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Contents
5
COVER STORY Rx and the Law — Advocacy State & Federal Updates
This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and MPhA through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.
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ADVERTISERS INDEX
20 Corporate Sponsors
2 Smith Drug Company 11. Cardinal Health 12 Independent Pharmacy Buying Group 20 EPIC Pharmacies, Inc. 22 HD Smith
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President’s Pad 4 MPhA News
6 | A Stepwise Guide to Planning and Implementing a “Healthy Kidneys” Event and Celebrating World Kidney Day
10 | Member Mentions
19 | Pharmacist Month Activities 20 | Welcome New Members 24 | Save the Dates
24 | 135th Annual Convention
Advocacy 9 | State & Federal Updates
Editorial
20 | First Quarter 2017: Pharmacy Time Capsule
20 | Thank You 2017 Corporate Sponsors
21 | Version III: Important Information Regarding Maryland Prescription Drug Monitoring Program
23 | What's New?
Continuing Ed
13 | Barriers to Optimal Health Care in the Hispanic Population: Considerations for Pharmacists
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Executive Director’s Message 23
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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
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
Paul R. Holly, PD, MPhA Foundation
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
Carole Miller, Operations and Program Associate
CONTRIBUTORS
Maryland Pharmacists Association, 9115 Guilford Road, Suite
200, Columbia, MD 21046,
call 443.583.8000, or
email altyah.horton@mdpha.com.
Special thanks to Graphtech, Advertising Sales and Design
President’s Pad
MPhA has exciting things in store for you
in 2017 including many opportunities to learn, advocate for our profession, and network with other pharmacy professionals throughout our state. We kicked off the 2017 CE events with our Annual Mid-Year Meeting on February 12th, which had CE for both
our pharmacist and pharmacy technician members focusing on clinical updates, career development, and timely updates on issues impacting our profession. The legislative update held during the Mid-Year Meeting is just one of the events that we scheduled for you to easily learn how to impact pharmacy at the ground level as the laws are being written. On February 9th, we also hosted
an interactive advocacy workshop, which provided an in-depth opportunity for participants to role-play, actively learn techniques and tactics to engage legislators, and gain a better understanding of the legislative issues, just in time for Legislative Day on February 16th! If you have never been to Legislative Day, this was the year for you to participate! Hundreds of pharmacists and pharmacy students met in Annapolis to share pharmacy views with our legislators and make sure our voice is heard. Many legislators heard directly from their own constituents and get to know what issues are impacting the area they serve, so this is truly an instance where every voice matters. Pharmacy has been building momentum in our legislative efforts over the years
and we have realized numerous successes including establishing collaborative practice, expanding vaccination authority and removing the proof of the English proficiency requirement for student pharmacists, just to name a few. We have also given information and testimony regarding numerous efforts with the potential to impact pharmacy interests, related to shrinking pharmacy networks and emergency refills, among many other issues. This year, we know that two of the items being discussed are pharmacists providing contraceptives, and student pharmacist intern requirements. MPhA has heard how important these legislative issues are to you and we see how they can directly impact our everyday practice. We have specifically engaged a lobbyist to help us take our forward momentum to the next level, but
we cannot do it without you. We hope you will lend your expertise and voice to
our legislative efforts and accompany us to Annapolis. If you are unable to come in person, write a letter or make a phone call to make sure that the pharmacy profession is represented, even a small effort is a step in the right direction. We are in the position to write our own story for our profession and we want to hear what issues are impacting your practice and what opportunities you see for growth.
Please feel free to email or call the office or come out to one of our upcoming events to talk in person and share your experience. We will have several CE dinners throughout the state this spring and several exciting events coming up at our headquarters. Keep an eye on the website and the Monday Message for upcoming events, and feel free to bring a pharmacy friend or two! I hope to see you there! @
- Far’ Nadices Mm ° a Oe Kristen Fink, PharmD, BCPS, CDE President
Cover Story
Rx and the Law
ADVOCACY
By Don. R. McGuire Jr., R.Ph., J.D.
This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and MPhA through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to
the pharmacy community.
To paraphrase John Godfrey Saxe; laws are like sausages, it's better not to see them being made. I am not an expert on sausages, but I would disagree with this comment with regards to laws. Even if we don't get involved in the making of laws, we will be subject to them nonetheless. Pharmacists can ill afford to be impacted by laws drafted by those who know nothing about pharmacy.
Unfortunately for many of us, lobbying is a word with very negative connotations. It projects images of under the table dealings and improper exchanges of cash. So how do we inform lawmakers of the impact of proposed laws on the practice of pharmacy? Through advocacy.
Advocacy is simply the act of supporting a cause, an idea, ora proposed policy. Many state and national associations organize advocacy meetings for their members. While we can all do this individually, a group of concerned citizens visiting the lawmaker's office together can certainly make a larger impact. The purpose of these visits is to educate the lawmaker and their staff on proposed laws that impact our profession. We might be in favor of a proposal, opposed to it
or want to amend the language as presented.
Lawmakers are serving because they want to make a positive difference in our society. However, they are not experts in every field. There is only one pharmacist, Buddy Carter of Georgia, in the 114th Congress. The other Senators and Representatives need pharmacists’ help to understand how proposals will affect pharmacy practice.
I have participated in advocacy meetings on both the state and national level. In my experience, the lawmakers and staffers are eager to hear how proposals will affect constituents in their districts. The meetings usually consist of an introduction, explanation of why you are there, what the real impact in their district will be, and what action you want them to take. For pharmacists, the potential impact is not always direct. The impact may be on our patients; denying access, increasing costs, or creating hurdles to care. Of course, these indirect impacts will have impact on your pharmacy practice. Many times the true impact on patients is not readily apparent. Pharmacists can explain how a particular policy will make it more difficult for
patients to get their medications. Don't expect immediate action. It is always a pleasant surprise to get a commitment, but many times the materials that you provide
are circulated in the office before decisions are made.
Not all advocacy has to take place in Washington, D.C. or your state capital. Invite your lawmaker to visit your pharmacy while they are home in the district. Then they will get to see first-hand what you are doing for your patients, their constituents. You can also advise them about how proposed laws will impact your ability to provide these services. First-hand knowledge and stories
of real impacts (not just theoretical ones) will have the most influence on the process.
If pharmacists don't educate lawmakers about the effects of the changes on their practices and their patients, who will? Don't think of it as lobbying. We are really educating our lawmakers. Joining and participating in professional organizations is a good way to get Started. In the end, the profession will benefit and ultimately, our patients will too. @
© 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 5
A Stepwise Guide to Planning and Implementing a “Healthy Kidneys” Event and Celebrating World Kidney Day
By Eugene Kwachuh, PharmD Candidate 2017 and Hoai-An Truong, PharmD, MPH, FNAP
The prevalence of chronic kidney disease (CKD), regardless of the stage in the adult population, was 14.8% in 2011-20141* The Centers for Disease Control and Prevention (CDC) states that about 10% of adults in the United States, which represents more than 20 million people, may have CKD.* Chances of developing CKD increases after age 50 and are most prevalent among adults older than 70 years.* One out of three adults with diabetes and one out of five adults with hypertension has CKD.* About 40% of individuals with CKD also have concomitant diabetes while 32% have hypertension and 40% have self-reported cardiovascular disease.' Besides these main risk factors, others include obesity, hypercholesterolemia, lupus as well as a family history of kidney disease. Most patients are asymptomatic during early stages and are often diagnosed at advanced stages. The highest increase in occurrence from 1999 to 2014 (5.45 to 6.6%) was observed in stage 3 cases.!
The prevalence of self-reported CKD in the United States is low because kidney disease is often asymptomatic in the initial stages, which makes
the need to screen and educate at risk populations, as well as performing medication therapy management vital. Adults with CKD have higher rates of premature death from all causes and are 16 to 40 times more likely to die than to reach end stage renal disease (ESRD).* CKD increases the chances of developing strokes, heart attacks and cardiovascular diseases. The CDC determined that the most efficient way to reduce personal suffering and associated costs of CKD is to prevent and treat its risk factors. Additionally, the Healthy People 2020 Initiative identified 14 objectives with focus on kidney disease, that highlights the necessity for an intervention.t The Center for the Advancement of Pharmacy Education (CAPE) educational outcomes* and the Standards and Guidelines of the Accreditation Council for Pharmacy Education (ACPE)* include domain and competency requirements in health promotion and wellness, and student organization initiatives also support active involvement of pharmacy students in public health activities. While the American Pharmacists Association Academy
of Student Pharmacists (APhA-ASP)°* has initiatives for some important
risk factors such as operations diabetes and heart, the Student National Pharmaceutical Association (SNPhA)'s Chronic Kidney Disease Initiative facilitates numerous activities to raise awareness on kidney disease throughout the year and could benefit from a guide to hosting an event.® This article describes a step-by-step guide to planning and implementing a healthy kidneys education and outreach project for pharmacists, preceptors and students, based on the assessment, policy development, and the assurance public health functions model. This stepwise approach applies the 10 essential services of public health’ coupled with an adaptation from another public health program, “Planning and Implementation of a Student- led Immunization Clinic: The Thirteen-step Process’8
6 MARYLAND PHARMACIST | WINTER 2017
Step 1 Conceptualize an Idea and Find an Organization with Aligned Goals
Ignite your passion for kidney disease awareness and find a professional and/or student organization with goals aligned to your passion. SNPhA’s CKD initiative raises awareness every year in March during Kidney Awareness Month. Contact your local SNPhA chapter and/or other kidney organizations and find out if a collaboration can be established to host an event.
Step 2 Conduct a Needs Assessment
To ensure an effective public health intervention, a needs assessment is required. Consult the CDC's kidney disease resources and the Healthy People 2020 objectives that focus on kidney disease; and identify a location and target population with a need for kidney
disease prevention education intervention. Consult your local health department to find out the prevalence of kidney disease in your area. Use the Assessment Development and Assurance Pharmacist's Tool (ADAPT)? to ensure highest quality and greatest impact. Another helpful resource is the National Council on Patient Information and Education (NCPIE).*°
Kidney Disease and Obesity
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Step 3
Set a Goal and Convene a Planning Team
Set a goal and target your plan based on your needs assessment. Reach out to the SNPhA CKD Initiative Chair of a pharmacy school within the vicinity. Plan with both the CKD Initiative Chair and the chapter president. Sell your idea
to stakeholders, such as a kidney organization, community pharmacy, pharmacists, co-preceptors and/or students.
Step 4 Seek Guidance and Support
Pharmacists and/or students
on APPE rotations should seek guidance from colleagues, co- preceptors, and faculty advisors of the student organizations. Preceptors should seek support from colleagues at organizational leadership levels. Also, establish
a relation with regional event organizers of associations, including the National Kidney Foundation (NKF) for resources.
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Step 5 Collaborate with Local Organizations
Collaborate with local health departments if possible. Visit the NKF website" and obtain contact information for the regional event organizer. Reach out and ask for assistance, including obtaining patient education materials. These individuals will most likely know the optimal location and logistics based on experiences and expertise.
Step 6
Recruit and Train Volunteers
Recruit pharmacists and/or student volunteers early to ensure their commitment. Create and send out a spreadsheet for student volunteers to sign up. Schedule a meeting with the team regularly and at three weeks before the event. Assign tasks and follow-up with responsible parties to review the event's schedule for readiness. Provide training for volunteers, as applicable to their roles and responsibilities.
Step 7 Promote the Initiative
Develop a press release and send
it to local newspapers and radio stations. Seek review and input from their marketing department if available. Create flyers and display at public places, such as a libraries or common areas. Use social media sites like Facebook and Twitter to promote the event.
Step 8 Put it All Together
Confirm that all educational materials, including posters, visual- aids and logistics are ready by doing a personal check. Collect any materials from partner organizations. Visit and inspect the site. Once everything is ready, use the ADAPT tool to double check attainment of preparation goals to ensure highest quality and impact.
Step 9
implement the Event and Manage Last-Minute Challenges
Arrange for the team to be on-
site at least an hour before commencement to setup. Convene the team for a huddle session and congratulate team for their planning efforts. Anticipate and resolve last minute challenges with a positive can-do attitude. Enjoy the event.
Step 10 Follow-up and Evaluation
Invite faculty of participating institutions and/or colleagues of partner organizations to review the content of educational materials and posters created by the students. Collect emails from attendees;
then, prepare and send out an online evaluation survey on the event. Complete reports for various stakeholders, such as partner organizations, student organizations and sponsors or supporters. Summarize feedback to improve future events.
MARYLANDPHARMACIST.ORG 7
In addition to the steps above, there are helpful resources and websites, such as the National Kidney Foundation (NKF)3 chronic kidney disease risk screening available at http://nkf.worksmartsuite.com/UserContentStart. aspx?pl=11-10-1814 or risk factor card at http://nkf:worksmartsuite.com/GetThumbnail.aspx?assetid=1761. Additional websites include: www.kidney.org, www.aakp.org, www.kidneyfund.org, www.americanheart.org, and www.snpha. com/initiatives/chronic-kidney-disease. With systematic planning and available resources, pharmacists and/or students will be able to implement an effective and quality “Healthy Kidneys” event for patients and celebrate World Kidney Awareness Month.
REFERENCES
aL
Healthy People 2020 [database online], Washington, DC: U.S. Department of Health and Human Services; 2014. Available at https://www.healthypeople. gov/2020/data-search/Search-the- Data#srch=kidney disease. Updated December 6, 2016. Accessed December 7, 2016.
Centers for Disease Control and Prevention (CDC). National Chronic Kidney Disease Fact Sheet: General Information and National Estimates on Chronic Kidney Disease in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2014.
American Association of Colleges
of Pharmacy (AACP) Center for the Advancement in Pharmacy Education (CAPE). Educational Outcomes 2013. AACP. Alexandria, VA, 2013.
4. Accreditation Council for Pharmacy
Education. Accreditation standards and guidelines for the professional program in pharmacy leading to the doctor of pharmacy degree. (Adopted: January 25, 2015; Effective: July 1, 2016). https://www.acpe-accredit.org/ pdf/Standards2016FINAL.pdf. Accessed December 6, 2016.
American Pharmacists Association — Academy of Student Pharmacist. http:// www.pharmacist.com/apha-asp. Accessed December 7, 2016.
Student National Pharmaceutical Association. https://snpha.org/about/ Accessed December 7, 2016.
Centers for Disease Control and Prevention. National Public Health Performance Standards Program.
Core Public Health Functions Steering Committee. Ten essential public health services. http://www.cdc.gov/nphpsp/ essentialServices.html. Accessed December 6, 2016.
8.
10.
le
Dang CJ, Dudley JE, Truong HA,
Boyle CJ, Layson-Wolf C. Planning
and Implementation of a Student-led Immunization Clinic. American Journal of Pharmaceutical Education. 2012;76(5):78. doi:10.5688/ajpe76578.
Truong HA, Taylor CR, DiPietro NA. The Assessment, Development, Assurance Pharmacist’s Tool (ADAPT) for Ensuring Quality Implementation of Health Promotion Programs. American Journal of Pharmaceutical Education. 2012;76(1):12. doi:10.5688/ajpe76112.
National Council on Patient Information and Education. http://www.talkaboutrx. org/about.jsp. Accessed December 6, 2016.
National Kidney Foundation https://www. kidney.org/about. Accessed December 5,
2016. @
THANK YOU TO OUR 2016 EPIC PHARMACIES CONTRIBUTORS
A Network Of Independently Owned Pharmacies
8 MARYLAND PHARMACIST | WINTER 2017
800-965-EPIC | epicrx.com
State & Federal Updates
Federal Pharmacist Provider Status Legislation Re-Introduced
HR 592, Pharmacy and Medically Underserved Areas Enhancement Act, has been reintroduced. The bill would allow Medicare Part B to
utilize pharmacists to their full capability by providing services to the underserved. 19 out of 24 counties in Maryland are considered to be medically underserved. The lack of pharmacist recognition as a provider limits the ability of pharmacists to provide services that they are qualified to perform and presents a barrier to care - this bill remedies
this situation. It would also reduce overall healthcare
costs and increase access
to healthcare services and improve healthcare quality outcomes for a very vulnerable population. If you have
not already done so, reach
out to your Congressional Representative via www.house. gov and express your support for the bill.
FDA Bans Sale and Use of Powdered Medical Gloves
Effective January 18, 2017, the Food and Drug Administration (FDA) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated
by labeling or a change in labeling.
Consequently, FDA is banning these devices. This ban includes the use of powdered gloves by pharmacists.
CMS Recognizes Impact of Expanding a Pharmacist’s Scope
In a guidance released on January 17, the Centers for Medicare & Medicaid Services (CMS) encourages state Medi- caid programs to consider expanding the ability of phar- macists to prescribe, modify, or monitor drug therapy to promote patient access to medically necessary and time- sensitive drugs. CMS recog- nizes the need for innovative tools to address public health issues, including the expan- sion of a pharmacist’s scope of practice by utilizing colla- borative practice agreements, standing orders, or therapy protocols to treat patients.
PTCB Suspends Implementation of Accredited Education Requirement Originally Planned for 2020
The Pharmacy Technician Certification Board (PTCB)
has decided to suspend the implementation of the planned 2020 accredited education requirement for pharmacy technicians who seek PTCB Certification.
PTCB originally announced in 2013 that the requirement would take effect in 2020
as part of a road map of program changes designed to keep pace with the evolution of technician roles in the pharmacy. “We have determined that additional deliberation and research are needed to address stakeholder input, develop supporting policy, and conduct further study of technician roles,” said Larry Wagenknecnht, BPharm, Chair of the PTCB Board of Governors, and CEO of the Michigan Pharmacists Association.
HHS Rule Gives Pharmacies Flexibility with Rewards
A final rule issued by HHS allows beneficiaries in government-programs, such as Medicare and Medicaid,
to participate in pharmacy customer rewards and
loyalty programs. Federal
laws had previously blocked government-program beneficiaries from participating in pharmacy rewards programs. This rule went into effect on January 6. @
MARYLANDPHARMACIST.ORG 9
Member Mentions
Welcome Baby Moody!
Congratulations to House Speaker Ashley Moody, PharmD, BCACP, AE-C and husband Ross! On January 25, they welcomed baby girl Ruth Maxine. She joined the world at 9lbs 6 oz. and 22 inches long.
Past Speaker Assumes Federal Role
Past Speaker W. Chris Charles, PharmD, BCPS, AE-C has joined
the Commissioned Corps of the US Public Health Service. He will be stationed at the Pine Ridge Indian Hospital providing care for the Oglala Sioux Tribe in Pine Ridge, South Dakota starting in February 2017,
Chris Charles with his daughter Emma and wife Fei in her hometown of Leshan, China
MPhA Past President joins Ranks of APhA Fellows
MPhA Past President Hoai-An Truong, PharmD, MPH, FNAP, and faculty at the University of Maryland Eastern Shore (UMES) School of Pharmacy and Health Professions, has been nominated and selected as a Fellow of the American Pharmacists Association (FAPhA). Fellows must have a minimum of ten years professional experience and demonstrated exemplary professional achievements and service to the profession through activities with APhA and other national, state, or local professional organizations. Hoai-An will be Officially recognized during
the APhA Annual Meeting and Exposition in San Francisco, CA, March 24-27, 2017.
Member to Member Ownership Transitions
John & Wayne VanWie (current MPhA Trustee) owners of Professional Pharmacy in Rosedale, MD, for more than 10 years,
recently announced that they have transitioned their ownership interest to MPhA Past President Christine Lee-Wilson PharmD, clinical pharmacist and entrepreneur.
