North Carolina Pharmacist Volume 101 Number 1

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North Carolina Pharmacist Volume 101 Number 1 Winter 2020

Advancing Pharmacy. Improving Health.

COVID-19 Go to to ncpharmacists.org for updates and resources Official Journal of the North Carolina Association of Pharmacists


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 LAYOUT/DESIGN Rhonda Horner-Davis EDITORIAL BOARD MEMBERS 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 Dave Phillips PRESIDENT-ELECT Beth Mills PAST PRESIDENT Debra Kemp TREASURER Thomas D’Andrea

North Carolina Pharmacist Volume 101 Number 1

Winter 2020

Inside • From the President .....................................................................................3 • From the Executive Director ...........................................................................4 • Role of Pharmacists in Smoking and Vaping Cessation......................................7 • Cancer Associated Venous Thromboembolism Treatment.................13 • Pharmacy Checks and Balances...........................................................20 • Sickle Cell Disease.................................................................................23 • Awards...............................................................................31

Check us out. Click here! North Carolina Pharmacist is supported in part by:

SECRETARY Matthew Kelm

• Pharmacists Mutual Companies ...........................................................6

BOARD MEMBERS

• EPIC Pharmacies Inc ...........................................................................9

Brianna Berish Courtney Bradley Shannon Brown Ouita Gatton Ryan Mills Holly Nunn Ann Marie Nye Vinay Patel 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.

• Pharmacy Technician Certification Board ..........................................12 • NCAP Career Center ..........................................................................19 • Pharmacy Quality Commitment ........................................................22

ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org


•From the President • David C. Phillips, PharmD, BCPS

Making Lemonade out of Lemons As spring begins and new life emerges, many are finding it difficult to be excited about the future as we face an unprecedented health crisis with the COVID-19 pandemic. In this time of uncertainty, it is crucial for North Carolina pharmacists to come together and support one another and our profession. Often when faced with a crisis, opportunities will present themselves. Maxwell Maltz said it best, “Close scrutiny will show that most ‘crisis situations’ are opportunities to either advance, or stay where you are.” Pharmacists across the world, including those in this great state of North Carolina, are rallying together to help fight the battle against COVID-19. As discussed in the March, Special Issue E-News, NCAP has been appointed to the North Carolina COVID-19 Health Care Coalition. This will allow NCAP and other stakeholders to disseminate information and gather data surrounding the current pandemic. In addition to the coalition, NCAP has signed onto numerous letters to state and federal government agencies

and personnel, highlighting what pharmacists can do and requesting waivers for regulations and other issues that hamper our ability to provide patient care. For more information visit the E-News for resources and information related to COVID-19. Also, watch your email and visit NCAP’s website regularly for the most up-todate information.

While it may be difficult to see beyond the COVID-19 pandemic at this time, we must build upon the legislative momentum NCAP generated in 2019 and push forward to advance our profession in 2020. As Dr. Penny Shelton, Executive Director, discusses in her letter (discussed in the 2019 Annual Report), 2019 was a very successful year for NCAP’s grassroots efforts. As we look forward in 2020, NCAP has established a robust legislative agenda including Senate Bill 432 and House Bill 659. Other issues on our legislative and regulatory radar for 2020 and 2021 are tele-pharmacy, medical cannabis, and long-term care medication access and disposal issues. Additionally, investigating the pharmacist’s role in treatment access for public health issues such as hormonal contraceptives, substance use disorders, as well as vaping and tobacco cessation. More detailed information can be found in the Legislative Newsletter posted to NCAP’s website. Also, watch the on-demand video recorded by our lobbyist, Tony Page 3

Solari, to learn more about our advocacy plans and legislative agenda. Finally, do not forget to mark your calendars for Legislative Day on June 9th. The event will be held virtually if necessary, but more details will be provided as the date comes closer.

Although it is hard to celebrate in times like these, I must recognize the fact that NCAP’s 20th anniversary is this year. 20 in 2020! This is a historical moment for pharmacy in North Carolina, and we should recognize and be proud of everything that has been accomplished. Keep your eyes out for more information in the coming weeks and months on how you can be a part of this momentous celebration.

In closing, I want to thank all pharmacists in North Carolina and across the world who are joining forces on the frontlines to combat COVID-19. We once again have an opportunity to display our capabilities and why pharmacists are one of the most trusted professionals. In the end, our determination and resilience will prevail, and we will succeed. I am proud to be a pharmacist in North Carolina, and I am calling on all North Carolina pharmacists to join NCAP in this fight. Relentless. Forward. Progress. Dave


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

Operation COVID-19 Until late February, I would bet that most of us had never heard the word “coronavirus” before. I dare say, I had not. I mean I knew about SARS and MERS, but until COVID-19, coronavirus was just not a term for which I was familiar. It makes it even harder to reconcile that, according to the CDC, coronaviruses date back to the 1960’s. Fast forward sixty years and “coronavirus” is most likely a strong contender for Oxford Languages 2020 “Word of the Year.” I hope that all of you and your families are staying safe during this time. Here at NCAP, we have moved to a remote work policy, with assigned days for individual employees to work or retrieve work in the office. Although this creates some unique challenges for the staff, we are working hard to make sure that our member services are provided as seamlessly as possible. Our new President, David Phillips, took the reins in January, and he makes mention in his column of our 2019 Annual Report. I had hoped that my column for this

first issue of 2020 would be filled with celebratory notes, first reflecting on 2019 as a record year for NCAP, and second sharing historical moments as 2020 represents our 20th Anniversary Year. But, these sentiments will rightfully have to wait, as our nation turns attention to stemming the morbidity and mortality associated with COVID-19. NCAP has shifted a considerable portion of my role to focus on COVID-19 and needs for pharmacists and pharmacy technicians during this crisis. Our operation status is seemingly all things COVID-19. I see NCAP’s role during this pandemic three-fold and essential. First, everyone has been and is continuing to experience COVID-19 information overload. One role the Association serves for our members is separating the wheat from the chaff, and feeding you important, as well as relevant information. We are trying to build a repository of such important information, and have created a NCAP COVID-19 Resources page on our website. We have divided the resources into three domains: North Carolina Information, Federal Information, and General Practice Information. As we receive information we place the content under the appropriate domain and often send a message out to either all members or to a specific group of members, based on the subject matter. Page 4

The second role that the Association provides for our members during this time, is representation. There are a number of stakeholder meetings taking place weekly and pharmacy’s voice needs to be heard. While you are on the frontlines providing much needed care for patients, the Association is speaking up for you to make sure you have what you need and that pharmacists are not an afterthought when serious discussions are taking place about essential health care workers. If you run into barriers or have specific needs in your day-to-day operations, while trying to care for patients, please do not hesitate to email me at penny@ncpharmacists.org. In addition, the Association plays a role in sharing pharmacy’s perspective with the media. The phone rings, regularly, with reporters wanting to gather information about how COVID-19 is impacting pharmacy operations and patient care. A third role that I see the Association fulfilling during this pandemic, is the gathering of and coordination of staffing needs. We have many pharmacists and pharmacy technicians willing to volunteer to help out pharmacies in need. Although we have not yet had a call from a pharmacy in need of help due to either increased volume, or because a staff member has fallen ill to COVID-19, we know from other


state’s experience, this is not an if, but a when. The latest projection for the peak in our state is the end of April, which means we are looking at a minimum of another two months of uncertainty, regarding what this virus may do to staffing needs. The Association will be helping to coordinate and match-up volunteers with pharmacies who need pharmacists, technicians, even delivery drivers. Please contact NCAP if your pharmacy is in need of staffing support, and we will do our best to assist you. NCAP has representation on the NC COVID-19 Health Care Coalition. I have tried to use the coalition to help gather information, and it has led to some specific connections, within NC DHHS, allowing me to share pharmacist-provided solutions for gaps in care, during this time

when primary care providers, and our health-systems may be overly stretched thin. I have also provided regular communications to legislators, Secretary Cohen and Governor Cooper during this time, in an attempt to keep pharmacists and pharmacies, in the forefront, as health care providers and community health care resources. Part of the messaging is that we should use this pandemic to illuminate gaps that can be plugged by advancing the role of pharmacists. North Carolina citizens deserve every health care advantage they can get and should have better access to clinical services provided by pharmacists. Our message is that pharmacists have the skill set and are strategically positioned, as well as poised to make a difference. We just need policymakers to remove the policy and regulatory barriers. NCAP has

Regarding NCAP events, COVID-19 will impact many decisions we may need to make. With your health and well-being in mind, we want to do everything we can to follow the guidelines and mandates that our government has put in place to help slow and eventually end the spread of this virus. Therefore, it is expected that we will face the need to cancel some of our events, but we will be looking for opportunities to reschedule or offer programming virtually, whenever possible. Please visit ncpharmacists.org to stay up to date with changes that may be made for future events.

also been calling for mandates which would suspend all forms of audits until we get through this emergency. In addition, we have been working with our national pharmacy association partners to make sure that CDC, CMS and other agencies recognize pharmacists as essential healthcare providers, and on the state side that pharmacists will have access to personal protective equipment as well as opportunities for testing and immunization once these are better realized. In closing, I will simply say, thank you for the care you are providing, how hard you are working during this time, and please, stay safe and healthy! Pharmacy Proud, Penny

Upcoming Events May 7th & 8th NC MPJE Class - Chapel Hill May 13th & 14th NC MPJE Class - Buies Creek June 9th Pharmacy Legislative Day - Raleigh July 17th Residency Conference - Winston-Salem October 29th and 30th Annual Convention - Winston-Salem Page 5



COVID-19:

One More Reason for Advancing the Role of Pharmacists in Smoking and Vaping Cessation By: Dr. Penny Shelton One of the high-risk groups for COVID-19 has further illuminated the need for pharmacists involvement in smoking or vaping cessation services. As we know, patients with chronic lung illnesses are at greater risk of succumbing to COVID-19. Smoking and vaping are two of the more common causes of chronic lung disease. NCAP has been working with the NC Department of Health and Human Services Tobacco Injury Prevention Branch to create policy that would better enable pharmacists to assist with nicotine cessation services. We continue to work on avenues such as a standing order or statewide policy giving pharmacists authorization to prescribe or furnish nicotine replacement and other smoking cessation treatments. In addition, we remain engaged with health plans to seek fair payment for the patient education and products related to such services. Today, North Carolina has greater than 10 million citizens, and while the use of traditional cigarettes in North Carolina has declined in recent years, cigarette use in our state remains above the national mean. Results from a 2017 CDC Behavioral Risk Factor Surveillance System showed that among a sample of 4,741 adults in North Carolina, 17.2% indicated current use of cigarettes, when compared to a national range of 8.9-26.4%. Meanwhile, the use of E-cigarettes or vaping has been on the rise with a >800% increase in recent years. E-cigarettes are a class of tobacco products which are battery-powered devices that provide doses of nicotine and other additives to the user in an aerosol, often referred to as vapor. There are

many types of these products available in the United States, including e-cigarettes, e-hookahs, hookah pens, vape pens, mods, e-cigars and others. Some are disposable, single-use varieties, while others can be refilled or recharged for repeated use. The most recent generation uses pre-filled pods that can be snapped into the device. Nicotine is highly addictive and poses health risks, particularly for young people. Nicotine is toxic to a developing fetus, and a pregnant woman can transfer nicotine to the baby. Evidence also suggests that during adolescence, nicotine exposure may harm brain development potentially up to the age of 25 years.

