dyslipidemia management protocol -...

09/04/18 USC School of Pharmacy

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Dyslipidemia Management Protocol

**CONFIDENTIAL DRAFT**

USC School of Pharmacy March 2015-Updates


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Purpose: To establish a pharmacist-physician collaborative practice service for USC clinical pharmacists practicing at affiliated AltaMed Clinics to manage patients with dyslipidemia. Goals and Objectives: The goal of the pharmacist-managed Dyslipidemia Management Program (DMP) is to work with the dyslipidemia patient and primary care team to ensure that patients meet their lipid goals. Attainment of target lipid levels requires a combination of medication, nutrition, exercise, education, and follow-up interventions. The objectives of the DMP are as follows:

1. Following educational sessions with pharmacists, patients will be able to:

a. Explain, in lay terms, the pathophysiology of dyslipidemia b. Describe the consequences of poorly-controlled dyslipidemia c. List nonpharmacologic interventions that effectively improve lipoprotein levels d. Identify the purpose / general mechanism of action, dose, route of administration, frequency, and storage

of all medications. 2. Identify and correct medication misuse, particularly nonadherence, through education and assistance device /

tools. 3. Implement drug therapy adjustments (e.g., addition, substitution, discontinuation, dose adjustment) that will

lead to attainment of lipid goals and other desired therapeutic outcomes. 4. Monitor lipid patients closely according to national and manufacturer recommendations to reduce the risk of

serious adverse effects and undesirable drug interactions. 5. Continually update providers on new dyslipidemia medications and guidelines Participants and Responsibilities: • Attending Physician (General Medicine/Family Practice):

a. Responsible for the overall function of the Dyslipidemia Clinic b. Provide appropriate supervision and oversight of the clinical pharmacist c. Provide initial and annual review of the protocol

• Clinical Pharmacist

a. Authorize appropriate medications used for dyslipidemia management based on treatment guidelines, literature evidence, and clinical judgment

b. Order pertinent laboratory procedures for the dyslipidemia management c. Perform point-of-care tests and interpret laboratory results (if applicable) d. Provide medication reconciliation for patients e. Provide patient counseling and education f. Provide medication education to the team as needed to improve medication-related outcomes

• Clinical Pharmacy Technician

a. Extract and distribute necessary information from or to patients b. Schedule appointments for dyslipidemia patients with the clinical pharmacist c. Provide any necessary job functions to assist the clinical pharmacist

• Clinic Staff

a. Provide typical support for any member of the healthcare team to assist the clinical pharmacist or work flow


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Eligibility / Recruitment:

1. Eligible patients are those diagnosed with dyslipidemia and receive medical care on a regular basis in the

affiliated AltaMed Clinics.

2. Patients may be recruited by the following methods: a. Identified by the internal data extraction with established criteria (“triggers”) b. Referral from primary care physicians (PCPs), allied health professionals, case, manager, or health

educators c. Recruitment from medication reconciliation services provided by the clinical pharmacy team d. Self-referral by patients in response to recruitment posters and flyers

Clinical Privileges:

1. Treatment: The clinical pharmacist may initiate, discontinue, and adjust doses of lipid-lowering agents and related therapies based on treatment guidelines, literature evidence, and clinical assessment. Examples of these agents include but not limited to: statin, fibric acid derivatives/fibrates, nicotinic acid (Niacin), cholesterol absorption inhibitors, and bile acid sequestrant.

2. Monitoring: The clinical pharmacist may order laboratory tests necessary for monitoring the safety and efficacy of lipid-lowering agents. Examples of these tests include but not limited to: liver function tests, CK, serum creatinine, and general chemistry.

