April 2017 Newsletter
Call for Nominations for GSHP Awards


2017 GSHP AWARDS
CALL FOR NOMINATIONS  
 
The Georgia Society of Health-System Pharmacists annually recognizes members for outstanding service and achievements in pharmacy. Very likely, you know someone in GSHP who is deserving of recognition. Every member of GSHP is eligible to nominate or be nominated for one or more awards. Please fill out the nominations form on the next page to nominate yourself or someone you know for the awards listed below. Awards will be presented during the GSHP Annual Meeting to be held at the Omni Amelia Island Resort in Amelia Island, FL on July 8, 2017. Deadline for nominations is May 15, 2017.
    
Pharmacists of the
Year Award
 
     GSHP Pharmacist of the Year Award  is the highest honor GSHP can bestow on any member and is presented to a Georgia health-system pharmacist to honor outstanding service and accomplishments in health-system pharmacy practice as well as participation in GSHP. All GSHP members are eligible for nomination. Nominations should include detailed information concerning the nominee's professional, civic, and other activities. Recipients of the GSHP Pharmacist of the Year Award serve on the Awards Committee for five years following receipt of the award.
 
25-Year Practitioner Awards
 
     25-Year Practitioner Awards  are presented to GSHP members who have actively practiced hospital or health-system pharmacy for 25 years or more. Members are encouraged to nominate peers. Also, they may also nominate themselves for this award unless they are a previous recipient.
 
Outstanding Pharmacy Practitioner Award
 
     The Outstanding Pharmacy Practitioner Award is presented to a health-system pharmacist employed in a staff position. The award recognizes outstanding service to the profession in a non-administrative, non-managerial position.
 
Outstanding Residency Preceptor Award
 
     The Outstanding Residency Preceptor Award is presented to a health-system pharmacy residency preceptor. The award recognizes residency preceptor for outstanding service to the profession by serving as a preceptor to pharmacy residents.
 
Outstanding Pharmacy Professional Representative Award
 
     The Outstanding Pharmacy Professional Representative Award is presented to a representative of a pharmaceutical manufacturer or wholesaler who has made outstanding contributions to health-system pharmacy through service to, participation in, and involvement with GSHP and those practicing as health-system pharmacists.
 
Outstanding Health-System Pharmacy Technician Award
 
     The Outstanding Health-System Pharmacy Technician Award recognizes a health-system pharmacy technician who has demonstrated practice excellence and leadership in the support of implementing pharmaceutical care.
 
Community Service Award
 
     The Community Service Award is presented to a GSHP member for Outstanding service to his/her community. Services rendered are not limited to those as a pharmacist, but include any activities which enhance or improve the quality of life of the community.
 
 
Outstanding Pharmacy Intern/Extern Award
 
     The Outstanding Pharmacy Intern/Extern Award recognizes excellence in our future pharmacists. Nominations may be presented by preceptors, educators, or any other GSHP member who has had direct contact with an intern or extern who has shown exemplary service in this role.
 
 
Outstanding Young Health-System Pharmacist Award
 
     Nominees for the Outstanding Young Health-System Pharmacist Award are not limited by age, but by the length of time in the profession. Nominees should have graduated from a pharmacy school within the past five years. The recipient is chosen based on exemplary service and dedication to the field of health-system pharmacy in this time period.
 
Outstanding Hospital or Health-System Pharmacy Newsletter Award
 
     Recipients are selected for the Outstanding Hospital or Health-System Pharmacy Newsletter Award based on submission and review of the three most recent editions of their newsletter. To be eligible for consideration, the newsletter must be hospital generated and not a purchased newsletter.
 
Best Paper Describing a New Pharmaceutical Care Service
 
     The award for Best Paper Describing a New Pharmaceutical Care Service will be presented based on publications by GSHP members in the pharmaceutical literature. Selection of the recipient is made by the Awards Committee and is based on a review of pharmacy journals and other publications for the 12-month period beginning May 2016 through May 2017.
  
GSHP Pharmaco-economics Research Award
 
     The GSHP Pharmaco-economics Research Award is designed to recognize a GSHP member who has performed a pharmacoeconomic analysis in a particular area of pharmacy practice and to encourage pharmacists to investigate and report the cost benefits of pharmaceutical care through the provision of cost effective pharmacy services. Members performing an analysis or investigation in an area related to the cost effectiveness, cost benefit, or cost utility of a particular medication therapy, type of patient care delivered by pharmacists or some aspect of pharmacy services are eligible.  
 
To nominate someone, go to https://www.surveymonkey.com/r/2017gshpawards


Save the Date

GSHP Summer Meeting

July 7-9, 2017 
Omni Amelia Island Resort 
Amelia Island, FL


Hotel Reservations

To Register 

 
FRIDAY (7 hours)
Date/Time
Topic
Speaker(s)
8:00-8:55 am
(1 hour)
ASHP's Practice Advancement Initiative (PAI):   Using the tools to optimize your practice
 
Panel Discussion
9:00-9:55 am
(1 hour)
Title: Topical Treatment of Pain
 
Objectives:
1. Discuss the role of topical nonsteroidal anti-inflammatory drugs (NSAIDs) in the management of pain
 
2. Discuss the role of transdermal lidocaine in the management of pain
 
3. Review the evidence for compounded formulations in the management of pain
David Bookstaver Pharm.D. BCPS
Chief, Clinical Pharmacy
Eisenhower Army Medical Center
Fort Gordon,GA
 
 
 
