Medicine Quality & AMR

pink and red pillsIt’s hard to believe that antibiotics have been around for less than a century. In that time, they have transformed medicine, making all sorts of more complex treatments like chemotherapy possible. But we’ve been careless with this precious resource, more or less ignoring the threat that bugs will get the better of medicines, even as we’ve seen antimicrobial resistance spread.

In the last couple of years, that has started to change. Global leaders, including UK Prime Minister David Cameron and U.S. President Barack Obama, have set up special commissions to consider possible responses to the threat posed by antimicrobial resistance (AMR). Most of the existing reports on AMR talk of its complex roots: doctors are too eager to prescribe antibiotics, and patients are too eager to take them (including when they are not prescribed). But they often take them sloppily, not finishing a whole course. Added to that, antibiotics are over-used in farming. We need to limit their use, but that in turn limits the interest of pharmaceutical companies in developing new antibiotics. Other antimicrobials are often most needed by poor patients in poor countries, so they’re not that attractive to industry either.

These issues are much discussed. But there’s something else promoting the development and spread of resistant pathogens, sometimes mentioned but rarely analysed in any depth: bad medicine. Ternyata Ltd was asked to look at this issue for the UK government’s Antimicrobial Review.

Our report on medicine quality and antimicrobial resistance found that sloppily made medicines churned out by low-cost producers for markets where oversight is low probably contribute far more to antimicrobial resistance world-wide than out-and-out fakes, although it is the latter that get more attention from the press and regulators. You can download the full report here (.docx – 2.54MB). It proposes a number of actions including better surveillance of medicine quality along the lines developed for tracking bad malaria drugs, and a radical expansion of the WHO’s medicine pre-qualification system. In addition, governments in the countries that make most low-cost drugs, notably India, must do more to ensure the quality of the drugs they export.

A partial summary by the AMR Review team is available here.(pdf)

Our report on medicine quality and antimicrobial resistance is also available from Google Drive here

This work also used in an article for Prospect Magazine: Why we are losing the war on bugs (January 21, 2016). Archived .pdf available here

Elizabeth Pisani discussed falsified and sub-standard medicine on BBC Radio 4’s “Start the Week” show on January 28th, 2019. here is an edited version of the show (12:18):

Listen to the full, un-edited episode here:

The political economy of substandard and falsified medicines an evidence informed risk assessment framework based on a multi country study (Researchgate):

This draft paper describes a study of the political and economic forces driving the markets for substandard and falsified medicines in four middle-income countries: China, Indonesia, Romania and Turkey (Dataverse):


Med quality video Dataverse, Full framework, English:

English language Indonesia video:

Indonesian language video: