Background

Affordable, good quality medicine is one of the bedrocks of a strong health system, 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 can start to cut corners, compromising quality. Hospitals can 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.

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.

We want to help countries understand and measure the problem, so that they can plan effective action and track change over time.

STARmeds (Sytematic Tracking of At Risk Medicines) is a three-year research project with the main objective of protecting the society from the dangers of substandard and falsified medicines by conducting several main research programs, including:

  1. Develop estimates of the prevalence of substandard and falsified medicines through a pilot study in 4 provinces in Indonesia;
  2. Develop models/methods for estimating health and economic impacts of substandard and falsified medicines in Indonesia;
  3. Cost effectiveness analysis random vs sentinel surveillance
  4. Sharing models/methods developed in Indonesia with other countries, as a global public commodity.

Study Importance

Protecting society from poor quality medicines is a formidable task for national medicine regulatory authorities, especially in a resource-limited setting such as in Indonesia. Although post-market surveillance is a routine activity for medicine regulators, each country has a different method in performing this task. To date, there are no globally recognized methods for estimating the prevalence of substandard and falsified medicines in a country, or for assessing their impact on health or the economy. This study will pilot a sentinel surveillance system for medicine quality, and to develop methods for estimating the prevalence, health, and economic impact of poor quality medicines. The estimation model that will be generated from this research will be useful to be applied in other countries.

Study Objectives

The overall aims of STARmeds Study are

  1. Trial risk-based sentinel surveillance for substandard and falsified medicines
  2. Develop methods for estimation of prevalence for substandard and falsified medicines
  3. Develop methods for estimation of impact for substandard and falsified medicines
  4. Estimate prevalence and impact of substandard and falsified medicines in Indonesia
  5. Integrate policy influence, and learning that used to improve medicine quality in Indonesia
  6. Expand sustainable capacity for medicine policy research in Indonesia

Sampling Location

STARmeds study is conducted at five Provinces in eight Districts/Cities, that consist of North Sumatera (Medan, and Labuhan Batu), DKI Jakarta (Jakarta Timur), West Java (Bekasi), East Java (Surabaya, and Malang), and East Nusa Tenggara (Kupang, and Timor Tengah Selatan).

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