Understanding DSCSA and A Collaboration to Continuing Ed MPhA Annual Awards |
How it Impacts You Enrich the Future Management of Type 2 Individual professional There is no time to waste Diabetes: Review of Drug excellence recognized in getting prepared for the Leader of Maryland Therapy and the Role of during the MPhA Annual March. 2016 enforcement of Pharmacy the Pharmacist Convention
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6 COVER STORY
On November 7, 2015, twenty-five student pharmacists and eighteen new practitioners
and experienced pharmacists from across : COALS SUCCESS the state attended a successful collaborative ate N SELF-ASSESSMENT
leadership workshop hosted by the ; VISION: VALU MEETINGS Baraaccieten dership PCREAUICatOn \ MEMBERS, CHAIRMAN,» EFFECTIVENESS, | PAWAICHMMMON)) ISSUE NEGOTIATION Institute (PLEI) and sponsored by the Maryland Pharmacists Association (MPhA) Foundation. PLEI Board Members Gary Keil, PAD and Michael Negrete, PharmD led the all-day workshop while MPhA members Monica Healy and Tim Rocafort provided
facilitation assistance.
14 a
7 | Save the Dates
9 | Member Mentions
11 | Understanding DSCSA and How it Impacts You
13 | MPhA Annual Awards
21 | Welcome New Members
14
Management of Type 2 Diabetes: Review of Drug Therapy and the
mL:
Role of the Pharmacist
. ADVERTISERS INDEX el CE Quiz
21 Corporate Sponsors
23
2 RJ. Hedges & Associates 5 Buy-Sell-A-Pharmacy 8 Cardinal Health 10 HD Smith 12 Bowl of Hygeia Award 22 Pharmacists Mutual 24 University of Maryland
MARYLANDPHARMACIST.ORG 3
President’s Pad
“1 believe that the state of MPhA is strong and growing thanks to
your ongoing engagement and support. As a team, let’s continue to carry out MPhA’s mission: Strengthen the profession of pharmacy, advocate for all Maryland pharmacists, and promote excellence in pharmacy practice.”
Dear Fellow MPhA Members,
Happy New Year. May 2016 bring you many blessings, especially health and happiness. Also, happy belated National Pharmacist Day which was on January i2. Did you know that was a day? I have been a pharmacist for over ten years and I did not know. My wife, Tanya, pointed that out to me. I always like to find reasons to celebrate our profession, so mark it on your calendar for next year!
I hope that you were able to attend MPhA’s Open House in February to celebrate MPhA‘s new headquarters in Columbia. If not, please invite your pharmacy friends and colleagues to visit, especially if they are coming from across the country to attend the APhA Annual Meeting in Baltimore on March 4-7. There is plenty of history in the new space for everyone to appreciate.
Also, big congratulations to Executive Director Aliyah Horton, CAE. This is her one year anniversary since joining in January 2015. Aliyah has facilitated MPhA’s move to the new headquarters and worked with members and staff to create a welcoming space. She has worked to provide more opportunities for member engagement and has transformed our new home into a venue that enhances the collaboration and professional development of the Maryland pharmacy community.
In addition, she has actively worked on behalf of MPhA to maintain long-term partnerships and build new networks of support in Annapolis as well as with the Department of Health and Mental Hygiene, the Board of Pharmacy, the Maryland Pharmacy Coalition and other affiliated communities. These relationships helped MPhA to have a more powerful voice in addressing challenges faced by different practice settings over the course of 2015 and will create new opportunities for 2016. Finally, she has worked with the MPhA leaders to create a strategic plan to guide our work over the next few years with a focus on governance, membership value, recruitment and retention.
In regards to MPhA’s Strategic Plan, one of the three goals is to align MPhA governance to facilitate organizational growth and pharmacy community engagement. Thank you to all the members of the Board Compositions Task Force, led by Past MPhA Honorary President Dr. Lynette Bradley-Baker, for multiple meetings and great efforts to research board compositions of professional organizations and provide recommendations on changes to MPhA’s Board of Trustees that will advance MPhA’s long-term strategic objectives. One deliverable
Continued on next page
4 MARYLAND PHARMACIST | WINTER 2015
anBACisr
© MPhA
Est, 98? MARYLAND PHARMACISTS ASSOCIATION
Yi WARY LAW ~ S NorIW\2©”
MANAGING EDITOR Kelly Fisher
MPhA OFFICERS 2015-2016
Dixie Leikach, RPh, MBA, FACA, Chairman
Hoai-An Truong, PharmD, MPH, President
Kristen Fink, PharmD, BCPS, CDE, Vice President ;
Matthew Shimoda, PharmD, Treasurer
Thomas Menighan, BS Pharm, MBA, ScD, FAPhA, Honorary President
HOUSE OFFICERS
W. Chris Charles, PharmD, BCPS, AE-C, Speaker
Ashley Moody, PharmD, BCACP, AE-C, Vice Speaker
MPHKA TRUSTEES
Nicole Culhane, PharmD, BCPS, FCCP. 2016
Mark Lapouraille, RPh, 2016
Cherokee Layson-Wolf, PharmD, CGP, BCACP, FAPhA, 2017
G. Lawrence Hogue, BSPharm, PD, 2017
Wayne VanWie, RPh, 2018
Chai Wang, PharmD, BCPS, AE-C, 2018
Shannon Riggins, ASP Student President
University of Maryland Eastern Shore
School of Pharmacy
EX-OFFICIO TRUSTEES Rondall Allen, PharmD, Dean University of Maryland Eastern Shore School of Pharmacy Natalie Eddington, PhD, Dean University of Maryland School of Pharmacy Anne Lin, PharmD, Dean Notre Dame of Maryland University School of Pharmacy David Jones, RPh, FASCP, MD-ASCP Representative Celia Proctor, PharmD, MBA, MSHP Representative Hanna Fenta, ASP Student President Notre Dame of Maryland University School of Pharmacy Elissa Lechtenstein, ASP Student President University of Maryland School of Pharmacy
PEER REVIEWERS
W. Chris Charles, PharmD, BCPS, AE-C
Caitlin Corker-Relph, MA, PharmD Candidate 2017
G. Lawrence Hogue, BSPharm, PD
Hanna Salehi, PharmD, MLS
STAFF
Aliyah N. Horton, CAE, Executive Director
Kelly Fisher, Marketing Coordinator
Shawn Collins, Membership Services Coordinator
We welcome your feedback and
ideas for future articles for Maryland Pharmacist. Send your suggestions to Kelly Fisher:
Maryland Pharmacists Association, 9115 Guilford Road, Suite 200, Columbia, MD 21046, call 443.583.8000, or email kelly. fisher@mdpha.com.
Special thanks to Graphtech, Advertising —
Sales and Design , :
already utilized was for the 2016 election. A guidance document was provided to the MPhA staff and Nominations Committee to assist in ensuring a formal process for MPhA elections and addressing diversity in election candidates. Stay tuned for specific recommendations, discussions, and vote on the
Board compositions at the Annual Convention.
Membership engagement and regional outreach have continued to be a focus of my, or better yet, our presidency. Special thanks
to several MPhA members and partners throughout the State for planning and/or hosting MPhA focus groups on membership value: Matt Balish, Tom Sisca, Darci Eubank, Brian Hose, Rosemary Botchway, the Eastern Shore Pharmaceutical Society, and the Primary Care Coalition of Montgomery County. The results and feedback will help
with membership programs and recruitment efforts. In addition, please continue to ask your pharmacist colleagues who are not MPhA members to ‘Ask Me
2 about MPhA’ in an effort to recruit members. Together, we can advocate better and stronger for our beloved profession. As always, if you have ideas or suggestions for programs or events, please reach out to me directly at htruong@ abcforyourhealth.org.
For the upcoming spring, |! am excited to share the launch of the MPhA Federal Pharmacists Network. Thank you to the co-founders LCDR Mathilda Fienkeng, CAPT Mary Kremzner, and CAPT (retired) James Bresette for all their leadership. Stay tuned for more information. Also, thank you to the New Practitioner Network and co-chairs Lauren Lakdawala and Sam Houmes for assisting with the bi-monthly
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membership program on April 21. This program will target the needs of recent and upcoming graduates. Check our website for more information as the date draws closer.
I believe that the state of MPhA is strong and growing thanks to your ongoing engagement and support. As a team, let's continue to carry out MPhA‘s mission: Strengthen the profession of pharmacy, advocate for all Maryland pharmacists, and promote excellence in pharmacy practice.” @
Sincerely,
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MARYLANDPHARMACIST.ORG 5
By: James L. Bresette, PharmD
Shannon Riggins, PharmD Candidate 2017, University of Maryland Eastern Shore School of Pharmacy
Cover Story
A Collaboration to Enrich the Future Leaders of
Maryland Pharmacy
n November 7, 2015, twenty-five
student pharmacists and eighteen
new practitioners and experienced pharmacists from across the state attended a successful collaborative leadership workshop hosted by the Pharmacists Leadership and Education Institute (PLEI) and sponsored by the Maryland Pharmacists Association (MPhA) Foundation. PLEI Board Members Gary Keil, PhD and Michael Negrete, PharmD led the all-day workshop while MPhA members Monica Healy and Tim Rocafort provided facilitation assistance.
Due to the work of Dr. Jim Bresette, Phi Lambda Sigma (PLS) funded a grant to support student pharmacists from the PLS chapters in each of the Maryland schools of pharmacy to participate in this workshop. This was the first time that all Maryland PLS chapters collaborated together. “Consistent with PLS mission and goals, this initiative was perfectly aligned to actively grow and prepare the next generation of Maryland pharmacists for leadership positions in their future work places and within the Maryland Pharmacist Association,” said proudly by Dr. Jim Bresette.
f
Ha Phan, a third-year student at the University of Maryland School of Pharmacy, appreciated these efforts, “I enjoyed being able to interact with my fellow colleagues irom different pharmacy schools who are also leaders in their schools. It was nice to see the overlap in core values and listen to what other students are passionate about."
The goal of the PLEI workshop was to discuss what it takes to be an effective leader, illustrate how to identify peoples’ strengths and align them with appropriate tasks, and examine how values can be used to allocate limited time and resources to
6 MARYLAND PHARMACIST | WINTER 2016
New practitioners who participated in the PLEI workshop
maximize meaning and purpose. Participants were asked not only
to look at their strengths, but also their weaknesses
in order to assess What areas could
be causing them
to falter as leaders. After participating in several activities aimed at self- analysis, participants were asked to share their conclusions through “pair sharing” and discuss the variances and Similarities that came up as a group.
‘LTremember a particular moment when the PLEI facilitator asked everyone to raise their hand if conflict resolution DID NOT bother them. After seeing an overwhelming number of leaders raise their hands,
I was shocked because | had never thought the topic of leadership could be made into a constructively positive experience. It then gave me a goal to work towards as a leader so that I,
too, could feel that way, said Geoffrey Saunders, a second- year student at
the University of Maryland Eastern Shore School Of Pharmacy.
During lunch, PLS chapter leaders from each of the schools of pharmacy sat together to talk about their chapters experiences and goals for the upcoming year
and to collect input about how to deal with challenges they might face. “This was an amazing
opportunity to learn from our fellow PLS members that we would not ordinarily have the opportunity
to work with,” said Brittany La- Viola, a fourth-year student at the Notre Dame of Maryland School of Pharmacy.
In one of the final activities of the day, each participant came up with a few goals for themselves and were asked to form an “accountabilibuddy” partnership to help achieve these goals.
Ryan Button of the University of Maryland School of Pharmacy expressed his viewpoint, “It’s about building interpersonal skills and interprofessional relationships.
I look at it as a chance to reach out to someone that understands the ebbs and flows, the stresses and satisfactions, which we all experience. It’s saying, ‘I'm taking accountability for you taking care of yourself so that we can accomplish something special together.’ It's a unique way to establish trust with someone.”
After a long day of reflection, sharing, and goal-setting, Rite Aid Corporation generously sponsored a networking dinner where
new practitioners and student pharmacists continued to interact with one another and share their perspectives on what had transpired for them throughout the day. It was clear that all participants found this workshop to be a valuable
Student pharmacists who participated in the PLE! workshop
experience in developing their leadership skills.
“The PLEI workshop is by far the most ambitious project that the MPhA Foundation has sponsored. The success of the workshop is vital to the future of the MPhA Foundation and its fundraising efforts as it illustrates what can be accomplished when resources are available to fund such endeavors. Financial support of the MPhA Foundation is necessary in order to continue its mission of supporting student pharmacists, recognizing practice innovation and in this instance, enhancing philanthropy
Save the Dates
that supports leadership,” said MPhA Foundation President Paul Holly.
On behalf of the students from Beta Lambda, Delta Beta, and Delta Nu chapters of PLS in Maryland,
we owe a collective thank you to PLS National, MPhA Foundation, MPhA, Rite Aid Corporation, and PLEI for the incredible and ennching experience that this workshop
has given Maryland student pharmacists and new practitioners as we move forward through the profession as the future leaders of pharmacy. To donate to the MPhA Foundation, please visit www. marylandpharmacist.org. @
5 17 27 Maryland Pharmacy March Board of Script Your Future Night at APhA Trustees Meeting April 27, Annual Meeting & March 17, MPhA HQ Exposition MPhA HQ March 5, Baltimore, MD
Visit www.marylandpharmacist.org to register online or for more information.
May Board of Trustees Meeting May 12, MPhA HQ
12 10-12
134th Annual Convention June 10-12, Ocean City, MD
MARYLANDPHARMACIST.ORG 7
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MEMBER MENTIONS
MPhA Past President Dixie Leikach, RPh, MBA has formed a non-profit organization, Pharmacy Ethics, Education and Resources (PEER), and is the President and CEO. The mission of PEER is to educate healthcare professionals on ethics to improve patient safety. The initial focus
of PEER is to develop a series of continuing education programs focusing on the role of ethics in
all areas of pharmacy and how ethics impacts patient safety. An ethics certificate program is also in development for those who would like to establish themselves as leaders in pharmacy ethics. If you are interested in more information about PEER, please visit www.
PeerRx.org.
MPhA President Hoai-An Truong, PharmD, MPH has returned to the University of Maryland Eastern Shore School
of Pharmacy and Health Professions as an Associate Professor in January 2016. Dr. Truong is a public health pharmacist, educator, and leader for over ten years. He has provided patient- centered care in an interprofessional collaborative model, part of
the Primary Care Coalition of Montgomery County, focusing on medication therapy management
to optimize medication use and
improve healthcare access, quality, and outcomes for underserved populations. Hoai-An has served as coordinator and preceptor for pharmacy and physician assistant students on a health mission trip to Haiti. He has also mentored public health students on a needs assessment trip to Vietnam and recently became a co-founder of International Community Initiative.
Seeeeeeseneeeeeeeeeeseeeteeeeeeeeeseeeeeees
MPhA Trustee Cherokee- Layson Wolf, PharmD, BCACP, FAPhA has been recognized with the American Pharmacist Association- Academy of Student Pharmacists’ (APhA-ASP) Outstanding Chapter Advisor Award. This award recognizes advisors
of APhA-ASP chapters who have promoted with distinction the welfare of student pharmacists through various professional activities. Cherokee is an associate professor in the Department of Pharmacy Practice and Science and associate dean of student affairs at the University of Maryland School of Pharmacy.
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Bethany DiPaula, PharmD, BCPP has been named a specialist member on the Board of Pharmacy Specialties’ Council
on Psychiatric Pharmacy. The psychiatric pharmacy specialist is
often responsible for optimizing drug treatment and patient care
by conducting such activities
as monitoring patient response, patient assessment, recognizing drug-induced problems, and recommending appropriate treatment plans. Bethany is
an associate professor in the Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy which is where she also received her Doctor of Pharmacy and completed her psychiatric pharmacy specialty residency.
Seeeeeeeseseseeeeseeoeseoseseseeseeeesesees
In Memoriam
Itis with great sadness we share that long-time member Richard “Dicks Baylis, PDeCEP. FASCP passed away on November 22, 2015.
Dick was the MPhA President in 2003 and the 2005 recipient of the Seidman Distinguished Achievement Award. He graduated from Albany College of Pharmacy in New York and worked in community, hospital, and long-term care pharmacy. Dick was also very active in the Maryland Chapter of American Society of Consultant Pharmacist (MD-ASCP) and served as president. After he retired, he became the Executive Director of the Georgia-ASCP Chapter. MPhA and MD-ASCP held
a Morning of Remembrance on December 12 at MPhA Headquarters. o
MARYLANDPHARMACIST.ORG 9
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Helping You Care For Your Community
While DSCSA went into effect over a year ago, its enforcement was delayed until March 1, 2016. MPhA knows that there is no time to waste in getting a solution in place. We have partnered with InfiniTrak, a track and trace software designed for independent pharmacists, to provide members with a deep discount on a timesaving solution to your DSCSA compliance needs. InfiniTrak helps you become compliant with the three key requirements of DSCSA and ensures that you remain compliant as the regulations continue to roll out. Here’s what you need to know!
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Created to ensure that our national drug supply is safe from counterfeit drugs, and that our pharmaceutical supply is safe and effective, DSCSA builds a nationwide electronic database that will track the ownership history of prescription drugs.
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Understanding DSCSA and How it Impacts YOU!
Drug Supply Chain Security Act (DSCSA) Readiness
Verification
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Do you hold transaction data for 6 years and, if need be, have a system to retrieve the information for submission to federal or state authorities within 48 hours? If you are asked to research a product in response to the FDA regarding a potential suspect product, do you have a system to keep the information for an additional 6 years?
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InfiniTrak manages the verification process for you and reminds you when your own license is coming up for renewal.
Suspect Product Process
Do you have a process in place to handle any suspect or potentially counterfeit products? Do you have training available for your employees about how to be on the lookout for suspect products, how to investigate them, and how to quarantine them?
InfiniTrak holds your information and allows you to produce reports at the touch of the keyboard. Quickly, easily, and accurately.
MARYLANDPHARMACIST.ORG 11
2015 Recipients of the “Bowl of Hygeia” Award
St, é je = a. Dan McConaghy Tom Van Hassel Nicki Hilliard Robert Shmaeff Sherman Gershman Kevin Musto Fritz Hayes Ron Stephens Alabama Arizona Arkansas California Connecticut Delaware Florida Georgia
Sd ood eae « / ’ Ne P, ae. bee Kerri Okamura Steven Bandy Jane Krause Richard Hartig Robert Nyquist Larry Stovall Lloyd Duplantis Kenneth McCall
Hawaii Illinois Indiana lowa Kansas Kentucky Louisiana Maine
X
Butch Henderson Paul Jeffrey Derek Quinn Jenny Houglum Robert Wilbanks Richard Logan Maryland Massachusetts Michigan Minnesota Mississippi Missouri
p< sf oY ha Gayle Hudgins Heather Mooney Richard Crowe Montana Nevada New Hampshire
Edward McGinley Amy Bachyrycz Benjamin Gruda New Jersey New Mexico New York
David Moody Kevin Oberlander Danny Bentley Gordon Richards, Jr. Ann Zweber Thomas Mattei Deborah Newell Sharm Steadman North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina
Renee Sutton Mac Wilhoit Jim Cousineau Marvin Orrock John Beckner Gregory Hovander South Dakota Tennessee Texas Utah Virginia Washington
Terri Smith Moore David Flynn Brian Jensen Randy Harrop Washington DC West Virginia Wisconsin Wyoming
The Bowl of Hygeia award program was originally developed by the A. H. Robins Company to recognize pharmacists across the nation FOUNDATION for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the State pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bow! of Hygeia is on display in the APhA Awards Gallery located in Washington, DC.
Boehringer Ingelheim is proud to be the Premier Supporter of the Bowl of Hygeia program.
2016 Maryland Pharmacists Association Awards Recognizing Pharmacy Excellence
Each year, MPhA recognizes individual professional excellence during MPhA’s Annual Convention. To nominate a deserving pharmacist for one of the awards described below, please visit us online to complete the nomination form at www.marylandpharmacist.org. You must include a brief statement and the nominee's current resume or curriculum vitae. Nominations are reviewed and selections are made by the Past Presidents Council. For consideration, nomination forms must be received by Friday, March 25, 2016.
Bowl of Hygeia Award
sponsored by the American Pharmacists Association Foundation and National Alliance of State Pharmacy Associations
Established in 1958, the Bowl of Hygeia Award recognizes pharmacists who possess outstanding records of civic leadership in their communities and encourages pharmacists to take active roles in their communities. In addition to service through their local, state, and national pharmacy associations, award recipients devote their time, talent, and resources to
a wide variety of causes and community service. Any MPhA pharmacist member who has not already received the Bowl of Hygeia Award is eligible for nomination.
The Bowl of Hygeia is the most widely recognized international symbol for the pharmacy profession and is considered one of the profession's most prestigious awards. The Bowl of Hygeia has been associated with the pharmacy profession since 1796, when the symbol was used on a coin minted for the Parisian Society of Pharmacy. The bowl represents a medicinal potion and the snake represents healing.
Maryland Pharmacists Association Seidman Distinguished Achievement Award
Created by Henry Seidman, this award honors a Maryland pharmacist who has performed outstanding service over a number of years and whose service has resulted in a major impact on the pharmacy profession. Any MPhA pharmacist member who meets the criteria for this award is eligible for nomination.
Excellence in Innovation Award
sponsored by Upsher-Smith Laboratories, Inc. Established in 1993, this award (formerly known as the Innovative Pharmacy Practice Award) aims to recognize forward-thinking pharmacists who have expanded their practices into new areas. Any practicing MPhA pharmacist member within the geographic area who has demonstrated innovative pharmacy practice resulting in improved patient care is eligible for nomination.