10 MARYLAND PHARMACIST | WINTER 2017
John and Wayne enjoyed serving the people of Rosedale, Whitemarsh and Essex communities providing medication services including fertility care, diabetes counseling, compounding, mental health care and immunizations. They are very confident that Christine will continue to serve the community well and expand the services
with her clinical skills. Christine has expressed excitement about taking on this new challenge and opportunity.
Past Student Trustee Receives National Committee Appointment
Shannon Riggins, PharmD Candidate 2017, University of Maryland Eastern Shore School of Pharmacy was appointed to the 2017 APhA Policy Reference Committee at the 2017 APhA House of Delegates.
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Continuing Ed
Barriers to Optimal Health Care in the Hispanic Population: Considerations for Pharmacists
Astrid Bernal, PharmD, Graduate Pharmacist Intern, Walgreens Pharmacy
Kathleen J. Pincus, PharmD, BCPS; Assistant Professor, Department of Pharmacy Practice and Science,
After reading this article, the learner will be able to:
1. Identify at least three considerations to incorporate when counseling a Hispanic patient
. List at least three herbal products commonly used
by Hispanic patients
University of Maryland School of Pharmacy
Learning Objectives
patients
3. Given a patient case, identify opportunities for pharmacists to improve the care of Hispanic
Key Words: Hispanic « Diabetes » Hypertension
Introduction
The Hispanic population is rapidly growing throughout the United States. “Hispanic” and “Latino"
are terms that are often used interchangeably to describe individuals from Mexico, Cuba, Puerto Rico, Central America, and South America.t The National Council of La Raza, estimates that there are 50.6 million Hispanic people living in the United States.* In Maryland, Hispanics are the second largest minority group.° The population of Hispanics in the state grew by 48% between 2000 and 2006 and is projected to continue to increase over the next several years. High rates of Hispanic patients face barriers
to receiving optimal health care, including lack of health coverage and low socioeconomic status.
In 2014, 27% of Hispanics living
in Maryland did not have health insurance, 13% were living under the poverty level, and 56% did
not own their own home.* Other barriers include low education levels, cultural beliefs about health care, and difficulty communicating with health care professionals.
These social determinants impact the recognition, management, and outcomes related to common chronic medical conditions including obesity, diabetes, and hypertension.
Obesity
More than 3 in 4 Hispanics in the United States are obese, defined as a BMI > 30 or a waist circumference > 35 inches in females or 40
inches in males.° Being overweight or obese increases the risk of developing other diseases including type 2 diabetes, hypertension, cancer, stroke, osteoarthritis, and nonalcoholic fatty liver disease.°*® The high fat, carbohydrate, salt, and sugar content in traditional Hispanic diets may contribute to the high rates of obesity seen in the Hispanic population. Each culture is associated with signature meals. As an example, popular meals in the Puerto Rican culture, consist
of pastels (meat pies), rice, beans, chicken, and other meats.” While in the Mexican culture, the diet is rich in complex carbohydrates, corn, tortillas, rice, beans, meats, and spices. Many Hispanics mention
that following a diet consistent with the USDA recommendations can be challenging because
it does not include traditional Hispanic foods.’ Hispanic cultures are typically family oriented with many celebrations incorporating traditional foods. An individual may feel like an outsider when he or she is unable to eat the same things as family and friends.’
Since many Hispanic immigrants also have low socioeconomic status, buying foods that are beneficial to their health may
be difficult. Many immigrant communities are located in food deserts; areas where fast food and small convenient stores are readily available, while fresh produce
and meats are scarce. The areas in which the majority of Hispanic immigrants live, also do not provide the safest environments for exercise. Diet and exercise are the most important factors that can help with weight loss and help reduce the risk of obesity- related diseases. While adjunctive medications to treat obesity, including phentermine and orlistat have FDA approval, they can be
MARYLANDPHARMACIST.ORG 13
expensive particularly for uninsured patients.
Diabetes
According to the U.S. Department of Health and Human Services Office of Minority Health, Hispanic adults are 1.7 times more likely to be diagnosed with diabetes than non-Hispanic whites.’ Biological characteristics, socioeconomic conditions, and cultural aspects contribute to the increased prevalence of type 2 diabetes.’° Increases in abdominal obesity and visceral fat have been found in the Hispanic population. This biological factor is thought to contribute
to the increased risk of insulin resistance in Hispanics compared to non-Hispanic whites.”° It has also been hypothesized that Hispanics may have a genetic predisposition for B-cell dysfunction.®
Since therapies to modulate genetic risk factors are not
SIDEBAR CASE
available, the main focus of diabetes prevention and treatment should be socioeconomic conditions and cultural aspects to decrease the disparity in diabetes- related outcomes. Studies have demonstrated a correlation between low socioeconomic status and increased risk of
type 2 diabetes diagnosis and amputation.!? Low socioeconomic status can cause patients to forgo their medication due to cost or lack of insurance. Medications for diabetes, particularly insulin, can be expensive. Insulin formulations that come in prefilled auto- injectors such as Lantus Solostar and Novolog Flexpens can cost over $300 and $480 per box respectively.""* For a patient without insurance this can become quite burdensome. Prescribing insulin vials may reduce cost,
but also increases complexity of administration, which is especially demanding for patients with poor
eyesight or conditions like arthritis that can affect manual dexterity. The additional cost of supplies including syringes must also be considered. Clinicians may turn to older insulin formulations like NPH or mixed insulins to further reduce cost ($27 for a 10 mL vial of Novolin N), though the pharmacokinetic profiles of these formulations
less closely resemble physiologic insulin production and may confer less stringent blood glucose control.’ These patients may also lack reliable transportation, which can limit their ability to regularly attend medical appointments.”°
Hispanic cultures are rich in cultural beliefs and traditions. Hispanics have been shown to have more medication-related concerns and misconceptions about their disease state and its management when compared to non-Hispanic whites.*? Some misconceptions include: fear of
Mrs. T is a 65-year-old Hispanic woman, from Mexico, who comes to your pharmacy for the first time. The patient lives at home with her daughter, son-in-law, and three grandchildren. Today she is here with her daughter, who speaks little English. She has a new prescription for Lisinopril 10 mg once daily and Metformin 500 mg twice daily. Because the patient is new to the pharmacy, you proceed to ask pertinent questions related to her health. Instead of answering the questions, the patient hands you documentation from her hospital visit. You see that
her BMI is 32 kg/me2. You ask the daughter about her mother's diet and she mentions that they eat tortillas with meat, white rice, and beans about four nights
a week. The mother doesnt drive, so it is difficult to get to the grocery store. Mrs. T often relies on family members for transportation to and from the grocery store and her medical appointments.
Allergies: Eggs (severe rash and stomach pain)
Medical Conditions: Diabetes, Hypertension, and obesity
Ht: 5'2" | Wt: 175 lbs | BMI: 32 kg/m2 | A1C: 8%
CE QUESTIONS
1) Which of these
is mentioned as a
folk remedy for the treatment of Diabetes that is most commonly used in the Mexican and Guatemalan population?
2) What is the
most likely reason
for uncontrolled hypertension among the Hispanic population?
A) Lack of insurance
A) Manzanilla B) Non-adherence
B) Sabila C) Nopal D) Yerba Buena
C) Trouble getting to medical appointments due lack of transportation
D) All of the above
14 MARYLAND PHARMACIST | WINTER 2017
3) Which of these is not a recommended resource for pharmacist when counseling Hispanic patients? (Select all the apply)
4) Which one of these foods is not listed as a popular dish in the Mexican population?
A) Complex carbohydrates (corn tortillas)
A) Google translator Bipaane C) Rice
D) Pastels (meat pies)
B) Telephone service
C) Bilingual pharmacist
) D) Family and friends
Answers on page 17
Table 1: Common Herbal Remedies Used in the Hispanic Population
Name in English Typical Common Side Drug (Spanish) Uses Effects Interactions
Aloe Vera Diabetes Abdominal pain and cramps Digoxin-increased risk of (Sabila)'>"® with aloe latex. Long term use toxicity related to potassium can cause diarrhea, potassium depletion depletion, etc.
Prickly Cactus Pear Diabetes
(Nopal)'"9
Mild diarrhea, nausea, abdominal fullness, and headache
May increase hypoglycemic effects when given with other antidiabetic agents (e.g. glyburide)
Garlic (Ajo) 20,21
Hypertension Prevention of arteriosclerosis
Malodorous breath, body odor, flatulence, weight loss, nausea, vomiting, facial flushing, insomnia
May enhance the effects of anticoagulants and antihypertensive medication
Nausea Vomiting
Ginger (Jengibre) 2°72
Abdominal discomfort, heartburn, diarrhea, and a pepper like irritant effect in the
May enhance effects of anticoagulants
becoming medication dependent, perceptions that patients can
feel when their glucose levels are high, beliefs that physicians can cure diabetes, and the impression that medication is not needed when they feel normal.*® Along with these misconceptions, other treatment beliefs and practices can affect the quality of care. Some Hispanics use folk remedies and natural medicines rather than seeking care at medical facilities [Table 1].*°2 Aloe vera, also known as sabila in Spanish, is an example of a folk remedy that Mexican
and Guatemalan people believe to have hypoglycemic properties and to be helpful for the treatment of diabetes. In most clinical trials, Sabila has been found to
be well-tolerated.”® Aloe latex,
the part of the plant between
the rind and inner gel, has been associated with abdominal pain and cramps.'® Long-term use of aloe latex can cause diarrhea, potassium depletion, albuminuria, hematuria, muscle weakness,
and heart disturbance.’® Caution should also be taken with patients who are taking digoxin because of a major drug-drug interaction that increases the risk of digoxin toxicity.’© Nopal (prickly pear cactus) is another example of a natural remedy that the Mexican
mouth and throat
culture believes to be helpful
for preventing and controlling type 2 diabetes.” Side effects
in patients taking Nopal include mild diarrhea, nausea, abdominal fullness, and headache.’® Patients that are taking antidiabetic
agents such as metformin and glyburide, should be cautious and monitor their blood glucose levels frequently when taking Nopal,
as the combination can increase the risk of hypoglycemia.’ These are only a few examples of how cultural beliefs, in addition to
low socioeconomic status, can play a major role in treatment for Hispanics diagnosed with diabetes.
Hypertension
Hypertension is another chronic condition that significantly impacts the Hispanic population. It is one of the leading causes of heart disease and stroke in the United States affecting one in every three adults.” Approximately $46 billion dollars are spent in this country on health care services, missed days of work, and medications used to treat
high blood pressure.** According
to the National Health and Nutrition survey, when compared to non-Hispanic whites and non- Hispanic blacks, Hispanics were
the population associated with the
least controlled hypertension.” A study done by Tong and colleagues reinforces this finding. This study found that Hispanic patients
had the highest percentage
of uncontrolled hypertension
due to non-adherence, when compared to non-Hispanic blacks and whites.*° Younger adults and those with low socioeconomic status were also associated with having low adherence rates.
The most commonly reported reason for non-adherence among the Hispanic population, was
not feeling that they needed to control their blood pressure.”° Factors relating to non-adherence in this population included, language barriers, cultural beliefs, lack of health insurance, lower income, and low health literacy. Interventions including community health workers or promoters de salud, were mentioned as possible options to improve disease
state education for the Hispanic population.® Increasing screening and awareness of the importance of controlling hypertension has the potential to have a significant impact on the progression to other cardiovascular diseases such as coronary artery disease, stroke, and heart failure.*° The barriers
of low socioeconomic status, limited access to healthy foods
MARYLANDPHARMACIST.ORG 15
and safe places to exercise, low health literacy, language barriers, are repeating themes that have the potential to impact many chronic disease states.
Pharmacist Training
Not only is it important for healthcare professionals to be educated on these barriers, but it
is also important to learn about each patient's culture, diet, and beliefs related to medications and healthcare. Cultural competency
is defined as having a ‘set of congruent behaviors, attitudes, and policies that come together ina system, agency, or among professionals that enables effective work in cross-cultural situations."“” Having an understanding of cultural competency is essential for providing optimal care in the growing Hispanic population. Pharmacists play an integral part
to a patient's overall care and it is important to provide education early in training to optimize the delivery of pharmaceutical care
to these populations. Cultural competency is a topic most often taught in pharmacy school through didactic or case based lessons, but not as consistently encountered through experiential education.”” Adding an advanced pharmacy practice experience (APPE) that incorporates interaction with Hispanics or other minorities would help translate what is taught in class into real life practice.®” In
a study done at Drake University College of Pharmacy and Health Sciences, 43 students completed
a Community Access Pharmacy APPE, which allowed them to engage with a culturally diverse population.” Students interacted with patients in the Hispanic community, homeless shelters, and at HIV Clinics. When interacting with the Hispanic patients, students had the opportunity to participate in various activities. Students practiced with Spanish interpreters and learned how to use a language
line service when interpreters were not present. Students were also given the opportunity to
visit a Hispanic grocery store to become familiar with the foods sold there.” In addition to visiting the grocery store, they provided
a nutritional plan for a Hispanic woman with diabetes. They spent some time with her at the grocery store, educated her on how to interpret food labels, and taught her how to measure serving sizes. This was essential to her diabetes education and treatment plan. Incorporating experiences such as this, helps increase student pharmacists’ awareness of the challenges Hispanics face on a daily basis and allows them to become more understanding
and empathetic healthcare professionals. Another topic that is discussed in the literature is the incorporation of a Spanish course in pharmacy school. In an article written by Dilworth and colleagues, it is mentioned that pharmacists feel that Spanish courses should be incorporated into pharmacy school, required as a prerequisite to pharmacy school, or be made part of a continuing education for pharmacists.”® With the Hispanic population expected to increase rapidly over the next several years, it is important to educate pharmacists early in their training So that they can be better prepared.
Pharmacists’ Role
Pharmacists practice in a variety of settings that require interaction with patients from different cultures and backgrounds. Whether in a hospital, outpatient clinic, or community pharmacy, the interaction between the patient and pharmacist is a vital part in providing optimal care [Table 2]. Pharmacists not only provide medication education and counseling, but they can also help make non-pharmacologic recommendations on topics such as diet and exercise. Establishing
16 MARYLAND PHARMACIST | WINTER 2017
a collaborative pharmacist- patient relationship through good communication skills can help improve medication adherence and reduce adverse drug events, which research has noted to be prevalent in patients who have limited English proficiency.” Reducing adverse events and improving medication adherence can help reduce healthcare costs and improve health care outcomes. Pharmacist can also play a role
in promotion of preventative health screenings in the Hispanic population, by stressing the importance of immunizations and cancer screenings. Hispanics and Blacks are both mentioned as the populations less likely
to receive preventative health screenings because of barriers
to receiving health care, in comparison to Whites.”?
Establishing an environment in which the Hispanic patient feels comfortable discussing his or her views, beliefs, and disease state understanding will help the patient feel connected to the healthcare team and encourage their active participation in their own treatment including attending regular follow- up appointments and adherence to medications. Communication can become difficult due to language barriers, but pharmacists should familiarize themselves with available interpretation resources. Some of these resources include computer programs that help translate pharmacy labels and educational brochures into Spanish, and interpreters. Interpreters
can take on many forms, which may include internet services, telephone services, scheduled live interpreters, bilingual pharmacists and/or staff, and a patient's family member or friend.*® Caution should be taken when using family members or friends as interpreters because they may not be able to accurately interpret the information given by the pharmacist.*® Family members may not know medical
Table 2: Counseling Tips for Pharmacists Interacting with a Hispanic Patient
Communication
Familiarize yourself with available interpretation services at your practice site
Evaluate patient’s level of education and acculturation (e.g., years of education, fluency in English)
Avoid using family members as medical interpreters whenever possible
Maintain eye-contact with the patient when using an interpreter
Use short sentences with frequent breaks
Request written information from hospitalizations and/or outpatient appointments to help clarify diagnoses, history, and instructions
Provide written documentation of your conversation with the patient that they can show to other healthcare providers
Dietary Counseling
Ask the patient to characterize their typical diet
Become familiar with foods typical of the patient population, visit local Hispanic grocery stores Individualize counseling on dietary modifications to include traditional foods
Focus on portion control
Assist patients in identifying stores in their area where they can purchase fresh foods
« Assist patients in developing specific exercise plans * Help patients identifying safe and affordable locations to exercise
Preventative Medicine and Health Care Access
Ensure that patients are screened for common medical conditions including: obesity, diabetes, and hypertension
Promote preventative medicine including immunizations and cancer screenings
Identify community based resources in your area including community health workers, low cost health centers, charity services, English Speakers of Other Languages (ESOL) classes
Medication Access and Understanding
Assess patient’s prescription coverage before making pharmacotherapeutic recommendations
Reinforce goals of therapy and the role of medications for long term control of chronic conditions
Assess for adverse effects of medications
Assess patient’s medication and medical beliefs
Ask the patient about the use of herbal products and folk remedies
Identify resources to help defer prescription costs: eligibility for prescription drug coverage, manufacturer coupons, and pharmacy discount cards
MPHA FOUNDATION
The MPhA Foundation expresses thanks for the members who have provided financial support to the MPhA Foundation through direct contributions and events in 2016.
MPhA Foundation Klein's Shop Rite of Supporter: $25 -— $99 General:
Legacy: $1,000+ Maryland Avis Austin Mimi Baker
Debra Weintraub Nutramax Labs Steven Barber Christopher Chidueme Cynthia Boyle Mark Ey Samuel Houmes
Evander Frank Kelly: Mark Freebery Michael Goldenhorn Paul Holly
$500 — $999 Gerald Herpel Butch Henderson Aliyah Horton
Healthsource Brian Hose Murhl Flowers Brandon Keith
Distributors Cherokee Layson-Wolf Andrew Haines Lauren Lakdawala
Dixie Leikach Jonas Nicholson Virginia Nguyen B. Olive Cole: Matthew Shimoda Mark Sanford Jordan Stieter
$100 — $499 Cynthia Thompson Maria Uy Apple Discount Drugs
Deep Creek Pharmacy
MARYLANDPHARMACIST.ORG 17
terminology either in English or in Spanish and may alter messages due to compassion for a loved one. Family members may also be embarrassed to ask certain sensitive questions particularly to an elder. When using interpreter services, it is important for the pharmacist to maintain eye contact with the patient and avoid long statements that may overwhelm the patient. Pharmacists can also request that the patient provide written documentation from hospitalizations or doctors visits. This can help the pharmacist
piece the puzzle together when learning about the patient as a whole and what is beneficial to their care. Since many of these patients also cannot afford their medications, identifying resources, finding coupons (if available), or enrolling patients in pharmacy discount programs can help defer medication costs and reduce the prescription payment burden on the patient. Lastly, pharmacists can become familiar with foods typical to the patient population they serve and become aware of community programs that can help
the Hispanic population in the area. Some examples include English
for Speakers of Other Languages (ESOL) classes, health promoters, and charity based programs. As a healthcare community, we have seen positive progress with aiding the Hispanic community, but there is still room for improvement. Future research should be geared towards implementing programs that can help train pharmacists to optimize interactions with minority populations.
REFERENCES
ib
10.
ata
12.
13:
18
Cipriano GC, Andrews CO. The Hispanic pharmacist: value beyond a common language. Sage Open Medicine 2015; 3: 2050312115581250 [epub]. DOI: 10.1177/20503121115581250. McDonough AM, Kamasaki C. An inside look at chronic disease and health care among Hispanics in the United States. Washing- ton, DC: National Council of La Raza; 2014. Available at: http:// Ichc.org/wp-content/uploads/chronic_disease_report_2014 pdf. Accessed 28 February 2016.
