3 Colo. Code Regs. § 719-1, app 3 CCR 719-1-G
This collaborative pharmacy practice statewide protocol authorizes qualified, Colorado-licensed, pharmacists ("Pharmacists") to provide pertinent assessment of patients with or at high-risk for cardiovascular (CV) events and prescribe HMG CoA reductase inhibitor therapy (henceforth known as "statin therapy") for the purpose of reducing the risk for new or recurrent CV events according to, and in compliance with, all applicable state and federal laws and rules.
Pharmacists may prescribe and dispense FDA approved medication(s) to eligible patients according to indications and contraindications recommended in current guidelines from the American Heart Association and American College of Cardiology (AHA/ACC) 1, ACC Expert Consensus Decision Pathway recommendations 2, or subsequent updated published guidelines recognized as the national standard of practice. Request for updates to this protocol shall be considered through the Board of Pharmacy rulemaking process.
Prior to prescribing and dispensing statin therapy per this protocol, the pharmacist must:
1. Hold a current license to practice pharmacy in Colorado
2. Be engaged in the practice of pharmacy
3. Have earned a Doctor of Pharmacy degree or completed at least 5 years of experience as a licensed pharmacist
4. Carry adequate professional liability insurance as determined by the Board
5. Complete a training program accredited by the Accreditation Council for Pharmacy Education, or its successor entity, pursuant to the protocol (in compliance with Board Rule 17.00.50 b.2.)
6. Pharmacists must also follow all board rules for statewide protocols in section 17.00.00.
If services are provided in a pharmacy, the pharmacy shall ensure that appropriate space is available to provide counseling and ensure confidentiality.
Records:
A. Pursuant to Pharmacy Board Rule 17.00.50, a process shall be in place for the pharmacist to communicate with the patient's primary care provider and document changes to the patient's medical record. If the patient does not have a primary care provider or is unable to provide contact information for his or her primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished, and laboratory test(s) ordered, and any test results.
B. Pharmacists shall comply with all aspects of Pharmacy Board Rules 17.01.00 and 17.02.00 with respect to the maintenance of proper records.
C. Statin Therapy Protocol
Under this protocol, pharmacists may assess patients at intermediate or high-risk for a CV event who are not currently on but in whom statin therapy is identified as a Class I recommendation according to AHA/ACC guidelines 1.
Eligibility Criteria: The pharmacist may consider and prescribe the patient statin therapy listed in Table I according to the following criteria:
1. Intermediate or high-risk primary prevention
a. 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk [GREATER THAN EQUALS TOO]20%, or 7.5-19.9% if one or more risk enhancing factors are present using the American College of Cardiology risk calculator (found at http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) age 40-75; or
b. LDL [GREATER THAN EQUAL TO]190 mg/dL tested using a fasting lipid panel, age 20-75
2. Primary prevention patients with diabetes mellitus
a. Type 2 diabetes mellitus (DM) age 40-75 as determined by patient report, medical records, or prescription history.
3. Secondary prevention
a. Prior history of acute myocardial infarction, acute coronary syndrome, stable or unstable angina, coronary or arterial revascularization by coronary artery bypass graft (CABG) surgery and /or stenting, non-cardioembolic ischemic stroke, transient ischemic attack, aortic aneurysm, or peripheral artery disease all stemming from atherosclerotic origins, as confirmed by patient report, medical records, or prescription history.
Ineligibility Criteria: Patients who should NOT be prescribed statin therapy under this protocol and should be referred to primary care provider for further action:
1. Patients who have a history of serious statin-associated side effects defined as a serum creatine kinase elevation >3 times the upper limit of normal, documented rhabdomyolysis from statin therapy, or hepatic transaminase elevations 3 times the upper limit of normal during prior treatment with statin therapy.
2. Patients who have active liver disease defined by medical history or by hepatic transaminases greater than 3 times the upper limit of normal.
3. Women who are pregnant or are of childbearing age and not using highly effective forms of contraception.
4. Patients with end stage renal disease (ESRD) or who are undergoing hemodialysis or peritoneal dialysis.
5. Patients with severe hypertriglyceridemia (fasting triglycerides [GREATER THAN EQUAL TO] 1000 mg/dL).
TABLE 1 - MEDICATION OPTIONS
Other FDA approved and guideline recommended medications or regimens can be used if they become available.
Formulations cautions and dose adjustments for statin medications shall minimally follow the AHA/ACC guidelines and package insert information for all regimens.
Pharmacist must screen for potential statin drug/drug interactions with patient's other known medications. If interactions are identified, appropriate selection of a safe statin regimen and counseling should be performed to mitigate risk.
