What is the best way to document a patient's decline of statin (HMG-CoA reductase inhibitor) therapy for hypercholesterolemia?

Documentation of Patient Decline of Statin Therapy

When a patient declines statin therapy for hypercholesterolemia, document the following elements in the medical record: (1) that statin therapy was recommended and offered based on guideline criteria, (2) the specific reasons the patient declined treatment, (3) that you discussed the cardiovascular benefits and risks of declining therapy, (4) alternative management strategies offered, and (5) a plan for follow-up discussion. 1

Essential Documentation Components

Document the Clinical Indication

• Record the patient's cardiovascular risk category (primary vs. secondary prevention, presence of atherosclerotic cardiovascular disease, diabetes, LDL-C level ≥190 mg/dL, or 10-year ASCVD risk) that qualifies them for statin therapy 1
• Note baseline lipid panel values, particularly LDL-C and non-HDL cholesterol levels 1
• Document any predisposing factors for statin-associated muscle symptoms that were assessed, including demographics, comorbid conditions, and concomitant medications 1

Document the Shared Decision-Making Discussion

• Record that you explained the cardiovascular benefits of statin therapy, including reduction in myocardial infarction, stroke, revascularization procedures, and mortality 1
• Note that you discussed the safety profile, including the low incidence of serious adverse effects (elevated transaminases in 0.5-2.0% of cases, with progression to liver failure being exceedingly rare) 1
• Document any specific patient concerns that led to the decline, as fear of side effects is the most common reason patients refuse statins (cited by the majority of patients who decline therapy) 2

Document Patient-Specific Reasons for Declining

The most common patient-reported reasons include 2:

• Fear of side effects or perceived side effects
• Concerns about medication safety or effectiveness
• Cost or insurance concerns
• Preference to try lifestyle modifications first
• Previous negative experience with statins or other medications

Document Alternative Management Plan

• Record intensive lifestyle modifications recommended, including dietary changes, physical activity goals, weight loss targets, and smoking cessation if applicable 1
• Note discussion of nonstatin cholesterol-lowering options if the patient is at very high risk (those with clinical ASCVD, baseline LDL-C ≥190 mg/dL, or diabetes) 1
• Document monitoring plan for lipid levels every 3-12 months 1

Follow-Up Documentation Strategy

Plan for Reassessment

• Schedule follow-up visits to reassess, rediscuss net clinical benefit, and potentially rechallenge with statin therapy, as 67.7% of patients who initially decline are willing to reconsider if offered again 2
• Document that adherence to lifestyle modifications will be monitored at each visit 1
• Note plan to exclude secondary causes of hyperlipidemia at follow-up 1

Address Common Pitfalls

• Avoid documenting vague statements like "patient refused" without elaboration on the discussion that occurred 1
• Do not simply note "patient declined" without documenting that you explained the significantly increased cardiovascular risk associated with untreating eligible patients (more than two-fold increased rate of cardiovascular events in high-risk patients) 3, 4
• Ensure documentation reflects that the patient was actually offered statin therapy, as 59.2% of untreated eligible patients report never being offered a statin by their physician 2

Special Considerations for High-Risk Patients

Secondary Prevention Patients

• For patients with established atherosclerotic cardiovascular disease who decline statins, emphasize in documentation the particularly high risk of adverse outcomes, including more than four-fold increased risk of death and stroke 3
• Note discussion that statin benefits extend beyond cholesterol lowering through pleiotropic effects (anti-inflammatory and antithrombotic mechanisms) 3

Documentation of Willingness to Retry

• If the patient expresses any openness to reconsidering in the future, document this explicitly, as 59.7% of patients who previously discontinued statins would consider retrying 2
• Record specific conditions under which the patient might reconsider (e.g., after trial of lifestyle modifications, if cardiovascular event occurs, if different formulation available) 1, 2