Distinguished Young Pharmacist Award sponsored by Pharmacists Mutual Companies This award is presented each year to a pharmacist who has
graduated within the past ten years and has made a significant contribution to the profession through service to a local, state, or national pharmacy organization. Any MPhA pharmacist member who has graduated from a school of pharmacy within the last ten years is eligible for nomination.
Maryland Pharmacists Association Mentor Award This award recognizes individuals who encourage pharmacists, technicians, and/or student pharmacists in the pursuit of excellence in education, pharmacy practice, service, and/
or advocacy. Any MPhA pharmacist member who meets the criteria for the award is eligible for nomination.
Cardinal Health Generation Rx Champions Award sponsored by Cardinal Health Foundation
This award honors a pharmacist who has demonstrated outstanding commitment to raising awareness of the dangers of prescription drug abuse among the general public and the pharmacy community. Any MPhA pharmacist member who meets the criteria for the award is eligible for nomination.
Maryland Pharmacists Association
Honorary President
An honorary position on the Board of Trustees is given to a person, not necessarily a pharmacist, who has worked for MPhA or Maryland Pharmacy over a long period of time. Any long standing contributor to the profession or the Association is eligible for nomination. @
This year’s Annual Convention will be on June 10-12 in Ocean City, MD at the Clarion Resort Fontainebleau Hotel. Online registration will open in the
spring. Be sure to follow our Annual Convention hashtag, #MPhAAnnual, for news and updates!
MARYLANDPHARMACIST.ORG 13
Continuing Ed
Zemen Habtemariam, PharmD Candidate 2016 Nina M. Bemben, PharmD, BCPS Mary Lynn McPherson, PharmD, MA, BCPS, CDE
University of Maryland School of Pharmacy
In the United States, diabetes is a major chronic disease. An estimated 29 million Americans have diabetes and of these, nearly 28 million Americans have type 2 diabetes. Diabetes remains the seventh leading cause of death in this country, and people with diabetes are 1.7 times more likely to die from cardiovascular disease than people without diabetes.'* Other potential complications of type 2 diabetes include cerebrovascular and peripheral vascular disease, retinopathy, nephropathy, and neuropathy.’ In addition, hypoglycemic events associated with the disease account for approximately 282,000 emergency room visits every year.!
While the complications of diabetes certainly increase morbidity and decrease patient quality of life, diabetes also has an effect on patient mortality. Zhuo and colleagues conducted a study that helped measure the impact of diabetes on patient life expectancy.* They found among patients at age 40 years, those with diabetes lose an average 6.7 survival-adjusted life years compared to patients without diabetes.’ Besides the direct effect on patient lives, diabetes also results in costs to the healthcare system and society at large. According to the Centers for Disease Control and Prevention (CDC), in 2012 direct medical costs attributable to diabetes were $176 billion and indirect costs, such as disability and reduced life expectancy, amounted to $69 billion.’
14 MARYLAND PHARMACIST | WINTER 2016
Diagnosis of Diabetes Mellitus
The American Diabetes Association (ADA) has developed four criteria for the diagnosis of diabetes mellitus and has established a diagnostic category referred to as prediabetes for patients at increased risk of developing diabetes.° Testing for asymptomatic people should
be considered for children and adults who are overweight or
obese and who have one or more risk factors for diabetes. Testing should begin at the age of 45 in all patients regardless of weight. When diagnosing diabetes, in the absence of a clear clinical diagnosis (e.g,., hyperglycemic crisis), a second test is required to confirm diagnosis
of diabetes mellitus. Criteria for diagnosing prediabetes and diabetes are as follows in the chart to the right.°
Goals of Care
The ADA has made recommenda- tions for glycemic control, as well as recommendations for blood pres- sure and cholesterol management. Glycemic targets are as follows, although targets may be customized for individual patients:®
e Alc < 70 %
e Preprandial capillary plasma glu- cose 80-130 mg/dl
e Peak postprandial (1-2 hours post beginning of meal) capillary plas- ma glucose < 180 mg/dl
As shown above, the ADA recom-
mends achieving a glycosylated hemoglobin (HbA1c) of <7.0%.°
2 hour post-prandial
Random plasma glucose with classic symptoms of hyperglycemia
Blood glucose levels consistent with this therapeutic goal are
<130 mg/dL for fasting glucose
and <180 mg/dL for a two-hour post-prandial.* The ADA does recommend individualizing therapeutic goals depending ona patient's remaining life expectancy, duration of disease, presence of complications of diabetes, as well as other comorbidities.*° For example, for a relatively young patient with newly diagnosed type 2 diabetes, no comorbidities or complications such as retinopathy or nephropathy, and a presumably long life- expectancy, more stringent control of blood glucose with a target HbAtic of 6.0-6.5% is appropriate. Conversely, in an elderly patient with long-standing diabetes already suffering from complications
such as retinopathy and multiple comorbidities, the benefits of stringent blood glucose control (decreased risk of microvascular complications) are not likely to outweigh the risks of hypoglycemia and adverse effects and a less stringent HbAtc goal of 7.5-8.0% may be reasonable.*
i
CRITERIA — | _ | PREDIABETES | DIABETES MELLITUS Fasting plasma glucose 100-125 mg/dl > 126 mg/dl (defined as no caloric intake for at least 8 hours) 140-199 mg/dl > 200 mg/dl (following WHO guidelines for testing)
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The ADA recommends people with diabetes and hypertension should be treated to a systolic blood pres- sure goal of <140 mmHg, although a goal of <130 mmHg may be more appropriate for selected patient populations.’ Diastolic blood pres- sure should be <90 mmHg, or <80 mmHg for selected patients.’ For people with diabetes under the age of 40 and no cardiovascular risk
_ factors, no pharmacologic ther-
apy is recommended to manage lipids. Patients over the age of 40 and those with cardiovascular risk factors should receive statin therapy (moderate or high intensity)’
Role of the Pharmacist
As medication experts, pharmacists are well trained to evaluate and improve drug regimens designed to maximize clinical, economic and humanistic outcomes from diabetes mellitus. As discussed later in this article, pharmacists may also provide patient education, both through patient counseling and Diabetes Self-Management Education (DSME) courses.
| ee é ee . we | Key Words ©
| "* diabetes |
| * diabetes self-management
| education
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| « type 2 diabetes ie sai "antidiabetic agents
+
MARYLANDPHARMACIST.ORG 15
To provide the best care to our patients, pharmacists should
be familiar with the appropriate treatment of diabetes and treatment plans consistent with evidence- based practice and patient-specific factors. In recent years, a dizzying number of medications have
been introduced to the market
for the management of diabetes; pharmacists are uniquely positioned to consider both patient and medication-related variables and make recommendations for optimal drug therapy that incorporate guidelines and evidence-based medicine. Tables 1 and 2 provide
a description of commonly used glucose-lowering agents in the US.
Diabetes Drug Therapies
At the time of initial diagnosis of type 2 diabetes, most patients should be initiated on drug therapy with metformin (in addition to implementing lifestyle modification) due to its efficacy, safety, and accessibility.2 Metformin typically does not cause hypoglycemia and has a neutral effect on weight. In addition, it may have cardiovascular benefits.? According to the ADA, metformin is the preferred first line agent for the management of type 2 diabetes unless patients have severe symptoms of hyperglycemia or severely elevated blood glucose levels (300-350 mg/dL or Alc >10%) at the time of initial diagnosis, in which case initial therapy should include insulin, with or without metformin.® If starting metformin therapy, the dose should be titrated up in order to achieve control of blood glucose levels; if a patient's blood glucose remains uncontrolled after three months, a second agent should be added to the drug therapy regimen.® Although the prescribing information states that metformin is contraindicated in men with
a serum creatinine >1.5 mg/dL
(>1.4 mg/dL in women), current evidence supports using metformin in patients with some degree of renal impairment, however it should not be used in patients with an
estimated creatinine clearance below 30 mL/min?
While metformin is the appropriate initial therapy for most patients, the choice of subsequent agents is less clear and should be tailored to a specific patient. A sulfonylurea, thiazolidinedione (TZD), GLP-1 agonist, DPP-4 inhibitor, SGLT2 inhibitor, or basal insulin are all rational drug therapy options.’ The choice of a particular agent should be individualized for each patient according to its adverse effect profile, cost, impact on patient weight, tolerable hypoglycemia risk, and patient preference.*?
Sulfonylureas have long been used as add-on therapy in addition to metformin due to its efficacy in lowering HbAic. However, unlike metformin, sulfonylureas are associated with weight gain and a risk of hypoglycemia.* In addition, sulfonylureas may have less efficacy as diabetes progresses, due to continued loss of pancreatic beta cell function. Although similar
to sulfonylureas, meglitinides may be preferred for patients with irregular meal patterns or those who experience post-prandial hypoglycemia with sulfonylurea therapy.’ A potential disadvantage of meglitinides is increased frequency of dosing compared to sulfonylureas.°
Thiazolidinediones are another rational choice for a second agent in addition to metformin. Like metformin, it is not associated with a risk of hypoglycemia, and its therapeutic efficacy may be preserved longer than that of metformin and sulfonylureas.* However, these agents have been associated with rare, but serious adverse effects which may limit its
utility in patients with comorbidities.
Rosiglitazone may be associated with an increased risk of myocardial infarction and pioglitazone may be associated with an increased risk
of bladder cancer.*® Other adverse effects associated with the TZDs include weight gain and edema, which may precipitate heart failure
16 MARYLAND PHARMACIST |! WINTER 2016
exacerbations in those patients at risks
GLP-1 agonists are injectable agents, which act by stimulating insulin secretion, slowing gastric emptying, promoting satiety and reducing glucagon secretion. Advantages of these agents include its potential to cause weight loss, efficacy in decreasing post-prandial glucose, and beneficial impact on some cardiovascular risk factors. Potential disadvantages include its non-oral route of administration, nausea and vomiting, and a possible risk of pancreatitis. In addition, medullary thyroid tumors have been observed in animal studies.°*?
Similar to GLP-1 agonists, DPP-4 (dipeptidyl peptidase) inhibitors increase post-prandial incretin levels by preventing the degradation of GLP, although with a more modest HbAtic lowering effect.* Unlike the GLP-1 agonists, DPP-4 inhibitors have a neutral effect on weight.
It is generally well tolerated and does not increase the risk of hypoglycemia. However, it has been associated with angioedema and itching, and may also be associated with acute pancreatitis or increased hospitalizations due to heart failure.’
The SGLT2 (sodium/glucose cotransporter 2) inhibitors are typically used in combination with metformin or DPP-4 inhibitors and have not yet been studied in combination with GLP-1 agonists.° Potential advantages of these agents include its association with decreases in weight and blood pressure and lack of hypoglycemia. However, SGLT2 inhibitors
may cause polyuria leading to hypotension, increased LDL cholesterol, and infections of the genitourinary tract.®
Although not a first line choice, alpha glucosidase inhibitors may be used in combination with metformin. However, its place
in therapy has traditionally been limited in the United States. The advantages of alpha glucosidase inhibitors include its efficacy
Pharmacists can provide patient education regarding diabetes management ... through provision of diabetes self-management education, or DSME, programs.
in controlling postprandial
blood glucose levels, its lack of hypoglycemia risk, and a potential cardiovascular benefit.? However, the modest overall impact on HbAic lowering, as well as poor patient tolerance due to adverse effects of flatulence and diarrhea, has limited its use.?
Due to the progressive nature
of diabetes, most patients will eventually require insulin therapy to maintain blood glucose control. Typically, insulin therapy is initiated with a basal insulin which may be the intermediate-acting neutral protamine Hagedorn or long-acting insulin glargine, insulin detemir, or insulin degludec.® If addition of basal insulin does not achieve adequate blood glucose control, particularly of post-prandial blood glucose levels, addition of a meal time or prandial insulin is often required.* Rapid- acting insulins such as lispro, aspart, or glulisine are frequently used,
but short-acting human regular insulin may also be used.® Although highly effective across all stages
of diabetes, initiation of insulin therapy is often resisted by patients and is associated with weight gain, hypoglycemia risk, and a need for patient education and training.®
Patient Education
As with any chronic disease, diabetes requires significant monitoring and patient education, which can be successfully provided by pharmacists. Due to the often complex medication regimen required to manage diabetes, provision of medication counseling by pharmacists is essential in
order for patients to use their medications safely and effectively. In addition to medication therapy, lifestyle modifications are an essential component of diabetes management throughout the course
of the disease. Patients should
be educated to understand that although diabetes is a progressive disease, progression may be slowed through adherence to drug therapy and lifestyle modifications such as diet and exercise. Pharmacists are both willing and able to provide this patient education. For example, one study showed over 61.9 percent of pharmacists wanted
to do more patient consultations and 58.5 percent of pharmacists stated they wanted to do more drug management activities.’°
Pharmacists can provide patient education regarding diabetes management in a more formalized manner through provision of diabetes self-management education, or DSME, programs. These courses teach patients about diabetes management and what they should know to best look out for their own progress. DSME courses must be provided by a Certified Diabetes Educator; this credential can be obtained by pharmacists through completion of a certificate program."
Conclusion
By maintaining a familiarity
with therapeutic strategies for managing diabetes and evaluating the evidence supporting the
use of an ever-increasing array
of agents, pharmacists can help both patients and primary care providers effectively manage type
2 diabetes. Pharmacists also have an important role to play in helping patients manage this chronic disease, through patient counseling on effective medication use and lifestyle modifications. Pharmacists with specialized training in diabetes management may also provide DSME courses to give patients in- depth training on self-management of this chronic disease. @
Sidebar Case
PM is a 56-year-old African American woman who presents to her primary care practitioner's office for her semi-annual routine visit. On questioning she states that she's been feeling “a triffle pooky” since her last visit. She says she has less energy than normal, and she has a pesky skin infection
in the skin fold under her abdomen. She's been under a lot of stress because her sister was diagnosed with breast cancer and she’s been helping take care of her.
The patient lives with her 58-year-old husband;
she prepares their meals although she’s been busy with her sister in the past four months or so that they have been eating a lot of frozen dinners. She acknowledges the frozen dinners have a lot of salt in them because she’s often thirsty after dinner and during the night. She gets up once or twice every night to get a drink of water and to urinate. The patient tells you she has to be so careful about her diet. She really likes to eat a donut or bagel for breakfast, but two hours later she gets very shaky and her heart starts to pound. She has to eat another donut to make these symptoms dissipate.
PM tells you she isn't sleeping well because of the stress in her life and she needs to get up in the middle of the night one or more times.
Continues on next page
MARYLANDPHARMACIST.ORG 17
sidebar Case continued
PMH: e CV: S1, S2 no murmurs/rub appreciated
e Dyslipidemia — 6 months (treated with dietary e Pulm: Clear to Auscultation
modification) mae e Skin: Fungal skin infection 2 cm x 4 cm right
e Hypertension — 2 years abdomen
¢ Irritable bowel syndrome (diarrhea) Laboratory data (two weeks ago)
e GERD ¢ Random:
¢ Sodium 135 mEq/L; Potassium 4 mEq/L; Cloride 98 mEq/L; Bicarbonate 26 mEq/L; Blood urea nitrogen 18 mmol/L; Serum creatinine 1.1 mg/dL; Glucose 240 mg/dL
Medications: e Lisinopril 20 mg po qd
e Pepcid Complete — 1 tablet as needed
e Imodium as needed e Hemoglobin Aic = 9.5%
* LDL-C 137 mg/dl; HDL-C 32 mg/dL; TG 220
Go ee ALAR SCL UNCER Nie oe: mg/dl; T cholesterol 227 mg/dl
PE: Laboratory data (one week ago)
e Vital Signs: sitting BP 162/98 HR 84 BPM regular
T: afebrile ¢ Fasting: Glucose 186 mg/dl
© Ht: 5'2” wt: 280 Ibs ¢ Hemoglobin Alc = 9.6%
¢ HEENT: Dry mucous membranes
You run the Pharmacotherapy Service in this primary care practice and the patient has been referred
to you for management.
1. Can PM be diagnosed with
diabetes?
a. Yes
b. No, she needs to take the 2 hour glucose tolerance test
c. No, she needs another fasting blood glucose drawn
d.No, she needs another Alc drawn
Yes, PM can be diagnosed with diabetes mellitus at this point. She presented with symptoms suggestive of hyperglycemia (feeling “a triffle pooky,”
less energy, persistent skin infections, increased thirst and
urination including nocturia) and has a random plasma glucose over 200 mg/dl (240 mg/dl). Her Alc at the time
of presentation also met the criteria for diabetes diagnosis (9.5%). A second Alc one week later was 9.6%, and a fasting plasma glucose of 186 mg/
dl, which exceeds diagnostic criteria of a fasting plasma glucose of 126 mg/dl or higher.
2. What recommendations would you make for PM at this time?
a. Lifestyle modification (weight loss, exercise plan) b. Metformin 500 mg po bid
18 MARYLAND PHARMACIST | WINTER 2016
c. Glyburide 10 mg po bid d.A and B e.A,B and C
According to the ADA guidelines, PM should begin lifestyle modifications immediately, along with metformin, therefore
the answer is D. PM has
no contraindications to metformin, and her serum creatinine is <1.4 mg/dl.
3.Which of the following values demonstrate PM has met her metabolic goals?
continued on page 20
sidebar Case continued
Response Fasting Plasma Glucose Two hour post- c Blood pressure prandial glucos
Al 90 mg/dl 162 mg/dl 138/84 mmHg 2
Eda 7
[ele selipel 135 mg/dl 210 mg/dl 146/94 mmHg 110 mg/dl 140 mg/dl 130/92 mmHg aes 60 mg/dl 120 mg/dl 142/94 mmHg
The correct answer is C. The goal fasting plasma glucose is 80-130 mg/dl, 2 hour post-prandial glucose <180mg/dl, Alc <7% and BP <140/90 mmHg. Only answer C meets all these metabolic goals.
4.Despite the recom- a. Glipizide The correct answer is E — all mendation you made b.Sitaliptin of the above. Per the ADA in question 2, PM has * guidelines, any of these agents not achieved her blood c. Plogliazone may be added to metformin glucose goal. Which of d Exenatide (and of course continue
the following are possible ON PST A PS lifestyle modifications). Some options that may be added patients may even progress to to her regimen? triple therapy. @
Table 1. Overview of Oral Antidiabetics*””
Biguanides Metformin (Glucophage”)
Mechanism of Adverse Effects Action
* Decreases hepatic 500mg PO twice daily, Indigestion, flatulence, glucose production and maximum 2550m<g/day in nausea, vomiting, diarrhea,
intestinal absorption 2-3 doses asthenia, headache
(primary effect)
Vitamin B deficiency
¢ Increases insulin sensitivity to yield larger
peripheral glucose uptake (secondary effect)
Lactic acidosis (rare)
Total daily dose Cinitial) = 0.1 - 0.2 units/kg body weight.
Hypoglycemia, injection site reaction, rash, weight gain
¢ Regulates glucose metabolism via decreasing hepatic glucose production and stimulating glucose
uptake by skeletal muscle
Insulin (basal) Insulin glargine (Lantus®)
Insulin detemir (Levemir*)
Insulin degludec (Tresiba”)
Titrated to glycemic goal.
Heartburn, nausea, hypoglycemia, weight gain
2.5-5mg PO once daily, Max=40mg/day in 1 to 2 divided doses
« Stimulates functional beta cells in pancreas
Sulfonylureas Glipizide (Glucotrol")
Heartburn, nausea, hypoglycemia
1.25-5mg PO once daily, Max=20mg/day in 1 to 2 divided doses
15-30mg PO daily, Max=45mg/day
A4mg PO daily, Max=8mg/ day
Glyburide (DiaBeta”)
Pioglitazone (Actos")
Rosiglitazone (Avandia”)
Edema, headache, weight gain, bone fracture, myalgia
Decreases insulin resistance in liver and peripheral vasculature
Thiazolidinediones (TZDs)
Severe: Heart failure, liver failure, Bladder cancer
Continued on next page
MARYLANDPHARMACIST.ORG 19
Table 1. Overview of Oral Antidiabetics®*”* continued
Drug Class Mechanism of Adverse Effects Action
SGLT-2 Inhibitors Canagliflozin (Invokana”) Blocks glucose 100mg PO daily, Polyuria, vulvovaginal reabsorption from Max=300mg daily pruritis, genitourinary
Empagliflozin (Jardiance”) proximal renal tubule, infections leading to increased
glucose excretion 10mg PO daily (Initial); Volume depletion,
Max=25mg once daily hypotension, dizziness
Rare: bone fracture, diabetic ketoacidosis, renal impairment Cin patients w/o renal impairment)
DPP-4 Inhibitors Sitagliptin (Januvia®) Blocks degradation of 100mg PO daily, Hypoglycemia, headache, incretin hormones by Max=100mg daily nasopharynglitis, DPP-4 (i.e., GLP) angioedema/urticaria Saxagliptin (Onglyza”)
5mg PO daily, Max=5mg daily
GLP-1 Agonist Exenatide (Byetta”) Acts as incretin mimetic; 5mcg SC twice daily a | Stimulates glucose- :
Liraglutide (Victoza”) dependent release of 0.6mg SC once daily Indigestion, decreased insulin and suppresses appetite, nausea, vomiting, secretion of glucagon diarrhea, headache
Acute pancreatitis
C-cell hyperplasia/medullary
thyroid tumors in animals Meglitinides Repaglinide (Prandin) Inhibits ATP-K+ channel 0.5mg PO two to four times | Hypoglycemia, weight
; ae ae on the membrane of daily before meals (Initial) gain, diarrhea, arthralgia,
Nateglinide (Starlix®) the beta islet cell, which canoe po eaters headache causes potassium efflux Harta Sth At ties En teachers times daily before meals induce insulin secretion (Maintenance)
Max=4mg/dose; 16mg/day 120mg PO three times daily at 30 minutes before meals
Alpha-glucosidase inhibitors | Acarbose (Precose”) Lowers postprandial 50-100mg PO three times Abdominal pain, flatulence,
glucose by inhibition daily; diarrhea Miglitol (Glyset”) of pancreatic alpha- Max=100 mg TID (>60kg); glucosidase hydrolase Max=50 mg TID (< 60 kg) enzymes in the intestines
Acute pancreatitis
50-100mg PO three times daily; Max=100 mg three times daily
Table 2. Classes of Oral Antidiabetics and Major Characteristics®
Drug Class Reduction in HbAlic | Hypoglycemic Risk | Weight Changes | Alpha-glucosidase
1.0-1.5% Neutral Gastrointestinal effects, lactic acidosis
-1. Low Low 4: Low
Thiazolidinedione 1.0-2.0% Edema, fractures, heart failure
SGLT-2 Inhibitor 0.5-1.0% Genitourinary effects, High dehydration
Alpha-glucosidase 0.5-1.0% Neutral Gastrointestinal effects Low
Inhibitors
Low LOW Low Low Low
HbAic reduction is shown as an average percentage reduction. Weight gain is signified by a +, while weight loss is signified by a -. The cost column is designated by low (cost <$100) moderate (cost $100 to $199) and high (cost >$200) in regards to the wholesale acquisition cost for a 30-day supply.
