender on the remaining 13 items.

There was no statistically significant difference in pharmacists’ attitudes and beliefs by age, years practicing pharmacy, practice setting, and religious affiliation (p> 0.05) across all 16 items.

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Table 1. Demographic and practice characteristics of respondents (n = 63)

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Table 2. Respondents’ opinions regarding the End of Life Option Act and PAS

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DiscussionMost respondents agreed/strongly agreed that “A terminally ill patient has the right to choose to end his/her own life” (n= 42, 67.8%), “Competent patients should have the right to end their own lives” (n=42, 66.7%), and that “It may be appropriate for doctors to help terminally ill competent patients to end their lives” (n = 44, 69.8%). These findings suggest that pharmacists in our study respect the wishes and rights of patients to end their lives if they choose. According to 2015 Gallup poll results, a similar proportion of the general public (68%) agreed that terminally ill patients should be allowed to end their lives.(5)

Similarly, a national survey of pharmacists found that 72.6% of respondents believed that assisted death may be appropriate in some situations.(2) The proportion of pharmacists and the general public who support physician aid in dying has been increasing over time. In 1994, only 48.6% of pharmacists believed that physician-assisted suicide (PAS) may be appropriate in some situations. The proportion of pharmacists who supported PAS in this study is higher than the 54% of US physicians who agreed that PAS should be allowed in 2014.(6)

Despite the pharmacists’ widespread support for PAS in general, slightly fewer than half of the respondents (n=30, 47.6%) were willing to personally dispense a lethal dose of medication requested by a terminally ill patient with a valid prescription, with the rest of them either not willing or neither willing nor unwilling to do so. Consistent with the findings of a previous survey of pharmacists,(2) this suggests that most respondents are not wholeheartedly participating in PAS. The limited participation of pharmacists may be explained by several factors, including their religious and moral beliefs as well as their lack of knowledge on PAS and ELOA.

Most pharmacists (84.2%) believed that they should have full access to the patient’s diagnosis and care plan when filling prescriptions intended for assisted dying. This finding, among others, suggests that pharmacists expect to be informed about the intended purposes of lethal prescriptions that they will be asked to fill. However, under the ELOA, prescribers are not required to discuss the prescribed use of medications with the pharmacist.(7) This can be problematic given the lack of standardized medications that are uniquely indicated for PAS. Consequently, a dispensing pharmacist may be unaware of the intended purpose of a lethal prescription arriving at his or her pharmacy. Having access to the patient’s diagnosis and care plan when filling prescriptions intended for PAS will help minimize the chances of inadvertently filling one. A previous study reported that most (66.6%) pharmacists believed that it was not appropriate for physicians to involve a pharmacist in PAS without his or her knowledge and consent.(2)

A majority of respondents (n=56; 88.9%) agreed they had the right to refuse to dispense a prescription intended to be lethal. Pharmacists’ as well as physicians’ and health systems’ participation in ELOA in California is voluntary, and they cannot face legal or economic consequences for declining to participate in ELOA. However, only 49 respondents (77.8%) knew this important fact regarding participating in ELOA in California.

Many California pharmacists indicated that they had inadequate knowledge concerning the ELOA and dispensing lethal medications. Many pharmacists are unaware of the law and its effects on their scope of practice. Only 25.4% (n=16) of our pharmacists felt they had adequate knowledge to dispense and counsel patients about an ELOA drug. This inadequate knowledge and training may limit pharmacists’ participation in d-

Table 3. Knowledge of pharmacists

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 19

ispensing and counseling patients about a lethal medication. Further education and training is needed to improve California pharmacists’ knowledge and awareness regarding medications intended to be lethal and the ELOA. This improved knowledge and awareness will help pharmacists to appropriately counsel patients about a lethal medication.

Similar to a previous study(2), the opinions of pharmacists varied by whether they considered themselves to be religious or not. Those who considered themselves religious were less likely to be supportive of some ELOA provisions. Age, gender, practice setting, and years practicing pharmacy were not statistically significantly related to pharmacists’ beliefs about PAS and their support for ELOA’s provisions.

Limitations of the StudyThe findings of the study need to be considered in view of the following two limitations. First, the study has a small sample size of 63 pharmacists. Second, the study utilized convenience rather than random sampling to select the pharmacists for inclusion. Consequently, not all California pharmacists had an equal chance of participating in our study. Significantly fewer surveys were distributed to pharmacists in Northern California. In addition, none of the study participants were of Jewish or Islamic faiths despite these religions being common in California. The opinions and beliefs of members of these faiths are therefore not represented in our study. The study findings may not be truly representative of the beliefs and attitudes of the entire population of pharmacists in California.

ConclusionFewer than half of the pharmacists surveyed were willing to personally dispense a lethal dose of medication requested by a terminally ill patient with a valid prescription. Many pharmacists do not have adequate knowledge concerning the End of Life Option Act. Further education, awareness, and training of California pharmacists regarding the End of Life Option Act is needed. Further research using a larger and more representative sample is needed to gain a better insight into the attitudes and beliefs of California pharmacists regarding the End of Life Option Act.

About the AuthorsPaul Gavaza, PhD is an Associate Professor at Loma Linda University School of Pharmacy, Dr. Gavaza has been a lead researcher in social and administrative pharmacy since 2010. Dr. Gavaza has no bias to report.

Jonathan Aspe, PhD is a 2019 PharmD candidate at Loma Linda University School of Pharmacy and a member of California Pharmacy Student Leadership (CAPSLEAD) 2016-2017. Dr. Aspe has no bias to report.

Carina Deck is a 2019 PharmD candidate at Loma Linda University School of Pharmacy and a member of California Pharmacy Student Leadership (CAPSLEAD) 2016-2017. Ms Deck has no bias to report.

Lap-Woon Keung is a 2019 PharmD candidate at Loma Linda University School of Pharmacy and a member of California Pharmacy Student Leadership (CAPSLEAD) 2016-2017. Mr Keung has no bias to report.

Stephanie Koch LeGrand is a 2019 PharmD candidate at Loma Linda University School of Pharmacy. She is President Elect of Academy of Managed Care Pharmacy (AMCP) at Loma Linda University, a member of California Pharmacy Student Leadership (CAPSLEAD) 2016-2017, and a Rite Aid Intern-Pharmacist. Ms LeGrand has no bias to report.

Franky Yan is a 2019 PharmD candidate at Loma Linda University School of Pharmacy and a member of California Pharmacy Student Leadership (CAPSLEAD) 2016-2017. Mr Yan has no bias to report.

Ko Eun Yoo is a 2019 PharmD candidate at Loma Linda University School of Pharmacy and a member of California Pharmacy Student Leadership (CAPSLEAD) 2016-2017. Ms Yoo has no bias to report.

Emineh Zohrabi is a 2019 PharmD candidate at Loma Linda University School of Pharmacy and a member of California Pharmacy Student Leadership (CAPSLEAD) 2016-2017. Ms Zohrabi has no bias to report.

Jim Pinder, JD, MBA, is Director of Academic Affairs and an Associate Professor at Loma Linda University School of Pharmacy. Mr Pinder has no bias to report

Farnoosh Zough, PharmD, BCPS, is Director of Introductory Pharmacy Practice Experiences (IPPE) in the Department of Experiential and Continuing Education at Loma Linda University School of Pharmacy. Dr. Zough has no bias to report

References1. Rupp MT. Physician-assisted suicide and the issues it raises for pharmacists. American Journal of Health-System Pharmacy. 1995;52(13):1455-1460.

2. Rupp MT, Isenhower HL. Pharmacists' attitudes toward physician-assisted suicide. American Journal of Health-System Pharmacy. 1994;51(1):69-74.

3. Veatch RM. The pharmacist and assisted suicide. American Journal of Health-System Pharmacy. 1999;56(3):260.

4. Vivian J, Slaughter R, Calissi P. Michigan pharmacists' attitudes about medically assisted suicide. Journal of Michigan Pharmacy. 1993;31:490-495.

5. Dugan A. In U.S., Support Up for Doctor-Assisted Suicide. 2015. http://www.gallup.com/poll/183425/support-doctor-assisted-suicide.aspx. Accessed June 13, 2017.

6. Kane L. Medscape Ethics Report 2014, Part 1: Life, Death, and Pain. 2014.

7. Assembly Bill No. 15. End of Life Option Act. In: Legislature C, ed. 15. Vol information. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520162AB15. Accessed October 3, 2016.

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20 www.jcphp.com | vol. 65, no. 3 | Journal of Contemporary Pharmacy Practice

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 21

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What are the requirements?The new statute states that in order for a pharmacist to be recognized by the California Board of Pharmacy as an advanced practice pharmacist, you must satisfy at least two of the following:

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pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric pharmacy, from an organization recognized by [ACPE] or another entity recognized by the board.”

2. 4210(a)(2)(B): “Complete a postgraduate residency through an accredited postgraduate institution where at least 50 percent of the experience includes the provision of direct patient care services with interdisciplinary teams.”