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In August 2019, E-cigarette or Vaping Association Lung Injury (EVALI) was officially recognized by the CDC.4 As of February 2020, according to the North Carolina Department of Health and Human Services, North Carolina has had 78 hospitalizations, and fortunately no deaths, due to EVALI. EVALI typically presents with severe respiratory symptoms, including cough and shortness of breath. Pa-

tients also report experiencing fever, fatigue, chest pain, nausea, vomiting, and diarrhea. Laboratory data indicate that vitamin E acetate, an additive in some vaping products is strongly linked to EVALI. In addition, patients who vape may not stop using traditional cigarettes, and both smoke and vape, increase the risk for developing EVALI.

that improve the health of our citizens.

As of December 20, 2019, federal law prohibits retailers from selling tobacco and vaping products to anyone under 21 years of age. In January 2020, the FDA issued a new rule banning the sale of e-cigarette nicotine cartridges or pods that come in flavors other than tobacco or menthol. The rule became effective on February 1, 2020. Today, there are still some pharmacies that legally sell tobacco and vaping products. NCAP strongly calls on these pharmacies to implement a ban on the sale of these agents. COVID-19 gives our profession another reason to do all that we can to help patients stop smoking and vaping. NCAP will do all that it can, as your state pharmacy association, to open up opportunities for providing and getting paid for services

The following map and infographic, available from the National Alliance of State Pharmacy Associations, provides a snapshot of talking points and policy-related tobacco cessation information for pharmacy in the United States. Bibliography:

1. https://www.cdc.gov/statesystem/cigaretteuseadult.html 2. https://www.ajpmonline.org/article/S07493797%2815%2900035-5/abstract?rss=yes 3. https://www.tobaccopreventionandcontrol. ncdhhs.gov/ecigs/ 4. https://www.yalemedicine.org/conditions/ evali/ 5. https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html 6. https://naspa.us/resources/

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Tobacco Cessation Prescribing Authority Based on data collected by NASPA (updated August 2019)

WA MT OR

ME

ND

ID

MN

VT WI

SD WY

NV CA

IA

NE UT

AZ

CO

IL KS

KY

TX

WV

VA NC

TN

CT NJ DE MD DC

SC

AR MS

AK

PA OH

IN

MO

OK

NM

NY

MI

NH MA RI

AL

GA

LA FL

HI

All FDA-Approved Tobacco Cessation Products All Nicotine Replacement Products Over-the-counter Nicotine Replacement Products

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Pharmacists Provide Access to Care Accessing Tobacco Cessation Aids from Community Pharmacies

$300

Pharmacy

Billion

Cigarette smoking is estimated to cause more than 480,000 deaths annually 1

Smoking-related illness in the United States costs more than $300 billion each year 1,2

Pharmacists are wellpositioned to initiate treatment and support individuals throughout the quitting process 3

Pharmacists are accessible – 91% of Americans live within 5 miles of a community pharmacy!4

When the stakes are this high... ...not only is it to utilize pharmacists' it's a public health training and accessibility to help patients quit smoking,

GOOD SENSE

IMPERATIVE

Accessing Tobacco Cessation Aids from Community Pharmacies New Mexico

Idaho

The Boards of Pharmacy and Medicine have authorized pharmacist prescribing of all FDA-approved tobacco cessation products since 2004.

Building Momentum Colorado pharmacists can also prescribe all FDA approved products.

Idaho passed legislation in 2017 giving pharmacists authority to prescribe all FDAapproved tobacco cessation products.

Four more states allow pharmacists to prescribe nicotine replacement products .

Bills were introduced in six states in 2018 related to tobacco cessation prescribing.

1. U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. https://www.cdc.gov/tobacco/data_statistics/sgr/50thanniversary/index.htm 2. Xu X, Bishop EE, Kennedy SM, Simpson SA, Pechacek TF. Annual Healthcare Spending Attributable to Cigarette Smoking: An Update. American Journal of Preventive Medicine 2014;48(3):326–33. 3. Tobacco Control Network. Access to Tobacco Cessation Medication through Pharmacists. Association of State and Territorial Health Officials (ASTHO), 2017. http://www.astho.org/Prevention/Tobacco/Tobacco-Cessation-Via-Pharmacists/ 4. National Association of Chain Drug Stores. Face-to-face with community pharmacies. http://www.nacds.org/pdfs/about/rximpact-leavebehind.pdf.

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Pharmacist Prescribing of Tobacco Cessation Aids: Just the FACTS

1

MYTH

Tobacco cessation aids are too dangerous for pharmacists to prescribe

2

MYTH Pharmacists aren't properly trained to prescribe medications.

3

MYTH Only physicians can effectively help patients quit smoking.

4

MYTH Allowing pharmacists to prescribe only NRT products is good enough.

In 2016, FDA removed the Boxed Warning from Chantix (varenicline) and Zyban (bupropion). 1 Pharmacists have been safely prescribing these medications in New Mexico since 2004.2

FACT

Pharmacists have a four-year, doctoral-level degree with extensive coursework in pharmacology, clinical patient care, drug selection and more. And there are many resources available for all healthcare providers who need a refresher in tobacco cessation counseling.3

FACT

In a study including over 1,400 participants, researchers showed that pharmacist-provided smoking cessation interventions have quit rates on par with other healthcare professionals. 4

FACT

The EAGLES study showed that tobacco users taking varenicline were 12% more likely to quit smoking compared to those who used a nicotine replacement product.5

FACT

1. U.S. Department of Health and Human Services. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. https://www.fda.gov/Drugs/DrugSafety/ucm532221.htm. Accessed 6.13.18. 2. New Mexico tobacco prescribing law 3. Many resources available. Here is one compilation from the CDC: https://www.cdc.gov/tobacco/campaign/tips/partners/health/hcp/index.html 4. Shen X, et al. Quitting patterns and predictors of success among participants in a tobacco cessation program provided by pharmacists in New Mexico. J Manag Care Pharm. 2014;20(6):579-87. 5. Anthenelli RM, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a doubleblind, randomized, placebo-controlled clinical trial. Lancet. 2016;387(10037):2507-20. 6. Based on data from the Centers for Disease Control and Prevention. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_sm oking/index.htm. Accessed 6.13.18.

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4.5M

If 12% doesn't sound like much, consider that if all smokers tried to quit smoking, a 12% increase in the success rate would mean 4,536,000 6 more people would quit.

To learn more, go to: www.NASPA.us/tobacco



Cancer Associated Venous Thromboembolism Treatment: A Review of the Literature By Amy Ogilvie Megan Parrish Kim Kelly

Introduction Venous thromboembolism (VTE) is a condition comprised of deep vein thrombosis (DVT) as well as pulmonary embolism (PE).1 Cancer associated VTE (CA-VTE) is the second leading cause of death in cancer patients, only behind cancer progression.1,2 Patients with active cancer are two to three times more likely to experience a DVT and five times more likely to have a PE compared to the general population.1-3 Studies have shown the rate of VTE in cancer patients is approximately 20% each year, compared to 6% in those without cancer.3 Along with VTE, bleeding is a major concern in this patient population. Approximately 15% of cancer patients experience a bleeding event associated with anticoagulation therapy compared to 8% of non-cancer patients.3 In patients with advanced, metastatic cancer, the

rate of developing a CA-VTE is nearly five times higher compared to those with non-metastatic cancer.2,3 When treating patients with CA-VTE, care must be taken to balance the risk of VTE sequelae and the potential for an increased risk of bleeding. The objective of this article is to review the current data for the treatment of CA-VTE to determine the appropriate treatment options for this unique patient population. Guideline Recommendations

National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) NCCN and ASCO are the two main organizations to publish cancer VTE treatment guidelines. The NCCN represents national cancer institute-designated comprehensive cancer centers in the United Page 13