Overview of Hispanic community in Maryland. Department of Legislative Services, Office of Policy Analysis. Annapolis, MD: 2008. Available at: http://dis.state.md.us/data/polanasubare/polanasu- bare_intmatnpubadnv/Overview-of-Hispanic-Community.pdf. Accessed 3 November 2016.
Demographic profile of Hispanics in Maryland, 2014. Pew Research Center. Washington, DC: 2016. Available at: http://www.pewhis- panic.org/states/state/md/. Accessed 3 November 2016 Overweight and Obesity Statistics. National Institutes of Health; October 2012. NIH Publication No. 04-4158. Available at: http:// www.niddk.nih.gov/health-information/health-statistics/pages/ overweight-obesity-statistics.aspx. Accessed 28 February 2016. NHLBI Obesity Education Initiative Expert Panel. The practical guide: identification, evaluation, and treatment of overweight and obesity in adults. National Institutes of Health; 2000. NIH Publica- tion No. 00-4084. Available at: http://www.nhlbinih.gov/files/docs/ guidelines/prctgd_c.pdf. Accessed 27 February 2016.
Hatcher E, Whittemore R. Hispanic adults’ beliefs about type
2 diabetes: Clinical Implications. J Am Acad Nurse Pract. 2007;19(10):536-545. DOI: 10.1111/).1745-7599.2007.00255.x. Cultural Diversity: Eating in American-Mexican-American Web site. Ohioline. College of Food, Agricultural, and Environmental Sciences. Columbus, Ohio: August 30, 2010. Available at: http:// ohioline.osu.edu/factsheet/hyg-5255. Updated. Accessed March 20, 2016.
Diabetes and Hispanic Americans. Office of Minority Health. U.S. Department of Health and Human Services: 11 May 2016. Available at: http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lviID=63. Accessed 3 November 2016.
Cersosimo E, Musi N. Improving treatment in Hispanic/Latino patients. Am J Med. 2011;124(10 supply):S16-21. DOI:10.1016/j. amjmed.2011.07.019.
Lantus. In: GoodRx [database on the Internet]. GoodRx, Inc Accessed 30 March 2016]. Available at: http://www.goodrx.com/ lantus.
Novolog. In: GoodRx [database on the Internet]. GoodRx, Inc Accessed 30 March 2016]. Available at: http://www.goodrx.com/ novolog.
Novolin N. In: GoodRx [database on the Internet]. GoodRx, Inc Accessed 9 April 2016]. Available at: http://www.goodrx.com/no- volinn.
MARYLAND PHARMACIST | WINTER 2017
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Weller SC, Baer RD, Pachter LM, et al. Latino beliefs about diabetes. Diabetes Care 1999;22(5):722-728. DOI: 10.2337/diacare.22.5.722. Aloe. In: Natural Medicines [database on the Internet]. Somerville, MA: Therapeutic Research Center [cited 28 March 2016]. Available at: https://naturalmedicines-therapeuticresearch-com.proxy-hs. researchport.umd.edu/databases/food,-herbs-supplements/profes- sional.aspx?productid=961.
Lemley M, Spies LA. Traditional beliefs and practices among Mexican American immigrants with type II diabetes: A case study. J Am Assoc Nurse Pract. 2014;27(4): 185-189. DOI: 10.1002/2327- 6924.12157.
Nopal. In: Natural Medicines [database on the Internet]. Somer- ville, MA: Therapeutic Research Center [cited 28 March 2016]. Available at: https://naturalmedicines-therapeuticresearch-com. proxy-hs.researchport.umd.edu/databases/food,-herbs-supple- ments/professional.aspx?productid=961.
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Garlic. In: Natural Medicines [database on the Intemet]. Somerville, MA: Therapeutic Research Center [cited 9 April 2016]. Available
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High blood pressure fact sheet. Centers for Disease Control and Prevention. 2015. Available at: http://www.cdc.gov/dhdsp/data_ statistics/fact_sheets/fs_bloodpressure.htm. Accessed February 28, 2016.
Hypertension prevalence and control among adults: United States, 2011-2014. Centers for Disease Control and Prevention. 2015. Available at: http://www.cdc.gov/nchs/data/databriefs/db220.htm. Accessed February 28, 2016.
Tong X, Chu EK, Fang J, Wall HK, Ayala C. Nonadherence to antihypertensive medication among hypertensive adults in the United States-HealthStyles, 2010. J Clin Hypertens (Greenwich). 2016;18(8):892-900. DOT: 10.1111/jch.12786.
26. Sorlie PD, Allison MA, Aviles-Santa ML, et al. Prevalence of hy- 28. pertension, awareness, treatment, and control in the Hispanic Community Health Study/Study of Latinos. Am J Hypertens. 2014:
27(6):793-800. DOI: 10.1093/ajh/hpu003.
27. Haack S. Engaging pharmacy students with diverse patient populations to improve cultural competence. Am J Pharm Educ. 29. 2008;72(5):124. Available at: http://www-ncbi-nilm-nih-gov.proxy- hs.researchport.umd.edu/pmec/articles/PMC2630151/. Accessed
February 28, 2016.
Dilworth TJ, Mott D, Young H. Pharmacists’ communication with Spanish-speaking patients: A review of literature to establish an agenda for future research. Res
Social Adm Pharm. 2009;5(2):108-120. DOI: 10.1016/j.sa-
pharm.2008.05.005
Lees K, Wortley P, Coughlin S. Comparison of racial/ethnic dispar- ities in adult immunization and cancer screening. Am J Prev Med. 2005;29(5):404—411. DOI:10.1016/j.amepre.2005.08.009. @
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: 12/29/16 Program Expiration Date: 12/29/19 This program provides for 1.0 contact hour (0.1) of continuing education
credit. Universal Activity Number (UAN) 0798-9999-16-164-H04-P
®
The authors have no financial disclosures to report.
This program is Knowledge Based — acquiring factual knowledge that is based on evidence as accepted in the literature by the health care professionals.
Directions for taking this issue's quiz:
This issue's quiz on Barriers to Optimal Healthcare in the Hispanic Population: Considerations for Pharmacists can be found online at www.PharmCon.com.
(1) Click on “Obtain Your Statement of CE Credits for the first time.
CE Questions Answers from page 14
1) B. Sabila also known as Aloe, is used by both the Mexican and Guatemalan population. Manzanilla (chamomile) is used for colic or upset stomach. Yerba Buena (spearmint) is typically used to
relieve upset stomach and headache.
2) D. All are contributing factors for uncontrolled hypertension in
the Hispanic population.
loved one.
(2) Scroll down to Homestudy/OnDemand CE Credits and select the Quiz you want to take.
(3) Log in using your username (your email address) and Password MPHA123 (case sensitive). Please change your password after logging in to protect your privacy.
(4) Click the Test link to take the quiz.
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.
3) A and D. It is important to use a reputable source when providing translation. Family and friends aren't the best resource because they may alter language out of compassion for their
4) D. Pastels (meat pies) are more common among those of Puerto Rican decent.
PHARMACISTS MONTH ACTIVITIES
MPhA-Rite Aid Flu Shot Clinic
In collaboration with our Corporate Sponsor Rite Aid, MPhA hosted a
Flu Shot Clinic. Patients included employees from the business park where MPhA headquarters is located. While waiting for their shots, patients were treated to a tour of the pharmacy exhibits and received ScriptYourFuture resources. It was a fun day to meet our neighbors, provide flu shots,
and educate them about the role of pharmacists in Maryland.
MPhA Provides Educational Support to Prevent Medication Errors
MPhA held its October CE focused on medication safety in cooperation with the Food and Drug Administration (FDA). Thank you to Kimberly DeFronzo, FDA, Division of Drug Information, for facilitating the collaboration and to presenter Mishale Mistry, PharmD, MPH for presenting, “Ongoing Role of FDA
in Medication Error Prevention.” The meeting room was packed and feedback from participants was overwhelmingly positive. Participants appreciated the greater understanding of the role of FDA plays in medication safety and
the impact pharmacists have in the organization.
Maryland Preceptors Gather at MPhA Headquarters
In collaboration with the University of Maryland Eastern Shore, Notre Dame of Maryland University and the University of Maryland Baltimore schools of pharmacy, MPhA hosted a
preceptor workshop entitled, “Adopting the Pharmacists’ Patient Care Process (PCPP) to Optimize Patient Care Outcomes.” The goal of the workshop was to bring together preceptors who serve pharmacy schools in Maryland
to promote consistency in patient care service delivery across the profession. The Pharmacists’ Patient Care Process is intended to be used for a wide array of patient care services as authorized under pharmacists’ scope of practice and delivered in collaboration with other members of the health care team. Workshop developers and presenters are pictured below.
OMPh* @MPh OMPh OMPh
Left to right: Drs. Mark Brueckel, Door Prize winner at Tosin David, Nicole Culhane Min Kwon, Sherry Moore and
Mark Freebery.
Preceptor Workshop
MARYLANDPHARMACIST.ORG 19
First Quarter 2017: Pharmacy Time Capsule
By: Dennis B. Worthen, PhD, Cincinnati, OH 1992 1967
The American Association ¢ Donald Brodie articulated of Colleges of Pharmacy the concept of drug use (AACP) passed a resolution control which would be- supporting a single entry come the central precept level professional degree. of clinical pharmacy and
; ce later pharmaceutical care. e Psychiatric pharmacy
recognized as a specialty by the Board of Pharmacy Specialties (BPS).
One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history.
Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door
1892
¢ Original passage of Utah Pharmacy Practice Act
1942
e American Foundation for Pharmaceutical Education incorporated in 1942 to provide financial support to colleges of pharmacy in need during World War II and later finance the Elliott Report.
e University of Minnesota College of Pharmacy founded by Dean Wulling
Maryland Pharmacists Association is a member of AIHP. The Past Pres- idents’ Council's History Committee are using their resources to aid in documenting the history of MPhA.
each year. To learn more, check out: www.aihp.org
WELCOME NEW MEMBERS
Kaushalendra P. Joshi Jason McCarthy Linda McKee
Danielle Molnar Danielle E. Morabito Joseph Parson
Henry Abeku Appiah Richard D'Ambrisi
=rnie Dimler
ivkha Garcia sethlenem Gebremichael
Justina Henok
; rrinT
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Thank you 2017 Corporate Sponsors Pharmacists Mutual
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Silver
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Rite Aid Corporation
We Deliver Solutions for
a Healthier Bottom Line
EPIC Pharmacies, Inc. provides more than 1,500 independent member pharmacies across the U.S. with the group buying power and managed
care solutions essential to delivering quality patient care.
Membership offers:
* Group volume purchasing power
* Aggressive wholesaler pricing programs
* Successful rebate program - $60.8 million returned to members in 2016
* EPIC Pharmacy Network, Inc. (EPN) membership fee
included at no cost — access to third-party contracts
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‘REGULATOR "free third-party claims reconciliation
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Version Ill: Important Information Regarding Maryland Prescription Drug Monitoring Program
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 « Authorized by law in 2011
e Maryland Department of Health and Mental Hygiene (DHMH) program
¢ Contains data on Rx controlled dangerous substances (CDS) dispensed to patients in Maryland
¢ Providers get free, online access through Chesapeake Regional Information System for our Patients (CRISP) at: www. crisphealth.org
What is CRISP?
¢ State-designated health information exchange (HIE) serving Maryland and the District of Columbia.
¢ Electronic system connecting all 46 acute care hospitals in Maryland
¢ Web-based portal gives providers secure access to patient PDMP, hospital and other clinical data
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: Practitioners authorized to prescribe CDS in Maryland must be registered with the PDMP by July 1, 2017. This
applies to physicians, physician assistants, nurse practitioners, nurse midwives, dentists, podiatrists and veterinarians. This mandate does not apply to the following categories of nurses: RNs, CNAs, and LPNs.
Version 3.0, September 30, 2016
Please note: a second provision in the law will, in the future, require PDMP registration prior to obtaining a new or renewal CDS prescribing permit from the Office of Controlled Substances Administration (formerly Division of Drug Control) after a positive determination is made by the DHMH Secretary, expected to occur July 1, 2017; that provision of the law is NOT in effect at this time.
2. Mandatory PDMP Use by CDS Prescribers & Pharmacists
Beginning July 1, 2018:
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.
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.
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.
REGISTER NOW with the PDMP through CRISP at www.crisphealth.org.
Look for the PDMP ‘Register’ button on the homepage or on the PDMP Services page.
For registration help, call CRISP Support at: 1-877-952-7477.
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 compliance dates and Frequently Asked Questions: http://oha.dhmh. maryland.gov/PDMP.
For more information about the opioid addiction and overdose epidemic in Maryland and what healthcare providers can do to help, visit http://obha.dhmh.maryland.gov/ OVERDOSE_PREVENTION/ .
Version 3.0, September 30, 2016 @ MARYLANDPHARMACIST.ORG 21
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Are you ready? Legislative Session is
on! Our elected leaders are in place. We are ready to work with our allies and educate others about issues that are important to pharmacy practice and the patients you serve.
As pharmacists, pharmacy technicians and student pharmacists you understand the professional world
you work in, and the day-to-day challenges and opportunities afforded the profession. Our lobbyists from
G.S. Proctor & Associates facilitate our entre to key committees and legislative leaders in Annapolis and Washington, DC. We collaborate with elected leaders to highlight the impact you have on patient's lives.
The Mid-Year Meeting was a great opportunity to learn more about the policy and legislative changes taking place at the national and state level, and how we work collaboratively with our pharmacy colleagues in Maryland.
With the ascension of Delegates who have shown support for the pharmacy community to greater leadership positions in Annapolis, we are taking advantage of opportunities. We partici- pated in a pharmaceutical services briefing with members of the Health and Governmental Operations Committee
in early February. The briefing was a
fantastic opportunity to share our story with the full committee.
Executive Director’s Message
National legislation, the Pharmacy and Medically Underserved Areas Enhancement Act (S 109/HR 592), has been reintroduced in Congress. MPhA is in support of this legislation that will allow pharmacists to be designated as healthcare providers under Medicare Part B. This legislation will enable pharmacists to fill healthcare voids, broaden services and be compensated for their work. As you may know, 19 out of 24 counties in Maryland are considered to be medically underserved. We are working to build Maryland delegation support for this important effort.
Remember MPhA is your advocate.
¢ We are promoting pharmacy
e We are defending pharmacy practice ¢« We are arguing for pharmacists to
work at the height of their education and to be paid for it
Your continued support enables MPhA to maintain these activities. What can you do to continue the momentum?
1) Share your concerns/questions with MPhA. We work with elected leaders and the Board of Pharmacy to get the answers and changes you need.
2) Get to know your elected leaders. Members of the General Assembly are accessible and open to gaining knowledge from their constituents. Find out who represents you in
Annapolis and in Washington, DC at http://mdelect.net/ .
3) Read the Monday Message and other communications from MPhA and take requested actions.
If you haven't done so already, be sure to renew your membership. We need you in the fight to protect and advance
pharmacy practice in the state. @
Respectfully,
Aliyah N. Horton, CAE Executive Director
RMR RTC ath eeee lve sss cassie otesssstececes WHAT'S NEW? Meee ecdacddaes chaeesteseteane ster s cuban corse
Tech-Check-Tech Task Force
Partnering for Pharmacist New Look to MPhA Career Emergency Preparedness and Patient Education Center Task Force Resources MPhA Career Center has An Emergency Preparedness
MPhA has partnered with Health Quality Indicators
to participate in a national initiative to improve population health. Our involvement provides access to resources for pharmacists to improve cardiac health and diabetic care with resources in English and Spanish. The partnership provides web resources and access to free webinars for MPhA members. In addition, the program has a “blue bag” initiative to support medication adherence. Visit www.marylandpharmacist. org for more information.
new enhancements to provide both employers and job seekers with a better user experience. New Career Resources content has been added as well as a “Jobs You May Like" option, which support a more personalized job search experience. The Career Center can be accessed via the MPhA Website.
Task Force was appointed to identify and collect resources that will be useful for pharmacies and pharmacists to be prepared in times
of natural or man-made disasters. The final products will be available via the MPhA website. If you are interested in working on this project contact Task Force Chair, Cherokee Layson-Wolf at cwolf@rx.umaryland.edu.
MARYLANDPHARMACIST.ORG 23
The Board of Trustees is looking at opportunities
to identify new practice models that will enhance
the ability of pharmacists
to practice at the height of their degrees and optimize patient outcomes. A recent effort is the appointment of a Tech-Check-Tech Task Force. The Task Force is bringing together stakeholders from various practice settings to collect member thoughts and ideas related to the opportunities and barriers to implementing a Tech-Check- Tech Pilot program in the community setting. MPhA is working in concert with the Maryland Society of Health System Pharmacists.
March 25 Maryland Pharmacy Night Reception — APhA Convention, San Francisco, CA
April 1 Spring Ahead Your Pharmacy Career — MPhA Headquarters
April 23
Strategies and Tools for Improving Medication Adherence and Safety — MPhA Headquarters
155th Annual Convention
June 23-26, 2017
Wisp Resort 296 Marsh Hill Road
McHenry, Maryland 2.1541
Contact admin@mdpha.com 443-583-8000
Visit MPhA Website for more detalls
April 29
MPhA Class of 2017 Graduation Social May 11
MPhA Public Board of Trustees Meeting — MPhA Headquarters
June 23-26 135th Annual Convention — The Lodge at Wisp, McHenry, MD
Regional CE Dinners Currently in Development — Stay Tuned
MPA
AsT.3882 MARYLAND PHARMACISTS ASSOCIATION
HIGHLIGHTS INCLUDE:
e CE on the most current trends in the pharmacy profession
¢ Opportunities to network, connect, and re-connect with your peers
« Chances to gain new perspectives from our dynamic speakers
e Recognition of professional accomplishments
¢ Social activities all ages may enjoy
We hope you will come join us to broaden your knowledge in the pharmacy profession.
MPhA News Editorial Article Continuing Education
135th Annual Convention: Rx and the Law: Indemnification Article
Taking Pharmacy to Management of Acne
New Heights Vulgaris: Review of Drug Therapy and the Role of the Pharmacist
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Contents
13
COVER STORY Highlights of the 2017 Session of the Maryland General Assembly
| The 2017 legislative session in Maryland was extremely active, with nearly 50 bills reviewed by the MPhA Advocacy Committee. This session demonstrated that Delegates are gaining understanding
of the role pharmacists can play as integral members of the healthcare team, and for good or naught are incorporating pharmacists into legislation to address critical healthcare needs in Maryland.
President’s Pad 4
MPhA News
8 | Member Mentions & News You Can Use 9 | 2017 Mid-Year Meeting Columbia, MD 11 | 135th Annual Convention: Taking
| n= |
Pharmacy to New Heights
16 | Welcome New Members
Advocacy
13 | Highlights of the 2017 Session of the Maryland General Assembly
Editorial
6 | Rx and the Law: Indemnification
16 | Pharmacy Time Capsule
| ADVERTISERS INDEX Sentinuind Ed
16 Corporate Sponsors 18 | Management of Acne Vulgaris: Review of D
rug Therapy and the Role
NO
Smith Drug Company of the: Phare 5 Cardinal Health 23 | CE Quiz ' 7 Value Drug : 12 Independent Pharmacy Executive Director’s Buying Group Message 26 , 15 EPIC 17 AB omit 25 SDS-RX 27 Pharmacists Mutual 28 QS/1
MARYLANDPHARMACIST.ORG 3
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WARYLAW,,
SST, 1887 MARYLAND PHARMACISTS ASSOCIATION
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 Pharrnacy
Natalie Eddington, PhD, Dean University of Maryland School of Pharmacy
Anne Lin, PharmD, Dean Notre Dame of Maryland University School of Pharmacy
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
Paul R. Holly, PD, MPhA Foundation
PEER REVIEWERS
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
Carole Miller, Operations and Program Associate
CONTRIBUTORS
Maryland Pharmacists Association,
9115 Guilford Road, Suite 200, Columbia, MD 21046, call 443.583.8000, or email aliyah.horton@mdpha.com
hanks to Graphtech, J Sales and Design
President’s Pad
Happy Spring!
