Pharmacy operations and clinical supply chain management in Kampala, Uganda: A commitment to capacity building
In 2017, the Makerere University Lung Institute (MLI) situated in the Mulago National Referral Hospital became a STREAM trial site for STREAM Stage 2. MLI is globally recognized as an essential TB treatment facility, but had limited experience with complex, multi-country phase III TB trials. This would bring complexities that had not been encountered at the site before and highlights the commitment from the MLI staff and the Sponsor to strengthen pharmacy operations and clinical supply chain management.
STREAM required a wide variety of supplies and Investigational Medicinal Products (IMPs) to be available at trial sites during the trial. Therefore, the first priority was to ensure that MLI had the proper pharmacy infrastructure and capacity to receive, store, dispense and maintain IMP accountability. This meant preventing stockouts or oversupply that could put a strain on IMP availability or cause IMP wastage due to expiry, or inappropriate storage respectively. With support of the STREAM Sponsor, Vital Strategies, MLI was able to modify one of its office spaces into a pharmacy and obtain necessary approvals for its function.
Temperature excursions can impact the stability, safety, and quality of IMPs, which could reduce their effectiveness; thus, IMPs must be stored in a temperature-controlled environment to preserve the pharmacological effects. When creating a sustainable pharmacy within MLI, a fully insulated and temperature-controlled storage unit was needed to achieve the required storage conditions for IMPs. Before the STREAM trial, storing IMPs for participants enrolled in clinical trials treated at the MDR-TB ward was not possible. Physicians and pharmacists had to walk from one end of the hospital to the other to drop off prescriptions and bring IMPs back for administration. Therefore, STREAM provided temperature-controlled storage units in the TB ward, to make IMPs available closer to the participants and the time between participant prescription and the administration of their IMPs was reduced, and as well as the waiting time for participants and providers.
Another area of capacity building was establishing a pharmacy team able to manage the complexity of the trial. STREAM trial participants received different combinations of up to 13 medicines during the 9-month minimum treatment period and MLI received 36 different batches of IMPs throughout the trial. The site hired a dedicated pharmacist to manage IMPs for STREAM which helped ensure adequate supplies and medications were available for trial participants.
To implement STREAM, the MLI pharmacy team had to address levels of complexity they had not experienced before and take on responsibilities specific to the trial which were new to them. The pharmacists’ activities involved managing import permits for incoming IMP shipments, stock management, repacking and dispensing prescribed IMPs for participants during their hospital stay and home treatment. The Sponsor pharmacists and the MLI team worked together to build systems that did not exist before as required. For example, to prevent any stockouts of IMPs which could interrupt treatment for participants, pharmacists at MLI created a robust database for trial drug management. Unfortunately, due to challenges with stable internet availability this system could not be used and a paper-based system had to be followed. The STREAM Sponsor pharmacists and MLI team also worked together to create a well-designed strategy to continuously monitor for risks that could cause such disruptions.
At the heart of the team’s success when faced with significant challenges was their resilience and agility. This was seen when building relationships with the National Drug Authority (NDA), which oversees the import of medicines, including IMPs, for clinical trials, to ensure succinct supply chains. The country of Uganda prides itself on its well established drug regulatory system overseen by the NDA and the pharmacy team quickly discovered that the importation of clinical supplies was lengthy and challenging resulting in long lead times for import permits and initial shipment licenses taking an average 69 days and 227 days, respectively. STREAM pharmacists fostered strong relationships with NDA representatives subsequently to better understand the process and regulatory agency requirements to mitigate potential bottlenecks and to ensure the site had the most up-to-date information regarding changes to the regulatory process. In doing so, turnaround times for permits and shipments decreased to 53 days in 2018 and further down to 36 in 2019.
The pharmacy team at MLI took on the STREAM clinical trial with expertise in pharmacy operations, but not necessarily experience with pharmacy needs for phase III TB trials. Through collaboration and an open commitment to strengthening capacity, the team built excellent and sustainable pharmacy operations and supply chain management systems. It is testament to this commitment that meant MLI avoided major stockouts and ensured all trial participants could continue their treatment without any interruptions.