10:00 am-10:15 am
Break
 
10:15 am -11:10 am
(1 hour)
The Challenge of C. difficile and Antimicrobial-Resistant Gram-negative Infections: Opportunities to Re-evaluate Current Management Approaches
  1. Explain current trends in local and regional antimicrobial resistance and identify patient risk factors for infection by problematic bacterial pathogens
  2. Assess the role of newer antimicrobial agents as part of the armamentarium in the management of infections caused by multidrug-resistant Gram-negative bacteria and C. difficile
  3. Evaluate the utility of novel approaches that reduce the risk of recurrent C. difficile infection in high-risk patients
  4. Describe antimicrobial stewardship strategies that aim to minimize the burden of serious bacterial infections in healthcare institutions
 
11:15 am - 11: 30 am
BREAK
 
 
11:30am - 12:40 pm [DC1] 
(1 hour)
Title: Reducing Hospital Readmissions in Heart Failure: Pharmacy's Pivotal Role
 
Objectives:
  1. Describe the high incidence and burden of heart failure, including the risk of hospitalization and the need to meet quality metrics for the reduction of readmissions in heart failure
  2. Explain the complex pathophysiology and risk factors for heart failure
  3. Integrate new classes of pharmacologic agents for heart failure into the current effective treatment paradigm
  4. Plan for the use of biomarkers and novel electronic monitoring technologies to workup, monitor treatment follow-up and medication adjustment in heart failure
 
12;45 pm - 1:40 pm
(1 hour)
TRACK A :
 
Title: Confronting the Rise of Cancers in the HIV Population
 
Objectives:
1. Summarize the incidence of AIDS and non-AIDS related cancer (NADC) diagnoses in HIV-infected patients
2. Review screening recommendations for people living with HIV/AIDS (PLWHA)
3. Discuss cancer treatment outcomes in PLWHA
lignancy in HIV
David L. DeRemer, Pharm.D. BCOP FCCP
Clinical Associate Professor
Outpatient BMT Clinical Specialist
University of Georgia College of Pharmacy
Augusta, GA
 
TRACK B
 
Title:   Scary Drugs for Small People
A Pharmaceutical Look at Pediatric Medical Emergencies
 
Objectives:
  1. Define key elements of pediatric emergency pharmacy that differ from adults
  2. Examine medications used in rapid sequence intubation in children
  3. Discuss drug choices in pediatric status epilepticus
  4. Explore pharmaceutical options in pediatric cardiac arrest and arrhythmias
 
Matt Post, Pharm.D., BCPPS
Emergency Room Pharmacist
Children's Hospital of Atlanta
 
1:45 pm - 1:55pm
(10 min)
BREAK
 
2:00pm-2:55 pm
(1 hour)
 
Track A
Management topic:     Billing- Overview of billing opportunities for pharmacists
 
Joshua B. Wyche, Pharm.D., MBA
Pharmacy Manager - Ambulatory & Oncology Services
Augusta University Health
Augusta, GA
Track B
 
Title: It's no longer a death sentence: an update in HIV/AIDS
 
Objectives:
  1. Describe the epidemiology of human immunodeficiency virus (HIV) in the United States
  2. Determine the approach to a baseline evaluation in a newly diagnosed HIV-infected patient
  3. Review differences between initial antiretroviral regimens
  4. Identify methods to promote patient adherence
  5. Discuss data supporting preexposure prophylaxis (PrEP) to prevent transmission
 
Daniel B. Chastain, Pharm.D., AAHIVP
Clinical Assistant Professor
University of Georgia College of Pharmacy, SWGA Clinical Campus
Clinical Pharmacy Specialist, Infectious Diseases
Phoebe Putney Memorial Hospital
Albany, GA
 
3:00 pm - 3:45 pm
(45 min)
ASHP Update
Paul Bush
President
ASHP
 
3:45 pm - 5:00 pm
Officer Installation and Awards
 
 
5:00pm - 7:00pm
 
Reception/Exhibits in Exhibit Hall
(2 hours)
------------
 
 
SATURDAY (3.5 hours)
Date/Time
Topic
Speaker(s)
(730-930)
REVERSE EXPO
8:00am - 9:25am
(1.5 hours)
Title: Biosimilars: Definitions and Impact to Health System Pharmacy
 
Objectives:
 
  1. Define "biosimilar"
  2. Differentiate between the terms biologic, biosimilar and bioequivalency
  3. Review efficacy and safety data on biosimilars in accordance with FDA guidelines
  4. Describe the role of the pharmacists regarding pharmacovigilance when reporting an adverse event involving a biosimilar
  5. List biosimilar products that pharmacists can expect to dispense in the future
 
Edward Li, PharmD, MPH, BCOP
Associate Professor, Pharmacy Practice
University of New England College of Pharmacy
Portland, ME
 
TRACK B
 
Title: Do you DOAC? Direct Oral Anticoagulation Management
               
Objectives:
  1. Discuss DOAC use and current practices
  2. Review DOAC use in subpopulations
  3. Illustrate the need for pharmacy involvement in DOAC patient care
  4. Propose strategies to expand or initiate pharmacy-driven DOAC management
Michelle McElhannon, Pharm.D. | Advanced Patient Care Pharmacist | AMS Clinic
Piedmont Athens Regional
Athens, GA
 
 
 
 
 
 
 
 
9:30am - 11:00am
Exhibits/Breakfast in Exhibit Area
(1.5 hours)
 
11:00am - 11:55am
(1 hour)
 
TRACK A
 
Title:   Using the Pharmacists' Patient Care Process to Enhance Students' Experiences in the Health-Systems Setting
 