Documentation:

All information related to each patient care encounter will be entered into the NextGen electronic health record within 24 hours of the encounter. This communication fulfills the legal responsibility that the clinical pharmacist has in regards to conveying treatment changes to the primary care provider and other members of the healthcare team (California State Pharmacy Law, Section 4052.2) Performance Data Reporting: Quality improvement reports will be generated at least quarterly focusing on metrics aligned with national standards (NQF, NCQA). Note: per HEDIS 2015 measures, the following indicators were retired: LDL-C screening and LDL-C control (<100 mg/dL). Clinic Supervision: The medical director, designee, or any medical staff member will serve as supervisor for the DMP, and will be available for consultation. DMP services provided by the Clinical Pharmacist may include the following: 1. Initial / baseline visit

Step 1: Determine the 4 Statin Benefit Groups (Appendix A)

1. Secondary prevention in individuals with clinical ASCVD* 2. Primary prevention in individuals ≥ 21 years of age with primary, severe elevations

of LDL-C ≥190 mg/dL 3. Primary prevention in individuals with diabetes** 40-75 years of age who have LDL-

C 70-189 mg/dL


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4. Primary prevention in individuals without diabetes and with estimated 10-year ASCVD risk ≥ 7.5%‡, 40 to 75 years of age who have LDL-C 70 to 189 mg/dL

*Clinical ASCVD is defined by the inclusion criteria for the secondary prevention statin RCTs (acute coronary syndromes, or a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin). **Per ADA in Diabetes Care (2015): CVD risk factors include LDL cholesterol >100 mg/dL (2.6 mmol/L), high blood pressure, smoking, and overweight and obesity. ‡Statin therapy initiation should be based on estimated 10-year ASCVD risk and risk vs benefit discussion between clinician and patient is recommended.

Step 2: Conduct initial evaluation on the following laboratories prior to statin initiation

• FLP, ALT, A1C, CK (if indicated), other secondary causes Step 3: Follow recommendations based on the determined Statin Benefit Group Step 3-1: If clinical ASCVD, initiate statin therapy

• Age ≤ 75 years without intolerance/contraindication– High-intensity statin recommended

• Age > 75 years or intolerance/contraindication to high-intensity statin – Moderate-intensity statin recommended

Step 3-2: If primary elevations of LDL-C greater than 190 mg/dL and ≥21 years of age

• High-intensity statin recommended (Moderate intensity statin if not candidate for high-intensity statin)

• Assess secondary causes of severe elevation of LDL-C

Step 3-3: If patients with diabetes 40–75 years of age with LDL-C of 70–189 mg/dL and without clinical ASCVD

• A high level of evidence supports the use of moderate-intensity statin therapy in this group Note: When patients not on statin, use 10-year ASCVD risk* to determine appropriate intensity of statin therapy

ü Estimated 10-year risk of ASCVD at least 7.5%- High-intensity statin is recommended

ü Estimated 10-year risk of ASCVD less than 7.5%- Moderate-intensity statin is recommended

* A downloadable spreadsheet enabling estimation of 10-year and lifetime risk for ASCVD and a web-based calculator are available at http://my.americanheart.org/cvriskcalculator and http://www.cardiosource.org/science-and-quality/practice-guidelines-and-quality-standards/2013-prevention-guideline-tools.aspx.

Step 3-4: If primary prevention without diabetes and with LDL-C of 70–189 mg/dL (not receiving statin

therapy) • Estimated 10-year ASCVD risk 5- 7.5%, age 40–75 years: Moderate- High-intensity

statin • Estimated 10-year ASCVD risk greater than 7.5%, age 40–75 years: High-intensity

statin


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Step 4: If patients do not belong one of 4 Statin Benefit Groups, additional factors below may be

considered to make treatment decision § Primary LDl-C ≥160 mg/dL or other evidence of genetic hyperlipidemias § FH of premature ASCVD with onset <55 years of age (1st degree male

relative) or <65 years of age (1st degree female relative) § High-sensitivtiy C-reactive protein ≥2 mg/dL § CAC score ≥300 Agaston units or ≥75th percentile for age, sex, and ethnicity § ABI <0.9

Step 5: Initiate the appropriate intensity of statin therapy based on step 2

Step 6: Initiate TLC both prior to and in concert with the use of cholesterol- lowering drug therapies

Nutrient Recommended Intake Total fat Saturated Polyunsaturated Monounsaturated

25-35% of total calories < 7% “ Up to 10% “ Up to 20% “

Carbohydrate 50-60% of total calories Fiber 20-30 gm/day Protein ~15% of total calories Cholesterol <200 mg/day Total calories Balance energy intake and expenditure to

maintain desirable body weight / prevent weight gain


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Step 7: Monitoring statin therapy

• Adherence to medication and lifestyle, therapeutic response to statin therapy, and safety should be regularly assessed

