Impact of pharmacists' interventions and simvastatin dose restrictions

On June 8, 2011, the United States Food and Drug Administration (FDA) reported safety concerns regarding statin-related myopathies and advised further restrictions on simvastatin dosing. These restrictions reduced the maximum dose for specific patient characteristics, primarily certain concomitant medications.

The purpose of this study was to compare the effectiveness of 2 different pharmacist-conducted educational interventions on appropriate simvastatin use in the primary care setting.

This retrospective cohort analysis was conducted in 2 academic medical center clinics. Patients prescribed simvastatin before June 8, 2011, requiring dosage adjustment based on labeling changes were evaluated for study inclusion. The pharmacists' interventions included: 30-minute didactic session for prescribers or patient-specific recommendation communicated with the physician during the patient's follow-up visit. Primary outcomes were the number of patients prescribed FDA-recommended simvastatin doses after pharmacist intervention and the intervention's impact on low-density lipoprotein (LDL).

Medical record review identified 1173 patients prescribed simvastatin prior to June 8, 2011; 126 patients qualified for study inclusion. After controlling for baseline characteristics, the likelihood of patients being prescribed an appropriate dose postintervention increased if they were in the patient-specific recommendation group (odds ratio [OR] = 10.59; 95% CI = 3.43-32.69; P < .0001). LDL change occurred at a similar rate between intervention groups (P = .652).

Following FDA labeling changes for simvastatin, patient-specific recommendations made by pharmacists correlated with a greater likelihood of appropriate simvastatin dosing compared with a one-time didactic education session. Patient-specific recommendations positively affect prescribing habits and making steps to improve patient safety.