Objectives:
1. Outline the JCPP Pharmacists' Patient Care Process
2. Identify how the various steps of the JCPP Process are employed in the health-system setting
3. Discuss ways to make the JCPP Process real and relevant during student pharmacy practice experiences
Lindsey H. Welch, Pharm.D., APPE Director, University of Georgia College of Pharmacy
 
Lori J. Duke, Pharm.D., Assistant Dean for Experience Programs, University of Georgia College of Pharmacy
 
Lindsey H. Welch, Pharm.D.
Public Service Associate
Director, Advanced Pharmacy Practice Experiences
University of Georgia College of Pharmacy
TRACK B
Title:   Optimizing the Digital Space in the Pharmaceutical Industry
 
Objectives:
After attending this session, participants should be able to
 
  1. Understand the importance of having a digital presence
  2. Identify key reasons for social media implementation
    1. Education
    2. Marketing
    3. Connectivity with Customers/ Patients
    4. Connectivity with Physicians/ Customers
    5. Clinical Trail engagement
    6. Listening and interacting
    7. Differentiate between relevant social media platforms
      1. In depth: Twitter, Facebook, LinkedIn, Blogging
      2. Analyze appropriate uses in accordance to company needs and FDA regulation.
        1. Design a company policy to fit individualized objectives
        2. Identity Standard
Tori Shober, BA
 
 

 

 
12:00pm - 1:00pm
(1 hour)
TRACK A:
 
Title:  Sticks and Stones May Break Bones, but Osteoporosis Doesn't Have To: A review of how to manage patients diagnosed with osteoporosis
 
Objectives:
  1. Describe the pathophysiology of osteoporosis
  2. Discuss risk factors associated with osteoporosis
  3. Summarize osteoporosis preventative care recommendations
  4. List non-pharmacologic and pharmacologic agents for the management of osteoporosis
  5. Design treatment and monitoring plans for the management of osteoporosis
 
Sharmon Osae, PharmD, BCACP
Clinical Assistant Professor, SWGA Clinical Campus
University of Georgia, College of Pharmacy
Albany, GA
 
TRACK B
 
Title: Sepsis 16: New Developments and Unsolved Mysteries
 
Objectives:
  1. Summarize the recently revised sepsis definitions and diagnostic criteria
  2. Discuss the new additions to the current guidelines
  3. Describe recommendations that lack clarity and review related evidence
 
 Anthony Hawkins, PharmD
University of Georgia College of Pharmacy
Albany, GA  
 
Resident Student Forum
 
SUNDAY (4 hours)
Date/Time
Topic
Speaker(s)
8:00am - 9:00am
(1 hour)
Title: Diabetes Update: Literature Evaluation of Recent Publications
 
Objectives :
  • Recall primary literature to support the use of new agents used in the management of diabetes
  • Identify changes to current guidelines because of recent publications
 
Anne Misher, PharmD, CDE
Clinical Assistant Professor
Clinical and Administrative Pharmacy
University of Georgia -
Southeast Georgia Campus
 
9:00am - 10:00am
(1 hour)
TBD 
 
10:00am - 12:00pm
(2 hour)
Controlled Substances-Best Practices
 
**Florida Approval Applied For**
Norman Tomaka
 
Total available to earn at conference is 14.5 hours



Clinical Articles
Statin and Non-Statin combination therapy: A new playbook for the management of cholesterol
 
Authors:  Lisa M. Sagardia, Pharm.D. Candidate Class of 2017 and Maria Miller Thurston, Pharm.D., BCPS
Corresponding Author:  Maria Miller Thurston, Pharm.D., BCPS, Clinical Assistant Professor, Mercer University College of Pharmacy, 3001 Mercer University Drive Atlanta, GA 30341, T: (678) 547-6253, F: (678) 547-6384, E: thurston_mm@mercer.edu
 
BACKGROUND
 
"Statins save lives!" This is a simple yet powerful statement. Students often recite this phrase with confidence and conviction when questioned about their recommendations to start statin therapy and with good reasoning. The clinical evidence supported by randomized controlled trials proves that statins are the preferred first-line therapy for low-density lipoprotein cholesterol (LDL-C) management. Additionally, statins contribute to significant improvements in cardiovascular outcomes. Statin therapy can provide a significant LDL-C reduction within 4-12 weeks, has a generally well-tolerated side effect profile, and has an abundance of evidence to support its use.1,2 It is clear that statins are the quarterback of the cholesterol game; however, the use of non-statins has been controversial as there was not a clearly defined approach for their use in practice. For this reason, non-statins have remained benched on the sidelines waiting for their chance to play on the field. The 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults provides vague guidance on the use of non-statins as adjunctive therapy. It states that the expert panel only encourages their use in high risk patients if they do not achieve the expected LDL-C reduction, cannot tolerate the maximum dosing of a recommended statin, or are statin intolerant.2 Luckily, there is now a new coach in town with a new playbook called 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 and it's ready to provide the necessary guidance on how clinicians can properly utilize non-statin therapy in the cholesterol game.1
 
Before taking a step away from the 2013 ACC/AHA cholesterol guideline to focus on the 2016 pathway document, it is time to huddle for a quick review of the statin benefit groups, definition of statin intolerance, and non-statin drug therapies. It is recommended that patients be placed into 1 out of the 4 statin benefit groups including: 2