Patient Category | Medication and Dosage | Renal Adjustment | Frequency |
High risk primary prevention* or secondary prevention | Atorvastatin 40-80 mg | No adjustment needed | Once daily |
Rosuvastatin 20-40 mg | CrCl < 30 ml/min/1.73m2: 5-10 mg or consider atorvastatin 40-80mg | Once daily | |
Primary | Atorvastatin 10-20 mg | No adjustment needed | Once daily |
prevention | |||
patients that are intermediate risk** or with DM and not "high Risk" | Fluvastatin 40 mg | No adjustment needed | Twice daily |
Fluvastatin XL 80 mg | No adjustment needed | Once daily | |
Lovastatin 4080 mg | CrCl <30 ml/min: 20 mg max dose | Once daily in evening | |
Pitavastatin 14 mg | GFR 15- 59 ml/min/1.73m2: 1-2 mg | Once daily | |
Pravastatin 4080 mg | Severe impairment: 10 mg | Once daily in the evening | |
Rosuvastatin 5-10 mg | No adjustment needed | Once daily | |
Simvastatin 20-40 mg | Severe impairment: start at 5 mg (titrate as needed up to 20mg daily) | Once daily in the evening | |
* High risk primary prevention patients include: baseline LDL-C [GREATER THAN EQUALS TOO]190 mg/dL, diabetes age 40-75 years with LDL-C < 190 mg/dL and multiple ASCVD risk factors, or age 40-75 with LDL-C 70-189 mg/dL and 10-year ASCVD risk [GREATER THAN EQUALS TOO]20%. ** Intermediate risk primary prevention patients include: age 40-75 with LDL-C 70-189 mg/dL and 10-year ASCVD risk 7.5-19.9% with one or more risk enhancing factor(s) | |||
TABLE 2 - RISK ENHANCING FACTORS
Patient Characteristics | * Family history of premature ASCVD* * LDL-C, 160-189 mg/dL (or non-HDL-C 190-219 mg/dL) * Metabolic syndrome * High-risk race/ethnicities (e.g., South Asian ancestry) |
Medical History | * CKD (eGFR 15-59 mL/min/1.73 m2 with or without albuminuria, and not dialysis or kidney transplantation) * Chronic inflammatory conditions (e.g., rheumatoid arthritis, HIV) * Premature menopause (< 40 years), pregnancy-associated conditions that increase later ASCVD risk (e.g., preeclampsia) |
Lipid/ Biomarkers | * Persistently elevated, primary hypertriglyceridemia ([GREATER THAN EQUALS TOO]175 mg/dL) * Abnormal biomarkers if measured: * High-sensitivity C-reactive protein [GREATER THAN EQUALS TOO]2.0 mg/L, Lipoprotein(a) [GREATER THAN EQUALS TOO]50 mg/dL, Apolipoprotien B [GREATER THAN EQUALS TOO]130 mg/dL, Ankle brachial index <0.9 |
ASCVD = atherosclerotic cardiovascular disease; CKD = chronic kidney disease; eGFR = estimated glomerular filtration rate; HDL-C = high-density lipoprotein cholesterol; HIV = human immunodeficiency virus; LDL-C = low-density lipoprotein cholesterol *male primary relative, age <55 years; female primary relative, age <65 years | |
TABLE 3 - ROUTINE REQUIRED MONITORING OF TREATMENT Labs:
Test | Frequency | Guideline recommendations | Notes |
Fasting Lipid Panel (FLP) | Every 3-12 months | Get FLP at baseline and then 4-12 weeks after therapy initiation, then every 3-12 months as needed to assess adherence and improvement | Guidelines allow for non-fasting lipid panels for baseline LDL-C but recommend fasting lipid panels for follow-up monitoring. Point of care (POC) testing acceptable. Baseline labs from PCP can be accepted if within 3 months of statin initiation. |
ALT / LFTs | Baseline required -Ordered by pharmacist or accepted documentation from PCP within 3 months of statin initiation | Routine monitoring not needed. | Patients presenting with signs or symptoms suspicious of liver disease should be referred for medical evaluation |
Renal function | Baseline and yearly | Not in guidelines | Yearly monitoring is recommended to determine if dose adjustment is necessary (as for all medications). This will be ordered by pharmacists, or communicated to patient for ordering and follow up by primary care provider. |
Counseling (at minimum):
* The importance of medication adherence with relation to efficacy of statin therapy and reduction in CV event risk, and what to do if patient misses a dose.
* Importance of therapeutic lifestyle changes in reducing lipids and CV risk.
* Proper use of medication, storage, dosage, schedule, and potential common and serious side effects (and how to mitigate).
* Signs/symptoms of myalgia and liver dysfunction, educate that side effects are not common
* Potential food and medication interactions (primarily with lovastatin and simvastatin)
* The necessity of follow up care with a primary care provider for usual care and lipid testing at least yearly.
Documentation:
* The pharmacist will notify the patient's primary care provider of a record of all medications prescribed. If a patient does not have a primary care provider, the pharmacist will provide the patient with a list of providers and clinics for which they may seek ongoing care.
* The pharmacist will also follow all documentation rules in Rule 17.
Referrals to primary care provider:
* Prior history of statin use with noted severe intolerance. Pharmacist encouraged to work collaboratively with PCP on options.
* On therapy, if patient experiences moderate to severe statin associated muscle symptoms that do not resolve with stopping medication
* On therapy, if patient experiences symptoms consistent with muscle weakness or rhabdomyolysis (dark brown urine with severe muscle symptoms) - patient should stop statin and be referred.
* On therapy, if the patient develops symptoms suggestive of liver disease (severe abdominal pain, yellow-colored eyes or skin) - patient should stop statin and be referred.
* On therapy if patient becomes pregnant - patient should stop statin and be referred.
* Suboptimal response to maximum tolerated statin therapy - patient continues statin and referred for further workup.
1 Grundy SM, Stone NJ, et al.
2018AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):e285e350. doi: 10.1016/j.jacc.2018.11.003. Epub 2018 Nov
10. Erratum in: J Am Coll Cardiol. 2019 Jun 25;73(24):3237-3241.
2 Lloyd-Jones D, et al. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 Oct, 80 (14) 1366-1418.
https://doi.org/10.1016/j.jacc.2022.07.006
2018AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):e285e350. doi: 10.1016/j.jacc.2018.11.003. Epub 2018 Nov 10. Erratum in: J Am Coll Cardiol. 2019 Jun25;73(24):3237-3241.
PMID: 30423393. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines | Journal of the American College of Cardiology (jacc.org)
3 CCR 719-1, app 3 CCR 719-1-G