The goal of this study was to assess the implementation of PharmaCheck for testing the quality of selected IMCI drugs in Indonesia. Two of the most frequently used IMCI antibiotics, Cotrimoxazole and Amoxicillin, were chosen for the study. The study was to be implemented in four phases. In the first phase, probes for testing these two antibiotics were to be developed at Boston University. The second phase involved a comparison between PharmaCheck and standard drug quality testing to test accuracy. If PharmaCheck showed reliable accuracy, the third phase would commence, in which PharmaCheck would be field-tested to investigate the correct amount of active ingredients present in Cotrimoxazole and Amoxicillin in 80 primary health care centers (PHCs) and 10 district hospitals in 10 districts in West Java. The 80 PHCs chosen had been trained in implementing IMCI, and the 10 hospitals were referral sites for the 80 PHCs. During the implementation, a cost study would be conducted to understand the cost of implementing PharmaCheck in Indonesia. In the fourth phase, analysis would be done to understand the potential application of PharmaCheck in Indonesia.

 

 

Initially, the project aimed to conduct an explorative pharmacokinetic (PK) study, examining different oral doses of rifampicin in TB meningitis patients. However, due to the slow development of Co-trimoxazole and Oxytocin test chips for PharmaCheck, the project objectives were adjusted. The new focus involved conducting a seminar on the use of rapid drug quality testing to improve drug quality at points of sale in Indonesia. This seminar, held in May/June 2018, was successfully executed with participation from various stakeholders.

 

Two meetings were conducted during the project. The first was a large conference at the School of Public Health, which was an open symposium featuring speakers on monitoring drug quality in Indonesia, the technical aspects of the Indonesian FDA, and a presentation on PharmaCheck. The second meeting was a technical discussion involving representatives from the University of Indonesia, the faculty of pharmacy, and the Indonesian FDA. These discussions emphasized the need for quick drug quality testing devices and the limitations of the current methods. 

During the symposium, it was highlighted that the Indonesia FDA requires indicators of drug quality not only during development but also at the point of sale. Current lab-based methods using HPLC are time-consuming and costly. Although PharmaCheck showed potential, it was not yet ready for widespread use. The MiniLab, while more portable, did not provide quantitative results and had limited probe availability.

 

Due to the limitations in PharmaCheck's testing capabilities and the uncommon nature of the drugs that could be tested in Indonesia, the project team planned to develop a policy recommendations paper. There are also plans for Indonesian researchers to visit Boston University for further discussions. The potential end users of the technology are labs at the provincial or district level, with current testing being done at 34 provincial labs funded by the central Indonesian FDA.

 

Due to the changes in project goals and the inability to utilize all the funds as initially planned, the project team returned the remaining funds to NAS.