1.      Individuals with clinical atherosclerotic cardiovascular disease (ASCVD)

2.      Individuals with LDL-C 190mg/dL

3.      Individuals with diabetes aged 40-75 years old with LDL-C between 70-189 mg/dL without ASCVD

4.      Individuals who do not have diabetes or prior clinical ASCVD with an LDL-C between 70-189 mg/dL but with a 10-year ASCVD risk of 7.5%

 
Atherosclerotic cardiovascular disease is defined in the guideline as any condition that has an atherosclerotic origin including myocardial infarction (MI), stable or unstable angina, transient ischemic attack or stroke, or a condition that required coronary revascularization . The statin benefit group classification dictates whether a moderate or high intensity statin will be utilized. 2

This is important because the new non-statin pathway document mimics this structure in their recommendations for additional non-statin therapy, with a few additional caveats. Furthermore, statin intolerance is defined as a continuous occurrence of muscle symptoms despite proper management, re-initiation with at least two to three different statins with varying metabolic pathways or lipophilicity, symptoms despite adjustment of the frequency and dosage administrations, and ruling out of other conditions that may increase myalgia risk such as hypothyroidism or vitamin D deficiency. The preferred non-statin therapies discussed in the 2016 pathway are ezetimibe, PCSK9 inhibitors, and bile acid sequestrants. Table 1 highlights key clinical features of the non-statin products included in the pathway including: efficacy in LDL-C lowering, dosing, adverse events, monitoring parameters, pertinent contraindications, and relevant counseling.1,2

TABLE 1: NON-STATIN THERAPY CLINICAL FEATURES2,3
EZETIMIBE (ZETIATM)
  • Efficacy: In combination with statin therapy, may lower LDL-C by an additional 23%4
  • Dosing: 10mg PO daily without regard to meals
  • Adverse Events: Fatigue, diarrhea, increased serum transaminases, gall stones, thrombocytopenia
  • Contraindications: Active hepatic disease
BILE ACID SEQUESTRANTS (BAS)
  • Available products: cholestryamine (PrevaliteTM) 4-12g twice daily, colestipol (ColestidTM) 30g/day, and colesevelam (WelcholTM) 6 tablets/day
  • Efficacy: Found to have 18-20% LDL-C reduction and may lower the HbA1c by 0.5%5
  • Adverse Events: Gastrointestinal effects (nausea, vomiting, bloating, flatulence), altered taste, elevated liver enzymes
  • Contraindications: Triglyceride level > 500 mg/dL due to the risk of pancreatitis as BAS increase triglyceride levels
  • Drug interactions: phenytoin and warfarin; acidic drugs
  • Counseling: Vitamin supplementation including iron, ADEK, and folic acid; separation of acidic drugs by 2 hours prior or 4 hours after administration of BAS
PCSK9 INHIBITORS
  • Available products: alirocumab (PraluentTM), evolucumab (RepathaTM), and bococizumab (RN316)-not yet FDA approved
  • Efficacy: In combination with statin, may lower LDL-C by 40-72%6
  • Adverse events: Nasopharyngitis, influenza, injection site reactions


PURPOSE
The purpose of the 2016 non-statin pathway document is to identify patients that are candidates for additional non-statin therapy, describe the clinical situations that would warrant a non- statin addition, provide guidance on the use of preferred non-statin agents outlined above, and provide more clarity regarding special population groups including patients with symptomatic heart failure, chronic kidney disease on maintenance dialysis, or women who are pregnant. The 2016 pathway document also provides specific LDL-C and non-HDL-C thresholds, in addition to expected LDL-C percent reductions, to guide assessment of therapeutic benefit. Finally, the 2016 pathway document sheds some light on the role of PCSK9 inhibitors including alirocumab (Praluent) and evolucumab (Repatha). 1
 
Currently, evidence associated with the addition of non-statin therapy for further ASCVD risk reduction is limited to the IMPROVE-IT trial (ezetimibe), HPS2-THRIVE trial (niacin), and ongoing ODYSSEY trial (alirocumab) data.7,8,9 The IMPROVE-IT trial found improved cardiovascular outcomes when ezetimibe was added to moderate intensity statin therapy with a 2% absolute risk reduction in the primary outcome of cardiovascular (CV) mortality, major CV event, or nonfatal stroke (NNT=50; [95% CI 0.89-0.99], p=0.016).7 The HPS2-THRIVE trial evaluated the addition of extended-release niacin-laropiprant to statin therapy; however, results demonstrated an increased risk of side effects including flushing, musculoskeletal adverse events, and gastrointestinal disturbances, with no benefits in cardiovascular outcomes.8 Finally, the ODYSSEY trial for alirocumab, a novel PCSK-9 inhibitor, is still pending with a completion date set for 2018. This large, double blind, placebo controlled trial involves approximately 18,000 patients with prior acute coronary syndrome, heterozygous familial hypercholesterolemia (HeFH), LDL-C > 70 mg/dL, and on maximally tolerated statin therapy. The primary outcome is change in LDL-C at 24 weeks and the primary endpoint is cardiovascular heart disease, MI, hospitalization, and ischemic stroke.9
 
2016 NON-STATIN PATHWAY RECOMMENDATIONS
Before considering the initiation of non-statin therapy, the expert consensus panel recommends the following must be optimized in each statin-benefit group:1
  1. 1.      Adherence to medication and lifestyle modifications including the addition of phytosterols or soluble dietary fiber. Sources of soluble fiber include fruits like blueberries and apples, oats, nuts, beans, tofu, carrots, and fiber supplements like Psyllium husk.10 These are important to incorporate into the diet as the combination can decrease LDL-C by 10%.11
  2. 2.      Statin therapy must be maximized with an inability to achieve expected LDL-C reduction, LDL-C threshold < 70-100 mg/dL, or non-HDL < 100-130 mg/dL if the patient is a diabetic, in accordance with the benefit group.
  3. 3.      Control the ASCVD risk factors including smoking, uncontrolled blood pressure, and diabetes.
  4. 4.      Engage in a clinician-patient discussion on the risks and benefits of therapy.
  5. 5.      Referral to a lipid specialist if there is a suspected underlying genetic predisposition.
 
