North Carolina Pharmacist
Volume 100 Number 1 Winter 2019 Advancing Pharmacy. Improving Health.
WE NEED YOU Pharmacy Legislative Day March 19, 2019
FREE Registration is now open at ncpharmacists.org. Please register by March 8 to be scheduled to meet with your legislator. WE NEED YOU to be an advocate for important pharmacy issues. Use this opportunity and your voice to promote positive change for pharmacy.
Official Journal of the North Carolina Association of Pharmacists
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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 1
Winter 2019
Inside • From the President .....................................................................................4
LAYOUT/DESIGN Rhonda Horner-Davis
• From the Executive Director ...........................................................................5
EDITORIAL BOARD MEMBERS
• Medication Reconciliation in the Long Term Care Setting.........................7
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 TREASURER Thomas D’Andrea
• Updates in Anticoagulation Reversal................................................11 • Non-Vitamin K Oral Anti-Coagulant Dosing...........................................18 • Commentary: Fragmented Drug Distribution Chain...................................23 • Elections and Awards.........................................................................................26 • NC Pharmacy Preceptors of the Year........................................................29 • National Poison Prevention Week..................................................................36 • NCAP Presidents Club........................................................................................38
North Carolina Pharmacist is supported in part by: • Smith Drug Company ...................................................................................2 • Epic Pharmacies Network .............................................................................6 • Pharmacists Mutual Companies ..................................................................17 • Pharmacy Technician Certification Board ...................................................22
BOARD MEMBERS
• NCAP Career Center ...................................................................................28
Sophia DeBerry Andria Eker Brock Harris Angela Livingood Holly Nunn Kevin Helmlinger Tasha Woodall Jennifer Wilson
• MedsOnCue ................................................................................................39
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 ...................................................................................40 • Pharmacy Quality Commitment ..................................................................42
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•From the President • Debra Kemp, PharmD need to get more involved.” “Yeah, I know it’s time.” “I keep telling myself to reach out to Penny and get plugged back in.” “I just don’t know what I could offer.” “I don’t even know what’s going on anymore.” My response is consistent – NCAP NEEDS YOU! Wondering where to start?
NCAP Members Welcome to 2019! I feel incredibly blessed to serve the association as NCAP President and follow in the footsteps of an impressive lineage of pharmacy innovators and leaders. Though their shoes are big to fill, my steps are falling on an increasingly solid foundation. Our Executive Director, Penny, has provided the stability we lacked for many years and propelled us forward with her endless enthusiasm and unwavering commitment. Our membership has increased, our partnerships are stronger, our presence outside of NCAP walls has expanded, and the overall renewed energy within the association is infectious. I say without hesitation that NCAP is in a great place! Moving forward into 2019, I would like to continue our focus on advocacy and membership. Membership initiatives are critical for NCAP’s continued success, and our need extends beyond increased numbers. The amount NCAP can accomplish is directly related to the level of member engagement. Interestingly, over the past few months, I have been more deliberate in my efforts to discuss NCAP with students, residents, and colleagues, many of whom mentored me in the association during my early years of participation. The stories I hear are often the same but spoken in different words. “I really
• Check your membership to make sure it’s active. Sounds simple I know, but trust me when I say that it is entirely too easy to forget to renew.
• Let us bring you up-to-speed. We welcome the opportunity! Email me, Penny, any of the Board members, or your practice forum leadership. We will help you get involved. Contact information can be found by following the ‘About NCAP’ link on top right of ncpharmacist. org homepage and then click the ‘Governance’ tab for a full roster. To see how to get more involved https://www.ncpharmacists. org/content.asp?contentid=218 To contact a board member
https://www.ncpharmacists. org/content.asp?contentid=203
• February 28 – March 1 was The Chronic Care and HealthSystem Conference at The Rizzo Center in Chapel Hill, NC. Jason Moss, Kira Harris, Tasha Woodall, Brock Harris, and others on the planning committee put in countless hours to develop an impressive agenda that provided 10 hours of CE credit and excellent networking opportunities. New this year was a designated Health-System Administrative/Leadership Track on
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Thursday, February 28th. Please complete the online evaluations of the program by March 5, 2019 to recieve your CE credit.
• Join us Tuesday, March 19th for Pharmacy Day in the Legislature in Raleigh, NC. Registration for this event is also open on the NCAP website, but guess what – it’s free. We are simply asking for your presence and voice! Advocacy is a fundamental component of professional associations, and 2019 is the year for NC pharmacists of all practice areas to stand together and advocate for the advancement of our profession. NCAP plans to introduce a bill to update our current collaborative practice authority statute, making it easier for physicians and pharmacists to collaborate. If you have not had the chance, I encourage each of you to review Penny’s ‘From the Executive Director’ column in the Fall 2018 issue of the NCAP Journal for a thorough explanation. Stay tuned for additional communication in the near future.
In the end, I hope NCAP feels like your professional ‘home’. This is our place to come together and share in both the joys and tribulations of providing the best care possible to residents of NC. Though we may not always agree, we are there to consistently support each other and ensure everyone is heard and included. Regardless of practice area, our mission is the same – to advance the practice of pharmacy. NCAP is OUR organization! Email me at dwobbleton@gmail. com. I look forward to hearing member perspectives.
Page 4 Volume 100 Number 1 Winter 2019
•From the Executive Director• Penny Shelton, PharmD, BCGP, FASCP
It Takes A Village, But Threats Abound When We Take Our Eye Off The Ball I frequently feel as though our profession is under siege, and thus we are all too often forced into a survivalist mode; and somehow simultaneously, we are seemingly persistently asked to demonstrate or prove our value. I recently attended a couple of stakeholder meetings, one where independent pharmacists needed to explain, to a group of legislators, how poor reimbursement and unfair business practices imposed on them by pharmacy benefit managers, are jeopardizing the very existence of the small, rural community pharmacy. The room was filled with pharmacists fighting for the survival of their pharmacies, but more importantly fighting for access to care for their patients and communities. The other stakeholder meeting was devoted to the role of the pharmacist in optimizing pharmacotherapy. This multi-stakeholder meeting, although extremely important for facilitating the integration of pharmacists in patient care, left me with an extreme case of deja vu. In fact, over the past couple of decades, I can’t even remember how many different meetings I have set in on, where some in attendance were apparently for the first time hearing about and seeing data that demonstrates the value of the pharmacist. As I have said before, pharmacists have historically been amazing adapters, learning to absorb and roll with the punches, and miraculously somehow emerging stronger. We have also repeatedly demonstrated our value, whether it
be in increasing access to care, improving patient outcomes, increasing patient satisfaction, decreasing costs, or improving physician resilience. Yet, somehow we have failed as a profession to link arm-in-arm to ensure that our collective voice is being heard. The tide has turned, and today, more and more pharmacists are partnering with NCAP to help shift our profession towards being proactive versus reactive. Never has it been more important for pharmacists and pharmacy technicians to band together. Whether it is for addressing poor or unsafe work environments, advocating for fair payment for services, taking the lead on advancing the profession, or neutralizing threats. We have a lot of work to do to bolster our profession. The threats are real, but not insurmountable, if we work together. We also cannot afford to rest on the successes of the past, for if we do, we will fail to recognize new opportunities and emerging threats. As the state’s pharmacy association, NCAP is tasked with representing pharmacists and technicians, and NCAP is challenged with staying vigilant; and vigilance is a priority, that everyone in the profession should help support.
On January 30th, an article was published, about community paramedicine, in Health Affairs Today. Normally, it would be an extremely rare circumstance for common ground to be found among pharmacists and paramedics. Yet, this article describe the new profession of community paramedicine; and whereas traditional paramedics handle emergencies and transport patients to hospitals, community paramedics are being trained to address patients’ needs caused by complex medication regimens. Community paramedicine certification programs have been legislatively supported and launched in Minnesota and Wisconsin. The description of what these specialized paramedics are certified to do sounds eerily familiar. They are trained to assess and recognize medication-related problems, including but not limited to problems arising
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from medication non-adherence. The success of their services hinges on their strong patient rapport and trust, as well as their ability to observe and assess patients’ medication behaviors. Within the article, success is also attributed to a “paradigm shift” from the traditional dispensing of medications to a more “patient-centric” service.
I am rather certain, that today, the vast majority of citizens would recognize pharmacists as medication experts. However, it has taken a very long time, decades, to arrive at this important recognition by the general public. We cannot afford to lose ground on the very specialty of what pharmacists bring to patient care. However, when it comes to complex medication needs, I think we would all agree that it takes more than a physician, or even more than the pharmacist, to resolve some patients’ medication-related problems. Having a community paramedic helping seems at least initially to be a welcome partnership. However, there are two key concerns that our profession should have regarding the establishment of community paramedics. First, why have we not used our collective voice and power to reshape the profession, to a great enough degree, that pharmacists can focus more on the patient care process versus spending the majority of their time on dispensing and resolving insurance issues? This is how we lose ground when we do not have pharmacists practicing to the height of their degree. Second, community paramedics are not working for free, so why are we creating a new profession versus utilizing pharmacists for their medication expertise? Finally, if we buy into the adage “it takes a village” to care for these complex patients, and therefore we are okay with community paramedicine. Then I would suggest, we cannot take our eye off the ball, and we need to make sure community paramedics work is done in partnership with patients’ pharmacists; and this means, we need to make we are proactive and our voice is heard on this and other threats.
