Bridging the gap between FDA safety warnings and patients: are pharmacists the appropriate messengers?

Purpose: This study evaluated acceptance of pharmacist interventions to address new simvastatin safety concerns. We hypothesize that safety warnings are not being effectively implemented into current practice due to the lack of a formalized process for patient identification and treatment re-evaluation. By identifying patients at risk and recommending alternatives, processes can be developed to decrease the number of patients exposed to potentially unsafe pharmacotherapy.

Methods: This is a prospective, descriptive quality improvement project involving patients in a university-based ambulatory care clinic who were identified as being treated outside the newly revised simvastatin labeling. After identification and review, pharmacist recommendations were made to providers to promote adherence with the most recent safety guidelines. The acceptance rate of recommendations and resources necessary to provide pharmacist interventions were measured. Percentage of patients treated outside the current simvastatin labeling on the date the safety alert was released (baseline), upon initiation the study (usual care without targeted interventions) and after completion of the study (usual care plus targeted interventions), and pharmacist and technician time necessary to complete the interventions was also measured.

Results: Six months after the warnings’ release, 48.1% of the 158 patients identified still had regimens that fell outside the revised simvastatin labeling. After the intervention, this decreased to 0.6%. Recommendations were accepted 92% of the time without modification and 7% of the time with modification. Total pharmacist time to conduct the interventions was 21.5 hours, with 3.9 hours of technician time spent contacting patients.

Conclusions: Targeted pharmacist interventions were effective in promoting adherence with this complex medication safety alert. A standardized, comprehensive approach to patient assessment, including use of evidence to support pharmacist recommendations, resulted in a high level of acceptance by prescribers. The template used in this evaluation can serve to jumpstart patient specific review processes on future medication safety alerts.