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Appendix 1a: Training Packet Participating Pharmacist Education

• Educate pharmacists and necessary staff o Investigators provide on-site training within usual work day o All information available in education packet provided in advance (Appendix 2) o Objectives

STAR Ratings and Quality Measures • What they are? • How they are influenced • Why they are important • How community pharmacies impact them

2013 ACC/AHA and 2016 ADA Guidelines • New lipid management recommendations

Refresher of diabetes medications • Basic list of diabetes medications (brand/generic/class)

Research project Training

• Where in workflow and how to identify patients with diabetes without statin therapy (See below)

• Review of materials used to tag a patient (Intervention Leaflet found in Appendix 6)

• Scripts for conversations with patients • Overview of educational materials available for patients (Patient Education

found in Appendix 5) • Overview of standard fax form (Fax form found in Appendix 4)

Topic 1: Review of ACC/AHA 2013 and ADA 2016 Recommendations

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 Guidelines1

The task force published updated guidelines that now focus on reducing the risk of atherosclerotic cardiovascular risk (ASCVD) and have left behind the method of “treat-to-goal” in patients with abnormal blood cholesterol levels. These recommendations are based on evidence found in randomized controlled trials (RCTs) that identified four population groups, termed, “Statin Benefit groups,” consisting of patients that would benefit the most from statin therapy in reducing their risk of ASCVD. The evidence found in the RCTs showed reduced ASCVD risk when patients who could be categorized in one of the Statin Benefit Groups were treated with maximum tolerated statin therapy. These Statin Benefit Groups address both primary and secondary prevention of ASCVD. No RCTs were identified to have shown reduced risk of ASCVD when treating to a specific LDL-C or non-HDL-C number goal. The Statin Benefit Groups are listed and detailed as follows:1

1) Individuals with clinical ASCVD* 2) Individuals with primary elevations of LDL-C ≥ 190 mg/dL 3) Individuals 40 to 75 years of age with diabetes with LDL-C 70–190 mg/dL 4) Individuals without clinical ASCVD or diabetes who are 40 to 75 years of age with LDL-C 70-189

mg/dL and an estimated 10 year ASCVD risk of 7.5% or higher1

Appendix 1a: Training Packet

Treating these benefit groups is now based on the intensity of the statin medication. “The Expert Panel defines intensity of statin therapy on the basis of the average expected LDL-C response to a specific statin and dose.” There are three categories of intensity: high-intensity, moderate-intensity, and low-intensity. The basis for the specific categorizations comes from the RCTs, where a high level of evidence showed greater reduced ASCVD risk from what are now termed “high-intensity” statins than those now termed “moderate-intensity.” The same can be stated for moderate-intensity showing more risk reduction than low-intensity. Table 1 lists the intensities and their respective statins and doses. The Expert Panel has also constructed a thorough, user-friendly flow diagram of how to apply the new recommendations to these four Statin Benefit Groups (Figure 1). It is important to note that the Expert Panel still strongly recommends lifestyle modifications as a vital component in ASCVD risk reduction. Modification should be made with or without pharmacologic therapy and should include heart healthy diet, routine physical exercise, smoking cessation, and maintenance of a healthy weight.1

Table 1: Statin Intensity Categories High-Intensity Moderate-Intensity Low-Intensity

Daily dose lowers LDL-C on average ≥ 50%

Daily dose lowers LDL-C on average 30% to 50%

Daily dose lowers LDL-C on average < 30%

Atorvastatin 40 & 80 mg Rosuvastatin 20 & 40 mg

Atorvastatin 10 & 20 mg Rosuvastatin 5 & 10 mg Pravastatin 40 & 80mg

Lovastatin 40 mg Simvastatin 20 & 40 mg Fluvastatin 40 mg BID Pitavastatin 2 & 4 mg

Pravastatin 10 & 20 mg Lovastatin 20 mg Simvastatin 10mg

Fluvastatin 20 & 40 mg Pitavastatin 1 mg

Adopted from: Stone NJ, et al. Journal of the American College of Cardiology. 2014;63(25):2889-2934.


Figure 1: Major recommendations for statin therapy for ASCVD prevention

Stone NJ, et al. Journal of the American College of

Cardiology. 2014;63(25):2889-2934. *Clinical ASCVD is defined as follows: acute coronary syndromes, history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin.