20 MARYLAND PHARMACIST | WINTER 2016
THANK YOU TO OUR 2015 CORPORATE
WELCOME NEW MEMBERS SPONSORS
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CONTINUING EDUCATION QUIZ
PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. A continuing education credit will be awarded within six to eight weeks.
Program Release Date: 1/19/2016 Program Expiration Date: 1/19/2019
The authors have no financial disclosures (2) Scroll down to Homestudy/ to report. OnDemand CE Credits and select the
This program is Knowledge Based — OB ee
acquiring factual knowledge that is based (3) Login using your username (your on evidence as accepted in the literature email address) and Password
by the health care professionals. MPHA123 (case sensitive). Please change your password after logging in to protect your privacy.
(4) Click the Test link to take the quiz.
Directions for taking this issue's quiz:
This issue’s quiz on Management of Type 2 Diabetes: Review of Drug Therapy and
This program provides for 1.0 contact hour (0.1) of continuing education credit. Universal Activity Number (UAN) 0798-9999-16-003-HO1-P
the Role of the Pharmacist can be found online at www.PharmCon.com.
(1) Click on “Obtain Your Statement of CE Credits for the first time.
Note: If this is not the first time you are signing in, just scroll down to Homestudy/ OnDemand CE Credits and select the quiz
you want to take.
References
1. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States. 2014. Available from: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed December 15, 2015.
2 American Diabetes Association. Statistics About Diabetes. 2015. Available from: http://www.diabetes.org/diabetes-basics/statistics/. Accessed December 152015;
3. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the
American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012;55:1577-1596.
Zhuo X, Zhang P, Barker L, et al. The lifetime cost of diabetes and its implications for diabetes prevention. Diabetes Care 2014'37:2557-2564.
American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care 2016;39(Supplement 1):S13-S20.
American Diabetes Association. Glycemic targets. Diabetes Care 2016;39(Supplement 1):S39-S46.
American Diabetes Association. Cardiovascular disease and risk management. Diabetes Care 2016;39(Supplement 1):S60-S71.
American Diabetes Association. Approaches to glycemic treatment. Diabetes Care 2016;39(Supplement 1):S52-S59.
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach. Update to a position
statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015;38:140-149.
10. Mott DA, Doucette WR, Gaither CA, Pedersen CA, Schommer JC. Pharmacist's attitudes toward worklife: results from a national survey of pharmacists. J Am Pharm Assoc 2004; 44:326-336.
11. National Certification Board for Diabetes Educators. Certification Information. 2015. Available from: http://www.ncbde.org/certification_info/. Accessed December 15, 2015.
12. Truven Health Analytics. Micromedex® Solutions. 2015. Accessed December 15, 2015.
13. Pharmacist’s Letter. Drugs for type 2 diabetes. Pharmacist's Letter 2012;28:280805. Available from: http://pharmacistsletter.therapeuticresearch.com/pl/ ArticleDD.aspx?nidchk=18cs=6s=PL&pt=28segment=46208dd=2808056AspxAutoDetectCookieSupport=1. Accessed December 7, 2015.
WOONAMA
MARYLANDPHARMACIST.ORG 21
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I AM GRATEFUL for the support from across the MPhA community including Staff, elected leaders and trustees, Past Presidents, Deans, committee chairs, MPhA members, corporate sponsors, and partners who have shared their vision, the history and dreams for MPhA. Thank you for investing your time and expertise
and allowing me to visit your practice settings and campuses.
Congratulations to the many members who were involved for nearly a decade in identifying the right location and design for MPhA’s home in Columbia, Maryland. We continue to receive positive feedback from visitors on the facilities and location. If you haven't visited yet, the door is open!
VISION
In 2015 the Board of Trustees asserted
its vision for MPhA to be the voice representing all Maryland pharmacists as innovative and respected members of the healthcare team focused on the health and well-being of Maryland residents. In order to achieve this vision, priority areas were identified in the areas of Governance, Membership Value, and Recruitment and Retention. Our mission is to strengthen the profession of pharmacy, advocate for all Maryland pharmacists and promote excellence in pharmacy practice.
A few highlights of how we are doing:
e Aligning MPhA Governance to facilitate organizational growth and pharmacy community engagement
o In September 2015, the Board of Trustees approved MPhA‘s cultural core (our vision, mission and values).
o In January 2016, the Board Composition Task Force presented recommendations to the Board of Trustees related to nomination and election policies and procedures as well as composition and representation on the Board of Trustees,
oO Operational structure and facilities in place that will continue to support and enhance the ability of MPhA to collaborate with strategic partners.
e Enhancing Membership Value, proposition in the areas of advocacy, communication, continuing education, networking, and professional development/visibility.
oO MPhA was fully engaged in the 2015 legislative session, actively participating in the passage of two Maryland Pharmacy Coalition bills that advanced and enhanced
Executive Director’s Message
“As | reflect on 2015, it is gratifying to be at the helm of an organization that is growing and changing to meet the needs of today’s pharmacists, student pharmacists, residents and pharmacy technicians. Collectively, we have navigated through opportunities and
challenges presented to our © MPhA collaborated with the MPhA community in 2015.”
pharmacist scope of practice as well as emergency legislation designed to address pharmacy network restrictions.
oO MPhA has hired a lobbying firm to assist in building our recognition in Annapolis and forge relationships with elected leaders to advance MPhA legislative priorities
o Communications, Professional Development and Membership Committees are working collaboratively to enhance MPhAss social media presence and to provide avenues for membership activity that address leadership, innovative practice, professional excellence and the collegiality of our organization.
o Board meetings are now held bi-monthly with CE activities and membership events on the off months.
o The Monday Message following the Board of Trustees Meetings includes meeting highlights and updates.
o An online Membership Directory is now available on our website, which gives you the ability to connect with new and old colleagues, classmates and friends.
o MPhA Meetings Committee launched a call for abstracts for the Annual Convention to ensure meeting content highlights diverse speakers and innovative content. Submit your topics and encourage others to as well. You can find the link in the Monday Message or on our website.
Foundation and various state agencies and national organizations to bring you Point-of-Care Training and leadership workshops as well as a newly implemented Health Information Exchange Task Force and collaborations on the Naloxone Standing Orders.
« Increase Pharmacist Community Membership Recruitment and Retention
o Initiated the Pharmacists Month video contest and membership CE and recruitment drive.
o Established new member benefits for financial education/ webinars, loan consolidation, and Drug Security Supply Chain Act compliance.
o MPhA leadership is conducting focus groups and outreach within different regions in the state and practice settings. Stay tuned for when we come to you!
There's much more to come. Cheers to an innovative and productive 2016! @
Aliyah N. Horton, CAE Executive Director
MARYLANDPHARMACIST.ORG 23
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MPhA News Provider Status Continuing Education University of Maryland
| An update on the 2016 Mid- Why provider status is Article School of Pharmacy Year Meeting, 16th Annual MPC important, what it means A Review of Abuse-Deterrent Celebrating its 175th Legislative Day, MPhA’s Open and why we're working so Opiod Formulations and Anniversary
| House, and APhA’s Annual
Place in Therapy | Meeting & Exposition
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Are you conducting FWA Prevention training annually? Do you have an “Anti-Kickback” Policy & Procedure (P&P)? Do you have your entire staff completing Conflict of Interest forms annually? Are you running OIG-GSA-SAM Exclusion Verifications each month on: Employees, Owners and Contractors Business Associates All vendors whose products are billed through Medicare
YES HIPAA
Do you have a HIPAA P&P manual/program in place? Has your Notice of Privacy Practice been updated since July 1, 2013?
Do you maintain a breach assessment when the patient receives another patient’s medication?
YES PATIENT SAFETY
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Contents
12
COVER STORY Provider Status
We talk a lot about the idea of pharmacists having “provider status.” But what exactly does that mean? Georgia Pharmacy Association CEO Scott Brunner sat down with Krystalyn Weaver, PharmD, the vice president of policy and operations for the National Alliance
of State Pharmacy Associations, to talk about that phrase — why provider status is important, what it means and why we're working so hard to achieve it locally and nationwide.
5 President’s Pad
1 O MPhA News . 6 | 16th Annual MPC Legislative Day 6 | 2016 Mid-Year Meeting 7 | MPhA’s Open House 7 | APhA’s Annual Meeting & Exposition 25 | Welcome New Members 25 | 134th Annual Convention
8 Advocacy 2016 Legislative Session Report
Editorial
11 | University of Maryland School of Pharmacy Celebrates 175th Anniversary
16 | The Role of Ethics in Pharmacy
19 Maryland Colles i; Phaniacy Continuing ed Building erected in 1886 2 EA SUZ
27 Executive Director’s Message
ADVERTISERS INDEX
25 Corporate Sponsors
2 RJ. Hedges & Associates Winter 2016 Correction 4 Cardinal Health The primary author was listed incorrectly on A ¢ ollab« ration : to Enrich the Future Leaders of Maryland Pharmacy. Shannon 18 Pharmacists Mutual Riggins, PharmD Candidate 2017 University of Maryland Eastern 25 Buy-Sell-A-Pharmacy Shore School of Pharmacy is the primary author. James | 26 HD Smith Bressette, PharmD is the secondary author
28 University of Maryland MARYLANDPHARMACIST.ORG 3
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President’s Pad
Dear Fellow MPhA Members,
Thank you for accepting my “ask” or invitation for you to be engaged with MPhA this past year. Thank you for embracing our theme
of “Ask Me 2 about MPhA’ and getting involved. And thank you
for reminding our patients to “Ask your pharmacist about your medications.”
It has been an amazing, enjoyable, and very fast-paced year.
I believe we have achieved our goals and plans, which would
not have happened without each of you. As I write my fourth president's message, it is appropriate to reflect upon our collective achievements in carrying out our mission and implementing the 2016 strategic plan, as well as upon ongoing efforts of the 20+
committees, taskforces, and networks from June 2015 to May 2016.
Together we implemented the 2016 strategic plan with priorities in governance, membership retention and recruitment, and membership value proposition including advocacy, communications, continuing education, networking, and professional development/visibility
Revised and recommended changes in by-laws as approved by the Board of Trustees in March 2016 and to be discussed/voted on at the House of Delegates at the convention
Engaged members by changing the monthly Board of Trustees meetings to bi-monthly to facilitate bi-monthly membership programs:
o American Pharmacists Month Celebration with Medication Safety CE in October 2015 oO Holiday Party in December 2015
o Advocacy Workshop in February 2016
o New Practitioners Workshop in April 2016
Moved to the new Headquarters in Columbia, secured a tenant in the additional building suite, and hosted an Open House
Had a successful Mid-Year Meeting in Columbia on January 31, 2016
Enhanced the Maryland Pharmacist journal to all-color starting with the Winter 2016 issue Collaborated with the Maryland Pharmacy Coalition (MPC) to advocate for pharmacy-related bills during the 16th Annual MPC Legislative Day on February 18, 2016 and throughout the 2016 legislative session
Organized three regional outreach CE programs and focus groups/surveys:
o Eastern Shore MD hosted by Eastern Shore Pharmaceutical Society on February 21, 2016
o Central MD hosted with Primary Care Coalition of Montgomery County on March 10, 2016 o Western MD hosted with Quad State Pharmacy Association on April 27, 2016
Collaborated with the three schools of pharmacy to host a record breaking Maryland Pharmacy Night Reception during APhA‘s Annual Meeting in Baltimore, March 5, 2016. Over 400 guests attended and networked together
Launched the Federal Pharmacy Network with a reception at the Food and Drug Administration on March 16, 2016
Coordinated a Script Your Future Medication Adherence event on April 27, 2016
Conducted two visits to the U.S. Capitol Hill on March 30, 2016 and April 29, 2016 to advocate and thank legislators for their support of pharmacists’ provider status bills and efforts Collaborated with the MPhA Foundation to present student scholarships and awards for grad- uates at the three schools of pharmacy graduations
Facilitated the Board's approval to be an affiliate organization with the Academy of Manage Care Pharmacists
With numerous initiatives and programs throughout the year, it would not be possible to recognize all individual volunteers on committees, taskforces, and networks in this message.
It has also been so valuable to have partners such as the MPhA Foundation, three schools of pharmacy, and our corporate sponsors. We could not have done it without each of you. I thank you and look forward to celebrating with you during our Annual Convention in Ocean City.
I still need you. MPhA still needs you. Our pharmacy profession still needs you. Please continue to be engaged and invite fellow pharmacists, student pharmacists, and technicians to be involved. As I pass the torch to incoming MPhA President Kristen Fink, it continues to be an exciting time with great momentum for MPhA and pharmacy. I am confident you will support her as you have supported me. It has been and continues to be an exciting journey for us to serve together. I sincerely thank you for allowing me to serve as your 2015-16 President. @
Sincerely,
hai Aw Hoai-An Truong, PharmD, MPH, FNAP President
i ARRAACS
or
PART LAW, Noni’
‘7.198% = MARYLAND PHARMACISTS ASSOCIATION
MANAGING EDITOR Kelly Fisher
MPhA OFFICERS 2015-2016
Dixie Leikach, RPh, MBA, FACA, Chairman
Hoai-An Truong, PharmD, MPH, FNAP President
Kristen Fink, PharmD, BCPS, CDE, Vice President
Matthew Shimoda, PharmD, Treasurer
Thomas Menighan, BS Pharm, MBA, ScD, FAPhA, Honorary President
HOUSE OFFICERS
W. Chris Charles, PharmD, BCPS, AE-C, Speaker
Ashley Moody, PharmD, BCACP., AE-C, Vice Speaker
MPhA TRUSTEES Nicole Culhane, PharmD, BCPS, FCCP. ~ 2016 Mark Lapouraille, RPh, 2016 Cherokee Layson-Wolf, PharmD, CGP, BCACP, FAPhA, 2017 G. Lawrence Hogue, BSPharm, PD, 2017 Wayne VanWie, RPh, 2018 Chai Wang, PharmD, BCPS, AE-C, 2018 Shannon Riggins, ASP Student President University of Maryland Eastern Shore School of Pharmacy
EX-OFFICIO TRUSTEES Rondall Allen, PharmD, Dean University of Maryland Eastern Shore School of Pharmacy Natalie Eddington, PhD, Dean University of Maryland School of Pharmacy Anne Lin, PharmD, Dean Notre Dame of Maryland University School of Pharmacy David Jones, RPh, FASCP, MD-ASCP Representative Celia Proctor, PharmD, MBA, MSHP Representative Hanna Fenta, ASP Student President Notre Dame of Maryland University School of Pharmacy Elissa Lechtenstein, ASP Student President University of Maryland School of Pharmacy
PEER REVIEWERS
W. Chris Charles, PharmD, BCPS, AE-C
Caitlin Corker-Relph, MA, PharmD Candidate 2017
Nicole Groves, PharmD
G. Lawrence Hogue, BSPharm, PD
Edward Knapp, PharmD, PhD
Hanna Salehi, PharmD, MLS
STAFF
Aliyah N. Horton, CAE, Executive Director
Kelly Fisher, Marketing Coordinator
Shawn Collins, Membership Services Coordinator
We welcome your feedback and
ideas for future articles for Maryland Pharmacist. Send your suggestions to Aliyah Horton:
Maryland Pharmacists Association, 9115 Guilford Road, Suite 200, Columbia,
MD 21046, call 443.583.8000, or email aliyah.horton@mdpha.com.
Special thanks to Graphtech, Advertising Sales and Design
What has MPhA been doing? Member Mentions highlighted below!
16th Annual MPC Legislative Day
MPhA participated in the 16th Annual Maryland Pharmacy Coalition (MPC) Legislative Day on February 18, 2016. Legislative Day is the centerpiece of MPC's effort to send a unified pharmacy message to Maryland state legislators. This annual event is instrumental in advancing the pharmacy profession and facilitates pharmacists and student pharmacists in educating legislators on the importance of pharmacists and how we improve healthcare for our patients. Legislative Day consistently brings together over 300 participants who represent nearly all of the Maryland
legislative districts and pharmacy practice settings.
The meeting kicked off with opening remarks by Senator John Astle (D-30). This year, MPC focused on issues relating to appropriate use of controlled substances by patients in Maryland, among many other pharmacy-related bills.
MPC representatives from each organization developed consensus statements on pharmacy related bills that were introduced at that time. For specific legislative updates, please see page 8.
Student pharmacists with Carlo Sanchez, Member of Maryland House of Delegates, Prince George’s County
Thank you to all the student pharmacists
for advocating for your profession and making sure your voices are heard!
2016 Mid-Year Meeting
MPhA held its annual Mid-Year Meeting on January 31, 2016 at the DoubleTree Hilton in Columbia, Maryland. It was a full-day of live continuing education, networking, and professional recognition!
Continuing education sessions included hot topics such as:
¢ Medication safety (See page 16 for a follow up on the Role of Ethics in Pharmacy)
¢ Maryland's naloxone state-wide standing order information and implementation
¢ Pharmacy legislative and advocacy updates
¢ Clinical updates on biosimilars and medicinal cannabis
6 MARYLAND PHARMACIST | SPRING 2016
Executive Director Aliyah Horton and President Hoai-An Truong with Pete Hammen, Chair of the House Health and Government Operations Committee
Executive Director Aliyah Horton and President Hoai-An Truong with Mac Middelton, Chair of the Senate Finance Committee
President Hoai-An Truong presented Kim Morris with MPhA's 2016 Pharmacy Technician of the Year Award for her significant contributions to the expanding role
of the pharmacy technician. Kim has been a pharmacy technician at Finksburg Pharmacy for over ten years.
He also presented MPhA’s 2015 Honorary President award to Thomas Menighan, American Pharmacists Association Executive Vice President and Chief Executive Officer. Tom is a long-time MPhA member and resident of Maryland who has made a career of significantly contributing to the pharmacy profession. MPhA was pleased to work with him and APhA staff to support their Annual Meeting held in Baltimore.
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Kim Morris accepting her award with MPhA members, Finksburg Pharmacist Manager Rai Cary and Owner Dixie Leikach
Thomas Menighan accepting his award with Executive Director Aliyah Horton and President Hoai-An Truong
@MPhA @MPh\ OMPhA @
MPhA’s Open House
On February 20, 2016, MPhA welcomed members
and partners at our Official open house and ribbon cutting ceremony at our headquarters in Columbia, Maryland. President Hoai-An Truong presented
Murhl Flowers, Relocation Committee Chair, and
Matt Shimoda, Building Committee Chair, with a certificate of recognition for their outstanding generosity, dedication, and leadership to MPhA. Murhl and Matt were instrumental in getting MPhA a secure, centralized, and charming location that will support the needs of MPhA now and in the future. Thank you to everyone who came and celebrated our new home with us.
Ribbon cutting time!
(left to right) Executive Director Aliyah Horton, Treasurer and Building Committee Chair Matt Shimoda, Relocation and History Committee Chair Murhl Flowers, MPhA Foundation President Paul Holly, and President Hoai-An Truong
Thank you to our
Past Presidents!
(back, left to right) Neil Leikach, Phil Cogan, Murhl Flowers, Paul Holly, Matt Shimoda, Howard Schiff, Current President Hoai-An Truong, Butch Henderson (sitting, left to right) Dixie Leikach, Christine Lee- Wilson, Jean Freels
@MPh @MPh @MPhA
APhA’s Annual Meeting & Exposition
The American Pharmacists Association (APhA) held
its Annual Meeting and Exposition on March 4-7 2106 in Baltimore, Maryland. Several MPhA members were recognized with awards and appointments! It was great seeing MPhA members recognized on a national level for their pharmacy efforts and having a strong Maryland presence throughout the meeting!
