What is the cost of poor quality medicine? Estimating the prevalence, health impact and economic cost of substandard and falsified medicines in Indonesia in the age of Universal Health Coverage

Efforts by low and middle income countries (LMICs) to achieve universal health coverage (UHC) are often constrained by inadequate resources. As demands on health systems expand, pressure to contain costs can threaten quality, including the quality of medicines on which all health systems rely. While the WHO believes substandard and falsified medicines (S&F meds) are on the rise, there are no agreed methods for measuring the problem, and thus no way of tracking progress in ensuring that medicines newly available to poorer patients through UHC efforts are safe and effective. Indonesia has vastly expanded its national health insurance since 2014; it now undertakes to provide free medicine to 222 million people, over 80% of citizens in the world's fourth most populous nation. Procurement policies that prioritise low cost over quality aim to reduce the deficit of £1.9 bln but have raised concerns, magnified by several recent scandals, that UHC is expanding access to S&F meds. Objectives We aim to support national efforts to ensure that Indonesians, especially the poorest who rely on insurance or informal markets, have consistent access to quality medicine. We will do this by working with the medicine regulator and intersectoral partners to better understand and quantify the prevalence and distribution of S&F meds nationally. In the process, we will: 1. Trial new methods for risk-based sentinel surveillance for S&F meds; 2. Develop robust, adaptable tools to estimate the prevalence, health impact and cost of S&F meds; 3. Pioneer the use of the tools, making the first national estimates of S&F meds in any LMIC; 4. Engage continuously with policy partners to facilitate appropriate intersectoral responses in Indonesia, and to adapt tools for other LMICs. 5) Promote institutionalisation of academic-policy partnerships to support the ongoing production and use of medicine policy research in Indonesia. Methods We have compiled 38 datasets from 12 Indonesian institutions, & are developing a model to flag the risk that a medicine is substandard or falsified. We'll use the model, together with the government's public health priorities, to choose groups of medicines for sentinel surveillance. We will collect samples (900 total) from the internet & 9 districts (Jakarta and 1 urban, 1 rural district in each of the 4 procurement regions). We'll visually inspect, screen with Minilab, and perform HPLC and dissolution testing on all samples, and test for impurities where degradation is suspected. Prevalence by therapeutic and risk group will be combined with granular market data on volume to make national prevalence estimates. We'll use a simple spreadsheet model with transparent, clearly recorded assumptions, allowing for improvement over time and easy adaptation to other settings. Prevalence estimates will be combined with data on outpatient service use and length of hospital stay to estimate the health impact of S&F meds, while claims, market price and household spending data will be added to calculate economic costs. Uses of data Indonesia's regulator supports efforts to improve surveillance and estimate the impact of S&F meds. We'll work with them on surveillance, and through an intersectoral consultative group to provide a platform for policy discussion and response to our findings. We'll also provide input to WHO members' group on risk based surveillance, prioritising the easy adaptability of our tools for other LMIC settings