States.4 This organization creates guidelines based on narrative reviews of the literature and is recognized for identifying effective treatments and prevention strategies of VTE in cancer patients.4 The ACSO publishes evidence-based guidelines for the treatment and prevention of VTE in cancer patients based on a systematic review of literature.5 The ASCO guidelines were updated in August 2019 with recommendations for the treatment of VTE in hospitalized and ambulatory cancer patients.5 Due to the differences in treatment of CA-VTE discussed within these guidelines, Table 1 compares the NCCN and ASCO guideline recommendations. With the assistance of the ASCO and NCCN guidelines, providers have a blueprint on which to base safe and effective care in patients with CA-VTE. Both ASCO and NCCN guidelines recommend low molec-


ular weight heparin (LMWH), unfractionated heparin (UFH), fondaparinux, or rivaroxaban as initial therapy for treatment of a CA-VTE, but choice of agent depends on renal/hepatic function, drug-drug interactions, and past medical history.4,5 ASCO specifically recommends UFH over LMWH for the first 5-10 days of therapy in a newly diagnosed CA-VTE, while NCCN does not explicitly address this situation.5 If patients refuse treatment with injectable products, direct oral anticoagulants (DOACs) including rivaroxaban and apixaban can be utilized.4,5 ASCO recommends rivaroxaban, while NCCN states either rivaroxaban or apixaban are appropriate options.4,5 Since there is a high rate of VTE recurrence in patients with CA-VTE, both ASCO and NCCN recommend treating with anticoagulation therapy for at least six months.4,5 ASCO guidelines recommend LMWH, edoxaban, or rivaroxaban for long-term anticoagulation, while NCCN recommends dalteparin or edoxaban as first-line therapy.4,5 According to NCCN guidelines, if first line agents are not available or contraindicated, enoxaparin, rivaroxaban, apixaban, or fondaparinux are appropriate alternatives.4 Due to reduced efficacy compared to other agents, vitamin K antagonists (VKA), are not recommended as first-line therapy.4-6 Warfarin is only preferred if patients are unable to afford therapy due to problems with patient non-compliance.5 NCCN only recommends fondaparinux for patients with CA-VTE who have experienced heparin-induced thrombocytopenia.4

Anticoagulation therapy longer than 6 months is only recommended in those with metastatic cancer, with gastrointestinal (GI) or genitourinary (GU) malignancies, that are bed bound, or that are undergoing chemotherapy due to being highest risk for VTE recurrence. 5,6 ASCO guidelines recommend LMWH, DOACs, or warfarin for this specific patient population.5 Clinical trials have not compared LMWH and VKAs for longer than 6 months; therefore, transitioning to warfarin should be based on clinical judgement.6

ASCO and NCCN guidelines recommend DOACs for both initial as well as long-term anticoagulation, but these medications come at a risk of increased major bleeding.4,5 Data show an increased risk of bleeding in GI and GU malignancies when using a DOAC for anticoagulation.4-5,7-10 Due to drug-drug interactions, DOACs may not be the best option in patients undergoing chemotherapy, as many chemotherapeutic agents work as P-glycoprotein (P-GP) and CYP3A4 inhibitors or inducers.4,5 It is recommended by ASCO guidelines to avoid or dose reduce anticoagulants when used in combination with these strong CYP3A4 and P-GP inhibitors or inducers to minimize adverse reactions and toxicities.5 Prescribing anticoagulants for long durations causes an increased frequency of adverse effects. ASCO guidelines recommend assessing anticoagulation intermittently to assess risk versus benefit of bleeding, cost of Page 14

therapy, quality of life, life expectancy, and patient preference.5

LMWH versus Warfarin Prior to 2003, the standard of care for CA-VTE treatment consisted of short-term parenteral anticoagulation followed by oral anticoagulation with warfarin.6 The Comparison of Low Molecular Weight Heparin Versus Oral Anticoagulant Therapy for Long Term Anticoagulation in Cancer Patients with Venous Thromboembolism (CLOT) trial was a multicenter, open-label, parallel group, randomized controlled trial comparing the use of dalteparin to warfarin therapy in adult patients with active cancer and a newly diagnosed VTE.6 There were 676 participants enrolled in the trial, with 338 participants randomized to each treatment group.6 Dalteparin 200 IU/kg/day subcutaneously for 1 month, followed by 150 IU/kg/ day for the remaining 5 months was compared to warfarin therapy with an INR goal of 2 to 3 over the course of 6 months. The primary endpoint was recurrent VTE over a 6-month period with secondary endpoints including bleeding and all-cause mortality.6 VTE occurred significantly less frequently in the dalteparin group compared to the warfarin group (8.0% vs. 15.8%, 95% CI 0.30-0.77, p=0.002).6 Secondary endpoints indicated that dalteparin had similar rates of major bleeding compared to warfarin (6% vs. 4%, p=0.27). The allcause mortality rate was similar between LMWH and the warfarin group (39% vs. 41%, p=0.53),


with 90% of mortality due to ty followed for 12 months.7 The 6 disease progression. primary outcome was a composThe CLOT trial provided evidence ite of VTE recurrence and major that dalteparin as compared to bleeding. Key secondary outwarfarin significantly reduced comes included recurrent VTE, DVT, PE and major bleeding.7 the incidence of recurrent VTE with no differences in bleeding or mortality. Since the complePrimary composite endpoint tion of this trial, guidelines were showed edoxaban to be non-inupdated to reflect these results as ferior to dalteparin (12.8% vs. described above.4,5 13.5%, HR 0.97, 95% CI 0.701.36, p=0.006 for non-inferiority, DOACs versus LMWH p=0.87 for superiority).7 Recurrent VTE was similar in the edoxEdoxaban aban group compared to LMWH (7.9% vs. 11.3%, HR 0.71, 95% Data for the use of DOACs in the CI 0.48-1.06, p=0.09). The oral treatment of CA-VTE, specifically anticoagulation group had higher edoxaban, has increased over rates of major bleeding comthe past two years. HOKUSANI pared to LMWH (6.9 vs. 4.0%, HR VTE is a randomized, open label, 1.77, 95% CI 1.03-3.10, p=0.04).7 non-inferiority trial that assessed The HOKUSAI VTE trial estabedoxaban versus the standard of lished edoxaban as a contender 7 care, LMWH. Participants were > for initial therapy after 5 days of 18 years old, had a CrCl > 30 mL/ parenteral anticoagulation due to min, had an active solid tumor or the reduced rate recurrent VTE in hematological malignancy, and active cancer patients.7 were diagnosed with a popliteal, femoral, or iliac DVT or had a PE.7 Based on results from the HOKUSAI VTE cancer trial, edoxaban is A total of 1,050 participants were now considered first line for the enrolled in a 1:1 fashion with 525 treatment of CA-VTE in the NCCN participants in both the edoxguidelines.4 aban and dalteparin group.7 The edoxaban group received at least Rivaroxaban 5 days of therapeutic LMWH followed by 60mg of edoxaban daily. Rivaroxaban is indicated as a If patients had renal impairment, once daily DOAC for the treatlow body weight, or began rement of VTE in both cancer and ceiving P-GP inhibitors such as non-cancer patients. A subgroup clarithromycin, ketoconazole, or analysis of the EINSTEIN-DVT azithromycin during the trial, the and EINSTEIN-PE trials evaluated dose was reduced to 30mg daily. the safety and efficacy of rivarThe comparison group received oxaban in patients with active dalteparin 200 IU/kg subcutane- cancer.11 Adult patients were ously daily for 30 days, then the included if they had active cancer dose was reduced to 150 IU/kg/ and a symptomatic DVT or PE. day for the remainder of the trial. Out of the 8,281 participants inPatients were followed for at cluded in the original two trials, least 9 months, with the majorithe subgroup analysis consistPage 15

ed of 462 with active cancer at randomization and an additional 193 who were diagnosed with cancer throughout the study period. Patients were randomized to receive either rivaroxaban 15mg twice daily for 21 days followed by 20mg once daily or enoxaparin 1mg/kg twice daily for at least 5 days plus warfarin with an INR goal of 2-3. Primary outcomes included symptomatic VTE, which included non-fatal DVT or PE. Safety outcomes consisted of a composite of major and clinically relevant non-major bleeds (CRNMB).11 Of the 655 participants with active cancer, 354 received rivaroxaban and 301 received enoxaparin/warfarin.11 Results showed similar rates of VTE recurrence between the DOAC and LMWH plus VKA groups (5.0% vs. 7.0%, 95% CI 0.35-0.99, p=0.24). Major bleeding was significantly lower with the rivaroxaban group compared to the enoxaparin plus warfarin group (2.0% vs. 5.0%, 95% CI 0.18-0.99, p=0.047). This analysis showed that rivaroxaban had similar efficacy to the standard of care for CA-VTE.11 In order to further evaluate rivaroxaban’s role in CA-VTE, the SELECT-D trial recruited adult patients with an active solid tumor or hematological malignancy, and a confirmed diagnosis of VTE.8 This pilot trial was designed as a multicenter, randomized, open-label, controlled trial. A total of 406 participants were used to compare treatment of rivaroxaban versus the standard of care for CA-VTE, LMWH.8 Participants were randomized in


a 1:1 fashion with 203 receiving rivaroxaban by mouth twice daily for 3 weeks, then 20mg daily for the remainder of the 6-month period. The other group consisted of 203 individuals, which received dalteparin 200 IU/kg/ day for 1 month, followed by 150 IU/kg/day for months 2 through 6.8 The primary endpoint was VTE recurrence, while secondary endpoints assessed major bleeding and CRNMB.8

A lower frequency of VTE recurrence was observed in the rivaroxaban group as compared to the LMWH group (4% vs. 11%, HR 0.43, 95% CI 0.19-0.99).8 However, rivaroxaban had a higher incidence of major bleeding as well as CRNMB compared to LMWH (6% vs. 4%, HR 1.83, 95% CI 0.68-4.96; and 13% vs. 4%, HR 3.76, 95% CI 1.63 to 8.96).8 Rivaroxaban showed a low rate of VTE recurrence but an increased risk of major bleeding.8 Due to the findings from these clinical trials, both ASCO and NCCN updated their guidelines to reflect this change. Rivaroxaban is now a recommended agent for initial and long-term anticoagulation therapy for CA-VTE treatment. Apixaban