3. 210(a)(2)(C): “Have provided clinical services to patients for at least one year under a collaborative practice agreement or protocol with a physician, advanced practice pharmacist, pharmacist practicing collaborative drug therapy management, or health system.”

BackgroundThe California Pharmacists Association (CPhA) spearheaded a bill also known as SB 493 signed by Governor Jerry Brown on

as the Advanced Practice Pharmacist (APh).

What is an Advanced Practice Pharmacist?According to the California State Board of Pharmacy’s website, “An advanced practice pharmacist is a licensed pharmacist who has been recognized by the board, pursuant to Section 4210. A board-recognized advanced practice pharmacist is entitled to practice advanced practice pharmacy, as described in Section 4052.6, within or outside of a licensed pharmacy. The advanced practice pharmacist license shall be coterminous with the licensee’s pharmacist license.”

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Successful candidates who meet two of the three criteria and apply with the California State Board of Pharmacy to become an APh are authorized to:

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What are the requirements?The new statute states that in order for a pharmacist to be recognized by the California Board of Pharmacy as an advanced practice pharmacist, you must satisfy at least two of the following:

1. 4210(a)(2)(A):

pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric pharmacy, from an organization recognized by [ACPE] or another entity recognized by the board.”

2. 4210(a)(2)(B): “Complete a postgraduate residency through an accredited postgraduate institution where at least 50 percent of the experience includes the provision of direct patient care services with interdisciplinary teams.”

3. 210(a)(2)(C): “Have provided clinical services to patients for at least one year under a collaborative practice agreement or protocol with a physician, advanced practice pharmacist, pharmacist practicing collaborative drug therapy management, or health system.”

BackgroundThe California Pharmacists Association (CPhA) spearheaded a bill also known as SB 493 signed by Governor Jerry Brown on

as the Advanced Practice Pharmacist (APh).

What is an Advanced Practice Pharmacist?According to the California State Board of Pharmacy’s website, “An advanced practice pharmacist is a licensed pharmacist who has been recognized by the board, pursuant to Section 4210. A board-recognized advanced practice pharmacist is entitled to practice advanced practice pharmacy, as described in Section 4052.6, within or outside of a licensed pharmacy. The advanced practice pharmacist license shall be coterminous with the licensee’s pharmacist license.”

CPhA partnered with the National Association of Chain Drug Stores (NACDS)

program provides pharmacists with the knowledge and skills to expand their scope of practice as an advanced practice pharmacist.

and interpreting drug-therapy related tests, patient referral, drug therapy management, and documentation.

» 30 hours (3.0 CEU) self-study modules with assessment exam

» 8.0 hour (0.80 CEU) live seminar with interactive case studies and hands on assessment

» By successfully completing this program, the candidate will receive a

to become an advanced practice pharmacist (APh). Visit appharmacist.com to learn more!

Successful candidates who meet two of the three criteria and apply with the California State Board of Pharmacy to become an APh are authorized to:

» Perform patient assessments

» Order and interpret drug therapy-related tests in coordination with a patient’s primary care provider or diagnosing prescriber to monitor patient progress

» Refer patients to other health care providers

» Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers

» In accordance with a protocol with a physician or facility, a pharmacist may initiate, adjust, and discontinue drug therapy upon referral from a patient’s treating prescriber when necessary and medically appropriate

did you know?

271licensed Advanced

Practice Pharmacists now practice in California

*according to the California Board of Pharmacy registered APh database as of 3/1/18

Become Certified as an Advanced Practice Pharmacist Advanced Practice Pharmacist Certificate ProgramBrought to You by CPhA & NACDS

upcoming programs

September 29, 2018CSU East Bay Conference Center

1000 BroadwayOakland, CA 94607

December 8, 2018 KGI School of Pharmacy

517 Watson DriveClaremont, CA 91711

register online atappharmacist.com

Offered through CPhA! See next page for details.

For more information, frequently asked questions, and registration options, visit www.appharmacist.com.

register early!This program has 30 hours (3.0 CEU) of self-study modules with an assessment exam to be completed prior to the live training program.

Learn more about how to become an APhAccess Frequently Asked Questions (FAQs) on the Advanced Practice Pharmacists Website at www.appharmacist.com

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24 www.jcphp.com | vol. 65, no. 3 | Journal of Contemporary Pharmacy Practice

Impact of a Shared Tobacco Cessation Curriculum in California Schools of Pharmacy

original research

AbstractPurpose: To characterize the long-term impact of a shared, evidence-based tobacco cessation curriculum (Rx for Change) on tobacco-related education in California schools of pharmacy (n=8).

Methods: Faculty members responsible for teaching tobacco-related content completed a survey assessing implementation of tobacco education, curricular time devoted to tobacco, and teaching and assessment methods utilized. Using historical data, the total number of students trained since 2000 was estimated.

Results: All schools utilized the shared curriculum, and in 2012-2013, a median of 435 minutes (range: 240-600 minutes) was devoted to tobacco-related content within required curricula. Between 2000 and 2013, an estimated 10,616 pharmacy students in California received Rx for Change training.

Conclusion: After more than a decade, a shared tobacco cessation curriculum continues to be widely utilized and provides a strong foundation for legislative efforts to enhance pharmacists’ scope of practice related to prescriptive authority for tobacco cessation.

IntroductionSmoking is the primary preventable cause of morbidity and mortality in the United States, accounting for more than 480,000 deaths annually.(1) The impact of tobacco dependence on public health and its burden on the economy warrant widespread adoption of enhanced tobacco control strategies, including expanding the role of health care providers in cessation.(2)

It is well established that health care providers have a proven, positive impact on patients’ ability to quit,(3) but until recently, most schools of pharmacy incorporated insufficient levels of tobacco-related content in their curricula(4) (i.e., less than three hours of total instruction).(5) In 1999, a California-based survey was conducted and determined that fewer than 8% of pharmacists had received formal tobacco cessation training, yet 93% of respondents believed that formal training would increase the quality of their tobacco-cessation counseling, and 70% believed it would increase the number of patients whom they counsel.(6) To address this gap in training, faculty members from all four California schools of pharmacy collaborated to develop the Rx for Change: Clinician-Assisted Tobacco Cessation program (www.rxforchange.ucsf.edu),(7) a shared, evidence-based curriculum for practicing clinicians and students in the health professions that has been described previously.(8)(9)

According to a 2016 AACP report commissioned by the Centers for Disease Control and Prevention, the Rx for Change materials were being utilized at 73.5% of the US schools and colleges of pharmacy.(10)

Because several states recently have expanded or are currently

Robin L. Corelli, PharmD; Nicolette A. Mehas, PharmD; Karen Cheung, PharmD; Dennis O. Ankrah, PharmD; Michael W. Blatt, PharmD; Karen Suchanek Hudmon, DrPH, FAPhA

in the process of expanding the pharmacist’s scope of practice for tobacco cessation through legislative efforts(11), the importance of an adequately trained workforce has become paramount.This study characterizes the status and longitudinal trends for tobacco education in schools of pharmacy within California, using a shared tobacco cessation curriculum that has been in existence since 1999. Additionally, the data presented here aim to estimate the number of trained graduates with the ability to assume expanded roles in the area of tobacco cessation.

MethodsTarget Population and Study DesignIn 2013, eight accredited schools of pharmacy existed in the state of California. Of these, four were the original implementers of the Rx for Change curriculum in 2000 (University of California-San Francisco, University of the Pacific, University of Southern California, and Western University of Health Sciences). Between 2002 and 2008, four new schools were founded and had accepted their inaugural class cohort (California North State University, Loma Linda University, Touro University, and University of California-San Diego). In combination, these eight schools constituted the target population for this study.

In September 2013, the lead faculty member responsible for the delivery of tobacco-related content at each school of pharmacy received a self-administered survey by courier delivery. The survey, which was modified from a previous version,(4) was administered as follows: (a) notification e-mail at -1 week, (b) survey mailed with cover letter describing the study, (c) e-mail reminder note at +1 week, and (d) e-mail reminder note or follow-up telephone call at +3 weeks. Respondents received a $20 gift card as compensation for their time. The Committee on Human Research at the University of California, San Francisco approved all study materials and procedures.

MeasuresSchools were characterized based on the number of students in the entering pharmacy class for academic year 2012-2013, and methods by which tobacco cessation content was incorporated into the required curriculum were assessed. Respondents estimated the number of minutes allocated to the following tobacco-specific topics: (a) epidemiology of tobacco use, (b) forms of tobacco, (c) pharmacology of nicotine and principles of addiction, (d) drug interactions with smoking, (e) pathophysiology of tobacco-related disease, (f ) weight maintenance in tobacco cessation, (g) assisting patients with quitting (comprehensive interventions), (h) assisting patients with quitting (brief interventions), (i) aids for quitting, and (j) addressing tobacco use in special populations. These 10 topics correspond to content areas addressed within the Rx for Change curriculum.(7) In addition, respondents

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indicated the professional year in which the content was taught and the total number of hours of formal instruction (including any assigned podcasted lectures or webinars for home study).