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Medication Reconciliation in the Long Term Care Setting
By Lauren Jacobs, PharmD and Suyasha Pradhan, PharmD The medication reconciliation process provides pharmacists with the unique opportunity to intervene as patients are entering the health care arena and as they are transitioned between health care systems. The concept of medication reconciliation was first proposed in the early 2000’s, and while once a relatively new concept, it quickly became a standard of care.1 Pharmacists, in particular, play an integral role in the medication reconciliation process due to their ability to identify potential issues and their placement across multiple points of care. According to the American Society of Health-System Pharmacists (ASHP), a pharmacist’s responsi-
bilities in medication reconciliation includes leading the design and management of the medication reconciliation process, educating patients and health care professionals regarding the benefits and drawbacks of the process, and advocating for patients during transitions of care.1 Using these recommendations, pharmacists working in all facets of healthcare can contribute to the medication reconciliation process. For example, emergency department pharmacists can identify errors before patients are admitted to the hospital, staff pharmacists can rectify issues as providers reorder home medications, decentralized floor pharmacists can work closely with providers to ensure patients are on the correct regimens, and
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pharmacists in the retail sector can assess discrepancies following hospitalizations. In the long term care setting, pharmacists are especially well-positioned to take on these responsibilities as their patients are frequently admitted to hospitals and subsequently re-admitted to the long term care facility. The Joint Commission recommends a five-step process to medication reconciliation.2 First, a comprehensive list of all current medications including all prescription and over-the-counter medications, vitamins, and dietary supplements should be made. Next, another list should be developed listing medications that should be prescribed in ac-
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cordance with current evidencebased medicine guideline recommendations. These two lists should then be compared and evaluated to ensure medication appropriateness. If a medication is deemed inappropriate (e.g., no indication or duplication in medication class), the fourth step is to identify those medications as well as to assess which medication(s) should be continued or discontinued based on interactions, potential for adverse events, and complexity of the regimen. The final step is to communicate these changes to the patient along with any healthcare providers involved in the patient’s care.2 With the assistance of pharmacists, the medication reconciliation process can serve to improve the quality and safety of patient care. Pharmacist involvement in medication reconciliation is not only to help clarify home medication lists, but also to contribute to a reduction in medication-related adverse events and mortality.3 A study conducted by Bond, et al., showed that pharmacist involvement in admission drug histories helped to prevent almost 4,000 deaths annually.4 This outcome could have larger implications as Gurwitz et al. estimated that of the 350,000 adverse drug events occurring annually in US nursing homes, half were preventable.5 Bootman et al. furthermore estimated that the total annual cost of drug-related morbidity and mortality in nursing homes in the US is $7.6 billion.6 Thus, pharmacy involvement in medication reconciliation not only optimizes clinical and safety outcomes, but
may also have a positive financial impact.
In the long term care setting, pharmacists review medication orders daily and provide comprehensive reviews monthly allowing them to have heightened familiarity with patients who have complex medication regimens, and positioning them to serve as mediators between patients and other healthcare providers.7 This can streamline the often cumbersome process of ensuring home medications carried into a hospital admission are accurate and that patients are discharged on appropriate medications. This process is important for all patients, but especially for the elderly population who is at greater risk for medication-related problems.7 One particular setting in which pharmacists have assumed responsibility for the medication reconciliation process is at Woodhaven, a long term care facility in Lumberton, NC. Pharmacists at Woodhaven amass information from a number of sources including pharmacy fill lists, patient bottles, hospital discharge summaries, and lists of diagnoses provided by primary care providers in order to establish an up-to-date master list for each patient. This list is then critically evaluated against any changes made during recent hospital admissions to identify issues or changes in treatment. Commonly identified issues on discharge summaries include reordering of historical medications that are no longer prescribed and patients
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unintentionally discharged home on incorrect formulations or dosages. This process is repeated for each change in the medication regimen until the patient is discharged from Woodhaven, at which point the pharmacist provides the patient with a comprehensive and up-to-date list of their medications including a note regarding any new or discontinued medication. According to Woodhaven pharmacist, Tina Bullard, RPh, “[the] medication reconciliation process at Woodhaven begins at admission and does not end until we discharge a patient. [This process] goes beyond responsibility; it is attention to detail and comprehensive in scope. It is a commitment to excellence.” One of the most challenging aspects of completing medication reconciliation is time. Medication reconciliation frequently requires a review of multiple resources and outreach to a number of providers. Not only is time needed to investigate medication lists, but also to provide discharge counseling regarding why certain medications were changed or stopped and to address issues with the patient’s primary care provider. ASHP and The Joint Commission provide recommendations on how medication reconciliations can be conducted and how pharmacists may get involved, but these recommendations should be adjusted and tailored to each practice site in order to identify a high-quality and time efficient system. The process used at Woodhaven was not developed overnight, but instead was honed over many years
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of practice. The medication reconciliation process has changed with the use of computerized systems that allow for improved maintenance of medical history records. Pharmacists are now privy to a wealth of information such as admission notes, medication lists, and discharge summaries; however, the increased convenience associated with these systems may unintentionally cause harm due to increased complacency. With the expectation that computerized information is immune from human error, it can become easier to overlook potential issues. Tina Bullard states, “[I] have seen more errors made with the inception of computerized records, mostly due to the reliance on electronic systems to complete the majority of the work. While these systems allow us to collect in-depth records, they also retain outdated medications and dosages. When physicians and pharmacists rely on these lists alone, medication errors can occur.” Tina cites an instance where a hospitalized patient became drowsy, unable to participate in therapy, and ceased eating. When the patient transitioned to Woodhaven, it was discovered that a hospital provider ordered baclofen from a prior admission list. With some investigation, the pharmacist, discovered that the patient had not filled the baclofen in over a year due to intolerable side effects. Subsequently, the baclofen was discontinued and the patient became alert and oriented once again. This serves as just one example where diligence and attention to detail by a phar-
macist beats the convenience and reliability of an electronic system. As patients transfer to and from the long term care setting, poor communication and incomplete transmission of information can pose significant challenges to reconciling medications; however, having a consistent process that involves a pharmacist can help to improve patient safety and create a more seamless transition of care. Pharmacists at Woodhaven advise “there are no shortcuts to a high quality process.” It is important to accept that these processes will change and improve over time with the introduction of new technologies. While pharmacists should utilize their resources, it is their trained attention to detail and ability to identify issues that has allowed this profession to help reduce discrepancies, adverse events, and mortality. Lauren Jacobs, PharmD and Suyasha Pradhan, PharmD are both PGY-1 Residents at Southeastern Regional Medical Center in Lumberton, NC. Pradha01@ srmc.org References:
Answers to the “See How Much You Know” on page 38. 1. False 2. True 3. True
1. ASHP Statement on the Pharmacist’s Role in Medication Reconciliation. American Journal of Health-System Pharmacy. 2013;70(5):453456. doi:10.2146/sp120009 2. The Joint Commission. Medication reconciliation: sentinel event alert. 2006. https://www.jointcommission.org/sentinel_event.
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aspx. Accessed 1/21/2019. 3. Splawski J, Minger H. Value of the Pharmacist in the Medication Reconciliation Process. P T. 2016;41(3):176-8. 4. Bond CA, Raehl CL. Clinical pharmacy services, pharmacy staffing, and hospital mortality rates. Pharmacotherapy. 2007;27(4):481–493. 5. Gurwitz JH, Field TS, Avorn J, et al. Incidence and preventability of adverse drug events in nursing homes. Am J Med 2000;109:87-94. 6. Bootman JL, Harrison DL, Cox E, The health care cost of drug-related morbidity and mortality in nursing facilities. Arch Intern Med 1997;157:2089-2096. 7. Gooen LG. Medication Reconciliation in Long-Term Care and Assisted Living Facilities: Opportunity for Pharmacists to Minimize Risks Associated with Transitions of Care. Clin Geriatr Med. 2017 May;33(2):225239.
4. False 5. False 6. True 7. True 8. False 9. True 10. True
Page 9 Volume 100 Number 1 Winter 2019
North Carolina Association of Pharmacists
North Carolina Multistate Pharmacy Jurisprudence Exam Study Guide
Click Here
Spring 2019 Geoffrey Mospan, Pharm.D., BCPS This study guide contains pertinent federal- and state-level statutes and regulations for the practice of pharmacy in North Carolina. There are 75 “Test Your Knowledge� questions spread throughout the sections of the study guide, and as an added bonus, the guide contains a mock test with 80 practice questions. The book will be shipped in the form of a binder with loose leaf pages for ease of highlighting and note taking. Purchase your copy today for $99 plus $10 shipping and handling. North Carolina Pharmacist
Page 10 Volume 100 Number 1 Winter 2019
Updates in anticoagulation reversal: Review of coagulation Factor Xa for reversal of serious bleeding
By Caitlin Smith, PharmD, BCPS Background It is no surprise that oral anticoagulant use has shifted significantly from vitamin K antagonists to direct oral anticoagulants (DOACs). A variety of reasons may be to blame for the shift, including new evidence prompting new DOAC drug approvals, newly accepted indications for DOACs, and increased appeal to both patients and third-party payers. Zhu and colleagues examined commercial and Medicare advantage enrollees and temporal trends in oral anticoagulant use.1 The proportion of oral anticoagulant users taking DOACs for nonvalvular atrial fibrillation has increased significantly in recent years. DOAC users accounted for 8.1% of this population in the fourth quarter of 2010, climbing to 78.9% in the first quarter of 2017. The third quarter of 2013 was the specific time point where DOAC use surpassed that of warfarin. These findings are reflective of the approval of dabigatran in 2010, rivaroxaban in 2011, apixaban in 2012, and edoxaban
in 2015. DOACs reduce stroke compared to warfarin, though with an increased risk of major gastrointestinal bleeding.1
A subset of DOACs, Factor Xa inhibitors, act on the step linking the intrinsic and extrinsic pathways in the coagulation cascade. Factor Xa inhibitors inhibit the conversion of prothrombin to thrombin, subsequently preventing fibrin clot formation. There are obvious reasons for increased use of Factor Xa inhibitors, including the potential for less monitoring and less diet restrictions; however, they have a shorter duration of action, higher cost, and until recently, lacked a specific reversal agent.1-2 Coagulation Factor Xa (CFXa) was approved May 3, 2018 for the reversal of anticoagulation with apixaban or rivaroxaban in life-threatening or uncontrolled bleeding. CFXa is a recombinant form of human Factor Xa that binds with high affinity to Factor Xa inhibitors, preventing anticoagulation via decreased
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circulating active (unbound) drug. CFXa was labeled as a U.S. Orphan Drug and Breakthrough Therapy by the Food and Drug Administration (FDA), receiving accelerated approval. Approval was based on studies examining the effect of CFXa on anti-Factor Xa activity in healthy subjects taking apixaban or rivaroxaban though additional post-marketing studies are being required by the FDA.3
This article is intended to review landmark clinical trials leading to CFXa approval, discuss implications of use of CFXa on healthsystems, and to examine the role of CFXa and other novel therapies in anticoagulation reversal. Clinical trials: ANEXXA-A and ANEXXA-R
Siegal and colleagues published the results of the first landmark CFXa trials, ANEXXA-A (apixaban) and ANEXXA-R (rivaroxaban). These were two multicenter, prospective, randomized, placebo-controlled studies