(left to right) APhA CEO Thomas Menighan, Executive Director Aliyah Horton, Past President Cynthia Boyle, Congressman Elijah Cummings, President Hoai-An Truong, University of Maryland School of Pharmacy Dean Natalie Eddington, Past President Magaly Rodriguez de Bittner
Source: American Pharmacists Association
e ASP President Elissa Lechtenstien from the University of Maryland School of Pharmacy was elected APhA- ASP Member-at-Large. Elissa was also recognized as a recipient for the 2016 APhA Foundation’s Mary Louise Andersen Scholarship.
e Salematou Traore from University of Maryland Eastern Shore School of Pharmacy was recognized as the recipient for the 2016 APhA Foundation’s Mary Munson Runge Scholarship.
e Carolyn Cooper from the University of Maryland Eastern Shore School of Pharmacy was selected as arecipient of the Ron Williams Memorial Fund Scholarship.
e Past President Butch Henderson was recognized as the 2015 Bowl of Hyegia Award recipient
e Trustee Cherokee Layson-Wolf was honored with the APhA-ASP Outstanding Advisor Award.
e Joey Mattingly was nominated as candidate for speaker-elect of APhA’s House of Delegates
e Notre Dame of Maryland University School of Pharmacy was recognized with the Outstanding IPSF Activity Award.
e University of Maryland School of Pharmacy APhA- ASP Chapter won second runner up of the Division A Chapter Achievement Award.
MARYLANDPHARMACIST.ORG 7
2016 Legislative Session Report
The 436th session of the Maryland General Assembly adjourned sine die at midnight on April 11, 2016 after 90 days of meetings to consider more than 2,800 bills and resolutions. By contrast, last year only roughly 2,200 bills were submitted making this a very busy year with committees meeting well into the evening and late night hours to
review legislation.
Major Topics
Each year there are a few topics that dominate the debate in Annapolis. Below you will find more information on some of the major topics debated this session. These topics cover only a small fraction of the total legislation considered.
Justice Reinvestment Act
After debate over the entire legislative session, a bill was passed on the final day will change how criminal justice is adrninistered
in the state. The bill includes
a provision that removes the mandatory minimums for providing bogus prescriptions but sets maximum sentences of 20 years for the first and second offenses,
25 years for the third and 40 years for the fourth.
Drunk and Drugged Driving
The most debated bill on this topic went by the name of “Noah's Law” in memory of Montgomery County Police Officer Noah Leotta who was killed by a drunk driver late last year. The legislation would require ignition interlock devices in the cars of all drunk driving offenders. Noah's Law passed on the final
day of the legislative session after lengthy debate about the details of implementation of the bill.
Earned Sick Leave
For supervisors and business owners, earned sick leave has been introduced without successful passage for several years. This year, for the first time, it was passed in the House of Delegates. The Senate vote came down to the final hours of the legislative session with the bill ultimately not passing. The bill would require that all companies with more than 14 employees provide earned sick leave at a rate no less than one hour per every thirty hours worked.
Prescription Drug Monitoring Program
Legislation was passed that
will create a prescription drug monitoring program to help curb the over-prescription of opiates and other narcotics. This is part of a number of bills aimed at reducing the illegal drug use epidemic in the state, a priority of the Hogan Administration. MPhA worked to remove pharmacist requirements for mandatory querying prior to dispensing. The bill does require pharmacists to be registered in the system. A more substantive review of the bill will be provided in future publications.
MPhA INTERIM ACTIVITIES
G.S. Proctor & Associates was committed to assuring MPhA‘s advocacy participation with our legislative priorities during the 2016 legislative session —
8 MARYLAND PHARMACIST | SPRING 2016
Prescription Drug Monitoring Program legislation, specialty
drugs legislation and other related bills. They are working to assure future successes by establishing relationships with key officials during the interim. G.S. Proctor committed meetings for MPhA‘s Executive Director to meet with Delegate Nic Kipke (specialty drugs bill sponsor), Senator Mac Middleton (PDMP bill sponsor), House Speaker Michael E. Busch, Senate President Mike Miller and Brian Frosh, Attorney General. These meetings will allow MPhA to provide information on issues and concerns and share legislative and regulatory priorities.
MPhA BILL UPDATE
The following chart includes bills reviewed by MPhA‘’s Advocacy Committee and tracked by G'S. Proctor & Associates during the 2016 Legislative Session. If there were bills in the 2016 legislative session that you believe MPhA should have tracked or taken a position on, you are encouraged to join the Advocacy Committee and provide your insight and perspective. Just add the Advocacy Committee in your member profile. If you need assistance, please contact MPhA at 443-583-8000.
Status 2016 Regular Session
Primary Status
Sponsor Unfavorable Unfavorable
Returned Passed
HBO015 Harford County—Suspected Overdoses—Reporting Requirement Requiring specified individuals who treat or are in charge of a hospital that treats an individual in Harford County for a suspected overdose that was caused or shows evidence of having been caused by a Schedule I controlled dangerous substance to notify the county sheriff, county police, or the Department of State Police of the suspected overdose within 48 hours after the individual is treated; requiring that a report of a suspected overdose include specified information; and establishing a specified penalty.
Delegate Szeliga
HB0024 Public Health—Overdose Response Program—Educational Training Program Requirement Requiring educational training for an Overdose Response Program overseen by the Department of Health and Mental Hygiene to include training in the requirement to immediately contact medical services after the administration of naloxone by a certificate holder instead of training in the importance of contacting emergency medical services.
Delegate Szeliga
HB0104 Medical Cannabis—Written Certifications—Certifying Providers Authorizing specified dentists, podiatrists, nurse midwives, and nurse practitioners, in addition
to physicians, to issue written certifications to qualifying patients by substituting the defined term ‘certifying provider" for “certifying physician” as it relates to laws governing medical cannabis; establishing that specified providers must be in good standing with the regulatory board regulating the licensing and certification of specified providers; providing for a delayed effective date; etc.
Delegate Morhaim
eliminate mid-wives— amendment was rejected
Unfavorable
HBO0006 Criminal Law—Improper Prescription of Controlled Dangerous Substance Resulting in Death Prohibiting an authorized provider from prescribing, administering, distributing, or dispensing a controlled dangerous substance to a person if such practice is not in conformity with specified provisions of law and the standards of the authorized provider's profession relating to controlled dangerous substances and the person's use or ingestion of the controlled dangerous substance is a contributing cause of the person's death; establishing penalties of up to 20 years in prison or a fine of up to $100,000 or both; etc.
HBO117 (SB0469) State Board of Pharmacy—Licensure Requirements for Pharmacists—Proof of Proficiency in English Providing that, for applicants for a license to practice pharmacy, graduation from a recognized English-speaking professional school accredited by the Accreditation Council for Pharmacy Education is acceptable proof of proficiency in the oral communication of the English language.
HB0437 (SB0537) Department of Health and Mental Hygiene—Prescription Drug Monitoring Program—Modifications Requiring that specified authorized providers
and prescribers be registered with the Prescription Drug Monitoring Program before obtaining a new or renewed controlled dangerous substance registration or by July 1, 2017, whichever is sooner; requiring that pharmacists be registered with the Program by July 1, 2017; altering the mission of the Program; authorizing the Secretary of Health and Mental Hygiene to identify and publish a list of monitored prescription drugs that have low potential for abuse; etc.
Delegate Young, K.
Returned Passed
Delegate Barron
Delegate Barron Returned Passed
Meetings to combine language with Gov’s Bill SB537—pg 7 lines 14-18 pharmacist language removed,
Unfavorable
Unfavorable Unfavorable
Continued on page 10
HB1241 Pharmacy Benefits Managers—Contracts With and Reimbursement of Delegate Kipke Pharmacists Requiring each initial and renewal contract between a pharmacy benefits manager and a contracted pharmacy to include the sources used to determine maximum allowable cost pricing; requiring a pharmacy benefits manager to update
its pricing information at specified intervals and for a specified purpose; specifying the format in which pricing updates must be provided by a pharmacy benefits manager to a contracted pharmacy; etc.
HB1i242 Pharmacy Benefits Managers—Reimbursement and Pharmacy Choice Delegate Kipke Prohibiting a pharmacy benefits manager from reimbursing a pharmacy or pharmacist for a pharmaceutical product or pharmacist service in a specified amount; authorizing a pharmacy or pharmacist to decline to provide a pharmaceutical product or pharmacist service to an individual or pharmacy benefits manager under specified circumstances; prohibiting a pharmacy benefits manager or health benefit plan from imposing specified conditions on an individual or covered entity under specified circumstances; etc.
HB1347 Maryland Medical Assistance Program—Managed Care Organizations— Delegate Kipke Disenrollment Authorizing a Maryland Medical Assistance Program recipient, under specified circumstances, to disenroll from a managed care organization to maintain continuity of care with a pharmacy provider; requiring the Department of Health and Mental Hygiene to provide timely notification to the affected managed care organization
of an enrollee’s intention to disenroll under specified provisions of the Act; etc.
MARYLANDPHARMACIST.ORG 9
HB1383 (SB1018) Health Insurance-Specialty Drugs—Participating Pharmacies Altering the conditions under which insurers, nonprofit health service plans, or health maintenance organizations may require a covered specialty drug to be obtained through a pharmacy participating in the provider network of the insurer, nonprofit health service plan, or health maintenance organization; altering the definition of “specialty drug”; etc.
HBO752 (SB0647) Physicians—Prescriptions Written by Physician Assistants—Preparing and Dispensing Providing that specified provisions of law do not prohibit a licensed physician from personally preparing and dispensing a prescription written by a physician assistant in accordance with a specified delegation agreement if the physician complies with specified requirements.
HB0826 Prescription Drug Repository Program—Repository Inventory Requirement —Revision Requiring a repository that participates in the Prescription Drug Repository Program to maintain a separate inventory of donated prescription drugs and medical supplies that the repository intends to dispense under a specified provision of law, instead of a separate inventory of all donated prescription drugs.
$B0091 Public HealthState—Identified HIV Priorities Requiring rebates received by
the Department of Health and Mental Hygiene from the Maryland AIDS Drug Assistance Program as a result of State General Fund expenditures to be distributed to a specified special nonlapsing fund and used only to fund State-identified priorities for HIV prevention, surveillance, and care; requiring the Secretary of Health and Mental Hygiene to adopt regulations establishing, as appropriate, income and other eligibility criteria for the receipt of specified HIV prevention and care services.
SB0806 State Board of Physicians—Naturopathic Doctors—Establishment of Naturopathic Doctors Formulary Council and Naturopathic Formulary Establishing a Naturopathic Doctors Formulary Council within the State Board of Physicians; providing for the membership, terms, compensation, chair, and staff for the Council; requiring the Council to develop and recommend to the Board a specified formulary, provide specified reviews of the formulary, and make specified recommendations to the Board; requiring the Board to adopt a specified formulary; etc.
HB0056 (SB0063) Investigational Drugs, Biological Products, and Devices—Right to Try Act Authorizing a manufacturer of an investigational drug, biological product, or device to make available the investigational drug, biological product, or device to eligible patients; specifying the manner in which a specified drug, product, or device may be provided
to eligible patients; prohibiting a health occupations board from taking specified action against a health care provider's license on a specified basis; establishing that this Act does not create a specified cause of action; etc.
HBO091 (SB0442) General Provisions—Commemorative Days—National Healthcare Decisions Day Requiring the Governor annually to proclaim April 16 as National Healthcare Decisions Day.
$B0418 (HB0404) Richard E. Israel and Roger “Pip” Moyer End-of-Life Option Act— Authorizing an individual to request aid in dying by making specified requests; prohibiting another individual from requesting aid in dying on behalf of an individual; requiring a written request for aid in dying to meet specified requirements; establishing requirements for witnesses to a written request for aid in dying; requiring a written request for aid in dying to be in a specified form; requiring an attending physician who receives a written request for aid in dying to make a specified determination; etc.
10 MARYLAND PHARMACIST | SPRING 2016
Primary Sponsor
Delegate Kipke
Delegate Cullison
Delegate Adams
Chair, Finance Committee
Senator Pugh
Delegate Young, K.
Delegate Morhaim
Senator Young
Status
Unfavorable
Returned Passed
Unfavorable
Approved by the Governor— Chapter 46
Returned Passed
Unfavorable
Returned Passed
Unfavorable Withdrawn
University of Maryland School of Pharmacy Celebrates 175th Anniversary
By: Malissa Carroll
A reflection on how the School continues to be one of the leaders in pharmacy education, scientific discovery, patient care, and community engagement across the state of Maryland and beyond.
Visiting the University of Maryland School
of Pharmacy today, one cannot help but notice some bold changes in the decor
both inside and around Pharmacy Hall. New signage along Pine and Fayette Streets, as well as colorful wrappings on the poles, stairs, and elevators in the Ellen H. Yankellow Grand Atrium signify the commemoration
of an important milestone in the School's history. It is the School's 175th anniversary, and throughout 2016, faculty, staff, students, alumni, and friends are celebrating its nearly two centuries of leadership in pharmacy education, scientific discovery, patient care, and community engagement across the state of Maryland and beyond.
one
reyes = 8: Sasa
Maryland College of Pharmacy Building erected in 1886
“This remarkable milestone in the School of Pharmacy’s history could not have come
at a more opportune time, as health care professionals and policymakers
alike begin to recognize the essential role that pharmacists play in the nation’s health care delivery system,” says Jay A. Perman, MD, president of the University of Maryland, Baltimore (UMB). “With cutting-edge practice and research initiatives in the fields of drug discovery, drug development, and drug delivery, the School makes a tremendous impact not only on the pharmacy profession, but also on patients’ lives. It is what the School has done for 175 extraordinary years, and what I hope it will continue to do for many more years.”
From Humble Beginnings
Established in 1841, the School of Pharmacy was first known as the Maryland College of Pharmacy. It was initially chartered by the Maryland General Assembly in response to concerns from practicing apothecaries about the need for more educated and better trained pharmacists and pharmaceutical assistants to address the increasing number of medicines available to treat different illnesses. Before gaining recognition as a thriving center for professional and graduate education, pharmaceutical care, research, and community service, the School's first class included only six students and was held in a single room at the corner of Gay and Baltimore Streets.
Now ranked as one of the top ten schools of pharmacy in the United States, the School boasts more than 90 faculty, 300 staff, 700 students across its Doctor of Pharmacy (PharmD) and graduate programs, and 5,500 living alumni.
Continued on page 17
MARYLANDPHARMACIST.ORG 11
Cover Story
Provider Status
We talk alot about the idea of pharmacists having “provider status." But what exactly does that mean? Georgia Pharmacy Association CEO Scott Brunner sat down with Krystalyn Weaver, PharmD, the vice president of policy and operations for the National Alliance of State Pharmacy Associations, to talk about that phrase — why provider status is important, what it means and why we're working so hard to
achieve it locally and nationwide.
Across practice settings, provider status is seen as the great brass ring for pharmacists. So let's start by defining the term: What is provider status, and why do we need it?
Today the federal government does not recognize pharmacists as medical “providers” — specifically in Part B of the Social Security Act. That means Medicare beneficiaries aren't able to access pharmacists’ patient- care services such as diabetes management, smoking cessation assistance, and even simple wellness visits through their Medicare benefits.
Hence our goal of attaining federal “provider status.” A major step of that would be passage of the Pharmacy and Medically Underserved Areas Enhancement Act, aka H.R. 592 or S.314. It would allow Medicare to pay for pharmacists services in medically-underserved areas.
But if you dig into the “why’ of that objective, it’s more than just about pharmacists. It’s about the fact that patients benefit from the valuable services pharmacists can provide. We know that when pharmacists are on the healthcare team, outcomes improve and costs go down.
To sum it up, the goal is to ensure that patients’ have access to pharmacists’ brains — not just the products we dispense.
Back to the term provider status. Medicare access is
a major step, but it’s only the first step. The reality is
that we need to approach ensuring patient access to pharmacists services from more than one angle. Though Medicare patients make up a huge population of those who would benefit from pharmacist’s knowledge and skills, there are many other patients who do not have Medicare coverage.
12 MARYLAND PHARMACIST | SPRING 2016
This interview first appeared in Georgia Pharmacy magazine.
Krystalyn Weaver, PharmD
So “provider status” is broader. It encompasses any effort to get patients access to these services, which makes the meaning of that term somewhat complicated.
Add to that the fact that not every pharmacist wants
to provide those services. Often when I'm talking
about integrating more patient-care services into Our practices, I get the inevitable comment: ‘I'm too busy
in the pharmacy as it is. There is no way I can add even more activities to my day-to-day operations and still get prescriptions filled.”
As a practicing community pharmacist myself (although it's only moonlighting), I can relate. Any pharmacist
(or consumer for that matter) knows how busy a community pharmacy can be. It is, in fact, difficult to add to that workload in the world we live in now.
But that’s the key phrase: In the world we live in now. It doesnt have to be this way.
I challenge my peers not to think of the current practice environment. When were talking about broadening pharmacists’ services, think of the future. Remember that the reason we aren't already doing this is because Our payment system is broken — it doesn't recognize the value pharmacists are capable of providing. A core premise of the provider status push is that we have
to change our business model. We need to change
the practice environment and make it feasible for our services to be delivered effectively.
We are talking about overhauling our workflow so patient-care services become a focus, not an add-on. And yes, we're talking about new streams of revenue.
I would also argue that considering the ever increasing pressures to decrease what Americans pay for
prescription drugs, that a change in our business model is likely essential for pharmacies to survive. Any pharmacy owner can attest to the fact that margins are decreasing. In order to keep pharmacist jobs viable, we need to leverage our most valuable asset: our ability
to optimize medication regimens, assist patients with disease management and prevention, and decrease overall health care costs — not just get the right drug to the right patient at the right time (although that will
always be important).
Absolutely, there are plenty of data to show that pharmacists can save payers on the overall cost of healthcare in both the short and long term. There
are hard data showing that within one year, simply paying pharmacists to provide modest MTM services for Medicaid patients delivered a 4 to 1 return on investment. And data for the long term is even stronger — an average ROI as high as 12 to 1.
Unfortunately, the way new federal bills are analyzed
doesn't account for these savings. The Congressional
If the case is so strong, what's keeping Congress?
That's a great question, but it assumes that policy decisions are always made with 100 percent reliance on facts and data. The reality is that national policy is influenced by political pressures. And one of the biggest political pressures we're facing today is our national debt and the ever ballooning costs of entitlement programs. Adding pharmacists’ services to Medicare benefits will come at an added cost to the program, at least initially.
So rather than reflecting on why it hasn't happened yet, I like to focus on why now is a good time. There has never before been more of an awareness on health policy in the larger policy environment. Policy makers are realizing that saving money is more than simply cutting costs — it’s also critical to get the most value.
Pharmacists are pros at keeping people healthy and maximizing the utility of a critical healthcare resource: medications. We have plenty of data to show that.
More people are realizing this, so not only do we
have unprecedented collaboration among pharmacy associations, wholesalers, and national pharmacy chains, we are now seeing support from many outside organizations such as the Centers for Disease Control
| challenge my peers not to think of the current practice environment. When we’re talking about broadening pharmacists’ services, think of the future. Remember that the reason we aren’t already doing this is because our payment system is broken — it doesn’t recognize the value pharmacists are capable of providing. A core premise
of the provider status. push
is that we have to change
our business model. We
need to change the practice environment and make it feasible for our services to be delivered effectively.
Budget Office assigns a “score” to bills that estimates the cost of the bill to the federal budget over the next 10
years. But that score doesn't take into account cost savings — which doesnt help our cause one bit. We've heard that this process may be loosening a bit but the score of the federal bill will continue to be a challenge, especially in an election year.
You've mentioned that Congress would need to enact provider status at the federal level. But what about at the state level? Is there any benefit to asking the legislature to grant pharmacists provider status on a state level? What would state provider status look like?
Absolutely, there is a lot states can do to ensure patients access to and coverage for pharmacists’ patient care services (which is really what we mean by “provider status,” remember). Unfortunately, it isn't as simple as a state legislature granting provider status. The state environment is different than the federal one. At the federal level,
a somewhat simple change of
definition in law results in a massive change in the payment structure for MANY patients across the country. At the state level this almost always isn't the case.
There are often several places in state law and regulation where the term “provider status” is defined, each with
and Prevention, the National Governors Association, the Office of the Surgeon General, and others.
Okay, so Congress is concerned about the price tag. I
get that. Isn't there research, though, to demonstrate that the long-term savings from compensating pharmacists as providers is greater than the short- term costs? I can imagine healthier patients and reduced hospital admissions could save Medicaid and Medicare some real money,
a different degree of impact on patient access to pharmacists’ services. They may be important in their own way but are very unlikely to be the broader solution that a federal change would be.
Additionally, it’s at the state level where scope of practice is defined, and that’s an essential factor in pharmacists’ ability to provide the care they want to provide. In recent years, states have made improvements to laws regulating pharmacists: broadening immunization and collaborative practice agreements, allowing pharmacists to prescribe
MARYLANDPHARMACIST.ORG_ 13
travel medication, and promoting access to public health services through pharmacies, such as smoking cessation products and hormonal contraceptives.
Finally, states can influence local payers including Medicaid, state employee plans, and private payers through legislative or regulatory action, or by simply working with those payers directly and sharing the business case with them.
of practice? Providing services under collaborative practice agreements with physicians? Or simply doing stuff pharmacists can already do but currently can't be compensated for?
All of the above. As we discussed before, state provider status efforts often include work to align pharmacists’ scope of practice with their clinical ability — so patients aren't missing out on pharmacists’ care because of outdated laws. Collaborative practice agreements can allow for increased collaboration and efficiencies in care delivery — unless the state laws and regulations are so restrictive that entering into an agreement becomes
a burden.
And finally there is “stuff” pharmacists can already
do and already are doing that they aren't being compensated for. It won't be as easy as just submitting a quick claim for services; we'll need to comply with the rules and regulations other providers comply with now — including credentialing, documentation, quality assurance, etc.
How do you think physicians will react to that? Does it change the physician—pharmacist relationship?
The examples we currently have of physician- pharmacist collaborations are relatively few and far
between because it requires great creativity to make the relationship financially viable. But when we are able to find sustainable revenue streams to take the strain off of the system, physicians often report favorably on working closely with pharmacists. I think physicians and other providers will embrace the presence of pharmacists
on the health care team. Let's face it — drugs are complicated and there are plenty of other things doctors, nurses, physician assistants, and nurse practitioners have to focus on. Having a medication expert on their side will make their job that much easier and allow them to provide care to more patients.
How do you see this new paradigm impacting the quality of patient care?
It's been said many times before, but I'll say it again: When pharmacists are on the team, health outcomes improve and costs go down. I think it’s a given that pharmacists’ services can improve quality. The impact pharmacists are already making, even in our broken system, is probably underappreciated. But I think if
we align the incentives appropriately — and build an infrastructure that allows pharmacists to access the patient health data they need — the system can be fixed to maximize pharmacists’ skills and improve patient care.
Let’s talk about compensation. If, as providers, pharmacists could be compensated for a broader range of their services, what does that look like? What are the mechanics of it?
I dont want it to sound like an easy, quick transition. We'll need to adjust workflows, reimagine how we use pharmacy technicians, implement infrastructure changes to allow pharmacists to plug into the information systems hospitals and doctors use, and learn how to
do medical billing. And medical billing is VERY different
PROVIDER STATUS IN MARYLAND
Richard DeBenedetto, PharmD, MS, AAHIVP, Chair, Provider Status Working Group, Maryland Pharmacy Coalition
The need for pharmacists to be recognized as providers to provide services that improve outcomes
for patients is great. Pharmacists being reimbursed for cognitive patient care services, similar to how other professions are reimbursed, is necessary to place more pharmacists into settings where they are monitoring all aspects of medication use. With small efforts to provide MTM services, we see substantial ROI, the expansion of MTM, disease state management, and other cognitive services. Expanded cost savings are
Medicare.
14 MARYLAND PHARMACIST | SPRING 2016
generated and value is placed on pharmacist services where it belongs — on the service and not on the product.
MARYLAND PHARMACY COALITION (MPC) AND PROVIDER STATUS
In the 2015 legislative session, MPC developed and facilitated passage
of two bills signed in to law that advance pharmacists as providers. The first bill allows pharmacists to be able to administer ‘self administered’ medications. While this sounds like
a minor effort, this is not allowed in many states and improves our ability to provide assistance to patients in need. A second bill expanded the scope of Drug Therapy Management Contracts,
While the federal provider status initiatives are helpful in some respects, they do not help all Maryland patients. The federal law only would apply to Medicare patients in underserved areas; we have many Medicare patients needing pharmacist services outside
of the specified areas and there are many patients who are not covered by
It’s been said many times before, but Ill say it again: When pharmacists are on the team, health outcomes improve and costs go Gown. t think it’s a given
that pharmacists’ services can improve quality. The impact pharmacists are already making, even in our broken system, is probably underappreciated. But | think
if we align the incentives appropriately
— and build an infrastructure that allows pharmacists to access the patient health data they need — the system can be fixed to maximize pharmacists’ skills and improve patient care.
than prescription billing, which is quick, automated and immediately tells you if a claim is covered.
In medical billing, a claim is submitted, but the provider may not know for weeks if it will be paid by the insurer. Copays have to be collected at the time of service but are only estimates of what the patient's cost share is
— meaning you have to bill the patient after the fact as well. And if a claim isn't covered, the dispute process can be lengthy and arduous. Obviously all of these challenges have been overcome by our colleagues in other health professions so they're not insurmountable, but they will be big changes for pharmacy.
also known as collaborative practice agreements. The changes allow for pharmacists to initiate therapy under protocol from physicians and also allow non-physician prescribers
be contractually contained or legally required in Maryland. We are also looking to work with Medicaid and other insurance providers to seek ways to include pharmacists in the listing of
Sounds like this is an issue pharmacists need to anticipate, so that when it’s enacted, our members are ready to take advantage of it on day one.
What can pharmacists be doing now to prepare themselves, their practices, and their patients for provider status?
Pharmacists can get themselves ahead of the game by incorporating services into their current business model now. Start small. Consider incorporating medication synchronization into your pharmacy. Incorporate other adherence interventions. Make sure to fulfill all of the Medicare Part D MTM opportunities that come your way. This will help you to get your workflow to a better place and start to change patient perceptions about the level of care pharmacists are capable of providing.
Build relationships in the community. Reach out to local physicians’ offices, get to know the care managers in the local hospital and see if you can find a way to help them with medication reconciliation at discharge. Building relationships will also build a referral network. Yes, this will mean business when we are able to bill Medicare for medical services, but it will also mean increased business now. If your local providers see
you as the go-to pharmacy for optimal medication management, they will send their patients to you.
Try to understand the quality measurement landscape — and beyond Star Ratings. Physicians, ACOs, medical homes, and hospitals are all held to different quality metrics. Learn what they are, learn what the pressure points are, and think of how pharmacists can help to achieve those metrics. Also, get to know the billing codes that may be available to us through Medicare. These include CPT codes, chronic care management codes, G-Codes and more. The Medicare Learning Network is a great resource. Sign up for their email list and get information sent to you regularly. @
WHAT CAN YOU DO?
e Urge your elected leaders to support HR 592/S314 Pharmacy and Medically Underserved Areas Enhancement Act
to enter into agreements with pharmacists.
Our current efforts are now focused on payment for pharmacist services. We are currently allowed to do many patient care activities, but have few funding mechanisms for this care. Through careful examination of several insurance benefits contracts and the law, we are researching areas where expansion of payment may
providers who can bill for services.
Finally, we are working to change
the status quo by educating other professions about the benefits of pharmacists in the direct care of
their patients. Not only are there cost benefits to the system for reducing patient care expenditures, but other providers can actually earn money by including pharmacists who can bill services on the patient care team.
Provide education to providers on what pharmacists are qualified and able to do for them and their patients
Engage in formal opportunities to collaborate in the professional setting and improve professional relations with other providers outside the medical setting @
MARYLANDPHARMACIST.ORG 15
The Role of Ethics in Pharmacy
By: Dixie Leikach, RPh, MBA, FACA
President and CEO of PEER (Pharmacy Ethics, Education, and Resources)
Pharmacy is an honorable profession. Pharmacists, student pharmacists, and pharmacy technicians work hard and spend their days in stressful environments, yet make a difference in patients’ lives. Pharmacy technicians are on the front lines and are a pharmacists’ eyes and ears. Student pharmacists study hard and dedicate the most time of any healthcare professional to the mastery of medications. While this article focuses on pharmacists and their role in making ethical decisions, this topic is relevant to all pharmacy professionals regardless of role. Ultimately, running a pharmacy is a team effort, and the team must play by the same set of rules to maximize efficiency and effectiveness.
There are core assumptions that those that decide on pharmacy as
a profession are knowledgeable, educated, and ethical, and that these individuals want what is best for the patient at all times. Ethics plays a large part in the public's perception of pharmacists and patient safety. However, little information on pharmacy-specific ethics exists,
and few educational sessions are available to improve pharmacist's knowledge. The more discussions pharmacists have on ethics, the better pharmacists can serve their patients.
Autonomy, beneficence, nonmaleficence, and justice are
the four leading healthcare ethical principles.* Autonomy is the principle that patients have the right to make their healthcare decisions, and the job of the healthcare professional
is to ensure the patient has all of the necessary information to make their decisions. The healthcare professional must respect the decision of the patient, even if
the decision doesn't perceive the patient's best interest. Beneficence is the principle that healthcare professionals must strive to do the best for every patient in every unique situation. Nonmaleficence is the principle of “first, do no harm” and is the principle that most healthcare professionals recognize and follow.® The last principle, justice, highlights that healthcare professionals
must be fair and consistent in treatment decisions and allocations of resources for every patient. In making a sound ethical decision of justice, healthcare professionals must be able to justify their actions.*
Although pharmacy is a healthcare profession, in many practice settings, it is also a business. Therefore, the principles of business ethics must also be considered. Healthcare is changing and payment models are shifting. Pharmacists must comply with both business and healthcare ethical principles when making decisions in their workplace in order to keep the patient's best interests
at the forefront. Many principles
are considered business ethics,
but there are common themes among all such as, trustworthiness, responsibility, citizenship, fairness, caring, and respect. Integrating all of these principles into each decision can be difficult, but one easy way to determine if a business decision is ethical is by considering whether it would hold up under the scrutiny of a regulatory review or audit.
16 MARYLAND PHARMACIST | SPRING 2016
Thorough knowledge and consideration of pharmacy regulations is a prerequisite to making sound decisions. This
is necessary not only because adherence is mandated, but also because many of the regulations resulted from high-profile
situations where the actions of
a few pharmacists purposefully
or accidentally ignoring sound ethics resulted in significant patient harm and great public concern. Consequently, laws were then changed to prevent a recurrence. Two cases in particular have had lasting effects on our profession, and it is important for all members of the pharmacy team to reflect on them.
One particular law that dictates most of the pharmacy profession today is the Federal Food, Drug,
and Cosmetic Act of 1938.4 This law was the result of the sulfanilamide tragedy, and with its many updates it still stands today. The pharmacist that concocted the poisonous substance containing diethylene glycol, an antifreeze agent, to hide the flavor of the bitter medication may or may not have known that there was a risk with the formula used. Whether the pharmacist knew beforehand this was a potent poison was never determined, but regardless of his knowledge, ultimately over 100 people died and countless more sustained serious illness. As healthcare professionals, the need to embrace change and look for new ways of healing are necessary. However, healthcare professionals always need to consider the worst Case scenario and make sure the mainstay principle of ethics is being
honored: nonmaleficence, first do no harm.
are not always easy and sometimes contradict each other. However, it is crucial to continue to increase awareness and education on the topic of ethics and how it plays an important role in pharmacy in order to better serve patients. @
patient harm and a tremendous change in the profession. As seen in both examples, the breach of ethics
More recently, the Drug Quality and can irrevocably change lives.
Security Act of 2013 is the result of the New England Compounding Center tragedy, where one pharmacy caused 64 deaths and illness in over 800 patients due to poor practice and alleged illegal activity.° Violations
Ethics plays a large role in healthcare professionals’ everyday lives. Pharmacists that consider ethics in their daily practice are more likely
to improve patient safety and their
of many ethical principles caused
References:
standard of practice. Ethical decisions
1. Buerki RA, Vottero LD. Pharmacy Ethics: A Foundation for Professional Practice. Washington, DC: American Pharmacists Association; 2013. 2. Runzheimer J, Larsen LJ. Basic Principles of Medical Ethics. Dummies Website. http://www.dummies.com/how-to/content/basic-principles-of-medical-ethics.html.
Accessed September 10, 2015.
3. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 2nd ed. New York, NY: Oxford University Press; 2013.
4. Martin Barbara J. Elixir: The American Tragedy of a Deadly Drug. Lancaster, PA: Barkerry Press; 2014.
5. Kennan Stephanie A. Drug Quality and Security Act What You Need to Know. McGuireWoods Website. https://www.mcgutrewoods.conv/Client-Resources/ Alerts/2013/12/Drug-Quality-and-Security-Act.aspx. Updated December 4, 2013. Accessed September 10, 2015.
University of Maryland School of Pharmacy
Celebrates 175th Anniversary continued from page 11
“All alumni should be proud to be part of the School's amazing 175-year legacy,” says Sharon Park, PharmD ‘04, president of the School's Alumni Association. “It is important to remember, however, that it is not only the number that is important, but also the excellence and dedication of the School's faculty, staff, students, and alumni that has persevered over all this time.”
A Grand Birthday Celebration
To formally kick-off the School's year-long anniversary celebration, Natalie D. Eddington, PhD, FCP, FAAPS, dean and professor of the School, hosted a birthday celebration for faculty, staff, students, and alumni on Feb. 10. The celebration, which featured birthday cakes decorated with photos of the five different buildings
in which the School has been housed throughout the years, offered an opportunity to reflect on the School's history and called on attendees to look beyond the School to how the advances being achieved within its walls could make the greatest impact on the
local community.
“The one word that comes to mind when | think
about the School on the occasion of its 175th anniversary is community,” says Eddington. “We are a strong, thriving community of scholars, practitioners, researchers, students, and staff. As we kick off the many celebrations that will mark this milestone year, my challenge to all of you is to think about the community beyond the walls of Pharmacy Hall. I want all of us to work together to focus on service during this 175th anniversary, and to build upon the great work that
our faculty, staff, and students already do with many community groups.”
Beyond the Wails of
Pharmacy Hall
From offering tutoring services for middle and high school students to conducting research that leads to the development of new medications, there is a lot of great work being done by faculty and students alike
to help enhance the local community. Faculty in the School's Department of Pharmacy Practice and Science partner with more than 200 community pharmacies, hospitals, nursing homes, and other agencies to provide services to residents and practitioners across the state of Maryland and beyond. The Patient- Centered Involvement in Evaluating the Effectiveness of Treatments (PATIENTS) program led by C. Daniel Mullins, PhD, professor and chair of the Department of Pharmaceutical Health Services Research at the School, has also been recognized for its groundbreaking work to empower patients to propose questions about their health care and participate in research studies designed to help answer those questions.
However, as Eddington notes, there is still much work to be done.
“Baltimore City is much different today than it was
in 1841," adds Eddington. “It is a vibrant, dynamic community, but it is also in need of our assistance. Many of our neighbors lack access to basic goods and services, as well as to health care. Faculty, staff, students, and alumni at the School have a multitude of expertise and the ability to help move our city forward. We have the manpower, the drive, and the heart to be more involved and to make more of a difference.” @
MARYLANDPHARMACIST.ORG 17
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Continuing Ed
Take Each Pill with a Grain of Salt:
A Review of Abuse-Deterrent Opioid Formulations and Place in Therapy
Diana Stewart, Pharm.D., PGY2 Pain and Palliative Care Resident
Mary Lynn McPherson, Pharm.D., MA, BCPS, CPE; Professor and Executive Director Advanced Post-Graduate Education in Palliative Care
University of Maryland School of Pharmacy
Opioids have been used for their analgesic and sedative properties throughout history; references to medical use of the opium poppy plant can be found dating back to ancient civilizations in Mesopotamia as early as 3000 B.C.! With the therapeutic use of opium came struggles with abuse and addiction, prompting the search for safer analgesic agents. Morphine (named for Morpheus, the god of dreams) was isolated in 1806, but was quickly found to have a similar potential for abuse as opium. When heroin was synthesized almost a century later, it was initially touted as a potent analgesic and abuse-free opioid.“ Needless to say, such claims of low potential for abuse and addiction from morphine and heroin have been thoroughly discredited.
Despite significant advancements in drug development in other therapeutic areas, opioids remain the gold standard for treatment of severe acute and cancer-related pain. The use of opioids for chronic non-cancer pain is more controversial. It is estimated that 90-95% of prescriptions for long-term opioid therapy are for non-cancer indications.’ Opioid prescribing increased significantly since the early 1990s when quality initiatives, such as ‘Pain as the 5th Vital Sign’ through the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Veterans Health Administration sought to address inadequately treated pain through the promotion of consistent standards for monitoring and treating pain.* Unfortunately, increases in opioid prescribing are mirrored in trends in abuse and overdose deaths and have led to an opioid epidemic in the United States.
Learning Objectives After completing this activity the participant will be able to: Key Words 1. Describe trends in opioid abuse and overdose in the United States. * Abuse deterrence
2. List the seven types of abuse-deterrent formulations as defined by * Opioids the FDA.
3. Describe the abuse-deterrent properties of commercially available products according to the FDA guidance.
e Drug formulation
e Pain management
4.Select an appropriate candidate for treatment with an abuse- deterrent opioid formulation within a patient case study.
MARYLANDPHARMACIST.ORG 19
The Opioid Epidemic
The sale of prescription analgesics has quadrupled in the United States since 1999. Likewise, the incidence of opioid-related overdose deaths has quadrupled in the same time frame, and more than sixty percent of drug overdose deaths involve an opioid.’ The agents most commonly implicated in prescription opioid overdose deaths are methadone, oxycodone, and hydrocodone.® It should be noted that 73 to 80 percent of methadone overdoses have been classified as unintentional, and the absolute number of overdose deaths involving methadone was less than those involving cocaine, oxycodone, hydrocodone, and fentanyl.’
The rate of heroin abuse has also increased substantially since 2006, and the rate of related overdose deaths
has more than tripled since 2010.° Heroin use is increasing in populations with historically low rates of abuse including women, the privately insured, and those with higher incomes. Prescription medications may
be perceived as safer than illicit substances, however addiction to opioid analgesics has been cited as the strongest risk factor for heroin addiction. Individuals who are addicted to opioids are forty times more likely to be addicted to heroin compared to fifteen times more likely if addicted to cocaine, and three times more likely if addicted to marijuana.?"° While inadequately treated pain was a concern in the early 1990s, the inextricable relationship between prescription opioids, and prescription and non-prescription opioid abuse, addiction, and overdose deaths is a national priority and has led to the recent implementation of initiatives at local, state, and federal levels.®
Sidebar Case
Combating Opioid Abuse
Many strategies aim to reduce access to opioids for illegitimate or non-medical uses. These include state prescription drug monitoring programs, educational programs for healthcare professionals and the public, overdose prevention measures with opioid antagonists such as naloxone, and punitive legislation.°' These tactics do not alter the abuse potential of opioids, and critics have voiced concern that stringent regulation of prescribing practices may limit access to appropriate therapy for patients with legitimate pain. Abuse- deterrent formulations are a newer tactic employed
by drug manufacturers to make the dosage form difficult to manipulate for non-medical purposes. This is differentiated from tamper-resistance, which typically refers to packaging requirements for a medication.
The most common route of administration implicated in opioid abuse is oral ingestion of an intact or compromised dosage form, but can also involve inhalation or injection. Dosage forms can be crushed, chewed, ground, pulverized or extracted to make the medication easier to swallow or allow for an unintended route of administration. Physical alteration decreases the time to maximum concentration (Tmax) and increases the maximum concentration (C3) achieved to enhance euphoric effects of the opioid. Many of the commercially available abuse-deterrent opioids make physical alteration difficult and thwart this dose-dumping effect. The U.S. Food and Drug Administration (FDA) released
a draft guidance report for pharmaceutical industry
on abuse-deterrent opioids in 2013 and final guidance in 2015. The intent of the guidance is to facilitate the development of safer, abuse-deterrent products by providing non-binding standards for abuse-deterrence studies, product formulations, evaluation, and labeling.
Prescribing Considerations for Abuse-Deterrent Opioids |
Henry, a 35 year-old man, was referred to a pain clinic for chronic lower back pain secondary to a motor vehicle accident. Henry's primary care physician referred him to the clinic after multiple early refill requests for opioids. His current analgesic regimen consists of acetaminophen 650 mg by mouth every 4 hours as needed, MS Contin® (morphine extended release) 15 mg by mouth every 8 hours, and oxycodone 5 mg by mouth every 4 hours as needed. He did not complete recommended physical therapy because he said “it didn’t do any stinking good" and high co-pays. Henry is an active smoker (1 pack per day) and has
a remote history of cocaine use ten years prior. The patient is 5'10" and weighs 280 pounds; when asked he says ‘I'm a couch potato and proud of it." When asked about his goals for the treatment plan, Henry states that he would like to increase the dose of his MS Contin® and breakthrough oxycodone so as to be able to return to his job as an accountant and play with his two young children. He is concerned about switching to one of those “new, fancy drugs” due to high costs.
Is this patient at risk for
opioid abuse?
Patients should be screened for risk of opioid abusive drug-related behaviors using a validated tool during initial
20 MARYLAND PHARMACIST | SPRING 2016
assessment. Risk factors that have been determined to be clinically significant include a family or personal history of substance abuse with alcohol, illegal drugs, or prescription drugs, age
between 16 to 45 years, history of pre- adolescent sexual abuse, concurrent psychological disease, and male gender.“ Henry has multiple “red flags” — he did not follow the complete plan
Potential formulations of abuse-deterrent opioids have been broadly defined within seven categories and are summarized in Table 1.*°
In order to meet the labeling requirements set forth
in the guidance, a medication must demonstrate safety and efficacy in pre- and post-market studies. Category 1 studies evaluate in vitro manipulation and extraction to assess the ease with which the abuse- deterrent properties can be defeated or compromised. Category 2 studies compare the pharmacokinetic profile of manipulated and intact formulations against comparator formulations through one or more route of administration. Category 3 studies are referred to as drug-liking studies and evaluate how probable it is that the formulation will be attractive to abusers. Category 4 post-market studies determine if the formulation resulted in a meaningful reduction in abuse, misuse, addiction, overdose, and death.’* Studies should
assess known or anticipated routes of abuse that are specific to that opioid. By limiting one form of abuse,
it is critical that the product does not encourage an alternative, potentially more dangerous route of abuse, such as intravenous injection of an opioid following reformulation to prevent crushing and snorting. Many of the abuse-deterrent products currently on the market target multiple potential routes of administration for this reason.
