PharmaChk: Poor quality medicines screening tool for resource-limited areas

Program/Project Purpose: Substandard medicines account for $75B of a $962B global pharmaceutical market and over 100K preventable deaths annually, leading to tremendous financial loss and emergence of drug resistance. Estimates indicate that 30e50% of all antimalarials are substandard. Additionally, while oxytocin has demonstrated high efficacy in saving maternal lives, it often fails quality tests in LMICs. Similar challenges are seen with many high impact pharmaceuticals. Production and sale of substandard drugs are indicators of a compromised health system that greatly undermine health programs. In absence of proper storage, drugs that initially pass quality testing often deteriorate before the point of sale. This project’s primary objective is to develop a scalable platform that comprehensively screens for substandard medicines, expand implementation from central to regional testing facilities, and create demand through awareness workshops over a four year period. Structure/Method/Design: Project goals: 1) Optimize PharmaChk platform based on pilot user feedback and testing results, 2) Scale-up testing ability to include fixed-dose combination artesunate therapies and oxytocin, 3) Scale-up PharmaChk pilot from one central location to three regional and six community health facilities in Ghana, and 4) Scale-up user demand and awareness by implementing education workshops targeting regulators, pharmacists, manufacturers, and other stakeholders. We work with local stakeholders in Ghana (Procurement and Supplies Department in Ghana’s Ministry of Health and leadership at the Ghanaian FDA and Central Medical Stores) through the US Pharmacopeia’s Promoting Quality of Medicines program. PQM is well-versed with challenges on the ground and provides valuable input on user and technology needs. Outcomes & Evaluation: PharmaChk was pilot tested at the Center for Pharmaceutical Advancement and Training in Accra, Ghana in March 2014. Samples of artesunate pills and injectables were locally sourced and tested using MiniLab , HPLC and PharmaChk. Quantification: Assay accuracy was tested and showed an average error of less than 6% compared to HPLC. Precision/Reliability: Field test revealed excellent device precision, with tests on both tablets and injectables showing< 5% variability. User-friendliness: User training and sample preparation was reduced. Throughput: Testing time was significantly decreased. MiniLab tests took two hours while PharmaChk tests took 15 minutes. Going Forward: Risk mitigation strategy: Inadequate chemical shelf-life might complicate commercial viability of device.User errors and fatigue -we will work closely with users to incorporate their feedback and experiences. Further reduce sample preparation and develop a testing protocol. Basic training protocols need to be designed. Lastly, strong program management, and contingency planning will ensure that we meet our milestones. Funding: US Pharmacopeia, Saving Lives at Birth Consortium, Coulter Foundation, National Collegiate Inventors and Innovators Alliance, Center for Integration of Medicine and Innovative Technology, the National Institutes of Health, USAID. Abstract #: 01ITIS012