Educational methods used to teach tobacco-specific content in required coursework were delineated as follows: (a) classroom lectures, (b) home study (podcast lectures or webinars), (c) provision of required reading materials, (d) case study discussion, (e) case-based counseling activities without formal evaluation, and/or (f) case-based counseling activities with formal evaluation. Respondents were also asked to indicate the assessment method(s) used to evaluate students’ tobacco cessation counseling during the 2012-2013 academic year. Response options included: (a) multiple choice exam, (b) short answer exam, (c) case-based multiple choice exam, (d) case-based short answer exam, (e) oral exam, (f) objective structured clinical examination (OSCE), and (g) none.

Utilizing data from previous studies(9)(12) and annual enrollment data for each of the California schools of pharmacy (extracted from the American Association of Colleges of Pharmacy Profile of Pharmacy Students),(13) the total number of California pharmacy students trained annually was estimated between academic years spanning 2000 to 2013.

Data Handling and AnalysesSurvey data were entered with 100% verification, and summary statistics were computed. The cumulative number of California students trained was estimated by summing the annual numbers of students enrolled in the class cohort that received tobacco cessation training since academic year 2000-2001. Analyses were conducted using IBM SPSS Statistics (Version 23).(14)

ResultsSurvey Response and Pharmacy School CharacteristicsCompleted surveys were received from eight schools of pharmacy (100%). The average number of students in the 2012-2013 entering class was 124 (range: 57-218).

Tobacco Cessation EducationTobacco content was incorporated into the required curricula in 100% of the schools and all schools utilized the Rx for Change program as their primary source of tobacco-related instructional content. Across all eight schools in 2012-2013, a median of 435 total minutes (range: 240-600) was devoted to tobacco content in the required curriculum, and this material was taught during the first professional year (n=4 schools), second professional year (n=3 schools), or first and second professional year (n=1 school). Specifically, the total numbers of minutes provided at the eight schools were 240 min (n=2), 300 min (n=1), 360 min (n=1), 510 min (n=1), 540 min (n=1), and 600 min (n=2). Most schools (n=6) allocated these hours to both lecture and workshop sessions; two schools delivered content exclusively through lectures.

All programs addressed the topics of epidemiology, forms of tobacco, pharmacology, drug interactions with smoking, assisting patients with quitting, and aids for cessation. The median number of minutes allocated to behavioral and medication aspects of tobacco cessation were: (a) assisting with quitting-comprehensive interventions, 60 min (range: 20-170 min), (b) assisting with quitting-brief interventions, 10 min (range: 0-60 min), and (c) aids for cessation, including medications, 90 min (range: 40-120 min).

Educational methods varied: class lectures and case study discussions were used by all schools, followed by required reading and case-based counseling with formal evaluation (n=6; 75%). Home study podcasts/webinars and case-based counseling without formal evaluation were used by two (25%) schools.

Assessment Methods for Evaluating Students’ CompetencyMultiple choice examinations were the most commonly used evaluation method (n=7), followed by case-based multiple choice examinations (n=5). Shor t-answer examinations with or without case-based scenarios (n=3) and OSCEs, which incorporated student role-playing or interactions with standardized patients (n=3) and oral examinations (n=1), were less commonly used.

Trends in Tobacco EducationSince academic year 2000-2001, when the Rx for Change program was launched in California, an average of 817 pharmacy students have received tobacco cessation training as part of their core curriculum each year (n=988 in 2012-2013). Cumulatively, over the 13-year observation period, an estimated total of 10,616 California pharmacy students received training (Figure 1).

DiscussionIn 1999, the California schools of pharmacy collaborated to develop and implement a shared, evidence-based tobacco cessation training curriculum(7-9) that continues to be used extensively throughout the state. To our knowledge, this collaboration resulted in the first freely shared teaching resource that was purposefully designed for broad-scale dissemination. This study demonstrates the power and sustainability of the shared curriculum approach,(15) which is particularly relevant to health professional schools attempting to achieve efficiency, due to constrained resources, while also being nimble in response to a rapidly evolving health care environment.

Within California, approximately 1,000 pharmacy students receive Rx for Change training each year, and since statewide adoption of the shared curriculum approach in 2000, more than 10,000 pharmacy students have been equipped with the necessary knowledge and skills to treat tobacco use and dependence. According to an AACP white paper, a minimum of six hours (and a recommended eight hours) of curricular time should be dedicated to tobacco cessation.(5) In a survey conducted in 2006, California pharmacy schools in existence at the time (n=7) all exceeded the recommended minimum hours of tobacco education by providing a median of seven hours of instruction (range: 360-480 min).(12) However, results presented here indicate that three of the eight schools surveyed were not meeting the minimum recommendation of six hours in 2012-2013 (although each was substantially higher than the national median of 170 minutes in 2001-2002).(4) All three of these schools cited “lack of available curricular time” as the primary barrier to further enhancing their tobacco-related content (data not shown). Although competing priorities for instructional content is an ongoing challenge within pharmacy curricula, recent changes in statewide legislation have raised the salience and therefore the imperative for schools of pharmacy to provide comprehensive tobacco cessation training to pharmacy students.

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Figure 1.

Specifically, in 2013, the state of California passed legislation(16)

giving pharmacists the ability to furnish prescription formulations of nicotine replacement therapy in accordance with a statewide protocol(17), and the strong anti-tobacco voice and commitment of faculty at California pharmacy schools served as a springboard for this legislation. Similarly, other states (Arizona, Colorado, Idaho, Indiana, Kentucky, Oregon, and Maine) have recently passed legislation to enable pharmacists to provide FDA-approved smoking cessation medications without written orders, following the example set by New Mexico, where pharmacists have been prescribing all cessation medications under a statewide protocol since 2004.(11) As additional states move toward expanded authority for pharmacists in the area of tobacco cessation, it will be incumbent on the profession to ensure that its graduates can competently and confidently provide treatment for tobacco use and dependence. In 2016, the Rx for Change curriculum was being utilized to teach tobacco cessation at nearly three-quarters of pharmacy schools nationally,(10) and this long-term, broad-scale adoption of a shared, comprehensive curriculum will undoubtedly increase the profession’s capacity to assume this expanded role under new authorities granted through legislation.

This study is limited in that the sample size is small and included only schools of pharmacy in California, a state that is progressive with respect to tobacco control and therefore likely is more conducive than most states to advancement of the pharmacist’s role in tobacco cessation. Although the surveys were completed by instructors responsible for teaching tobacco-related content, which increases the likelihood of accuracy, a limitation of this study is that the responses were self-reported, without verification.

ConclusionAfter more than a decade, Rx for Change, a shared, evidence-based tobacco cessation curriculum, continues to be widely utilized and provides a strong foundation for legislative efforts to enhance pharmacists’ scope of practice related to prescriptive authority for tobacco cessation.

AcknowledgementsThis work was supported by the Vince Isnardi Opportunity Fund as a gift to the UCSF School of Pharmacy. The efforts of Drs. Robin L. Corelli and Karen Suchanek Hudmon were supported, in part, by National Cancer Institute grants R25 CA 90720 and R25 CA 174665. The authors acknowledge the California faculty members for their timely assistance with completing the study survey.

About the AuthorsRobin L. Corelli, PharmD, FAPhA is a Professor and Vice Chair in the Department of Clinical Pharmacy at the University of California-San Francisco, School of Pharmacy. She has no conflicts of interest to report.

Nicolette A. Mehas, PharmD is the Director of Quality Measurement at the National Quality Forum. At the time of this study she was a student at the Purdue University College of Pharmacy, Indianapolis, IN. She has no conflicts of interest to report.

Karen Cheung, PharmD, BCPS is an Inpatient Pharmacist Specialist at the Kaiser Permanente Fontana Medical Center. At the time of this study she was a student at the University of California-San Francisco, School of Pharmacy. She has no conflicts of interest to report.

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Dennis O. Ankrah, PharmD is an Inpatient Pharmacist Specialist at the University of California, Irvine Medical Center. At the time of this study he was a student at the University of California-San Francisco, School of Pharmacy. He has no conflicts of interest to report.

Michael W. Blatt, PharmD is the Pharmacy Director for Central California Alliance for Health in Scotts Valley CA. At the time of this study he was a student at the University of California-San Francisco, School of Pharmacy. He has no conflicts of interest to report.

Karen Suchanek Hudmon, DrPH, FAPhA is a Professor of Pharmacy Practice at the Purdue University College of Pharmacy Indianapolis, IN and Professor of Clinical Pharmacy at the University of California-San Francisco, School of Pharmacy. She has no conflicts of interest to report.

References1. US Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.

2. Centers for Disease Control and Prevention. Best Practices for Comprehensive Tobacco Control Programs—2014. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.

3. Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: US Department of Health and Human Services. Public Health Service; 2008.

4. Hudmon KS, Bardel K, Kroon LA, Fenlon CM, Corelli RL. Tobacco education in U.S. schools of pharmacy. Nicotine Tob Res. 2005;7(2):225-232.

5. McBane SE, Corelli RL, Albano CB, et al. The role of academic pharmacy in tobacco cessation and control. Am J Pharm Educ. 2013;77(5):93.

6. Hudmon KS, Prokhorov AV, Corelli RL. Tobacco cessation counseling: pharmacists' opinions and practices. Patient Educ Couns. 2006;61(1):152-160.

7. UC Regents. Rx for Change: Clinician-Assisted Tobacco Cessation. San Francisco, CA, 1999-2018. Available at: http://rxforchange.ucsf.edu. Accessed August 25, 2018.

8. Hudmon KS, Corelli RL, Chung E, et al. Development and implementation of a tobacco cessation training program for students in the health professions. J Cancer Educ. 2003;18(3):142-149.

9. Corelli RL, Kroon LA, Chung EP, et al. Statewide evaluation of a tobacco cessation curriculum for pharmacy students. Prev Med. 2005;40(6):888-895.

10. Lang W, Elkhadragy N, Hudmon KS. Getting to zero: The role of academic and professional pharmacy in tobacco cessation. Available at: https://www.aacp.org/sites/default/files/2017-11/TCReportFINAL.pdf. Accessed August 25, 2018.

11. Adams AJ, Hudmon KS. Pharmacist prescriptive authority for smoking cessation medications in the United States. J Am Pharm Assoc (2003);58(3):253-257.

12. Hudmon KS, Corelli RL, Kroon LA. Rx for Change: Dissemination and implementation of a shared tobacco cessation curriculum for pharmacy schools. Presented at: American Association of Colleges of Pharmacy Annual Meeting, Kissimmee, FL, July 2012.

13. American Association of Colleges of Pharmacy. Profile of Pharmacy Students. Available at: https://www.aacp.org/research/student-applications-enrollments-and-degrees-conferred. Accessed August 25, 2018.

14. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp. Released 2015. Version Release 6.1. Chicago.

15. Maine LL. Sharing our wealth. Am J Pharm Educ. 2007;71(6):Article 114.

16. California Senate Bill No. 493. Chapter 469. Approved by Governor and filed with Secretary of State October 1, 2013. Available at: http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201320140SB493. Accessed August 25, 2018.

17. Protocol for Pharmacists Furnishing Nicotine Replacement Products. Section 1746.2 of Article 5 of Division 17 of Title 16 of the California Code of Regulations. Available at: http://www.pharmacy.ca.gov/laws_regs/1746_2_pt.pdf. Accessed August 25, 2018.

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Biosimilars and the Pharmacist:A Review of the Legal and Regulatory IssuesPart 1

review

SummaryBiosimilars are a new and rapidly expanding area of drug therapy. An abbreviated FDA approval process has been established for biosimilars using a stepwise approach to demonstrate biosimilarity, and nine biosimilars have been approved in the US since 2015. Biosimilars are approved through a unique framework that emphasizes bioanalytic similarity to the originator drug first, with limited clinical studies done to resolve any residual uncertainty about similarity. Biosimilars use such varied and potentially unfamiliar concepts as totality of the evidence, residual uncertainty, immunogenicity, and switching studies. These drugs have the potential to reduce costs and increase access to beneficial biologic therapies. However, policy decisions on pharmacovigilance systems, record-keeping, naming conventions, and reimbursement are still shaping the use of biosimilars. Pharmacists will be responsible for ensuring appropriate implementation of these policies and monitoring the safety and effectiveness of biosimilar therapy in patients.

ConclusionScientific, legal, and regulatory issues will be important for ensuring safe and effective use of biosimilar drugs now and in the future. Pharmacists need to understand these issues to contribute to policy discussions, answer questions from patients and prescribers, and assure appropriate use of these important medications.

Keywords: biosimilar pharmaceuticals; biological products; drug substitution; postmarketing drug surveillance; generic drugs.

IntroductionBiosimilars are drugs that have the same properties and clinical effects as a reference biologic drug. In theory, the concept is similar to generic versions of brand-name small-molecule drugs. However, the nature and production process of biologic drugs is much more complex than that of small molecules, which complicates the approval process for biosimilars. The US Food and Drug Administration (FDA) has developed a regulatory pathway for biosimilars, allowing a shorter development and approval process than what is required for a new biologic. It utilizes a stepwise approach to analyzing the molecule, using a variety of studies and assessing the accumulated evidence to inform the approval for each drug. This regulatory path is relatively new and involves unique concepts including totality of the evidence, extrapolation, immunogenicity, and interchangeability. The

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market for biosimilars has grown rapidly in recent years, and this is likely to continue. Thus, pharmacists have an obligation to be well informed.

Basics of Biosimilars Biosimilar drugs must be understood in the context of their reference products: biologics. The term biologic encompasses a wide variety of compounds used for the prevention and treatment of disease, from vaccines to blood products to engineered versions of human proteins.(1)

With small-molecule drugs, the placement of every atom is precisely known and can be identically reproduced, yielding structurally and functionally equivalent brand and generic versions.(1) In contrast, biologics are highly complex and anywhere from 200 to 1,000 times larger than small molecules.(2) Additionally, the activity of a protein drug is dependent on numerous levels of structure as well as post-translational modifications, which require precisely controlled manufacturing conditions. If changes are made to the manufacturing process of a biologic drug, the FDA requires that the manufacturer prove that these changes do not result in any meaningful changes in the product. The manufacturing is even more difficult with development of biosimilars, since the manufacturer does not have access to the proprietary processes used by the innovator company. All manufacturers are limited by current analytical technologies for detecting changes in drug formulations, which can sometimes lack precision.(1)

The concept of biosimilarity as defined by the FDA means “that the biological product is highly similar to the reference product notwithstanding minor differences in clinical inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”(3) A biosimilar drug must be identical to its reference in mechanism of action, strength, dosage form, and route of administration. It also can only be approved for indications that the reference product has been approved for, though it need not seek approval for all of these indications.(4) All currently FDA-approved biosimilars are protein drugs, mostly monoclonal antibodies, and many future biosimilars are likely to fall into this category. As discussed, it is not reasonable to expect perfectly identical products from batch to batch of a single protein drug, let alone when comparing a biosimilar to its reference product. Thus, the goal of the biosimilar approval process is to ensure that any minor variations do not affect the safety and efficacy of the biosimilar drug.(1)

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FDA Regulatory Process Small molecules are regulated under section 505 of the federal Food, Drug, and Cosmetic Act (FDCA). To gain approval, manufacturers must submit a New Drug Application (NDA) to the FDA. In contrast, biologics are regulated under section 351 of the Public Health Service Act (PHSA) and require a Biologics Licensing Application (BLA) for approval. It is worth noting that the line between small molecule and biologic is not always very clear, and some drugs that would ordinarily be considered biologics have been approved under the FDCA.(5) A few examples are insulin, glucagon, and human growth hormone.(6)

For over 30 years, manufacturers of small-molecule drugs have been able to use two abbreviated approval pathways to bring generic drugs to market once their brand-name equivalents have exhausted their market exclusivity.

Until recently, there was not a corresponding pathway for biologic drugs. Any proposed biologic, regardless of comparability to a previously approved product, would have to submit a full BLA or, in selected cases, an NDA with the entire complement of analytical, animal, and human clinical data.(7) However, this changed with the enactment of the Biologics Price Competition and Innovation Act (BPCIA) of 2009. This act allows a sponsor to develop and market a biologic drug through an abbreviated pathway under section 351(k) of the PHSA by proving comparability to a previously approved reference biologic.(3) The BPCIA also established a grace period, lasting until March 2020, wherein applications for biosimilars may still be submitted via the Hatch-Waxman process instead of the BPCIA. After that date, the 351(k) pathway must be used.(4)

In terms of regulatory status, the BPCIA and the Hatch-Waxman act both have two levels of similarity that a follow-on product may achieve. Generic small-molecule drugs are categorized in the FDA Orange Book with an A rating, indicating bioequivalence and interchangeability, or a B rating, indicating only bioequivalence. A ratings are common among generic small molecules, and this has allowed the widespread substitution of these drugs for their more expensive brand equivalents at the pharmacy level.(4)

Biologic drugs are classified in the FDA purple book as biosimilar or interchangeable. The basic designation of biosimilar is comparable to a B rating, and this category encompasses all drugs approved through the abbreviated BPCIA pathway to date. The BPCIA also establishes a higher level of biosimilarity, known as interchangeability, which is comparable with an A rating. The potential for interchangeable biologics is just beginning to be explored, and there are currently no such products approved by the FDA.(4)

In some sense, biosimilars can be conceptually likened to generic small-molecule drugs. However, biosimilars are not generics, and there are key differences between these categories that are a common source of confusion. To reiterate, the structural nature and simple production of small-molecule drugs allows for an easier process of proving bioequivalence, and the FDA is generally satisfied with a standard complement of analytical data showing that the brand and generic drugs are identical. In contrast, the complexity of biologic drug structure and production makes this unrealistic and necessitates a dif ferent approach.