We are off to a running start in 2017 and MPhA has been busy at work for you.
We kicked off the year with our Annual Mid-Year Meeting in February and had a wonderful opportunity to network while enjoying clinical updates, discussing career development, and learning about issues impacting our profession.
Our Professional Development Committee, in conjunction with our fantastic APhA student chapters from University of Maryland Baltimore, University of Maryland Eastern Shore, and Notre Dame of Maryland Univer- sity, held “Spring Ahead in Your Pharmacy Career,” a day of interactive learning which focused on the development of key leadership skills and highlighted numerous opportunities in pharmacy and research.
SEI ————
On the legislative front, we have seen the most active legislative season to date with over 45 bills related to pharmacy. MPhA has been engaged in statewide efforts to track and respond to each these bills to ensure that pharmacists voices are heard as issues related to our profession are discussed. Our Legislative Committee, lobbyists, Aliyah, and many of you have dedicated hours to actively engaging our delegates, drafting, and providing testimony at the bill hearings. We have seen some success in several key areas that will greatly impact Maryland pharmacy including:
e The Pharmacy Intern Law: First year pharmacy students are now able to register as interns at the beginning of their school year, rather than waiting until the completion of their first year. This will allow them to put what they are learning into practice and benefit from an additional year of honing their pharmacist skills under the tutelage of seasoned pharmacists.
e The Pharmacists Prescribing and Dispensing Contraceptives Bill: PASSED!! This is the first time pharmacist “prescribing” is officially in the law. Maryland is the 4th state to enact legislation and we are thrilled to be on the forefront of increasing access to care for patients.
¢ Drug Pricing and Transparency: There has been a lot of controversy surrounding this topic over the past year. The legislature has begun an in-depth look at the stakeholders involved in the process of getting medications from research development to the patients. MPhA is an active participant in these discussions and will continue to engage key leaders to ensure that pharmacists on the front line have the ability and opportunity to provide the best care for patients.
We are gearing up for end of school year events — celebrating the year’s accomplishments with our students and welcoming the new pharmacy graduates into the “real pharmacy world” as new practitioners!
We look forward to our Annual Convention in Deep Creek at the end of June. Keep an eye on the website and the Monday Message for updates on some of the fun events that we will be having at the convention, as well as upcoming events at our headquarters.
I look forward to seeing you in Deep Creek! @
: on Kristen Fink, PharmD, BCPS, CDE President
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Rx and the Law | INDEMNIFICATION
By Don. R. McGurre 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.
John from Anytown Pharmacy
is negotiating to become the supplier of prescriptions and other pharmacy services to the county jail. As a possible vendor to the county, John is presented with a contract covering this relationship. One of the paragraphs is entitled, “Indemnification”. John reads through the paragraph, but he doesnt really understand it. In his eagerness to win the contract, John signs it and returns it to the county. What is Indemnification and was it wise for John to agree to it before he understood it?
Indemnification is“... the obligation [or duty] resting on one person to make good any loss or damage another has incurred or may incur by acting at his request or for his benefit.”! It is also known as a Hold Harmless agreement. What it boils down to is if the county gets sued for something Anytown Pharmacy has done wrong; Anytown Pharmacy will defend the county. This can account for significantly higher defense costs, such as attorney fees, to be incurred by Anytown Pharmacy. The pharmacy may also be paying the county's portion of any judgment in the case.
Indemnity agreements can be one- sided or mutual. A mutual indemnity agreement provides for each party to protect the other. However, a one-sided agreement requires only one party has to protect the other. This is a very important distinction and could result in significant
costs for the indemnifying party. Anytown Pharmacy should review the agreement to ascertain what it provides. Many vendor agreements as presented do not provide for mutual indemnity.
Another important part of the review is to know what acts
qualify for indemnification. Most commonly, indemnification is provided for breach of contract. Other actions that can be covered by indemnification include negligent acts, grossly negligent acts, wanton & reckless acts, intentional acts, and criminal acts. These are listed in
an ascending order of seriousness under the law. Part of the pharmacy’s negotiations should be the types of acts that are covered by the indemnification agreement. This is important because many parties entering into such agreements assume that their insurance will take care of this indemnification. However, this is not always true as most insurance policies will likely not provide any coverage for breach of contract, intentional acts or criminal acts. The insurance policy is a contract between the pharmacy and the insurance company and it is unaffected by any contract between Anytown Pharmacy and the county. Any promises to indemnify made by the pharmacy that are not covered by insurance will have to be paid by the pharmacy.
The acts are not the only key element in the Indemnification agreement. The types of indemnity
payments provided can also be listed. Examples of these payments include: any and all losses, claims, expenses, fines, penalties, damages, judgments or liabilities. Again, there may be payments promised within the Indemnification agreement that are not covered by insurance, such as fines and penalties.
The Indemnification agreement may also provide the procedure that the party requesting indemnification has to follow in order to qualify contractually. This usually involves promptly notifying the other party and providing relevant documents to them. The party asking for indemnification has to cooperate
in the defense of the claim with
the other party and may have
input into the choice of the lawyer who will defend the case. The choice of lawyer can be critical to the success of your case, but this language has the potential to create a disagreement when it comes time to make the choice.
Depending on the language contained in the county's contract, John may have made
an expensive promise because he didn't fully understand what he was agreeing to in promising to indemnify the county. Obviously, if nothing goes wrong, the issue
is moot. But hope is not the best risk management strategy. Careful review of the content of the entire contract, including indemnification requirements, before signing it is a more reliable strategy. @
© 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.
6 MARYLAND PHARMACIST | SPRING 2017
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Member Mentions & News You Can Use
MPhA at APhA
Maryland Pharmacy Night
Fun was had by all! A great event sponsored by MPhA and the
three schools of pharmacy. It
was a wonderful opportunity to connect with friends, colleagues and classmates. The reception was also a time to highlight the MPhA members making an impact at APhA!
Nominees for Office
Two MPhA Past Presidents are
on the ballot for national office. Magalay Rodriguez De Bittner for APhA Trustee and Hoia-An Truong for APPM Member-at-Large.
Tolani Adebanjo (UMES) and Meryam Gharbi (UMB) both ran
for APhA-ASP Member-at-Large. Congratulations to Meryam for winning the seat and to Tolani for being the first UMES student to run for APhA-ASP national office.
Additional Recognitions
Hoai-An Truong — APhA was recognized as am APPM Fellow. Mayrim Millan — Barea (NDMU) received the APhA — ASP Student Leadership Award. David Sproul was the first UMES student to place in the top 10 in the national patient counseling competition.
Thank you to the Members of MPhA who served as delegates in the American Pharmacists Association House of Delegates in San Francisco March 24-27. The policies adopted during the session are now Official APhA policy and can be found at http://bit.ly/2pmAZUS.
8 MARYLAND PHARMACIST | SPRIN¢
(L-R) Ashley Moody, Larry Hogue, Matt Shimoda, Anne Lin, Brian Hose and Hoai-An Truong
Holstein and Wherley Recognized
Certificates of Recognitions were presented to Shelby Holstein and Andrew Wherley during the 2017 Mid-Year Meeting for their role in advancing the Pharmacy Technician Network during the past year. The Technician Network continues
to see growth in numbers and in participation at MPhA Meetings.
Spring Ahead in your Pharmacy Career
Students from the three schools of pharmacy in Maryland, University of Maryland School, Notre Dame of Maryland University and the
University of Maryland Eastern Shore and the Professional Development Committee hosted collaborative event to get students ready for
their professional careers. Students learned about conflict management and email etiquette and were able to network with pharmacists in a wide variety of practice settings across Maryland. Students also had the opportunity to present research pro- jects to their peers and to pharma- cists. Thank you to CVS Pharmacies for supporting the event.
7 eee
A On on on Se
OR Om oe &
One of the many interactive sessions
— OMPh
@MPhA = @MPhA = @MPHA
OMPh ©MPh OMPh @MPh
Student and new practitioner planners of the event
Student poster presentation
Continued on page 11
2017 Mid-Year Meeting — Columbia, MD
By Bonnie Li-McDonald
The great weather on February 12 fostered a festive atmosphere where MPhA members and colleagues gathered to learn about the latest and greatest in pharmacy. The meeting covered clinical and policy topics as well as practice innovations.
Trash the Ash: A Best-Practice Approach for Smoking Cessation
Dr. Yen Dang reviewed the latest best-practice approaches for smoking cessation. Combination nicotine replacement therapy consisting of rescue (e.g. nicotine gum) and maintenance (e.g. bupropion, nicotine patch, varenicline) drugs is the most effective treatment for smoking cessation. She also presented the latest studies on varenicline related to mental health side effects and cardiovascular risks.
Pharmacists Protecting an Aging Population
Dr. Michelle Fritsch engaged attendees on a discussion around changes due to the aging process. She briefly reviewed the pharmacokinetic and pharmacodynamics consequences of medications in the aging body. She also provided useful resources for identifying fall risk using the CDC Stopping Elderly Accidents, Deaths & Injuries (STEADI) tool and how to address these risks with the ASCP/ National Council on Aging (NCOA) Tool. She also introduced the Fall Risk Inducing Drugs (FRID) list that identifies drugs that may increase fall risk in aging patients.
Self Care: The Comprehensive Approach
Drs. Loren Kirk and Monet Stanford discussed the history of over-the-counter (OTC) drugs and how they contribute to improving patient care. They emphasized how pharmacists are in the best position to explain indications, benefits, and risks of OTCs to allow patients to make more empowered decisions. They also engaged attendees in a discussion on which drugs could potentially become available OTC.
Mobile Health and Remote Monitoring in Pharmacy
Dr. Joey Mattingly reviewed the latest in mobile health apps for chronic diseases and the ethical questions surrounding this new development in health care. Mobile health apps (Buddy, Health, MyFitnessPal) are useful tools that can help monitor health conditions such as diabetes, blood pressure, and weight management. The challenges and barriers to mobile health and monitoring in pharmacy are privacy concerns, security, and literacy of the patient population. More research and better processes are needed to improve this fast-growing field.
HIV 101- Basics of HIV Patient Care
Dr. Richard DeBenedetto reviewed the most up-to-date HIV combination therapies and quizzed attendees on correct vs. incorrect regimens, drug-drug interactions, and ways to help patients improve adherence to their medications.
State and National Legislative Update
GS Proctor & Associates Lobbyists G. Steve Proctor and Sherrie Sims spoke about the increased legislative activities for the year, especially bills impacting pharmacy. Alicia Kerry Mica from APhA provided a national update on provider status. Dr. Chai Wang helped educate pharmacists and students on how to advocate for patients and the profession of pharmacy on a regular basis and in particularly, as part of the Maryland Pharmacy Coalition’s Advocacy Day. See the Maryland Legislative Session Recap on page TK for a wrap- up of the outcomes.
Advancing Your Pharmacy Technician Career
Zachary Green and Dr. Tara Feller shared how the recent changes within the pharmacy profession impacts pharmacy technicians. They identified the evolving roles of pharmacy technicians in assuming more technical activities to
free time for pharmacists to be engaged in more clinical and patient care interactions. They provided updates on regulatory changes in various states and encouraged technicians to become involved in association activities.
Medication Safety Error Prevention — The Role of the Pharmacy Technician
Richard D’Ambrisi provided a step-by-step process for how pharmacy technicians should be able to identify and describe medication errors, determine the cause of such errors, and work towards reducing them. The session empowered technicians to recognize the significant role they play in reducing errors in the pharmacy and directed them towards resources to assist them in this expanded role.
Thank You
Thank you to our Mid-Year Meeting Exhibitors and Sponsors e HealthSource Distributors
e Ideal Protein USA
e Pharmacists Mutual Insurance Companies
e Rite Aid Inc. @ MARYLANDPHARMACIST.ORG 9
2016 Recipients of the “Bowl of Hygeia’ Award
Buddy Bunch John Cotter Carl Labbe Jon Wolfe Fred Mayer Randy Knutsen Ernie Mrazik Pat Carroll-Grant
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware
Armando Bardisa Hugh Chancy Marcella Chock Joyce Fogleman H. Christian Johnson Ken Anderson David Schoech Ron Poole Florida Georgia Hawaii Illinois Indiana lowa Kansas Kentucky
ie rite j Marty McKay Roberta Brush Ellen Yankellow Diane Martin Geri B. Smith Louisiana Maine Maryland Massachusetts Michigan
Py
va as y, Robert Salmon David Eden Tobey Schule Adam Porath John V. Mini, Jr. Stephen Brickman Mississippi Missouri Montana
Nevada New Hampshire New Jersey
Jack Volpato Mike Duteau Joseph Moose James Carlson Marialice Bennett Greg Huenergardt Ann Murray Gayle Cotchen New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania
Francisco Javier Jiménez Heather Larch Dan Bushardt Curt Rising Ronnie Felts Nathan Pope Alex Wiatt Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia
3 Ea ee
Li, gee
Nanci Murphy Patricia Noumedem Robert Stanton James Olson Jaime Hornecker Washington 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 for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the state pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bowl of Hygeia is on display in the APhA Awards Gallery located in Washington, DC.
FOUNDATION
Boehringer Ingelheim is proud to be the Premier Supporter of the Bowl of Hygeia program.
135" MPhA Annual Convention
Friday, June 23 - Monday, June 26, 2017
KW EN
TAKING PHARMACY
Py SS
To NEW HEIGHTS
WISP Resort
296 Marsh Hill Road McHenry, MD 21541
Register before June 5 for early bird rates — www.marylandpharmacist.org. Convention room block rates available through June 5.
Member Mentions continued from page 8
Script Your Future Medication Adherence and Safety Program
MPhA’s Script Your Future Program hosts an annual event to bring together healthcare and business stakeholders to discuss medication adherence and safety. The 2017 Program was chaired by Yen Dang, Pharm D, University of Maryland Eastern Shore School of Pharmacy and sponsored by the Maryland P3 Program. Prior to the CE program, Pfizer provided a presentation on Pneumococcal Vaccination Delivery and Adherence Program. Speakers include James L. Bresette, PharmD, USPHS, CAPT (Ret.), University of Maryland Eastern Shore School of Pharmacy; Hoai-An Truong, PharmD, MPH, FNAP, University of Maryland
Eastern Shore School of Pharmacy; John Miller, BS, MidAtlantic Business Group and Cynthia Warriner BS, RPh, CDE, Health Quality Innovators.
Seeking Volunteers for MPhA's
Maryland Pharmacy Law Book Update
MPhA is embarking on a reboot of our Maryland Pharmacy Law Book. The effort is being led by Matt Balish and Julie Mathias. The intent is to make the book more user-friendly for students practicing for law exam review and to address FAQs by practicing pharmacists. If you are interested in working on this project, please contact Julie at jul2486@ gmail.com or Matt at mdbalish@ gmail.com.
Specific volunteer roles that need to be filled:
1. 2016 Graduate who could co-write the section on “Helpful Suggestions to Study for MPJE."
2. Institutional Pharmacy Chapter — pharmacist who works in institutional pharmacy
3. Long Term Care Pharmacy Chapter — pharmacist who works in long term care pharmacy
4. Anyone else who would like to get involved
The current law book and update is available for purchase at www. marylandpharmacist.org under RESOURCES. @
MARYLANDPHARMACIST.ORG 11
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The 2017 legislative session in Maryland was extremely active, with nearly 50 bills reviewed by the MPhA Advocacy Committee. This session demonstrated that Delegates are gaining understanding of the role pharmacists can play as integral members of the healthcare team, and for good or naught are incorporating pharmacists into legislation to address critical healthcare needs in Maryland.
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We kicked off the season with the from House Speaker Pro Tem the General Assembly by Senate Maryland Pharmacy Coalition's Adrienne A. Jones and Delegate President Mike Miller and House (MPC) Legislative Day on February Shelley Hettleman. In addition, Speaker Michael E. Busch. More 12. The group received greetings participants were recognized before than 300 pharmacists and student
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Delegate Shelley Hettleman and Speaker Pro Tem Adrienne A. Jones with
Legislative Day participants
MARYLANDPHARMACIST.ORG_ 13
pharmacists blanketed the General Assembly with the consensus positions statements of MPC. While MPhA continues to build its brand in Annapolis, our participation in MPC enables pharmacy to have
an all-encompassing voice and cohesive message on pharmacy issues. For more information about MPC and Legislative Day visit www. marylandpharmacist.org and click on the Advocacy tab.
SIGNIFICANT
Pharmacist Prescriptive Authority
Expands the scope of practice
for a licensed pharmacist to include prescribing contraceptive medications and self-administered contraceptive devices approved
by the US Food and Drug Administration. Maryland is the fourth state in the county to approve this type of prescriptive authority. MPhA with other stakeholders
will provide consultation to the Board of Pharmacy to develop
the regulations. Pharmacists must provide written information on the importance of following up with a practitioner and provide the patient with a copy of the assessment information.
Regulations will be required regarding the pharmacist’s education. The requirements
will be waived for a pharmacist who has already undergone the training as part of their formal educational program. Pharmacist counseling services will be covered by Maryland Medical Assistance Program, Maryland Children’s Health Program and commercial payers. MPhA advocated strongly to maintain payment provisions. The bill is effective July 2017, regulations must be promulgated on or before September 2018. Pharmacists may begin prescribing after January 1, 2019.
Pharmacy Interns
Establishes an exemption from
the requirement to register as
a pharmacy technician for a pharmacy student who is currently completing the first year of a professional pharmacy education program.
Medication Synchronization
Requires carriers that provide coverage for prescription drugs, including through a PBM, to
allow and apply a prorated daily copayment or coinsurance amount for a partial supply of a prescription drug dispensed by an in-network. pharmacy, with some restrictions: 1) best interest of the patient; 2) the prescription is for more than three months; 3) the patient requests; 4) the prescription is not a Schedule
II controlled dangerous substance; and 5) the supply and dispensing of the drug meet specified prior authorization and utilization management requirements.
Medication Affordability
Two bills were introduced during the session: one focused on
price gouging, and the other on transparency. In the end the price gouging bill was passed. The
bills were in response to national attention on soaring drug costs. Stakeholders leading this charge included Maryland's Attorney General and a host of health and patient advocate stakeholders. Its passage is the first of its kind in the nation. The legislation is limited to generic and off-patent drugs that experience “unconscionable” price increases. The attorney general would be authorized to take action if a manufacturer raises the cost
of a drug to a level defined as unjustifiable. This legislation was in line with the medication affordability policy passed by the MPhA House of Delegates in 2016.
14 MARYLAND PHARMACIST | SPRING 2017
Expedited Partner Therapy
Authorizes a licensed pharmacist
to dispense antibiotics therapy prescribed to any sexual partner of a patient diagnosed with chlamydia, gonorrhea or trichomoniasis under the state's expedited partner therapy (EPT) protocols. This had previously been a pilot program in Baltimore. Efforts were made to include pharmacists’ liability protection for dispensing EPTs; these amendments were denied by bill sponsors.
Opioid Epidemic
House Opioid Workgroup reviewed more than 30 proposed bills and incorporated the concepts in the Heroin and Opioid Prevention Effort (HOPE) and Treatment Act of 2017. The bill eliminates requirements
for patients/caregivers to have Overdose Response Program certificates in order for pharmacists to dispense naloxone; guidelines to be established for co-prescribing naloxone. Healthcare providers with prescriptive authority may prescribe naloxone under certain conditions; expands scope of who can issue standing orders.