Abuse Deterrent Opioids
Three products have received FDA approval for abuse- deterrent labeling in the United States. Oxycodone is an opioid that has been widely abused, particularly the extended release formulation OxyContin®. This was the first opioid to be reformulated with abuse-deterrent properties in 2010 and received FDA approval for
abuse-deterrent labeling in 2013. OxyContin® utilizes proprietary INTAC® technology that is resistant to crushing, breaking, and dissolution and is categorized as a physical/chemical barrier. If submerged in an aqueous environment, the tablet forms a viscous hydrogel that resists passage through a needle and cannot easily
be snorted. Early category 4 post-marketing studies demonstrated a 32-33 percent reduction in abuse, a
15 percent reduction in overdoses, and a 22 percent reduction in street price.**°
Hysingla®, extended release hydrocodone, received approval for abuse-deterrent labeling in 2014 and is classified as a physical/chemical barrier. This agent utilizes a proprietary RESITEC® formulation that confers tablet hardness to resist crushing or chewing, and forms a viscous substance if dissolved in aqueous solutions to deter snorting or injecting.”
Embeda® is an agonist/antagonist formulation that was approved in 2014. It contains a combination of extended release morphine and the opioid antagonist naltrexone, which is sequestered and has no effect if taken as directed. The naltrexone is fully released if the dosage form is crushed, chewed, or dissolved in
a solvent and may precipitate withdrawal in opioid- dependent patients.”
Other commercially available opioids have physical/ chemical barriers against abuse, but have not received FDA approval for abuse-deterrent labeling. Zohydro®
is extended release hydrocodone formulated with BeadTek®, an excipient that inmediately forms a viscous gel if the tablet is crushed and dissolved to deter snorting or injecting.18 Exalgo® is an extended release product containing hydromorphone. Exalgo® is formulated with an osmotic delivery system that is resistant to crushing - and extraction, and releases the hydromorphone at a
of care (physical therapy), history of smoking and cocaine use, and multiple requests for early refills.
What observed behaviors might be of concern for opioid abuse
or misuse?
Aberrant behavior describes patient actions that are inconsistent with
the prescribed treatment plan. These range from mild behaviors, such as using pain medication to treat other symptoms such as anxiety, to more severe behaviors such as crushing and snorting oral medications to achieve more rapid onset. Drug- seeking behavior is often a red flag to prescribers, but behaviors may overlap with signs of untreated pain: frequent emergency room visits, preoccupation
with obtaining pain relief, and requesting specific analgesics by name.” Henry's physician states the patient is consistently requesting early refills of opioids.
What factors should be considered prior to recommending an abuse- deterrent opioid?
First, determine if the patient is an appropriate candidate for opioid
analgesia based on the pain syndrome.
For example, low back pain is a chronic condition where opioids are usually NOT recommended. Henry should follow the plan of care for drug and non-drug therapy, and life style modification is likely an important part of his treatment plan (lose weight, exercise). Also, neuropathic pain is
generally a considerable part of low back pain; Henry would likely benefit from an adjunctive analgesic such
as gabapentin, pregabalin, a tricyclic antidepressants, or duloxetine.
Assuming opioid therapy is appropriate, it is important to obtain a thorough history and conduct a validated risk assessment to identify patients who are actively abusing
or at high risk for abusing opioids, and by what route. Other factors to consider include insurance formularies and the patient's ability to afford the medication, if the abuse-deterrent formulation targets anticipated routes of abuse, and if the patient is able to ingest the intact dosage form.
MARYLANDPHARMACIST.ORG 21
controlled rate over 24 hours.’? New abuse-deterrent opioids are currently under development, some of which feature aversion technology with substances like niacin that would cause nasal irritation and flushing if the tablet were crushed and snorted.
Conclusion
The number of abuse-deterrent opioids that have been brought to market in recent years is reflective of a collective commitment to addressing the national opioid epidemic. Despite this, place in therapy for these products remains unclear due to several factors. The rate of opioid-related deaths has continued to increase despite the introduction of abuse-deterrent formulations.*° A study of 11,000 drug users at 150 treatment centers across the U.S. revealed that 25 percent continued to abuse OxyContin® even though they found the new abuse-deterrent formulation to be less attractive.*! Perhaps a more sobering trend is an increase in heroin abuse by almost 100 percent which has coincided with a 474 percent reduction
in OxyContin® abuse. This is largely due to reduced availability of the old OxyContin® formulation that lacked barriers to abuse, and a lower relative cost of heroin
Regulations and medication-based technology must
be capable of evolving with rapidly changing trends
to continue to provide a meaningful impact in abuse. Users who are determined to obtain euphoric effects can easily find tips and how-to videos on web-based forums with detailed instructions on defeating abuse-deterrent properties. Although the new formulations prevent alteration of the dosage form, they do not prohibit patients from ingesting a higher quantity than directed to achieve desired effects and do not protect against the most common form of ingestion in opioid overdoses — the oral route.
Most importantly, reformulating opioids to reduce abuse does not address underlying issues with addiction or prevent patients from becoming addicted. The abuse- deterrent formulations may be beneficial in a subset
of patients; particularly those identified as high risk for abuse based.on validated screening tools. Patients who abuse opioids by inhalation or injection may also be appropriate candidates for abuse-deterrent formulations, but must be monitored closely to ensure they are not shifting to heroin abuse. Patients may even request these products if they are concerned about diversion
in the home from family, friends, or caregivers. Crush-
compared to OxyContin®.~ Cost is a limiting factor for many patients, as generic products are more favorably priced and the abuse-deterrent products are currently brand-only. Coverage for OxyContin® under Medicare Part D actually decreased from 61 percent to 33 percent from 2012 to 2015 while the generic immediate-release formulation of oxycodone, which lacks abuse-deterrent properties, was fully covered.* Price competition may reduce prices as more abuse-deterrent formulations are approved however high co-pays are a barrier for many
resistant opioids are not appropriate for all patients, particularly those with enteral feeding tubes. It is imperative that healthcare providers remain aware of the distinction between abuse-deterrence and abuse- proof to avoid developing a false sense of security. The prescribing of abuse-deterrent formulations does not preclude completing initial and repeat risk assessments, performing appropriate monitoring and follow-up, or using good clinical judgment. Opioid abuse is a complex and deep-rooted problem that requires a multimodal
patients. approach in order to affect meaningful change.
References
1. Teall EK. Medicine and doctoring in ancient 10. Compton WM, Jones CM, Baldwin GT. 17, Embeda?® [package insert]. New York, NY: Pfizer Mesopotamia. Grand Valley Journal of History Relationship between nonmedical prescription- Inc.; 2014.
2014 S(i alee: opioid use and heroin use. N Engl J Med 18. Zohydro® [package insert]. Morristown, NJ: Pemix
2. Brownstein MJ. A brief history of opiates, opioid 2016;374:154-163. Therapeutics, LLC.; 2016. peptides, and opioid receptors. Proc NatlAcad Sci 11. Webster LR. Ending unnecessary opioid- 19. Exalgo® [package insert]. Hazelwood, MO: 1993;90:5391-5393. related deaths: a national priority. Pain Med Mallinelcodt Brae Crariace tical bier
3. Sullivan M, Ferrell B. Ethical challenges in the 2011;12:S13-S15. 20. Leece p, Orkin AM, Kahan M Taneenteaeone management of chronic nonmalignant pain: 12. U.S. Food and Drug Administration Center for ; drugs ceneaeenetha opioid crisis. CMAJ 2015: Negotiating through the cloud of doubt. J Pain Drug Evaluation and Research. Abuse-deterrent DOI:10.1503/cmaj.150329 2005;6:2-9. opioids — evaluation and labeling guidance for 1G TJ, Ellis MS. A :
4. Pletcher Md, Kertesz SG, Kohn MA, et al. Trends in industry. Silver Spring, MD 2015. puget pa isa pale mld hs. opioid prescribing by race/ethnicity for patients 13. Harris SC, Perrino PJ, Smith I, et al. Abuse United ere pete Payenan aol Toes: seeking care in US emergency departments. potential, pharmacokinetics, pharmacodynamics, 430 JAMA 2008;299(1):70-78. and safety of intranasally administered crushed an F
5. Centers for Disease Control and Prevention. oxycodone HCl abuse-deterrent controlled- Es ee Leas fier pe oe ee Increases in drug and opioid overdose deaths — release tablets in recreational opioid users. J Clin a One en OF Ore ONT SIDE Nes a United States. 2000-2014. MMWR 2015;64:1-5. Pharmacol 2014;54(4):468-477. . RNIN oe
6. Ossiander EM. Using textual cause-of-death 14. Severtson SG, Bartelson BB, Davis JM, et al. es Mages ae eo au Pee data to study drug poisoning. Am J Epidemiol Reduced abuse, therapeutic errors, and diversion chalieto ae a ave Ankh ie gkes k 2014:179(7):884-894. following reformulation of extended-release properies: Weshiigeory =.
oe oxycodone in 2010. J Pain 2013;14(10):1122-1130. 24. Webster LR, Webster RM. Predicting aberrant
7. Kung HC, Hoyert DL, Xu JQ, et al. Deaths: Final behaviors in opioid-treated patients: limi data for 2005. National vital statistics report 15. Butler SF, Cassidy TA, Chilcoat H, et al. Abuse idanowiad tee cee cae en 2008:56(10):1-124. rates and routes of administration of reformulated peewee vies a pase rer eee ee
8 ; f extended-release oxycodone: initial findings d i : : | Dart RC, Surratt HL, Cicero TJ, et al. Trends in from a sentinel surveillance sample of individuals 25. Larance B, Degenhardt L, Lintzeris N, et al. opioid analgesic abuse and mortality in the F initi i United States. N Engl J Med 2015:372-241-248 assessed for substance abuse treatment. J Pain Definitions related to the use of pharmaceutical
ee is g net ; 2013;14(4):351-358. opioids: extramedical use, diversion, non-
enters for Disease Control and Prevention. Vital 16. Hysingla® [package insert]. Stamford, CT: Purdue adherence, and aberrant medication-related
signs: Today's heroin epidemic — more people at risk, multiple drugs abused. MMWR 2015.
Pharma L.P.; 2014.
22 MARYLAND PHARMACIST | SPRING 2016
behaviors. Drug Alcohol Rev 2011;30:236-245.
Table: Abuse-Deterrent Formulations (12)
FORMULATION DESCRIPTION EXAMPLES
Physical/ chemical barriers | Drug release limited following e Physical barriers prevent chewing, manipulation, or physical form is changed crushing, cutting, grating, or grinding to make it more difficult to abuse
e Chemical barriers resist opioid extraction with water, alcohol, or organic solvents
Agonist/ antagonist Interfere with, reduce, or defeat euphoria ¢ Opioid antagonist, such as naloxone, combinations associated with abuse may be sequestered so that it is only released upon product manipulation
e Irritation to nasal mucosa if manipulated product were snorted
Aversion Substance added to opioid to produce unpleasant effects if the dosage form is manipulated or used at a higher dose
than directed
Delivery system Drug-release designs or delivery methods e« Depot injections and implants that are that offer resistance to abuse difficult to manipulate
New molecular entities Could contain a chemical barrier to in vitro | « Need for enzymatic activation and pro-drugs conversion to active opioid to deter abuse
¢ Different receptor binding profiles
e Slower penetration into the central nervous system
e Other novel effects
Combination Two or more formulations combined to e Combination of physical barrier deter abuse and aversion
Novel approaches Novel approaches or technologies not captured in previous categories
CONTINUING EDUCATION QUIZ
PharmCon is accredited by The authors have no financial disclosures ae Ba cd pone eno (2) Scroll down to Homestudy/ ot aeee peal oe This program is Knowledge Based — OnDemand CE Credits and select the ® Sees en ee acquiring factual knowledge that is based Quiz you want to take. r : d ccepted in the literature . continuing education credit ae oe Tash ve oeedl eters eines (3) Log in using your username (your will be awarded within six to eight weeks. y email address) and Password Directions for taking this issue’s quiz: MPHA123 (case sensitive). Please
Program Release Date: 05/01/16 change your password after logging
This issue's quiz on Take Each Pill with in to protect your privacy.
Program Expiration Date: 05/01/19 a Grain of Salt: A Renew of Abuse-
This program provides for 1.0 contact Deterrent Opiod Formulations and (4) Click the Test link to take the quiz.
hour (0.1) of continuing education Place in Therapy can be found online Note: If this is not the first time you are
credit. Universal Activity Number (UAN) at www.PharmCon.com. signing in, just scroll down to Homestudy/
ee eed (1) Click on “Obtain Your Statement of OnDemand CE Credits and select the quiz CE Credits for the first time. you want to take.
CE Questions Answers from page 24 4)-B:.2) C;.3) A; 4) D;'5) B; 6) A; 7) D; 8) C; 9) B; 10) A
MARYLANDPHARMACIST.ORG 23
CE Questions
1 Physical barriers against opioid abuse are best 6 The incidence of OxyContin® abuse has decreased described as: substantially since the product was reformulated in 2010. What other trend has coincided with this
A. Medication formulations that prevent oral change?
ingestions
B. Medication formulations that prevent chewing, A. Increase in heroin use
crushing, or grinding . Increase in insurance coverage for OxyContin®
C. Chemicals that inactivate the opioid if the product . Decrease in heroin use
is manipulated Decrease in the use of other opioids
D. Medication formulations that inhibit addictive
properties of opioids a 7 Which opioids use physical/chemical barriers to
prevent abuse? What category of abuse-deterrent formulation studies A evaluates how probable it is that the formulation will be attractive to abusers in drug liking studies B. Exalgo
A. Category 1 C. Embeda
B. Category 2 D. AandB C. Category 3 E.All of the above D
OxyContin
Category 4 8 The most common route of administration involved in
eek opioid overdoses: Which of the following was the first opioid to receive
FDA approval for abuse-deterrent labeling? A. Inhalation A. OxyContin® Injection
B Vicodin® Cam Oral D. Rectal
B C. Hysingla® D. Exalgo®
9 Which of the following is a barrier to the utilization of
“4 abuse-deterrent opioid formulations? 4 The sale of prescription opioids has almost :
quadrupled in the last decade, while the incidence of A. Lack of guidance from regulatory bodies has quadrupled as well. High cost associated with branded products
B Opioid-induced constipation C. Lack of prescriber awareness of opioid abuse D
Marijuana abuse No opioids have been approved with abuse-
Reported pain by patients deterrent labeling
Opioid-related overdose deaths
10 Prescribing abuse-deterrent opioids for patients with pain would be most appropriate based on which of
5 Embeda® (extended release morphine/naltrexone) the following characteristics?
utilizes which type of abuse-deterrent formulation?
A. Patients who report crushing and snorting opioids A. Physicalichemical barrier to achieve faster onset of analgesia
Agonist/antagonist combination B. Patients with young children in the home
Patients with multiple emergency department
B C. Aversion technology D. Delivery system visits for back pain
Patients who require medications be crushed for administration through a PEG tube
Answers on page 23
24 MARYLAND PHARMACIST | SPRING 2016
THANK YOU TO OUR 2016 CORPORATE SPONSORS
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WELCOME NEW MEMBERS
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Waves of Change OCEAN OF OPPORTUNITY
Cruzita Bryant
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Register online today! www.marylandpharmacist.org.
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APPRECIATION
I express sincere appreciation for all the hard work MPhA volunteers do throughout the year, whether they have an “official” role or not, our volunteers are the fuel that powers MPhA.
If you are not already involved, get involved! It
is the best way to get to know your colleagues and engage with people beyond your practice site. There are numerous short-term projects and longer-term leadership opportunities that need your diversity of thought, practice specialty, and experience to make them a success. Many new initiatives come from suggestions made by individual members like you.
The first quarter of 2016 has been quite busy for MPhA!
ADVOCACY
MPhA didn't introduce legislation this year, but we had an engaged legislative session, much of the work involved providing feedback on policy, legislative, and regulatory issues. Thank you to the Advocacy Committee, for providing timely feedback and comments during the session. We made strides in distinguishing MPhA from many other pharmacy interests by providing oral and written testimony; participating in committee working groups; and using our lobbyist to provide follow-up information; and having one-on-one meetings
with Delegates.
MPhA connected with the Maryland Congressional Delegation in Washington, DC to educate them about MPhA and to encourage more support of provider status legislation. It was great fun to the attend the APhAPAC reception in Baltimore, which featured Congressman Elijah E. Cummings. He is an advocate for the profession and has a powerful story to tell about his connection to the Maryland pharmacy community.
What's Next?: More meetings with Maryland Congressional delegation. Preparation for the 2017 General Assembly — meetings are already scheduled with General Assembly leadership, Delegates and members of Hogan's administration.
COMMUNICATIONS ¢ OUTREACH
Maryland pharmacists strive to be innovative and respected members of the healthcare team. Part of that effort means we must share with the broader public the great things we are doing. Please continue to share that information with MPhA staff. We have set up a communications model to get press and media communications out quicker. Thank you to the Communications Committee for initiating the Facebook “Likes Campaign,” streamlined our social media hashtags, and have other efforts underway to assist with giving the MPhA brand more staying power. Outreach means more
Executive Director’s Message
targeted connections with prospective members. Kudos to the Membership Committee for developing and welcoming the Federal Pharmacist Network.
What's Next? MPhA Trivia Week; Member Spotlights; and Pharmacist technician programming.
CONTINUING EDUCATION ¢ NETWORKING
There were many activities that provided CE credits, but also gave time for you to meet and connect with old colleagues and build new relationships. In the first quarter, Hoai-An and
I traveled to the Eastern Shore, Mid-state, and we are looking forward to visiting our Western Maryland friends at the end of this month. Thank you to the Meeting Planning Committee and others who have facilitated increased CE content for the Mid- Year and Annual Convention. Thank you to the NPN Network for continuing to provide engaging activities that keep new practitioners connected to MPhA. Thank you to our University Partners — APhA’s Maryland Pharmacy Night Reception had record attendance and was enjoyed by all!
What's Next?: New Practitioner Network Activities for recent graduates focused on transitioning from student to practicing professional and a new on-staff CE Coordinator.
PROFESSIONAL DEVELOPMENT ¢ PROFESSIONAL RECOGNITION
We have a new Pharmacist Advocate Award, sponsored by Buy-Sell-A-Pharmacy, which recognizes the government affairs activity that has raised pharmacists’ awareness of the political process, improved the pharmacy profession and the political process, and/or improved service and education to the patient. The award will be presented at the June Convention.
What's Next?: A medication synchronization and adherence panel discussion bringing together national leaders and Maryland innovators under the ScriptYourFuture Maryland (SYFM) banner. We will also see the launch of a CRISP Portal Accessibility Pilot for Pharmacists. There will also be roll- out of Provider Outreach materials from the Professional Development Committee.
Thank you again to the many MPhA volunteers and to your support network. Your time and commitment is appreciated!
If | don't see you beforehand, I'll see you in the OC! @
Aliyah N. Horton, CAE Executive Director
MARYLANDPHARMACIST.ORG 27
Do you know a pharmacy technician ready to take on more responsibility in the pharmacy?
The University of Maryland School of Pharmacy’s new, online PharmTechX Program will elevate a technician’s abilities and improve the efficiency of your pharmacy.
The PharmTechX Program at At the end of the program, technicians will be able to: the University of Maryland ¢ Assist with medication management and storage School of Pharmacy offers ¢ Conduct medication profile reviews
an online, self-paced, ¢ Assist with patients’ medication histories
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¢ Complete medication checking ¢ Monitor for medication errors ¢ Facilitate improvement of the medication process
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Contact us at pharmtechrx@rx.umaryland.edu for more information or visit www.pharmacy.umaryland.edu/PharmTechx.
134" Annual Convention
The Opening Session Speaker at the 134" Annual Convention presented on Keeping Cool, Calm & Collected when the Pressure is On.
SUMMER 2016
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PHARMACY CREDENTIALING ASSESSMENT vesno @& FWA sno @ PHARMACY OPERATIONS
Are staff members trained on CMS 10147
Adherence if a “569 error” occurs?
Do you have Policies and Procedures (P&P) to meet Interest forms annually? Pharmacy Medicare Part D credentialing
Are you running OIG-GSA-SAM Exclusion Verifications each month on: requirements?
Are you conducting FWA Prevention training annually? Do you have an “Anti-Kickback” Policy & Procedure (P&P)? Do you have your entire staff completing Conflict of
Employees, Owners and Contractors Are you keeping annual records of all trainings Business Associates (HIPAA & FWA with 10 years of retention)? All vendors whose products are billed through Medicare Do you review your EQuiPP scores monthly? Do you have a Medication Adherence Program? YES HIPAA
Do you have P&P’s for: Do you have a HIPAA P&P manual/program in place? Has your Notice of Privacy Practice been updated since July 1, 2013? Do you maintain a breach assessment when the patient receives another patient’s medication?
YES PATIENT SAFETY
Do you have a Quality Assurance Program? Are you enrolled in a Patient Safety Organization?