Biosimilar AnalysisThe FDA emphasizes a stepwise approach to establish biosimilarity between a new product and its reference biologic (Figure 1). As data come in from initial analytic studies, the FDA works with the developer to identify areas of “residual uncertainty” about the biosimilarity of the proposed product. The need for and extent of subsequent studies is determined on a case-by-case basis, and the FDA has the final say on what is required. It is important to note that the goal of these studies is not to “independently establish the safety and efficacy of the proposed product,”(1) since this has already been extensively studied for the reference product. Rather, the proposed biosimilar must prove that it has no clinically meaningful differences from the reference product.(1)

The first step is structural and functional characterization of the proposed product and its reference. This involves sensitive comparative analysis of the structures of the compounds, as well as assessment of batch-to-batch variation and evaluation of pharmacological activity. These assays are an important foundation for demonstrating biosimilarity, and strong data can reduce the requirements for subsequent studies.(1)

The next step is animal studies to assess toxicity of the proposed products, including general safety concerns, fetal risk, and carcinogenic toxicity. These are conducted based on the extent of data from previous studies and may not be necessary in some cases. However, they can be useful if there is uncertainty regarding the drug’s pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity.(1)

Finally, the FDA may require clinical studies to eliminate any residual uncertainty about the comparability between the proposed and reference products. Human PK and PD are not the same as in animals, so data on these are usually required. Likewise, assessing the immunogenicity of a biosimilar product generally requires human studies. This parameter is unique to biologic drugs and will be discussed in more detail below. Based on the results of these studies, the FDA will determine the need for comparative clinical studies that directly assess any remaining doubt of the biosimilarity of the products in question.(1) The FDA encourages drug sponsors to conduct their studies with doses, patient populations, and endpoints that are as sensitive as possible for detecting differences between the products in questions.(3)

The need for continued safety monitoring for a biosimilar drug after its approval is, as with other aspects of the process, variable and situationally determined. In reviewing the proposed biosimilar application, the FDA will determine the need for and extent of additional post-marketing studies.

The FDA looks at the totality of the evidence when evaluating proposed biosimilars.(1) This means that data is considered from all the studies enumerated above to inform the FDA’s final decision on a product. As mentioned before, the presence of small variations between the proposed product and the reference does not mean that the former cannot be approved as a biosimilar. However, the drug’s sponsors must prove in subsequent studies that they do not result in clinically meaningful differences from the reference product.(1)

As a side note, it is important to realize that innovator biologics also undergo subtle changes over time due to frequent changes in the manufacturing process.(8) With each change, the manufacturer must show that the characteristics of the newly produced product are the same as the originally approved drug. Thus, the way the FDA looks at a biosimilar is similar to how it re-

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views manufacturing changes for innovators.

ExtrapolationExtrapolation is an idea frequently encountered in discussions of biosimilarity. It refers to the approval of a biosimilar drug for the treatment of multiple indications for which the reference product was originally approved, without explicit clinical study of the biosimilar in each of those indications. The manufacturer must provide adequate evidence that this approach is justified, and data may only be extrapolated to indications approved for the reference product. As with biosimilars more generally, the FDA looks at the totality of the evidence in assessing the appropriateness of extrapolation.(1)

Different regulatory bodies have taken different approaches to the approval of individual drugs for extrapolated indications, and not all biosimilars have been approved for all their reference product’s indications.(2) In the US, extrapolation of indications has been common for the biosimilars approved so far, though approval via extrapolation in one country does not automatically entail the same approach in another.(9)

There is much debate surrounding extrapolation. For biosimilars to offer financial benefits, there must be a way of reducing the costs of their development and production. Extrapolation is an important mechanism for this, since it reduces the number of indications that must be tested in clinical trials.(10) But some advocacy groups have raised concerns that it is dangerous to use drugs in populations for which they have not had extensive study or in which the mechanism of action is not well understood.(11)

A position statement on biosimilars from the American College of Rheumatology (ACR) urges restraint in the practice of extrapolation, noting that proving safety and efficacy in one disease state does not guarantee it in others. It also notes the difference between drug action in adults and children, and advocates judicious use of pediatric studies. The guidance stresses the need for physician autonomy in clinical decision-making, and warns against blindly following cost-driven policies without due consideration of patient factors.(12)

Nonetheless, since analytical and clinical pharmacology studies have already demonstrated similarity of the biosimilar to its innovator product, the FDA takes the position that clinical studies for every approved indication are not necessary.

ImmunogenicityA unique factor in the discussion of therapeutic protein drugs, both biologics and biosimilars, is immunogenicity. This term refers to the ability of these drugs to stimulate the human immune system to react against the drug. This can manifest in numerous ways, from asymptomatic production of antibodies to life-threatening anaphylaxis. The main immunological concern with biosimilars is the production of antibodies.

On exposure to a protein drug, the immune system may recognize it as foreign and produce anti-drug antibodies (ADAs) against it. This is especially true if the protein is produced in a cell other than a human one, and some products are more intrinsically immunogenic than others. Antibodies may affect drug clearance or directly block the drug’s activity, in the case of neutralizing antibodies.(13) And subsequent administration of the same or a similar product may result in a toxic reaction or at least reduced effectiveness of the product over time.(7)(14)

Current evidence from clinical studies does not suggest that immunogenicity is increased with the use of biosimilars. A 2017 review article looked at 53 switching studies between reference products and biosimilars. About half of these studies included information on immunogenicity, and generally there was no difference in incidence of adverse effects. There are still limited data on the subject, though. Many articles and organizations urge careful consideration of patient-specific factors when switching and only doing so for clinical reasons, not merely for cost savings.(15) This has added significance in the case of interchangeable biosimilars.

Interchangeability Interchangeabil ity is another aspect of biosimilar development that is surrounded by uncertainty. When the ACA established the pathway for abbreviated biosimilar approval in 2010 (the BPCIA), it also defined a more rigoror-

Figure 1. The totality of evidence approach used by the FDA to approve a biosimilar. PK/PD = pharmacokinetics/pharmacodynamics.

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ous level of biosimilarity, which requires that “the proposed interchangeable product can be expected to produce the same clinical result as the reference product in any given patient.”(16)

This designation also requires that “for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such an alternation or switch.”(16) The safety of switching is a commonly cited concern in regard to biosimilars, and several studies have recently been conducted to address this.(17)(18)

For example, NOR-SWITCH is an important yearlong trial that was conducted in Norway to establish the noninferiority of switching patients from reference infliximab to the biosimilar CT-P13. NOR-SWITCH followed 482 patients being treated with infliximab, including individuals with each of its six approved indications. Half of these infliximab patients were switched to biosimilar infliximab, while the other half continued their current treatment with the reference product. The primary endpoint was disease worsening, and adverse effects and ADA levels were measured at each visit. Though the study was not large enough to confirm noninferiority for each disease state, in aggregate, biosimilar infliximab was shown to be equal in efficacy and safety to the reference product.(17) The biosimilar product in question, CT-P13, was approved by the FDA in 2016 and is marketed in the US as Inflectra or infliximab-dyyb.(19)

The FDA only released a draft guidance document for the industry on interchangeability in January 2017, which closed for comments in mid-June. This guidance details considerations for developers looking to demonstrate interchangeability. The FDA proposes a stepwise approach to amassing evidence of comparability, as discussed with demonstration of basic biosimilarity. Other considerations include product-specific factors such as structural complexity, risk of adverse effects, and level of clinical experience with the product in the US or other markets. The FDA also requires that packaging and delivery systems be designed such that the intended administrator may switch between reference and biosimilar products without supplemental training.(16)

The demonstration of interchangeability is unique in that the FDA emphasizes the importance of switching studies. These are designed to assess the effect of alternating exposure to two proposed interchangeable products and consist of at least two alternating intervals of treatment with each product. Consistent with the definition of interchangeability given above, this type of switching must be proven to not result in lower efficacy or higher incidence of adverse effects.(16) Others have also advocated for studies with multiple switches, since many alternating exposures to biosimilar products may increase the likelihood that patients will develop a detectable immune response.(20)

One study that implemented this sort of switching was the EGALITY study, a yearlong RCT conducted in Europe and South Africa to compare the efficacy, safety, and immunogenicity of a proposed etanercept biosimilar (GP2015) to Enbrel. EGALITY followed 526 patients with plaque psoriasis. Half the patients were assigned to each drug for the first 12 weeks and were then reassigned to either continue on their initial treatment or to undertake three switches between the drugs between week 12 and week 30. Each treatment period was six weeks, and at week 30, all patients continued on their current treatment until the end of the study. The results supported the biosimilarity of GP2015 to Enbrel in terms of efficacy, safety, and immunogenicity.(21)

GP2015 was subsequently approved in the US under the trade name Erelzi.(19) This study is unique given the use of multiple switches between the two products, after which there was no o-

bserved decrease in efficacy or increase in ADA formation.

Since many biosimilar versions of biologic drugs are likely to become available in the coming years, it is crucial that the decision to switch among them is supported by adequate evidence of preserved safety and efficacy.(20) This is especially important with interchangeables, since they may be substituted for the reference product by the pharmacist without direction by the prescriber.(16)

The BPCIA has a unique provision that awards one year of exclusivity to the first sponsor of an interchangeable product over subsequent interchangeable products for the same biologic. Additionally, the ability of pharmacists to automatically substitute the interchangeable product will speed its adoption. Thus, interchangeability, though it entails additional approval requirements, has definite economic incentives.(4)

No interchangeables have been approved in the US to date, but the recent release of the FDA draft guidance and the associated economic benefits are likely to change that.

