North Carolina Pharmacist Volume 100 Number 4

North Carolina Pharmacist Volume 100 Number 4 Fall 2019

Advancing Pharmacy. Improving Health.

Happy Holidays Get the New Year off to a great start by joining NCAP today or renewing your membership. There is no better time than now to unify as a profession. Together we can make a difference.

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Official Journal of the North Carolina Association of Pharmacists 1101 Slater Road, Suite 110 Durham, NC 27703 Phone: (984) 439-1646 Fax: (984) 439-1649

www.ncpharmacists.org EDITOR-IN-CHIEF Tina Thornhill

North Carolina Pharmacist Volume 100 Number 4

Fall 2019

Inside • From the President .....................................................................................4

LAYOUT/DESIGN Rhonda Horner-Davis

• From the Executive Director ...........................................................................5

EDITORIAL BOARD MEMBERS

• Post Convention Highlights.............................................................................9

Anna Armstrong Jamie Brown Lisa Dinkins Jean Douglas Brock Harris Amy Holmes John Kessler Angela Livingood Bill Taylor

BOARD OF DIRECTORS EXECUTIVE DIRECTOR Penny Shelton PRESIDENT Debra Kemp PRESIDENT-ELECT Dave Phillips PAST PRESIDENT Stefanie Ferreri

• Rite of Roses Tribute....................................................................................15 • Role of Aspirin for Primary Prevention............................................................17 • Romosozumab Approved for Osteoporosis.................................................21 • Alpha-Gal Allergies.................................................................................23 • Continuing Education.......................................................................30

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North Carolina Pharmacist is supported in part by: • Smith Drug Company .....................................................................................2 • Pharmacists Mutual Companies ....................................................................7

TREASURER Thomas D’Andrea

• UnitedHealthcare .............................................................................................8

BOARD MEMBERS

• Pharmacy Quality Commitment ..................................................................16

Shannon Brown Andria Eker Brock Harris Angela Livingood Holly Nunn Kevin Helmlinger Tasha Woodall Jennifer Wilson North Carolina Pharmacist (ISSN 0528-1725) is the official journal of the North Carolina Association of Pharmacists. An electronic version is published quarterly. The journal is provided to NCAP members through allocation of annual dues. Opinions expressed in North Carolina Pharmacist are not necessarily official positions or policies of the Association.

Publication of an advertisement does not represent an endorsement.

Nothing in this publication may be reproduced in any manner, either whole or in part, without specific written permission of the publisher.

• EPIC Pharmacies Inc ....................................................................................12 • Osteoarthritis Action Alliance .....................................................................20 • VUCA Health .................................................................................................22 • Pharmacy Technician Certification Board ..................................................25 • NCAP Career Center .....................................................................................36

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•From the President • Debra Kemp, PharmD, BCPS, BCACP

Dear Members –

With a few blinks of the eye, the holiday season is upon us, and soon we will wake to 2020. As cliché as it is to say, I cannot help but ask myself where the year went. Though it feels like the past 12 months hurried by, one cannot help but realize how much NCAP has accomplished.

Staff expansion, increased educational activities, updated bylaws with the addition of a new academy for ambulatory care practitioners, updated strategic plan, increased stakeholder engagement, legislative efforts, development of a formal independent pharmacy group, and so much more. Wow! As Penny states in this issue of North Carolina Pharmacist, 2019 truly has been a banner year for NCAP. What an amazing opportunity it has been to serve as the state association president and work with such a compassionate, invested group of leaders. Thank you for all of your support during my tenure as president and for propelling NCAP and the pharmacy profession forward. The association would not be where it is today without your selfless engagement!

If you did not have the chance to attend the 2019 NCAP Annual Convention in September, you definitely missed out! The meeting was full of energy, innovation, and collaboration. Based on attendee feedback from previous years, the planning committee dedicated more time for participants to network, hosted new certificate and training programs, and included multiple hot topic sessions with speaker panels to share a variety of experiences and opinions. Personally, I thoroughly enjoyed the CBD educational session as it was incredibly informative and sparked interesting debates amongst attendees. Forums for Health-System Administrative/Leadership and the NC Medicaid Managed Care provided an excellent venue to gather individuals facing similar issues and strategically develop solutions. And new this year, we sprinkled in school colors so all could showcase their pharmacy roots. It was a blast! Sad you missed it? Or ready to participate again? Mark your calendars for October 29-30, 2020 at the Benton Convention Center in the Twin City.

As I close my last column, I would like to leave you with a few thoughts, many of which I have consistently shared throughout the year.

North Carolina Pharmacist

ü There is no better time than now to unify as a profession. Come together.

Advocate together. Fight together. Celebrate together. ü NCAP is alive and doing well! If you hear or think differently, please engage any of the NCAP officers, board members, or reach out directly to Penny. We would love to bring you up to speed and we love hearing new ideas! ü NCAP is OUR organization!

It is the professional home for NC pharmacy. Join us.

There is always a spot at the table for you to become active within the association and directly contribute to the advancement of our profession.

I would like to wish each of you and your families a Happy Holiday Season. May your holidays glitter with love, laughter, and cheer. I look forward to serving the association in 2020 and celebrating NCAP’s 20-year anniversary.

Debra Kemp, PharmD, BCPS, BCACP

Page 4 Volume 100 Number 4 Fall 2019

•From the Executive Director• Penny Shelton, PharmD, BCGP, FASCP

2019 A Banner Year for NCAP

As I write this column for the North Carolina Pharmacist’s last issue in 2019, I am coming off of a week of stakeholder meetings, new board member orientation, and a couple of days of staff development. As I sat contemplating what topic to share with you, I found myself thinking back through the year, and realized that 2019 has shaped up to be a banner year for the Association!

NCAP has never been as active, on as many different levels, as it has been in this year. It is commonplace that pharmacists and technicians turn to their state association for help with advocacy, education, practice tools and resources, updates and cutting-edge information, as well as networking. This year, NCAP has offered and accredited more continuing education programs, both live and on-demand, than in recent years. For the first time, we instituted an advocacy plan that led to not just the monitoring of healthcare-related bills, but actually the introduction, support and/or grassroots work on four important pieces of legislation.

NCAP obtained more grant funds

to support practice advancement than in any other year before; moreover, our Board of Directors shored-up our commitment to helping equip pharmacists with the resources and tools that they need to advance practice by approving the hiring of the Association’s first Director of Practice Advancement. To enable networking in an era where many members prefer direct access, we have invested in new technology designed to enable online networking through virtual communities. We also generated more social media posts and electronic communications with our members this year as compared to previous years.

Doing a better job at meeting or rather exceeding the reasons why members join the Association is just one aspect of what makes 2019 a banner year. Another sign has to do with achieving major outcomes for the metrics traditionally used to measure the success or rather the health of an association. The health of any organization has much to do with its effectiveness as an organization and its ability proactively.

Essentially the health of an organization is framed in both its stability and agility; and the metrics used to determine the health of non-profit associations, such as

North Carolina Pharmacist

NCAP, are typically: governance, leadership, operations, finances, resources, membership, strategy and services.

This year we have worked hard to further refine and improve our governance, leadership, operations and strategies. The membership voted this fall to adopt new bylaws designed to better meet member needs and instill additional operational efficiencies. Throughout 2019, the Board of Directors and the Executive Committee drafted and approved a new strategic plan centered around five overarching strategic goals. Both the bylaws and the strategic plan will go into effect January 1, 2020.