Once the above have been implemented and optimized, clinicians can consider the addition of non-statin therapy. Table 2 summarizes the expert panel recommendations regarding the initiation and escalation of non-statin therapy.1


TABLE 2: NON- STATIN BENEFIT GROUPS, TARGET GOALS, AND TREATMENT
RECOMMENDATIONS*1
Benefit Groups
Target Therapy Goals
First-line Therapy
Alternative First-line Therapy
Second-line Therapy
Individuals with Clinical ASCVD With and Without Comorbidities
Without comorbidities:
-50% LDL-C reduction from baseline or LDL-C < 100 mg/dL
 
With Comorbidities:
-50% LDL-C reduction from baseline, LDL-C < 70 mg/dL, or non-HDL < 100 mg/dL
With and without comorbidities:
-Ezetimibe
With and without comorbidities:
-Alirocumab or evolocumab
With and without comorbidities:
-BAS
Individuals with LDL-C > 190 mg/dL
Not Due to Secondary Causes With and Without ASCVD
Without Clinical ASCVD:
-50% LDL-C reduction from baseline, LDL-C < 100 mg/dL, or non-HDL < 130 mg/dL
 
With Clinical ASCVD:
-50% LDL-C reduction from baseline or
LDL-C < 70 mg/dL
Without Clinical ASCVD:
-Ezetimibe or alirocumab/ evolucumab
 
 
With Clinical ASCVD:
-Alirocumab or evolocumab
Without Clinical ASCVD:
-Ezetimibe or alirocumab/ evolucumab
 
With Clinical ASCVD:
-ezetimibe
With and Without Clinical ASCVD:
-BAS
 
Individuals With Diabetes and LDL-C 70-189 mg/dL Without Risk Factors and ASCVD < 7.5% or With High Risk Factors and ASCVD 7.5%
-50% LDL-C reduction from baseline, LDL-C < 100 mg/DL, or non-HDL-C < 130 mg/dL
-Ezetimibe
-N/A
-BAS
Individuals with a 10-year risk of Clinical ASCVD 7.5%
-50% LDL-C reduction from baseline or
LDL-C < 100 mg/dL
-Ezetimibe
-N/A
-BAS


*all adjunctive therapy must be used in combination with maximally tolerated statin therapy
BAS= bile acid sequestrant
 
Non-Statin Benefit Groups
The first non-statin benefit group, individuals with clinical ASCVD, is broken down into two subgroups: subgroup 1 include those with or without comorbidities and subgroup 2 include those with clinical ASCVD and LDL-C 190 mg/dL not due to secondary causes. Examples of comorbidities include: diabetes, recent ASCVD or ASCVD event following the initiation of therapy, and uncontrolled risk factors including smoking and uncontrolled blood pressure. Secondary causes refer to hypothyroidism, kidney disease, or extreme dietary issues.  If a patient has failed to meet the expected cholesterol reduction outcomes despite treatment with a maximally tolerated statin and dietary and lifestyle alterations, consideration for adjunctive non-statin therapy may be appropriate. For individuals with clinical ASCVD with and without comorbidities, the treatments are the same with first-line therapy being ezetimibe, alternative first-line therapy with PCSK9 inhibitors such as alirocumab and evolocumab, and second-line treatment with bile acid sequestrants.  There are, however, differences in the LDL-C thresholds assigned to each group. Those with comorbidities or history of ASCVD have a stricter anticipated LDL-C threshold of < 70 mg/dL. When treating patients with diabetes, it is also important to assess the non-HDL level as this may be still be elevated even though the LDL-C is normal.  Those individuals with clinical ASCVD and LDL-C
190 mg/dl may consider first-line therapy with alirocumab or evolocumab as these medications may lower LDL-C by 40-72% in patients who have difficulty clearing blood cholesterol, such as those with familial hypercholsteremia.1,4
 
In understanding the role of PCSK9 inhibitors, it is important to understand familial hypercholesterolemia. As stated previously, these individuals typically have LDL-C
190 mg/dL and the underlying pathophysiology involves the inability to remove cholesterol from the blood due to 1 of 16,000 mutations in the LDL-C receptor. The pattern of inheritance is autosomal co-dominant homozygous (HoFH) or heterozygous (HeFH) and you can see coronary artery calcification presenting as early as 11 years old. The latter is more prevalent with a rate of 1: 200 births and the former, which is more severe, occurs in 1:1,000,000 births. Those with HoFH have an impaired ability to reduce LDL-C blood cholesterol by 53%. In order to maximally reduce the higher circulating LDL-C levels in these patients, first-line therapy should be with a maximally tolerated dose of a high intensity statin in combination with a PCSK9 inhibitor. This expert consensus pathway document places a stronger emphasis on the referral to a lipid specialist as these patients must be treated early, require life-long therapy, dietary restrictions, and family screening.1,12,13
 