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evaluating the effects of CFXa on anti-Factor Xa activity in healthy subjects treated with apixaban or rivaroxaban for 4 days. Notable inclusion criteria included: age 50-75 years, blood pressure <160/92 mmHg, normal coagulation markers (prothrombin time, activated partial thromboplastin time, activated clotting time), serum creatinine <1.5 mg/ dL, body mass index 19-31 kg/ m2, and weight greater than or equal to 60 kg. Subjects were excluded if they had a history of bleeding or thrombosis, as well as if they had used non-steroidal anti-inflammatory drugs or oral contraceptives within the past seven days. Bolus and bolus plus infusion dosing was performed. The primary endpoint was the change in anti-Factor Xa activity (%) from baseline to nadir. Secondary endpoints included proportion of participants with greater than or equal to 80% decrease in anti-Factor Xa activity, change in unbound inhibitor plasma concentration, change in thrombin generation, and occurrence of endogenous thrombin potential above the lower limit of the baseline-derived range at its peak.4
There were 65 participants in the ANEXXA-A study who received apixaban 5 mg twice daily for 3.5 days, which resulted in 48 subjects in the CFXa group and 17 in the placebo group. CFXa dosing consisted of a 400 mg intravenous (IV) bolus and a 4 mg/ minute infusion for 120 minutes, when applicable. There were 80 participants in the ANEXXA-R study who received rivaroxaban 20 mg daily for 4 days, which resulted in 53 subjects in the
CFXa group and 27 in the placebo group. CFXa dosing consisted of an 800 mg IV bolus and an 8 mg/ minute infusion for 120 minutes when applicable.4 Subjects in the ANEXXA-A and ANEXXA-R studies averaged 57.9 years of age, were 39% female, and were well-balanced between groups with regard to age, body mass index, serum creatinine, and race. The results of the primary endpoint, change in antiFactor Xa activity from baseline to nadir are shown in Table 1. CFXa significantly reduced antiFactor Xa activity compared to placebo. All secondary endpoints also reached statistical significance with CFXa decreasing unbound inhibitor concentration to a level at which there is little to no anticoagulant effect, as well as increasing thrombin generation. There were no serious or adverse events including thrombotic events. The biggest limitation of this study is that the target population, patients requiring emergent anticoagulation reversal, were not included. Additionally, many of the biomarkers measured in the study are not normally utilized in the clinical setting, making them difficult to interpret. In conclusion, the ANEXXA studies showed that CFXa quickly restores Factor Xa activity and thrombin generation in healthy subjects.4 Clinical trial: ANEXXA-4
Connolly and colleagues published the results of an interim analysis of 67 patients enrolled in the ANEXXA-4 study. ANEXXA-4 is an ongoing multicenter, prospective, open-label, single-group
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cohort study evaluating CFXa in the setting of acute major bleeding. The cases analyzed took place from April 2015 through June 2016 in 22 centers in the United States, United Kingdom, and Canada. Patients were included if they were 18 years of age, had received apixaban, edoxaban, enoxaparin (at least 1 mg/ kg/day), or rivaroxaban within 18 hours, and had acute major bleeding. Of note, CFXa for reversal of edoxaban and enoxaparin was also examined in a limited number of healthy volunteers prior to inclusion of these agents in the ANEXXA-4 study. Acute major bleeding was defined as life-threatening hemodynamic compromise, a 2 g/dL drop in hemoglobin or hemoglobin less than or equal to 8 g/dL without a known baseline, or acute symptomatic bleeding into a critical body site. Patients were excluded if they had an intracranial hemorrhage with a Glasgow Coma Scale of less than seven, estimated hemorrhage volume of less than 60 mL, expected survival of less than one month, a major thrombotic event within two weeks prior, and had received any of the following within seven days prior: dabigatran, prothrombin complex concentrate, warfarin, or whole blood or plasma products.5-8
Patients receiving apixaban or rivaroxaban greater than seven hours prior received a 400 mg bolus of CFXa over 15-30 minutes followed by a 480 mg infusion over two hours. Patients receiving edoxaban, enoxaparin, or rivaroxaban less than or equal to seven hours prior (or timing unknown) received an 800 mg
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bolus of CFXa over 15-30 minutes followed by a 960 mg infusion over two hours. The safety population included all patients receiving CFXa, while the efficacy population included those meeting a prespecified amount of baseline anti-Factor Xa activity and acute major bleeding as previously defined.5
Co-primary outcomes of the ANEXXA-4 study were percent change in anti-Factor Xa activity and rate of excellent or good hemostasis at 12 hours after the infusion. Excellent hemostasis in patients with intracranial hemorrhage is defined as an increase in volume of less than or equal to 20% from baseline at one and 12 hours. Good hemostasis is defined as an increase in volume of less than or equal to 35% from baseline at one and 12 hours. For other bleeding types, including gastrointestinal, excellent hemostasis is defined as a drop in hemoglobin and hematocrit of less than 10%. Good hemostasis is defined as a drop in hemoglobin and hematocrit of less than 20% plus less than or equal to two units of additional blood factor product. Secondary outcomes are change in unbound inhibitor concentration and percent change in endogenous thrombin potential. Forty-seven patients were included in the efficacy analysis, 20 in the apixaban group, 26 in the rivaroxaban group, and one in the enoxaparin group. The study will be ongoing until 162 patients are included in the efficacy analysis.5 Patients in the efficacy analysis averaged 77 years of age and all had a history of thrombotic events and cardiovascular dis-
ease. The median daily dose of anticoagulant was 5 mg for apixaban and 20 mg for rivaroxaban. The single enoxaparin patient had received 200 mg per day. Bleeding sites comprised of 25 (53%) gastrointestinal, 20 (43%) intracranial, and 2 (4%) other sites. The results of the co-primary outcomes are summarized in Table 2 (excluding the single enoxaparin case). CFXa significantly reduced the median anti-Factor Xa activity at all-time points, as well as provided excellent or good hemostasis in the majority of patients at 12 hours after the infusion.5 Secondary endpoints also reached statistical significance, with CFXa decreasing unbound inhibitor concentration as well as increasing thrombin generation, notably above baseline in all groups at 8, 12, and 72 hours. Unbound inhibitor concentration results showed that as CFXa effects decline, unbound drug rises again slowly, tapering off again at around 12 hours with normal drug metabolism. Safety endpoints were measured through 30 days. Twelve patients (18%) had a thrombotic event and only one of these 12 patients had resumed anticoagulation. Ten patients (15%) died â&#x20AC;&#x201C; six from cardiovascular causes. There were no infusion reactions.5 ANEXXA-4 includes more clinically relevant outcomes than did the prior ANEXXA-A and ANEXXA-R studies, with criteria for hemostasis adopted from previous studies examining prothrombin complex concentrate for similar indications. However, the strength of evidence from
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the ANEXXA-4 study is limited by the lack of a comparator arm and the low number of patients. The full ANEXXA-4 study is estimated to be complete in 2022. In conclusion, the ANEXXA-4 trial shows that CFXa quickly reverses anti-Factor Xa activity as well as achieves hemostasis by 12 hours for the majority of patients; however, a head-to-head comparison study is needed to assess if thrombotic events and deaths are comparable to what is expected in this population.4,5 Impact of coagulation Factor Xa use on health-systems and operations
Current clinical evidence aside, CFXa brings about logistical and financial challenges of which pharmacists should be aware. CFXa is packaged in 100 mg vials that come four per carton and should be refrigerated, but not frozen. Vials must be reconstituted with 10 mL of sterile water for injection, swirling until dissolved (around three to five minutes). If dissolution is incomplete, the vial should be discarded. Bolus doses should be placed into a polyolefin or polyvinyl chloride bag less than or equal to 250 mL in size. Reconstituted vials are stable for eight hours at room temperature or 24 hours refrigerated. Reconstituted drug in IV bags is stable for eight hours at room temperature or for 16 hours refrigerated.9 The specific drug and/or timing of Factor Xa inhibitor will dictate the recommended CFXa dose. It should be noted that the FDAapproved dosing differs slightly from the dosing used in the ANEXXA-4 study, though possible
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explanations exist for this difference. In ANEXXA-4, all patients who received apixaban were treated with low-dose CFXa; however, the median daily dose of apixaban in this study was 5 mg and the standard dosing for atrial fibrillation is 5 mg twice daily. Additionally, dosing of CFXa for rivaroxaban use was based purely on timing without regard to dose; however, the median daily dose of rivaroxaban in this study was 20 mg. To summarize, both a dose and time requirement must be met for a patient to receive high-dose CFXa. The ANEXXA-4 trial and current FDAapproved dosing regimens for CFXa are outlined in Table 3.5,9
Considering the previously discussed information on preparation and dosing of CFXa, the preparation of CFXa is an important step in the administration process that may significantly impact the time it takes for the drug to reach a patient. The lowdose regimen would require nine vials of drug, and the high-dose regimen would require 18 vials of drug. Use of CFXa may require consult approval followed by order verification, preparation, and delivery. Even in the most efficient of circumstances, this process may take close to one hour. “Generation 1” manufacturing of CFXa includes the currently available 100 mg vials, though supply limitations mean that CFXa is only available at approximately 40 institutions throughout the United States. In North Carolina, this includes Duke University Hospital and the University of North Carolina Medical Center (personal communication with Portola® Pharmaceuticals; August
2018). Based on availability of the drug itself as well as current evidence, formulary restrictions (e.g. intracranial hemorrhage with neurology approval) are seemingly common. The “Generation 2” manufacturing process of 200 mg vials is pending FDA approval, and is predicted to begin in early 2019.3,9
There are additional considerations regarding CFXa use that were not previously discussed. CFXa has not been studied specifically in renal impairment, obesity, pediatrics, or pregnancy. CFXa has also not been adequately studied for and does not carry FDA-approval for use in persons anticoagulated with betrixaban, edoxaban, enoxaparin, or fondaparinux. CFXa carries a Boxed Warning for increased risk of venous thromboembolism, myocardial infarction, ischemic stroke, cardiac arrest, and sudden death. Patients should be monitored for signs and symptoms of these complications.6 The timeline for re-anticoagulation in patients with a resolved emergent bleed remains unclear and will likely be individualized to each patient scenario. In the ANEXXA-4 study, restarting anticoagulation was encouraged as clinically indicated.5 Given current logistical as well as clinical limitations surrounding CFXa use, it is important to review the current standard of care for Factor Xa inhibitor reversal. In a situation where CFXa is not an option, 4-factor prothrombin complex concentrate (Factors II, VII, IX, X, Protein C, Protein S) or anti-inhibitor coagulant complex are routinely used off-label for
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life-threatening bleeding associated with DOACs. Though based largely on observational evidence, multiple societal guidelines recommend this approach.10-13
Review of CFXa would not be complete without considering costs. The average wholesale price of CFXa is $3,300 per vial. Therefore, the low dose regimen totals $29,700 in cost and the high-dose regimen totals $59,400. For comparison, a dose of 4-factor prothrombin complex concentrate, which is typically maxed at 5,000 units, has an average wholesale price of $13,850.14,15 Future directions
As previously mentioned, FDAapproval of CFXa was contingent upon post-marketing requirements. CFXa will be compared to usual standard of care in a randomized clinical trial with an estimated timeline of 2019 to 2023. This will be the first study of CFXa against an active comparator, and should help to provide clarity surrounding CFXa’s true impact on both emergent reversal as well as post-treatment complications compared to current practice. As CFXa use increases, it is also possible that reversal of Factor Xa inhibitors other than apixaban and rivaroxaban may be a focus of future studies.3,16
Clinicians will likely encounter many questions regarding the recent approval of CFXa. Consideration should be given to a possible impact on provider and patient preference for apixaban
Page 14 Volume 100 Number 1 Winter 2019
and rivaroxaban due to perceived Carolina Medical Center. Caitlin. risk reduction. Pharmacists may smith@unchealth.unc.edu be asked to troubleshoot logistiReferences cal and clinical barriers to CFXa use and may be called upon to 1. Zhu J, Alexander GC, Nazarian discuss current evidence surS, Segal JB, Wu AW. Trends and variation in oral anticoagulant rounding CFXa with both patients choice in patients with atrial and providers. fibrillation, 2010-2017. PharmaCFXa is not the only novel agent in the realm of anticoagulation reversal. Ciraparantag (aripazine) is a new drug in the research and development pipeline that binds a variety of anticoagulants, including apixaban, argatroban, edoxaban, dabigatran, rivaroxaban, unfractionated heparin, low-molecular weight heparins, and fondaparinux. Aripazine is a small synthetic molecule that binds these anticoagulants, preventing them from binding to their specific molecular targets. Like CFXa, aripazine has received FDA Fast Track designation, which allows for expedited review of agents intended to treat serious or lifethreatening conditions or for drugs that possess the potential to provide novel approaches to clinical scenarios where options may be lacking.16 Summary
Coagulation Factor Xa is a newly FDA-approved reversal agent for apixaban and rivaroxaban in the setting of life-threatening or uncontrolled bleeding. Clinical and logistical limitations exist, but new data and expansion of availability are expected to prompt changes in current practice. Caitlin Smith, PharmD, BCPS is a PGY2 Pharmacotherapy Resident at the University of North
cotherapy. 2018; doi: 10.1002/ phar.2158. [Epub ahead of print].
