By Gladys Dabaja, Pharm.D., director of pharmacy, Henry Ford Wyandotte Hospital, Wyandotte and SMSHP president-elect

The Southeastern Michigan Society of Health-System Pharmacists (SMSHP) continues to be busy with several continuing education (CE) programs during the third and fourth quarter of 2017. Our Board meetings resumed in September with a primary focus on upgrading and improving the SMSHP website. This will help promote membership growth and engagement as well as community outreach. The new website is more user friendly, and it will provide ease of service to our members. The Board has also been busy planning various events such as the Residency Showcase which was held on Oct. 11 at VisTaTech Center in Livonia. We had a great turnout and there was much enthusiasm among the students and program directors. Also, the Board has been working on finalizing the Annual Awards Banquet. General elections for president-elect, treasurer and two Board of Directors members were also held on Nov. 8.

By Marina Maes, Pharm.D., PGY1 pharmacy practice resident, University of Michigan Health System, Ann Arbor and Kaylyn Dougherty, Pharm.D., MHIIM, PGY1 managed care resident, University of Michigan Prescription Drug Plan, Ann Arbor 

Cardiovascular disease accounts for nearly one of every three deaths in the United States and is the leading global cause of death, representing 31 percent of all global deaths in 2013.¹ Low-density lipoprotein (LDL) is a well-established modifiable risk factor for cardiovascular disease, and reduction in LDL has been associated with risk reduction in negative cardiovascular outcomes including myocardial infarction, stroke and mortality. 

In 2013, the American College of Cardiology (ACC) and American Heart Association (AHA) developed new practice guidelines for the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults.² Prior to the development of these guidelines, the management of cholesterol and cardiovascular risk reduction was largely based on lowering LDL cholesterol to a specific target goal. In patients at highest risk, the recommended LDL goal was <70 mg/dL. However, in the updated guidelines, less emphasis was placed on targeting a specific LDL goal, and instead the focus shifted toward targeting and treating high risk patient populations. Specifically, the guidelines recommend that patients 21 years and older with clinical atherosclerotic cardiovascular disease (ASCVD) should be initiated on high-intensity statin therapy.² The current guidelines make no recommendations for or against specific LDL cholesterol goals in this patient population. 

Although statins are the primary pharmacologic agents for secondary prevention of ASCVD, several non-statin medications are used in clinical practice for management of cholesterol and ASCVD risk reduction including, but not limited to, ezetimibe, and more recently, evolocumab and alirocumab. Ezetimibe is an oral medication that reduces absorption of cholesterol from the gut through targeting the Niemann-Pick C1-like 1 (NPC1L1) protein, while evolocumab and alirocumab are newer monoclonal antibody injectable agents targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibition of PCSK9 leads to an increased availability of LDL-receptors which are essential for clearance of LDL cholesterol from the blood. 

In recent years, new data has emerged regarding the benefits of adjunct non-statin therapy. In 2015, the outcomes of the IMPROVE-IT trial were announced. This randomized, double-blind, placebo-controlled trial evaluated the effect of ezetimibe and statin therapy compared to statin therapy alone in patients following an acute coronary syndrome (ACS) event. The primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization, or nonfatal stroke was modestly lower in the combination arm compared to the statin monotherapy arm (hazard ratio 0.94, 95 percent confidence interval 0.89-0.99, p=0.016).³ Additionally, the combination arm had a lower LDL than the statin monotherapy arm (53.7 mg/dL vs. 69.5 mg/dL; p<0.001). 

In March 2017, the results of the FOURIER trial were published. This randomized, double-blind, placebo-controlled trial evaluated the addition of evolocumab to statin therapy in patients with ASCVD.⁴ The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization. The primary endpoint was reduced in the evolocumab arm (HR 0.85; 95 percent confidence interval 0.79 to 0.92; p<0.001).⁴ It is also important to note that the median LDL achieved in the evolocumab arm was 30 mg/dL. The ODYSSEY Outcomes trial is currently in progress, evaluating the effect of statin therapy with the addition of alirocumab on the occurrence of cardiovascular events in patients who have recently experienced an ACS event. Study completion is expected December 2017.⁵

The LDL cholesterol levels achieved in the FOURIER and IMPROVE-IT trials were lower than recommended LDL target goals of <70 mg/dL for the highest risk patient populations found in older guidelines. The patients in these trials were on background therapy with moderate-to-high intensity statins and the primary endpoints were still statistically significant. Based on this new evidence, perhaps targeting lower LDL cholesterol levels for secondary prevention in patients with ASCVD may still have a place in practice. 