Appendix 1a: Training Packet American Diabetes Association Standards of Medical Care in Diabetes – 20162

The Professional Practice Committee (PPC) of the American Diabetes Association (ADA) published their latest recommendations for diabetes care and cholesterol management in January 2016. The ADA first supported the ACC/AHA’s switch to statin-intensity therapy to reduce ASCVD risk from a treat-to-goal model with cholesterol-lowering therapies with their 2015 guideline publication.3 With the 2015 publication, the PPC acknowledged the evidence and benefits of statin-intensity therapy in reduction of ASCVD risk and followed in line with ACC/AHA’s 2013 recommendations for the Statin Benefit Group, “Individuals 40 to 75 years of age with diabetes with LDL-C 70–190 mg/dL.1,3” The updated 2016 guidelines still hold the same recommendation for those aged 40 to 75; but, the PPC has now included recommendations for diabetics who are less than 40 years of age, diabetics that are greater than 75 years of age, and have recommended alternative agents in addition to a moderate-intensity statin for those that cannot tolerate a high-intensity statin. Table 2 summarizes the recommendations for statin therapy based on age and risk factors for people with diabetes.2

Table 2: Recommendations for statin and combination treatment in people with diabetes

Adopted from: Cefalu WT, et al. Journal of Clinical and Applied Research and Education. 2016;39(1):S1-S112.

Now, the ADA is recommending that any diabetic patient with ASCVD be treated with high-intensity statin therapy, regardless of their age, as long as they can tolerate it. If they cannot tolerate the high-intensity dose, they now recommend a moderate-intensity statin plus ezetimibe (Zetia). This recommendation is based on evidence from the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), that showed reduced major adverse cardiovascular events in those treated with a moderate-intensity statin and ezetimibe. With this new mortality data, ezetimibe may now be used to reduce risk of ASCVD. As for the new age groups, even though there is little data for patients that are less than 40 years of age or greater than 75 years of age, the ADA recommends adding statin therapy to their regimen if they present with ASCVD risk factors.3 Especially for our geriatric population, the risk vs benefit should be regularly and thoroughly evaluated. With the emerging allegations associated with statin therapy and long term use and use in the geriatric population and little evidence to deny or support, caution should be advised and heeded in these populations. As is always dictated, clinical and professional judgement should be used to make the best decision for the patient as a whole.

Age Risk Factors Recommended statin intensity*

< 40 years None ASCVD risk factor(s)** ASCVD

None Moderate or high High

40-75 years

None ASCVD risk factors ASCVD ACS and LDL > 50mg/dL in pts who cannot tolerate high-dose statins

Moderate High High Moderate + ezetimibe

>75 years

None ASCVD risk factors ASCVD ACS and LDL > 50 mg/dL in pts who cannot tolerate high-dose statins

Moderate Moderate or high High Moderate + ezetimibe

*In addition to lifestyle therapy **ASCVD risk factors include LDL ≥ 100, high BP, smoking, overweight and obesity, and family history of premature ASCVD


References:

1) 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: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2014;63(25):2889-2934. Accessed August 10, 2016.

2) Cefalu WT, Bakris G, Boulton AJM, et al. American Diabetes Association Standards of Medical Care In Diabetes – 2016. Journal of Clinical and Applied Research and Education. 2016;39(1):S1-S112. Accessed August 10, 2016.

3) Grant RW, Donner TW, Fradkin JE, et al. American Diabetes Association Standards of Medical Care In Diabetes – 2016. Journal of Clinical and Applied Research and Education. 2015;38(1):S1-S93. Accessed August 26, 2016.

Appendix 1a: Training Packet Topic 2: List of available hypoglycemic agents Drug Class Generic Brand

Glitinides Repaglinide Prandin Nateglinide Starlix

Alpha-Glucosidase Inhibitors Acarbose Precose Amylin Analog Pramlintide SymlinPen

2nd Generation Sulfonylureas Glimepiride Amaryl Glipizide Glucotrol Glyburide Diabeta, Micronase

Biguanides Metformin Glucophage

Thiazolidinediones (TZDs) Pioglitazone Actos Rosiglitazone Avandia

Dipeptidyl Peptidase-4 Inhibitors (DPP-4)

Sitagliptin Januvia Saxagliptin Onglyza Linagliptin Tradjenta Alogliptin Nesina

Glucagon-like Peptide-1 Analogs (GLP-1)

Exenatide Bydureon, Byetta Liraglutide Victoza Dulaglutide Trulicity Albiglutide Tanzeum Lixisenatide Adlyxin