• Fasting lipid panel performed within 4-12 weeks after statin initiation or dose adjustment • If anticipated therapeutic response: Reinforce continued adherence à Follow up in 3-12

months

Note: If less than anticipated therapeutic response, consider the following: • Reinforce improved adherence

a. Increase statin intensity b. Consider addition of non-statin drug therapy

• If statin intolerance à switch to lower dose or other statin • If no statin intolerance

a. Reinforce medication adherence b. Exclude secondary causes of hypercholesterolemia and follow-up in 4-12 weeks

Step 8: In individuals not receiving cholesterol-lowering drug therapy, recalculate estimated 10-y ASCVD risk every 4-6 years in individuals aged 40-75 years without clinical ASCVD or diabetes and with LDL–C 70-189 mg

2. Follow-up visits

a. Review the following baseline test results if available / applicable; consider ordering if necessary: lipid

panels, LFTs, HbA1c, BG, SCr, thyroid functions tests. If test results suggest a secondary cause of dyslipidemia, the clinical pharmacist will work with the patient and PCP to conduct further studies or initiate / adjust appropriate treatment.

b. Frequency, severity, and cause of adverse effects.

c. Diet (including EtOH consumption), exercise, & weight history

d. Evaluate treatment regimen i. Adherence assessment: Patient will be instructed to bring all medications (prescription and over-the-

counter) to every visit with a clinical pharmacist. Patient will be asked to identify each medication, provide a general mechanism of action, and the route, dose, and frequency of administration. The


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clinical pharmacist will attempt to identify and resolve any discrepancies between the patient’s use of the medication and the prescribed regimen. Causes for the discrepancies will be identified and resolved (e.g., medication adverse effect, forgetfulness, inconvenience of dosing frequency, etc.) Adherence aids, such as medication boxes and patient dosing charts, will be utilized as needed.

ii. If indicated, drug therapy adjustments may be initiated in order to reach treatment goals. These adjustments will strictly adhere to only scientifically valid resources such as 2013 ACC/AHA guidelines, FDA-approved dosing and monitoring for individual medications, and protocols from applicable randomized controlled trials.

e. Patient Education: Provide instruction, both verbally and in writing, on the following topics:

i. General pathophysiology and diagnosis ii. Purpose and common adverse effects of each medication prescribed, management of adverse effects,

and importance of compliance. iii. Importance of lifestyle management including TLC, ethanol and tobacco abstention, exercise and

weight management. iv. Importance of contacting assigned clinical pharmacist if any change occurs in medication regimen,

including both prescription and over-the-counter drugs. v. Subsequent pharmacist follow-up can be made through clinic visit or telephone depending on the

needs of the patient and the nature of the follow-up. Suspension of patient care:

Since the purpose of the DMP is to work with the most challenging patients, all efforts will be made to retain patients in the program. Patients who miss appointments will be contacted by a clinical pharmacy technician and/or other clinic personnel involved in rescheduling missed appointments for rescheduling. As an alternative to in-clinic visits, follow-up with patients may be conducted by phone or through selective home visits depending on each patient’s circumstances. In rare cases, patients may be suspended from the DMP, e.g., behavior that is threatening to the safety of the clinical pharmacy team members. Exit Criteria: Patients who meet lipid goals (e.g., tolerance and adherence to statin therapy, lipid panel indicating expected LDL% reduction when compared to baseline at least 6 weeks apart) will be considered for exit to ongoing usual care from the medical home.

Patients who may remain in the DMP, in agreement with the primary care team, despite meeting treatment goals include:

1. Patients undergoing major medication changes 2. Patients requiring frequent follow-up to ensure adherence with prescribed treatment


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Workflow:


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General References: 1. 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. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45.

2. National Cholesterol Education Program. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. National Institutes of Health Publication No. 01-3305, May 2001. [Summary Report: JAMA vol 285(19) 5/16/01:2486-2497]

3. ATP III Update 2004: Implications of Recent Clinical Trials for the ATP III Guidelines. Available at:

http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm 4. Clinical Pharmacology on-line, available at http://www.cp.gsm.com/ Approved: (Physician Name, Title) Date


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Appendix A: Summary of Statin Initiation Recommendations1

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