Apixaban has been considered one of the first line therapies for treatment of non-cancer VTE since showing benefits of oral therapy in the AMPLIFY trial.12 A subgroup analysis of AMPLIFY evaluated the safety and efficacy of apixaban versus the standard of care, LMWH and VKA, in patients with CA-VTE. Adult

patients having active cancer and a confirmed symptomatic DVT or PE were included. Out of the total 5,395 participants, 169 had active cancer at baseline and were included in the subgroup analysis. Participants were randomized to receive either apixaban or enoxaparin/warfarin. Apixaban was dosed at 10 mg by mouth twice daily for 7 days, followed by apixaban 5mg twice daily for the remainder of the 6-month period. The comparison group received enoxaparin 1mg/ kg twice daily for at least 5 days, followed by warfarin with a goal INR of 2-3. The primary efficacy outcome consisted of recurrent symptomatic VTE or VTE related death. The safety outcome included major bleeding events in patients who received at least one dose of the study drug.12

aban and dalteparin to assess major bleeding as well as rate of recurrent VTE.9 Adult patients with confirmed active cancer and a thrombus were included while patients with active bleeding, severe liver or kidney disease, or prior HIT were excluded.9 Primary safety endpoints consisted of any episode of major bleeding. While secondary efficacy endpoints assessed VTE recurrence, which included DVT, PE, fatal PE, or arterial thromboembolism.9 Participants were randomly assigned in a 1:1 fashion, with 150 participants receiving either apixaban or dalteparin.9 The experimental group received apixaban 10mg twice daily for 7 days, then 5mg twice daily for the remainder of the 6-month period. The participants in the comparison group received dalteparin Over the course of 6 months, 88 200 IU/kg/day for 1 month, then participants received apixaban, 150 IU/kg/day for the remaining while 81 received enoxaparin and 5 months. Results showed that there were similar rates of major warfarin.12 Recurrent VTE was lower in the apixaban group com- bleeding in the apixaban group compared to LMWH group (0% pared to the enoxaparin/warfarin group (3.7% vs. 6.4%, RR vs. 1.4%, p=0.138), but when 0.56, 95% CI 0.13-2.37). Those assessing for efficacy, there were significantly less recurrent VTEs receiving apixaban had a lower rate of bleeding compared to the in the apixaban group compared subjects receiving enoxaparin/ to dalteparin (0.7% vs, 6.3%, 95% CI 0.013-0.780, p=0.0281).9 warfarin (2.3% vs. 5.0%, RR 0.45, 95% CI 0.08-2.46).12 These results showed that apixaban can ADAM proved that apixaban has be an option for patients with a lower rate of VTE recurrence CA-VTE. with a similar safety profile in those with active malignancy To further distinguish apixaban’s when compared to the standard role in CA-VTE, apixaban and of care, LMWH.9 Therefore, the dalteparin in active malignanNCCN continues to recommend cy-associated venous thromapixaban as an alternative agent boembolism (ADAM VTE) was for the treatment of CA-VTE.4 conducted.9 ADAM was a randomized, open label, superiority DOACs Safety in GI Cancer-Astrial designed to compare apixsociated VTE Treatment Page 16


Gastrointestinal cancer has been associated with a higher incidence of VTE as well as major bleeding complications when treated with DOACs with previous studies showing DOAC usage results in an increased risk of major bleeding in patients with GI malignancies.7-8 ASCO guidelines recommend LMWH as the preferred agent in GI cancers due to the high risk of hemorrhagic complications associated with oral anticoagulants.5 A study by Recio-Boiles et al. sought to determine the safety and efficacy of DOAC use in GI malignancy through a retrospective chart review.10 Participants selected for a chart review had confirmed GI malignancy, an acute symptomatic or incidental VTE and undergoing chemotherapy.10 The primary efficacy endpoint was the rate of recurrent DVT, nonfatal PE, or fatal PE. Safety endpoints assessed major bleeding events.10 Rivaroxaban and apixaban were the only DOACs assessed in the study due to being FDA approved at the start of the study period.10 A total of 106 patients were included in the review, with 29 receiving apixaban, 37 receiving rivaroxaban, and 40 receiving enoxaparin.10 No differences occurred in the rate of recurrent VTE for enoxaparin, apixaban, or rivaroxaban, respectively (7.5%, 6.8%, and 2.7%, all p=non-significant (p=0.06 for rivaroxaban vs. LMWH, p=0.16 for rivaroxaban vs. apixaban, p=1.00 for apixaban vs. LMWH)). Major bleed at 6 months was less with LMWH and apixaban compared to rivaroxaban (5% vs. 6.8%, 21.6%,

all p=0.048; vs. LMWH pairwise p=0.042).10 The ASCO guidelines recommended using DOACs with caution in those with GI malignancies.5 The 2019 retrospective chart review was published after the ASCO guidelines, but findings showed an increased risk of bleeding with rivaroxaban compared to apixaban and enoxaparin.10 Therefore, based on guideline recommendations and primary literature data, rivaroxaban should be avoided for GI malignancies, but enoxaparin and apixaban can be considered as anticoagulation options.5.10 Conclusion VTE is the second leading cause of death in patients with cancer, only behind disease progression; therefore, it is imperative to treat VTE to prevent recurrence as well as minimize major bleeding events. DOACs have shown to be effective in reducing VTE recurrence but come at a higher risk of major bleeding events compared to LMWH therapy, especially in GI cancer. Data shows that certain DOACS may be better than others in helping balance the risk of bleeding versus VTE recurrence. A summary of the findings from these trials can be found in Table 2. Tailoring the choice of DOAC or LMWH should be based on specific patient characteristics such as type of cancer, renal or hepatic dysfunction, and patient preference. Authors: Dr. Amy Ogilvie, PharmD is a PGY1 Pharmacy Residency, Acute Care at Harnett Page 17

Health System alogilvie0521@campbell.edu; Ms. Megan Parrish is a PharmD Candidate 2022 at Campbell University College of Pharmacy & Health Sciences; Dr. Kim Kelly, PharmD, BCPS is a Clinical Assistant Professor and Residency Program Director at Campbell University College of Pharmacy & Health Sciences and Harnett Health. References:

1. Khorana AA, Francis CW, Culakova E, Kuderer NM, and Lyman GH. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost. 2007;5:632-634. 2. Sorensen H, Mellemkjaer L, Olsen J, and Baron J. Prognosis of cancers associated with venous thromboembolism. N Engl J Med. 2000;343:1846-1850. 3. Prandoni P, Lensing A, Piccioli A, et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002;100(10):3484-3488. 4. Streiff M, Holmstrom B, Angelini D, et al. Cancer-Associated Venous Thromboembolic Disease. J Natl Compr Canc Netw. 2018;16(11):1289-1303. 5. Key NS, Khorana AA, Kuderer NM, et al. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2019;37:1-27. 6. Lee A, Levine M, Baker R, et al. Low-Molecular-Weight Heparin versus a Coumarin for the


Table 1: NCCN vs. ASCO Guidelines NCCN Guideline4

First Line

Second Line

Alternatives

ASCO Guideline5

Dalteparin LMWH + Edoxaban

LMWH Rivaroxaban Edoxaban

UFH Warfarin

Warfarin

Enoxaparin Fondaparinux Rivaroxaban Apixaban

Fondaparinux UFH

Key: LMWH = low molecular weight heparin; UFH = unfractionated heparin

Table 2: Summary of clinical trials Trial (Year)

Drugs evaluated

CLOT6 (2003)

Warfarin vs. Dalteparin

EINSTEIN-DVT & EINSTEIN-PE Subgroup Analysis11 (2014)

Rivaroxaban vs. enoxaparin + warfarin

ABILIFY Subgroup Analysis12 (2015)

Apixaban vs. enoxaparin + warfarin

HOKUSAI – CANCER7 (2018)

Edoxaban vs. Dalteparin

SELECT-D8 (2018)

Rivaroxaban vs. Dalteparin

ADAM9 (2019)

Apixaban vs. Dalteparin

VTE Recurrence Dalteparin significantly reduced VTE recurrence compared to warfarin (8.0% vs. 15.8%, 95% CI 0.30-0.77, p=0.002).

Rivaroxaban has similar rates of VTE recurrence compared to LMWH + warfarin (5.0% vs. 7.0%, 95% CI 0.350.99, p=0.24).

Bleeding Rate There were similar rates of bleeding between warfarin and LMWH (6.0 vs. 4.0%, p=0.27).

Rivaroxaban had lower rates of major bleeding compared to LMWH + warfarin (2.0% vs. 5.0%, 95% CI 0.18-0.99, p=0.047).

VTE recurrence was lower with apixaban compared to LMWH + warfarin (3.7% vs. 6.4%, RR 0.56, 95% CI 0.132.37).

Bleeding rates were similar between apixaban and LMWH/VKA (2.3% vs. 5.0%, RR 0.45, 95% CI 0.08-2.46).

Rivaroxaban decreased the risk of recurrent VTE compared to dalteparin (4.0% vs. 11.0%, HR 0.43, 95% CI 0.19-0.99).

Rivaroxaban is associated with increased risk of major bleeding compared to dalteparin (6.0% vs. 4.0%, HR 1.83, 95% CI 0.68-4.96).

Edoxaban significantly reduced the risk of VTE compared to dalteparin (12.8% vs. 13.5%, 95% CI 0.70-1.36, p=0.006).

VTE recurrence was reduced with apixaban compared to dalteparin (0.7% vs. 6.3%, 95% CI 0.013-0.78, p=0.0281). Page 18

Edoxaban had an increased risk of major bleeding compared to dalteparin (6.9% vs. 4.0%, 95% CI 1.03-3.10, p=0.04).

Apixaban is associated with similar rates of bleeding compared to dalteparin (0% vs. 1.4%, p=0.138).



Pharmacy Checks and Balances to Preserve Business Value and Quality of Life By Bonnie Bond Katie Musorofiti

The common image of a community or independent pharmacist is someone in a white lab coat, filling pill bottles and discussing dosage and drug interactions with patients at the counter. Behind the counter is another story. Pharmacists are health advocates, but they are also community members who are trying to build a business and life balance.

