Implementation of new FDA-mandated dose limitations with simvastatin in an outpatient family medicine clinic

Purpose: Widespread and timely implementation of medication labeling changes is difficult to implement. In June 2011, the FDA released recommendations and labeling changes regarding dosing, drug interactions, and contraindications with simvastatin.

Methods: We developed and implemented a clinical pharmacist-managed protocol to apply the FDA-mandated changes for simvastatin. Patients taking simvastatin 80 mg, a contraindicated medication, or medication requiring simvastatin dose limitation were identified through the medication list in the clinic electronic health record (EHR). These patients were scheduled for an appointment with the clinical pharmacist. If patients saw their physician, the change was made following the pharmacist-written protocol. If patients did not follow up, letters were sent to the patients and prescriptions were faxed to their pharmacies. When clinical pharmacists saw patients, they were authorized to order a lipid profile and CK if necessary, decrease the dose of simvastatin, switch to another statin, and switch gemfibrozil to fenofibrate.

Results: A total of 125 patients were identified. After 43 patients were excluded, 82 patients entered the study.  Clinical pharmacists implemented the change in 51 of the patients (63%); physicians implemented the remainder. A total of 68 patients had follow up lipid profiles. Of these 68 patients, 52 (76%) were below their goal LDL at baseline. Following intervention and medication change, 52 (76%) were below their goal LDL. Fourteen patients did not have follow up lipid panels drawn. LDL was lower after intervention than at baseline in 27 patients (40%).

Conclusion: A protocol written and implemented by clinical pharmacists was successful in applying FDA-mandated changes regarding simvastatin dosing with no change in the percentage of patients below goal LDL. Currently, work is being done to obtain follow-up lipid panels in the 14 patients with incomplete follow-up, and this will be presented in the final data. A pharmacist-managed protocol can be implemented for other labeling changes.