In 2016, the ACC released the first expert consensus decision pathway describing the role of non-statin therapies for LDL-cholesterol lowering in the management of ASCVD risk.⁶ Since then, additional evidence surrounding the safety and efficacy of PCSK9 inhibitors has been published, including the FOURIER trial mentioned above. In September 2017, the Committee released revised recommendations pertaining to patients with clinical ASCVD with or without comorbidities on statin therapy for secondary prevention. They recommended consideration of ezetimibe or a PCSK9 inhibitor, such as evolocumab or alirocumab, in all patients with clinical ASCVD who do not achieve at least a 50 percent reduction in LDL cholesterol with a maximally tolerated statin. Following the initiation of the first agent, the addition of a second non-statin medication is reasonable as needed. The consideration of either ezetimibe or a PCSK9 inhibitor should also factor in patient preferences, costs and route of administration in addition to percent of LDL lowering desired. For <25 percent of additional LDL lowering, ezetimibe may be preferred, while in patients who require >25 percent additional LDL lowering, a PCSK9 inhibitor may be preferred. Additionally, they recommend considering an LDL cholesterol goal of <70 mg/dL in all patients, with or without the presence of comorbidities, diagnosed with clinical ASCVD on statin therapy for secondary prevention, though guidance is not explicit of when to use this target.⁶

Although these recent studies demonstrate a clear benefit in reduction of cardiovascular outcomes with the use of non-statin therapies in addition to standard of care with statins, there is much information that is still unknown. We do not know what the long-term effects are of these newer medications and we do not know what the ideal target LDL cholesterol level should be, or if there should even be a target. Furthermore, the cost of the newer PCSK9 agents are prohibitive for many patients and health plans. Additional studies and time are needed to fully assess the implications of non-statin therapies and LDL cholesterol goals. 

References: 
1. Benjamin EJ, Blaha MJ, Chiuve SE, et al; on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics – 2017 update: a report from the American Heart Association [published online ahead of print January 25, 2017]. Circulation. doi: 10.11.61/CIR.0000000000000485. 
2. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. Circulation. 2013: 01.cir.0000437738.63853.7a. 
3. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015; 372:2387-2397. 
4. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med 2017; 376:1712-22. 
5. ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment with Alirocumab. (2017). Retrieved from http://clinicaltrials.gov/ct2(Identification No. NCT01663402)
6. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk. JACC 2017; 70 (14) 1785-1822. 

By Dana Staat, Pharm.D., clinical pharmacy specialist, Spectrum Health, Grand Rapids and MSHP president

At the conclusion of every year, I am consistently surprised at how time seemed to race by. I feel this way, even more so, this year. When starting out the Michigan Society of Heath-System Pharmacists (MSHP) presidency year, it is easy to get overwhelmed by the Board meeting calendar, the charges that need to be written for each committee and the feeling of responsibility for this great organization’s success. In the blink of an eye, the committees have met, the meetings have all occurred, the charges are complete and the year is now over. Now it is time to reflect on the year that was. 

Notable Accomplishments

Revision of the MSHP Mission Statement and Goals: Due to outdated terminology within the MSHP mission statement and goals, the MSHP Board of Directors decided it was time for the mission statement to be revised. After much research, the Organizational Affairs Committee suggested that the MSHP goals be removed from the bylaws, revised, and placed into the MSHP Chapter Manual. Society goals often require frequent updating, so by removing the goals from the bylaws and placing them in the Chapter Manual, there would be fewer barriers to future updates. Subsequently, the Committee recommended that the revision of the MSHP goals be addressed as a future committee charge. At the MSHP Annual Meeting in October, a new mission statement was approved by the MSHP membership. The new mission statement reads: 

MSHP’s mission is to provide leadership, support, and a collective voice for its members as they practice and advance the pharmacy profession to achieve desired health outcomes through optimal medication use.
Approval of the MSHP Vision Statement: Prior to 2017, MSHP did not have a vision statement. The Organizational Affairs Committee worked throughout 2016 to craft a vision statement. That vision statement was approved in January 2017 by the MSHP Board of Directors. The MSHP vision statement will now be placed into the MSHP Chapter Manual. As you can see, the vision statement complements the revised MSHP mission statement. The MSHP vision statement reads:

MSHP’s vision is that all people in Michigan have pharmacy care providers to ensure optimal, safe and effective medication use.
Ambulatory Care Workshop: The Ambulatory Care Committee organized an excellent Ambulatory Care Workshop that occurred Sept. 14, 2017. The workshop focused on facilitating completion of the American Society of Health-System Pharmacists (ASHP) Ambulatory Care Self-Assessment tool within the state of Michigan. There were also a number of speakers who concentrated on sharing information about the ambulatory care services they provide. The 2017 workshop prompted a follow-up workshop that will occur in 2018 supported by a Practice Advancement Initiative (PAI) State Affiliate Workshop Grant provided by ASHP, where MSHP can utilize information obtained from the Ambulatory Care Self-Assessment tool.