2. Yeh CH, Fredenburgh JC, Weitz JI. Oral direct factor Xa Inhibitors. Circ Res. 2012;111:10691078.
3. Miller C, Teller C. U.S. FDA Approves Portola Pharmaceuticals’ Andexxa®, First and Only Antidote for the Reversal of Factor Xa Inhibitors. News Release. Portola Pharmaceuticals, Inc. 2018 August 13. Available from: http://investors.portola.com/phoenix. zhtml?c=198136&p=irolnewsroomArticle&ID=2347018 4. Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. 2015;373:2413-24.
5. Connolly SJ, Milling TJ, Eikelboom JW, et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. N Engl J Med. 2016;375:1131-41.
6. Crowther M, Levy G, Lu G, et al. A phase 2 randomized, doubleblind, placebo-controlled trial demonstrating reversal of edoxaban-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), a universal antidote for factor Xa (fXa) inhibitors. Blood. 2014;124:4269. 7. Crowther M, Lu G, Conley P, et al. Reversal of factor Xa inhibitors-induced anticoagulation in healthy subjects by andexanet alpha. Crit Care Med. 2014;42:A1469. 8. Lu G, Deguzman F, Hollenbach S, et al. Reversal of low molecular weight heparin and fondaparinux by a recombinant antidote (r-Antidote, PRT064445). Circulation.
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2010;122:12420.
9. Andexxa ® [package insert]. South San Francisco (CA): Portola Pharmaceuticals; 2017.
10. Frontera JA, Lewin JJ, Rabinstein AA, et al. Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine. Neurocrit Care. 2016;24(1):6-46. 11. Heidbuchel H, Verhamme P, Alings M, et al. Updated European Heart Rhythm Association practical guide on the use of non-vitamin-K antagonist anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J. 2017;38(27):2137-2149.
12. Hemphill JC, Greenberg SM, Anderson CS, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46:2032-2060. 13. Tomaselli GF, Mahaffey KW, Cuker A, et al. 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2017;70(24). 14. Coagulation Factor Xa/Andexanet Alfa (Andexxa ®). Lexicomp [online database]. Hudson, OH: Wolters Kluwer Health; updated May 7, 2018. Accessed August 2018.
15. Prothrombin complex concentrate (Kcentra ®). Lexicomp [online database]. Hudson, OH: Wolters Kluwer Health; updated May 7, 2018. Accessed August 2018.
16. Ruff CT, Giugliano RP, Antman EM. Management of bleeding with non–vitamin K antagonist oral anticoagulants in the era of specific reversal agents. Circulation. 2016;134:248-261.
Page 15 Volume 100 Number 1 Winter 2019
Table 1. ANEXXA-A and ANEXXA-R: primary endpoint results Change in anti-Factor Xa activity (%) from baseline to nadir, CFXa vs. placebo Bolus Bolus + 2-hour infusion Apixaban -94±2% vs. -21±9%, P<0.001 -92±3% vs. -33±6%, P<0.001 Rivaroxaban -92±11% vs. -18±15%, P<0.001 -97±2% vs. -45±12%, P<0.001
Table 2. ANEXXA-4 interim analysis: co-primary endpoint results
Primary outcome #1: median anti-Factor Xa activity (ng/mL) Apixaban Baseline 149.7 Decrease End of bolus 10.3 93% (95% CI, 87-94) End of infusion 12.5 92% (95% CI, 85-94) 4 hours from infusion 103 30% (95% CI, 23-46) Rivaroxaban Baseline 277 Decrease End of bolus 16.8 89% (95% CI, 58-94) End of infusion 30.6 86% (95% CI, 55-93) 4 hours from infusion 177.7 39% (95% CI, 27-45) Primary outcome #2: excellent or good hemostasis at 12 hours after infusion Patients, n % (95% CI) Apixaban 20 75 (51-91) Rivaroxaban 26 81 (61-93) Enoxaparin 1 100 Overall 37 79 (64-89)
Table 3: Coagulation Factor Xa dosing
ANEXXA-4 Trial
Apixaban
Rivaroxaban
Apixaban
Rivaroxaban
Timing of last dose < 8 hours or unknown 8-18 hours ≤ 5 mg Low dose > 5 mg or unknown Low dose Low dose ≤ 10 mg High dose > 10 mg or unknown High dose Current, FDA-approved CFXa dosing Timing of last dose Last dose < 8 hours or unknown 8-18 hours ≤ 5 mg Low dose > 5 mg or unknown High dose Low dose ≤ 10 mg Low dose > 10 mg or unknown High dose Last dose
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Non-Vitamin K Oral Anti-Coagulant Dosing in Non-Valvular Atrial Fibrillation – Challenges and Consequences By Felicia R. Britt, PharmD
Warfarin was approved by the Food & Drug Administration (FDA) in 1954 and has remained the primary oral anticoagulant used in the United States until recently. In 2010, a new class of oral anticoagulants became available with the approval of dabigatran (Pradaxa), the first non-vitamin K antagonist oral anticoagulant (NOAC) used for non-valvular atrial fibrillation (NVAF).1,2 Soon to follow was rivaroxaban (XareltoÒ) in 2011, apixaban (Eliquis) in 2012, and edoxaban (Savaysa) in 2015.3-5 This new class of medications changed the landscape for prescribers and patients alike, but not without posing challenges. Complex dosing regimens and multiple exclusion criteria associated with NOACs make prescribing the optimal oral anticoagulant challenging for any provider.
(i.e., potential overdose); while 13.3% of patients without renal dysfunction received a reduced dose (i.e., potential under-dose).6 Furthermore, the findings by Yao et al. were not unique. The ORBITAF and XANTUS trials revealed similar findings regarding inappropriate dosing.6-8 Patients with severe kidney disease (CrCl 15 to 30 mL/min per 1.73 m2) did not receive a dose-adjusted NOAC 36% and 56% of the time in the XANTUS and ORBIT-AF trials, respectively.7-8 Additionally, 10% of the patients in the ORBIT-AF trial with normal renal function received reduced dosing.7
It is imperative to consider the consequences of these potentially mis-prescribed doses for the patient. The most common adverse event associated with overdosing is bleeding (ranging Recent evidence suggests that ap- from mild nosebleeds to severe proximately 16% of patients with gastrointestinal or intracranial NVAF taking apixaban, dabigatran bleeding); whereas the most comor rivaroxaban are either over- or mon adverse events associated under-dosed according to their re- with under-dosing are stroke and nal function.6 A study published in systemic embolism.6 With the the New England Journal of Medi- exception of dabigatran where patients may experience some cine by Yao and colleagues found mild dyspepsia (5-10%), NOACs that among patients in which a renal dose reduction was indicat- have few adverse side effects with ed, 43% received a standard dose minimal need for consideration of North Carolina Pharmacist
meal intake.2-5 While the NOACs, in general, offer a safer profile than warfarin, these agents must be dosed appropriately based on patient-specific factors to avoid serious complications. Improving Prescribing Patterns – Recommendations for Pharmacists When determining the appropriateness of anticoagulation regimens in NVAF patients, it is important to consider the patient’s HAS-BLED score (a tool accounting for hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, age (>65 years), drugs/ alcohol concomitantly), CHA2DSVASc score (a tool accounting for 2 congestive heart failure, hypertension, advancing age, diabetes mellitus, previous stroke/transient ischemic attack, vascular disease, and gender), weight, renal function and ability to adhere to prescribed treatment plan.9,10 Table 1 outlines the recommended dosing for the four NOACs indicated for NVAF and some considerations for their use. Monitoring NOAC Drug Levels While monitoring of NOAC drug levels is not considered routine, it can be done.11 The ARISTOTLE trial found a median Cmax value of 123 ng/mL with a 68.5−221 ng/ mL range for apixaban 2.5 mg BID and a median Cmax apixaban value of 171 ng/mL with a 91-321 ng/
Page 18 Volume 100 Number 1 Winter 2019
mL range for the 5 mg BID dose.11 Consideration for monitoring NOAC levels may be warranted in the case of emergent surgery, trauma, obesity, or when receiving thrombolytic therapy.11 Serum levels may also be useful in the presence of poor renal function, low body weight, and/or treatment failure.11 Of note, anti-Xa tests for rivaroxaban, apixaban, and edoxaban that measure drug-specific levels are on the horizon.11
the market. Idarucizumab, (PraxbindÒ), a humanized monoclonal antibody fragment, is FDA-approved for the reversal of dabigatran.13 Andexanet alfa (AndexxaÒ), a recombinant modified human factor Xa decoy protein, was recently approved by the FDA in May 2018 for reversal of apixaban and rivaroxaban.14,15
NOACs in Obesity & Monitoring Drug Levels
Prescribing of NOACs for NVAF could be improved with increased knowledge of each medication’s prescribing guidelines as well as NOAC-specific dosing implications. Pharmacists can play a key role in this area whether it be in a hospital or community setting by screening for drug interactions, monitoring patients, and checking for signs and symptoms of adverse events. Educating the patient is key for these medications given the consequences of under- or over-dosing. As one of the most accessible health care providers, it is crucial that pharmacists utilize their expertise and assist prescribers with recommended dosing of NOACs as well as interviewing the patient at each encounter to ensure no signs or symptoms of an adverse event are taking place.