Sodium-Glucose Cotransporter 2 Inhibitor (SGLT-2)

Canagliflozin Invokana Dapagliflozin Farxiga Empagliflozin Jardiance

Rapid-acting Insulin

Aspart Novolog Lispro Humalog Glulisine Apridra Oral Inhalation Afrezza

Regular-acting Insulin Insulin Regular Humulin R, Novolin R, Humulin U-500 Intermediate-acting Insulin Insulin NPH Humulin N, Novolin N Long-acting Insulin Glargine Lantus, Toujeo Detemir Levemir Degludec Tresiba


Topic 3: Star Ratings and Quality Measures The Centers for Medicare & Medicaid Services (CMS) Star Ratings system is used for Medicare Part C

and D plans, where the rating indicates the overall performance of the plan in patient clinical outcomes based on performance metrics. A five-star scale, where one star indicates poor performance and five stars indicates excellent performance, will now be used to rate each individual plan based on their designated performance measures.1 Different measures carry different weight for the rating process; for example, screenings and annual flu vaccines have a weight of 1, whereas medication adherence carries a weight of 3. These ratings are publicly available for access and comparison of available plans.

In 2016, there are 15 different measures of quality for Medicare Part D, and five of those measures directly relate to patient safety, appropriate medication use, and adherence – prime areas of opportunity for community pharmacies to impact.2

It is important to note that pharmacies do not get rated. Rather the plan alone receives the report; yet, health insurance companies are recognizing the importance of the pharmacy in helping boost their Star Rating. Thus, health insurance plans now have contracts and offer incentives to pharmacies for preferred network status and payment bonuses for improved quality measure performance.3 Because of this, community pharmacies have already begun to shift their attention to these metrics and focus on ways to improve these numbers of performance.

Pharmacies and healthcare plans can view performance reports on the Electronic Quality Improvement Platform for Plans and Pharmacies (EQuIPP) dashboard. EQuIPP is an online information platform that can be used by pharmacies to assess and evaluate their impact on patient care through the designated metrics.4 There is a two-year lag in data collection and implementation of data used to rate a plan, i.e. 2015 data will be used for 2017 Star Ratings; thus, high performance now will lead to maintained or improved business for the future.3

A new measure was endorsed by the Pharmacy Quality Alliance (PQA) in November of 2014, Statin Use in Persons with Diabetes. This new measure was later endorsed by the National Quality Forum in May of 2016 and will be implemented as a display measure for 2017 and 2018 (using 2015 and 2016 data), and a Star Rating in 2019 (using 2017 data); however, it has already been added to the EQuIPP dashboard for pharmacies and plans to track their performance.3,5

Having this data available now gives pharmacies an advantage and opportunity to build their performance values before the metric is implemented, affecting their contracts, compensation, and qualifications with plans.

References

4) Medicare Rights Center. The five-star rating system and Medicare plan enrollment. New York, NY; 2016. Available at: http://www.medicareinteractive.org/. Accessed August 4, 2016.

5) Pharmacy Quality Alliance. Update on Medication Quality Measures in Medicare Part D Plan Star Ratings – 2016. Springfield, VA; 2016. http://pqaalliance.org/measures/cms.asp. Accessed August 4, 2016.

6) Hester SA. PL Detail-Document, Quality Measures for Pharmacies. Pharmacist’s Letter/Prescriber’s Letter. July 2016. Accessed August 9,

2016. 7) Electronic Quality Improvement Platform for Plans & Pharmacies. I am a Pharmacy Professional. Durham, NC; 2016.

https://www.equipp.org/professional.aspx. Accessed August 4, 2016. 8) Centers for Medicare and Medicaid Services. Announcement of calendar year (CY) 2017 Medicare Advantage capitation rates and Medicare

Advantage and Part D payment policies and final call letter. Baltimore, MD; 2017. https://www.cms.gov/Medicare/Health-Plans/ MedicareAdvtgSpecRateStats/Downloads/Announcement2017.pdf.


Topic 4: Research Project Title: Community Pharmacist-Led Intervention to Identify Persons with Diabetes Not on Statin

Therapy Primary Investigator: Evan Drake Co-investigators: Danielle Harris, Macary Marciniak Purpose: To determine the impact of a pharmacist workflow intervention in increasing identification

of persons with diabetes not prescribed statin therapy, and thus, the pharmacist intervening to establish this therapy with the patient and the prescriber.