The Biologics Prescribers Collective (BPC), comprising groups of physicians in disciplines that use biologics, suggests switching studies with well-defined standards and a minimum of three switches between the products in question, not the two switches currently included in the draft guidance. It also reiterates the importance of caution in extrapolating data between indications and clear information on the extent of interchangeability of a product for the various potential indications.(21) A representative from the American College of Rheumatology (ACR) also noted that appropriate information for safe use must be readily available in the packaging of biosimilars.(22)

ConclusionScientific, legal, and regulatory issues will be important for ensuring safe and effective use of biosimilar drugs now and in the future. Aspects of this process may be unfamiliar, and well-informed pharmacists will be an asset to the healthcare team as more biosimilars are developed and marketed. Part 2 of this two-part article will cover the current biosimilars market in the United States and issues related to their use in clinical practice.

About the AuthorsDonald R. Miller, PharmD, FASHP is a Professor of Pharmacy Practice at North Dakota State University. He is currently a member of the Committee on Rheumatologic Care for the American College of Rheumatology and a past member of the FDA Arthritis Advisory Committee. He has no conflicts of interest to report.

Arianna Vidger, BS, is a 2019 PharmD candidate at North Dakota State University. Ms. Vidger has no conflicts of interest to report.

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References1. US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry (April 2015) https://www.fda.gov/downloads/Drugs/https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf (accessed May 16, 2017).

2. Blandizzi C, Meroni PL, Lapadula G. Comparing Originator Biologics and Biosimilars: A Review of the Relevant Issues. Clin Ther. 2017;39(5):1026-1039.

3. US Food and Drug Administration. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (December 2016). https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf (accessed June 1, 2017).

4. Koyfman H. Biosimilarity and Interchangeability in the Biologics Price Competition and Innovation Act of 2009 and FDA’s 2012 Draft Guidance for Industry. Biotechnol Law Rep. 2013;32(4):238-251.

5. Wong AY-T, Rumore MM, Chan AW-K. Biosimilars in the United States: Emerging Issues in Litigation. BioDrugs. 2017;31(3):189-205.

6. Johnson JA. FDA Regulation of Follow-on Biologics (April 2010). Congressional Research Service. https://primaryimmune.org/advocacy_center/pdfs/health_care_reform/Biosimilars_Congressional_Research_Service_Report.pdf (accessed July 20, 2017).

7. Li E, Ramanan S, Green L. Pharmacist Substitution of Biologic Products: Issues and Considerations. J Manag Care Spec Pharm. 2015;21:532-539.

8. Casadevall N, Flossman O, Hunt D. Evolution of biological agents: how established drugs can become less safe. BMJ 2017;357:j1707.

9. Declerck P, Danesi R, Petersel D, Jacobs I. The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects. 2017;77(6):671-677.

10. Lakhanpal A, Brahn E. Biosimilars in rheumatic diseases: structural and functional variability that may impact clinical and regulatory decisions. Clin Rheumatol. 2016;35(12):2869-2875.

11. US Food and D rug Admin is t ra t ion . Summar y Minutes of the Arthritis Advisory Committee Meeting, July 12, 2016 (July 2016). ht tps://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM520027.pdf (accessed Aug 2, 2017).

12. Committee on Rheumatologic Care. Position Statement on Biosimilars (May 2016). American College of Rheumatology. https://www.rheumatology.org/Portals/0/Files/Biosimilars-Position-Statement.pdf (accessed May 16, 2017).

13. US Food and Drug Administration. Immunogenicity Assessment for Therapeutic Protein Products: Guidance for Industry (August 2014). https://www.fda.gov/downloads/drugs/guidances/ucm338856.pdf (accessed June 11, 2017).

14. McKoy JM, Stonecash RE, Cournoyer D, et al. Epoetin-associated pure red cell aplasia: past, present, and future considerations. Transfusion. 2008;48(8):1754-1762.

15. Moots R, Azevedo V, Coindreau JL, et al. Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician. Curr Rheumatol Rep. 2017;19(6):37.

16. US Food and Drug Administration. Considerations in Demonstrating Interchangeabil ity With a Reference Produc t : Gu idance For Indus t r y (D ra f t Gu idance) (January 2017). ht tps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf (accessed May 16, 2017).

17. Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304-2316.

18. Glintborg B, Sorensen IJ, Loft AG, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017;76(8):1426-1431.

19. US Food and Drug Administration. List of Licensed Biological Products with Reference Product Exclusivity and Biosimilar ity or Interchangeabil i ty Evaluations to Date (Purple Book) (November 2017). https://www.fda.gov/downloads/Drugs/Deve lopment Approva lProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf (accessed Nov 7, 2017).

20. Faccin F, Tebbey P, Alexander E, Wang X, Cui L, Albuquerque T. The design of clinical trials to support the switching and alternation of biosimilars. Expert Opin Biol Ther. 2016;16(12):1445-1453.

21. Physician groups applaud FDA for interchangeability draft guidance, urge for robust data (2017). Biologics Prescribers Collective. http://biologicsprescribers.org/resources/physician-groups-applaud-fda-for-interchangeability-draft-guidance-urge-for (accessed July 14, 2017).

22. Worthing A. Biosimilar Interchangeability Draft Guidance Strikes the Right Balance Between Speed And Safety (2017). Center for Biosimilars. http://www.centerforbiosimilars.com/contributor/angus-worthing/biosimilar-interchangeability-draft-guidance-strikes-the-right-balance-between-speed-and-safety (accessed July 14, 2017).

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Assessing the Acceptance of the Pay-For-Performance Model in a Segment of California Pharmacists

original research

AbstractBackgroundPay-for-performance (P4P) is a payment system in which providers are rewarded financially for the outcome of patient care. This study surveyed pharmacists to gain an overall understanding of their knowledge, experience, and attitude toward P4P. We investigated if having prior experience with P4P influences one’s attitude toward and acceptance of this payment model.

MethodsA cross-sectional study was performed where a survey was sent to pharmacists affiliated with the University of California, San Diego (UCSD) School of Pharmacy. Data was collected over a two-week period. Chi-square and odds-ratio (OR) tests were used to assess an association between payment preference and the following factors: management experience, experience with P4P, years of practice, and familiarity with P4P. Six benefits and six problems relating to P4P were evaluated.

ResultsEighty-seven pharmacists participated in our survey. Fifty preferred traditional pay, and thirty-seven preferred P4P. The OR analysis suggests: 1) Pharmacists with P4P experience are 50% more likely to prefer P4P, 2) Pharmacists with management experience are 39% more likely to prefer P4P, and 3) Pharmacists with less than five years of working experience are 12% more likely to prefer P4P. The top perceived benefit of P4P was increased collaboration among healthcare providers. The main perceived challenge was cumbersome billing processes.

ConclusionPharmacists with P4P experience held more positive views of the payment system. Pharmacists without experience in the program were less supportive. The positive responses about P4P from those with P4P experience suggest that employers may receive more support for P4P from their staffs by educating them about the benefits of the model.

James Colbert, PharmD; Sarah McBane, PharmD; Michael S. Lam, 2019 PharmD candidate; Alice Blaj, 2019 PharmD candidate; Briana Zimmers, 2019 PharmD candidate; Michael Yoon, 2019 PharmD candidate; Brian Park, 2019 PharmD candidate; Thu Le, 2019 PharmD candidate; Han Dinh, 2019 PharmD candidate; Jessie Wang, 2019 PharmD candidate

ObjectivesThis study aimed to investigate the correlation of pharmacists’ willingness to use a P4P system if they have prior experience or understanding of P4P. The secondary aim was to survey the perceived benefits and problems of implementing P4P in a pharmacy setting.

BackgroundPay-for-performance (P4P) was introduced nearly 20 years ago as a way to improve patient outcomes while reducing healthcare costs.(1) Healthcare is one of the most-discussed topics in the United States. Lawmakers and care providers are constantly finding ways to make healthcare affordable. An innovative method of reducing healthcare costs is exploring the possibility of implementing a pay-for-performance payment system. In P4P systems, providers are financially rewarded when their patients show improved health outcomes.(2) A non-fee-for-service payment model such as P4P has the potential to enhance quality of care, reduce hospital readmissions, and effectively reduce costs to our healthcare system.(3)

As the role of pharmacists in healthcare continues to expand, the P4P payment model is becoming more important. The number of specialized pharmacists involved in clinics such as pediatrics, oncology, infectious diseases, and psychiatric care has significantly increased in the past couple of years.(4) Pharmacists have historically been compensated for their involvement in dispensing activities. It is equally essential that pharmacists participating in expanded healthcare roles be compensated for those actions as well. A recent study has shown that infectious disease pharmacists could save a hospital $200,000-$900,000 annually on reducing antibiotic use. Medication therapy management (MTM) pharmacists have been shown to save hospitals $12 for every $1 spent.(5)(6) When the Centers for Medicare and Medicaid Services (CMS) penalized hospitals for poor value-based performances, hospital directors sought to improve their pharmacy departments, because many of the hospital performance measures could be remedied with changes in both inpatient and outpatient pharmacy directives.(7) The P4P model is significant because it shows the importance of pharmacists’ key contributions to savings.

