Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial

Abstract

Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. The study enrolled 2629 women at 15 clinical research sites in Malawi, Uganda, South Africa and Zimbabwe who were randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a matching placebo vaginal ring. The vaginal rings and packaging were identical in appearance in order to maintain the study blind. A real-time, documented second check of the dispensing process was conducted by a second pharmacy staff. Frequent inventory counts and real time accountability audits were also useful for rapidly identifying a dispensing error. A total of 52,625 vaginal rings were dispensed with only three documented pharmacy dispensing errors. There were zero dispensing errors at 13 of the 15 sites with an overall rate of <1.0 per 10,000 rings dispensed. Our study findings support the implementation of a double check dispensing process and real time accountability audits as standard practice in clinical trials.

Keywords: Dispensing errors; GCP, Good Clinical Practice; ICH, International Council for Harmonisation; IP, Investigational Product; Investigational product; NCR, No-carbon required; PTID, Participant Identification; Pharmacy; Quality checks; SOPs, Standard Operating Procedures.

Fig. 1

Example of partial prescription.

Fig. 2

Example of a portion of a participant-specific dispensing record.

Fig. 3

Sample vaginal ring label.

Fig. 4

Example of an accountability record.

Fig. 5

MTN-020 record of receipts of participant specific study product.