Primary Outcome: Percent of eligible patients flagged for intervention by the pharmacist; i.e. the numerator will be the number of patients flagged for intervention, the denominator will be the number of eligible patients requiring intervention.

Duration: 1-2 months

Topic 5: Implementation of Workflow Intervention

Pharmacist Product Review Workflow Intervention 1) At final point of product review, identify a diabetes medication 2) Pharmacist will check patient’s profile for a statin prescription to be on file

a. If a statin prescription is on file, the pharmacist may proceed with usual product review workflow

b. If no statin prescription is on file, the pharmacist will then check for inclusion criteria: i. Patient is 40-75 years of age

ii. Patient has prescriptions on file for 2 or more diabetic medications iii. Patient has Medicare Part D insurance coverage

3) If the patient meets all eligible criteria, the pharmacist will then tag the prescription bag with provided “Study Patient” leaflet and write the prescription number on designated area of leaflet (Appendix 6)

a. If the patient does not meet all of the eligible criteria, the pharmacist will proceed with usual product review workflow

4) The pharmacist will then make a comment in the patient profile that they have either identified and tagged the patient for intervention or identified that the patient does not qualify for intervention using the following phrases:

a. “Patient meets study inclusion criteria and has been tagged for intervention [DATE + initials]” b. “Patient does not meet study inclusion criteria for intervention [DATE + initials]”

Appendix 1a: Training Packet Point of Sale (POS) Station 1) The pharmacist/technician/resident/student pharmacist/store administration will identify the

patient tagged for intervention and alert the pharmacist on duty 2) Pharmacist should first identify and verify that they are speaking directly to the patient flagged for

intervention a. If, someone else has come to pick up the eligible patient’s prescription do NOT proceed with

intervention b. Pharmacist will need to call the eligible patient and proceed with intervention via telephone

communications 3) Using the provided script (Topic 6), the pharmacist will identify the patient has diabetes and inquire

if they are currently on statin therapy a. If the patient answers YES – follow script prompts and record appropriate information on the

leaflet i. Circle “Y” in the “On Statin Therapy?” section

ii. Provide where they get their statin medication in appropriate section b. If the patient answers NO – follow script prompts and record appropriate information on the

leaflet i. Circle “N” in the “On Statin Therapy?” section

ii. Obtain verbal consent 1. If they DO agree, provide education materials and continue following script

prompt regarding notification of their prescriber a. Confirm who the primary care physician is with the patient

2. If they do NOT agree, provide education and record why they do not want intervention

a. Inquire about barriers to intervention and address barriers where appropriate; provide education materials

4) For all patients, after intervention: a. Record remaining appropriate information on the leaflet – date, if education materials

provided, barriers, barriers addressed, if fax sent b. Pharmacist signature required after each intervention

Pharmacist to Prescriber Intervention 1) The pharmacist will fax the prescriber of each patient that agreed to intervention using the

standardized fax materials provided by the researcher (Appendix 4) a. Fill in patient name and date of birth

2) If the physician has not returned communication within 7-10 days, follow-up once via telephone 3) Record encounters


Topic 6: Scripts and Addressing Barriers from Patients and Prescribers Script 1: Patient picking up Rx and Intervention is Identified

1) After formal greeting and confirmation of patient identification: 2) I noticed that you are picking up [insert diabetes medication names], are you using these to

treat diabetes? a. IF NO – OK, thank you for your time. (Proceed with check out process) b. IF YES – OK. Proceed to step 3.

3) Are you currently taking a statin medication used for cholesterol? (Provide examples of statin medications if needed).

a. Record answer on tagging leaflet b. IF YES – If you do not mind me asking, where are you getting these medications filled? I

noticed that you are not getting one dispensed through Walgreens. i. Record answer on tagging leaflet

c. IF NO – Proceed to step 4. 4) Has your doctor spoken with you about statin medications before?

a. IF YES – What did he explain to you? Proceed to Step 5 if applicable. b. IF NO – OK. Proceed to Step 5.