The next statin benefit group, individuals with LDL-C 190 mg/dL without ASCVD, the expected outcomes of treatment would be a 50% or greater LDL-C reduction, LDL-C level of < 100 mg/dL, or non-HDL < 130mg mg/dL. These expected outcomes are much more lenient than those for patients with clinical ASCVD and a LDL-C 190 mg/dL. For this treatment group, clinicians have a choice of ezetimibe or alirocumab/evolocumab as first-line treatment options, with no preference specified. However, the clinician can take into consideration patient specific factors including cost, pill burden, ease of administration, and adherence barriers when considering therapies. Second-line therapy would be with a bile acid sequestrant, which is the universal theme throughout the pathway. These agents are not as well tolerated by patients due to the bloating, flatulence, and other gastrointestinal disturbances, require vitamin supplementation, and should not be used in individuals with triglycerides > 300 mg/dL.3
 
The third statin benefit group, individuals with diabetes and LDL-C 70-189 mg/dL, is broken down into two subgroups: subgroup 1 includes individuals without high risk factors with a 10-year ASCVD risk of 7.5% and subgroup 2 includes individuals with high risk factors and a 10-year ASCVD risk of 7.5%. High risk factors include diabetic retinopathy, elevated albumin or lipoprotein(a), or coronary artery calcification. The difference in these groups is the starting point in regards to statin intensity. Individuals in the former group may be started on a moderate intensity statin with lifestyle modifications including the addition of phytosterols and soluble fiber. Escalation in therapy to a high intensity statin may occur if the patient cannot meet the expected LDL-C percent reduction of 30-49% for moderate intensity statin therapy. Patients that fall into the latter group typically start with a high-intensity statin. Regarding the addition of non-statin therapy, both groups have the same first-line therapy recommendation of ezetimibe and second-line therapy option of a bile acid sequestrant. It should be noted that PCSK9 inhibitors do not have a role in this statin benefit group or the next due to a lack of safety and efficacy information from randomized controlled trials.
 
For the final statin benefit group, individuals with ASCVD 10-year risk
7.5%, there is a limited role for non-statin therapy and no role for PCSK9 inhibitors, as stated previously. Consideration may be given to starting a moderate or high intensity statin initially to reach the anticipated LDL-C reduction. Consideration for non-statin additions include: a 10-year ASCVD risk > 20%, family history of ASCVD, evidence of coronary artery calcification, chronic kidney disease, or inflammatory conditions that may increase overall risk. First-line non-statin therapy recommended is ezetimibe and second-line therapy includes a bile acids sequestrant in combination with a maximally tolerated statin with an expected LDL-C outcome of < 100 mg/dL or a 50% reduction in LDL-C from baseline.
 
Special Populations
For pre-menopausal women considering pregnancy, statins must be discontinued at least one to three months prior to any attempts for conception due to the concern for fetal harm.  A suitable alternative for these patients during pregnancy for LDL-C management would be a bile acid sequestrant. However, referral to a lipid specialist is highly recommended for continued monitoring of lifestyle modifications and LDL-C levels. Statins and alternate non-statin therapies may be re-initiated after the period of breast-feeding is over. 1
 
For patients with symptomatic heart failure, the CORONA and GISSI-HF trials evaluated the use of statin therapy in patients with ischemic and non-ischemic cardiomyopathy in an attempt to shed light on the controversy that statins may not improve survival outcomes in these patient populations. Overall, the results did not demonstrate improvements in mortality. However, the trials showed a reduction in all-cause hospitalizations (p=0.007), which favors the continuation of statin therapy in this population. Nevertheless, the results of this trial are not generalizable to this entire patient population as the trial only used one statin type at a lower dose than would have typically been utilized. The expert panel leaves the decision to the professional judgment of the clinician in determining if the patient would live long enough to benefit from the statin therapy. Regarding non-statin therapy initiation, there is no data to support their use in this patient population and this disease state remains an exclusion criteria for the ongoing PCSK9 inhibitor trials. 1,14,15
 
The final patient population reviewed in the 2016 consensus pathway includes those with chronic kidney disease and those undergoing maintenance hemodialysis, to which evidence from the SHARP and AURORA trials establish no significant benefit in those undergoing hemodialysis. These trials evaluated simvastatin and ezetimibe versus placebo to assess the reduction of atherosclerotic events with this LDL-C lowering combination. While the patient population with chronic kidney disease did see a statistically significant 2% relative risk reduction in atherosclerotic events (p=0.0021), the subgroup analysis of hemodialysis patients showed a non-significant 0.7% reduction in the primary event (HR 0.95, 95% CI 0.78-1.15). At this time, the expert panel once again recommends clinicians use their clinical judgment in assessing if their patients would benefit from treatment. 1,16,17
 