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Figure 1.

There is a huge potential of saving money by implementing a P4P payment system to pharmacists; however, only a few pharmacy departments in the United States have utilized P4P. Most P4P studies focus on patient outcomes and economics for medical doctors, but not specifically for application in pharmacy. A recent study by Rosenthal et al. investigated pharmacists’ perceptions of P4P in Canada. They concluded that pharmacists prefer a hybrid of fee- and outcome-based payment models, but they only collected data from eight pharmacists, and the study was not conducted in the United States. In this study, we hope to gain insight into the attitudes of pharmacists regarding a P4P payment model. Understanding pharmacists’ attitudes and knowledge regarding P4P can help others implement this payment model. By surveying pharmacists across San Diego County, California, this study aims to better understand whether there is a preference among pharmacists for the P4P payment model or the traditional payment model.

MethodsA cross-sectional study was performed. A 21-question survey was sent to approximately 700 pharmacists affiliated with the UCSD School of Pharmacy. This population included UCSD faculty, alumni, and practicing pharmacists from diverse aspects of the pharmacy community, mainly located in San Diego County. The survey was administered via Google Forms from August 4, 2016, to August 19, 2016. The UCSD IRB office gave ethical approval for the study.

Our main inclusion criterion was that all participants must be licensed United States pharmacists. The survey consisted of demographic questions and questions about years of experience, completion of residency, prior management roles, and practice settings. The survey focused on the participant's knowledge, experience, and attitude toward P4P. To ensure that the participants had a standard understanding of P4P, we defined P4P in the survey as a “payment model that gives financial incentive to health providers based on improved patient outcomes.”

STATA 13 was used to analyze data, and GraphPad Prism 7 was used to create charts and graphs. Chi-square and odds-ratio (OR) tests were used to assess an association between payment preference and the following factors: management experience, experience with P4P, years of practice, and familiarity with P4P. The a priori level of significance was set at p < 0.05 for statistical tests. Six benefits and six problems relating to P4P were evaluated. Participants were asked to choose strongly disagree, disagree, neutral, agree, or strongly agree, with an assigned value of -2, -1, 0, +1, and +2, respectively; the summed value per question was used to assess the magnitude of the benefit and problem.

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Figure 2.

Figure 3.

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Figure 4.

Figure 5.

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 41

ResultsA total of 87 pharmacists participated in our survey. The average age was 41, with a range of 26-72 years old. Of the participants, 48 were female, 36 were male, and 3 declined to state their gender. About half of the participants (43%) practice in acute care, 28% in ambulatory care, 14% community pharmacy, and 10% work in pharmacy administrations. The participants had 14 years of working experience on average. About a quarter of the participants had P4P implemented in their past or current practice, and nearly half state they are “somewhat familiar” to “extremely familiar” with P4P. The odds ratio analysis suggests the following will make participants more likely to prefer P4P:

1. Pharmacists with P4P experience are 50% more likely to prefer P4P (Figure 2).

2. Pharmacists with management experience are 39% more likely to prefer P4P (Figure 3).

3. Pharmacists with less than five years of working experience are 12% more likely to prefer P4P (Figure 4). We also found that pharmacists with P4P experience were 40% more likely to believe that P4P will be implemented in the future.

DiscussionThis study surveyed the general attitudes toward and experiences with pay-for-performance among pharmacists with various backgrounds. Our data suggests that having prior experience using the P4P payment model is an important factor for acceptance. Those with P4P experience are more likely to accept it as a form of payment and see it being implemented in the future. Those with no experience with P4P tend to have negative opinions about the model and would prefer to have traditional pay (Figure 2). Interestingly, we also found that people with management experience are more likely to accept P4P (Figure 3). A plausible explanation is that managers are more interested in improving productivity and collaboration. The data suggest that one of the main benefits of P4P is increased collaboration among healthcare providers (Figure 5). In addition, it was found that pharmacists with less than five years of working experience are more likely to prefer P4P (Figure 4). Younger pharmacists may be more willing to accept changes in the workforce than their more experienced colleagues.

Nevertheless, a team-based approach introduces certain barriers to the implementation of a P4P model in pharmacy settings, specifically on who should receive credit, and thus compensation, for improving patient outcomes. For example, in community pharmacy, it is often the pharmacy, not the pharmacists, that is rewarded for improved patient outcomes. To get more pharmacists interested in a P4P model, pharmacists need to be directly compensated. Other limiting factors to P4P for pharmacists include low reimbursement rates, burdensome billing processes, lack of privacy in the pharmacy for extensive consultations, scant publicity concerning the availability of services, and indifference among physicians and patients.(8) Equally important, having provider status makes reimbursement for value-based services attainable; however, not every pharmacist is legally recognized with such a title.(9)

Although our data was not statistically significant, the noticeable dif ferences among the results should not be disregarded. Most of the statistical tests were underpowered because responses were gathered from a small sample size of less than 100 pharmacists. Most pharmacists who have a favorable response to P4P had prior P4P experience. This suggests that employers should ensure that staff is well informed and understands P4P before implementing it in the workforce. Employers could thoroughly educate their staff members about the benefits P4P provides, and pharmacists who have experience with P4P tend to like it.

LimitationsThis study has several limitations. The participants were mostly faculty, alumni, or affiliates of the UCSD School of Pharmacy, thus, the data might not reflect the viewpoints of California pharmacists. The participants’ occupational setting may differ from that of a traditional pharmacist given their affiliations with a major academic health center. Receiving input from a larger and more diverse selection of pharmacists could have powered the study to show statistically significant responses. Therefore, another limitation was the 12% response rate to the survey.

ConclusionRoughly half of the pharmacists who participated in our survey preferred traditional pay over P4P compensation. Pharmacists with prior P4P experience were more likely to accept its integration in their workforce. The top benefit of P4P was believed to be increased collaboration, while the most commonly perceived problem was cumbersome billing processes. The need for a new payment model is increasing as the role of pharmacists continues to expand. A non-fee-for-service model such as pay-for-performance compensation could increase productivity, enhance patient care, and have huge savings potential for our healthcare system. Informing pharmacists about P4P is likely an effective way to implement such a payment model.

About the AuthorsDr. James Colbert, PharmD, corresponding author, is a Health Sciences Clinical Professor and Associate Dean for Experiential Education at the University of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences. Dr. Colbert has no bias to report.

Dr. Sarah McBane, PharmD, is a Professor and Chairman in the Department of Pharmacy Practice at West Coast University. Dr. McBane has no bias to report.

Michael S. Lam, Alice Blaj, Briana Zimmers, Michael Yoon, Brian Park, Thu Le, Han Dinh, and Jessie Wang are PharmD candidates from the class of 2019 at the University of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences. They have no bias to report.

References1. Watkins RW. Understanding Quality Improvement Is More Important Now Than Ever Before. N C Med J. 2014;75:220-3.

2. Koenigsfeld CF, Horning KK, Logemann CD, Schmidt GA. Medication therapy management in the primary care setting: a pharmacist-based pay-for-performance project. J Pharm Pract. 2012;25:89-95.

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3. Parker D. Pay for Performance Vs. Fee for Service: Why You Should Care How Your Doctor Gets Paid (July 2015). Anthem Blue Cross. https://thebenefitsguide.com/pay-performance-vs-fee- service-care-doctor-gets-paid/ (accessed Aug 1, 2016).

4. Blouin RA, Adams ML. The Role of the Pharmacist in Health Care: Expanding and Evolving. N C Med J. 2017;78:165-7.

5. Owens RC, Fraser GL, Stogsdill P. Antimicrobial stewardship programs as a means to optimize antimicrobial use. Insights from the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2004;24:896–908.

6. Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc. 2008;48:203–11.

7. Riddle S. The P4P crossroads: is hospital pharmacy leadership ready? (January 2013). Drug Topics. http://drugtopics.modernmedicine.com/drug-topics/news/drug-topics/health-system-news/p4p-crossroads-hospital-pharmacy-leadership-ready (accessed 2016 Aug 15).

8. Houle SK, Grindrod KA, Chatterley T, Tsuyuki RT. Paying pharmacists for patient care: a systematic review of remunerated pharmacy clinical care services. Can Pharm J (Ott). 2014;147:209-32.

9. Snella KA, Trewyn RR, Hansen LB, Bradberry JC. Pharmacist compensation for cognitive services: focus on the physician office and community pharmacy. Pharmacotherapy. 2004;24:372-88.

