Potential role of a pharmacist to enhance medication-related aspects of clinical trials conducted in a dedicated clinical research unit.

Purpose: Pharmacist involvement in medication reconciliation has been shown to have a positive impact on patient care in a number of settings [1-6], but there have been no evaluations of the effect of this pharmacist role on patient care during the conduct of clinical trials. Pharmacist involvement in the medication reconciliation process for clinical trials may provide improved protocol compliance.

Methods: This was a retrospective pilot study conducted in a dedicated research unit that assessed completeness of the medication reconciliation process by clinical trial teams for patients participating in a clinical trial involving investigational medication(s). Patients' medication lists in the EHR were reviewed after their study visit. Pharmacy staff evaluated the medication list for accurate inclusion of IDs and any prohibited or restricted concomitant medication(s) per the study protocol.

Results: Ninety-five patient visits over two months were evaluated and showed only 20.6% of IDs were listed in the EHR after study visits. Of those included, only 40% had the correct dose and 50% had the correct frequency listed. There were 20 potential protocol prohibited medications identified. There were four medications listed in a fashion that may have compromised maintenance of blinding status in the EHR.

Conclusions: This pilot study showed potential roles for pharmacy personnel involvement in medication reconciliation in the clinical research setting. Pharmacists have the opportunity to ensure that IDs are accurately included in patient medication lists and to identify the use of potential protocol prohibited concomitant medications.