COMPARISION OF EXPERT OPINIONS REGARDING NON-STATIN THERAPY
There seems to be a consensus among opinion writers that the 2016 non-statin expert consensus pathway will serve as a key player when the ACC/AHA cholesterol guidelines are updated in the next couple of years. The pathway provides additional efficacy outcomes in the form of absolute LDL-C and non-HDL-C values, in addition to assessing LDL-C percent reduction. These expectations will give the clinician more guidance in assessing if therapy is effective or needs to be adjusted. In addition, most critiques agree that the expert consensus pathway lays an organized framework for clinicians to properly utilize non-statin therapy for additional LDL-C lowering and provides a place in therapy for PCSK9 inhibitors that was not previously defined.18,19,20 However, additional trials should be conducted to solidify the universal application of ezetimibe in addition to statin therapy for cardiovascular event prevention as controversy still exists within the United States and Europe over its use in practice. While the IMPROVE-IT trial revealed improved cardiovascular outcomes for the trial's subset of patients with acute coronary syndrome, the Food and Drug Administration FDA advisory committee did not initially recommend its use to apply to all patients for ASCVD risk reduction. This 2016 consensus pathway utilized the IMRPOVE-IT trial data to support its recommendations while the European Medicine Agency (EMA) similarly relied on the IMRPOVE-IT trial results to justify ezetimibe approval for cardiovascular event prevention.20 The results of this trial raise a second question about pursuing high intensity cholesterol lowering therapy over high-intensity statin therapy. Currently, high-intensity statin therapy is the preferred regimen for reduction in ASCVD events with a goal of at least 50% LDL-C reduction. However, with the proposition of new LDL-C target outcomes by the 2016 pathway, those with a LDL-C > 140mg/dL on maximally tolerated statin therapy face the obstacle of meeting a LDL-C target of < 70 mg/dL, which is correlated with reduced negative cardiovascular outcomes. With these new efficacy targets in mind, future trials need to focus on the combinations of statin and non-statin therapy to evaluate long-term safety and tolerability in patients with acute coronary syndromes and reframe their focus on high intensity lipid lowering therapy.21
 
CONCLUSION
The 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies serves as a guide for the addition of non-statin therapy to maximally tolerated statin treatment.  In addition, the expert committee provides additional LDL-C thresholds for clinicians to determine if therapy is optimized and if there is additional need for LDL-C reduction to prevent adverse cardiac risks. As a general rule, every effort should be made to ensure the initiation requirements for non-statin therapy are met, including adherence to therapy and assessing for issues associated with statin intolerance. Ezetimibe is generally the first-line non-statin option for all treatment groups due to its clinically significant results in LDL-C reduction and improvement in cardiovascular outcomes from the IMPROVE-IT trial. Bile acid sequestrants are usually a second-line alternative due to their inconvenient dosing, adverse gastrointestinal disturbances, and risk for drug interactions. Finally, while PCSK9 inhibitor outcomes trials are still pending, they show promise as additional first-line adjunctive therapy in individuals with clinical ASCVD and a LDL-C > 190 mg/dL, for maximum LDL-C lowering.  It is unclear if the phrase "non-statins save lives" will ring as tried and true in the classroom setting or clinical practice, but clinicians should prepare to see non-statin therapy step off the sidelines into the game of LDL-C lowering.
 
REFERENCES

1.       

Lloyd-jones DM, Morris PB, Ballantyne CM, et al. 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: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2016;68(1):92-125.

2.        Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2889-934.

3.        Lexi-Comp, Inc. (Lexi-Drugs). Lexi-Comp, Inc.; September 21, 2016.

4.        Morrone D, et al. "Lipid-altering efficacy of ezetimibe plus statin and statin monotherapy and identification of factors associated with treatment response: a pooled analysis of over 21,000 subjects from 27 clinical trials". Atherosclerosis 2012;223:251-261

5.        Insull W, Toth P, Mullican W, et al. Effectiveness of colesevelam hydrochloride in decreasing LDL-C cholesterol in patients with primary hypercholesterolemia: a 24-week randomized controlled trial. Mayo Clin Proc. 2001;76(10):971-82.

6.        Mckenney JM, Koren MJ, Kereiakes DJ, Hanotin C, Ferrand AC, Stein EA. Safety and efficacy of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease, SAR236553/REGN727, in patients with primary hypercholesterolemia receiving ongoing stable atorvastatin therapy. J Am Coll Cardiol. 2012;59(25):2344-53

7.        Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015;372(25):2387-97.

8.        Landray MJ, Haynes R, Hopewell JC, et al. Effects of extended-release niacin with laropiprant in high-risk patients. N Engl J Med. 2014;371(3):203-12.

9.        Odyssey outcomes: Evaluation of Cardiovascular Outcomes after an acute coronary syndrome during treatment with alirocumab SAR236553 (REGN727). Clinicaltrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT01663402. Accessed September 26, 2016.

10.     Dietary fiber: Essentials for a Healthy Diet." Available at: http://www.mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/fiber/art-20043983. Accessed September 26, 2016.

11.     Shrestha S, Volek JS, Udani J, et al. A combination therapy including psyllium and plant sterols lowers LDL-C cholesterol by modifying lipoprotein metabolism in hypercholesterolemic individuals. J Nutr. 2006;136(10):2492-7.

12.     Grossman M, Rader DJ, Muller DW, et al. A pilot study of ex vivo gene therapy for homozygous familial hypercholesterolaemia. Nat Med. 1995;1(11):1148-54.

13.     Gidding SS, Bookstein LC, Chomka EV. Usefulness of electron beam tomography in adolescents and young adults with heterozygous familial hypercholesterolemia. Circulation. 1998;98(23):2580-3.

14.     Clearfield M. Rosuvastatin in older patients with systolic heart failure. Curr Atheroscler Rep. 2009;11(1):5-6, 8.

15.     Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet. 2008;372(9645):1223-30.

16.     Baigent C, Landray MJ, Reith C, et al. The effects of lowering LDL-C cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011;377(9784):2181-92.

17.     Fellström BC, Jardine AG, Schmieder RE, et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009;360(14):1395-407

18.     Hughes, Sue. New Guidance on Use of Nonstatin Cholesterol-Lowering Drugs Available. Medscape 2016. http://www.medscape.com/viewarticle/865894. Accessed September 27, 2016.