Usual and Customary
Patient Counseling Practices Mis-fill Procedures
Medication Recall Procedures Medication Expiration Procedures Generic/Brand Price Disclosures Demographics and Allergy Capture Partial Refills
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Contents a eh We
10 VA : COVER STORY =, Aneta |
134" Annual Convention Updates my, NY 4 ees wn Annual Convens; Follow-up to Martha Bryan's presentation on Keeping Cool, Calm & bys A ae)
Collected when the Pressure is On. Awards and recognitions. Thank you to all our supporters and contributors who assisted in making / i the 134" Annual Convention a success. ee é
, 5 © : rt v
4 President’s Pad
MPhA News
6 | Congratulations
6 | Maryland Appointees to APhA 2016-2017 House of Delegates
6 | Medical Mission Trip to Haiti
6 | Pharmacy School Highlights
15 | Welcome 2016-2017 MPhA Board of Trustees
22 | Welcome New Members
23 | Save the Dates
8
Editorial
5 | Updated Information Regarding Maryland Prescription Drug Monitoring Program
7 | Pharmacy and the Law
8 | Congratulations to the 2016 Graduating Classes
25 | Tne New Normal — DSCSA Compliance Tips: Policy Matters
suolponeed
17 ADVERTISERS INDEX Continuing Ed 25)|,CE.Quiz 22 Corporate Sponsors 27
2 RJ. Hedges & Associates 15 EPIC Pharmacies 16 Pharmacists Mutual 24 Cardinal Health 20, HD Smith 27 Buy-Sell-A-Pharmacy
28 University of Maryland MARYLANDPHARMACIST.ORG 3
Executive Director’s Message
AREMACISy,
© MPhA
EST, 1882 MARYLAND PHARMACISTS ASSOCIATION
RYL
wna, S
Noriyioo”
MPhA OFFICERS 2016-2017
Hoai-An Truong, PharmD, MPH, FNAP, Chairman
Kristen Fink, PharmD, BCPS, CDE, President
Cherokee Layson-Wolf, PharmD, CGP, BCACP. FAPhA, Vice President
Matthew Shimoda, PharmD, Treasurer
David Sharp, PhD, Honorary President
HOUSE OFFICERS
Ashley Moody, PharmD, BCACP, AE-C, Speaker
Richard Debenedetto, PharmD, MS, AAHIVP, Vice Speaker
MPhA TRUSTEES
Mark Ey, RPh, 2017
G, Lawrence Hogue, BSPharm, PD, 2017
Wayne VanWie, RPh, 2018
Chai Wang, PharmD, BCPS, AE-C, 2018
Amy Nathanson, PharmD, BCACP, AE-C, 2019
Darci Eubank, PharmD, 2019
Rachel Lumish, ASP Student President University of Maryland School of Pharmacy
EX-OFFICIO TRUSTEES
Rondall Allen, PharmD, Dean University of Maryland Eastern Shore School of Pharmacy
Natalie Eddington, PhD, Dean University of Maryland School of Pharmacy
Anne Lin, PharmD, Dean Notre Dame of Maryland University School of Pharmacy
David Jones, RPh, FASCP, MD-ASCP Representative
Celia Proctor, PharmD, MBA, MSHP Representative
Mayrim Millan Barrea, ASP Student President Notre Dame of Maryland University School of Pharmacy
Tolani Adebanjo, ASP Student President University of Maryland Eastern Shore School of Pharmacy
PEER REVIEWERS
W. Chris Charles, PharmD, BCPS, AE-C
Caitlin Corker-Relph, MA, PharmD Candidate 2017
LCDR Mathilda Fienkeng, PharmD, RAC
Nicole Groves, PharmD
G. Lawrence Hogue, BSPharm, PD
Edward Knapp, PharmD, PhD
Frank Nice, RPh, DPA, CPHP
Hanna Salehi, PharmD, MLS
STAFF
Aliyah N. Horton, CAE, Executive Director
Shawn Collins, Membership Services Coordinator
We welcome your feedback and ideas for future articles for Maryland Pharmacist. Send your suggestions to Aliyah Horton:
Maryland Pharmacists Association, 9115 Guilford Road, Suite
200, Columbia, MD 21046,
call 443.583.8000, or
email aliyah.horton@mdpha.com.
Special thanks to Graphtech, Advertising Sales and Design
President’s Pad
Dear Fellow MPhA Members,
Hello Everyone! I hope you had a wonderful summer! It is truly an honor and pleasure to serve the members of the Maryland Pharmacists Association as President. I look forward to this coming year.
I extend great appreciation to the new chair of the Past President's Council Dixie Leikach for her many years of service and leadership to MPhA. I also thank Hoai-An Truong for his leadership this past year and for engaging with me to ensure a smooth transition.
We had a very active year culminating in a fantastic 134'" Annual Convention, where pharmacists from around the state convened to learn, network and celebrate the
notable accomplishments of our colleagues and friends. I hope you enjoyed yourself at both the CE sessions and social events and enjoy looking at the recap in this issue.
As many of you know I place a high priority on mentoring pharmacy residents and students to assist them in discovering the niche of pharmacy that inspires them, and developing their leadership skills. As Pharmacists, we are natural leaders and key contributors to excellence in patient care. By making connections with our fellow colleagues and becoming actively involved in our profession through MPhA and the MPhA Foundation, we can ensure that Maryland pharmacy remains strong, connected and passionate about the work we do to serve the residents of Maryland, no matter the practice setting.
This year, we will have many exciting opportunities to get involved and engage in pharmacy and our greater community. I encourage you to take time to connect with a committee or a cause, lend your voice, and encourage your colleagues to join MPhA. The more diverse but united voices we have, the better MPhA will be able to serve you, meet your needs and represent the profession on issues that impact our daily ability to practice. Having worked in hospital, chain, managed care and independent pharmacy, I understand the unique challenges and opportunities we face. Our collective voice can serve to expand the role we play in patient care. I believe that we are at a crucial tipping point for pharmacy, on the brink of achieving Provider status which will allow us to provide comprehensive pharmacy services to an even greater number of patients within our state. We have made significant strides in our legislative efforts. By joining together to present one face for Pharmacy in Maryland we have
the power to continue to grow our profession in exciting new directions. At the same time our active voice must also work to protect our ability to provide patient care ina way the puts the patient first. MPhA is here to provide the professional development, advocacy tools and resources to make this happen.
Get active, lend your voice, your expertise and experience. We will all benefit. I look forward to working with many of you as we reconvene in the Fall.
Again, congratulations to all our award winners and others who received recognition the Annual Convention. May they all inspire us! @
Sincerely,
Mec. WA, Eo Se Kristen Fink President
IMPORTANT Ee
UPDATED Information Regarding Marylan Prescription Drug Monitoring Program
©
New law requires providers to REGISTER with and USE PDMP
The Maryland Prescription Drug Monitoring Program (PDMP) was created to support providers and their patients in the safe and effective use of prescription drugs. The PDMP is part of Maryland's response to the epidemic of opioid addiction and overdose deaths.
MARYLAND PDMP FACTS WHAT IS CRISP? e Authorized by law in 2011 e State-designated health information exchange
e Maryland Department of Health and Mental Hygiene ae een? Hie ln seamen mele Sg amet (DHMH) program Columbia.
e Electronic system connecting all 46 acute care hospitals in Maryland
e Web-based portal gives providers secure CRISP access to patient PDMP, hospital and other clinical data
S e Contains data on Rx controlled dangerous substances , ° 4N (CDS) dispensed to patients in Maryland
¢ Providers get free, online access through Chesapeake Regional Information System for our Patients (CRISP)
LEGAL CHANGES AFFECTING PROVIDERS On April 26, 2016, Governor Hogan signed into law HB 437 which includes the following legal changes: 1. Mandatory PDMP Registration for CDS Prescribers & Pharmacists Pharmacists: Licensed pharmacists in Maryland must be registered with the PDMP by July 1, 2017.
Prescribers: Beginning October 1, 2016, practitioners authorized to prescribe CDS in Maryland must be registered with the PDMP prior to obtaining a new or renewal state CDS Registration (issued by the Division of Drug Control) OR by July 1, 2017, whichever occurs sooner. This applies to physicians, physician assistants, nurse practitioners, nurse midwives, dentists, podiatrists and veterinarians. This mandate does not apply to nurses.
REGISTER NOW with the PDMP through CRISP at https://crisphealth.org/. Click on PDMP ‘Register’ button on the left-hand side of the screen. For registration help, call 1-877-952-7477.
2. Mandatory PDMP Use by CDS Prescribers & Pharmacists Beginning July 1, 2018:
e Pharmacists must query and review patient PDMP data prior to dispensing ANY CDS drug if they have a reasonable belief that a patient is seeking the drug for any purpose other than the treatment of an existing medical condition.
Prescribers must, with some exceptions, query and review their patient's PDMP data prior to initially prescribing an opioid or benzodiazepine AND at least every 90 days thereafter as long as the course of treatment continues to include prescribing an opioid or benzodiazepine. Prescribers must also document PDMP data query and review in the patient's medical record.
Information regarding Mandatory Use is available on the DHMH PDMP website. DHMH will provide additional information and reminders closer to, but before the implementation date.
3. CDS Prescribers & Pharmacists May Delegate PDMP Data Access
Prescribers and pharmacists may delegate healthcare staff to obtain CRISP user accounts and query PDMP data on their behalf. Delegates may include both licensed practitioners without prescriptive authority and non-licensed clinical staff that are employed by, or under contract with, the same professional practice or facility where the prescriber or pharmacist practices.
TO LEARN MORE
Visit the DHMH PDMP website for updated information, important For more information about the opioid addiction and overdose
compliance dates and Frequently Asked Questions: http://oha.dhmh. epidemic in Maryland and what healthcare providers can do to help, maryland.gov/PDMP. visit http://bha.dhmh.maryland.gov/OVERDOSE_PREVENTIOW/. S
MARYLANDPHARMACIST.ORG 5
Version 2.0, June 6, 2016
MPhA News
What has MPhA been doing? Member Mentions highlighted below!
Congratulations to Kristen Fink and Andrew Wherley Kristen and Andrew welcomed Baby Boy John Andrew Wherley on May 25, 2016. @
Maryland Appointees to APhA 2016- 2017 House of Delegates
The following MPhA members will serve
as the Maryland Delegation in the APhA 2016-2017 House of Delegates: G. Lawrence
Hogue; Brian Hose; Anne Lin; Ashley Moody;
Matthew G. Shimoda; Hoai-An Truong; and Alternate: James Dvorsky @
Medical Mission Trip to Haiti
Hoai-An Truong and Frank Nice travelled to Haiti with students from the University of Maryland Eastern Shore on a pharmacy medical mission trip. The mission brought donated pharmacy and healthcare supplies and assisted with ee care. @
See
sie
Source: Hoai-An Truong
6 MARYLAND PHARMACIST | SUMMER 2016
PHARMACY SCHOOL HIGHLIGHTS
Governor Larry Hogan Spring Visit to University of Maryland Eastern Shore
President Juliette B. Bell, Dean Rondall E. Allen, faculty and students at the University of Maryland Eastern Shore School of Pharmacy and Health Professions welcomed Governor Larry Hogan and members of the Maryland House and Senate to campus this LE EL, past Spring. The visit was an nen to express ea iy for funding the planned pharmacy and health profession facility for the school. @
Elizabeth Seton High School’s Pharmacy Technician Training Program Partners with Notre Dame of Maryland University School of Pharmacy
Dr. Paul Vitale, Interim Chair & Associate Professor of Clinical & Administrative Sciences was invited to assist Elizabeth Seton High School in the evaluation of a pharmacy technician curriculum for its new pharmacy technician training program. At his recommendation, Dr. Barbara McHenry, a licensed pharmacist with over 35 years of experience, was hired as the program coordinator. The program is accredited by the Maryland State Board of Pharmacy. Dean Anne Lin attended the White Coat Ceremony of the inaugural group of students and Mr. Daniel Ashby, Senior Director of Pharmacy, Johns Hopkins Hospital was the keynote speaker. Twenty-eight students along with Dr. McHenry visited Notre Dame during the spring semester and utilized the Pharmacist Care Lab facility for a three- hour sterile preparations class. School of Pharmacy faculty along with Dr. McHenry taught sterile technique. The School of Pharmacy and Elizabeth Seton High School will explore further opportunities for collaboration. Elizabeth Seton is the only college preparatory high school in the state of Maryland that is officially accredited by the Maryland State Board of Pharmacy for its Pharmacy Technician Program. @
Pharmacy and The Law
By: Don. R. McGuire Jr., R.Ph., J.D.
This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.
NEW ADVANCES
We are entering another period of change in the pharmacy profession. We experienced such a period
during the 1990's when collaborative practice and pharmacist-administered immunizations were new topics of conversation. Now we are seeing an enhancement of pharmacist-provided, patient-centered services. And these changes are dovetailing with the drive for provider status for pharmacists. | remember performing kinetic dosing for aminoglycosides at our hospital
in the 1990's. We were very proud of how progressive and advanced we were. Our results were improving our patients’ outcomes. It was only later that we discovered that collaborative practice wasn't yet authorized by our state practice act.
At the opposite end of the spectrum from those who blindly race ahead are those who resist such changes. These are pharmacists who are comfortable in their existing practices and are worried about the extra liability when performing new patient care services. These extra liability concerns have been discussed in previous articles. Change and progress are necessary to stay relevant and useful in the modern world. The key to managing change is preparation.
Ohio enacted a law at the end of
2015 that enhanced the ability of pharmacists and physicians to enter into collaborative practice agreements. Among the authorities granted to pharmacists are; ordering blood and urine tests, analyzing those results, modifying drug regimens (including ordering new drugs), and authorizing a refill of critical medications. Oregon
has a new law going into effect in 2016 which authorizes pharmacists to prescribe self-administered oral or transdermal birth control. California has also passed a law similar to Oregon's. Typically these statutes authorize pharmacists to expand their practices, but they do not require them to do so. So how do you prepare to expand your (and your patients’) horizons?
Examine the new practices open to you in your state. Which of them are you currently competent to perform? Which can you obtain addition training relatively quickly and become competent? Which ones best serve the needs of your patients? Once you know that, you can assess your liability exposure in performing those services. This is done by reviewing your legal duties to your patients. What duties are required for you to provide the service? What possible ways could those duties be breached? What possible injuries could result from that breach? In this way, you can evaluate your exposure for providing any new service.
Once you have decided to move ahead, the next step in preparation is to examine your insurance coverage. You can't just assume that new practices are covered. Individual insurance companies can determine what they do and do not want to cover ina policy, regardless of what constitutes the scope of practice in your state. It is never safe to assume that you have coverage for something without first asking and validating that with your insurance carrier. For example, there are policies available in the marketplace that exclude damages
resulting from patient counseling
— whether or not the counseling is required by law. While we are talking about optional activities and services here, your insurance policy should certainly cover the activities that you are required to perform. To avoid problems later, it is a good practice to read your insurance policy to make sure that it provides the coverage that you need.
Once you have assessed your possible exposure and verified your insurance coverage, you are ready to begin providing advanced services like those authorized in Oregon, Ohio, California and other states. You are part of the next wave of change in pharmacy practice. The profession of pharmacy has come a long way in a relatively short period of time. In the 1950's,
it was unethical to tell a patient the name of their prescribed medication. Now pharmacist are engaging in extensive collaborative practices, providing MTM and immunizations; even prescribing medications whose names they weren't allowed to disclose a few years ago. It is an exciting time to be a pharmacist! @
© Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company.
This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys
and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly.
MARYLANDPHARMACIST.ORG 7
Congratulations to the 2016 Graduating Classes!
2016 University of Maryland School of Pharmacy Graduates
Solomon Tesfaye Abera Sinthi Hau Acey
Naim Haque Adrienne Isabella Herman
Oluwadamilola Oyinade Ademiluyi Kenneth Odianosen Agboifo Jihye Ahn
Rebecca Oluwatosin Akujor Seid Beshir Ali
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Yaa
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8 MARYLAND PHARMACIST | SUMMER 2016
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Sharina Nandwani
Kevin Khun Ngo
Anh Nguyen
Francis Nguyen
Jamie K. Nguyen
Natalie Dan Nguyen
Vy Lam Nguyen
Salin Nhean
Andongfac Nkobena Nnamdi Francis Ofoegbu Chikezie Obinna Okoro Peace Anya Oluchi Siyou Abdulafeez Ayodeji Oluyadi Innocent Fowah Ongey Inhuoma Uzochi Onyewuchi Shannon Marie Osbome Mirian Paik
Paulomi Tapan Patel Ngoc Thi Thanh Pham Joshua Charles Pozanek Holly Suzanne Robertson
Daniel Shu
Andrew Michael Shuler Steven Earl Sligh Stephanie Ann Smisko Rachel Denise Smith Chenxi Song
Yong Eun Song Christopher Olen St. Clair Sheema Sultana
Melody Wen Sun
Bilal Tariq
Saad Tariq
Kara Leigh Tarr
Selimene Stephanie Tenkeu Veronica Lee Timmons Hung Vinh Truong
Lena Truong
Brian Lao Ung
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YeSeul Yoo
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Wajiha Abdallah Reem Abdullah Camille Agosto Monica Aguilar Sharon Ahem Jennifer Aiken Betel Ali
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~ Te TI ET rg NE et Pe ETE ALI ATPL LS ACL
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Long La
David Leach
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a FT
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<hai Nguyen
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Ju Hyung Park Anokhi Patel Dhrumil Patel
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Hera Saleem
Farid Salehani Rasoul Samadani Shauna Smith
Sean Stewart Michelle Mae Tandoc April Tepfer
Brittany Thomas Tram Tran
Amanda Welk
Jude Wenerick Ashley Yee
Doo Young Yoo
MARYLANDPHARMACIST.ORG
Annual
Convention Q
10 MARYLAND PHARMACIST | SUMMER 2016
DMPh
@OMPh
@ MPh
@MPh
Cover Story
134" Annual
Convention
Martha N. Bryan
The Opening Session Speaker at the 134" Annual Convention presented on Keeping Cool, Calm & Collected when the Pressure is On. This article is provided as a follow-up to her presentation and iS DED CARED MOsiTOSEWHO WANTETO.GERMORE LIFE OUT OF LIFE!
All of us want to live longer and enjoy life more, but in our search for healthier living we have overlooked the most important element. Each year we spend more and more money on diets and diet pills, exercise programs, wellness books and videos, vacations, and health club memberships; but the key to a healthy, happy life is to “enjoy our work.” When we are fully engaged in work we enjoy, we are at our very best, we are happiest, and we are healthiest.
George Bernard Shaw said, “A master in the art of living knows no sharp distinction between their work and their play, their labor and their leisure, their mind and their body, their education and their recreation... They simply pursue their vision of excellence through whatever they are doing and leave others to determine whether they are working or playing.” John Gardner in his book Self - Renewal said, “The last day you will ever work is the day before you fall in love with whatever you are doing for a living.” | When a person is making a success of something, it is not work — it is a way of life.
A survey asking people to select the top ten business people America produced in the past 200 years concluded that the average age of death for achievers like Ford, Bell, Sanders, and Penney was 87. These people were all in professions that are considered to be highly stressful, but each found tremendous: a their work.
se Gre Know ‘what
People who.enjoy their workare. th
they want and deliberately do tt the > things that will lead to. =
MEDICATION AFFORDABILITY
The Maryland Pharmacist Association supports efforts to limit unjustified
or unreasonable pricing by pharmaceutical companies that may affect the affordability of medications for patients.
getting them what they want. They put their whole heart and soul into using their unique talents and abilities to make a difference in the world.
Health c comes from the direc tion in whict 1 we are moving. We are happiest when we are thinking planning, working, and climbing in purs goals. We are at our best emotionally, mentally, and physically when we are on the road to somet want to bring about
ult of our own
hing we
Health and happiness comes when we dedicate ourselves to the development of our natural talents and abilities.
And, health comes by doing what we love to do and doing it better and better in service to others.
To make that happen, we need to commit ourselves to a cause that is greater than us. We will need to fill our thoughts with purpose, our future with a plan, our days
swith work, our leisure with good friends and family,
and our mind with good memories. That is to have succeeded! @
AUTHOR
Martha N. Bryan, Bryan & Bryan Associates marthabryan@bryanandbryanassoc.com 3521, - 105th Place SE,.Everett WA 98208
425 - 337 - 1838 *** Fax 425 - 338 - 4509
www.bryanandbryanassoc.com
PHARMACISTS ROLE IN NALOXONE The Maryland Pharmacist Association supports: 1. Training all pharmacists to administer naloxone
2. Training all pharmacists to teach the public to administer naloxone
3. Dispensing naloxone to patients and those associated with persons at risk for opioid overdose.
4. Educating patients and the public to reduce the risks of opioid misuse. MARYLANDPHARMACIST.ORG 11
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Bowl of Hygeia Award presented to Ellen H. Yankellow, PharmD.
Established in 1958, the Bowl of Hygeia Award recognizes pharmacists who possess outstanding records of civic leadership in their communities and encourages pharmacists to take active roles in their communities. In addition to service through their local, state, and national pharmacy. associations, award recipients devote their time, talent, and resources to a wide variety of causes and community service.
The Bowl of Hygeia is the most widely recognized international symbol for the pharmacy profession and is considered one of the profession's most prestigious awards. Sponsored by Boehringer Ingelheim, American Pharmacists Association and the National Alliance of State Pharmacy Association.
e All awards presented by MPhA President Hoai-An Truong, unless otherwise noted. @
Excellence in Innovation Award, sponsored by
Upsher-Smith Laboratories and the MPhA Foundation, presented to Yen Dang, PharmD
MPhA Mentor Award Distinguished Young presented to Pharmacist Award, soonsored
James Bresette, by Pharmacists Mutual PharmD Companies, presented to
Ashley E. Moody, PharmD,
BCACP. AE-C
12 MARYLAND PHARMACIST | SUMMER 2016
aay Pharmacist Advocate Awa. sponsored Buy-Sel/-A-Pharma presented Murhl Flowers, R.