OTHER PBMs
There were several PBM-related bills introduced during the session that sought to remove retroactive DIR- fees, clarify definition of specialty drugs, and allow pharmacists
to engage in conversation with patients when PBMs reimburse less than the cost of the drugs. All the bills were withdrawn during the session. However, the concerns that were brought before the General Assembly and the ensuing discussions between pharmacists, PBMs, insurers and managed
care providers garnered enough attention that a summer study session was convened. The summer study session is being led by the Maryland Insurance Administration. The first meeting was held in early April. The intent is to address issues
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do not cover acquisition costs, perceived retribution against pharmacists that file appeals, among other issues and bring some type of resolution.
Biosimilars
Legislation clarifying how interchangeable biosimilars will
be handled in Maryland was
passed. MPhA fought to remove interchangeable notification requirements. The bill was amended to allow for the notifications of substitutions to be made by various means of communication to the prescriber and only for the first time.
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MPhA supported the single dispensing bill as another tool in the medication adherence toolbox. The bill did not pass, but would have allowed pharmacists to convert
a 30-day prescription with two refills to 90-day single dispensing, without seeking authorization from the physician. The amended bill included some exceptions related to contraceptives and Schedule
II drugs. The bill was ultimately withdrawn as consensus could not be reached between pharmacy stakeholders and the psychiatric community.
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There were other bills that MPhA lodged significant opposition and were able to get bills withdrawn or an unfavorable report by the committee of jurisdiction. Those bills were related to physician's assistant dispensing; requirements for lockable vials; oncologists dispensing; and law enforcement notifications when naloxone is administered, among others.
A comprehensive bill tracking chart is available for members-only under the Advocacy tab at www. marylandpharmacist.org. @
MARYLANDPHARMACIST.ORG:_ 15
Second Quarter 2017: Pharmacy Time Capsule
By: Dennis B. Worthen, PhD, Cincinnati, OH
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Continuing Ed
Management of Acne Vulgaris
Review of Drug Therapy and the Role of the Pharmacist
Melissa Fiscus, PharmD Candidate 2017, Jill A. Morgan, PharmD, BCPS, BCPPS, Neha Sheth Pandit, PharmD, AAHIVP, BCPS
Pharmacist Learning Objectives
After completing this activity, the participant will be able to:
1. Explain the prevalence and disease burden of acne vulgaris in the United States and list the most common causative organism(s).
. State the efficacy, mechanism of action, and role of medications used in the management of acne vulgaris.
Introduction
Acne vulgaris is acommon skin disease that is especially prevalent in adolescents and young adults. It has been estimated that up to 50 million individuals in the United States
have acne, and acne affects 85% of people between 12-24 years of age.! While there is no mortality associ- ated with acne, many individuals experience physical and psychoso- cial morbidities, including perma- nent scarring, depression, anxiety, and poor self-esteem.’ The direct costs associated with the treatment of acne vulgaris was estimated to be $2.5 billion, and the true cost could be as high as $3 billion per year in terms of treatment and loss of pro- ductivity.* The purpose of this article is to review the current recommen- dations for the treatment of acne vulgaris based on the recently re- leased guidelines from the American Academy of Dermatology (AAD).
Acne Pathogenesis
Acne vulgaris is defined as a chronic inflammatory dermatosis which causes open or closed comedones (blackheads and whiteheads) and inflammatory lesions.* Acne develops in the pilosebaceous unit, a hair
3. Describe three ways in which pharmacists can contribute to the appropriate management of acne vulgaris.
Pharmacy Technician Learning Objectives
After completing this activity, the participant will be able to:
1. Describe prevalence and disease burden of acne vulgaris in the United States.
follicle in the skin that is connected to an oil gland (sebaceous gland).* The hair, sebum (oil), and skin cells that are present in the follicle may produce a plug, which prevents sebum from reaching the surface of the skin through a pore. The mixture of oil and cells allows bacteria to grow in the plugged follicle.* The most common bacterium implicated in acne is Propionibacterium acnes (P. acnes), a gram-positive anaerobic rod. When the wall of the plugged follicle breaks down, sebum, skin cells, and bacteria spill into the nearby skin, leading to the formation of pimples.°
Classification of Acne
Determining the severity of acne
is key to selecting an appropriate regimen. Unfortunately, there is no universally agreed-upon grading system for the classification of acne. The AAD recommends that clinicians use a consistent classification system to make treatment decisions and
to assess response to therapy.”
These classification systems should assess the number and type of acne lesions, sites where acne is located, and the presence of any scarring.
In addition, the AAD does not
18 MARYLAND PHARMACIST | SPRING 2017
University of Maryland School of Pharmacy
oe
Identify medications used to treat acne vulgaris and describe how they work.
Key Words
e Acne vulgaris
e Isotretinoin
¢ Benzoyl peroxide
recommend routine microbiologic or endocrinologic testing for the majority of patients with acne? Full treatment recommendations for acne vulgaris can be found in Table 1.
Topical Therapies for the Treatment of Acne Vulgaris
There are four main categories of acne treatments: topical therapies, systemic antibiotics, hormonal therapies, and oral isotretinoin. Of the four categories, topical therapies contain the most diverse products and are available over-the-counter or by prescription. Topical therapies can be used to treat mild to severe acne, and can be used as monotherapy
or in combination. Common topical therapies include benzoyl peroxide, topical antibiotics (clindamycin, erythromycin), topical retinoids (tretinoin, adapalene, tazarotene), azelaic acid, dapsone, and salicylic acid.*
Benzoyl peroxide (BP) is a bactericidal agent with no reported resistance that kills P acnes through the release of oxygen free radicals. BP is available over the counter in strengths up to 10% and can be used as monotherapy or in combination. When used in combination with
other agents, BP enhances results and may reduce the development of antibiotic resistance. However, BP therapy is limited by staining
or bleaching of fabric, severe skin irritation, and rare contact allergy. Patients initiating BP therapy should gradually increase the amount of product used and frequency of application to reduce skin irritation. Results of BP therapy can be noted in as soon as five days.*
Another available topical modality is topical antibiotics, including clindamycin and erythromycin. These antibiotics accumulate in the follicle and work through anti- inflammatory mechanisms and antibacterial effects to treat acne. Currently, clindamycin 1% gel or solution is preferred over topical erythromycin for acne therapy due to the development of erythromycin- resistant Staphylococcus and
P. acnes. Topical antibiotics are available with a prescription, are generally well tolerated, and should only be used in combination with BP to increase efficacy and reduce antibiotic resistance.
Topical retinoids are vitamin A derivatives that are available with
a prescription for the treatment
of acne. Presently, there are
three agents available: tretinoin, adapalene, and tazarotene. Each retinoid binds to a different retinoic acid receptor, which confers slight difference in activity, efficacy,
and tolerability. Topical retinoids enhance any topical acne regimen, prevent the formation of clogged pores, and maintain clearance after discontinuation of oral therapy. Retinoid use can be limited by dryness, peeling, redness, or irritation of skin, and photosensitivity. To avoid issues with photosensitivity, pharmacists can counsel patients to apply topical retinoids at night. In addition, tretinoin cream or
gel may be inactivated by the coadministration of BP. Patients should be counseled to apply these two agents at different times. There is NO such interaction with tretinoin microsphere formulation, adapalene, or tazarotene.*
Azelaic acid 20% (Azelex®) is a comedolytic, antibacterial, and anti-inflammatory agent that is
TABLE 1
available with a prescription for the treatment of acne vulgaris. This agent is mildly effective and used mostly in patients with sensitive skin, or patients with post-inflammatory hyperpigmentation seen most commonly in patients with darker skin (Fitzpatrick skin types IV or greater) due to a lightening effect. Azelaic acid's efficacy increases as the dose increases, but burning
has been reported at higher concentrations.® It should be noted that no matter the dose, azelaic acid is not as effective as BP or topical retinoids.
Dapsone 5% gel is a sulfone agent that is also used for the treatment of acne vulgaris. The mechanism of action is poorly understood, but topical dapsone showed modest to moderate efficacy in the reduction of inflammatory lesions in clinical tnals. Furthermore, topical dapsone has greater efficacy in females as compared to male or adolescent patients. Topical dapsone can be oxidized by the coadministration of BP, causing an orange-brown discoloration of the skin.’ It should be noted that this discoloration is not
Treatment guidelines for the management of acne vulgaris
ET a
ist Line Treatment | _,;-
Topical retinoid
-OrT-
Topical combination therapy
Alternative
Treatment (if not on already)
-OT-
Consider alternate retinoid
-OT-
Consider topical Dapsone
Benzoyl peroxide (BP)
Add topical retinoid or BP
Topical combination therapy
-OT-
Oral antibiotic + topical retinoid
sree
-OrTr-
Topical combination therapy + oral antibiotic
-OT-
Oral isotretinoin
Oral antibiotic + topical retinoid
+ BP + topical antibiotic
therapy
=O) =
Consider change in oral antibiotic
-OT-
Add combined oral contraceptive or oral spironolactone (females)
-OYT-
Consider oral isotretinoin
Consider alternate combination | Consider change in oral
antibiotic -Or-
Add combined oral contraceptive or oral spironolactone (females)
-OT-
Consider oral isotretinoin
MARYLANDPHARMACIST.ORG 19
Continuing Ed
permanent and can be brushed or washed off.
Salicylic acid is a comedolytic agent available over-the-counter in 0.5% and 2% strengths for the treatment of acne vulgaris. While it is generally well tolerated, salicylic acid is less efficacious than BP
and topical retinoids, and clinical trials demonstrating the efficacy of salicylic acid are limited.’ Salicylic acid can irritate the skin, which can lead to erythema, peeling, and exacerbations of inflammatory lesions in some individuals.®
Systemic Antibiotics for the Treatment of Acne Vulgaris
Systemic antibiotics are commonly used in the treatment of moderate to severe inflammatory acne in combination with topical therapies. There is evidence supporting the efficacy of tetracyclines (doxycycline and minocycline), macrolides (erythromycin and azithromycin), penicillins, cephalosporins, trimethopriny/sulfamethoxazole (TMP/SMX), and trimethoprim.? While systemic antibiotics are effective
for many patients, monotherapy with oral antibiotics is strongly discouraged due to the development of antibiotic resistance. Antibiotic usage should be limited to the shortest possible duration, ideally 3-4 months or less, to prevent the development of complications including inflammatory bowel disease, pharyngitis, and Clostridum difficile infection.* Combining systemic antibiotics with topical therapies has led to decreased antibiotic use, decreased antibiotic resistance, and continued efficacy months after discontinuation of systemic antibiotics.
Tetracyclines are considered first-line therapy for moderate to severe acne unless contraindicated. Contraindications to tetracycline therapy include pregnancy, age
<8, or allergy. Tetracyclines inhibit protein synthesis by binding to
the 30S subunit of the bacterial ribosome. Previous guidelines recommended minocycline as
a superior agent to doxycycline; however, a recent Cochrane review determined that minocycline is effective, but not superior to other antibiotic therapies.’ The most common side effect noted with tetracyclines is photosensitivity, particularly with doxycycline. In addition, doxycycline is more often associated with dose-dependent gastrointestinal symptoms, while minocycline has been associated with tinnitus, dizziness, and tooth discoloration at higher doses.?
If a patient cannot use a tetracycline,
macrolide antibiotics are an effective alternative agent. Macrolides, such as erythromycin and azithromycin, work to treat acne vulgaris by binding to the 50S subunit of the bacterial ribosome. Azithromycin has been the macrolide most commonly studied, and dosing regimens ranging from three times a week to four days a month have shown to be effective after 2-3 months of therapy. Macrolides most commonly cause gastrointestinal symptoms, and erythromycin in particular has a higher incidence of abdominal discomfort, diarrhea, and nausea.*
Another option for patients with a contraindication to tetracyclines are penicillins or cephalosporins. These antibiotics treat acne vulgaris by inhibiting bacterial
cell wall synthesis. Very little data exists to support the use of these medications; however, a small retrospective chart review with cephalexin indicated a majority
of patients showed some clinical improvement.’ Common side effects associated with penicillin or cephalosporin therapy include hypersensitivity reactions and gastrointestinal disturbances.’
TMP/SMX and trimethoprim have also been used to treat acne vulgaris, although the
20 MARYLAND PHARMACIST | SPRING 2017
data supporting their use is
limited to mostly case reports. Sulfamethoxazole blocks bacterial synthesis of folic acid and trimethoprim is a folic acid analog that inhibits dihydrofolate reductase. Together, these two agents treat acne vulgaris by inhibiting cell division. Side effects of TMP/SMX include gastrointestinal upset, photosensitivity, and rare drug eruptions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.* The use of TMP/SMX should be avoided in pregnancy due to risk of congenital malformations if used in the ist trimester and risk of kernicterus if used close to time of delivery.
Hormonal Therapies for the Treatment of Acne Vulgaris
Combination oral contraceptives (COCs) are prescription medications used for contraception that can also be used for the treatment of mild to moderate acne vulgaris. COCs contain an estrogen and a progestin and treat acne through antiandrogenic effect. Currently, there are four COCs approved
by the FDA for acne treatment: ethinyl estradiol/norgestimate, ethinyl estradiol/drospirenone, ethinyl estradiol/drospirenone/ levomefolate, and ethinyl estradiol/ norethindrone acetate/ferrous fumarate. It's important to note that COCs are only approved for acne treatment in women who also desire contraception, and use of COCs for acne should be avoided within two years of the onset of menses or in patients who are younger than 14 years of age.
A recent Cochrane review analyzed the effect of COCs on acne in women and concluded that all COCs reduce acne, but there is no COC that is consistently superior
to other agents.’ There are a wide variety of side effects associated with COCs, including cardiovascular risks and possible increased risk
of breast and cervical cancer. The use of a COC increases the risk of venous thromboembolic events (VTEs) for all women; however, myocardial infarction (MI) or stroke is uncommon among healthy women of reproductive age. Patients should be counseled that acne reduction with COCs will take time, and significant acne reduction might not be appreciated until three months of therapy.®
Another hormonal agent that is
used for the treatment of acne is spironolactone. Spironolactone is
an aldosterone receptor antagonist that decreases testosterone production and inhibits the binding of testosterone to androgen receptors through antiandrogen activity.* Spironolactone is generally well tolerated, and common side effects include diuresis, menstrual irregularities, breast tenderness, and breast enlargement. While frequently used in practice, spironolactone has not been approved by the FDA for the treatment of acne. A recent Cochrane review examined the small number of available studies and concluded that there was insufficient evidence to support the use of spironolactone in the treatment of acne.*° Despite this, AAD guidelines still acknowledge the use of spironolactone in select women based on available evidence, experience, and expert opinion.”
Oral Isotretinoin for the Treatment of Acne Vulgaris
Isotretinoin is an isomer of retinoic acid and has been used for more than 30 years to treat severe acne
Or moderate acne that is treatment- resistant. Isotretinoin is highly effective and its use results in reduced sebum production, decreased number of acne lesions, and minimal acne scarring. When dosing isotretinoin, the AAD recommends a cumulative dose regimen for severe acne (120 to 150 mg/kg total) and a low-dose regimen for moderate acne. (0.25 to 0.4 mg/ kg/day) However, intermittent dosing of isotretinoin is not recommended due to decreased efficacy and higher relapse rates.*
Before initiation of isotretinoin therapy, there are many details prescribers and patients should understand. First, isotretinoin is highly lipophilic and is best absorbed when taken with food, preferably a high fat meal. Recently, manufacturers have released new formulations which encase isotretinoin with lipid agents and allow the medication to be taken on an empty stomach." It is important that patients know which formulation they are taking and understand
the appropriate way to take their medication.
In addition, there are side effects to isotretinoin that require laboratory monitoring. Isotretinoin can cause an increase in liver function enzymes tests, triglycerides, and serum cholesterol. All patients receiving isotretinoin should receive laboratory monitoring of liver function and lipid panel tests at baseline and at biweekly intervals until treatment response
is established. Other common side effects of isotretinoin therapy include arthralgia, musculoskeletal pain,
and dry eyes. These side effects are
temporary and fully resolve after discontinuation of the drug.*
Furthermore, isotretinoin is highly teratogenic and can lead to severe birth defects if taken while pregnant. Every patient (male and female) receiving isotretinoin is required
to enroll in the risk management program, “iPLEDGE,” prior to starting therapy. The iPLEDGE program provides education about the teratogenicity of isotretinoin, requires female participants to undergo
routine pregnancy tests before, during, and after therapy, and requires female patients to use two contraceptive methods for at least one month before treatment, during treatment, and one additional month after finishing treatment.” Despite this, nearly 600 isotretinoin-exposed pregnancies occurred between the years of 2008-2011." Therefore, every woman of child-bearing age should continue to be counseled about the risks of isotretinoin therapy and the importance of contraception throughout their treatment.’
Role of the Pharmacist
With the prevalence of acne in
all patient populations and the availability of over-the-counter treatments, pharmacists are key to appropriate management of acne vulgaris. Pharmacists can determine if self-treatment is appropriate, recommend a suitable regimen, counsel on potential side effects, and provide non-pharmacologic recommendations as necessary.
Continued on page 23
CONTINUING EDUCATION QUIZ
PharmCon is accredited by the Accreditation Council for Pharmacy Education as
Of: @ pharmacy education. A
a provider of continuing continuing education credit will be awarded within six to eight weeks. Program Release Date: 4/14/17 Program Expiration Date: 4/14/20 This program provides for 1.0 contact hour (0.1) of continuing education credit. Universal Activity Number (UAN) 0798-9999-17-091-H01-P & T
The authors have no financial disclosures to
report.
This program is Knowledge Based — acquiring
factual knowledge that is based on evidence
as accepted in the literature by the health care
professionals.
Directions for taking this issue’s quiz:
This issue’s quiz on Management of Acne
Vulgaris: Review of Drug Therapy and 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.
(2) Scroll down to Homestudy/OnDemand CE Credits and select the Quiz you want to take.
(3) Log in using your username (your email address) and Password MPHA123 (case sensitive). Please change your password after logging in to protect your privacy.
(4) Click the Test link to take the quiz.
Note: If this is not the first time you are signing
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CE Credits and select the quiz you want to take.
MARYLANDPHARMACIST.ORG 21
Continuing Ed TABLE 2
Counseling Information for First-Line Therapies Benzoyl peroxide Mild to Moderate AV e No reported resistance e Can be used as monotherapy or in combination
e Adverse effects include staining of fabric, concentration- dependent irritation, photosensitivity, and rare hypersensitivity reactions
Topical clindamycin | Mild to Moderate AV Preferred over topical erythromycin due to erythromycin resistance
¢ Must be used in combination with benzoyl peroxide
Topical tretinoin Mild to Moderate AV Cream and gel formulations are inactivated by the co- administration of benzoyl peroxide
Adverse effects include dryness, peeling, redness, or irritation of skin, and photosensitivity
e Due to case reports of congenital malformations, other agents are preferred during pregnancy.
Topical adapalene Mild to Moderate AV Adverse effects include dryness, peeling, redness, or irritation of skin, and photosensitivity
¢ Due to case reports of congenital malformations, other agents are preferred during pregnancy.
Topical tazarotene Mild to Moderate AV Adverse effects include dryness, peeling, redness, or
irritation of skin, and photosensitivity ¢ Due to case reports of congenital malformations, use in pregnancy is contraindicated.