5) Because you are have diabetes, the American College of Cardiology, American Heart Association, and American Diabetes Association all recommend that you be on statin therapy. Statins are a group of medications that are used to lower cholesterol. Over time, cholesterol can leave deposits in your blood vessels and eventually a plaque or blockage can be formed, leading to a stroke or heart attack. Having diabetes puts you at an increased risk for these cardiovascular events due to the high sugar levels in your blood causing damage to these same blood vessels. Studies have shown that statin therapy in diabetic patients ages 40 to 75 reduces the risk of heart attack and stroke. If you are in agreement, I would like to contact your doctor regarding this gap in therapy and recommend he place you on statin therapy. Do I have your permission to make that contact?

o Record answer on tagging leaflet o IF YES – Proceed to step 6. o IF NO – Would you mind telling me your concerns or why you would not like me to

contact your doctor? Record answer on tagging leaflet Proceed to step 7

6) Thank the patient for their willingness to let you intervene. Provide them with the “Patient Education” handout. Ask if they have any questions about statins or the recommendations. Refer to the handout or the “Common Concerns of Initiating Statin Therapy” handout if needed.

a. Proceed to Step 8 7) If one of the reasons provided is addressed on the “Common Concerns of Initiating Statin

Therapy,” provide them with this information and ease any fears possible with available resources and knowledge.

a. After addressing the concerns brought up, ask the patient if they would now be willing to let you intervene with their prescriber regarding this therapy gap.

i. If YES, proceed to step 8 ii. If NO reassure them that you are available for further questions and they can

ask for intervention anytime 1. Record answer on tagging leaflet


8) Thank the patient for their time and willingness to allow you to intervene. a. Tear off tagging leaflet prior to sale b. Fax prescriber using provided faxing materials c. File leaflet in provided folder/bin d. Record on leaflet that the fax has been sent to the prescriber

Common Concerns of Initiating Statin Therapy:

1. “Patient’s cholesterol is normal/good” → If the patient does not have high cholesterol, there is strong evidence from studies that show if a patient has diabetes and their LDL cholesterol is anywhere between 70 and 189 mg/dL, a moderate-to-high intensity statin reduces incidence of heart attack and stroke significantly (please see Table 1 for further details).1,2,3,4

2. “History of muscle pain from statin/pt. cannot tolerate statins” A patient is not considered “statin intolerant” until there has been documented, “…unacceptable muscle-related symptoms that resolve with discontinuation of therapy and occur with rechallenge on at least 2-3 statins, preferably ones that use different metabolic pathways and have different lipophilicity, and 1 of which is prescribed at the lowest approved dose5.”

o First, evaluate secondary causes of muscle pain: Recent increase in exercise activity Low Vitamin D levels Hypothyroidism Drug-drug interaction that increase systemic statin exposure

o Second, if you are able to exclude secondary causes and believe the muscle pain is

from the statin, the guidelines4,5 indicate to: Hold statin therapy until muscle pain symptoms resolve and then rechallenge

with same statin at the same or lower dose to verify statin-related adverse symptoms

Switch to different statin of different metabolism and lipophilicity beginning at lowest dose and titrate slowly (may repeat this step with different statin medication if desired)

Can trial patient on co-administration with Coenzyme Q-10 Switching to a statin with a long half-life to trial alternative dosing of 3 times per

week

o Third, if statin intolerance does prove true to the patient, consider adding Zetia to patients maximally tolerated statin intensity regimen Always reinforce adherence and lifestyle modifications IMPROVE-IT trial6

• Zetia 10mg added to moderate-intensity statin showed additional decrease in LDL-C levels compared to moderate-intensity statin monotherapy

• Dual therapy was also statistically significant for ASCVD reductions over a 7 year follow up period


3. “Pt. is on fenofibrate/niacin/other non-statin cholesterol medication” → There is actually no supporting evidence that adding one of the above non-statin medications reduces the incidence of heart attack and stroke. The strongest evidence supports a moderate- or high-intensity statin in patients with diabetes to reduce the risk of heart disease. (ACCORD Trial7)

4. “I would like to see the pt. before initiating prescription” → Okay, we hope that you discuss this option with them and provide them with the best therapy available!

5. “Pt. has refused statin in the past” → If you think a statin is appropriate treatment for the patient, I would strongly recommend that you please bring it up at their next appointment. Feel free to use any of the information I have provided to ease their concerns. Trialing a statin is also a great option for patients with firm reservations.

References 1. Cholesterol Treatment Trialists Collaboration. Efficacy and safety of more intensive lowering of LDL

cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010;376:1670–1681.

2. Colhoun HM, Betteridge DJ, Durrington PN et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;364:685–96.

3. Cholesterol Treatment Trialists Collaboration, Kearney PM, Blackwell L et al. Efficacy of cholesterol- lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet 2008;371:117–25.

4. 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: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2014;63(25):2889-2934. Accessed August 10, 2016.

5. Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly Jr DD, DePalma SM, Minissian, MB, Orringer CE, Smith Jr SC, 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, Journal of the American College of Cardiology (2016), doi: 10.1016/j.jacc.2016.03.519.

6. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015;372:2387-97.

7. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74.

Appendix 1b: Pharmacist Screening Algorithm

Diabetes Medication?

YES

1) Age 40-75?

YES

2) Medicare Part D?

YES

3) Statin on file?

NO

Eligible Patientfor

Intervention

YES

NO

Continue Normal

Workflow

Appendix 1c: Intervention Leaflet

Rx number: On Statin therapy? Y or N If yes, where? Date:

Education & materials provided? Y or N

Patient provided verbal consent to contact prescriber?

Y or N

If no to MD consent, what is their barrier?

Did you address the patient’s barrier and as a result, consent provided?

Fax Sent? Y or N Date(s) Fax Sent:

Pharmacist Signature:

Demographics (for investigator use only)

Rx number: On Statin therapy? Y or N If yes, where?

Date:

Education & materials provided? Y or N

Patient provided verbal consent to contact prescriber?

Y or N

If no to MD consent, what is their barrier?

Did you address the patient’s barrier and as a result, consent provided?

Fax Sent? Y or N Date Fax Sent:

Pharmacist Signature:

Demographics (for investigator use only)

Study Patient

Study Patient

Appendix 1d: Patient Education

Heart disease is the No. 1 cause of death in the United States with one person dying every 40 seconds due to heart disease.1

Too much cholesterol in the blood can form plaques between layers of artery walls, making it harder for your heart to circulate blood. Those plaques can also break open and cause blood clots. A clot in an artery that feeds the brain causes a stroke and a clot in an artery that feeds the heart causes a heart attack.

What do statins do? Statins are medications that control your cholesterol, which can help prevent heart disease, heart attacks and stroke. Statins work in the liver to lower the amount of cholesterol in the blood. Statins are most effective at lowering the

Statin Medications for People with Diabetes

Statins are

medications that

control your

cholesterol –

helping prevent

heart disease,

heart attack and

stroke.


LDL (bad) cholesterol, but also have some effects on lowering triglycerides (blood fats) and raising HDL (good) cholesterol.

Who needs to take a statin?2

The American College of Cardiology and the American Heart Association came out with new recommendations in 2013 addressing four populations that would benefit most from statin therapy.

1) Individuals with clinical ASCVD* 2) Individuals with primary elevations of LDL-C ≥ 190 mg/dL 3) Individuals 40 to 75 years of age with diabetes with LDL-C 70–190 mg/dL 4) Individuals without clinical ASCVD or diabetes who are 40 to 75 years of age

with LDL-C 70-189 mg/dL and an estimated 10 year ASCVD risk of 7.5% or higher1

*Clinical ASCVD is defined as follows: acute coronary syndromes, history of heart attack, stable or unstable angina, coronary or other arterial revascularization, stroke, Transient Ischemic Attack, or peripheral arterial disease presumed to be of atherosclerotic origin.

New treatment guidelines2,3

The American College of Cardiology (ACC) and the American Heart Association (AHA) 2013 guidelines focus on evaluating the risk of heart attack and stroke and then recommending statin therapy based on that risk. The American Diabetes Association (ADA) is in agreement with the ACC and AHA, as their newest recommendations (2016) detail the necessity of statin therapy for patients with diabetes. Factors considered when evaluating risk of heart attack and/or stroke

• Gender • Age • Race • Cholesterol levels • Does the patient have diabetes? • Blood pressure • Is the patient taking medication for high blood pressure? • Does the patient smoke?

New statin recommendations:

• High-Intensity Statin Therapy: Daily dose lowers LDL, on average, by about 50% or more

• Moderate-Intensity Statin Therapy: Daily dose lowers LDL, on average, by about 30% to 50%

Individuals 40 to

75 years of age

with diabetes

with LDL-C 70–

190 mg/dL


• Low-Intensity Statin Therapy: Daily dose lowers LDL, on average, by 30% or less

Any decision about treatment should be the result of you working with your doctor to decide the best preventive strategy. Statins currently available in the U.S. include:

• Atorvastatin (Lipitor®) • Fluvastatin (Lescol®) • Lovastatin (Mevacor®, Altoprev™) • Pitavastatin (Livalo®) • Pravastatin (Pravachol®) • Rosuvastatin Calcium (Crestor®) • Simvastatin (Zocor®)

Statins are also found in the combination medications Advicor® (lovastatin + niacin), Caduet® (atorvastatin + amlodipine), and Vytorin™ (simvastatin + ezetimibe).

