Case study #1107
Phase IV Voluntary Patient Registry
Predict potential medication error rate as reflected by caregiver reported observations of pharmacists dispensing specialty drug and subsequent administration to patients.
Written survey recording caregiver observations on prescriptions dispensed.
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.
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%.