Oral doxycycline Moderate to Severe AV e Use contraindicated in pregnancy, age <8, or allergy Adverse effects include photosensitivity, and gastrointestinal symptoms
Oral minocycline Moderate to Severe AV ¢ Use contraindicated in pregnancy, age <8, or allergy Adverse effects include photosensitivity, tinnitus, dizziness, and hyperpigmentation
Combination oral Moderate to Severe AV Use only in female patients who also desire contraception
EINES SoU ce Use should be avoided within 2 years of the onset of -
menses or in patients age <14
Adverse effects include VTE, MI, stroke, and breast/cervical cancer
Oral isotretinoin Severe or Treatment-resistant Best absorbed when taken with food, preferably a high-fat Moderate AV meal
All patients must enroll in iPLEDGE prior to initiation of therapy
Female patients are required to undergo routine pregnancy tests before, during, and after therapy due to teratogenicity.
All patients must use 2 contraceptive methods while on therapy
22 MARYLAND PHARMACIST | SPRING 2017
TABLE 3
Summary of Key Recommendations
Topical benzoyl peroxide and topical retinoids are effective first-line agents that can be used as monotherapy for the treatment of acne.
Monotherapy with topical or systemic antibiotics is not recommended due to the risk of bacterial resistance.
Systemic antibiotic use should be limited to the shortest possible duration.
Combined oral contraceptives (COC) are effective for treatment of acne in females but should only be used
if patients desire contraception.
Oral isotretinoin is recommended for severe acne or moderate acne that does not respond to other
therapies.
All patients treated with isotretinoin must adhere to the iPLEDGE risk management program and receive
routine laboratory monitoring.
PATIENT CASE
Ms. Martin is a 17-year-old high school student who presented to your clinic for a requisite physical for her high school volleyball team. During the visit, Ms. Martin stated that she had been bothered by facial acne for the past 2 years. She described facial breakouts that began gradually, varied in severity, and never completely cleared. Ms. Martin has been washing her face daily with soap and warm water but has not tried any acne products
yet. Ms. Martin is not currently taking any other medications and denies any allergies. A physical examination revealed a healthy young woman with 10 non-inflammatory closed comedones located on her chin and forehead. She has no lesions on her chest, back, or shoulders. Additional history and physical examination
findings were noncontributory.
1) What agent would you recommend to Ms. Martin at this time?
A) Topical dapsone
B) Oral doxycycline
C) Topical benzoyl peroxide D) Topical erythromycin
2) What counseling would you provide Ms. Martin about the use of
benzoyl peroxide for the management
of acne?
While many patients with mild to moderate acne can successfully self-treat with non-prescription products, patients with severe acne, patients with persistent acne despite appropriate use of non- prescription therapies, and patients with exacerbating factors (e.g. drug-induced acne or irritation- induced acne) should be referred to a physician for a more complete evaluation of their acne.” For all acne patients however, pharmacists are uniquely positioned to educate on prescription and non-prescription acne therapies. A compilation of
CE QUESTIONS
A) Benzoyl peroxide should not be used as monotherapy due to the development of resistance
B) Side effects of benzoyl peroxide include skin irritation and staining or bleaching of fabric
C) Benzoyl peroxide has greater efficacy in females as compared to male or adolescent patients
D) It can take 14 days before you see results of benzoyl peroxide therapy
important counseling points for the most common acne therapies can be found in Table 2.
In addition to education on pharmacologic modalities, pharmacists can provide patients with non-pharmacologic recommendations. To prevent the formation of acne, patients should avoid exposure to irritating factors such as dirt, dust, chemical irritants, tight-fitting clothes, or helmets. Limiting frequent handling of skin and maintaining adequate hydration can also reduce or minimize the
3) What course of action do you recommend for Ms. Martin at this time?
A) Add on a topical retinoid B) Add on ethinyl estradiol/norgestimate
C) Change to oral doxycycline
) D) Change to oral isotretinoin
Answers on page 24
formation of acne flare-ups. Patients with existing acne lesions should gently wash their face with a mild cleanser twice daily and avoid touching or squeezing pimples, as this can lead to worsening acne and scarring.>*
Furthermore, many patients often have questions about whether certain foods lead to the formation or worsening of acne. Emerging evidence has suggested that
high glycemic index diets could
be associated with acne. Ina
2007 randomized controlled trial,
MARYLANDPHARMACIST.ORG 23
Continuing Ed
subjects assigned to follow a low glycemic index diet had significant improvement in acne severity in addition to a reduction in weight and BMI. However, this study was limited by its small sample size
of 23 patients and the fact that both cohorts lost weight. A similar trial conducted in 2012 found
that subjects randomized to the low glycemic index diet also had improved acne severity, although
CE QUIZ ANSWERS
1.C. Benzoyl peroxide is an effective first-line agent that can be used as monotherapy for the treatment of acne. Topical dapsone would be appropriate for mild acne, but only if first-line options haven't worked. Topical erythromycin should not be used as monotherapy due to the development of erythromycin- resistant Staphylococcus and P
acnes. Finally, oral doxycycline is not
a preferred option for patients with
mild acne and should not be used as
monotherapy.
2. B. Benzoyl peroxide frequently causes skin irritation and staining
there was no change in weight or BMI.*° Given the current data, the AAD does not recommend any specific dietary changes for the management of acne.*
Conclusion
Acne vulgaris is a common skin disorder affecting patients of all ages. There are many first-line agents for the treatment of acne, including topical therapies, oral antibiotics,
starting BP therapy should be counseled about these side effects. Benzoyl peroxide can be used as monotherapy, may reduce the development of antibiotic resistance, has equal efficacy in males and females, and patients can see results in five days.
Over the course of four months, Ms. Martin's acne has increased to 20 lesions on her chin, forehead, and cheeks. She has been using benzoyl peroxide but has not seen any improvement. Ms. Martin went to see a dermatologist who diagnosed her with moderate acne and referred her
combination oral contraceptives, and oral isotretinoin. The selection of an appropriate agent depends largely on acne severity and patient preference. Due to the wide variety of non-prescription and prescription acne products available, pharmacists are a great resource for triage, suitable product selection, and education on pharmacologic and non-pharmacologic therapies for the management of acne vulgaris.
3. A. One of the first line recommendations for moderate acne is topical combination therapy. Ms. Martin should try a first-line topical combination therapy before selecting an alternative regimen, such as a combined oral contraceptive. Oral doxycycline could be used to treat moderate acne, but not as monotherapy. Oral isotretinoin is only indicated for severe acne or moderate acne that is treatment resistant.
or bleaching of fabric. All patients
REFERENCES
uh,
2.
Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013;168(3):474-85.
Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care
for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-73.
Bickers DR, Lim HW, Margolis D, et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. J Am Acad Dermatol. 2006;55(3):490-500.
Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012;379(9813):361-72.
Miller LH, Chase C, Katz KA, Cowen EW, Moshell A. Questions
and answers about acne. National Institute of Arthritis and Musculoskeletal and Skin Diseases Web site. http://www.niams. nih.gov/health_info/acne/. Updated September 2016. Accessed January 23, 2017.
Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003;49:S200-10. Garner SE, Eady A, Popescu CM, Newton J, Li Wan Po A. Minocycline for acne vulgaris: efficacy and safety. Cochrane Database Syst Rev. 2012;8:CD002086.
Fenner JA, Wiss K, Levin NA. Oral cephalexin for acne vulgaris: clinical experience with 93 patients. Pediatr Dermatol. 2008;25(2):179-83.
Arowojolu AO, Gallo MF, Lopez LM, Grimes DA. Combined oral contraceptive pills for treatment of acne. Conchrane Database Syst Rev. 2012;7:CD004425.
24 MARYLAND PHARMACIST | SPRING 2017
10.
i
WA
1)
14.
aks},
16.
to you for a recommendation.
Brown J, Farquhar C, Lee O, Toomath R, Jepson RG. Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne. Cochrane Database Syst Rev.
2009; (2):CD000194.
Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-
Lidose) and the innovator isotretinoin formulation: a
randomized, 4-treatment, crossover study. J Am Acad Dermatol. 2013;69(5):762-7.
iPLEDGE Committed to pregnancy prevention Web site. https:// www.ipledgeprogram.com/AboutiPLEDGE.aspx. Accessedon December 11,2016.
Collins MK, Moreau JF, Opel D, et al. Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol. 2014;70(1):55-9.
Foster K, Coffey C. Acne. In: Krinsky D, Ferreri S, Hemstreet B, Lamont Hume A, Newton G, Rollins C, et al., eds. Handbook of Non-Prescription Drugs. 18th ed. Washington, DC: American Pharmacists Association; 2015:685-—97.
Smith RN, Mann NJ, Braue A, Makelainen H, Varigos GA. The effect of a high-protein, low glycemic-load diet versus a conventional, high glycemic-load diet on biochemical parameters associated with acne vulgaris: a randomized, investigator-masked, controlled trial. JAm Acad Dermatol. 2007;57(2):247-56.
Kwon HH, Yoon JY, Hong JS, Jung J, Park MS, Suh DH. Clinical and histological effect of a low glycaemic load diet in treatment of acne vulgaris in Korean patients: A randomized, controlled trial. Acta Derm Venereol. 2012;92(3):241-6.
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As I reflect on our most recent accomplishments, whether it is our newly achieved prescriber status for contraceptives (the first state on the East Coast and the 4th in the nation!) or our other legislative successes, the word PARTNERSHIP comes to mind.
While pharmacists have the education, experience and Statistics on our side, our ongoing success hinges on the partnerships we forge with pharmacy schools, pharmacy technicians, elected leaders, pharmacists across practice settings and of course patients. We cannot advance pharmacy practice alone.
We must continue to work with all aspects of the pharmacy community and healthcare stakeholders to protect prescriptive drugs as an essential health benefit and protect the funding that provides the foundation for advances in medications, evidence-based prescribing and treatment of chronic diseases.
We must continue to forge relationships with our elected leaders. When nembers of the General Assembly and Congress understand the value pharmacists bring to the healthcare team and our ability to provide ncreased healthcare access, they fight or us. They work to ensure you are able to practice at the height of your education AND receive appropriate compensation. They are also more open to supporting strategic roles
Executive Director’s Message
for pharmacists to mitigate crises in Maryland like the spread of sexually transmitted diseases and opioid overdoses.
Partnerships take time and resources. As MPhA continues to find new partnerships to support practice advancement, you are encouraged to continue to invest your time and your resources in MPhA. Encourage your colleagues to do the same. Your effort and support yield results.
I look forward to seeing you June 23-26
at The Wisp Resort in McHenry, MD
for MPhA‘s 135th Annual Convention.
Our theme, Taking Pharmacy to New
Heights, will explore the evolving role
of pharmacy in addressing today’s
healthcare challenges. Sessions will
explore:
¢« Opioid epidemic from a clinical perspective and pharmacist’s role due to legislative changes in MD
e Updates on new drugs
« USP 800
e 2017 legislation
e Communication strategies for patient safety
e« Pharmacy robbery and fraud prevention
« Management of depression ¢ COPD management
e Technician- focused sessions on pharmaceutical calculations
e Financial planning sessions for new practitioners and more seasoned professionals
¢ Oral chemotherapy in outpatient settings
MPhA is taking pharmacy to new heights by providing pharmacists and pharmacy technicians with relevant and timely CE activities. We also look forward to having a good time, welcoming new leadership and saluting those who have served MPhA and the pharmacy community well.
See you at Wisp! @
Respectfully,
Aliyah N. Horton, CAE Executive Director
Please consider making a gift this year to the MPhA Foundation. MPhA Foundation gifts’ are recognized at the following levels:
Ss
Noli”
MP
MARYLAND PHARMACISTS ASSOCIATION
ee ORIbLS BU. TOM PaG) ys Supporter:
$25-$99 B. Olive Cole: $100-$499
Evander Frank Kelly: $500-$999
MPhA Foundation Legacy: $1,000+
You can make a gift by donating online at www.marylandpharmacist.org or by calling 443-583-8000.
Our Mission is to invest in the future of pharmacy by:
«Supporting student pharmacists
eRecognizing practice innovation and advancements
eEnhancing philanthropy that supports leadership
Thank you for your support!
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MPhA News
Highlights of 135th Annual Convention
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OVER STORY
Thank you to Darci Eubank, Sadhna Khatri and the Meeting Planning Committee for putting together a great program of CEs and fun activities!
30 | Legislative and Policy Updates
28 Corporate Sponsors 6 | Phi Lambda Sigma & MPhA 13 | Rx and the Law: Cybersecurity ea Foundation Partner for MPJE 18 | Pharmacy Time Capsule
2 Smith Drug Company Study Strategies and Test
5 Cardinal Health Taking Tips
7 Value Drug 8 | Member Mentions & News You 20 | eco Mes oh ne i 12 Independent Pharmacy ent) ee Cardiovascular Risks and Benefits
; of Antidiabetic Agents Buying Group 8 | In Memoriam — Samuel Lichter | 19 HD Smith | 24 | CE Quiz 9 | Graduating Members PIC
Sek 11 | MPhA Foundation 29 Pharmacy Quality 31
14 | 135th Annual Convention —
Commitment+ . Taking Pharmacy to New Heights
31 CARE Pharmacies CAREY?
pelo eT TSO aN MARYLANDPHARMACIST.ORG 3
ARYL
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NOW 507
@MPh\
Sst. 198? MARYLAND PHARMACISTS ASSOCIATION
MPhA OFFICERS 2017-2018
Kristen Fink, PharmD, BCPS, CDE, Chairman
Cherokee Layson-Wolf, PharmD, CGP, BCACP., FAPhA, President
Chai Wang, PharmD, BCPS, AE-C, Vice President
Matthew Shimoda, PharmD, Treasurer
Samuel Lichter, Honorary President
HOUSE OFFICERS
Richard Debenedetto, PharmD, MS, AAHIVP., Speaker
Matthew Balish, PharmD, RPh, Vice Speaker
MPhA TRUSTEES
Kerry Cormier, PharmD, 2020
Darci Eubank, Pharm, 2019
Sadhna Khatri, PharmD, 2018
Anne Lin, PharmD, 2020
Amy Nathanson, PharmD, BCACP, AE-C, 2019
Wayne VanWie, RPh, 2018
Patricia Dieso, ASP Student Representative — Notre Dame of Maryland University School of Pharmacy
EX-OFFICIO TRUSTEES Rondall Allen, PharmD, Dean University of Maryland Eastern Shore School of Pharmacy atalie Eddington, PhD, Dean University of Maryland School of Pharmacy Paul R. Holly, PD, MPhA Foundation John Lee, University of Maryland School of Pharmacy Divya Vepuri, University of Maryland Eastern Shore School of Pharmacy
PEER REVIEWERS
Caitlin Corker-Relph, MA, PharmD 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
Carole Miller, Operations and Program Associate
CONTRIBUTORS
NASPA Services Company, LLC, Editorial
Albert Ayernor, PharmD Candidate, 2018 Convention Photographer
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:
Happy Summer! We have just returned from the 135th MPhA Annual Meeting at the Wisp Resort, and I, like many of those in attendance, have come back refreshed by all the educational topics, networking and camaraderie. We also celebrated the practice, service and leadership accomplishments
of our members. It is amazing to be able
to honor our colleagues and friends for
the work they do every day, and it is even more remarkable that these same people share their time and efforts with MPhA. Congratulations to all the award winners!
ATER ONE slealetadasieres anaes oa
We had an amazing meeting, and one that has wrapped up an action packed year for MPhA with all the events and practice- changing bills passed during this year’s legislative season. The Board of Trustees and committee chairs have done amazing work this year to help realize the vision of Kristen Fink's presidency by enhancing our engagement with student pharmacists, and also continue the mission of MPhA.
As the incoming MPhA president, my vision for this coming year is for our membership to be “Provider Ready.” Our members have made many efforts to advocate for provider status, and every practice bill that is passed brings us even closer to pharmacists being recognized as providers a reality. Along with all our advocacy work, we must also ensure that we are advancing our knowledge, skills and abilities
to provide patient care in all the settings that we practice and to also understand the factors that impact our ability to provide patient care. I will work with the Board of Trustees, our committees and members to provide resources and education so we are ready for the responsibility of provider recognition.
We cannot do this work alone, and I thank many of you who have served as an advocate for pharmacy and for providing the important patient care you already do
in your practices. I also thank you for sharing your expertise, guidance and input
with us as we work to strengthen our outreach and resources to our members and the Maryland pharmacy community. I invite you to continue your engagement with MPhA, and to also bring others along with you. We can do so much work when we support each other, and understanding our practice and advocacy needs at minimum will help support our provider status efforts. We look forward to having you join us for our numerous programming and networking opportunities this year. Please be sure to check out the Monday Message, the MPhA website, the MPhA journal, MPhA Facebook and Twitter accounts, and finally our regular meetings to keep up to date with what we ve got in store for you!
I sincerely look forward to serving as president of MPhA this year and hope that you will join us in becoming “Provider Ready.” @
Kindest regards,
Cherokee Layson-Wolf President
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September 19 November 16
Expedited Partner Therapy CEs Public Board of Trustees
— Location TBD Meeting — MPhA Headquarters,
Columbia, MD
September 28
Public Board of Trustees December 14 August 24 Meeting — MPhA Headquarters, Public Board of Trustees Meeting An Introduction to Collaborative Columbia, MD and Holiday Party — MPhA Practice Agreements Webinar — Headquarters, Columbia, MD
October 12
Register at www.maryland
pharmacist.org Medication Safety CE — MPhA
Headquarters, Columbia, MD September 14
Expedited Partner Therapy CEs October 26 — Location TBD Public Board of Trustees
Meeting — MPhA Headquarters, Columbia, MD
Phi Lambda Sigma & MPhA Foundation Partner for MPJE Study Strategies and Test Taking Tips
On a bright and early Saturday June morning, Phi Lambda Sigma members hosted 42 pharmacists and student pharmacists preparing for the MPJE at Notre Dame's Knott Auditorium with a common goal in mind: improve the Maryland MPJE first-time pass rate. Among other issues that negatively affect the pharmacy workforce are declining NAPLEX and MPJE pass
and transferring pharmacists face a
rates across the nation. With the MPJE 2014-2016 Passing Rates for Graduates per Pharmacy School 2017 NAPLEX increasing to a six- a Trae | Peo Tse | |. 2016 hour, 250-questions exam, and ree Be ee below the national MPJE average, Aa! _fatero — Maryland's new graduates, residents, University 94.34%
of Maryland
95.41% 82.57% Baltimore greater challenge entering Maryland wach University 87.18% 90.32% 51.61% Dracuce. of Maryland The three Schools of Pharmacy all ee xperienced MPJE first-time pass — = =
ite declines during 2014-2016 et oe URMLES T1128 see table). This suggests that the Jniversity pr oblem lies not with students, ource: NABP https://nabp.pharmacy/wp-content/uploads/2017/02/2016-MPJE-Pass-Rates.padf instructors, or courses, but rather with the Maryland MPJE itself. Continued on page 8
6 MARYLAND PHARMACIST |
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_MPhA News |
Member Mentions & News You Can Use
Past President Elected New Maryland Board of Pharmacy
to APhA Board Commissioners of Trustees Congratulations to the MPhA members who joined the Past MPhA President MPhA Board of Pharmacy in May: Rhonda M. Toney as
an At-Large Representative and Neil B. Leikach as an Independent Representative.
Magaly Rodriguez de Bittner, PharmD, FAPhA was elected to the APhA Board of Trustees! The new Trustees will be installed at the APhA Annual Meeting in Nashville in March 2018. Congratulations Magaly!
MPhA Member in the News
MPhA Member Matthew Balish recently conducted
two interviews with his local cable channel's Focus on Health series. The two interviews, Medication Disposal and Immunizations & Older Adults, can be found on the Focus on Health YouTube channel.