The International Society on Thrombosis and Hemostasis (ISTH) does not recommend using a NOAC if the patient has a BMI > 40 or weight > 120 kg as these patients may have decreased drug exposure, reduced peak concentrations, and shorter half-lives that may result in underdosing.12 However, if a NOAC is determined to be the most feasible anticoagulation option in these patients, the ISTH recommends checking a serum drug level and continuing close monitoring. Reversal Strategies Traditional supportive care for patients experiencing bleeding include blood products, activated charcoal (if taken within a couple of hours of administration), and dialysis for some agents such as dabigatran, and surgical interventions for severe cases; however, in the last few years, there have been some targeted agents arrive on
Conclusion
Case Study A 76-year-old woman presents to the clinic with dyspnea on exertion, fatigue, palpitations, weakness, and decreased exer-
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cise tolerability. She states, “it’s getting harder and harder for me to walk to the mailbox.” She endorses these symptoms occurring multiple times a day for the past two weeks but denies syncope or lightheadedness. The only thing she says that helps is resting for ~10 minutes after any amount of exercise. She takes a daily multivitamin and amlodipine. PMH: Her past medical history is significant for hypertension and cataracts; today’s EKG reveals atrial fibrillation. SH: She lives alone, does not drive, but is otherwise fairly independent. Her labs today are stable and reveal a SCr of 0.85. Her weight is also stable at 68 kg. Based on your assessment, she should be anticoagulated to prevent thromboembolism. What would you recommend for this patient? Answer: Anticoagulation is indicated because her CHA2DS2-VASc score is 4 (hypertension (+1), age (+2), and female sex category (+1)) and her HAS-BLED score is 1 (elderly age). Guideline-recommended therapy suggests warfarin with a goal INR of 2-3 (Level of Evidence: A) or a NOAC (Level of Evidence: B).16
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When considering initiation of warfarin, her social history points to transportation challenges that may make it difficult to properly manage warfarin at this time. Consideration could be given to home INR monitoring, but her vision may preclude safe and reliable monitoring. A NOAC (e.g., apixaban 5 mg BID) could be considered which would reduce the need for routine follow-up (e.g., weekly blood monitoring at the start of therapy). If apixaban is chosen, a reduced dose is not recommended by the manufacturer because her renal function is stable (SrCr is < 1.5 mg/dL), her weight is stable (> 60 kg), and although her age is > 80 years, she does not meet the criteria for a reduced dose (two criteria must be met). Not adhering to these recommended guidelines can put her at risk for stroke and/ or systemic embolus.6 She should be counseled on the proper use of this medication and encouraged to avoid other medications that could increase her bleeding risks (e.g., aspirin, nonsteroidal anti-inflammatory drugs, some herbal supplements). Monitoring for potential adverse events is always indicated, and her renal function should be re-evaluated when clinically indicated and at least annually (Level of Evidence: B).16 Dr. Felicia R. Britt, PharmD, is a PGY1/PGY2 HSPA Resident at
Massachusetts General Hospital. fbritt@email.unc.edu References:
1. Coumadin (warfarin) [Package Insert]. Princeton, NJ: BristolMyers Squibb Company 1954.
2. Pradaxa (dabigatran etexilate mesylate) [Package Insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2010. 3. Xarelto (rivaroxaban) [Package Insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2011. 4. Eliquis (apixaban) [Package Insert]. Princeton, NJ: BristolMyers Squibb Company 2012. 5. Savaysa (edoxaban) [Package Insert]. Tokoyo, Japan: Daiichi Sankyo Co., LTD. 2015.
6. Yao X, Shah ND, Sangaralingham LR, Gersh BJ, Noseworthy PA. Non-Vitamin K Antagonist Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Renal Dysfunction. J Am Coll Cardiol. 2017 Jun 13;69(23):27792790. 7. Steinberg BA, Holmes DN, Piccini JP, Ansell J, Chang P, Fonarow GC, Gersh B, Mahaffey KW, Kowey PR, Ezekowitz MD, Singer DE, Thomas L, Peterson ED, Hylek EM; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation. J Am Heart Assoc. 2013 Nov 25;2(6):e000535. doi: 10.1161/ JAHA.113.000535. PubMed PMID: 24275632; PubMed Central PMCID: PMC3886732. 8. Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, Kuhls S, van Eickels M, Turpie AG; XANTUS Investigators. XANTUS: a real-world, prospective, observational study of patients
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9.
treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016 Apr 7;37(14):1145-53. doi: 10.1093/eurheartj/ehv466. Epub 2015 Sep 1. PubMed PMID: 26330425; PubMed Central PMCID: PMC4823634. Pisters, Ron; Lane, D. A.; Nieuwlaat, R; De Vos, C. B.; Crijns, H. J.; Lip, G. Y. (2010). “A Novel User-Friendly Score (HAS-BLED) to Assess 1-Year Risk of Major Bleeding in Patients with Atrial Fibrillation”. Chest. 138 (5): 1093–100. doi:10.1378/ chest.10-0134. PMID 20299623.
10. January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, ContiJB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/ HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. Erratum in: Circulation. 2014 Dec 2;130(23):e2701. PubMed PMID: 24682348. 11. Apixaban Anti-Xa. Lab Corp. https://www.labcorp.com/testmenu/20326/apixaban-anti-xa. Accessed January 17,2018
12. Martin K, Beyer-Westendorf J, Davidson BL, Huisman MV, Sandset PM, Moll S. Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH. J Thromb Haemost. 2016 Jun;14(6):1308-13. doi: 10.1111/ jth.13323. Epub 2016 Apr 27. PubMed PMID: 27299806; PubMed Central PMCID: PMC4936273.
13. Praxbind (idarucizimab) About Praxbind. https://www.praxbind. com/idarucizumab?gclid=CjwKCAjws6jVBRBZEiwAkIfZ2qXcMnkkXBbB8oFqEz0tMLgMP6vuwpa91 L1RA_A-Av87IdZr1QgnZxoCtVEQAvD_BwE. Accessed July 8, 2018.
14. Sartori M, Cosmi B. Andexanet alfa to reverse the anticoagulant activity of factor Xa inhibitors: a review of
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design, development and potential place in therapy. J Thromb Thrombolysis. 2018 Apr;45(3):345-352. doi:10.1007/s11239-018-1617-2. Review. PubMed PMID: 29372400.
15. Andexanet (Andexxa). Portola Pharmaceuticals Inc. https://www. andexxa.com/andexxa-product-
Table 1: NOAC Dosing in NVAF2-5 Drug Class
NVAF Recommended Dosing and Considerations
locator/?lpr-search=27520. Accessed July 8, 2018.
16. Writing Committee Members, January CT, Wann LS, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/
American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199e267. doi:10.1161/ CIR.0000000000000041.