Side effects Most side effects are mild and generally go away as your body adjusts. Below are a few of the common side effects and some facts about each.

Muscle Pain o Uncommon, but can happen o Usually occurs in the lower extremities o Likely to go away over time o Some studies have shown that over-the-counter supplement Co-

Enzyme Q-10 may help muscle problems caused by statins o Other causes for muscle pain to consider:

Vitamin D deficiency New exercise routine when starting a statin medication Low thyroid levels Drug-drug interactions

Liver Problems o Rare o May still need regular liver function tests

Food interactions o Grapefruit juice may increase the amount of medication in your

system. You will need to avoid drinking more than 1 quart of grape fruit juice each day.

It is important to talk to your health care provider about the potential risks and benefits from statins.

Most side

effects are mild

and generally

go away as your

body adjusts.


References:

1. Mozaffarian D, Benjamin EJ, Go AS, et al., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics— 2015 update: a report from the American Heart Association [published online ahead of print December 17, 2014]. Circulation. doi: 10.1161/CIR.0000000000000152.

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: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2014;63(25):2889-2934.

3. Cefalu WT, Bakris G, Boulton AJM, et al. American Diabetes Association Standards of Medical Care In Diabetes – 2016. Journal of Clinical and Applied Research and Education. 2016;39(1):S1-S112.

Appendix 1e: Fax Form

CONFIDENTIAL HEALTH INFORMATION: Healthcare information is personal information related to a person’s healthcare. It is being faxed to you after appropriate authorization or under circumstances that do not require authorization. You are obligated to maintain it in a safe, secure and confidential manner. Redisclosure of this information is prohibited unless permitted by law or appropriate customer and/or patient authorization is obtained. Unauthorized redisclosure or failure to maintain confidentiality could subject you to penalties described in federal and state laws. IMPORTANT WARNING: This message is intended for the use of the person or entity to whom it is addressed and may contain information that is privileged and confidential, the disclosure of which is governed by applicable law. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this information is strictly prohibited. If you have received this message in error, please notify us immediately.

Date:

CLINICAL ALERT: Statin Use in Persons with Diabetes Working together to reduce your patient’s risk of heart disease

Dear Prescriber fax:

Based on our records, our mutual patient has been dispensed two or more medications for diabetes, but is not currently on a statin medication to reduce the risk of heart disease. I have spoken with the patient and provided education about the benefit of statin therapy based on the 2013 American Heart Association/American College of Cardiology Clinical Practice Guideline* and 2016 American Diabetes Association Standards of Medical Care in Diabetes Guideline.1,2 Based on the information we have, I would recommend initiating a statin in our patient to reduce the risk of heart attack and stroke. Please consider prescribing a statin as you deem clinically appropriate, fill out the prescription below, and return this fax to us at [ ]. Please see the following sheet regarding common concerns about initiating statin therapy and if you have any further questions or would like to have further discussion, please feel free to call me at [ ]. I look forward to collaborating with you to help our patient maximize current recommendations for their benefit.

Patient Name: Patient DOB:

Take 1 tablet by mouth daily

Quantity #: Refills:

Substitution Permitted Dispense As Written

Authorized by: NPI:

• No, I would not like to begin a statin for this patient at this time (please indicate why below):

THANK YOU for working to close this therapeutic gap and review statin use in Diabetes management. Please note the return fax of this form will act as a prescription by law in the state of North Carolina.

[PHARMACIST NAME], [Degree] Walgreens Pharmacist

[ADDRESS] [PHONE]

[FAX]

Please respond within 3 business days of receiving this notice.



Common Concerns of Initiating Statin Therapy:

1. “Patient’s cholesterol is normal/good” → If the patient does not have high cholesterol, there is strong evidence from studies that show if a patient has diabetes and their LDL cholesterol is anywhere between 70 and 189 mg/dL, a moderate-to-high intensity statin reduces incidence of heart attack and stroke significantly (please see Table 1 for further details).1,2,3,4

2. “History of muscle pain from statin/pt. cannot tolerate statins” A patient is not considered “statin intolerant” until there has been documented, “…unacceptable muscle-related symptoms that resolve with discontinuation of therapy and occur with rechallenge on at least 2-3 statins, preferably ones that use different metabolic pathways and have different lipophilicity, and 1 of which is prescribed at the lowest approved dose5.”