MPhA Member Honored by Baltimore County Department of Aging
Congratulations to George Garmer, owner of Halethorpe and Independent Pharmacies, for being honored as the Baltimore County Department of Aging Business Partner of the Year.
“In Memoriam ~ SAMUEL LICHTER
The Maryland Riana: community lost a friend, — ~ colleague and mentor, Samuel Lichter on April
17,2017. Sam was a Past President and remained — active in the MPhA. In acknowledgement of
his contributions, the Past President's Council posthumously honored ~~ him as MPhA‘s 2017-2018 E Sa President. bd
MPJE Study Strategies continued from page 6
Several detrimental effects from this phenomenon include delays
Taking Tips’ to supplement and optimize prior learning. Developed
True to Albert Einstein's quote, "In the middle of difficulty lies
in employment, higher employee and employer costs and ACPE implications for the state's three pharmacy schools.
In response, Phi Lambda Sigma chapters from UMB, NDMU, and UMES partnered with the MPhA Foundation to offer a course titled "MPJE Study Strategies and Test
and taught by Beta Lambda chapter alumnus Andrew York, Pharm.D., J.D., the course augments the fact- based law courses emphasizing efficiency and effectiveness of study strategies and testing skills. The
Phi Lambda Sigma chapters are committed to continuing to offer this course annually.
8 MARYLAND PHARMACIST | SUMMER 2017
opportunity,” Phi Lambda Sigma and the MPhA Foundation partnered on an opportunity to address a specific need for those seeking to enter pharmacy practice in Maryland. With MPhA‘s support, the three organizations proved the value proposition that we are indeed, “better by association.”
.
Graduating Members
Congratulations to all the 2017 PharmD Graduates!
MPhA and the New Practitioners Network look forward to working with you and supporting you as you transition from student to practicing pharmacist.
University of Maryland
School of Pharmacy
Sameh Abdelmalak Larra Achmar Esther Adenuga Harrison Akujor Leslie Anforth Jillian Aquino Benedicta Asamoah Tyler Atkinson Songe Baek Courtney Bannister Felicia Bartlett Alexis Berk
Lauren Biagiotti Brandon Biggs Nana Brobbey
Ross Broton
Alison Bukowitz Ryan Button Theresa Chea
Alan Chen
Eric Cheng
Seung Hee Cho Joshua Chou
Yujin Chung
Mary Colson
Caitlin Corker Relph Maureen Cutright Dania Demashkieh Gregory Dickerman Tiffany Do
Jola Dyrmishi Emmanuel Ebhohon Sarah El-Gendi Marcus Ellis Michael Evans Ashley Fan
Melissa Fiscus Macy Forman Caroline Garber Parima Ghafoon Susan Giang
Eli Gluck
Caleb Goodrich Julie Gould
Zemen Habtemariam Ava-Dawn Hammond Jae Han
Ting He
Sara Higa
Frederick Hindman Timothy Hirama Yoon Duk Hong Robyn Hunt Sunyup Hwang
Abiodun Igandan Alexander Joachim Aris Keshishian Nadia Khan
Nishu Kharel Caroline Kim
Minji Kim
Shi Yoon Kim Yujin Kim
John Kim
Wambui Kiruthi Vitaliy Klimov Dongha Le
Tran Le
Elissa Lechtenstein Hannah Lee
Kevin Lei
Willy Li
Brian Lindner Deena Liu Wilhelmina Lord-Adem Lon Luong
Jeffrey Ma
Amy Malmquist Christin McCulley Patrick Mensah Benjamin Moy Jonathan Myung Edward Neuberger Charles Ng
An Nguyen
Peter Nguyen
Duong Nguyen
Dan Nguyen Kwabena Nimarko Hye Young Oh Anthonia Okojie Olajumoke Olaomi Sijuwade Olayiwola Ene Omakwu
Bob Pang
Susie Park
Shashvat Patel
Disha Patel
Justin Penzenstadler Brianna Phair
Ha Phan
Kim Phan
Erika May Pineda Pemmarin Potisarach Emily Powell
Elaine Pranski
Jean Ra
Priya Rajendran Kumaran Ramakrishnan Molly Rincavage Jenny Ro
Simcha Rosenberg Dennisse Rubio Colon Dhakrit Rungkitwattanakul Jessica Ryu
Mellisa Sanchez-Guevara
Pragya Shrestha Amrita Singh Kyle Slavin
Rene Cosme Soh Fongang Sophie Soo
Ryan Starr Katarina Stelzer Andrew Su Dennis Su Sidonie Takougang Kevin Tang Farrah Tavakoli Kayla Tegeler Raimonda Tetz Caroline Timothy Monica Tong Huan Tran
David Tran
Huy Truong Lynn Tsang Emmanuel Ventura Thao Vo
Thuc Quyen Vu Yibei Wang Diane Won Joyce Yu Changjun Zhang Jackson Zheng Manal Ziadeh Sara Zifa
Michael Zook
MARYLANDPHARMACIST.ORG 9
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Oluwatosin E. Abayomi Winifred A. Abinteh Alexander Accinelli Yvonnediane Agyekum Adedamola A. Ajiboye Shoghag A. Aktavoukian Edwin D. Allen
Javaria M. Alvi
Prince K. Amponsah Anthony F. Angu Mohammed T. Anjum
Ikenna U. Anyanwu Maranatha Baah Julia Brocato
Laura D. Byrd
Joel L. Copper Aegan A. Cox
Sally Daamash Maheder Y. Dachew
Deborah O. Demehin
Collins B. Edusei Mfon Ekanem
Notre Dame of Maryland University
UMES School of Pharmacy Class of 2017
10 MARYLAND PHARMACIST | SUMMER 2017
Sara El-baff
Raisa El-kurdi Clement N. Etoke Ayorinde O. Falase Brandon J. Green Mallory B. Greenberg Gregory C. Hayes Luis D. Hernandez Tariku Y. Irango Danielle J. Krastel Eugene T. Kwachuh
Edwin K. Langat Andrew Lee Sarah S. Lee Amanda R. Lehmann Kunsang Lhamo Phuong H. Luong Katherine Ma Shadana P. Maddox, Chukwuka T. Maduako Ojong O. Manfred Welay F. Megos Kimberly J. Mitchell Desta A. Muleta Damaris F. Ndam Ernest N. Ngassa Nga H. Nguyen Robertine Nzesse Kapguep Emmanuel C. Ofili Ike Ojiaku Olawumi O. Olabamiji James I. Onayiga Greta S. Park Ashley E. Payne Linda K Raleigh Shannon R. Riggins Leonard B. Rybak Mohamed Sackor Geoffrey M. Saunders Michelle Sebok Emma Shtridelman Macgiland M. Sikod Michael R. Smith Rene L. Tamah Frederick Taylor Visesh Velagapudi
ry
Bryan Ahlstrand Elizabeth Alvarez Shogheeg Apkarian Vala Behbahani Mohamad Beydoun Ryan Boasi
Sheryl Canlas Dante Carroll Andrew Chi
Jason Choe Andrew Choi Bik-Ho Florence Chung Megan Cook
Emily Dang
Ketan Dankhara Rachel Dewberry Jerlin Jermae Dizon Jacek Domagala Lauren Dupont Courtney Ensor Hanna Fenta Kristine Halley
Kimberly Kirkpatrick Rhiannon Marselli
Courtney Lanehart Tameem Mousa Brittany La-Viola Steve Mowder Soo Jeong Lee Kelly Nguyen Connie Lee Amanda Nguyen Erica Letow Barbara Obot David Lewis Rafael Otero De Santiago Reine Lienou Tejas Patel Kanchalita Marom Dipen Patel (PhA Outstanding Student Pharmacist
Trinh Phan
Alexandra Phan
Emily Pitts
Sei Ra
Sormeh Rahimi-Chegini Joyce Camille Ramano Keila Rentas Centeno Naveen Samuel
Joel Shery
Thanh Tran
Kieu Trinh Vo Olivia Weiss Shayne Wharton Julia Wood
Seo You
Hina Zaidi Jordan Zangla
Congratulations to the following students who were recognized with the MPhA‘s Outstanding Student Pharmacist Achievement Award. The Award recipients received a crystal award and a $250 check.
Shannon Riggins, PharmD, University of Maryland — Eastern Shore
MARYLANDPHARMACIST.ORG
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| ( NATIONAL COMMUNITY “WW 0 0 l ) PHARMACISTS ASSOCIATION NATIONAL
Rx and the Law | CYBERSECURITY
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.
Cybersecurity continues to make the news and to be a source of concern for all business owners. The recent WannaCry ransomware attack affected companies and governments in more than
150 countries. Data breaches
and cyberattacks also occur in healthcare. In Rhode Island, the car of an employee of the state's largest health network was broken into and a laptop was stolen. The laptop contained sensitive information
on about 20,000 of the network's patients. A healthcare provider
in Texas had an unencrypted
hard drive stolen. The hard drive contained information (e.g., social security numbers, dates of birth, driver license numbers, insurance information, etc.) about its patients going back to 2009. It is critical
for pharmacies to assess their
data security and take steps to strengthen it.
Stronger regulations are sure to come, but improvements to your data security now will minimize
the chances that your pharmacy ends up as your community's lead news story. As an example, the New York Department of Financial Services recently promulgated new rules for cybersecurity of financial institutions.' This includes banks, insurance companies, and other financial services institutions. It does not apply to health care organizations or entities. The regulations contain 15 requirements for a cybersecurity program. This article will not review all of them, but will address some that apply to the situations we have already seen.
The regulations require penetration testing and vulnerability assessments. This would mean
at least annual testing of firewalls and other portions of the overall cybersecurity program. This should alert you to any shortcomings in your security and give you the opportunity to remedy them before an incident occurs.
Also required is training and monitoring for your system's users. Training is an integral part of a security program because a leading cause of data breaches is the people using the system. Phishing attacks and similar techniques succeed because they fool a user into allowing unauthorized access to the pharmacy’s data.
Encryption is another important
tool and New York's regulation is going to require it. The regulation requires that data be encrypted both while being transmitted (such as by e-mail) and also while resting on hard drive. This requirement would help secure data that is physically taken, such as in the stolen laptop or server examples. Many people think to encrypt data while it is in transit, but steps should also be taken while it is being stored.
The regulation also requires that organizations periodically dispose of sensitive information no longer needed for business operations. This will require the organization to assess the need to retain sensitive information and then follow their own policies and procedures to securely dispose of unneeded information. This action may have mitigated the damage done when the hard drive containing seven years of data was stolen in Texas.
The world continues to move toward more virtual and digital realms, so these challenges are
not going away. Dealing with
data breaches is expensive. Some studies estimate around $200
per record affected. For the data
of those 20,000 patients on the laptop, this equates to around
$4 million. And this doesn't take into account your reputational damage. The pharmacist-patient relationship is built on trust and data breaches will seriously damage these relationships. Ransomware can also be devastating to your pharmacy. Having your system held hostage until you pay the ransom (or can re-construct your system from back-ups) will, ata minimum, inconvenience your patients. It may cause them to question whether they should share their personal information with you.
There is no reason to wait for a law or regulation to be passed before shoring up your data security. You are already holding sensitive patient information and there are already numerous threats out there in cyber- space. A cyber incident can cause significant financial and reputational damage to your practice. This is not the time to take an ostrich approach to your data security.
REFERENCES 1 23 NYCRR 500.00 to 500.23
© Don R. McGuire Jr., R.Ph., J.D., is Gen- eral Counsel, Senior Vice President, Risk Management & Compliance at Pharma- cists 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 employ- ers and insurance companies, and act accordingly. @
MARYLANDPHARMACIST.ORG 13
hank you
{ to Darci Eubank, Sadhna Khatn and the Meeting Planning Committee for putting together a great program of CEs and fun activities! Photos courtesy Albert Ayemor, PharmD Candidate 2018.
Chairman: Kristen Fink; President: Cherokee Layson-Wolf; Vice President: Chai Wang; Treasurer: Matt Shimoda; Speaker of the House: Richard DeBenedetto; Vice Speaker: Matthew Balish; Trustees: Kerry Cormier, Anne Lin, Darci
Eubank, Amy Nathanson, Wayne Van Wie, Sadhna Khatri, Patricia Dieso (APhA-ASP NDMU)
Ashley Moody, Outgoing Speaker 2016-2017
Lawrence Hogue (2nd from left) and Mark Ey (2nd from se right), Outgoing Trustees 2016-2017 Cherokee Layson-Wolf (right), Incoming
rresiqent
| an | Seed aie ae | Kristen Fink, Outgoing pit . (LIMB Aliyah Horton (Secretary President 2016-2017
14 MARYLAND PHARMACIST |
- Ww) < Lu LL a < (a UO
Continued on page 16
MARYLANDPHARMACIST.ORG 15
16
; |
larship Winner
AIA j ith ct pn | Are joelle Smith, student, University of
land Eastern Shore School of Pharmacy
MARYLAND PHARMACIST |
5th Annual Convention continued from page 15
nG Ow Cr Ly 4 q> =!
bvare I3555
33,
B53 350)
MPhA Scholarship Winner: Jessica Wearden, student, University of Maryland Eastern Shore School of Pharmacy
MPhA Scholarship Winner: Albert Ayernor, student, University of Maryland Eastern Shore School of Pharmacy
Mentor Award Winner: Nicole Culhane, Distinguished Young Pharmacist Award Excellence in Innovation Award Winners: Dixie Leikach PharmD Winner: Darci Eubank, PharmD. Sponsored RPh, MBA, FACA (2nd from left) and Neil Leikach, by Pharmacists Mutual Companies RPh (1st from right). Soonsored by Upsher-Smith Laboratories, Inc. and the MPhA Foundation
Pharmacist Advocate Award Winner: Chai Seidman Distinguished Achievement Award Generation Rx Champions Award Winner: Jacob Raitt Wang, PharmMD, BCPS, AE-C. Sponsored Winner: Gerard (Jerry) Herpel, PD PhD. Sponsored by Cardinal Health Foundation by Buy-Sell-a-Pharmacy
Archived Policy 16. Maryland DHMH Emergency Response
1. Emergency Preparedness and Response
MPhA supports and encourages its members and all pharmacists, Student pharmacists, and pharmacy technicians all pharmacists to
be knowledgeable of their vital role and prepared to respond to local community needs in the event of a public health emergency and to assist on a larger scale by becoming members of the Maryland Responds Medical Reserve Corps as promulgated by the Maryland Department
of Health.
For current MPhA Policies visit www.marylandpharamcist.org — About MPhA — Governance — Policies
Dn et a ee Ra th one a at? ion on uen penn on Propo PC Bv-Law Cnanages
In addition, two amendments to the MPhA Bylaws were approved by the House of Delegates. The first amendment adds an elected Trustee seat for a Dean from one of Maryland's three schools of pharmacy.
The seat would be voted on by the entire membership. The second amendment clarifies the role of the Resolutions Committee. The amendments must be approved by MPhA members. An electronic ballot was distributed in July.
Bowl of Hygeia Award Winner: Cynthia Boyle, PharmD. Sponsored by the : American Pharmacists Association Continued on page 18 Foundation and National Alliance of State
Pharmacy Associations
MARYLANDPHARMACIST.ORG_ 17
135th Annual Convention continued from page 17
THANK YOU SPONSORS & EXHIBITORS |
CONVENTION SPONSORS EXHIBITORS Buy-SellAPharmacy.com American Associated Nutramax Laboratories EPIC Pharmacies Pharmacies Pfizer Inc.
Cardinal Health Pharmacist Mutual CVS Health . Insurance Companies
Health Source Distributors
McKesson Corporation MPhA Foundation Ideal Protein of America Qst
PharmCon/FreeCE.com Kaiser Permanente Rite Aid
University of Maryland School MPhA Foundation Smith Drug Company
of Pharmacy Notre Dame of Maryland University
156th Annual Convention Ocean City, MD e June 29 — July 2, 2018
Third Quarter 2017: Pharmacy Time Capsule |
By: Dennis B. Worthen, PhD, Cincinnati, OH
1992 1967 1942 1917 _ 1892
Jerome Schentag, ¢ World's First ¢ Heparin marketed e« US enters WW I « The New PharmD, professor Heart Transplant by Upjohn, with a declaration Jersey College of pharmaceutic operation in originated from of war on of Pharmacy, science at the South Africa by Johns Hopkins Germany now the Ernest University of Buffalo, Dr. Christiaan Mario College co-inventor of the N Barnard and of Pharmacy, computer-controlled Thomas Starzl founded in “smart pill,” which performs the Newark. can be electronically first successful tracked and human liver | instructed to transplantation, at One of a series contributed by the American Institute of the History of Pharmacy, deliver a drug to the University of a unique non-profit society dedicated to assuring that the contributions of a predetermined Colpracio death your profession endure as a part of America’s history. Membership offers the
: i satisfaction of helping continue this work on behalf of pharmacy, and brings five location in the Sciences Center. or more historical publications to your door each year. To learn more, check out: gastrointestinal tract. www.aihp.org
18 MARYLAND PHARMACIST | SUMMER 2017
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Continuing Ed
Antidiabetic Agents
Recent Updates on the Cardiovascular Risks and Benefits
Kathleen J Pincus, PharmD, BCPS, University of Maryland School of Pharmacy
Learning Objectives
After completing this activity, the participant will be able to:
1. Identify which agents used to treat type 2 diabetes have demonstrated positive
effects on cardiovascular outcomes since
2008
Introduction
Type 2 diabetes mellitus (T2DM) affects over 29 million people, or one out of every 11, in the United States (US).1 While this is a common condition, T2DM is also associated with significant morbidity and mortality. The risk of mortality is 50% higher for adults with T2DM compared to those without, and
is recognized as the 7th leading cause of death in the US." Risks of myocardial infarction (MI) and stroke are increased by 1.8 fold and 1.5
fold respectively, and T2DM is the leading cause of kidney failure, non- traumatic lower limb amputations and new cases of blindness among US adults.’ Over 25 pharmacologic agents from 9 classes have been approved by the US Food and
Drug Administration (FDA) for the treatment of T2DM. All of these have been shown to improve surrogate markers of glycemic control including reducing hemoglobin A1c, and fasting and post-prandial blood glucose. However, the majority of phase III trials for these medications have been of relatively short duration and have not assessed patient-oriented outcomes such as
2. Compare the outcomes that were measured among the relevant clinical trials
Key Words Glucagon Like Peptide-1 Agonists | SGLT-2 Inhibitors | Diabetes Mellitus
reduction in morbidity or mortality measures.
Multiple guidelines exist to support clinicians treating patients with T2DM. The Standards of Care
in Diabetes from the American Diabetes Association (ADA) and the Consensus Statement on the Comprehensive Type 2 Diabetes Management Algorithm from the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ ACE) are most commonly cited.** Both guidelines emphasize the cardiovascular benefits of intensive glycemic control based on the results of the original United Kingdom Prospective Diabetes Study (UKPDS) trial and 10-year observational follow-up. The follow-up study showed significant reduction in the risk of all-cause mortality and MI in patients initially randomized to receive intensive therapy with sulfonylureas or insulin, with a larger reduction in risk for patients receiving intensive therapy with metformin.
Other early studies have also shown potential risks of intensive glycemic control in older patients
20 MARYLAND PHARMACIST | SUMMER 2017
3. Given a clinical case for a patient with
type 2 diabetes mellitus, determine whether sodium glucose transporter-2 (SGLT2) inhibitors or Glucagon like peptide-1 (GLP1) agonists are safe and effective therapeutic options
with longer duration of T2DM and multiple cardiovascular risk factors. The intensive glycemic control
arm of the ACCORD trial was stopped early due to findings of increased mortality.° In contrast the ADVANCE and VADT trials showed no difference in cardiovascular
or all-cause mortality between treatment groups,°’” and a 10-year follow-up from the VADT trial shows a decrease in major cardiovascular events in patients randomized to intensive therapy.’ The findings
of these trials emphasize the
risks of severe hypoglycemia and its association with mortality, particularly in patients with multiple cardiovascular risk factors.