Dabigatran (PradaxaÒ)
Rivaroxaban (XareltoÒ)
Apixaban (EliquisÒ)
Edoxaban (SavaysaÒ)
Direct Thrombin Inhibitor
Direct Xa inhibitor
Direct Xa inhibitor
Direct Xa inhibitor
§ 150 mg BID
§ If CrCl 15-30 mL/ min, use 75 mg BID § Avoid use if CrCl <15 mL/min
§ 20 mg daily with evening meal
§ If CrCl 15-50 mL/ min, use 15 mg daily with food § Avoid use if CrCl <15 mL/min
§ 5 mg BID
§ 60 mg daily
§ Reduce to 2.5 mg BID for patients with 2 of 3 “high risk” criteria: age ≥ 80, wt ≤ 60 kg, SCr ≥ 1.5 mg/dL
§ Do NOT use if CrCl > 95 mL/min
§ Best to avoid use in patients with a serum creatinine >2.5 mg/dL or CrCl <25 mL/ minute
§ If CrCl 15-50 ml/ min, use 30 mg daily § Avoid use if CrCl <15 mL/min
§ Antiplatelets
§ Anticoagulants Some Notable Drug Interactions § CYP3A4 Inducers § Estrogen Derivatives § Factor X § NSAIDs
§ Rifampin
§ Ketoconazole § Ritonavir
§ St. John’s Wort North Carolina Pharmacist
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Commentary: Fragmented Drug Distribution Chain Ryan Mills PharmD, MBA, MHA, BCPS Healthcare, and specifically medication costs, is a topic of focus among all health systems in America today.1 Many Americans are spending more on healthcare than on their mortgage.2 Healthcare as we know it is unsustainable, but we continue to see rising drug expenses and policy changes that may negatively impact the communities we serve, such as amendments to the 340B program, which has provided financial assistance to safety-net hospitals to help them manage the rising prescription drug costs. For pharmacy enterprises to maintain financial vitality, they must position themselves to disrupt the current supply-chain drug-distribution model. The Trump administration released its drug-pricing blueprint for reducing prescription drug prices and stressed that supplychain intermediaries are capturing much of the money that is often categorized as drug spending.1 To understand at which point to disrupt the current drug distribution model, one must identify the parties involved, how profits are generated, and the function of the involved parties. A recent article in Health Affairs, “Spending on Prescription Drugs in the US: Where does the Money Go?” breaks down the gross profits generated amongst the different purchasers and payers across the US drug-supply chain (Figure 1). Their research estimated annual gross profits of $480 billion per year for all drug supply chain participants. The majority
of the profits, $323 billion, come from drug manufacturers, and the remaining $157 billion comes from Pharmacy Benefit Managers (PBMs), wholesalers, pharmacies, providers, and insurers. Of that $157 billion, PBMs represent $23 billion, and $17.7 billion is attributed to wholesalers. When looking at the percentages represented, one must consider that PBMs own and operate specialty and mail-order pharmacies, which are included under “Pharmacies” category; therefore, the PBMs percentage of gross profits in the drug supply chain is much higher than 5%.1 The pharmacy distribution diagram represented in Figure 2 depicts a simplified version of the financial flow of drug spending from the manufacturer to the patient.3 As illustrated, there are many intermediaries involved
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that are vulnerable to disruption, such as PBMs and wholesalers, resulting in some unnecessary transaction costs that lead to increased prescription prices for the patient. PBMs in the Health System PBMs influence which medications are added and restricted on their formulary determining how much pharmacies will be paid for dispensing them. They do this by negotiating rebates from manufacturers in exchange for preferred formulary placement. The primary responsibility of PBMs is to determine the formulary and clinical step therapies for patients, which is also being done by health systems’ Pharmacy & Therapeutics (P&T) Com-
Page 23 Volume 100 Number 1 Winter 2019
mittees. Most health systems’ P&T committees create restricted formularies in the acute care setting and have an open formulary in the outpatient setting to accommodate third-party benefit plans. A health system’s P&T committee consists of an interdisciplinary committee of providers, nurses, pharmacists, and other subject matter experts who are responsible for determining which medications are on the formulary. Their decisions are based on optimizing patient care by ensuring access to clinical gap, safety, and efficacy, and cost-effective medications.4 P&T committees utilize medication-use evaluations to make formulary decisions and to determine how medications are used within the health-system. P&T committees function in the same manner for the healthsystem as PBMs; raising the question of what value do PBMs add to health systems or for the patient? Another variable to consider is the rebates; do PBMs act in the best interest of the patient or favor drugs to formularies based on rebates that maximize their profits? Visionaries such as Amazon, Berkshire Hathaway, and JPMorgan Chase see this complex drug distribution model as an opportunity. They have developed innovative ways to cut costs by eliminating intermediaries that they believe do not add value to the system. They have already obtained wholesale distribution
approval from numerous state pharmaceutical boards, giving them the capability to disrupt mail-order pharmacy services. Healthcare systems need to cut the unnecessary transactions costs that add no additional value to the patient. One way is to enter into value-based contracts with brand or generic manufacturers for targeted specialty medication, thereby eliminating the wholesaler. For example, an outcome-based contract is a form of value-based contract that ties in drug reimbursement with health outcomes. In an outcomesbased contract, a pharmacy will enter into a contract with the manufacturer and have outcomebased quality metrics established by the manufacturer they need to meet to receive rebates or discounts. Specialty pharmacies, in particular, will benefit from outcome-based contracting with targeted high-cost medication. Drug wholesalers are vital to the drug-supply chain, but an opportunity exists to carve out a handful of those drugs to cut prescription costs and pass those benefits along to our patients. In light of the trends in healthcare and the population health initiatives, cutting unnecessary transactional costs out of the equation is paramount to enable healthcare organizations to maintain financial vitality for the future. PBMs continue to evolve, and we are seeing two emerging trends – vertical integration with PBMs and insurers (e.g., CVS/Aetna,
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Cigna/Express Scripts, Prime Therapeutics (BCBS)/Walgreens (Alliance), Anthem/Ingenio Rx), resulting in formulary restrictions, and channel management in which PBMs are redirecting outpatient infusion services to home care or community-based providers who offer these services at more competitive rates. Both strategies lower costs, but at the expense of the patient (e.g., access). How are health systems going to adapt to secure their financial vitality for the future? Health systems know they must lower costs, but few have been successful in disrupting this fragmented model. The most successful healthcare organizations will be the ones that move beyond these obstacles, and when they do, the cost savings can be passed on to their patients making care more affordable and helping them realize their vision of providing remarkable care. Ryan Mills, PharmD, MBA, MHA, BCPS is a Pharmacy Manager at Novant Health. rsmills@ novanthealth.org References 1. Healthaffairs.org. (2018). Spending on Prescription Drugs in the US: Where Does All The Money Go? [online] Available at: https://www.healthaffairs.org/do/10.1377/ hblog20180726.670593/ full/ [Accessed 26 Aug. 2018].
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2. Rosenthal, at: E. (2014). How the High Cost of Medical Care Is Affecting Americans. [online] Available at: https://www.nytimes.com/ interactive/2014/12/18/ health/cost-of-health-carepoll.html [Accessed 26 Aug. 2018].
Figure 1. 2016 US Pharmaceutical Sector Retained Revenue Percentage (total $480 billion)1
3. Adam J. Fein, P. (2018). Follow the Dollar: The U.S. Pharmacy Distribution and Reimbursement System. [online] Drugchannels.net. Available at: https://www. drugchannels.net/2016/02/ follow-dollar-us-pharmacydistribution.html [Accessed 26 Aug. 2018]. 4. Foster, J. (2016). Management Q&A: The Health-System Pharmacy and Therapeutics Committee. [online] Available at: https://www. pharmacytimes.com/publications/health-system-edition/2016/september2016/ management-qanda-thehealth-system-pharmacyand-therapeutics-committee
Figure 2. Financial Drug Spend: The U.S. Pharmacy Distribution and Reimbursement System3
North Carolina Pharmacist
Page 25 Volume 100 Number 1 Winter 2019
2019 Elections & Awards Deadline May 1, 2019
Elections NCAP members interested in serving on the NCAP Board and/or Practice Forum Executive Committees are invited to submit their bios by May 1 for the following important roles: NCAP Board of Directors
NCAP will elect a President-Elect (to serve as President in 2021) and one At-large Board Member (3-year terms). Please send bio to Stefanie Ferreri Stefanie_ferreri@unc.edu
Chronic Care Practice Forum
The Practice Forum will elect a Chair-Elect (3-year term) and three Executive Committee members (3-year terms). Please send bio to Tasha Woodall, 2019 Chair of the Practice Forum tasha.woodall@mahec.net
Community Care Practice Forum
The Practice Forum will elect a Chair-Elect (3-year term) and three Executive Committee members (3-year terms). Please send bio to Andria Eker, 2019 Chair of the Practice Forum andriaeker@gmail.com
Health-System Practice Forum
The Practice Forum will elect a Chair-Elect (3-year term), three Executive Committee members (3-year terms) and one Delegate to ASHP (3-year term). Please send bio to Brock Harris, 2019 Chair of the Practice Forum johnbrockharris@gmail.com
North Carolina Pharmacist
Page 26 Volume 100 Number 1 Winter 2019
Awards It is a privilege for the North Carolina Association of Pharmacists to recognize excellence within the profession. NCAP members are invited to nominate deserving members for the following awards to be presented at the Annual Convention. Nominations must be in writing (see nominations form on the website www.ncpharmacists.org or you may request from Angie Broughton). Send nominations to the NCAP Awards Committee, c/o Angie Broughton, 1101 Slater Road, Suite 110, Durham, NC 27703; FAX 984-439-1649; or e-mail angie@ncpharmacists.org
Bowl of Hygeia Award
Sponsored by American Pharmacists Association Foundation and National Alliance of State Pharmacy Associations Criteria for this award are: (1) Licensed to practice pharmacy in NC; (2) Has not previously received the Award; (3) Is not currently serving nor has he/she served within the immediate past two years on its awards committee or as an officer of the Association in other than an ex officio capacity; (4) Has compiled an outstanding record of community service, which, apart from his or her specific identification as a pharmacist, reflects well on the profession.
Don Blanton Award
Presented to the pharmacist who has contributed most to the advancement of pharmacy in North Carolina during the past year. This award was established by Charles Blanton in memory of his father, Don Blanton, who served the North Carolina Pharmaceutical Association as President 1957-58.
Excellence in Innovation Award
Sponsored by Upsher-Smith Laboratories Presented to a pharmacist practicing in North Carolina who has demonstrated Innovative Pharmacy Practice resulting in improved patient care.
Distinguished Young Pharmacist Award
Sponsored by Pharmacists Mutual Companies Criteria for this award are: (1) Entry degree in pharmacy received less than 10 years ago (2009 or later graduation date); (2) Licensed to practice pharmacy in NC; (3) Actively practices retail, institutional, managed care or consulting pharmacy; (4) Participates in national pharmacy associations, professional programs, state association activities and/or community service. Please send nominations for this award to Kevin Helmlinger, 2019 Chair of the New Practitioner Network kevin.helmlinger@gmail.com North Carolina Pharmacist
Page 27 Volume 100 Number 1 Winter 2019
North Carolina Pharmacist
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NC Pharmacy Preceptors Of the Year community rotations for CPHS. She is an outstanding pharmacist that is respected amongst her peers and by her students. Students have described her as a “great preceptor who gives just the right amount of autonomy and help when you need it.” Yearly, students specifically request her as a preceptor for the advanced community rotation. Additional accolades for Dr. Bastidas include: “Dr. Bastidas is a great teachThe Campbell University College of Pharmacy & er. She truly creates an enjoyable work environment Health Sciences (CPHS) Pharmacy Preceptors of that students can look forward to going to every day.” the Year are selected from nominations submit- Students value their time with her and undoubtedly ted by students who have completed a rotation recognize the impact that a caring, compassionate, in the current experiential year. Students submit and conscientious pharmacist can make on the lives nominations for individual preceptors believed of their patients. to be excellent teachers and pharmacist mentors deserving of the recognition as a “Preceptor of the Year.” The Office of Pharmacy Experiential Educa- Janna Beavers, PharmD tion at CPHS is pleased to recognize the following Dr. Janna Beavers awardees for 2017-18. graduated from Campbell in 2013 with both her PharmD and MasErin Bastidas, PharmD ters of Science in Clinical Research degrees. Dr. Erin Bastidas gradFollowing graduation, uated from Campbell Dr. Beavers completed University College of both a PGY1 PharmaPharmacy with her cy Practice residency PharmD degree in and a PGY2 Cardi2000. Following gradology residency at uation, Dr. Bastidas WakeMed Health & Hospitals. She has been a Board worked for Kerr Drug Certified Pharmacotherapy Specialist since 2014 until 2011 where she and earned Added Qualifications in Cardiology in served in numerous 2018. Dr. Beavers is currently the Cardiology Clinical roles ranging from Pharmacy Specialist at WakeMed. In addition to her staff pharmacist, pharmacy manager, and a district clinical responsibilities at WakeMed, she is the Resisupervisor. In 2011, she began working for Harris dency Director for the PGY2 Cardiology Residency. Teeter as a pharmacy manager. Recently, she has Dr. Beavers is a member of the Heart Failure Society was named the pharmacy manager at the new Harris of America and was recognized in 2018 as a Future Teeter pharmacy in Holly Springs. Dr. Bastidas has Leader in Heart Failure. She is also an active member served as a preceptor for Campbell students for nearof the American College of Cardiology, North Carolina ly 15 years. She precepts advanced and introductory Association of Pharmacists, and the American College North Carolina Pharmacist
Page 29 Volume 100 Number 1 Winter 2019
of Clinical Pharmacy. At Campbell Dr. Beavers holds an Adjunct Clinical Assistant Professor appointment, provides an elective course in cardiology and gives additional lectures in the pharmacotherapy course. She offers an advanced pharmacy practice cardiology elective rotation as well. In their nominations of Dr. Beavers, the following information was provided: “Dr. Beavers provided a great rotation with a clearly defined and logical structure. I valued the opportunity to participate in transitions of care activities on a daily basis where Dr. Beavers allowed me to provide patient counseling. Her rotation offered me every opportunity to grow as a pharmacy student. She was very prepared for my rotation. She asked me about specific interests ahead of my arrival and made sure everything I asked for was accomplished before the end of the month. She was a great example of someone who is masterful at time and energy allocation management. She very accurately understood my strengths and weaknesses and provided me with constructive and actionable feedback. She was receptive to my feedback as well.”