Too often, pharmacists are limited in their roles by the numbers — not by the number of patients or scripts filled, but by the numbers on their profit and loss (P&L) statement. Focused on purchasing inventory, paying bills and processing payroll each month, they end up taking on too much administration. This leaves pharmacists with little time to assess how they stand financially. Without current and accurate accounting, they are unable to make growth-minded business decisions. The burden of daily and weekly administration should not fall on the pharmacist alone. While there are few studies on

the health of pharmacists, some reports indicate that they face the same pressures and risks of burnout as physicians; complex industry requirements are only complicating matters further.1

Pharmacists do not go to school to be accountants. Therefore, the following pharmacy business checks and balances can move independent pharmacists from the back office to the front counter and into the community. At the same time, these checks and balances can empower the pharmacy team to be more engaged in the business and learn skills that add to long-term business value and personal satisfaction. The variety of areas outlined here are not a solution on their own, but they work in tandem to free up the pharmacist’s time and improve team involvement. Once they are in place, independent pharmacists can build a more sophisticated back office accounting process that provides accurate financials for business-growth decisions. Page 20

Daily Sales and Script Reports Point of sale reports and script audit logs can tell a lot about a pharmacy’s business, tracking everything the pharmacy sells in a given day and how it was sold — and the sales tax that was collected. The point of sale report should reconcile with the daily bank deposit. Any small discrepancies can snowball through the month and lead to unnecessary and time-consuming, month-end adjustments. Train in a tech or clerk to pull the point of sale report and script audit log every day. Have point of sale data reconciled daily against the daily bank deposit. Outsource this daily reporting to a CPA that works regularly with independent pharmacies. In this way, the pharmacist creates a simple administrative process that supports accurate accounting, sales tax returns and also accurate financial statements for making business decisions. Weekly Third-Party Adjudication

A pharmacy should be in contact with its third-party adjudication service every week. Regular monitoring is critical to support accurate and timely claims processing and receivables. Without this attention, a pharmacy can miss windows for reimbursement as well as inaccuracies that can lead to lost revenue. A healthy receivables report should show 95 percent of receivables aged in the 0 to 60 days column. That remaining 5


percent in the 61-90 days column should be pursued with the help of the pharmacy’s assigned adjudication or reconciliation analyst. The analyst can investigate things like rejected claims, late processing, inaccurate pricing and inaccurate receivables.

Weekly administration of receivables can be delegated to a trained tech or clerk who opens the mail, enters any paper payments, contacts the analyst and reviews receivables reports. That way the pharmacist can oversee an accurate receivables report and address more complex claims reimbursement discrepancies related to pricing or inventory management on the pharmacy side. Outsourced Payroll

One of the biggest time savers for pharmacies is to outsource their payroll to a corporate payroll service. Not only can the payroll service process payroll, it can also apply, adjust and track withholdings for tax and other reporting purposes. Employees can access their pay stubs and have automatic deposit services to their personal bank accounts.

This might seem like a common sense decision in the age of technology, however, there are still community and independent pharmacists processing payroll on their own, taking precious evening or weekend time to make sure that employees are paid. This is not only taking them away from family or time to focus on growing the business, it can also lead to inaccuracies for withholdings and tax compliance.

Investigate an outsourced payroll service by consulting with fellow pharmacists or your CPA. Moving to an electronic system will alleviate issues with missing documents, inaccurate timekeeping or processing deadlines — saving the pharmacy time and money in the long run. These services can also typically sync with the pharmacy’s accounting systems for more accurate financial and tax reporting. Online Bill Paying

Moving accounts payable to an online interface is another way to free up the pharmacist’s time from the back office. The pharmacist will still have final approval of all outgoing payments, but a trusted employee can handle the administration of setting up payments in the system for e-payments. By choosing a service that requires electronic owner approvals, the pharmacist can log into the system when the bills are ready to be paid, review the list of payments, approve or reject, and move on with the day. Value of Proactive Pharmacy Operations

The value of delegating administrative tasks to the pharmacy team is three-fold. First, the pharmacist can free up time to focus on patient care, top line growth and more attention to education, friends and family. Secondly, business decisions will be guided by accurate accounting and financial statements. Whether or not the pharmacy has a bookkeeper, Page 21

the checks and balances outlined here are the first steps toward a more sophisticated accounting process tied to oversight by a knowledgeable CPA. And lastly, employees will be more engaged, as they have a role in the sustainability and growth of the community pharmacy. Again, these pharmacy business checks and balances aren’t the total solution, but they are a great place to start for financial accuracy, team engagement and more confidence in the future — a future for the community pharmacy and the pharmacist’s long-term health. Authors: Bonnie Bond, B.S. Accounting, MBA, CPA; Bonnie@ sykes-cpa.com and Katie Musorofiti, B.S. Accounting, MSIA, CPA; Katie@sykes-cpa.com. Sykes & Company, P.A., Edenton, NC; 252.482.7644 References

Barker, Alex. Pharmacists and burnout: the first step is to acknowledge the data about providers. Pharmacy Times. 2018 Dec 05. https://www.pharmacytimes.com/contributor/ alex-barker-pharmd/2018/12/ pharmacists-and-burnout-thefirst-step-is-to-acknowledge-thedata-about-providers 1



SICKLE CELL DISEASE: A PHARMACOTHERAPY REVIEW

By Lister Hokanson Kim Kelly Introduction Sickle cell disease (SCD) is a group of inherited blood disorders where a gene mutation results in production of an abnormal hemoglobin (HbS) rather than normal hemoglobin A. This leads to the formation of hard, sticky, C-shaped or “sickled” red blood cells which are short-lived and inflexible, thereby occluding blood vessels and inducing tissue ischemia, pain, and organ damage. Complications of sickle cell are extensive and include vaso-occlusive pain, anemia, acute chest syndrome (ACS), venous thromboembolism, stroke, myocardial infarction, priapism and multi-organ damage.1

In the United States, approximately 100,000 people have SCD, and it is most prevalent in African Americans where 1 in every 350 children is born with the disease.2 The only cure for SCD is bone marrow or stem cell transplant, a high risk procedure that is reserved for use in cases of severe SCD for children who have minimal organ damage from the disease.1 Folic acid supplementation in SCD is hypothesized to reduce anemia symptoms resulting from depletion of folate stores by hemolysis stimulated

dosage form, adverse effects and cost are summarized in Table 1. The objective of this review is to discuss the evidence supporting use of these four approved agents and their role in therapy. Hydroxyurea

Hydroxyurea, an antimetabolite, was FDA-approved for in SCD in March 1999. It is indicated to reduce the frequency of painful crises and to reduce the need erythropoiesis, but this practice for blood transfusions in pais controversial with some studtients with recurrent moderate ies showing no benefit.3,4 There to severe painful crises. While are four medications currently the precise mechanism by which FDA-approved for the treatment hydroxyurea produces cytotoxof SCD: hydroxyurea, l-glutamine, ic and cytoreductive effects is crizanlizumab and voxelotor. The unknown, it is hypothesized to most recent treatment guidelines, act as a ribonucleotide reductase published in 2014 by the Nation- inhibitor which inhibits DNA synal Heart, Lung and Blood Instithesis. The most powerful effect tute (NHLBI), recommends hyof hydroxyurea in SCD is increasdroxyurea as it was the only drug ing fetal hemoglobin (HbF) levels therapy for SCD at that time.1 which inhibits sickling by inhibImportant considerations when iting HbS polymerization, thereevaluating these four approved fore preventing vaso-occlusion. agents such as the patient’s age, Page 23


Other beneficial pharmacologic effects in SCD include decreasing neutrophils, increasing the water content of RBCs, increasing deformability of sickled cells, and altering the adhesion of RBCs to the endothelium.5, 6

Hydroxyurea is available in a generic formulation (500 mg) as well as branded formulations for SCD (Droxia® 200 mg, 300 mg, 400 mg and Siklos® 100 mg and 1000 mg).4,5 The NHLBI guideline recommends an initial dose of 15 mg/kg/day as a single oral daily dose, titrated by 5mg/kg/day increments every eight weeks until mild myelosuppression (absolute neutrophil count 2000-4000 / mcL) is achieved, up to a maximum dose of 35 mg/kg/day.1 The Siklos® formulation, however, has an initial dose of 20mg/kg/day as a single daily dose.6 There are no dose adjustments in the presence of hepatic impairment, but the dose should be reduced by 50% when the CrCl <60 ml/min. Hydroxyurea carries a boxed warning for bone marrow suppression and secondary malignancy. Treatment should be interrupted for hematologic toxicity (neutrophils <2,000/mm3, platelets <80,000/ mm3, hemoglobin <4.5 g/dL, or reticulocytes <80,000/mm3 with hemoglobin <9 g/dL) and resumed at a reduced dose (5 mg/ kg/day lower for Siklos® or 2.5 mg/kg/day lower for Droxia®) upon hematologic recovery. 5,6 Treatment should be permanently discontinued if hematologic toxicity occurs twice. 5,6 Common adverse effects occurring in >10% of patients include macrocytosis (42%), infection (40%), neutropenia (13%) and eczema (13%).5,6

The NHLBI guidelines recommend hydroxyurea initiation in adults with ≥3 sickle cell associated moderate to severe pain crises, adults with sickle cell-associated pain that interferes with activities of daily living and quality of life, adults with history of severe and/or recurrent ACS and adults with severe symptomatic chronic anemia that interferes with daily activities or quality of life. 1 These guidelines also suggest considering hydroxyurea for anyone aged 9 months and older regardless of clinical severity to reduce SCD-related complications.1

The Multicenter Study of Hydroxyurea in Patients with Sickle Cell Anemia (MSH) facilitated the approval of hydroxyurea in SCD. This was a randomized, double-blind, placebo-controlled, phase 3 clinical trial involving 299 adults ≥18 years who had experienced three or more vaso-occlusive crises (VOCs) in the previous year.7 Patients were randomized 1:1 to hydroxyurea (initial dose of 15 mg/kg/day, increased by 5 mg/kg/day every 12 weeks) or placebo with close hematological monitoring. All patients also received 1 mg daily of folic acid. The primary efficacy endpoint was the occurrence of VOCs. Secondary efficacy endpoints were time to first and second crises, incidence of ACS, number of patients requiring blood transfusions and hematological values (hemoglobin levels, mean corpuscular volumes (MCVs), HbF levels, proportions of F cells, white blood cell, platelet, reticulocyte and dense cell counts).7 Page 24