In 2007, a meta-analysis of 42 clinical trials concluded that use of rosiglitazone, a thiazolidinedione (TZD), was associated with a significantly increased risk of MI and a trend toward increased risk of cardiovascular mortality.? A similar meta-analysis of 19 clinical trials using pioglitazone did not demonstrate this increased risk, instead finding a decreased risk of all-cause mortality, MI or stroke.?° While these findings indicated that increased cardiovascular risk
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was not a class effect with TZDs, it highlighted the need for long-term cardiovascular data with anti- diabetic agents.
The following year, the FDA released a guidance statement recommending that sponsors of
all new anti-diabetic therapies should demonstrate there is not
an “unacceptable increase in cardiovascular risk."* Within the last 5 years data has emerged to support the impact of certain anti-diabetic agents on all-cause mortality, cardiovascular mortality and
composite cardiovascular outcomes.
This article will review key trials on the cardiovascular impact of specific anti-diabetic therapies since this guidance was issued [Table 1].
Sodium-Glucose Co- Transporter 2 (SGLT2) Inhibitors
Sodium glucose cotransporter-2 (SGLT2) inhibitors are the newest class of agents approved for
treatment of T2DM. SGLT2 regulates glucose reabsorption in proximal renal tubules. SGLT2 inhibitors reduce blood glucose levels by
increasing urinary glucose excretion.
FDA approved SGLT2 inhibitors include: canagliflozin (Invokana, 2013, Janssen Pharmaceuticals), dapagliflozin (Farxiga, 2014, AstraZeneca Pharmaceuticals)
and empagliflozin (Jardiance,
2014, Boehringer Ingelheim Pharmaceuticals). Given the relation between the mechanism of action and renal function,
all three agents in this class are contraindicated in patients with severe renal impairment (eGFR <45 ml/min/1.73 m? for canagliflozin and empagliflozin, eGFR <60 ml/min/1.73 m° for dapagliflozin), end-stage renal disease or on dialysis. Other class related precautions include hypotension, acute kidney injury or renal function impairment, urinary tract infections and genital mycotic infections.
The EMPA-REG Outcome study was a large, placebo-controlled prospective study investigating
the effect of empagliflozin on cardiovascular morbidity and mortality as add-on therapy in patients with T2DM and high cardiovascular risk.’* Patients (N=7,020) were randomized to receive empagliflozin 10 mg, 25
mg or placebo for a median of
2.6 years. Background medication regimens related to diabetes
or other cardiovascular co- morbidities were not dictated
by the study investigators. The majority of patients were treated with recommended agents to reduce cardiovascular risk including angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), statins and aspirin. To be eligible for the study, participants had to be adults with uncontrolled T2DM, a BMI < 45 kg/ m?’, eGFR > 30 ml/min/1.73 m¢, stable on current diabetic regimen
MARYLANDPHARMACIST.ORG 21
Continuing Ed
(or no medications), and have a high risk of cardiovascular events.
A high-risk of cardiovascular events was defined by at least one of
the following: (1) history of MI, (2) history or stroke, (2) coronary artery disease (CAD) based on imaging or prior revascularization, (3) unstable angina, or (4) occlusive peripheral artery disease (PAD). The enrolled study population had an average age of 63 years, 72% were male and 72% were white. More than half of participants had a T2DM for longer than 10 years and the average Alc was 8%. Background anti-diabetic therapies included metformin (74%), insulin (49%), and sulfonylureas (42%).
The primary outcome, a composite of cardiovascular mortality, MI
and stroke, occurred in 10.5% of participants in the empagliflozin group and 12.1% of participants
in the placebo group, indicating superiority for empagliflozin (hazard ratio [HR] 0.86, p=0.04). Secondary analyses also showed lower risks of all-cause mortality, cardiovascular mortality, and heart failure (HF) hospitalizations in the groups treated with empagliflozin. There were no differences in the rates of MIs or strokes. As the largest risk reductions were seen with
HF hospitalizations, it has been suggested this may be the driving force for the observed overall cardiovascular risk reductions.° Higher rates of genital infections and urosepsis, a rare finding, were found in the empagliflozin group. Other adverse events were similar to placebo. There were no significant differences between doses related to cardiovascular outcomes. The authors caution that this study population included patients at a high risk of cardiovascular events and should not be extrapolated to the general population of patients with T2DM.
Continued on page 25
Patient Case
BL is a 67 yo Caucasian male with a 8 year history of T2DM. He currently takes metformin 1,000 mg po BID, but his Alc remains elevated, most recently 7.8% 2 weeks ago. He has received education on diet and exercise interventions to improve his diabetes control, and has cut out sodas and ice cream from his diet, but has difficulty adhering to all of the recommended changes. He also states that pain in his legs limits his ability to exercise. He recently saw a vascular specialist who took blood pressures in his ankles and his arms and found the ankle-brachial index (ABI) to be 0.84. Other past medical history includes hypertension and GERD.
Questions
1.For which of the following trials would BL meet enrollment criteria?
a. EMPA-REG outcome study b. ELIXA study
c. EXAMINE study
d. LEADER study
2.BL differs from the average participant in this study in what way? a. Most participants were younger b. Most participants were African American c. Most participants were not on metformin
d.Most participants had a longer duration of diabetes
3.You recommend that BL be started on liraglutide. Based on the findings from the LEADER study what impact might this have?
a. Decreased all-cause mortality b. Decreased cardiovascular mortality c. Decreased rate of MI
d. Decreased rate of stroke
4.BL should be educated on which of the following potential adverse effects of liraglutide?
a. Gastrointestinal upset b. Hypotension c. Urinary tract infections
d.Weight gain
Answers on page 28
22 MARYLAND PHARMACIST | SUMMER 2017
Medication (N)
EMPA-REG
Outcome” (N=7,020)
CANVAS? Canagliflozin (N=10,142)
LEADER! Liraglutide (N=9,340)
ELIXA’® Lixisenatide (N=6,068)
SUSTAIN-6” Semaglutide
(N=3,297)
Empagliflozin
TABLE 1: Comparison of Key Eligibility Criteria and Outcomes of Antidiabetic Cardiovascular Studies
Eligibility Criteria
Adults with high risk of CV events
Age > 30 with CV disease or
Age > 50 with > 2 CV risk factors
Age > 50 with CV comorbidity
or
Age > 60 with 1 CV risk factor
Acute coronary event within prior 180 days
Age > 50 with CV comorbidity or
Age > 60 with 1 CV risk factor
Primary Outcome
Composite: CV mortality, MI and Stroke
10.5% empagliflozin, 12.1% placebo
HR 0.86, p=0.04
Composite: CV mortality, MI and Stroke
26.9/1,000 patient- years canagliflozin, 31.5/1,000 patient- years placebo, HR
0.86, p=0.0158
Composite: CV mor- tality, MI and Stroke 13% liraglutide, 14.9% placebo, HR 0.87, p=0.01
Composite CV mortality, MI, Stroke, hospitalization for unstable angina
13.4% Lixisenatide,
13.2% placebo, HR 1.02, p=0.81
Composite CV mortality, MI, stroke
6.6% semaglutide,
8.9% placebo, HR 0.74,
p=0.02
Secondary CV Outcomes
Favoring treatment:
¢ All-cause mortality ¢« CV mortality ¢ HF hospitalizations
No difference between groups:
e MI
e Stroke
e Revascularization
Favoring treatment: ¢ HF hospitalization
No difference between groups:
All-cause mortality CV Mortality
MI
Stroke
Favoring treatment: ¢ All-cause mortality ¢ CV mortality
No difference between groups:
e MI
e Stroke
¢ HF Hospitalizations e Revascularization
Favoring treatment: e None
No difference between groups: CV Mortality MI Stroke All-cause mortality Unstable angina hospitalizations HF hospitalizations Revascularization
Favoring treatment: e Stroke e Revascularization
No difference between groups:
e All-cause mortality ¢ CV Mortality
« MI
« Stroke
Table 1 continued on page 24
Key Safety Findings Increased risk of:
¢ Genital infections e Urosepsis
Decreased risk of:
e Progression of albuminuria Composite: 40% reduction in eGFR, need for renal- replacement ther- apy, and death from renal causes Serious adverse effects
Increased risk of:
« Amputations
e Fractures Volume depletion
¢ Genital infections
¢ Diuresis
Decreased risk of:
¢ Nephropathy
e Severe hypoglycemia
Increased risk of:
e GI adverse events
e Discontinuation due to adverse events
Increased risk of:
e Discontinuation due to adverse events Nausea or vomit- ing
Decreased risk of:
¢ Nephropathy
e Serious adverse events
Increased risk of:
¢ Diabetic retinopathy
e Discontinuation due to adverse events
¢ Gastrointestinal disorders
MARYLANDPHARMACIST.ORG 23
Medication (N)
Sitagliptin (N=14,671)
SAVOR-TIM#9 Saxagliptin
(N=16,492)
Continuing Ed
TABLE 1 continued Comparison of Key Eligibility Criteria and Outcomes of Antidiabetic Cardiovascular Studies
Eligibility Criteria
Age > 50 with CV disease
Age > 40 and CV event or
Age > 55 (men) or 60 (women) with CV risk
Primary Outcome
Composite CV mortality, MI, stroke, hospitalization for unstable angina
11.4% sitagliptin, 11.6%
placebo, HR 0.98, p=0.65
Composite CV mortality, MI, Stroke
73% saxagliptin, 7.2% placebo, HR 1.00,
Secondary CV Outcomes
Key Safety
Finding Favoring Treatment e« None
No significant differences in adverse events No difference between
groups:
e All-cause mortality
¢ HF hospitalizations
e MI
e Stroke
Increased risk of: e Minor hypoglycemia
Favoring Placebo:
¢ HF hospitalizations (3.5% saxagliptin, 2.8% placebo, HR 1.27, p=0.007)
EXAMINE”
factor
Alogliptin
(N=5,380) prior 15-90 days
Acute CV event within
p=0.99 Favoring Treatment e None
No difference between groups:
e All-cause mortality
« CV mortality
e Revascularization
Composite CV mortality, MI, Stroke
Favoring Treatment e None
No significant differences in adverse events 11.3% alogliptin, 11.8% | No difference between
placebo, HR 0.96, groups:
p=0.32 e All-cause mortality
CV mortality
HF hospitalizations
CV=Cardiovascular; HF=Heart Failure; HR=Hazard Ratio; MI=Myocardial Infarction
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: 8/9/17 Program Expiration Date: 8/9/20
This program provides for 1.0 contact hour (0.1) of continuing education credit. Universal Activity Number (UAN) 0798-9999-17-185-H01-P & T
The authors have no financial disclosures to report.
This program is Knowledge Based — acquiring factual knowledge that is based on evidence as accepted in the literature by the health care professionals.
24 MARYLAND PHARMACIST | SUMMER 2017
Directions for taking this issue's quiz:
This issue's quiz on Recent Updates on the Cardio- vascular Risks and Benefits of Antidiabetic Agents can be found online at www.PharmCon.com.
(1) Click on “Obtain Your Statement of CE Credits for the first time.
(2) Scroll down to Homestudy/OnDemand CE Credits and select the Quiz you want to take.
(3) Log in using your username (your email address) and Password MPHA123 (case sensitive). Please change your password after logging in to protect your privacy.
(4) Click the Test link to take the quiz.
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.
The CANVAS study, published
in June 2017, enrolled patients (N=10,142) with uncontrolled T2DM and either age > 30 years and history of cardiovascular disease
or age > 50 years and multiple cardiovascular risk factors.’ In this study a history of cardiovascular disease was defined as prior stroke, MI, hospitalization for unstable angina, coronary revascularization including coronary artery bypass graft or percutaneous coronary intervention, and PAD including revascularization, symptomatic disease or amputation. Cardiovascular risk factors included: (1) duration of diabetes > 10 years, systolic blood pressure >140 mmHg on > 1 antihypertensive agent, current smoking, albuminuria, or HDL < 38.7 mg/dL. The average age of participants was 63 years, 65% were male and 78% were white. The average Alc at enrollment was 8.2% and the average duration of diabetes was 13.5 years. Participants received canagliflozin 300 mg, 100 mg or placebo as add-on antidiabetic therapy and were followed for
a median of 2.5 years. Results
were reported as events per 1,000 patient-years, and not percentages as in the other studies discussed
in this review. Less patients in the combined canagliflozin groups experienced the primary composite endpoint of cardiovascular mortality, MI or stroke (27 vs. 31 per 1,000 patient-years, HR 0.86, p=0.0158), though the individual components of the composite outcome were not found to be statistically significantly different from placebo. All-cause mortality rates were not different between groups, though the risk of HF hospitalizations was lower in the canagliflozin group. While patients with eGFR <30 ml/min/1.73 m* were excluded from the CANVAS study, progression of albuminuria occurred less frequently in the canagliflozin group than placebo. In addition to increased rates of volume depletion, urinary and genital infections, this study also found increased rates of fractures and amputations in the canagliflozin group.
Macrovascular outcomes were not included in the initial prescribing information for any of these
agents, though the package insert for empagliflozin was updated in December 2016 to reflect the results of the EMPA-REG Outcomes study. Empagliflozin currently carries
an indication “to reduce the risk
of cardiovascular death in adult patients with T2DM and established cardiovascular disease."* Changes to package labeling have not yet been approved for canagliflozin based on the recently published CANVAS study. The package labeling for canagliflozin and dapagliflozin include a statement that there are no clinical studies establishing evidence of macrovascular risk reduction. There are also multiple ongoing studies with empagliflozin including the DECLARE-TIMI 58 trial, which will help determine if the cardiovascular benefits shown with empagliflozin and canagliflozin apply to the SGLT2 drug class.
Glucagon-like Peptide 1 (GLP1) Agonists
Glucagon-like peptide 1 (GLP1)
is an incretin mimetic hormone with a multitude of physiologic actions, including triggering insulin release and inhibiting glucagon secretion in response to blood glucose levels. GLP1 agonists are synthetic analogs that activate GLP1 receptors, but have longer half-lives by avoiding natural degradation enzymes. Currently approved products include: exenatide
(Byetta, 2005 and Bydureon, 2012, AstraZeneca Pharmaceuticals), liraglutide (Victoza, 2010, Novo Nordisk), albiglutide (Tanzeum, 2014, GlaxoSmithKline), dulaglutide (Trulicity, 2014, Eli Lilly and Company), and lixisenatide (Adlyxin, 2016, Sanofi-Aventis). Products vary in regards to injection device, half- life, and dosing frequency. Of note, liraglutide is also FDA approved under a different brand name (Saxenda) and at a higher dose
for chronic weight management
in patients with a BMI > 30 kg/m? or BMI > 27 kg/m? with a weight-
related comorbid condition, including diabetes. Combination products that include long-acting insulin and a GLP1 agonist are
also approved, including insulin degludec/liraglutide (Xultophy,
2016, NovoNordisk) and insulin glargine/lixisenatide (Soliqua, 2016, Sanofi-Aventis). Package labeling for exenatide and lixisenatide only list hypersensitivity as contraindications, while other agents in this class are also contraindicated in patients with a personal or family history
of medullary thyroid carcinoma
or personal history of multiple endocrine neoplasia syndrome based on findings of animal
studies and post-marketing
reports. Precautions include risk of pancreatitis and acute kidney injury, and risk of hypoglycemia when used in combination with other agents like insulin. Recommendations suggest avoiding use in patients with severe gastrointestinal disease.
Liraglutide
The LEADER Trial prospectively investigated the impact of liraglutide on cardiovascular outcomes. Participants with uncontrolled T2DM were eligible if they were age >
50 years with one cardiovascular comorbidity, or age > 60 years
with one cardiovascular risk factor. Cardiovascular comorbidities included: CAD, stroke, PAD, > stage 3 chronic kidney disease (CKD),
or New York Heart Association HF class II or III. Cardiovascular risk factors included microalbuminuria, proteinuria, hypertension with
left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or PAD. Exclusions to enrollment included type 1 diabetes, use of GLP1 agonists, dipeptidyl peptidase 4 (DPP4) inhibitors, pramlintide, or rapid-acting insulin, family or personal history of multiple endocrine neoplasia type
2 or medullary thyroid cancer,
or MI or stroke within 14 days of randomization. Patients (N=9,340) were randomized to receive 1.8
mg of liraglutide or placebo and continued on treatment for a
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median of 3.5 years. The average age of the study population was
64 years, with 64% male, average duration of diabetes of 13 years, and average Alc at enrollment of 8.7%. Background diabetes medications included metformin (76%), sulfonylureas (50%), and insulin (44%).
The primary outcome, a composite of cardiovascular mortality, MI,
or stroke, occurred in 13% of the liraglutide group compared to 14.9% of the placebo group (hazard ratio 0.87, p=0.01). Cardiovascular and all-cause mortality rates were also statistically significantly lower in the liraglutide group, as were rates of nephropathy events. No statistical differences were seen in the rate of MI or stroke. In subgroup analyses benefits were found to be greater
in patients with impaired renal function (eGFR <60 ml/min/1.73 m2) and established cardiovascular disease at baseline. Gastrointestinal adverse events, including those that lead to discontinuation of therapy, were increased in the liraglutide
group.
Lixisenatide
The effect of lixisenatide in patients (N=6,068) with T2DM and MI or hospitalization for unstable angina in the preceding 180 days followed for a median of 25 months was evaluated in the ELIXA Trial.*® Enrolled patients had an average age of 60 years, were predominately male (70%) and white (75%). Average Alc was 7.6% and average duration of diabetes was 9 years. A majority of patients had hypertension (76%) and prior percutaneous coronary intervention (67%) at baseline.
The majority of qualifying events were Mls, occurring an average
of 72 days prior to randomization. Glycemic management including initiation, discontinuation and
dose adjustment of other glucose lowering agents aside from GLP1 agonists and DPP4 inhibitors was
at the discretion of the treating physician. There was no difference between lixisenatide and placebo groups in the primary outcome,
a composite of cardiovascular mortality, MI, stroke, or hospitalization for unstable angina. There were also no differences in secondary outcomes including individual components of the composite outcome, all-cause mortality, HF hospitalizations,
or coronary revascularization. Patients in the lixisenatide group had statistically lower Alc values and more weight loss, they also — had statistically higher rates of discontinuation due to adverse events driven by nausea and vomiting.
The ELIXA study population differed from trials previously discussed
in this review because it included patients with recent cardiovascular events not just those at increased cardiovascular risk. While it is reassuring that lixisenatide does not negatively impact outcomes in this population, the results of this study does not indicate benefit in the adding lixisenatide to baseline medication regimens for patients with recent cardiovascular events.
Semaglutide
A new drug application for Semaglutide, a once-weekly GLP-
1 agonist, was submitted to the
FDA by Novo Nordisk in December 2016, but is not yet approved. Patients (N=3,297) with uncontrolled T2DM on < 2 oral antidiabetic agents, with or without basal or premixed insulin, were enrolled
in the 2-year SUSTAIN-6 trial to assess the cardiovascular effects of this investigational drug following the same inclusion criteria as the LEADER trial.” Exclusion criteria included use of GLP1 agonists, DPP4 inhibitors, or basal insulin, coronary or cerebrovascular event within 90 days prior to enrollment, planned revascularization and dialysis. The
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average age of