Calamatn =a DA
salematou Traor olen Gh A | +h A/ lt ( A Aliyah INV. Ho! LOl), CAE
Salematou Traore, PharmD, University of Maryland Eastern Shore School of Pharmacy
Michael Goldenhorn, PharmD, University of Maryland School of Pharmacy
Nghia Nguyen, PharmD, Notre Dame of Maryland University School of Pharmacy
Pn a er ere ON te ee Michael Goldenhorn, PharmD with
[7 ~~ LAA tomy
MPhA Scholarship - Brian Lindner, University of Maryland Dean Natalie Eddingtc School of Pharmacy
MPhA Scholarship - Geoffrey Saunders, University of Maryland Eastern Shore School of Pharmacy
MPhA Foundation Scholarship - Tolani Adebanjo, University of Maryland Eastern Shore School of Pharmacy
Cardinal Health Generation Rx MPhA Seidman Distinguished Champions Award, Achievement Award presented to the House Recognit sponsored by Cardinal Health G. Lawrence Hogue, BS Pharm, PD presented Foundation, presented to W. Christopher Charles F Dy jei6
Tali Johnson, PharmD (righb by Honorary President -
insert name David Sharp PhD (no picture)
MARYLANDPHARMACIST.ORG 13
Cover Story
Thank you to all the supporters and contributors who assisted in making the 134 Annual Convention a success!
CONVENTION PLANNING COMMITTEE Chair: Darci Eubank
Committee Members: Nicole Culhane, Kristen Fink, Sara Hummel, Lauren Lakadawla, Cherokee Layson-Wolf, Christine Lee-Wilson,
Dixie Leikach, Sara Martin, Marie-Therese Oyalowo,
Deanna Tran, and Hoai-An Truong.
PHOTOGRAPHERS AND VIDEOGRAPHERS Arnie Honkofsky, Bonnie Li-Macdonald, and Deanna Tran
CONVENTION SPONSORS Asthma and Allergy Network HD Smith
Infinitrak
Maryland P3 Program
MPhA Foundation PharmCon/FreeCE.com Program Management Services, Inc. Shoppers Pharmacy Whitesells Pharmacy
Your Community Pharmacy
EXHIBITORS
American Associated Pharmacies Amerisource Bergen Boehringer Ingelheim Calmoseptine, Inc.
Cardinal Health
CVS Health
HD Smith
Infinitrak
Kaiser Permanente
Maryland Board of Pharmacy Pfizer
McKesson
MPhA Foundation
Notre Dame of Maryland Sg 4 * 4
me
Novo Nordisk Inc. Nutramax Laboratories Consumer as nc.
Pe
Pharmacist’s Education Advoéac
14 MARYLAND PHARMACIST | SUMMER 2016
, SouneiM(PEAC)™ = PEER (Pharmacy Ethics, Education & Resouitces) ie
EXHIBITORS (continued) PharmCon Inc./FreeCE .com Pharmacists Mutual Companies QS1 Rite Aid Smith Drug Company University of Maryland Eastern Shore School of Pharmacy University of Maryland School of Pharmacy
GIVEAWAYS AND SAMPLES CONTRIBUTORS Calmoseptine, Inc.
Commission for Certification in Geriatric Pharmacy EPIC Pharmacies
Hisamitsu America, Inc.
Infinitrak
Mission Pharmacal Company
Pharmacists Mutual Companies
Rx Systems Inc.
Target Marketing
University of Maryland School of Pharmacy Aimprint
® MARYLAND PHARMACISTS ASSOCIATION FO.U NLD A Ph ON
Thank you to the following sponsors and contributors for your support of the 2016
Barry Poole Memorial Golf Tournament, which benefitted the programs and services of the MPhA Foundation.
Apple Discount Drug Deep Creek Healthsource Distributors Klein's ShopRites of Maryland Nutramax Labs Pharmacists Mutual Companies
Chairman: Hoai-An Truong, PharmD, MPH President: Kristen Fink, PharmD, BCPS, CDE
Vice President: Cherokee Layson-Wolf, PharmD, CGP, BCACP, FAPhA,
Treasurer: Matthew Shimoda, PharmD Honorary President: David Sharp, PhD
Speaker: Ashley Moody, PharmD, BCACP, AE-C
Vice Speaker: Richard DeBenedetto, PharmD, MS, AAHIVP
S = = > = = = = = = — — —
Mark Ey, RPh « G. Lawrence Hogue, BS Pharm, PD Wayne VanWie, PD « Chai Wang, PharmD, BCPS, AE-C Amy Nathanson, PharmD, BCACP, AE-C
Darci Eubank, PharmD
UM ASP President: Rachel Lumish
NDMD SOP: Anne Lin, Dean
UMES SOP: Rondall Allen, Dean
UM SOP: Natalie Eddington, Dean
UMES ASP President: Tolani Adebanjo NDMU ASP President: Mayrim Millan Barea
MPhA Foundation: Paul Holly
We Deliver Solutions for
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EPIC Pharmacies, Inc. provides more than 1,400 independent member pharmacies across the U.S. with the group buying power and managed
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Membership offers:
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MARYLANDPHARMACIST.ORG 15
Endorsed’ by:
MARYLAND PHARMACISTS ASSOCIATION
Our commitment to quality means you can rest easy.
Pharmacists Mutual has been committed to the pharmacy profession for over a century. Since 1909, we've been insuring pharmacies and giving back to the profession through sponsorships and scholarships.
Rated A (Excellent) by A.M. Best, Pharmacists Mutual is a trusted, knowledgeable company that understands your insurance needs. Our coverage is designed by pharmacists for pharmacists. So you can rest assured you have the most complete protection for your business, personal and professional insurance needs.
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When to Say When:
The Use and Overuse of Oral Proton Pump Inhibitors
Priya Rajendran, PharmD Candidate 2017 Mary Lynn McPherson, PharmD, MA, BCPS, CPE Professor, Executive Director Advanced Post-Graduate Education in Palliative Care University of Maryland School of Pharmacy
Introduction
Proton pump inhibitors are among the most widely prescribed drugs worldwide, and in the United States.!
They are the third most widely sold drug class, with annual sales of $13.9 billion. In comparison to other acid- suppressing medications, such as histamine-2 (H2) receptor antagonists, proton pump inhibitors (PPI) are considered to be more potent at effectively inhibiting acid secretion. PPIs work to suppress gastric basal and stimulated acid secretion by irreversibly inhibiting the H+/K+ ATPase pump located on the basolateral side of
the parietal cell, resulting in prolonged duration of activity (up to 3 days).* Proton pump inhibitors are now FDA approved for healing erosive esophagitis (EE), maintenance of healed EE, risk reduction for development of gastric ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs), short-term treatment and maintenance of duodenal ulcers, pathological hypersecretory diseases such as Zollinger-Ellison (ZE) syndrome, and as a part of a multidrug regimen for Helicobacter pylori eradication (Table 1).°*
As aresult of being well tolerated and highly effective, PPIs have become one the most prescribed classes of medications in primary and specialty care, and over-the-counter availability has further increased their use.’ However, overuse of these medications occurs as many patients continue to take a PPI beyond the recommended duration of therapy. Consumers often take an over-the-counter PPI without an initial or follow-up assessment, and continue therapy beyond the recommended course of therapy. With long-term use (4 months to >2 years), there are many different side effects that can occur such as atrophic gastritis, carcinoma, Clostridium difficile associated disease (CDAD), fractures, hypomagnesemia, interstitial nephritis and vitamin B12 deficiency.* These adverse effects can result in long-term complications requiring hospitalization and/or worsening of other co-existing conditions.
Last, there are various studies showing that no PPI is considerably clinically superior to another; however, there are large price differences among this class of medications. With OTC formulations on the market, now there are much more affordable options available to patients.
Learning Objectives After reading this article, the learner will be able to: Key Words
1. List proton pump inhibitors on the market and differentiate ¢ Proton pump inhibitor (PPI) between prescription and nonprescription formulations. Acid-suppressing » Omeprazole
2. List the indications for available proton pump inhibitors and Lansoprazole * Dexlansoprazole
recommended duration of therapy for each indication.
Esomeprazole e Pantoprazole Rabeprazole e GERD Adverse effects
3. Describe and explain adverse effects from long-term use of proton pump inhibitors and the proposed mechanisms of action.
4 Given a patient case, select a proton pump inhibitor and provide three patient counseling points.
MARYLANDPHARMACIST.ORG 17
Sidebar Case
Prescribing Considerations
You're working in your pharmacy one day when RJ, a 58 year-old overweight man approaches the pharmacy counter, and tosses down a box of Prilosec OTC. "This is the FIFTH time I've had to buy this stuff for my indigestion. Why isn't it working?" When you question him, he says that most days he experiences a burning sensation behind his breast bone, and occasionally up his neck. At least several times a week he burps and has acid regurgitation. He frowns when he admits, “Sometimes the chest pain is so severe I worry I'm having a heart attack.” He states he has taken four, two-week courses of Prilosec OTC in the past four months (with a two-week hiatus in between courses) and it doesn't seem to be helping. He says he feels a little better while he's taking the Prilosec OTC, but the symptoms go back to baseline severity during the two-week hiatus.
What is your assessment of RJ’s symptoms as he’s described them?
a. Typical symptoms of simple heartburn
b. Sounds like simple heartburn and possibly gastroesophageal reflux disease (GERD)
c. Symptoms seem suggestive of peptic ulcer disease
d. Symptoms are classic dyspepsia only
Adverse Effects Vitamin Bi2 Deficiency
Although there is not enough evidence that proves
a direct correlation between vitamin B12 deficiency and long-term (>2 years) proton pump inhibitor use, some studies have shown that there may be evidence of an association. Gastric acidity and pepsin enable the release of ingested vitamin B12 from its protein- bound state; subsequently through a series of steps, vitamin B12 is ingested through the terminal ileum via intrinsic factor°. Since gastric acidity is involved in the initial cleavage of vitamin B12, there may be a link of long-term proton pump use and Bi2 deficiency. This, however, may not create an issue in normal, healthy adults that have a large functional reserve of B12 because the usual human diet contains more B12 than required.° Patients on long-term proton pump inhibitor therapy can also still produce intrinsic factor which allows for reabsorbing enterohepatically-recycled cyanocobalamin and retaining ability to absorb unbound cobalamin.° Problems with B12 deficiency may become an issue for elderly patients who have
a higher prevalence of vitamin B12 deficiency, those who are malnourished, and individuals with lower B12 SLOTES.
Clostridium-difficile associated diarrhea
Clostridium difficile is an anaerobic, spore-forming bacterium that is a leading cause of nosocomial infectious diarrhea in adults.®° Though the exact mechanism is unclear, it is proposed that proton pump inhibitors increase the pH of the stomach, allowing
for bacteria overgrowth and increased risk of infection
18 MARYLAND PHARMACIST | SUMMER 2016
The burning sensation and movement toward the neck are suggestive of simple heartburn. However, RJ also states he has acid regurgitation several times a week which suggests GERD. Therefore, the correct answer is B.
Do you recommend RJ purchase this box of Prilosec OTC for the fifth time?
a. Yes
b. No, he should switch to lansoprazole 15 mg (Prevacid 24HR)
by many different pathogens including Clostridium difficile ®’ Bacterial overgrowth increases the level of unconjugated bile acids in the stomach which in turn support the conversion of ingested C. difficile spores to the more virulent vegetative form.° Mild to moderate
C. difficile symptoms include mild to moderate
watery diarrhea without blood, along with abdominal cramping; however more severe cases can include symptoms of fever, malaise, and high-volume diarrhea.® As the infection becomes systemic, more serious complications include pseudomembranous colitis and sepsis.® The risk for C. difficile infection is the greatest for patients who are chronically ill, immunosuppressed, and/or on antibiotic therapy, especially in the inpatient setting.? Long-term use of PPI therapy should be evaluated especially in cases of serious or recurrent enteric infections if there is no urgent indication for acid suppression.°® If possible, use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.®
Carcinoma
Although the risk of developing gastrointestinal cancer from proton pump inhibitors is extremely
low especially in patients without H. pylori infection, long-term proton pump inhibitor use with H. pylori infection is associated with gastric inflammation and development of atrophy.° Acid-suppressing drugs such as PPIs alter the gut environment through acid suppression, thereby increasing the pH of the stomach.’ The more alkaline environment of the stomach allows for bacterial growth which can cause inflammation
of the stomach and altered signaling between cells of the stomach.’ Two cells involved in cell signaling and
c. No, he should switch to omeprazole 20 mg/sodium bicarbonate 1100 mg (Zegerid)
d. No, he should be referred to his primary care practitioner
RJ is a mess! Five courses of Prilosec OTC? Clearly this isn't getting the job done. Actually RJ has several contraindications to self-treatment including the following:
e Frequent heartburn for more than 3 months
¢ Heartburn while taking recommended dosages of nonprescription PPI therapy
e Severe heartburn and dyspepsia
RJ should be referred to his primary care provider at this time and he should NOT purchase the Prilosec OTC. Therefore, the correct answer is D.
Several weeks later RJ returns to the pharmacy with a prescription for a PPI. He tells you he’s had several medical tests and it seems that he has severe reflux disease. The doctor told him he would be taking this prescription PPI for
production of gastric acid are: enterochromaffin-like cells (ECL cells) and gastrin-producing cells (G cells).° Enterochromaffin-like cells are located beneath the epithelium of gastric glands of the gastric mucosa that aid in gastric production via the release of histamine on parietal cells.? Gastrin-producing cells, located in the stomach antrum, produce gastrin which serves
2 functions: first, to stimulate ECL cells to produce histamine, and second to directly stimulate parietal cells to produce hydrochloric acid.’ In the presence of acid-suppressing drugs, G cells continually produce gastrin which acts on ECL cells and can lead to hyperplasia and further to form liner hyperplasia, micro-carcinoids, and carcinoids.’ Gastrin's action on parietal cells can lead to hypertrophy and hyperplasia.’
Fractures
A large nested case-control study conducted by Yang et al. showed the risk of hip fracture was significantly increased among patients on long-term high dose PPIs; the strength of the association increased with increasing duration.’° Short-term use of PPIs (less than 1 year) regardless of the daily dose is not associated with increased risk of fractures. The theory supporting this association is that an acidic environment in the stomach facilitates the release of ionized calcium
from the insoluble calcium salts into soluble calctum salts which then can be absorbed." This proposed theory, however, does not account for ingested soluble calcium; further, PPI therapy may only hinder calcium absorption taken without a meal.” The risk for fractures seems greater in patients already presenting with a
risk factor such as those who are elderly, on long- term steroid therapy, and those with osteoporosis."
the foreseeable future. RJ asks “My wife checked this out on the computer, and she’s worried about the side effects if I keep taking this medicine. Should I be worried?”
Which of the following MAY be adverse effects associated with long-term PPI therapy?
a. Vitamin B12 deficiency
b. Clostridium-difficile associated diarrhea c. Fractures
d. Hypomagnesemia
e. All of the above are POSSIBLE side effects; encourage RJ to keep all appointments with his primary care provider
As you read in this article, all of the adverse effects shown above have been associated with PPI therapy. This doesn't mean RJ will necessary develop any of these, or other adverse effects associated with long-term PPI therapy. Of course it’s advisable that he keep all follow up appointments with his primary care provider. Therefore, the correct answer is E.
Given the significant morbidity and mortality from hip and other fractures, providers should weigh the risk and benefits of PPI in vulnerable patients.° It is
recommended to use the lowest effective dose for the shortest duration of time, and to supplement vitamin D and soluble calcium in the form of citrate rather than insoluble calcium carbonate.*"°
Hypomagnesemia
Although hypomagnesemia is very rare with PPI
use (less than 30 cases since 2006), it is suggested that the possibility of hypomagnesemia is greater with long-term use of PPIs.° A few patients with hypomagnesemia received PPIs for only 1-2 years, but most cases were associated with long-term PPI use: 17 of 28 patients (61%) had received PPI therapy for five or more years and eight (29%) for at least 10 years.° Normalization of plasma magnesium levels occurred after PPI discontinuation and reoccurred with days after restarting PPI.1° Although the
exact mechanism is unclear and there are many proposed theories, it is thought that PPIs might impair the paracellular transport of magnesium by altering intestinal permeability and tight junction function.? Hypomagnesemia may be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias.’ Providers should consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter.°*
MARYLANDPHARMACIST.ORG 19
Acute Interstitial Nephritis (AIN)
A nationwide nested case-control study in New
Zealand completed by Blank et al showed omeprazole,
pantoprazole, and lansoprazole were associated with a significantly increased risk of acute interstitial nephritis resulting in hospitalization compared with past use.'° Although the risk was low, the risk was substantially higher in older users.’° The mechanism of AIN is unknown and appears to be an idiopathic hypersensitivity reaction with no relation to dosage, latency, time to recovery, age, or gender.’* Acute interstitial nephritis (AIN) is characterized by the presence of an inflammatory cell infiltrate in the interstitium of the kidney. Patients with AIN present with nonspecific symptoms of acute renal failure including oliguria, malaise, anorexia, nausea and vomiting.“ PPI therapy should be discontinued if AIN develops.
Heartburn (OTC — 14 days)
H. pylori eradication (10-14 days)**
(3-6 months)
Proton Pump Inhibitor Indications
i (4-8 weeks)
3 (4-8 weeks) (4-8 weeks) (4-8 weeks)
NSAID associated gastric ulcer prophylaxis
Differentiating between PPIs
Proton pump inhibitors on the market are all similar in terms of chemical structure and mechanism of action. The PPIs differ in their pKa, bioavailability, peak plasma levels and excretion which can elicit different characteristics that may align with patient preferences. Lansoprazole/dexlansoprazole and pantoprazole have been shown to be the most bioavailable with the highest plasma levels. Rabeprazole has a slightly faster onset of action due to its pKa whereas pantoprazole
is considered the most “gastro-specific” because of its binding to cysteine residues 813 and 822 within the alpha-subunit of the proton pump.’* However, the clinical relevance of these differences has not been established.’
A number of studies have evaluated differences between PPIs and although some show that one PPI may be slightly superior to another PPI, the
Table 1 - Indications and Approved Duration of Therapy for PPis*'*
Kole Xi RX X | X
=| |_| esomeprazole
X
X
CPx] [| zeseria T= == =|] taoprasote aa
=| SSS] crerasat
Pathological hypersecretory conditions X X X 1X (as long as clinically indicated)
eS eee
Risk reduction of upper GI bleed in critically ill patients X (14 days)
*Injection only. For risk reduction of rebleeding in patients postendoscopy for acute bleeding gastric or duodenal
ulcers in adults.
**May require additional treatment duration depending on regimen.
20 MARYLAND PHARMACIST | SUMMER 2016
Table 2 - Proton Pump Inhibitor Prescribing Information?"5
Generic Rx/OTC Generic Product
Formulations Dose Range (mg)/once daily Administration Combination Monthly Cost
Capsule ae aie . ays (Rx Omeprazole Prilosec i Yes Packet 20-40 ral Zegerid uf CC. Suspension $20 14/ Ue 28 days (OTC)
Capsule Suspension Tablet
‘ Rx ih é
Dexlansoprazole
Esomeprazole Nexium
Pantoprazole
$176.90/ 30 days (Rx) 15-30 Oral Prevpac $10.67/ 14 days (OTC)
oO
30 days (Rx)
Capsule aanmeae Packet Oral Vimovo SNE ; 20-40 IV Solution IV $9.84/ Tablet 14 days (OTC)
Packet Tablet abe S368.22/ IV Solution
te 90 days (Rx)
Tablet $343. - Rabeprazole Aciphex Rx Yes 20-60 Oral *Prices based off of minimum dose of generic and OTC formulation. PharmCon is accredited by The authors have no financial disclosures (2) Scroll down to Homestudy/ the Accreditation Council to report. OnDemand CE Credits and select the for repiaes ennai! as This program is Knowledge Based — Quiz you want to take. Me ee EAS Be ean acquiring factual knowledge that is based (3) Log in using your username (your ease es ane ee Ait on evidence as accepted in the literature email address) and Password pee coUeanon er by the health care professionals. MPHA123 (case sensitive). Please
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This issue’s quiz on When to say When: The Use and Overuse of Oral Proton
This program provides for 1.0 contact Pump Inhibitors can be found online Note: If this is not the first time you are hour (0.1) of continuing education at www.PharmCon.com. signing in, just scroll down to Homestudy/ credit. Universal Activity Number (UAN) (1) Click on ‘Obtain Your Statement of OnDemand CE Credits and select the quiz
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MARYLANDPHARMACIST.ORG 21
magnitude of the difference is small and of uncertain clinical importance.” Any difference in efficacy may
not warrant a change in PPI when considering cost-
effectiveness. Table 2 compares the PPIs including generic availability, prescription/non-prescription status, frequency of use, and the average monthly cost.'® As expected, non-prescription or generic equivalents are less expensive than branded products. Nonprescription PPIs may be beneficial for consumers who do not have prescription coverage or occasional heartburn (<2 days/week) and are just as effective as
more expensive prescription alternatives.
Conclusion
Given the potential for long-term side effects, it is important for healthcare providers to consider the
following regarding PPI therapy:
e Assess whether there is an indication for a PPI
risk patients
¢ Periodically assess PPI dosage and frequency e Assess whether the treated condition is improving
¢ Consider vitamin supplementation in elderly or at-
e Reassess whether PPI therapy is still appropriate or should be discontinued.
If there is no longer an indication for PPI use, the PPI should not be discontinued abruptly as rebound acid hypersecretion and reflux can occur. Instead, the
PPI dose should be decreased slowly over a period
of time. For example, if the current dose is 40 mg of esomeprazole (Nexium) once daily, the dose can be reduced initially to 20 mg once daily for 2-3 weeks. After the patient is stabilized on this dose, the PPI can