Dr. Ryan Mills The Experiential Department of the Fred Wilson School of Pharmacy at High Point University has the pleasure of recognizing Dr. Ryan Mills as our Preceptor of the Year for 2018. Each year this award is presented to a pharmacist preceptor, nominated by our students, who not only is a great teacher, but someone who encourages and mentors our students.
Students wrote, “Dr. Mills was an inspiration and from day one on my IPPE rotation, he welcomed me, challenged me and immersed me into the world of hospital pharmacy.” Students also added,” His teamwork, respect, and passion for ensuring that pharmacy is a valuable part of the medical team were the ultimate lessons learned on this IPPE rotation.”
After completing his PharmD degree from the West Virginia University School of Pharmacy, Dr. Mills earned a dual master of business administration and master of healthcare administration (MBA-MHA) from Pfeiffer University. He is also a board-certified pharmacotherapy specialist (BCPS). Dr. Mills is a member of the American Society of Health-System Pharmacists (ASHP), Pfeiffer Alumni Board of Directors, North Carolina Association of Pharmacists Health-System Practice Forum and Community Outreach Committee, and ASHP: Section Advisory Group on Advancing Pharmacy Practice with Technicians.
A longtime employee of the multi-state healthsystem Novant Health, Dr. Mills currently oversees comprehensive operational and regulatory processes at two south-central North Carolina medical centers. Before assuming this pharmacy management position in March of 2017, Dr. Mills served two years as a pharmacy supervisor at Novant Health Presbyterian Medical Center in Charlotte and three years as a clinical staff pharmacist at both Novant Health Presbyterian Medical Center and Novant Health Forsyth Medical Center in Winston-Salem. Preceptors play a vital role for our student’s experiential education component and we are honored that Dr. Ryan Mills is the High Point University Fred Wilson School of Pharmacy 2018 Preceptor of the Year.
Advanced Opioid Workshop: Transforming Practice to Save Lives Hendersonville, NC March 16, 2019 8:00-5:00
Go to ncpharmacists.org to register today!
Scott Wilkie, PharmD, MS, BS, BCPS The UNC Eshelman School of Pharmacy is pleased to recognize Dr. Scott Wilkie as Experiential Faculty Instructor of the Year. Dr. Wilkie is an Assistant Professor of Clinical Education with UNC Eshelman School of Pharmacy Asheville Campus. He is board certified in pharmacotherapy by the Board of Pharmaceutical Specialties. After receiving his Doctor of Pharmacy at the University Of Houston College Of Pharmacy, Dr. Wilkie completed a PGY1 residency in general clinical pharmacy and second year specialty residency in internal medicine at the Albert B. Chandler Medical Center at the University of Kentucky. Dr. Wilkie’s practice site is Mission Memorial Hospital in Asheville, NC. His specialty area is internal medicine where he has precepted numerous pharmacy students, pharmacy residents and medical residents in addition to coordinating research projects. His scholarship interests have focused on clinical education and antimicrobial stewardship initiatives. Dr. Wilkie’s teaching career began at the high school level where he taught students chemistry, forensics and health. Since that time, his approach to teaching continues to advance based on the collective review of literature, observations of other preceptors, and students’ feedback. The foundation of Dr. Wilkie’s teaching philosophy is building a relationship with the learner and providing a patientcentered clinical experience: “Once the student understands my ultimate goal is to assist them in reaching their goals, I am able to engage that student to make meaningful clinical interventions on behalf of the patient.” Setting a rigorous and foNorth Carolina Pharmacist
cused clinical experience for the student brings out the student’s best effort which Dr. Wilkie believes is a springboard for a successful career in pharmacy. The following are comments from student nominations: “Dr. Wilkie is one of the toughest and kindest preceptors I have ever had. He pushes his students to see the potential that he sees in us all. He wants us to strive for the best because he sees the best in us. I feel fully prepared for residency as I now know where my potential lies but also what my limits are. He was an amazing preceptor during and after the loss of one of his students; it was a situation that devastated the Mountain AHEC family, but it allowed us to reflect as a family and brought us all much closer as one unit. He is a really great teacher who just wants the best for his students.”
Mary Hobbs, BSPharm, RPh
The UNC Eshelman School of Pharmacy Claude Paoloni Preceptor of the Year in Community Pharmacy was awarded to Ms. Mary Hobbs. Mary graduated with a B.S. degree in pharmacy at UNC Eshelman School of Pharmacy in 1986. After graduation, Mary started working for Revco/CVS pharmacy as a staff pharmacist in Elizabeth City, NC and has been with the company for 34.5 years. She has served in many roles during her employment including staff pharmacist, pharmacy manager, and pharmacy supervisor overseeing 40 plus stores in NC and Roanoke VA. One thing that has not changed over these years is Mary’s passion to serve patients and to educate them on ways to improve their health. While working in Elizabeth City, she and other members of the community came together and opened a non-profit pharmacy serving patients in two counties who could not get assistance in paying for their medications. It was one of the most rewarding projects Mary participated in. This pharmacy has grown into a free clinic as well. Currently Mary serves as staff pharmacist at CVS Pharmacy in Wilson NC. She serves on the
Page 31 Volume 100 Number 1 Winter 2019
Advisory Committee for Eastern AHEC and is an Adjunct Faculty member for UNC Eshelman School of Pharmacy. She still strives every day to make a difference with the patients she encounters. Mary has taken this passion and served as a preceptor for 17 years. She encourages students to build a relationship with the patients. She provides management training to help students hire the right staff and to continue to develop them. Mary dispels the notion that “community practice does not require clinical skills.” Mary teaches students that there is no limit on what they can do to promote health; encouraging them to embrace each new day as a new opportunity to make a difference in someone’s life. For Mary, precepting is a way of giving back to the profession she loves. The following comments were provided in student nominations: “Mary is an outstanding preceptor that not only serves as a knowledgeable pharmacist and mentor, but as a caring advocate for her students. She demonstrates dedication to the rotation by outlining multiple lessons and projects during the month, while seeking input into our areas of interest and incorporating our interest into the month as well. Mary genuinely cares about both her patients and her students. She is a wonderful example of a community pharmacist able to build relationships with her patients while completing the busy tasks at hand on a daily basis. Mary is an outstanding community pharmacy preceptor who is deserving of this award.”
M. Lindsey Kennedy, PharmD, BCPS, BCPP M. Lindsey Kennedy, PharmD, BCPS, BCPP was honored as UNC Eshelman School of Pharmacy Claude Paoloni Preceptor of the Year in Health Systems. Dr. Kennedy is a clinical pharmacist who specializes in psychiatric pharmacy. She earned her PharmD degree from the University North Carolina Pharmacist
of North Carolina at Chapel Hill School of Pharmacy. She completed her PGY2 residency in Psychiatric Pharmacy at South Texas Veterans Health Care System, The University of Texas Health Science Center at San Antonio, and The University of Texas College of Pharmacy. Dr. Kennedy has practiced pharmacy in a variety of settings, including rural community pharmacy, operating room pharmacy, and acute care neurology and psychiatry. She currently is a clinical pharmacy specialist at UNC Medical Center and residency program director for the ASHPaccredited PGY2 Psychiatric Pharmacy Residency. Her practice site provides her the ability to care for a variety of ages and psychiatric disorders in an acute, inpatient setting. Her clinical interests include substance use disorders, woman’s mental health and destigmatizing mental illness. She is board certified in both Pharmacotherapy and Psychiatric Pharmacotherapy. She has enjoyed professional development in several different capacities via the College of Neurologic and Psychiatric Pharmacists, from committee membership and clinical pearl presentations, to standards setting with the Board of Pharmaceutical Specialties. Her precepting philosophy is to create a welcoming, relaxed environment for all levels of learners to grow both professionally and personally. At the beginning of each rotation, she tries to get to know the learner to assess their personal learning style, strengths and weaknesses. She then designs the rotation to meet the leaner where they are. She entrusts many activities for students to complete independently. “You don’t need to be a pharmacist to have a conversation with a patient about their family, favorite foods, or pets. These conversations help build a therapeutic alliance for both the student pharmacist and our profession as a whole. She teaches learners that patients are not just a name on their list, but human beings that should be treated as a whole person, not their diagnosis.” The following are student comments from her nomination: “Dr. Kennedy was an excellent role model in her care towards patients, her leadership in the community, and her mentoring of students. She always went to bat for her patients and put them first, even if an attending was tough to win over. She was actively involved in the UNC pharmacy community and assisting with pharmacy week, as well as serving on patient advocacy boards for the
Page 32 Volume 100 Number 1 Winter 2019
state. Even with everything else she had going on, I was never afraid to approach her with questions or discuss a patient. She made time to be present with her students and teach them useful skills that could be applied to life, such as mindfulness and meditation. She has gone above and beyond since my rotation in assisting me with the residency process.â&#x20AC;?
