Case Studies

Case Study #1107

Study Type: Phase IV Voluntary Patient Registry
Objective: Predict potential medication error rate as reflected by caregiver reported observations of pharmacists dispensing specialty drug and subsequent administration to patients.
Data Collection: Written survey recording caregiver observations on prescriptions dispensed.
Utility: Comply with FDA mandated NDA approval requirement and monitor impact of educations programs designed to improve labeling comprehension and compliance among dispensing pharmacists and reduce associated potential medication errors.

Results: Dose setting error rate data collected shows sensitivity to company efforts to educate dispensing pharmacists. Registry data indicates programs implemented in June 2007 had a profound impact on dose setting errors, reducing predictable error rate from 30% to 9.1%.