19.     American College of Cardiology Publishes Guidance for Non-Statin Therapies. Journal of Invasive Cardiology. http://www.invasivecardiology.com/news/american-college-cardiology-publishes-guidance-non-statin-therapies. Accessed September 27, 2016.

20.     Guo, Yifang. What do we learn from the 2016 ACC Expert Consensus  Decision Pathway on Non-Statin Therapies for LDL-C Lowering in the Management of Atherosclerotic Cardio- vascular Disease Risk? Cardiology Plus 2016, Vol 1. No. 2. Accessed September 27, 2016.

21.    

Masana L, Pedro-botet J, Civeira F. IMPROVE-IT clinical implications. Should the "high-intensity cholesterol-lowering therapy" strategy replace the "high-intensity statin therapy"?. Atherosclerosis. 2015;240(1):161-2.



Lowering Lung Cancer Mortality: Your Pharmacist Can Help!  

By: Michelle Borg, Pharm.D. and Arpita Gandhi, Pharm.D., BCOP
 
Lung cancer is the second most commonly diagnosed cancer in both men and women and accounts for more deaths than colon, breast, and prostate cancers combined.  Only 16% of lung cancers are diagnosed at a localized stage, meaning that the vast majority of patients have diffuse and incurable disease at the time of diagnosis.  Lung cancer has an extremely high mortality rate, with a 5-year survival rate of only 17%.1  Since lung cancer is associated with poor outcomes overall, there is a dire need for methodologies that would reduce disease-related mortality.  Screening facilitates detection of disease at earlier stages, which would lead to an improved 5-year survival rate of 55%.1
 
Cigarette smoking is the most important risk factor for lung cancer, accounting for 80% of the lung cancer deaths in the United States.  This risk increases with both quantity and duration of smoking.1  While lung cancer screening is not an alternative to smoking cessation, annual screening for lung cancer with low-dose computer tomography (also called a low-dose CT scan, or LDCT) in a defined population of high-risks persons can prevent a substantial number of lung cancer-related deaths.2
 
Currently, LDCT is the only recommended screening test for lung cancer. Screening is only recommended for those that meet the high-risk criteria outlined below and who currently have no symptoms. 
 
The USPSTF recommends yearly lung cancer screening with LDCT for people who:2
  • Are aged between 55-80 years
  • Have a 30 pack-year smoking history (A pack-year is defined as the number of packs smoked per day multiplied by the number of years the person has smoked.  For example, a person who smokes 2 packs per day for 20 years has a 40 pack year smoking history.)
  • Those who currently smoke or have quit within the past 15 years
 
Screening should be stopped when one of the following criteria has been met:
2
  • Person turns 81 years old
  • Has not smoked in the past 15 years
  • Develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery
 
Like with any medical test, there are potential harms associated with lung cancer screening.  These include:2
  • False-negative and false-positive results.  False-negative results indicate that a person does not have cancer when in fact they do and false-positive results indicate that a person does have cancer when in fact they do not.
  • Overdiagnosis/incidental findings.  This is when the test finds cancer, but it may have never caused a problem for the patient and can lead to treatment that is not needed.
  • Radiation exposure.  Cumulative radiation exposure has the potential to cause cancer in otherwise healthy people.
 
Research has shown that pharmacists counseling patients on medications for quitting smoking positively impacts overall smoking cessation rates.3  Pharmacists can help patients select the most appropriate prescription or nonprescription product depending upon their lifestyle and smoking habits, ensure that patients understand how to use it, are willing to use it as prescribed, and most importantly are able to afford it.3  Pharmacists are an untapped resource that can stress the important health benefits of smoking cessation, some of which include decreasing the risk of lung cancer, stroke, and coronary heart disease.  Since pharmacists interact with patients on a daily basis, they can help guide patients to the decision to quit by employing the "5 A's" technique (Ask about tobacco use, Advise the patient to quit, Assess readiness to quit, Assist with quitting, and Arrange follow-up). 
 
Studies show that the use of pharmacologic agents (or medications) for cessation doubles the likelihood of successful quitting, and the effects of pharmacologic agents are substantially increased when combined with behavioral interventions.3 Pharmacists have the ability to recommend cost-effective and easy-to-use methods for smoking cessation.  The most commonly used medications include the nicotine replacement therapies (NRTs).  This group is comprised of nicotine gum, patch, lozenge, nasal spray, and inhaler. Prescription medication options can be discussed in detail with your pharmacist. Of note, e-cigarettes should not be used as a method for smoking cessation.  There is no established safety or efficacy data associated with their use as an alternative to smoking. 
 
If you are thinking about getting screened, talk to your doctor or other healthcare provider about your risk for lung cancer.  Visit the NCCN Guidelines for more information on lung cancer and whether or not screening is right for you.
 
The best way to reduce your risk of developing lung cancer is to abstain from smoking and avoid secondhand smoke.  Lung cancer screening with LDCT is not a substitute for smoking cessation.  For additional information and help regarding smoking cessation, please visit here .  
 
  1. American Cancer Society. (2016). Cancer Facts & Figures 2016. Retrieved from http://www.cancer/org/acs/groups/cid/documents/webcontent/003111-pdf.pdf
  2. Moyer V. Screening for Lung Cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 2014;160(5):330-338. doi:10.7326/m13-2771.
  3. Hudmon, Karen Suchanek et al. "Reducing Pulmonary Disease: The Pharmacist's Role In Smoking Cessation"Journal of Pharmacy Practice 14.2 (2001): 143-159. Web. 25 Jan. 2017.
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