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%.