Improving Assessments of Fake and Substandard Drugs in the Field

Introduction

Substandard and counterfeit drugs can be lethal to patients and accelerate drug resistance across at-risk populations. This is a major problem for diseases like malaria with few high-quality treatments available. Some African governments, notably Nigeria and Ghana, have responded to this challenge, often with help from donors, and have deployed an array of technologies to assist them.

In 2007, our research team tested anti-malarial drugs collected from six African cities and found that roughly a third of the medicines failed at least one quality control test. In 2010, further research was published on repeat testing of drugs collected from some of the original cities as well as additional cities in different countries.

This research provided some interesting data about quality differences by location and drug type. It also showed that over time drug quality has probably improved in at least some cities. But the details of the testing results might also point to a potential problem for authorities, which we discuss here alongside potential solutions.

The drugs were tested using the Global Pharma Health Fund e.V. Minilab®, which is a series of tests forming a useful protocol. It begins with a visual inspection of the product, followed by an easy and inexpensive dye test for active ingredient and a disintegration test for basic solubility. A more complicated, but still relatively inexpensive, thin-layer chromatography (TLC) assay for active pharmaceutical ingredient (API), is the next phase. After these tests, suspect products can then be sent to a proper laboratory for more detailed analysis, such as high performance liquid chromatography (HPLC). Following such a protocol, including compendial laboratory analysis, fake and substandard drugs can be identified allowing authorities to take appropriate action.

But in the real world, the entire protocol may not be followed, and even the more complex but more portable parts may not be followed either. Visual inspection is easy in principle but harder than one would expect even for those with patience. Thankfully, disintegration and dye tests are straight forward, but while TLC is not very complex, it does require electricity, a fair number of chemicals and laboratory equipment, and some training. A high school graduate could be trained in a week, and someone with laboratory experience from a university, such as myself, could competently use the Minilab® in a couple of days. But even those with training will attest that it takes quite a bit longer to truly appreciate this science, which is also something of an art form in interpretation.

So it is possible that in at least some settings, the only tests actually undertaken will be visual inspection and maybe the appropriate dye test. These tests are enough to find the most obvious fakes; but a considerable problem in emerging markets is substandard and degraded products, which, like the "better" fakes, might contain enough active ingredients to pass dye tests. So, one has to wonder how many fakes are missed by just performing the simplest tests?

Read the full paper as an Adobe Acrobat PDF.

Roger Bate is the Legatum Fellow in Global Prosperity at AEI.

Photo Credit: Copyright WHO/P. Virot

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