The results showed that the annual rate of VOCs was lower with hydroxyurea compared to placebo (median [IQR], 2.5 [0.6 to 7] vs 4.5 [2 to 10.2]; p<0.001). Compared to placebo, hydroxyurea also had lower annual rate of crises requiring hospitalization (median [IQR], 1 [0 to 3.5] vs 2.4 [0.6 to 5]; p<0.001), longer time to a first crisis (median, months, 3.0 vs 1.5, p=0.01), longer time to a second crisis (median, months, 8.8 vs. 4.6; p<0.001), lower incidence of ACS (25 patients vs 51 patients; p<0.001) and reduced need for blood transfusions (48 patients vs 73 patients; p=0.001). The trial was planned for a 2-year follow-up period but was stopped 4 months early due to substantially reduced VOCs in the hydroxyurea group.7

Since the MSH study, longer follow-up analysis of MSH participants has demonstrated continued safety and benefit of hydroxyurea, including mortality benefit.8,9 A 9-year follow up analysis of MSH participants found that taking hydroxyurea was associated with a 40% reduction in mortality (p=0.04).8 A 17.5year follow up analysis showed decreased mortality rates with increasing years of hydroxyurea exposure (0% in patients with ≥15 years of hydroxyurea exposure and 22.5% with 10-15 years exposure), while higher mortality rates were seen less than 10 years of exposure (36.4% in those never exposed, 55.7% in <5 years exposure and 47.3% with 5-10 years exposure).9 These studies all support the role of hydroxyurea as the first-line option


for SCD treatment given morbidity (reduction of VOCs, ACS and anemia) and long-term mortality benefit. However, close hematological monitoring is required due to associated bone marrow suppression. L-glutamine

L-glutamine is an amino acid approved by the FDA in June 2017 to reduce the acute complications of SCD in adult and pediatric patient’s ≥ 5 years of age. While its precise mechanism of action for SCD is not fully known, l-glutamine is hypothesized to increase the availability of reduced glutathione, thereby reducing oxidative stress phenomena in sickled red blood cells which contribute to chronic hemolysis and VOCs associated with SCD. For the indication of SCD, l-glutamine is available in the branded formulation (EndariTM) as 5 g packets to be mixed with a beverage or food. There are no renal or hepatic dose adjustments provided in the manufacturer labelling. The most common adverse reactions occurring in >10% of patients include gastrointestinal effects (flatulence, constipation, nausea, abdominal pain, 17-22%), chest pain (12%), headache (18%), limb pain (13%), back pain (12%), and cough (16%).10 L-glutamine was FDA-approved following data from a multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial of 230 patients. Patient’s ≥5 years, with ≥2 painful crisis within 12 months of enrolment, were randomized 2:1 to receive either l-glutamine (0.3 g/kg) or placebo for 48 weeks.11 Patients

on a stable hydroxyurea regimen 3 months prior to screening were allowed to continue hydroxyurea therapy. The primary efficacy end point was the number of pain crises through week 48. Secondary efficacy end points included the number of hospitalizations for sickle cell–related pain, the number of emergency department (ED) or outpatient treatment center visits for sickle cell–related pain, and changes in hematologic measures (hemoglobin and hematocrit levels and reticulocyte count) from baseline through week 48.11

Approximately 66% of patients in each group received concomitant hydroxyurea therapy. The primary endpoint of pain crises over 48 weeks was less in the l-glutamine group compared to placebo (median [range], 3 [0 to 15] vs 4 [0 to 15]; p=0.05). In addition, compared to placebo, the l-glutamine group also had fewer hospitalizations (median [range], 2 [0 to 14] vs 3 [0 to 13]; p=0.05), fewer days of hospitalizations (median [range], 6.5 [0 to 94] vs 11 [0 to 187] ; p=0.02), more days to first pain crisis (median [95% CI], 84 [62 to 109] vs 54 [31 to 73]; p=0.02), more days to first second crisis (median [95% CI], 212 [153 to 250] vs 133 [115 to 179]; p=0.03), lower incidence of ACS (8.6% vs 23.1%; p=0.003) and more patients without an episode of ACS (91.4% vs 76.9%; p=0.003). There were a similar number of ED visits without hospitalization (median [range], 1 [0 to 12] vs 1 [0 to 15]; p=0.09) and similar changes in hemoglobin, hematocrit and reticulocyte values although specific values were not reported. A subgroup analyPage 25

sis according to hydroxyurea use showed similar treatment effect between patients who also used hydroxyurea (rate ratio 0.77; 95% CI 0.58 to 1.03) and those who did not (rate ratio 0.78; 95% CI 0.51 to 1.2). Adverse events occurring more with l-glutamine than placebo, and with ≥5% incidence were nausea, arm or leg pain, and back pain. This trial showed that l-glutamine can be used as an alternative or adjunct to hydroxyurea to lower the incidence of VOC.11 Crizanlizumab

Crizanlizumab is a monoclonal antibody that was approved in November 2019 to reduce the frequency of VOCs in patient’s ≥ 16 years with SCD. It exerts its effect by binding to P-selectin on the surface of activated endothelium and platelets, blocking interactions between endothelial cells, platelets, red blood cells, and leukocytes. 12 This interaction blockade may result in decreased platelet aggregation and vaso-occlusion. It is available in the branded formulation (Adakveo®) as a 100 mg/mL intravenous (IV) solution. The recommended dosing is a 30 minute-IV infusion of 5 mg/kg every 2 weeks for 2 doses, followed by 5 mg/kg every 4 weeks thereafter. There are no renal or hepatic adjustments provided in the manufacturer’s labeling. Common adverse effects occurring in >10% of patients who received crizanlizumab include nausea (18%), arthralgia (18%), back pain (15%) and fever (11%).12 Crizanlizumab was FDA-approved following data from


the SUSTAIN trial, a 52-week, randomized, multicenter, placebo-controlled, double-blind study. One hundred ninety-eight patients aged ≥ 16 years with a history of 2 to10 VOCs in the previous 12 months were randomized 1:1:1 to crizanlizumab 5 mg/kg, crizanlizumab 2.5 mg/ kg, or placebo administered as a 30-minute infusion, every 2 weeks for 2 doses and every 4 weeks thereafter.13 The primary efficacy end point was the annual rate of sickle cell–related pain crises. Secondary efficacy endpoints included the annual rate of days hospitalized, times to first and second crises, annual rate of uncomplicated crises (defined as crises other than ACS, hepatic sequestration, splenic sequestration, or priapism), annual rate of the ACS, and Brief Pain Inventory questionnaire results.13

Approximately 62% of patients were on concomitant hydroxyurea therapy. The primary endpoint of annual rate of VOCs was 45.3% lower with high dose crizanlizumab compared to placebo (median rate [range], 1.63 [0 to 3.97] vs 2.98 [1.25 to 5.87]; p=0.01) and 32.6% lower with low dose crizanlizumab (median rate, 2.01 [1 to 3.98] vs 2.98 [1.25 to 5.87]; p=0.18). Compared to placebo, high dose crizanlizumab had lower annual rate of days hospitalized (median, days [IQR], 4 [0 to 25.72] vs 6.87 [0 to 28.3]; p=0.45), longer time to first VOC (median, months [IQR], 4.07 [1.31 to non-reportable value as the 75% value was not observed] vs 1.38 [0.39 to 4.9]; hazard ratio [95% CI], 0.50 [0.33 to 0.74]; p=0.001), longer time to second VOC (median, months

[IQR], 10.32 [4.47 to non-reportable value as the 75% value was not observed] vs 5.09 [2.96 to 11]; hazard ratio [95%CI], 0.53 [0.33 to 0.87]; p=0.02) and lower annual rate of uncomplicated VOCs (median [IQR], 1.08 [0 to 3.96] vs 2.91 [1 to 5]; p=0.02). On the other hand, compared to placebo, low dose crizanlizumab had a similar annual rate of days hospitalized (median, days [IQR], 6.87 [0 to 18] vs 6.87 [0-28.3]; p=0.84), similar time to first VOC (median, months [IQR], 2.2 [0.95 to 6.6] vs 1.38 [0.39 to 4.9]; hazard ratio [95% CI], 0.75 [0.52 to 1.1]; p=0.14), similar time to second VOC (median, months [IQR], 9.2 [3.94 to 12.16] vs 5.09 [2.96 to 11]; hazard ratio [95%CI] 0.69 [0.44 to 1.09]; p=0.1) and similar annual rate of uncomplicated VOCs (median [IQR], 2 [0 to 3.02] vs 2.91 [1 to 5]; p=0.12).

No patient in either of the three groups developed ACS. A subgroup analysis according to concomitant hydroxyurea use revealed that compared to placebo, patients receiving high-dose crizanlizumab with concomitant hydroxyurea had a 32.1% lower annual crisis rate (median 2.43 vs 3.58) while those receiving high-dose crizanlizumab without concomitant hydroxyurea had a 50% lower annual crisis rate (median 1 vs 2). Common adverse effects occurring in ≥ 10% of patients receiving crizanlizumab were arthralgia, diarrhea, pruritus, vomiting and chest pain.13 This trial showed that crizanlizumab is effective in reducing VOCs, as an alternative or adjunct to hydroxyurea. Studies assessing other effects on priapism, kidney function, pediatrics ≥ 6 months Page 26

old and comparing the 5mg/kg dose with 7.5 mg/kg dose are currently ongoing.14 Voxelotor

Voxelotor is an HbS polymerization inhibitor that was approved in November 2019 for SCD treatment in patient’s ≥12 years of age. It exerts its effect through dose-dependent inhibition of HbS polymerization by increasing the affinity of Hb for oxygen, thereby inhibiting RBC sickling, improving RBC deformability and reducing whole blood viscosity. 15 It is available in the branded formulation (OxbrytaTM) as 500mg tablets and the recommended dosing is 1500 mg taken orally one-time daily with or without hydroxyurea. The dose is not renally adjusted, but it should be reduced to 1 g one time in severe hepatic impairment (Child Pugh Class C). 15 The most common adverse reactions occurring in ≥ 10% of patients receiving voxelotor include headache (26%), diarrhea (20%), abdominal pain (19%), nausea (17%), skin rash (14%), fatigue (14%) and fever (12%).15 The HOPE trial, a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of 274 patients facilitated voxelotor’s FDA approval. In this study, patients aged ≥12 years, with 1 to10 VOCs 12 months prior to enrollment, were randomized 1:1:1 to either voxelotor 1500 mg (n=90), voxelotor 900 mg (n=92) or placebo (n=90). Patients receiving stable doses of hydroxyurea for at least 90 days were allowed to continue it throughout the study. The prima-


ry end point was the percentage of participants who had a hemoglobin response, defined as an increase from baseline of more than 1.0 g/dL at week 24. Secondary end points included the change in hemoglobin level from baseline to week 24, laboratory markers associated with hemolysis (indirect bilirubin level, absolute reticulocyte count and percentage of reticulocytes, and lactate dehydrogenase level), and the annualized incidence rate of VOCs.16

