Pre-Study Set Up

A pharmacy compliance group was established at Alfred Health to oversee the pharmacy component of the PrEPX study. The PrEPX pharmacy team was responsible for engaging with, training, and supervising PrEPX dispensing over the course of the study, in all participating states.

The PrEPX pharmacy team, created a checklist for GCP compliance and regulatory dispensing requirements for a community pharmacy acting as a clinical trial pharmacy. Key features of a clinical trial pharmacy are 1) drug storage, 2) record keeping, 3) monitoring of stock, 4) destruction of drugs if permitted by the protocol, 5) assistance with adherence to study protocol, 6) counseling of participants and monitoring medication adherence, 7) and provision of information to participants (Abraham, 2009; Australian Government Department of Health TGA, 2018).

Community pharmacies in close proximity to PrEPX study clinics were approached and invited to participate as a clinical trial pharmacy in the study. A brief survey was sent out to selected pharmacies to determine their current practices, and to identify gaps in clinical trial pharmacy requirements. The PrEPX pharmacy team worked with individual pharmacies to address each identified gap so that pharmacies could dispense clinical trial study drug, in accordance with ICH-GCP requirements (ICH-GCP ICOHGCP, 1996; Abraham, 2009), as per Supplementary Figure 1 .

Ambient temperature conditions are not routinely monitored or recorded within community pharmacies in Australia. Pharmacies that did not have temperature monitoring were provided with a testo automated temperature monitoring system (Testo Pty Ltd., 2015) at no cost to the pharmacy. This device was selected as it had been used successfully within Alfred Health Hospital Pharmacies. An active Wi-Fi connection was required to activate individual temperature monitors at each pharmacy. Temperatures were continuously recorded during the study, sending automatic hourly notifications to the secure PrEPX Cloud account. The minimum and maximum temperatures (15°C, 30°C) were set on each device, in line with the study drug storage conditions recommend by the drug manufacturer (Mylan Health Pty Ltd., 2014). In the event of temperatures exceeding the minimum and maximum, an alarm was automatically sent via text message to the PrEPX pharmacy manager and the site pharmacist. Hospital-based clinical trial pharmacies are conventionally connected to back up generators, however back-up generators were not purchased for this study as it was determined that pharmacy ambient temperature could be corrected in a timely manner.

The PrEPX study supplied individual, lockable cabinets for study drug storage to participating community pharmacies as needed. The lockable cabinets were placed in the dispensary to comply with GCP requirements that study drug be stored in a restricted access area, under lock and key (Abraham, 2009; Australian Government Department of Health TGA, 2018).

GCP training was provided to all study pharmacists who did not have current GCP certification (Whitehall Training, 2016). The TransCelerate online training course (Whitehall Training, 2016) was used and all study pharmacists were required to achieve at least 85% correct responses and provide a certificate of competency to PrEPX pharmacy manager prior to dispensing PrEPX study medications. Pharmacists were reimbursed $350AUD and provided six (Australian Government Department of Health, 2018) Continuing Professional Development points for successfully completing the GCP course (Pharmacy Board of Australia, 2018). Pharmacists who successfully completed GCP training were required to attend a site initiation visit, at which the study protocol and implementation were described. Site pharmacists who were not GCP certified were not permitted to dispense PrEPX study drug, in accordance with Australian Clinical Trial Regulations (Australian Government Department of Health TGA, 2018).

A PrEPX study prescription form was designed by The PrEPX pharmacy team. The prescription form collects all data required in a clinical trial prescription and is consistent with standard practice at the Australian Clinical Trial pharmacies. The prescription form was printed on bright yellow paper to distinguish it from regular PBS prescriptions (Health AGD of. Pharmaceutical Benefits Scheme (PBS) | For PBS Prescribers [Internet], 2018; Australian Government Department of Health.). The PrEPX prescription form included participant name, date of birth, address, participant study number, study visit number or visit month, allergies, consent yes/no, Medicare number, concession number (if applicable), name of prescriber, prescribing date, treatment date, and signature of prescriber ( Supplementary Figure 1 ). All PrEPX prescriptions were required to be filled out by hand, by the PrEPX prescriber, using only black ink.