Dr. Thao Nguyen Wingate University School of Pharmacy is proud to recognize Dr. Thao Nguyen as the student-selected 2018 IPPE Preceptor of the Year. Dr. Nguyen received a Doctor of Pharmacy from the University of Illinois Chicago in 2000 and relocated to North Carolina in 2002. Dr. Nguyen has been a pharmacist with Harris Teeter Pharmacy in Matthews, NC for 14 years and precepted WUSOP students for eight years. Prior to her role at Harris Teeter, she worked for Eckerd Drug. She is highly regarded for providing exemplary patient care and creating a nurturing learning environment for students. Her desire to invest in the next generation of pharmacists is evident in consistent provision of availability for all rotation blocks and development of a challenging and inspiring pharmacy practice experience. Dr. Nguyen is a shining light in community pharmacy, and future pharmacists are fortunate to learn from and be inspired by her. North Carolina Pharmacist
When describing her pharmacy practice experience with Dr. Nguyen, one student recently wrote:
Dr. Nguyen became a preceptor to pay it forward. When she was in pharmacy school, she had preceptors who demonstrated what being a great pharmacist meant. These experiences have influenced her career and I can truly say that she embodies the kind of pharmacist that I hope to one day become. She was understanding, making sure that I learned at a comfortable pace, but she also had great expectations of me. Prior to my rotation, I had a firm set of beliefs of what community pharmacy was, but I honestly have to say that my perception has completely changed because I had such a great experience at my rotation site. This experience showed me the possibilities of a nurturing work environment that enables a pharmacist to perform at a peak level. When not at work, Dr. Nguyen enjoys spending time with her 10-year-old twins and volunteering at their school. She also volunteers her time at a local free clinic.
Save the Date 2019 NCAP Annual Convention
September 26-27 Benton Convention Center Winston-Salem, NC
Page 33 Volume 100 Number 1 Winter 2019
How to Apply to be a Pharmacy Preceptor in NC Pharmacists interested in precepting Campbell student pharmacists should visit: https://cphs.campbell.edu/academic-programs/pharmacy/doctor-of-pharmacy/experiential-education/preceptors/ and complete the online application. If you have any questions, please contact Shawn Carrillo, Director of Experiential Education at scarrillo@campbell.edu or call 910.893.1709. Pharmacists interested in precepting HPU student pharmacists should complete the online application form at this link: https://rxpreceptor.com/signup/ p/?HighPointUniversity Password: PRECEPTOR
Once your application is received you will be contacted by the Office of Experiential Education at HPU. Orientation will be conducted and a site visit will be scheduled. Pharmacists interested in precepting UNC Eshelman School of Pharmacy student pharmacists should visit: https://faopharmacy. unc.edu/student-admin/oep/preceptors-2/.
Contact Pam Jackson, Preceptor and Partner Specialist, pam_jackson@unc.edu to access a brief preceptor application. After completion of the application, a member of the Office of Experiential Programs team will follow-up with you about next steps. Pharmacists interested in precepting Wingate students should reach out to Christy Inge, Practice Experience Coordinator (c.inge@ wingate.edu, 704-233-8354).
North Carolina Pharmacist
Christy will provide you with a short application form. In addition to the application form, you will be asked to submit a CV and headshot, and complete the Preceptor Orientation CE (1 hour) prior to hosting their first student.
Page 34 Volume 100 Number 1 Winter 2019
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Page 35 Volume 100 Number 1 Winter 2019
National Poison Prevention Week
March 17 – 23rd, 2019 Pharmacists can educate patients to poison proof their home and keep medications out of reach from children (and pets) and locked away. Additionally, the safety cap should always be securely locked. The first step is encouraging patients to program the Poison Help line (1-800-222-1222) into their phones. This toll-free number connects individuals to a local poison control center where all information is confidential, and translation is available in 161 languages. Below is a partial checklist to help in the event of a poisoning. For the full checklist, go to: https://poisonhelp.hrsa.gov/what-can-you-do/emergency-checklist/index.html. First steps
§ If the person is not breathing, call 911. § If the person inhaled poison, get him or her fresh air right away. § If the person has poison on the skin, take off any clothing the poison touched. Rinse skin with running
water for 15 to 20 minutes.
§ If the person has poison in the eyes, rinse eyes with running water for 15 to 20 minutes. § Do not use activated charcoal when you think someone may have been poisoned. § Make sure to have the container of the product you think caused the poisoning nearby.
has important information.
The label
Be ready (if you can) to tell the expert on the phone: § The exposed person’s age and weight § Known health conditions or problems § The product involved § How the product contacted the person (for example, by mouth, by inhaling, through the skin, or
through the eyes) § How long ago the poison contacted the person § What first aid has already been given § Whether the person has vomited § Your exact location and how long it would take you to get to a hospital
Carolinas Poison Center
Carolinas Medical Center P.O. Box 32861 Charlotte, NC 28232 1-800-222-1222 Visit Web site North Carolina Pharmacist
Page 36 Volume 100 Number 1 Winter 2019
See How Much You Know ....................
about poisons and poison prevention!
1. True or False. Poinsettias and Christmas cacti are poisonous.
2. True or False. Poisonous mushrooms, called “death caps,” often grow in yards and parks.
3. True or False. Only 30 percent of caregivers are able to accurately measure a correct dosage of over-the-counter medications to their children.
4. True or False. If the product swallowed is burning, irritating or caustic, AND the person is conscious, not having convulsions, and able to swallow, advise them to drink at least 3-4 glasses of water or milk immediately. 5. True or False. Berries that birds and other animals can eat are safe for people.
6. True or False. Activated charcoal is generally preferred over Ipecac Syrup for gastrointestinal decontamination of pediatric poisoning.
7. True or False. Before advising a parent to give their child either activated charcoal or Syrup of Ipecac, the Poison Control Center should be called.
8. True or False. The safest way to defrost a turkey is by letting it sit on the counter (covered) for several hours. 9. True or False. Iron overdose is a common cause of poisoning in children under the age of 6 years.
10. True or False. Bacteria grow most quickly at temperatures between 40°F and 140°F. So, cold foods must be held below 40°F, while hot foods must be kept at 140°F or higher.
The answers can be found on page 9
North Carolina Pharmacist
Page 37 Volume 100 Number 1 Winter 2019
NCAP PRESIDENT’S CLUB NCAP and The Endowment Fund wish to thank the following for their support in 2018. If you wish to make a tax-deductible contribution, you may do so on your membership renewal form, on the website or by mailing your contribution to the NCPhA Endowment Fund, 1101 Slater Road, Suite 110, Durham, NC 27703.
Gold $100 - $999 Vestal Irving Boyles – Statesville, NC David Catalano – Wake Forest, NC Robert Cisneros – Buies Creek, NC Nicole Eastman – Charlotte, NC Evan Frasure – Cary, NC Angela Livingood – Burgaw, NC Debra Miller – Charlotte, NC Wallace Nelson – Hertford, NC Ritesh Patel – Raleigh, NC Dan Schenkat – Chapel Hill, NC Toyin Tofade – Durham, NC Kaye Vass – Mint Hill, NC Davie Waggett – Wilmington, NC Lori Wilson – Shelby, NC Roland Wood – Four Oaks, NC
Silver up to $99 Stephen Caiola – Chapel Hill, NC Joseph Casacchia – Greensboro, NC Christie Dresback – Candler, NC Kira Durr – Burlington, NC Lindsay Edwards – Bryson City, NC Charles Fenske – Louisburg, NC Donna Gibson – Charlotte, NC Alicia Gilsenan – Cary, NC Rola Habib – Cary, NC Lisa Hampton – Asheboro, NC Shelby Hudson – Salisbury, NC Daniel McClure – Fayetteville, NC Cynthia Parrish – Selma, NC Jacqueline Roh – Greensboro, NC Anna Ross – Benson, NC Sarah Russell – Lillington, NC Sylvia Saint-Amand – Fayetteville, NC Rod Teat – Concord, NC North Carolina Pharmacist
Page 38 Volume 100 Number 1 Winter 2019
Call for Peer Reviewers The North Carolina Pharmacist is currently seeking pharmacist volunteers to serve as peer reviewers. The journal is published online quarterly and is intended to inform, educate, and motivate pharmacists, from students to seasoned practitioners, and pharmacy technicians in all areas of pharmacy. Peer review helps to validate research and increases networking possibilities.
We are especially interested in pharmacists with expertise in the following areas: Anticoagulation Business Cardiology Compounding Hematology Immunizations Informatics Nutrition Oncology Hospice/Palliative Care Pharmacy Law / Legislative Issues Surgery
Did you know the average pharmacy prints 35 miles of paper each year?
Don’t miss this opportunity to share your knowledge and experience with the North Carolina pharmacy community by serving as a peer reviewer for the North Carolina Pharmacist.
By using MedsOnCue you can do your part to #savetheearth. VUCA Health has been engaging with boards of pharmacy across the country and your pharmacy management system vendor to allow patients to select a new digital form of medication information, including videos. Contact us today to learn more on how you can enhance your patient engagement and minimize your printing burden.
407.878.1662 | info@vucahealth.com | www.VUCAHealth.com
If you wish to be considered as a reviewer and/or want more information, please email Tina Thornhill, PharmD, FASCP, BCGP, Editor, at tina.h.thornhill@gmail.com. North Carolina Pharmacist
Page 39 Volume 100 Number 1 Winter 2019
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North Carolina Pharmacist
Page 40 Volume 100 Number 1 Winter 2019
Summit 2019
Hey North Carolina pharmacists, do you know how good you have it? You have the support and leadership of NCAP. You have the beaches, the Piedmont, the mountains, and Asheville! You are the home of the Asheville Project.
You are the birthplace of the Medipreneurs Summit! Healthcare and pharmacy practice are changing. Technology is rapidly expanding. The time is ripe to develop new ideas, practice models, and funding models. There are some trailblazing pharmacists who started down the entrepreneurial road years ago. Others have started innovative new practices and services within their places of employment (intrapreneurs). That is what the Inaugural Medipreneurs Summit was all about! Check out what attendees from April 2018 had to say at this link. It was apparent from the very first informal gathering of attendees as they arrived that this Summit had a special kind of energy. Even the primary sponsor said,
“The last 10 meetings I’ve attended haven’t had this much energy, and this one hasn’t even started yet”.
Join us this year! Change has to start somewhere. Will it start with you? Register for the 2019 Medipreneurs Summit at www.medipreneurs.com. Michelle Fritsch Pharm.D. BCGP, BCACP Co-founder Medipreneurs CEO & Founder, Meds MASH, LLC Call me with any questions! 410-472-5078
North Carolina Pharmacist
Page 42 Volume 100 Number 1 Winter 2019