Work in Progress

The 2017 MSHP theme was “Geared up for Provider Status.” Many of the charges that were developed for the MSHP committees focused on how we can prepare pharmacists for the day where we are listed as providers within section 1861(s)(2) of the Social Security Act. We had hoped that 2017 would bring a vote and approval by the federal legislature of H.R. 592 and S. 109 also known as The Pharmacy and Medically Underserved Areas Enhancement Act. Unfortunately, the bills have not been approved yet. However, there has been continual action and bipartisan support of these bills throughout the year. As of December 2017, 14 additional legislators have even cosponsored the bills. I look forward to 2018 and the opportunities that these bills may provide pharmacists as we work toward goals of increasing access and improving quality for Medicare beneficiaries through pharmacist-provided care services.

The Future

As I have often quoted J.R.R. Tolkien this year, “The greatest adventure is what lies ahead.” I truly believe that our profession is on the cusp of significant changes. I am honored to have served as the 2017 MSHP president. Here’s to the adventures we will encounter together in 2018. 

By Anuvrat Chopra, Pharm.D., BCPS, pharmacy resident, St. John Hospital and Medical Center, Detroit

The Michigan Society of Health-System Pharmacists’ (MSHP) Annual Meeting was held on Friday, Oct. 27, 2017, at the Kellogg Hotel and Conference Center in East Lansing. The event offered several networking opportunities for all attendees along with several continuing education seminars and numerous chances to meet and interact with fellow Michigan Pharmacists Association (MPA)/MSHP members and delegates. 

The event began with registration and continental breakfast, during which attendees networked over coffee and light refreshments. The keynote session was delivered by Scott J. Knoer, Pharm.D., chief pharmacy officer at Cleveland Clinic, Cleveland, Ohio, and Nadia Haque, Pharm.D., clinical pharmacy specialist at Henry Ford Hospital, Detroit, where population health management strategies related to medication use were discussed as well as guidance regarding the role of pharmacists participating in population health initiatives was provided. The Town Hall Meeting followed the keynote session, where Board Officers were sworn in as members of the MSHP Board, committee chairs and members were recognized for their services and the annual MSHP awards were handed out as well. Winners of this year’s MSHP Awards were: Pharmacist of the Year, Denise Pratt, Pharm.D., critical care specialist, Sparrow Hospital, Lansing; Joseph A. Oddis Leadership Award, Paul Walker, Pharm.D., clinical professor, University of Michigan College of Pharmacy, Ann Arbor; Professional Practice Award, Henry Ford Oral Chemotherapy Management Program Team, Henry Ford Health-System, Detroit, and lastly, President’s Award, Amber Lanae Martirosov, assistant clinical professor, Wayne State University, Detroit. This year, MSHP also awarded Rich Lucarotti, long-time executive vice president of the Society with the Service Award for his 25+ years of service and dedication to the Society and its mission. 

The morning concluded with the general session presented by Susan DeVuyst-Miller, Pharm.D., assistant professor at Ferris State University College of Pharmacy, Grand Rapids. Dr. Miller explained the role of opioid medications, signs of opioid overdose, the role of naloxone in preventing accidental prescription overdose and the current recommendations of the State and local opioid task force. The Clinical Skills Competition was also held in the morning, where teams composed of the best and brightest students from each Michigan College of Pharmacy competed to create a patient care plan. Winners of this year’s clinical skills competition were Maryam Abbo and Adina Poparad, Wayne State University pharmacy students.

After an excellent lunch with exhibitors, attendees had the option of choosing between three tracks: clinical, leadership/management and residency. Attendees choosing to start with the clinical track had the opportunity to attend a very informative presentation of recent updates in oral anticoagulation presented by Mona Ali, Pharm.D., clinical pharmacist specialist (anticoagulation) at Beaumont Hospital, Royal Oak and Jenna M. Holzhausen, Pharm.D., clinical pharmacist specialist (cardiac critical care) at Beaumont Hospital, Royal Oak. Attendees who chose to start with the leadership track attended a presentation by Jassu Dulai, Pharm.D., assistant director of pharmacy at Beaumont Hospital, Grosse Pointe, where new regulations for hazardous drugs mandated by USP 800 standards were discussed. Attendees interested in the residency track attended a seminar about new practitioner transitions and self-assessment skills presented by Nancy MacDonald, Pharm.D., transition of care coordinator and pharmacy resident on-call program coordinator at Henry Ford Hospital, Detroit, and Nicholas P. Torney, Pharm.D., clinical pharmacist (infectious diseases) at Munson Medical Center, Traverse City. 