Approximately 65% of patients received concomitant hydroxyurea therapy. Compared to placebo, more patients in the 1500 mg voxelotor group achieved the primary outcome of hemoglobin response at week 24 (percentage [95%CI], 51% [41 to 61] vs 7% [1 to 12], p<0.001). On the other hand, compared to placebo, the 900mg voxelotor group had 33% (95% CI 23 to 42) of patients with hemoglobin response at week 24. Compared to the placebo group, the 1500 mg voxelotor group and 900 mg voxelotor groups had less acute anemic episodes (annualized incidence rates 0.06 vs 0.04 vs 0.18 episodes per person-year, respectively), greater mean change in hemoglobin level from baseline to week 24 (1.1 g/dL vs 0.6 g/dL vs -0.1 g/dL, respectively), greater decrease in indirect bilirubin level from baseline to week 24 (mean change, −29.1% vs -20.3 vs −3.2%, p<0.001), and greater relative change in the percentage of reticulocytes (mean change −19.9% vs -1.3% vs 4.5%; p<0.001). Similar responses were observed in the per-protocol analysis, and regardless of

concurrent hydroxyurea use or anemia severity at baseline.16

More patients randomized to voxelotor received blood transfusions, which was controlled by recording lab values prior to transfusion (33% with 1500 mg voxelotor, 32% with 900 mg voxelotor and 25% with placebo). The incidence of VOCs was similar between the three groups (67% with 1500mg voxelotor, 66% with 900 mg voxelotor and 69% with placebo); however, there was a trend of reduced VOC incidence over time with voxelotor compared to placebo with less total number of VOCs occurring with voxelotor 1500 mg and 900 mg compared to placebo (179 vs 183 vs 219, respectively). The most common adverse events associated with voxelotor, with an incidence of at least 20%, were headache and diarrhea.16 In conclusion, this study showed a benefit of reducing anemia, demonstrating its role as an alternative or adjunct to hydroxyurea therapy; however, data on other clinical outcomes such as mortality are lacking. A long-term follow-up study of participants who received at least 72 weeks of voxelotor is currently ongoing as well studies on pediatric patients ≥ 2 years old.17 Conclusion

Hydroxyurea remains the mainstay of SCD treatment given clinical trial data showing morbidity and mortality benefit. Its low cost, data for use in patients as young as 2 years and guideline suggestions for use in patients 9 months and older make it an attractive first line agent. However, Page 27

hydroxyurea use may be limited by its bone marrow suppression. Newer agents such as l-glutamine, voxelotor, and crizanlizumab currently lack long-term safety and efficacy data as well as data for use in patients less than 5, 16 and 12 years, respectively. Nevertheless, they are a welcome addition to the SCD pharmacotherapy armamentarium by targeting unique pathways in the pathophysiology of SCD and by providing additional options as an alternative or adjunct to hydroxyurea therapy. Authors: Dr. Lister Hokanson, PharmD is a PGY1 Pharmacy Resident in Acute Care at Campbell University College of Pharmacy & Health Sciences (CPHS) and Harnett Health System; lmhokanson0512@email.campbell.edu. Mr. Franklin Etarock is a P4 pharmacy student at CPHS. Dr. Kim Kelly is a Clinical Assistant Professor of Pharmacy Practice and PGY1 Residency Director at CPHS and Harnett Health System. References

1. National Institute of Health, National Heart Lung and Blood Institute, Division of Blood Diseases and Resources. Evidence-based management of sickle cell disease. NHLBI 2014. Available at: https://www.nhlbi. nih.gov/sites/default/files/media/docs/sickle-cell-disease-report%20020816_0.pdf. Accessed 3/7/2020. 2. Centers for Disease Control and Prevention. Data & Statistics on Sickle Cell Disease. Available at: https://www.cdc.gov/ ncbddd/sicklecell/data.html.


Accessed 2/4/2020. 3. Rodriguez-cortes HM, Griener JC, Hyland K, et al. Plasma homocysteine levels and folate status in children with sickle cell anemia. J Pediatr Hematol Oncol 1999;21(3):219-23. 4. Van der dijs FP, Schnog JJ, Brouwer DA, et al. Elevated homocysteine levels indicate suboptimal folate status in pediatric sickle cell patients. Am J Hematol 1998; 59(3):192-8. 5. Droxia (hydroxyurea) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; December 2019. 6. Siklos (hydroxyurea) [prescribing information]. Rosemont, PA: Medunik USA Inc; May 2019. 7. Charache S, Terrin ML, Moore RD, et al. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. N Engl J Med 1995; 332 (20):1317-22. 8. Steinberg MH, Barton F, Castro O, Pegelow CH, Ballas SK, Kutlar

A, et al. Effect of hydroxyurea on mortality and morbidity in adult sickle cell anemia: risks and benefits up to 9 years of treatment. JAMA 2003; 289(13):1645-51. 9. Steinberg MH, McCarthy WF, Castro O, Ballas SK, Armstrong FD, Smith W, et al. The risks and benefits of long-term use of hydroxyurea in sickle cell anemia: A 17.5-year follow-up. Am J Hematol 2010; 85(6):403-8. 10. Endari (glutamine) [prescribing information]. Torrance, CA: Emmaus Medical, Inc; October 2019. 11. Niihara Y, Miller ST, Kanter J, et al. A Phase 3 Trial of l-Glutamine in Sickle Cell Disease. N Engl J Med 2018; 379(3):226235. 12. Adakveo (crizanlizumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2019. 13. Ataga KI, Kutlar A, Kanter J, et al. Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease. N Engl J Med 2017; 376

Page 28

(5):429-439. 14. Crizanlizumab│Sickle cell disease. Clinicaltrials.gov Available at: https://clinicaltrials. gov/ct2/results?cond=sickle+cell+disease&term=crizanlizumab&cntry=&state=&city=&dist=. Accessed 2/7/2020. 15. Oxbryta (voxelotor) [prescribing information]. South San Francisco, CA: Global Blood Therapeutics Inc; November 2019. 16. Vichinsky E, Hoppe CC, Ataga KI, et al; HOPE Trial Investigators. A phase 3 randomized trial of voxelotor in sickle cell disease. N Engl Med 2019; 381 (6):509519. 17. Voxelotor│Sickle cell disease. Clinicaltrials.gov. Available at: https://clinicaltrials.gov/ct2/ results?cond=Sickle+Cell+Disease&term=voxelotor&cntry=&state=&city=&dist= Accessed on 2/4/2020. 18. GoodRx.com; Pricing information. Accessed 2/4/2020. 19. Drugs.com. Pricing information. Accessed 2/4/2020.


Table 1: Summary of drugs approved for use in SCD

Drug

Hydroxyurea5,6

L-glutamine10

Classification

Anti-metabolite; ribonucleotide reductase inhibitor

Amino-acid

Monoclonal antibody; P-selectin inhibitor

HbS polymerization inhibitor

Mechanism of action

Decreases sickling, increases deformability and alters adhesion of RBCs

Reduces RBC oxidative stress phenomena

Decreases platelet aggregation and vaso-occlusion

Inhibits sickling, improves RBC deformity and improves blood viscosity

Approved age for Use

≥ 2 years

≥ 5 years

≥ 16 years

≥ 12 years

Dosing

Oral: 15mg/kg/day initially increased by 5mg/kg/day; Max dose is 35mg/ kg/day

Oral: <30 kg: 5 g twice daily 30-65kg: 10 g twice daily >65kg: 15 g twice daily

IV: 5mg/kg every 2 weeks for 2 doses, followed by 5mg/ kg every 4 weeks thereafter

Oral: 1500mg once daily

Common adverse effects

Eczema, macrocytosis, neutropenia, infection

Chest pain, headache, flatulence, constipation, nausea, abdominal pain, limb pain, back pain, cough

Nausea, arthralgia, back pain, fever

Headache, diarrhea, abdominal pain, nausea, skin rash, fatigue, fever

Boxed warning

Bone marrow suppression and secondary malignancy

None

None

None

Average retail cost per month for a 70kg patient18, 19

$60 per month

$3600 per month

2400 per month

$10,300 per month

Page 29

Crizanlizumab12

Voxelotor15


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2020 Chronic Care and Health-Systems Conference Awards

Health-Systems Pharmacist of the Year Nita Johnston

Chronic Care Pharmacist of the Year Heather Eaton-Erskine

Dale Jones Memorial Award Holly Nunn

Page 31


P recep tors of the Y ear The faculty, staff, and students of the Campbell University College of Pharmacy wish to recognize Dr. Julie Langley and Dr. Christian Shaw as the 2019 Preceptor’s of the Year for their outstanding contribution to the educational development of our student pharmacists. This award is given to select preceptors who demonstrate high standards of professionalism, ethics and clinical practice as recognized by the students and the Office of Experiential Education. She said, “Every student I have precepted over the past 15 years has enriched my career. I always look forward to the student and what they will teach me.” When she is not working, she likes to travel, spend time with family, attend Broadway shows, and spoil her two cats, Mia and Simon. Dr. Julie Langley graduated from UNC School of Pharmacy in 2004. In 2005, she completed a Community Pharmacy Practice Residency with Kerr Drug and Campbell University in Benson, NC. She took a job as a Clinical Coordinator/Pharmacist with Kerr Drug in Raleigh where she began to precept students from Campbell and UNC. When her career path took another turn to Harris Teeter, where she is currently a Pharmacy Manager, she was able to continue precepting students. When asked what she enjoys about teaching and precepting she said, “I enjoy watching as students have the ‘Aha! Moment’ and grasp a new concept. I also enjoy giving the students life advice on being a pharmacist right out of school (from a residency to working full time in a community setting).”