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Change Champions Required to Promote Use of an Advanced EMR in a Mobile Community Health Clinic

business model

Description of the Practice Model This paper focuses on use of a new EMR system in the RotaCare Bay Area (RCBA) Concord mobile clinic with an attached pharmacy.(1)(2) RotaCare Bay Area Inc. is a nonprofit 501(c)(3) public benefit corporation providing free medical care to people with the greatest need. RCBA is supported through grants/donations and staffed primarily by volunteers. It provides myriad services, including medical exams, diagnostic testing, and an extensive formulary of free medications.(3) The Concord clinic operates from a mobile RV stationed at key sites in the city, providing continuous care to the extent possible through case management. The Concord clinic recently implemented a new EMR system to improve patient tracking, record-keeping, and data collection. The previous EMR system required significant paper documentation and could not be used to send external orders to labs, integrate pharmacy, nor provide clinical decision support. The new EMR system, athenaNet, was donated by Athenahealth Inc. Its implementation was led by the clinic operations manager and supported by volunteers designated as “superusers,” i.e., staff with training in and additional access to the EMR. The operations manager exhibited the qualities of a “change champion,” such as participating in the EMR’s final design and assuming a key role in decision-making.(4)

This facilitated excitement among staff, providers, and student volunteers.

Upon arrival to the clinic, patients are checked into the system and triaged for documentation of vital signs, basic history, and chief complaint(s). While awaiting the physician, the patient is seen by a nurse who performs a glucose check and retrieves past lab values. A scribe enters patient data into athenaNet while a treatment plan is developed. Following diagnosis, the scribe transmits orders to the external lab and documents prescriptions for dispensing in the clinic or electronic submission to retail pharmacies. The pharmacist reviews the prescription order summary on athenaNet to ensure that the prescription label is written in the patient’s preferred language and counsels the patient prior to discharge. Drugs are dispensed in one- to three-month supplies to patients at no cost.

Benefits of the new EMR are readily apparent and include more easily accessible information in spaces with limited physical storage, improved coordination and quality of service, enhanced physician/pharmacist recall, and reduced likelihood of error. The system does come at a high cost, however, if the clinical is unable to attract monies for its purchase and implementation, including maintenance and staff training.

Shane P. Desselle, RPh, PhD, FAPhA; James E. Lessenger, MD, FACOEM; Mustafa Sultani, 2021 PharmD candidate; Bushra Alsharif, 2021 PharmD/MPH candidate; Sam Pournezhad, 2021 PharmD candidate

Resource Requirements (staffing, equipment, capital)The RCBA Concord team is composed of part-time volunteers, including primary care physicians, nurse practitioners, physician assistants, and pharmacists assisted by interns. Professional interpreters are routinely on-site. The remaining staff, such as scribes and IT personnel, are volunteers, often in training for various healthcare careers. The staff is led by a volunteer medical director and paid clinic operations manager.

The Concord clinic operates out of a mobile RV that includes two exam rooms, a small nurse station, and a pharmacy stocked with a limited number of generic drugs typically found on top 200 lists. The drug formulary is adjudicated by a P&T Committee that includes the medical director and a pharmacist. It targets conditions common to the treated population: hypertension, diabetes, infections, acute chest pain, allergies, thyroid problems, and airway diseases. The pharmacy also stocks medical devices, such as glucometers and pill cutters.

Description of Successes (both anecdotal and measurable)RCBA has successfully delivered care to underserved populations in the Bay Area for nearly 30 years through 12 clinics. The Concord clinic has been operating since 2010. Its workflow has been improved by recent implementation of athenaNet; for example:

• The clinic operations director recently used the new EMR to extrapolate data for a grant application. She acquired data such as the number of patients treated per year, stratified by gender, age, ethnicity, and other demographics. Grant-writing for operations like RotaCare is essential to their long-term solvency, the quality of care they provide, and the number of patients treated.

• The pharmacists note that electronic prescriptions make for easier and improved verification and concurrent drug utilization review. This not only reduces the likelihood of error but also helps to optimize the patient’s therapeutic regimen. The EMR creates a role for pharmacy interns to verify orders and print prescription labels. It also provides interns with insight into clinical decision-making. With interns handling the EMR, the pharmacist has more opportunity to consult with physicians and counsel patients.

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Journal of Contemporary Pharmacy Practice | vol. 65, no. 3 | www.jcphp.com 45

• Diagnosticians have more time to focus on direct patient care, including personal interaction, while scribes input information more efficiently. Diagnosticians are accorded the opportunity to employ a vital signs and lab values trends tool to assess the success of the patient’s care plan. They can assess whether treatment plans are improving outcomes. For example, a patient presenting with swollen lymph nodes had physical signs and lab values documented. Upon follow-up, a different physician noted even larger lymph nodes and worsening lab values, indicating possible cancer. This diagnosis was possible due to improved continuity of care provided by athenaNet. Anecdotally, there has been an increase in patients remarking positively on self-care after more comprehensive consultations, and diagnosticians are noting better control and self-efficacy for chronically ill patients. The new system provides monitoring parameters that the previous system was not able to provide by documenting patient progress. As such, more formal evaluation of patient outcomes in several diseases is underway.

• Scribes are able to quickly view information on past visits and share this information with the providers. This is especially critical for continuity of care, as most patients will see a different provider during subsequent appointments. This reduces any ambiguity for the physician regarding the patient’s ongoing care plan. Additionally, having lab values automatically downloaded onto the patient’s profile accompanied with target ranges for those values provides additional time-saving and optimization of care planning.

• The new EMR provides a greater number of and more accurate/modernized aler ts for nurses. The system recognizes keywords from triage, and a data field is highlighted in the patient’s chart. Nurses are trained to recognize these alerts and perform any relevant tests or ask questions before the patient is seen by the physician. Examples include diabetes follow-up triggering the need for additional blood glucose assessments and a complaint of pain with urination triggering an alert for urinalysis. Nurses believe the tool has facilitated identification of patients at risk for diabetes and promotes early counsel for lifestyle modifications. Patients have been observed to be more adherent to these lifestyle modification recommendations due to more time spent with them.

Limitations of the Model or Restrictions that Limit its PortabilityRotaCare Concord is currently the only RCBA affiliate utilizing the new EMR. The EMR does not provide prescription labels, so separate printer software is required. Another constraint is the inability for various RCBA affiliates to share information due to use of different EMRs in their clinics.

Additionally, the EMR does not ease challenges associated with the need for multilingual care. Translators are still needed, and finding volunteers who are fluent Spanish (and other language) speakers is difficult. Furthermore, some patients do not have proper identification, and referring them for lab work or other procedures can be problematic.

The staff are volunteers who, thankfully, dedicate much time and effort; however, identifying champions among them to create culture change and facilitate implementation of new technology is difficult given that these persons are already challenged for time, given other work and family obligations.

The superusers were the staff most involved with educating and ensuring the system functioned optimally, but were also volunteers. They were not able to fully educate providers on all functions of the EMR until well after implementation. By involving superusers as change champions, more diagnosticians would be aware of functions and benefits of the EMR.(5)

Business Case and Legal / Regulatory Restrictions on the ModelRCBA does not bill or receive direct reimbursement for services rendered. It receives donations and grants from Rotary International, various California foundations, local hospitals, and the city of Concord.

RCBA clinics are all under the same umbrella of RotaCare Bay Area Inc.; however, they are not considered a chain medical center. They do not necessarily use the same technology, they do not share staff, and each has different capabilities and scopes of practice.

The Concord affiliate is among the few that provides free medicines. It does not treat pediatric patients but does offer clinics specifically for women. Some other RCBA affiliates operate as clinics specifically for families with children.

Future Plans and DirectionOther RCBA affiliates have plans to implement the new EMR. This will allow patients to be seen at different clinics and have their information be accessible to all clinics. A patient portal is also planned that will allow patients to access their medical records and communicate with clinics. The EMR system is critical to any medical care operation, particularly for continuity of care to at-risk populations. Accompanying any modifications or new technology must be the right culture fueled by effective agents of change. This is important in any setting, but especially clinics operated by volunteers caring for the underserved.

About the AuthorsShane P. Desselle, RPh, PhD, FAPhA is a professor of Pharmacy at Touro University California. He is the active Editor-in-Chief of Research in Social and Administrative Pharmacy. Dr. Desselle has no conflicts of interest to report, and is the corresponding author.

James E. Lessenger, MD, FACOEM is the medical director of RotaCare Bay Area Concord clinic. Dr. Lessenger has no conflicts of interest to report.

Mustafa Sultani is a 2021 PharmD candidate at the Touro University California College of Pharmacy. He is also the Research Director of the ISPOR Touro University California Student Chapter. Mr. Sultani has no conflicts of interest to report. He is a contributing author.

Bushra Alsharif is a 2021 PharmD/MPH candidate at the Touro University California College of Pharmacy. She is also the Poison Committee Clinic Director of the CPhA Touro University California Student Chapter. Ms. Alsharif has no conflicts of interest to report. She is a contributing author.

Sam Pournezhad is a 2021 PharmD candidate at the Touro University California College of Pharmacy. He is also the President of the ISPOR Touro University California Student Chapter. Mr. Pournezhad has no conflicts of interest to report. He is a contributing author.

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