After the first round of presentations, the next clinical track seminar was presented by Susan L. Davis, Pharm.D., clinical associate professor of pharmacy practice at Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences, Detroit; Bernard L. Marini, Pharm.D., clinical pharmacy specialist (inpatient hematology) at University of Michigan Health System, Ann Arbor and Nisha Patel, Pharm.D., clinical pharmacist (internal medicine) at Henry Ford Hospital, Detroit. At this seminar clinical updates in infectious diseases, pulmonary hypertension, oncology and hematology were discussed. The afternoon leadership/management track included a very informative session presented by Ryan P. Mynatt, Pharm.D., clinical pharmacist (infectious diseases) at Detroit Receiving Hospital, Detroit Medical Center, Detroit and Christine N. Yost, Pharm.D., clinical pharmacy specialist (infectious diseases) at Beaumont Hospital, Royal Oak, where tactics to approach the Joint Commission Antimicrobial Stewardship survey were discussed. The final residency track presentation covering mentorship in the profession of pharmacy was presented by Daniel J. Lobb, B.S.Pharm, pharmacist, Walgreens and representative of the Wayne County Pharmacists Association, Westland, Richard L. Lucarotti, Pharm.D., professor at Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences, Detroit, and Joshua Raub, Pharm.D., clinical pharmacist specialist (internal medicine) and director - PGY1 pharmacy residency program at Detroit Receiving Hospital, Detroit Medical Center, Detroit. 

Exhibitors also had the option to attend the reverse exhibitor program where representatives had the opportunity to have one-on-one discussions with key pharmacy decision makers about their products and company information. 

Next year’s meeting is planned for Friday, Nov. 2, at the Sheraton Detroit Novi Hotel in Novi, Mich. We can’t wait to see you there!

By Tyler Fenton, Pharm.D. candidate 2017, University of Michigan College of Pharmacy, Ann Arbor

Two years have passed since I made the decision during my second year of pharmacy school to get more involved in the profession of pharmacy within my State. At that time, while evaluating my options, the obvious choice seemed to be joining Michigan Pharmacists Association (MPA)/Michigan Society of Health-System Pharmacists (MSHP). The website did a good job of informing me about some of the various benefits, such as discounted education materials and a reduced registration fee for the MPA Annual Meeting and Exposition, but the value I eventually came to see in this organization was far beyond any monetary savings. The greatest value for me has come from the interactions I have had with the organization’s staff as well as with other members from around the State. 

The more I became involved with MPA/MSHP, the more I came to realize that its employees work tirelessly to represent our profession in the best possible way every chance they get. I had the pleasure of working with Amanda Lick, former MPA manager of advocacy, governmental and regulatory affairs, on various occasions and every time I was amazed by her depth of knowledge and involvement pertaining to politics on the State and national level. As we continue to advocate for provider status and expansion of our scope of practice, it is important to have someone lobbying for the interests of Michigan pharmacists, and MPA’s staff does an incredible job of that. Another wonderful ambassador to the organization is the Chief Executive Officer himself, Larry Wagenknecht. Over the past thirty years, Mr. Wagenknecht has built MPA into one of the largest and most influential state pharmacy associations in the country. He has done this while continuing to represent our profession through actively participating in various State healthcare task forces and committees. Even with all of the work they do, staff also continues to find time to work with pharmacy students from around the State through events at individual pharmacy schools or larger scale initiatives like Pharmacy Day at the Capitol. 

I have also had the opportunity to attend several meetings of the Wayne County Pharmacists Association and serve as a student representative on the MPA/MSHP Membership Committee. These experiences have given me the chance to network with a plethora of pharmacists from around the state who, like me, are passionate about working for the betterment of pharmacy practice. I have been told many times about how small the profession of pharmacy is, and every time I attend an event associated with MPA, that statement becomes more and more evident. Speaking from the perspective of a student, it is extremely rewarding recognizing familiar faces whenever I attend any kind of pharmacy-related event in this State, or sometimes even outside of it. 

As I continue progressing toward graduation with my Doctorate of Pharmacy in the spring, I can say that one of the best decisions I made during my time as a graduate student was to become a member of MPA/MSHP. I fully plan to maintain my membership because of the great experiences I have had as a student in this organization. It also feels great to know that my yearly membership dues allow important work to be done toward ensuring that I am practicing in a State where pharmacists will be continuing to expand their profession for years to come. I encourage any student pharmacists and new practitioners to join me in being a part of this wonderful organization.