overseeing all clinical initiatives at the facility, performing stewardship activities including active consultation with the ID physician daily. He also has responsibility for building and implementing medication-related order sets for the hospital’s EHR. Through collaborations with the Duke Center for Antimicrobial Stewardship and Infection Prevention, Dr. Shaw has been actively involved in numerous multi-center studies funded by the CDC and other agencies. This includes the recently completed Feasibility Assessment of Stewardship Interventions in Community Hospitals. Christian also serves as a preceptor for High Point University, University of North Carolina Chapel Hill, and Husson University schools of pharmacy. Dr. Christian M Shaw, BCPS is the He enjoys sharing his passion for Clinical Coordinator for the Dethe important role of the hospital partment of Pharmacy at Wilson pharmacist with future members Medical Center. He graduated of the profession. with a BS in Pharmacy from Massachusetts College of Pharmacy On behalf of the students, facand a PharmD from University of ulty, and staff Campbell College Florida. Dr. Shaw completed his of Pharmacy wants to thank pharmacy residency training at Drs. Langley and Shaw for their the University of Rochester Medsupport of our program and for ical Center where he remained serving as outstanding role modon staff until relocating to NC in els, teachers, and mentors to our 2005. His daily activities include students! Page 32


P recep tor of the Y ear The Experiential Education Department of the Fred Wilson School of Pharmacy at High Point University has the pleasure of recognizing Dr. Ahunna Freeman as our Preceptor of the Year for 2019. Each year this award is presented to a pharmacist preceptor who is nominated by our students for excellence in providing instruction, inspiration and mentorship.

Dr. Freeman is the Director of Clinical Services at Southside Discount Pharmacy, a local independent community pharmacy in Winston-Salem, North Carolina. Dr. Freeman believes that the community pharmacy should not only serve as a medication dispensary, but as a healthcare “hub� for community residents; a place where patients can fully gain knowledge about medication-related issues, properly manage their disease states with the assistance from an expert in the community, and as a place to understand the importance of preventive care. Dr. Freeman opened Southside Discount Pharmacy in 2014 to fully serve her community through the pharmacy profession by education and empowerment.

Dr. Freeman completed her undergraduate studies in Chemistry at The University of North Carolina at Asheville. She earned her Doctor of Pharmacy Degree at Campbell University College of Pharmacy and Health Sciences in 2009.

Under the leadership of Dr. Ahunna Freeman, Southside Discount Pharmacy achieved The Myrna Miller Employer Award from The North Carolina Diabetes Advisory Council, an American Diabetes Association (ADA) recognized Diabetes Self-Management Education/ Training Program, and a CDC recognized Diabetes Prevention Program. Driven by the passion for education and empowerment, Dr. Freeman serves as the clinical pharmaPage 33

cist at Ardmore Family Practice where, in collaboration with the providers, she helps patients with uncontrolled hypertension and hyperlipidemia meet clinical goals through medication therapy management and/or lifestyle modification. She plays an active role in her local community as a member of advisory boards, and as a guest speaker for numerous community health events. She is a contributing guest columnist at her local newspaper featuring educative articles on self-care, healthcare, and chronic illnesses. We are honored that Dr. Ahunna Freeman is the High Point University Fred Wilson School of Pharmacy 2019 Preceptor of the Year.


P receptors

of the

Y ear

Congratulations to three exceptional preceptors who received experiential awards from UNC Eshelman School of Pharmacy in 2019: Dr. Caitlin Akerman, Dr. Chad Auten, and Ms. Rebecca Chater. Residency and a PGY2 Cardiology Residency at WakeMed Health & Hospitals. She also completed a formal teaching certificate program through the UNC Eshelman School of Pharmacy.

Caitlin Ackerman, PharmD, BCPS 2019 Experiential Faculty Instructor of the Year Dr. Akerman received the Experiential Faculty Instructor of the Year Award. Students from all class years nominated outstanding experiential faculty members who demonstrate excellence in leadership, patient care, progressive pharmacy practice, scholarly activity, and teaching. Dr. Akerman serves as the Internal Medicine Clinical Pharmacist Specialist at WakeMed Health & Hospitals and an Assistant Professor of Clinical Education at the UNC Eshelman School of Pharmacy. She graduated from the UNC Eshelman School of Pharmacy and completed a PGY1 Pharmacy Practice

At her site students have the opportunity to round daily with multidisciplinary internal medicine teams. The service is structured to provide opportunities for students to round independently or layered with her and pharmacy residents. This allows students to take complete ownership of their assigned teams and learn in a layered model, gaining experience and mentorship from her, PGY1, and PGY2 residents. She also values evidenced-based medicine and enjoys spending time with her students in the afternoon teaching and applying core pharmacotherapy principles directly to their patients. Excerpts from student nominations include: “[Dr. Akerman] is the best preceptor I have had throughout all of my rotations. She works to develop learners’ weak points but does so in a sustainable way in which the learner can become independent. [She] was…invested in my learning Page 34

and truly wanted me to get out as much as I could out of this rotation… she did a great job setting expectations that were challenging but not unreasonable. [Dr. Akerman] goes above and beyond to take advantage of EVERY teaching opportunity despite how busy she is. Throughout the month we would have ‘Feedback Fridays’ which were a great time to discuss things that were going well or not going well and how to approach the next week. Overall she is an excellent role model, and I hope to be a great pharmacist just as she is.” The Claude Paoloni Preceptor of the Year awards were presented to Dr. Chad Auten and Ms. Rebecca Chater. The recipients of the Claude Paoloni Preceptor of the Year awards are nominated by students to recognize two preceptors for outstanding contributions to the educational development of future pharmacists. These individuals have demonstrated high standards of professionalism, ethics and clinical practice. Provided by the UNC Eshelman School of Pharmacy, these awards are given by the Paoloni family in memory of Claude Paoloni and in recognition of his many years of service


to the UNC Eshelman School of Pharmacy. Claude Paoloni was instrumental in the evolution of the clinical pharmacy program and the growth of development of the AHEC system for statewide pharmacy student education

Chad Auten, PharmD 2019 Claude Paoloni Preceptor of the Year Dr. Auten received his Doctor of Pharmacy from UNC Eshelman School of Pharmacy serves as a pharmacy manager with Harris Teeter Pharmacy. With regards to his teaching philosophy, his goal is to create an encouraging atmosphere that fosters excitement for learning and promotes curiosity. He believes in providing students with the autonomy they need explore their knowledge but push it further in its application to patient care. Examples of comments from nominating students include: “[Dr. Auten] may very well be the closest picture of perfection when it comes to a community pharmacy preceptor. [He] was willing to answer even my most off-the-wall questions about any part of phar-

macy and managerial operations throughout my rotation, remaining open and realistic in his answers and encouraging me to ask about whatever I felt I might need to know. [Dr. Auten] tasked me with quite a lot during my time at his pharmacy, but I felt this may have been the ultimate sign of respect to give me problems with varying levels of complication to solve, not doubting that I could do so. [He] was very clear with what he expected from me, and his intermittent quizzes and projects helped to refresh and cement so much pharmacy knowledge that I guarantee I wouldn’t have thought to look back over (or learn for the first time before going over it in classes!). [He] was honestly a great role model for me, and I hope that I can take such a can-do attitude and aptitude as his with me in my own pharmacy practice. By the end of my rotation, I felt that there was clear improvement in my abilities and confidence, as evidenced by [his] intermittent discussion of my development as a student Pharmacist and by his support of me in my learning efforts.”

Rebecca Chater, RPh, MPH, FAPhA 2019 Claude Paoloni Preceptor of the Year Rebecca Chater earned both her Page 35

B.S. in Pharmacy and Masters in Public Health from the University of North Carolina in Chapel Hill. She is the Director of Clinical Healthcare Strategy with Omnicell, a healthcare technology company providing innovation to support safe and adherent medication use throughout the healthcare continuum. Throughout her career, Chater has championed the pharmacist as a medication expert, integral to the healthcare team. Her career in pharmacy spans many settings–community practice, medical practice, academia, long term care, and specialty pharmacy–with more than twenty years of experience in advancing community pharmacy-based clinical services utilizing an appointment-based model. She is the recipient of numerous national and state awards including the American Pharmacists Association prestigious Gloria Neimeyer Franke Leadership Mentor award and the UNC Eshelman School of Pharmacy Distinguished Service award. She is a past recipient of the Preceptor of the Year Award, demonstrating her long commitment to student education. She has also served as a member and Past President of the NC Board of Pharmacy. She believes students are the future of our profession and it is our responsibility as teachers to help them see their potential and inspire them to greatness. Some core tenants of her teaching philosophy include leading by example, showing humility, and demonstrating life-long curiosity and learning. Examples of nominating comments from students include:


“[Rebecca Chater} is one of the most innovative and enthusiastic pharmacy leaders I have ever met. She has a remarkably hopeful and passionate spirit about the future of pharmacy, as evidenced by her many contributions to the world of pharmacy during her career. Additionally, she is an incredibly genuine and kind person who cares about anyone she comes into contact with. I have learned so much from her in such a short period of time. [She] was always available to answer any questions I had and always ensured our understanding of anything we had confusion about. She embodies many of the qualities I strive to achieve for myself. She is intelligent, patient, articulate, and

intrinsically motivated by her passion to help patients. I could not think of anyone more deserving of this award. The impact she makes on students and her colleagues is a testimony to her character. She is the “Michael Jordan” of pharmacy. [Rebecca Chater] ignited my interest in pharmacy informatics, which I feel so passionately about that I now plan to pursue pharmacy informatics as a career. Despite her hectic schedule, she always prioritizes her students’ learning experience. I felt extremely welcomed at Omnicell because everybody knows Ms. Chater, and Ms. Chater knows everybody. She is always professional, and treated everybody with kindness and respect, regardless of title or

position. I am impressed by her passion for the advancement of the profession of pharmacy, and by the optimism she brings to Omnicell.”

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