Financially, NCAP will finish the year in the black. This financial stability comes from both an uptick in grant funding as well as membership growth. This year we launched a new network for independent pharmacists and technicians. We have begun discussions with local pharmacy associations across the state on how best to connect these smaller, local groups with the state pharmacy association. There will be many more new initiatives, services and changes designed to create more value for the member coming in 2020.

Page 5 Volume 100 Number 4 Fall 2019

When I first took the position as your Executive Director, I purchased, read and now use as a frequent resource, a book

by Coerver and Byers titled Race for Relevance: 5 Radical Changes for Associations. This book addresses the existential threat to membership associations and how adaption away from the traditional association operating model is imperative if associations not only want to survive, but thrive in the midst of generational changes, the digital era, and the work-life balance constraints of volunteers needed to lead. The radical changes necessary for associations to claim relevance include: overhauling governance and committee operations; empowering the chief operating officer and staff expertise; rigorously defining the member market; rationalizing programs and services; and building a robust technology framework. NCAP has embarked on many of these changes, but we still have much work to do; however, the success of 2019 has proven that we are on the right path together.

In closing, I recognize that this column does not provide the space needed for details outlining the successes mentioned above; therefore, I will be providing members with a 2019 Annual Report currently scheduled for e-publication in late January 2020. Until then, I wish you much warmth and joy this holiday season.

Pharmacy Proud,

Penny

Save the Dates 2020 NCAP Annual Spring Conference Rizzo Conference Center Chapel Hill, NC March 5- March 6 2020 NCAP Annual Convention Benton Convention Center Winston-Salem, NC October 29 - October 30 Exhibitors Contact Rhonda Horner-Davis at rhonda@ncpharmacists.org

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Page 6 Volume 100 Number 4 Fall 2019

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2019 Convention Awards NCAP Leadership Award and McKesson Leadership Award David Phillips

Bowl of Hygeia Dennis Williams

Technician of the Year Deb Hewitt

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Page 9 Volume 100 Number 4 Fall 2019

Community Care Pharmacist of the Year Christina Nunemacher

Excellence In Innovation Irene Ulrich

Don Blanton Award Ritesh Patel

North Carolina Pharmacist

Page 10 Volume 100 Number 4 Fall 2019

NC Pharmacy Ambassador Award Jennifer Burch

Student Pharmacist of the Year Jennifer Sato

Distinguished Young Pharmacist Patrick Brown

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Page 11 Volume 100 Number 4 Fall 2019

Awards not Pictured NCAP President Award Debra Kemp NCAP President’s Service Award Miranda Hill Tina Thornhill NC Pharmacy Ambassador Award Jay Campbell

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Rite of Roses Michael Boykin Paul Clark Tom Miya Tara Ann Zachary In Loving Memory of our NCAP Members

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Page 14 Volume 100 Number 4 Fall 2019

NCAP Rite of Roses Special Tribute Dean Tom Miya NCAP reflects on the life of member and former Dean of the UNC Eshelman School of Pharmacy, Tom Miya who passed away on May 30, 2019 at the age of 96.

gy from the University of Nebraska, received his Ph.D. in pharmacology from Purdue University and joined the faculty there in 1948. Miya left Purdue in 1956 to come back to his alma mater at Nebraska and serve as associate professor Dean Miya, born in Hanford, California, led the and chairman of pharmaUNC Eshelman cology. He returned to PurSchool of Phardue in 1958 as professor macy from 1977 to and became chair of the De1992. During his partment of Pharmacology tenure, the growth in 1963. of pharmacy education at the School Miya’s research focus was began to unfold, pharmacodynamics, biothe North Carolina chemical pharmacology and AHEC program betoxicology. A well-known gan, and the Pharresearch scholar, he was macy Foundation also recognized as a leader of North Carolina in pharmacy education and undertook aggresin 1975 was elected presisive action in dedent of the American Assoveloping its assets. ciation of Colleges of Pharmacy (AACP).

Dean Miya had a powerful story of When Miya visited Chapel perseverance that Hill to be interviewed for included surviving the dean’s position, he saw Japanese interna tremendous amount of ment camps durpotential for growth in the ing WWII, pushing Triangle area and on the to be accepted into pharmacy school, serving in campus, according to the School’s history. the U.S. Army and later receiving his doctorate in pharmacology. He shared his story of deter- Dean Miya is survived by daughter Pamela of mination in this video.

Omaha and brother Harry of Hanford, CA, sisters-in-law Nancy of Hanford, CA and Patricia of Miya graduated with a B.S. degree in pharmacy Redondo Beach, CA, as well as numerous nieces and M.S. degree in physiology and pharmacolo- and nephews.

North Carolina Pharmacist

Page 15 Volume 100 Number 4 Fall 2019

Role of Aspirin for Primary Prevention in Older Adults Jamie Cronquist, PharmD, MBA, CPP, BCPS, BCGP

The risk versus benefit of aspirin for primary prevention in the elderly has been controversial due to factors such as bleeding risk, and life expectancy versus time to benefit. It is known that older adults have a higher risk of bleeding and appear to be more vulnerable to the adverse effects of antithrombotic therapy.(1,2) However, the incidence of cardiovascular (CV) and cerebrovascular events also increases with age.(3) The U.S. Preventive Services Task Force recommendation regarding use of aspirin for primary prevention of CV disease and colorectal cancer, last updated in 2016, states that there is insufficient evidence to assess balance of risk versus benefit for adults 70 and older.(4) However,

since this last update, three large randomized controlled trials have been published to clarify the role of aspirin for primary prevention in this age group.

The ASCEND trial (5,6) was a randomized, placebo-controlled trial that included 15,480 participants with diabetes but no evident CV disease. Participants were 40 years or older and were randomized to receive either aspirin 100mg daily or matching placebo. The primary efficacy outcome was time to first serious vascular event (myocardial infarction (MI), stroke, transient ischemic attack (TIA), and vascular death, excluding any confirmed intracranial hemorrhage (ICH)). The primary safety outcome was time to first major bleeding event

North Carolina Pharmacist

(ICH, sight-threatening bleeding event in eye, gastrointestinal (GI) bleed or other serious bleeding).

Secondary outcomes included GI tract cancer.

Pertinent baseline characteristics included: an average age of 63 years, with approximately 24% 70 years or older; average BMI of 30; 63% male; 97% Caucasian; 62% with hypertension (patientreported); and approximately 40% with a low 5-year vascular risk score, 42% moderate, and 17% high. During mean followup of 7.4 years, significantly fewer vascular events occurred in the aspirin group versus placebo (8.5% vs 9.6%, p=0.01, number needed to treat (NNT) 91); however, significantly more major bleeding events also occurred in

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the aspirin group (4.1% vs. 3.2% p=0.003, number needed to harm (NNH) 111), with the majority being GI bleeds. Of note, fatal bleeding events and hemorrhagic stroke were similar between the two groups. No difference was seen between groups with respect to GI tract cancer. However, when the primary efficacy endpoint was analyzed by age, although older adults had the highest incidence of vascular events or revascularization, a statistically significant benefit for aspirin was not observed in this age group (age <60 years RR 0.79 (0.66-0.96), 60-69 RR 0.87 (0.75-1.02), 70+ RR 0.95 (0.81 to 1.10)). Also, in reference to the major bleeding endpoint, overall there were more bleeding events in older adults in both the aspirin and placebo groups, but significantly fewer major bleeds in the placebo group (age <60 years RR 1.07 (0.79-1.45), 60-69 RR 1.41 (1.07-1.87), 70+ RR 1.37 (1.041.80)).

The ASPREE (7-9) trial was a randomized, placebo-controlled trial that included 19,114 participants aged 70 years or older (or 65 years or older among blacks and Hispanics in the United States) without CV disease, dementia or disability. Those with a life expectancy less than 5 years were excluded. Participants were randomized to receive either aspirin 100mg daily or placebo. The primary endpoint was a composite of death, dementia, or persistent physical disability. Secondary endpoints included individual components of the primary endpoint, major hemorrhage, and CV disease.

Pertinent baseline characteristics include: median age of 74 years;

44% male; 86% Caucasian; 30% obese; 11% with diabetes; 2% frail; and 31% with 0-1 CV risk factor, 42% with 2 CV risk factors, and 28% with 3-4 CV risk factors . The trial was terminated early after a median follow-up of 4.7 years when it was determined that benefit with continuation of aspirin was unlikely. The rate of the composite endpoint was not significantly different between the aspirin and placebo groups (HR 1.01 (0.92 to 1.11)).

However, there was a statistically higher rate of major hemorrhage with aspirin versus placebo (HR 1.38 (1.19 to 1.62)).

All-cause mortality was also significantly increased in the aspirin group (HR 1.31 (1.10-1.56)), with an excess of 1.6 deaths per 1000 person-years compared with placebo. Surprisingly, this was mostly attributed to cancer-related deaths (3.1% in aspirin group versus 2.3% in placebo group, HR 1.31 (1.10-1.56)).

A secondary composite endpoint of fatal coronary heart disease, nonfatal MI, fatal or nonfatal stroke, or hospitalization for heart failure was also determined to be statistically equal between the aspirin and placebo groups (HR 0.95 (0.83 to 1.08)).

Finally, the ARRIVE trial (10) was a randomized, placebo-controlled trial that included 12,546 participants aged 55 years or older (men) or 60 years or older (women) with moderate CV risk.

Those with diabetes or high risk of GI bleed or other bleeding were excluded. As with the other trials, participants were randomly assigned to receive aspirin 100mg daily or placebo. The primary endpoint was a composite of time to first occurrence of

North Carolina Pharmacist

CV death, MI, unstable angina, stroke, or TIA. Pertinent baseline characteristics include: average age of 70 years; 70% male; 98% Caucasian; mean BMI 28; mean ACC/AHA 10-year ASCVD risk score 17%. During the median follow-up of 5 years, there was no statistically significant difference between the aspirin and placebo groups with regard to the primary endpoint the either the intention-to-treat (ITT) analysis (HR 0.96 (0.81 to 1.13)) or the per-protocol analysis (HR 0.81 (0.64 to 1.02)). However, in the per-protocol secondary endpoint analysis, there were statistically fewer fatal or nonfatal MI (HR 0.53 (0.36 to 0.79)) and nonfatal MI (HR 0.55 (0.36 to 0.84)) in the aspirin group versus the placebo group. The overall incidence of treatment-related adverse events was significantly higher in the aspirin group (p<0.0001), including higher incidence of dyspepsia (3.6% vs 3.14%), epistaxis (1.85% vs 0.89%), gastro-esophageal reflux disease (1.12% vs 0.96%), upper abdominal pain (1.08% vs 0.92%), and drug-related GI bleed (0.24% vs 0.03%).

Two recent meta-analyses assessing efficacy and safety of aspirin for primary prevention of CV events included ASCEND, ASPREE and ARRIVE, and neither found benefit for all-cause or CV mortality, while they did confirm a significant increase in major bleeding. (11,12) The Zheng, et al. analysis did find a reduction in composite CV outcome (including all-cause and CV mortality, MI, and ischemic stroke), which was mostly due to a significantly lower risk of MI and ischemic stroke; NNT for composite CV

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outcome was 265, MI 361, and ischemic stroke 540 (11). As expected, when separated out by degree of CV risk, the NNT for the overall composite increased to 297 in low-risk individuals and decreased to 196 in high-risk individuals. The Mahmoud, et al. analysis only found a significant decrease in MI with a NNT of 333, but high heterogeneity among included studies was noted. The NNH for major bleeding was 210 (11) to 250 (12); intracranial hemorrhage NNH was 927 (11) to 1000 (12). Of note, neither of these meta-analyses provided a sub-group analysis of the results stratified by age.

In March 2019, the American College of Cardiology and American Heart Association published a guideline on the primary prevention of CV disease, which includes a recommendation on aspirin use. The guideline states that low-dose aspirin may be considered in adults 40 to 70 years of age who are at higher risk for ASCVD but without increased bleeding risk. However, the guideline recommends against the use of aspirin for primary prevention in adults greater than 70 years of age or adults of any age at an increased risk of bleeding (13).

In conclusion, with the vast amount of recently published data, the benefit of aspirin, specifically in the elderly for primary prevention, does not appear to outweigh the risk. It is imperative to critically assess the clinical necessity and risk versus benefit in patients on aspirin for this indication, especially in our older adult patients.

Dr. Jamie Cronquist is a Clinical Pharmacist at CarePartners PACE (Program of All-Inclusive Care

for the Elderly) in Asheville, NC. j.rickards14@gmail.com) References 1. Fitzmaurice DA, Blann AD, Lip GY. Bleeding risks of antithrombotic therapy. BMJ. 2002;325(7368):828–831.

2. Capodanno D, Angiolillo DJ. Antithrombotic therapy in the elderly. J Am Coll Cardiol 2010;56:1683–92

3. Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46e215

4. Final Update Summary: Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer: Preventive Medication. U.S. Preventive Services Task Force.

April 2016. https://www.uspreventiveservicestaskforce.org/ Page/Document/ UpdateSummaryFinal/aspirin-to-preventcardiovascular-disease-andcancer 5. The ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med 2018; 379:1529-1539

6. The ASCEND Study Collaborative Group. Supplementary appendix: Effects of aspirin for primary prevention in people with diabetes. N Engl J Med 2018; 379:Suppl 1 7. McNeil JJ, Nelson MR, Woods RL, et al (The ASPREE Investigator Group). Effect of aspirin on disability-free survival in the healthy elderly. N Engl J Med 2018; 379:1499-1508

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8. McNeil JJ, Nelson MR, Woods RL, et al. (The ASPREE Investigator Group). Effect of aspirin on all-cause mortality in the healthy elderly. N Engl J Med 2018;379:1519-28.

9. McNeil JJ, Nelson MR, Woods RL, et al (The ASPREE Investigator Group). Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med 2018; 379:1509-1518 10. Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomized, double-blind, placebo-controlled trial. Lancet. 2018;392(10152):10361046

11. Zheng SL, Roddick AJ. Association of aspirin use for primary prevention with cardiovascular events and bleeding events: A systematic review and metaanalysis. JAMA. 2019;321(3):277 12. Mahmoud AN, Gad MM, Elgendy AY, et al. Efficacy and safety of aspirin for primary prevention of cardiovascular events: a meta-analysis and trial sequential analysis of randomized controlled trials. Eur Heart J. 2019;40(7):607.

13. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/ AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Circulation. 2019. Available at: https://www.ahajournals. org/doi/pdf/10.1161/ CIR.0000000000000678. Accessed 12/5/2019.

Page 19 Volume 100 Number 4 Fall 2019

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New Drug Update: Romosozumab Approved for Osteoporosis Hien Nguyen, PharmD, CPP

A new treatment option for osteoporosis was approved by the Food and Drug Administration in April 2019 for postmenopausal women with a history of fracture, multiple risk factors for fracture, or those who have failed or not tolerated other osteoporosis treatments. The first in its class, romosozumab is a sclerostin inhibitor.

Sclerostin is a regulatory factor in bone metabolism that ordinarily blocks bone formation by inhibiting osteoblasts. Romosozumab is designed to increase bone formation, and to a lesser extent, decrease bone resorption by osteoclasts. While its mechanism of action is unique, it joins parathyroid hormone analogs teriparatide (Forteo) and abaloparatide (Tymlos) as an anabolic drug that stimulates bone development rather than just reducing bone breakdown like the antiresorptive agents.

In a 24-month long, phase 3 randomized, doubleblinded study of 4,093 postmenopausal women with osteoporosis and a prior fragility fracture, romosozumab significantly reduced the risk of new vertebral, nonvertebral, and hip fractures when used for a year before transitioning to alendronate, compared with alendronate therapy alone for two years. Participantsâ&#x20AC;&#x2122; mean age was 74 years, and 70% were non-Hispanic. T-scores for patients included in this study ranged from -2.99 to -2.78 (lumbar spine, total hip, and femoral North Carolina Pharmacist

neck). The majority (96%) of participants had a history of vertebral fracture, 38% had a history of non-vertebral fracture, and 9% had a history of hip fracture. In the romosozumab-to-alendronate group (R-A), 6.2% (127/2046 patients) developed new vertebral fractures compared to 11.9% (243/2047 patients) in the alendronate group (AA) (RR 0.52, 95% CI 0.40-0.66). Clinical vertebral fractures were also significantly reduced (9.7% for the R-A group vs. 13.0% for the A-A group, RR 0.73, 95% CI 0.61-0.88). Numbers needed to treat (NNT) over two years for R-A compared with A-A are provided in the table below.

Fracture Type New vertebral fracture Clinical vertebral fracture Nonvertebral fracture Hip fracture

NNT over 2 years 18 30 53 83

Romosozumab carries a boxed warning about potential risk for myocardial infarction, stroke, and cardiovascular death. Fifty patients in the R-A group (2.5%) vs. 38 patients (1.9%) in the A-A

Page 21 Volume 100 Number 4 Fall 2019

group sustained an adjudicated serious cardiovascular event (cardiac ischemic event, cerebrovascular event, heart failure, death, noncoronary revascularization, and peripheral vascular ischemic event not requiring revascularization); OR 1.31, 95% CI 0.85-2.00. However, there were lower incidences of heart failure, noncoronary revascularization, and peripheral vascular ischemic event not requiring revascularization when analyzed as individual outcomes observed in the group receiving romosozumab.

Romosozumab is available as brand name Evenity®, a monthly injection that is recommended to be administered by a healthcare provider. It is packaged with two separate syringes (105 mg each), intended to be injected subcutaneously in the abdomen, thigh, or upper arm, one syringe after the other for a total dose of 210 mg. Currently, evidence does not support use of romosuzumab for greater than 12 months. Per manufacturer recommendations, if osteoporosis therapy is indicated beyond 12 months, an antiresorptive agent such as a bisphosphonate or denosumab (Prolia) should be used after the course of romosozumab is completed.

Romosuzumab is contraindicated in individuals with hypocalcemia. It is noted that in patients with severe renal impairment or receiving dialysis that romosuzumab should be used with caution, as the risk of hypocalcemia is higher. The most commonly noted adverse effects are: arthralgia (813%), headache (5-7%), hypersensitivity reaction (7%), and injection site reaction (5%).

Dr. Hien Nguyen is a PGY2 Geriatrics Resident at Mountain Area Health Education and UNC Eshelman School of Pharmacy. hien.nguyen2@pennmedicine.upenn.edu

Bibliography Evenity (romosozumab-aqqg) [prescribing information]. Thousand Oaks, CA: Amgen Inc; April 2019.

Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427.

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Expansion of Outpatient “Coumadin Clinics” to DOAC Monitoring

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Alpha-Gal Allergies: Essential Information for Healthcare Professionals

Andrew T. Darkow, PharmD, MBA, BCPS

Introduction Galactose-alpha-1,3-galactose, or alpha-gal, is an oligosaccharide present in mammalian meat. This includes beef, pork, lamb, venison, goat, and bison. (1) Allergies to alpha-gal are Type I IgE-mediated allergic reactions that were first described in 2009. (2) They can be difficult to identify and complex for patients and healthcare professionals to manage, as many medications contain alphagal or mammalian meat as inactive ingredients. These allergies have been implicated in delayed hypersensitivity reactions with an onset of three to six hours after ingestion of mammalian meat. Intravenous preparations containing alpha-gal can incite allergic responses in less than one hour after administration.

(3) Patients with alpha-gal allergies can exhibit signs and symp-

toms ranging from mild to lifethreatening which may include indigestion, stomach cramps, rash, headaches, nausea, hives, angioedema, and anaphylaxis.

(3,4) Individual patient sensitivity to alpha-gal can be variable, with some patients only reacting to ingestion of pork kidney, while routinely tolerating mammalian muscle meat or alpha-gal containing medications. (5)

The Lone Star Tick and Alpha-Gal Allergies

Alpha-gal allergies are most common in the southeastern United States but have been reported in many locations around the world. (2) The onset of these allergies can occur at any age, but they are more likely to occur in adults. It is theorized that lone-star tick bites are the most

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common mechanism for initial sensitization to alpha-gal, though chiggers and mites have been recently implicated as well. Local allergic reactions after a tick bite such as erythematous papules or plaques with persistent itching are routinely observed in individuals who are sensitized to alpha-gal. If a lone-star tick bite sensitizes an individual to alphagal, the person may develop an allergic response upon the ingestion of alpha-gal containing products. (5) It is important to note that not all patients who are bit by a lone star tick will develop an allergy to alpha-gal. As with most allergies, patients allergic to alpha-gal are often unaware of the allergy until they experience an allergic response. Due to the delayed nature of the response, alpha-gal allergies can sometimes be difficult to identify.

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Medications and Additives that Incite Alpha-Gal Allergies Many medications are derived from mammalian meat or contain additives that are derived from mammalian meat which can incite allergic responses in patients with alpha-gal allergies. Though these medications are being increasingly recognized over time, there is not a comprehensive list of medications to avoid in patients with an allergy to alphagal. Cetuximab, a recombinant chimerical monoclonal antibody with an alpha-gal component used for the treatment of several types of cancer, was the first medication documented to incite an allergic response to alpha-gal.

(6) Since then allergic reactions have been documented with multiple medications including antivenom, gelatin in volume colloids, vaccines, porcine enzymes taken as digestion aids, and several others. (5) Several common additives of medications may also be derived from mammalian meat including gelatin, glycerin, glycerol, stearic acid, magnesium stearate, and lactic acid. It is essential to recognize that different manufacturers of the same generic medication may use different additives, meaning that some may contain alpha-gal while others do not. Dairy products, protein powder with whey, and gelatin in sweets may also contain alpha-gal. (7)

Provider Management of Patients with Alpha-Gal Allergies As with any documented al-

lergy, avoidance of the allergen is essential. It is imperative for healthcare professionals to have strategies to ensure patients with alpha-gal allergies do not ingest mammalian meat or products that contain alpha-gal. In addition to the medications listed above, patients with a documented allergy to alpha-gal should avoid medications with additives derived from mammalian meat.

Clinicians should review package inserts of prescribed medications to ensure they do not contain additives that may be derived from mammalian meat as listed above. Manufacturers are not required to document if medications contain alpha-gal in package inserts. Contacting the manufacturer of each medication can help determine if a medication contains alpha-gal or any animal by-products. This process can be time-consuming, so maintaining a list of medications that have previously been evaluated for alpha-gal content may be time efficient. It is essential to recognize that inactive ingredient information can change at any time, and the FDA does not require manufacturers to alert the public if this occurs. (1) Healthcare professionals should be cognizant of the signs and symptoms of alpha-gal allergies which most commonly present three to six hours after the ingestion of mammalian meat in patients with a history of tick exposure. These allergies occur most commonly in the southeastern United States. If a patient has a documented allergy to alphagal, clinicians should instruct patients to avoid the use of medications or products derived from mammalian meat. Addi-

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tional information may be found at alpha-gal.org. (7) References 1.

Kar I, et al. Alpha-gal allergy: Implications for pharmacists.

Pharmacy Times. May 2015.

3.

Meat Allergy. American College of Allergy, Asthma, and Immunology Website. https://acaai. org. Accessed March 4, 2019.

2.

4.

5.

6.

7.

Commins SP, Satinover SM, Hosen Jet al. Delayed anaphylaxis, angioedema, or urticaria after consumption of red meat in patients with IgE antibodies specific for galactose‐alpha‐1,3‐ galactose. J Allergy Clin Immunol 2009; 123(2): 426–33.

Fischer J, Biedermann T. Delayed Immediate-Type Hypersensitivity to Red Meat and Innards: Current Insights into a Novel Disease Entity. Journal of the German Society of Dermatology. 2016 Jan;14(1):38-44.

Hilger C, Fischer J, Wolbing F, Biederman T. Role and Mechanism of Galactose-Alpha-1,3Galactose in the Elicitation of Delayed Anaphylactic Reactions to Red Meat. Curr Allergy Asthma Rep. 2019; 19(1): 3.

O’Neil BH, Allen R, Spigel DR, et al. High incidence of cetuximabrelated infusion reactions in Tennessee and North Carolina and the association with atopic history. J Clin Oncol.

2007;25:3644–8.

Alpha-gal basics. Alpha-Gal Allergy Awareness website. http://alpha-gal.org. Accessed May 5, 2019.

Dr. Darkow is a Clinical Pharmacist at Duke Regional Hospital in Durham, North Carolina. Email: andrew. darkow@duke.edu.

Page 24 Volume 100 Number 4 Fall 2019

Overview of the 2019 American Diabetes Association (ADA) Clinical Practice Guidelines for Type 2 Diabetes and A Description of Diabetes Self-Management Education and Support (DSME) Programing in the Community Pharmacy Setting Anna Armstrong, PharmD, BCACP Clinical Pharmacist Community Care of North Carolina Email: aarmstrong@wakedocs.org

Samantha Arrants, PharmD Clinical Pharmacist Realo Discount Drugs - New Bern, NC Email: sarrants@realodiscountdrug.com

*The authors have no relevant financial relationships or conflicts of interest to disclose.* Objectives

1. Review the 2019 ADA clinical guideline recommendations for patients with Type 2 diabetes 2. Implement guideline recommendations when managing adult patients with Type 2 diabetes 3. Describe a community pharmacy-based Diabetes Self-Management Education (DSME) program

Introduction

The American Diabetes Association (ADA) has released an annual guideline called Standards of Medical Care in Diabetes since 1989, and its recommendations are widely accepted by the medical community.1 The differences between the 2018 and 2019 guidelines are minimal, and the changes are largely focused on improving the flow of information presented and updating the level of evidence for recommendations based on any newly released data.1 Some of the updates include the addition of a Diabetes Technology section, clarifying North Carolina Pharmacist

the utility of the 10-year atherosclerotic cardiovascular disease (ASCVD) risk score, and emphasis on aligning pharmacologic treatment recommendations with other key patient factors such as concomitant cardiovascular disease. A consensus report published in 2018 by the ADA and European Association for the Study of Diabetes (EASD) was aimed at reevaluating recent data to determine the best patient-centered approach to managing diabetes with the goal of reducing associated risks (ie cardiovascular) and improving patientsâ&#x20AC;&#x2122; quality of life.2 The recommendations included in this article are meant to be highlights of both publications aimed at providing the most relevant information to those providing care to patients with Type 2 diabetes.

Diagnosis

Type 2 diabetes is caused by the loss of beta cell function and insulin secretion mostly due to insulin resistance.3 Patients at a high risk for developing Type 2 diabetes should be screened according to the criteria outlined in Table 1.3 The 2019 guidelines support the use of two abnormal test results from the same sample as sufficient for diagnosis unlike previous guidelines that recommended two separate samples be obtained.1 Therefore, a patientâ&#x20AC;&#x2122;s single blood sample can be evaluated with a Hemoglobin A1c (HgA1c) test and plasma glucose test to determine if the patient meets diagnostic criteria. The diagnostic criteria for Type 2 diabetes is detailed in Table 2.3 Keep in mind, patients with a random plasma glucose of >200 mg/dL must also present with classic symptoms of hyperglycemia such as frequent urination, extreme thirst, lethargy, and vision changes.

Page 26 Volume 100 Number 4 Fall 2019

Treatment Recommendations Metformin is still considered first-line for newly diagnosed Type 2 diabetic patients, and doses should be slowly titrated up to a target dose of 1000mg twice daily. Some patients may have a contraindication to therapy (i.e. poor kidney function) or an intolerance such as nausea and diarrhea. Reducing a patient’s dose, taking the medication with food, or switching the patient to the extended release formulation are all methods for reducing gastrointestinal upset and attempting to continue metformin. Metformin should be continued indefinitely even when additional therapies are added including insulin. Consider a B12 supplement in addition to metformin as chronic use of metformin can lead to B12 deficiency3.

Figure 1 outlines the various second, third, and fourth line pharmacotherapy agent choices depending on patient-specific factors.3 The 2019 guidelines emphasize the need to consider the patient’s goals and preferences in addition to the patient’s clinical and social needs. Therapy recommendations may change depending on the patient’s comorbidities, hypoglycemia risk, body weight, and cost concerns. Special emphasis is placed on patients with cardiovascular disease (CVD) and/ or chronic kidney disease (CKD). Several classes of medications have shown clinical benefit in patients with CVD and/or CKD and are considered first-line agents after initiation of metformin.3 The sodiumglucose cotransporter 2 (SGLT-2) inhibitors and glucose-like peptide 1 receptor (GLP-1) agonists have shown benefit in patients with CVD and CKD3.

Below are additional details about each of these drug classes and their corresponding benefits.

The SGLT-2 inhibitors are the newest drug class for diabetes management and work in the kidneys to allow excess glucose excretion in the urine. Two of the agents in this class have been studied in patients with CVD and empagliflozin has slightly stronger evidence compared to canagliflozin3. Of note, studies did show a higher incidence of lower limb amputations with canagliflozin3, so clinicians typically avoid this agent in patients with a history of amputations or who are at high risk of amputation. These study results impact clinician preferNorth Carolina Pharmacist

ence for a particular agent but insurance formulary restrictions should always be considered. Other agents in this drug class have not been studied or did not show a significant benefit in patients with CVD. Also, studies have shown both canagliflozin and empagliflozin have reduced HF and CKD disease progression3. SGLT-2 inhibitors as a class can cause hypotension, mild dehydration, and gynecologic infections due to the excess glucose release.

Caution should be used in patients with renal dysfunction and existing low bone mineral density. The advantages to this drug class include oral dosage form, once daily dosing, CVD, CKD, and HF benefit with specific agents, and possible weight loss or at least weight neutrality3.

Glucose-like peptide 1 receptor (GLP-1) agonists are preferred over insulin in patients needing additional glucose lowering and who are amenable to injectable medications3. GLP-1 agonists should be considered for patients who may benefit from weight loss and who have established CVD. All agents in the class induce weight loss, but the strongest evidence for CVD benefit is agent specific: liraglutide > semaglutide > exenatide ER3. Other agents in this class have either not been studied for CVD benefit or did not show a significant benefit.

Concomitant use of dipeptidyl-peptidase-IV (DPPIV) inhibitors and GLP-1 inhibitors is not needed as both work on the same glucose lowering pathway, and no additional benefit is seen in patients on both medications. These medications carry a lower risk of hypoglycemia as they work in response to food, but they do slow gastric emptying time which can result in nausea and vomiting at initiation.

Patients should be reminded to slowly titrate their dose up to therapeutic dosing (product specific) and to try eating more slowly by eating half of a normal meal and waiting 10 to 15 minutes before finishing the remainder if still hungry. GLP-1 agonists can be costly as all the current products are brand name, but most insurances cover at least one of the medications in this drug class and manufacturer coupons are also available for patient’s that qualify. Patients with a history of poor medication adherence or hesitancy regarding daily injections should try the products that are dosed every 7 days. Lastly, GLP-1 agonists should not be used in patients with a history of pancreatitis or thyroid

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tumors and caution should be used in patients with severe renal impairment.

The 2019 guidelines emphasize the importance of using insulin as a last line options for patients except those with signs of cell breakdown, severe hyperglycemia evidenced by blood glucose levels > 300mg/dL or HgA1c >10%3. Patients being initiated on insulin should begin with basal insulin injected once daily and titrated to achieve a goal fasting blood glucose (FBG)3. If further glycemic control is needed around mealtime, prandial insulin can be considered. Clinicians typically start by adding a set dose of rapid acting insulin 15 minutes prior to the largest meal of the day and slowly incorporate a dose with other meals of the day as tolerated or needed. If patients are confident in their ability to carbohydrate count or calculate sliding scale corrective dosing, this is the ideal way to ensure patients are receiving the correct amount of rapid acting insulin prior to meals. Otherwise, an average dose for each meal can be set for patients who cannot realistically calculate their own dosage.

Patients who prefer only using one type of insulin daily or have cost or insurance limitations may benefit from an insulin mixture which contains both a short acting and long acting component and can be dosed twice daily before meals. Patientâ&#x20AC;&#x2122;s on insulin will need to test their blood glucose more frequently per day. Typically, this will include testing a fasting blood glucose and at least 1 to 3 tests before or after meals depending on how the rapid acting insulin is dosed. Insulin carries a high risk of hypoglycemia and weight gain, but both insulin degludec and insulin glargine have demonstrated safety in patients with CVD3. Also, some products are still brand name and can be costly. Patients need to be aware of proper storage and injection technique as well. Despite its complexity and drawbacks, insulin is ideal for patients who need a more tailored approach to glucose management and have failed or have contraindications to all other therapies.

Other drug classes listed in Figure 1 include: sufonylureas (SU), thiozolidinediones (TZDs), and DPPIV inhibitors. SU and TZD medications are ideal for patients with cost concerns3. They are cheap comparatively due to their generic availability and longevity on the market. SU carry a high risk of hypoglycemia especially when combined with North Carolina Pharmacist

insulins. Also, they can cause some weight gain and are less effective as diabetes progresses secondary to their mechanism of action involving the beta cells. They need beta cells to function in order to exert their action; as diabetes progresses beta cells begin to die off. TZDs can cause fluid retention and some studies have linked them with worsening heart failure. Although more recent studies have dispelled some of the originally published data on heart failure risks, clinicians typically avoid these agents due to their side effects which include fluid retention, abdominal weight gain, minimal glucose lowering efficacy, and possible risks in HF patients.

Lastly DPP-IV inhibitors, are newer agents to the market and offer modest glucose lowering, once daily dosing, and an oral dosage form. Unfortunately, CVD risk studies have not proven any significant benefit with these agents; however, they do appear to be neutral in their effect on CVD outcomes. They are also overall weight neutral and carry a low risk of hypoglycemia. One of their primary drawbacks is simply cost versus benefit as all the agents are still brand name medications.

Fortunately for patients with diabetes, there are many treatment options that involve unique mechanisms of action, delivery systems, dosing intervals, and combination therapies. As a clinician, the choices can seem overwhelming, but the guidelines recommend ruling out any contradictions, considering the benefits of each drug based on patientspecific factors, and finally involving the patientâ&#x20AC;&#x2122;s preference in determining the best medication regimen for each patient.

Glycemic Targets

HgA1c serves as the primary measure of glucose control and gives a snapshot of the patientâ&#x20AC;&#x2122;s average glucose over the last 3 months. The 2019 ADA HgA1c goals have not changed from previously published guidelines. The goal HgA1c for most non-pregnant adults is <7%, but goals can vary based on specific patient factors.3 Patients may be able to tolerate a stricter goal of <6.5% if they are newly diagnosed, have a long life expectancy, have no significant comorbidities, and do not experience frequent hypoglycemia when achieving the lower target.3 Those with a more severe or progressive

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clinical picture may benefit from a less stringent goal of <8%.3 These patients typically have a limited life expectancy, several comorbidities, advanced microvascular and macrovascular complications, long history of diabetes, and have experienced severe episodes of hypoglycemia.3

Fasting (pre-prandial) blood glucose should fall between 80-130 mg/dL, and the postprandial glucose target is <180mg/dL.3 It is important to remind patients that fasting glucose is considered 8 hours without food or drink, and postprandial glucose is measured 2 hours after the start of a meal.

diagnosis and annually if retinopathy is present.

Less frequent (every 2 years) may be appropriate if patients have evidence of good glucose control, but more frequent exams may be needed for patients with symptoms of progressing retinopathy.3 Foot exams to test for peripheral neuropathy should be performed annually for everyone and only those with high risk for ulceration should be examined at every visit.3 Managing Comorbid Conditions

Patients with diabetes should have their blood pressure checked at each clinic visit, and any reading >140/90 should be confirmed with a separate Patients should always be counseled on the signs reading on a different day prior to diagnosis of and symptoms of hypoglycemia (blood glucose hypertension.3 Guideline recommendations for <70mg/dL), and clinicians should assess for hypatients with both diabetes and hypertension poglycemia unawareness in patients at high risk. diagnoses are further aligned with current AmeriIf the patient is conscious, the recommended can College of Cardiology (ACC) and American method of treatment is to ingest 15-20 grams of carbohydrates, retest after 15 minutes, repeat dose Heart Association (AHA) hypertension guidelines.

Patients with an ASCVD risk score of >15% should of 15-20 grams of carbohydrates if blood glucose 3 maintain a blood pressure <130/80 mmHg, and remains <70mg/dL. A small meal or snack should those with an ASCVD risk score of <15% should be be consumed after the patientâ&#x20AC;&#x2122;s blood glucose has 3 normalized to prevent a subsequent episode of hy- treated to a less stringent goal of <140/90 mmHg. Most patients can be started on single drug therapy poglycemia.3 Patients at high risk of hypoglycemia to treat their hypertension, but those with blood should be prescribed a glucagon pen for caregivpressure >160/100 mmHg at diagnosis should be ers or family members to administer if the patient 3 initiated on two drugs.3 Historically, guidelines embecomes unconscious due to hypoglycemia. phasized the importance of using ACE inhibitors or angiotensin receptor blockers (ARB) in all patients Monitoring with diabetes, but these should be first-line in patients with an elevated urinary albumin-to-creatHgA1c should be assessed at least twice per year inine ratio (>300mg/g or 30-299 mg/g creatinine).3 for patients with stable glycemic control and at The lipid management recommendations also least quarterly for those not meeting glycemic taralign with current ACA/AHA hyperlipidemia mangets.3 Self-monitoring blood glucose (SMBG) may not be as important for patients with Type 2 diabe- agement guidelines. Patients >40 years old with tes on non-insulin regimens.3 Recommendations for diabetes should be on a moderate intensity statin; this recommendation includes those >75 years.3 frequency of monitoring should be individualized Patients with an ASCVD risk score of >20%, regardand may be more beneficial in patients with poor less of age, should be on a high-intensity statin.3 A glucose control, concern over accuracy of HgA1c moderate intensity statin should be considered for results, episodes of hypoglycemia or sickness, and 3 patients <40 years old with an ASCVD risk score following physical activity. <20%.3 Low dose aspirin therapy (75-162mg/day) is recommended for secondary prevention, but risk Assessment of urinary albumin and estimated glomerular filtration rate (eGFR) should be performed versus benefit should be assessed in patients using it for primary prevention.3 annually in all patients with Type 2 diabetes. Eye exams to screen for retinopathy should occur at North Carolina Pharmacist

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Lifestyle Management

Diabetes Self-Management Education (DSME)

Non-pharmacological recommendations are critical to the health maintenance of patients with diabetes. The guidelines recommend personalized meal planning with a registered dietician who can provide medical nutrition therapy (MNT).3 Any reasonable approach to meal planning is acceptable as long as it addresses glucose control and weight management.3 The guidelines further recommend that patients participate in at least 150 minutes per week of moderate to vigorous aerobic activity.3 Patients should exercise at least 3 days per week with no more than 2 consecutive days without activity.3 Also, engaging in resistance training exercises at least 2 to 3 times per week is advisable.3 It is also important for patients to be counseled on the importance of smoking cessation including the use of e-cigarettes as well as limiting alcohol intake.3

Patients with diabetes require a multidisciplinary team approach to help facilitate care coordination and to improve health outcomes. All members of the healthcare team, including pharmacists, are encouraged to manage a patient’s diabetes collaboratively.3 It is important to empower patients to take an active approach to managing their health by helping them access community resources, providing appropriate education, and recognizing social determinants of health that may impact a patient’s ability to care for themselves. Additionally, aiding with food insecurity, housing, and other financial burdens can greatly impact the patient’s ability to focus on their disease.2 The guidelines recognize the importance of having community health workers available to advocate for patients’ socioeconomic needs especially those in underserved communities.3

Teaching patients to take an active role in the decisions and management of their disease is critical to improving outcomes. The ADA-EASD consensus document recommends everyone with Type 2 diabetes should be offered access to ongoing Diabetes Self-Management Education and Support (DSMES) programs especially at diagnosis, annually, presence of disease complications, and during care transitions.2,3 North Carolina Pharmacist

DSMES programs serve to empower patients with diabetes to take control of their own diabetesrelated care and improve their health outcomes. A systematic review exploring the effect of DSMES on glycemic control found that 61.9% of the interventions reported a significant improvement of HgA1c in patients who received DSMES compared to those who did not. There are several different factors that can affect the impact DSMES services have on reducing HgA1c, including mode of delivery (group versus individualized), total contact hours, and baseline HgA1c. DSMES seems to be most effective in lowering HgA1c when combining group and individualized education, providing more than 10 hours of contact, and when patients start out with poor glycemic control (HgA1c > 9%).4

The National Standards for DSMES are criteria that ensure DSMES programs deliver consistent and evidence-based education. The Standards are reivewed every few years by experts within the diabetes education community. A Task Force was brought together in 2016 by the American Association of Diabetes Educators (AADE) and the ADA to review the National Standards for approprateness, relevance, and scientific basis and to make updates based on available evidence and expert consensus.

There are 10 standards that provide guidance on the structure, process, and outcomes of a DSMES program. 5 The National Standards are listed below:

Standard 1: Internal Structure- The provider(s) of DSMES services will define and document a mission statement and goals. The DSMES services are incorporated within the organization-large, small, or independently operated.

Standard 2: Stakeholder Input- The provider(s) of DSMES services will seek ongoing input from valued stakeholders and experts to promote quality and enhance participant utilization.

Standard 3: Evaluation of Population Served- The provider(s) of DSMES services will evaluate the communities they serve to determine the resourc-

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es, design, and delivery methods that will align with the population’s need for DSMES services.

Standard 4: Quality Coordinator Overseeing DSMES Services- A quality coordinator will be designated to ensure implementation of the Standards and oversee the DSMES services. The quality coordinator is responsible for all components of DSMES, including evidence- based practice, service design, evaluation, and continuous quality improvement.

Standard 5: DSMES Team- At least one of the team members responsible for facilitating DSMES services will be a registered nurse, registered dietitian nutritionist, or pharmacist with training and experience pertinent to DSMES, or be another health care professional holding certification as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM). Other health care workers or diabetes paraprofessionals may contribute to DSMES services with appropriate training in DSMES and with supervision and support by at least one of the team members listed above.

Standard 6: Curriculum- A curriculum reflecting current evidence and practice guidelines, with criteria for evaluating outcomes, will serve as the framework for the provision of DSMES. The needs of the individual participant will determine which elements of the curriculum are required.

Standard 7: Individualization- The DSMES needs will be identified and led by the participant with assessment and support by one or more DSMES team members. Together, the participant and DSMES team member(s) will develop an individualized DSMES plan.

Standard 8: Ongoing Support- The participant will be made aware of options and resources available for ongoing support of their initial education and will select the option(s) that will best maintain their self-management needs.

Standard 9: Participant Progress- The provider(s) of DSMES services will monitor and communicate whether participants are achieving their personal diabetes self-management goals and other North Carolina Pharmacist

outcome(s) to evaluate the effectiveness of the educational intervention(s), using appropriate measurement techniques.

Standard 10: Quality Improvement- The DSMES services quality coordinator will measure the impact and effectiveness of the DSMES services and identify areas for improvement by conducting a systematic evaluation of process and outcome data.

5

Standards 1-4 focus on the structure of the program and ensure there are clear roles, support, and coordination within the program. Standards 5-8 focus on the program structure while ensuring instructors have adequate training to provide education and follow-up using a curriculum based on current evidence and practice guidelines. Standards 9-10 focus on outcomes of the program, including a written continuous quality improvement (CQI) plan and patients’ individual goals.5

For a community pharmacy to implement DSMES services, they should first choose which organization to apply for accreditation/recognition with, either the AADE or ADA. Both have similar costs and application processes with the AADE requiring an application fee and telephone interview that is not required by the ADA. Each organization requires that at least one participant has completed the program including follow-up and documentation prior to accreditation. The application process can take about 4-6 weeks through the AADE and about 30 days through the ADA. Both organizations initial accreditation lasts for 4 years and could include an on-site audit in which the program would be provided with a 2 weeks’ notice. The renewal process includes completing an application and submitting supporting documentation such as a de-identified chart, stakeholder input minutes, and CQI plan.

Both organizations offer various support services that are unique to each association to ensure members have the sources available to provide a quality program. 6 DSMES services may be reimbursed through the Centers for Medicare and Medicaid Services (CMS) and other private insurers with a referral from a patient’s health care provider. In order to obtain

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reimbursement from CMS, a DSMES program must be accredited by either the ADA or AADE. Medicare Part B covers up to 10 hours of initial DSMES training (1 hour of individual and 9 hours of group training) and up to 2 hours of follow-up training each year thereafter.7

The United States Diabetes Conversation Map® tool is one curriculum available for DSMES programs to utilize. It is created by Healthy Interactions, Inc. in collaboration with the ADA and sponsored by The Merck Journey for Control Program. The Conversation Map® is to be used with a group of 3-10 participants and includes interactive activities to engage the group in conversation. This allows them to share and learn from one another based on their personal knowledge and experiences living with diabetes. The instructor’s role is to facilitate the conversation by following the guidance provided by the Conversation Map® tools and facilitator guide.

The five maps included in the education tools cover information regarding the basic concepts and natural course of diabetes, long term complications, healthy eating, monitoring blood glucose, medications, gestational diabetes, etc. Each session lasts two hours and ends with all participants setting short and long-term goals, making an action plan, and identifying their support network. 8 A community pharmacy setting is an ideal location for pharmacist led DSMES services. This setting is easily accessible to a variety of patients and community pharmacists have the necessary training to educate patients about diabetes and help motivate a change in behaviors. This is a great opportunity for community pharmacies to generate income from the delivery of a patient care service.

DSMES programs, once approved, are eligible for reimbursement regardless of provider status or an existing relationship with a prescriber. Lastly, DSMES services should be provided in collaboration with the patient’s other healthcare providers to allow an opportunity to work directly with physicians, nurses, dieticians, and other members of the healthcare team.

References

North Carolina Pharmacist

1) American Diabetes Association. Summary of Revisions: Standard of Medical Care in Diabetes 2019. Diabetes Care 2019 Jan; 42(Supplement 1): S4-S6.https://doi.org/10.2337/dc19-Srev01 2) Davies, Melanie et al. Management of Hyperglycemia in Type 2 Diabetes, 2018: A consensus report by the ADA and EASD. Diabetes Care 2018 Dec; 41(12): 2669-2701. https://doi. org/10.2337/dci18-0033 3) American Diabetes Association. Standards of Medical Care in Diabetes - 2019 Abridged for Primary Care Providers. Clinical Diabetes 2019 Jan; 37(1): 11-34. https://doi.org/10.2337/ cd18-0105 4) Chrvala CA, Sherr D, Lipman RD. Diabetes selfmanagement education for adults with type 2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient Education and Counseling. 2016 Jun;99(6):926–43.

5) Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, et al. National standards for diabetes self-management education. Diabetes Care. 2010 Jan;33 Suppl 1:S89–96.

6) Beck J, Greenwood DA, Blanton L et al (2017) 2017 National Standards for Diabetes SelfManagement Education and Support. Diabetes Educ 43:449–464 7) Centers for Disease Control and Prevention. Diabetes Self-Management Education and Support (DSMES) Toolkit: Comparison of AADE and ADA Accreditation/Recognition Process [Internet]. 2018 [cited 2019 Feb 27].

Available at: https://www.cdc.gov/diabetes/ dsmes-toolkit/accreditation-recognition/comparison.html 8) Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, et al. Diabetes Selfmanagement Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. The Diabetes Educator. 2015 Aug;41(4):417–30.

9) Merck Pharmaceuticals Journey for Control Program. Conversation Map® program [Internet]. c2017 [cited 2019 Feb 27]. Available at: https://www.journeyforcontrol.com/diabeteseducator/about-conversation-map/.

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Appendices

Table 13

Table 23

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Figure13

Claim your Credit .......

• Answer the quiz questions on page 35 • Log-in on the NCAP Website at ncpharmacists.org • Click on North Carolina Pharmacist Quiz • Find your quiz • Enter your answers In order to receive quiz credit you must be an NCAP member and enter your answers online.

The passing score is a 70 or higher. If you fail you may retake the test.

You should receive an email immediately after completing the quiz online.

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Page 34 Volume 100 Number 4 Fall 2019

1. Which of the following ideas is emphasized in the 2019 ADA guidelines?

a. Technology innovations are not important to the management of diabetes. b. The presence of cardiovascular disease should be considered when making medication recommendations. c. Metformin is not considered first-line treatment for most newly diagnosed Type 2 diabetes patients due to the availability of newer agents. d. Diet and exercise management only helps those trying to prevent diabetes onset and are not effective once a patient is diagnosed with Type 2 diabetes.

2. A patient receives fasting blood work at his wellness visit with his PCP. His doctor is concerned because his fasting blood glucose was 145mg/dL (normal is 100-125mg/dL); however, the patient reports no symptoms of hyperglycemia. Which result from a second test would confirm a diabetes diagnosis?

a. HgA1c = 6.9% b. Oral Glucose Tolerance Test (OGTT) = 150 mg/dL c. HgA1c = 5.8% d. Random Prandial Glucose = 190mg/dL

3. Utilizing Figure 1 from the article, when is the use of a sulfonylurea the most appropriate second-line agent for a patient already on metformin? a. Weight loss is needed b. History of severe hypoglycemia c. Presence of chronic kidney disease (CKD) d. Cost is primary concern

4. A Type 2 diabetic patient begins to express his frustrations to you, his community pharmacist, regarding his metformin. He has been taking the maximum dose (1000mg twice daily) for several months, and he is still not reaching his glycemic goals. He is extremely opposed North Carolina Pharmacist

to injecting medications at this time, but does have a history of myocardial infarction and could benefit from weight loss. He wants to know what medication he may be able to take in addition to the metformin. He plans to ask his doctor about your recommendation at his next visit. Utilizing Figure 1 from the article, what is the most appropriate second-line agent for this patient? a. b. c. d.

DPP-IV inhibitor Insulin SGLT-2 inhibitor GLP-1 receptor agonist

a. b. c. d.

<6.5% <7% <8% <8.5%

5. What is the most appropriate HgA1c goal for an 80 year old patient with a 15 year history of diabetes who has significant retinopathy and neuropathy.

6. Use the ASCVD risk score calculator (link) to assist in answering the following question.

What is the recommended blood pressure goal and statin intensity for a 50 year old African American male with diabetes, current smoker, not currently treated with anti-hypertensives, with the following labs: Total Cholesterol = 200 mg/dL, HDL = 30 mg/dL, and Systolic Blood Pressure = 150 mmHg). a. Blood pressure <130/80 mmHg; high intensity statin b. Blood pressure <140/90 mmHg; moderate intensity statin c. Blood pressure <130/80; moderate intensity statin d. Blood pressure <140/90 mmHg; high intensity statin

7. True or False: The following factors can affect the impact DSME has on HgA1c: mode of delivery, total contact hours, and baseline HgA1c.

8. How many hours of initial DSME training will the Centers for Medicare and Medicaid Services (CMS) pay for? a. b. c. d.

5 8 10 12

Page 35 Volume 100 Number 4 Fall 2019