o First, evaluate secondary causes of muscle pain: Recent increase in exercise activity Low Vitamin D levels Hypothyroidism Drug-drug interaction that increase systemic statin exposure

o Second, if you are able to exclude secondary causes and believe the

muscle pain is from the statin, the guidelines4,5 indicate to: Hold statin therapy until muscle pain symptoms resolve and then

rechallenge with same statin at the same or lower dose to verify statin-related adverse symptoms

Switch to different statin of different metabolism and lipophilicity beginning at lowest dose and titrate slowly (may repeat this step with different statin medication if desired)

Can trial patient on co-administration with Coenzyme Q-10 Switching to a statin with a long half-life to trial alternative dosing of 3

times per week

o Third, if statin intolerance does prove true to the patient, consider adding Zetia to patients maximally tolerated statin intensity regimen Always reinforce adherence and lifestyle modifications IMPROVE-IT trial6

• Zetia 10mg added to moderate-intensity statin showed additional decrease in LDL-C levels compared to moderate-intensity statin monotherapy

• Dual therapy was also statistically significant for ASCVD reductions over a 7 year follow up period

3. “Pt. is on fenofibrate/niacin/other nonstatin cholesterol medication” → There is

actually no supporting evidence that adding one of the above non-statin medications reduces the incidence of heart attack and stroke. The strongest evidence supports a moderate- or high-intensity statin in patients with diabetes to reduce the risk of heart disease. (ACCORD Trial7)



4. “I would like to see the pt. before initiating prescription” → Okay, we hope that you

discuss this option with them and provide them with the best therapy available!

5. “Pt. has refused statin in the past” → If you think a statin is appropriate treatment for the patient, I would strongly recommend that you please bring it up at their next appointment. Feel free to use any of the information I have provided to ease their concerns. Trialing a statin is also a great option for patients with firm reservations.

Table 1: Excerpt from the 2013 ACC/AHA Blood Cholesterol Guidelines of the Evidence Statements

In adults with diabetes (some of whom had CHD), statin therapy reduced the RR for CVD events by approximately 20% per 1 mmol/L (38.7 mg/dL) LDL–C reduction. This 1 mmol (20%) risk reduction relationship was similar for more intensive compared with less intensive statin therapy and for statin therapy compared with placebo/control.

Secondary Prevention (includes diabetes

subgroup) Primary Prevention in

Individuals with Diabetes

Adults with type 2, type 1, and no diabetes had similar RRRs in CVD per 1 mmol/L (38.7 mg/dL) LDL–C reduction.

Primary Prevention in Individuals with

Diabetes

In adults with diabetes without CVD, moderate-dose statin therapy, compared with placebo/control, reduced the RR for CVD events by approximately 27% per 1 mmol/L (38.7 mg/dL) LDL–C reduction.


Diabetes

In adults with diabetes, statin therapy reduced the RR for CVD by a similar magnitude for subgroups of diabetic men and women, aged <65 and >65 years; treated hypertension; body mass index <25, >25 to <30, and >30; systolic blood pressure <160 and >160 mmHg; diastolic blood pressure <90 and >90 mmHg; current smokers and nonsmokers; estimated GFR <60, >60

to <90, and >90 mL/min/1.73 m2; and predicted annual risk for CVD <4.5%, >4.5% to <8.0%, and >8.0%. Whereas RRRs are similar across these subgroups, absolute risk reductions may differ for various subgroups.


Diabetes

In adults aged 40 to 75 years with diabetes and >1 risk factor, fixed moderate-dose statin therapy that achieved a mean LDL–C 72 mg/dL reduced the RR for CVD by 37% (in this trial LDL–C was reduced by 46 mg/dL or 39%).


Diabetes



References:

1. Cholesterol Treatment Trialists Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010;376:1670–1681.

2. Colhoun HM, Betteridge DJ, Durrington PN et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;364:685–96.

3. Cholesterol Treatment Trialists Collaboration, Kearney PM, Blackwell L et al. Efficacy of cholesterol- lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet 2008;371:117–25.

4. 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: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2014;63(25):2889-2934. Accessed August 10, 2016.

5. Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly Jr DD, DePalma SM, Minissian, MB, Orringer CE, Smith Jr SC, 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, Journal of the American College of Cardiology (2016), doi: 10.1016/j.jacc.2016.03.519.

6. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015;372:2387-97.

7. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74.

appendix 1a: training packet€¦ · appendix 1a: training packet . participating pharmacist...

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