Study Product Assessments

Product use assessment, pill and applicator counts were used as tools by pharmacists to assess product returns. The assessment included a reconciliation of study products dispensed to and returned by participants using a product returns worksheet. Product labels bearing participant unique identifiers and pharmacy specific product codes were checked against pharmacy records to verify that participants returned the correct product. Whilst these tools were used to monitor adherence, the pharmacy procedures also helped to identify return of study product not dispensed to these participants. If a code did not match the pharmacy records, this implied that either the wrong product was dispensed or the participant returned another participant’s product. Investigations were also conducted by pharmacists to check for dispensing errors which could have contributed to incorrect product returns.

Discrepancies with product returns prompted discussions with the participants, pharmacists and clinic staff. These discussions were initiated by pharmacists to determine reasons for discrepant counts. Pharmacists ensured that blinding was always maintained during these discussions by not divulging product specific information. During these discussions, some participants disclosed the reasons why they returned products not previously dispensed to them. Data on all discussions and possible product sharing incidents were collected from November 2009 to August 2012. Ethical and study protocol considerations were important factors that impacted on the manner in which discussions were conducted with participants.

All cases of product sharing identified by pharmacists were reported to DAIDS and the SAMRC Ethics Committee. The Ethics Committee acknowledged reporting of these incidents.