Title: 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
Funder: Department of Health and Social Care

Abstract: 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._x000D_ _x000D_ 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._x000D_ _x000D_ Objectives_x000D_ 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:_x000D_ _x000D_ 1. Trial new methods for risk-based sentinel surveillance for S&F meds;_x000D_ 2. Develop robust, adaptable tools to estimate the prevalence, health impact and cost of S&F meds;_x000D_ 3. Pioneer the use of the tools, making the first national estimates of S&F meds in any LMIC;_x000D_ 4. Engage continuously with policy partners to facilitate appropriate intersectoral responses in Indonesia, and to adapt tools for other LMICs._x000D_ 5) Promote institutionalisation of academic-policy partnerships to support the ongoing production and use of medicine policy research in Indonesia._x000D_ _x000D_ Methods_x000D_ 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._x000D_ 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._x000D_ _x000D_ Uses of data_x000D_ 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

Lay abstract: Affordable, good quality medicines are a bedrock of strong health systems, something governments aspire to deliver as they expand health care to more citizens, especially the poorest. But budgets don't always match political aspirations or patient demand, and health authorities have to squeeze down spending on medicines or services. If prices are pushed too low, drug manufacturers sometimes cut corners, compromising quality. Hospitals also protect profits by pushing patients towards medicines not covered by insurance. Poor patients then buy on the internet or in street markets, where they are easy targets for criminals who sell fake medicines. So while expanding health systems are delivering more medicines, poorer people may be getting "medicines" that don't actually work, and which can cause real harm._x000D_ _x000D_ The World Health Organisation says substandard and falsified medicines are a major problem in poorer countries with rapidly-growing markets, but no-one knows how bad the problem really is. Some prefer to turn a blind eye, worrying that quality enforcement could reverse progress towards wider access. And with no reliable numbers, it's easy for politicians to ignore the threat, at least for a while. Over time, though, bad quality medicines hurt patients, waste money, drive out responsible companies and undermine confidence in the whole health system. And if sub-par antibiotics don't deliver full doses to patients, they'll kill only the weaker bugs, allowing resistant infections to spread._x000D_ _x000D_ We want to help countries understand and measure the problem, so that they can plan effective action and track change over time. That's hard to do, because the market for medicines is huge and complex. We've been working in Indonesia to use information about price, sales outlet and company history to try and predict which medicines are most likely to be substandard or fake. We believe our model could be used to improve the efficiency of surveillance systems, helping governments to save money by sampling from the market and testing the medicines most likely to be poor quality. We also want to build simple tools to estimate the overall size of the problem in a country, and the toll it takes on health and on the economy._x000D_ _x000D_ We'll work with WHO to make these methods useful for many countries. First, we want to try the system in Indonesia, the world's fourth most populous country, where 106 million people live on less than £1.25 a day. In the last 5 years most of them have joined another 116 million citizens as members of the national health insurance scheme, which carries a deficit of £1.9 billion. Medicine prices have been slashed, and several recent scandals, as well as our research, suggest that poor quality medicines are common._x000D_ _x000D_ Working with the regulator, we plan to sample and test medicines from categories our model predicts are at risk (e.g. expensive medicines with recent shortages sold on the internet; or products sold for under 20% of a benchmark price). We'll work in 9 districts in 4 market regions, and use the results, together with assumptions based on market volumes, insurance claims and discussion with our policy partners, to estimate the prevalence, impact and cost of poor quality medicines in Indonesia. Those policy discussions can provide a springboard for action needed to ensure that quality is built in to medicine procurement, while the methods we develop will provide a blueprint for other countries facing similar challenges.

Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE;8.5 RESOURCES AND INFRASTRUCTURE (HEALTH SERVICES)
Health categories: GENERIC HEALTH RELEVANCE